Patent Docs

Biogen Idec, Inc. v. GlaxoSmithKline LLC (Fed. Cir. 2013)

By Donald Zuhn --

Yesterday, in Biogen Idec, Inc. v. GlaxoSmithKline LLC, the Federal Circuit affirmed the determination by the District Court for the Southern District of California that the claim term "anti-CD20 antibody" as used in U.S. Patent No. 7,682,612 was limited by prosecution history estoppel.  The '612 patent is directed to the treatment of hematologic malignancies associated with circulating tumor cells using anti-CD20 antibodies.  Representative claim 1 recites:

1.  A method of treating chronic lymphocytic leukemia in a human patient, comprising administering an anti-CD20 antibody to the patient in an amount effective to treat the chronic lymphocytic leukemia, wherein the method does not include treatment with a radiolabeled anti-CD20 antibody.

As the majority opinion notes, it was initially believed that only one large loop (epitope) of the CD20 antigen (at right) was exposed on the surface of cancerous B cells, and therefore, that there was only one suitable target for the anti-CD20 antibody.  However, after Biogen filed the application that issued as the '612 patent, other researchers discovered that the CD20 antigen had a second small loop to which certain anti-CD20 antibodies could bind.

During the prosecution of the application that issued as the '612 patent, the examiner rejected the claims because the specification did not provide enablement commensurate with the scope of the claimed invention, which the examiner contended included "any and all anti-CD20 antibodies, no matter the specificity or affinity for the specific epitope on the circulating tumor cells."  The examiner acknowledged that the specification was enabling for Biogen's chimeric gamma 1 anti-human CD20 antibody, Rituxan® (rituximab), but was silent concerning the specificity and affinity that would be necessary for other anti-CD20 antibodies.  In response to the rejection, Biogen stated that:

[E]ven though antibodies directed to the same antigen might have different affinities and functional characteristics, one of skill in the art could readily identify an antibody that binds to CD20 with similar affinity and specificity as does RITUXAN® using techniques that are well known in the art.  . . .  With that knowledge in hand, the skilled artisan could readily produce anti-CD20 antibodies using similar techniques, and screen such antibodies for those having an affinity and functional activity similar to RITUXAN®.

The examiner then withdrew the rejection and allowed the application.

In March 2010, Biogen filed suit against GlaxoSmithKline, asserting that GSK's anti-CD20 antibody Arzerra® (ofatumumab) infringed claims 1-4, 6, 8-10, 14-17, 20-22, and 58-60 of the '612 patent.  In contrast with Rituxan®, Arzerra® binds to the second small loop of the CD20 antigen, has a much greater affinity for the CD20 antigen, and is a fully human antibody.  The District Court conducted a Markman hearing to construe three terms, including the term "anti-CD20 antibody."  The District Court rejected Biogen's broad construction of "an antibody that binds to a cell surface CD20 antigen," and instead adopted GSK's construction "rituximab and antibodies that bind to the same epitope of the CD20 antigen with similar affinity and specificity as rituximab."  In adopting the latter construction, the District Court noted that prosecution history disclaimer applied because Biogen had limited the term to overcome the examiner's enablement rejection.  Following this construction, Biogen stipulated to noninfringement and appealed the District Court's construction to the Federal Circuit.

Writing for the majority, Judge Reyna notes that because neither the claims nor the specification compelled a construction that was contrary to the one offered by Biogen, the question before the Court was whether statements in the prosecution history were sufficient to overcome the heavy presumption that the term "anti-CD20 antibody" carries its full ordinary and customary meaning.  The majority concludes that Biogen's statements during prosecution were sufficient.  In particular, the majority observes that:

[R]ather than challenging the examiner's understanding of the crucial terms, the applicants argued that the specification was enabling for anti-CD20 antibodies with similar affinity and specificity as Rituxan®.  Indeed, the applicants conceded that other "antibodies directed to the same antigen [i.e., CD20] might have different affinities and functional characteristics," and limited their claims to antibodies similar to Rituxan® nonetheless.  . . .  [I]t is clear that they were limiting their invention to what the examiner believed they enabled: antibodies that have a similar specificity and affinity for the specific epitope to which Rituxan® binds.

The majority also found both of Biogen's arguments regarding why the plain and ordinary meaning of the term should control to be unpersuasive.  First, in response to Biogen's argument of claim differentiation (that claim 1 broadly covers any and all anti-CD20 antibodies and several dependent claims are directed to specific types of antibodies, i.e., chimeric, rituximab, humanized, and human), the majority counters that "[o]ur cases make clear . . . that where found, prosecution history disclaimer can overcome the presumption of claim differentiation."  In response to Biogen's second argument that the '612 patent incorporates U.S. Patent No. 5,736,137, and that the '137 patent's broader definition of "anti-CD20 antibody" should control, the majority states that "[t]he problem with this argument is that the '137 patent expressly and uniquely defines 'anti-CD20 antibody' for use therein, that is, within the '137 patent."

Writing in dissent, Judge Plager states that "[b]ecause I do not find anywhere in the majority opinion or in the prosecution history that clear and unmistakable evidence of a disclaimer as required by our precedents, I cannot agree with the majority that such a disclaimer was made by Biogen during the prosecution of its application for the '612 patent."  Noting that "[t]he only dispute is whether the applicants disclaimed the plain meaning of 'anti-CD20 antibody' during prosecution," Judge Plager states that "[t]he majority purports to tease out of the prosecution history such a disclaimer."  The dissent continues:

Nowhere in the prosecution history did the applicants state that antibodies that bind to the same epitope on CD20 with similar affinity and specificity as RITUXAN® must be used, or that antibodies lacking those characteristics must not be used.  To the contrary, the applicants repeatedly made clear -- including in the same discussion as the allegedly disclaiming statement -- that because the invention was based on the discovery that anti-CD20 antibodies could treat CLL, the claimed methods were not limited to the use of any particular type anti-CD20 antibody.

"Because the district court's construction eviscerates the 'clear and unmistakable' requirement for prosecution disclaimer," Judge Plager states that he "cannot join the majority in affirming that erroneous construction."

Biogen Idec, Inc. v. GlaxoSmithKline LLC (Fed. Cir. 2013)
Panel: Circuit Judges Dyk, Plager, and Reyna
Opinion by Circuit Judge Reyna; dissenting opinion by Circuit Judge Plager

Allergan, Inc. v. Barr Laboratories, Inc. (Fed. Cir. 2013)

By Michael Greenfield --

Those of you who dabble with chemical structures while prosecuting or litigating pharmaceutical patents may find Allergan v. Barr Laboratories, Inc., interesting.  In this ANDA litigation brought by Allergan against Barr, Teva, and Sandoz ("Barr"), the Federal Circuit opined on issues of claim construction and obviousness with respect to Allergan's Lumigan®, an ophthalmic solution used to treat high eye pressure in people with open-angle glaucoma or ocular hypertension.  The active ingredient in Lumigan® is bimatoprost (cyclopentane N-ethyl heptenamide-5-cis-2-(3α-hydroxy-5-phenyl-1-trans-pentenyl)-3, 5-dihydroxy, [1α,2β,3α,5α]):

(The ethyl amide moiety in the red square is where all the action was focused in the case.)  Allergan asserted claim 10 of U.S. Patent No. 5,688,819 ("the '819 patent"), which recited a method of treating ocular hypertension or glaucoma with a compound selected from a Marksuh group of five compounds listed by their chemical name.  Bimatoprost was one of them.

Claim Constructions

Barr had argued that bimatoprost did not fall within the scope of claim 5, from which claim 10 ultimately depended.  Claim 5 recited a method of treating ocular hypertension or glaucoma using a compound of formula

where Z can be =O and X can be –N(R₄)₂, "wherein R⁴ is selected from the group consisting of hydrogen, a lower alkyl radical having from one to six carbon atoms . . . ."  The issue was framed as whether claim 5 encompassed compounds in which the two R₄ moieties of "-N(R₄)₂" must be identical or could differ (as required by bimatoprost, where one R₄ moiety must be hydrogen and the other C₂-alkyl).  Both the District Court and the Federal Circuit held that claim 5 encompassed compounds in which the R₄ moieties were non-identical.

Barr argued that the plain meaning of "-N(R₄)₂" required identical R₄ moieties, relying on extrinsic evidence such as, for example, expert testimony that "[t]he (X)_y nomenclature" was "commonly used" to represent identical substituents.  The Federal Circuit was unpersuaded, relying heavily on Phillips v. AWH Corp. for the proposition that claim terms are to be given the meaning as one of ordinary skill in the art would understand them in the context of how they are used in the patent at issue and concluding, "[t]he inventor's lexicography governs when the specification reveals a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess."

In arriving at the conclusion that "-N(R₄)₂" encompassed compounds in which the R₄ moieties were non-identical, the Court pointed to the fact that of the five compounds recited in claim 10 (which, you'll remember, depended from claim 5), three (including bimatoprost) possessed an "-N(R₄)₂" moiety having non-identical R₄ moieties.  The Court also noted that same relationship between claim 18 (which recited the same three compounds) and claim 11 (which recited a method of treating other diseases using compounds defined in the same manner as claim 5.  (It's of some interest to note that the specification used the exact same language at issue in the claims.)  And, finally, the Court noted that the specification disclosed the same three compounds as useful in the pharmaceutical compositions and methods of the invention.  The Court held that in this context the patent clearly manifested that "-N(R₄)₂" encompassed compounds with non-identical R₄ moieties.

Practice tip:  Save yourself a lot of heartache and your client a lot of money, and in these situations define R₄ more clearly, such as, "each R₄ is independently selected from . . . ."

Obviousness

The Federal Circuit next considered the Barr's assertion that claim 10 (the method of treating glaucoma using one of bimatoprost or four other compounds) was obvious, first (a) dismissing the credibility of the defendants' expert, who was described as being "eviscerated" (ouch!) on cross examination and whose testimony was "flawed on a fundamental level" and (b) determining that the nature of the involved technology did not lend itself to lay interpretation, but required expert testimony.  This appears to have left Barr in the position of having to rely on the plaintiff's experts, an uncomfortable position, one imagines, at best.  As explained below, and not surprisingly, the defendants were unable to extract the support they needed to carry their burden of proving the claim obvious.

Barr asserted that bimatroprost was obvious over the isopropyl ester analog of compound 2 of Stjernschantz (WO 90/02253 [sic, WO 90/02553]),

which was disclosed as useful for treating the very same conditions as bimatoprost.  The defendants argued that the plaintiff's expert testimony supported three facts necessary to establish obviousness:

(1)    Stjernschantz taught that bimatoprost-free acid lowered intraocular pressure;
(2)    Stjernschantz's compound 2 hydrolyzed into bimatoprost-free acid when placed in the eye; and
(3)    a skilled artisan would have known that substituting an amide for the ester at the C-1 position would result in a prodrug that hydrolyzed into bimatoprost-free acid in the eye.

In not so many words, the Federal Circuit held, "close, but no cigar," finding that although Allergan's expert testimony supported the first two points, the testimony in fact contradicted the third point.  Allergan's expert testified that an amide (such as found in bimatoprost) converts into a carboxylic acid at such a low rate ("500-year half life" of an amide in water) that one of ordinary skill in the art would not have considered it as a prodrug.  With Barr left empty-handed expert-wise, Allergan's expert opinion prevailed, and the Federal Circuit upheld the District Court's finding that claim 10 was not invalid as obvious.

Allergan, Inc. v. Barr Laboratories, Inc. (Fed. Cir. 2013)
Panel: Chief Judge Rader and Circuit Judges Bryson and Wallach
Opinion by Circuit Judge Wallach

Solicitor General Counsels against Certiorari Grant on Claim Construction

By Kevin E. Noonan --

There are more issues in patent law that the Supreme Court may consider than those raised by Association for Molecular Pathology v. Myriad Genetics, and as if to illustrate that point, the Solicitor General filed his brief at the end of November in Retractable Techs., Inc. v. Becton, Dickinson & Co.  The Questions Presented by Petitioner Retractable Technologies are these:

1.  Whether a court, in construing a disputed term in a patent claim, may draw inferences from the patentee's use of the same term elsewhere in the patent's specification.

2.  Whether, in reviewing a district court's interpretation of a patent claim, the court of appeals should give deference to the district court's resolution of subsidiary factual questions.

In the Solicitor General's view, "neither of the questions set forth in the petition for a writ of certiorari warrants review in this case."

To recap the proceedings below, Retractable Technologies sued Becton Dickinson for infringing claims of U.S. Patent Nos. 5,632,733; 6,090,077; and 7,351,224.  These patent claims were directed to syringes configured to retract the needle into the body of the syringe after use, to reduce the likelihood of needle-stick injury.  The claim term at issue was "body," specifically whether the term should be construed to be limited to single-piece versus multiple piece embodiments.  The District Court construed "body" as "a hollow outer structure that houses the syringe's components," and concluded that the term "body" was not limited to a one-piece structure.

The Federal Circuit reversed, in a decision by Judge Lourie joined by Judge Plager and (in part) by Chief Judge Rader.  The panel reversed the District Court with regard to meaning of "body," finding that the term should be limited to a one-piece structure.  The panel found that the claim language was not determinative, and disclosure in the specification supported its one-piece body construction.  The specification described the claimed invention as comprising a one-piece body, all the figures illustrated syringes comprising a one-piece body, and the specification disparaged prior art syringes made of multiple piece bodies.  Moreover, there was no disclosure of a multiple piece syringe body in specification.  In reversing the District Court's construction, the majority said:

There is a fine line between construing the claims in light of the specification and improperly importing a limitation from the specification into the claims.  In reviewing the intrinsic record to construe the claims, we strive to capture the scope of the actual invention, rather than strictly limit the scope of claims to disclosed embodiments or allow the claim language to become divorced from what the specification conveys is the invention.

(citations omitted)

Judge Plager filed a concurring opinion expanding on this theme, saying that "the claims cannot go beyond the actual invention that entitles the inventor to a patent" and that "the [patentee's] obligation [was] to make full disclosure of what is actually invented, and to claim that and nothing more."  Chief Judge Rader, dissenting-in-part, argued the primacy of the claim language, and that it is impermissible to read limitations from the specification into the claims.

These disagreements regarding both the proper claim construction here and the proper method for performing claim construction generally also arose in the Federal Circuit's decision not to grant en banc review.  Two dissents were filed in the Court's decision not to hear the claim construction decision en banc:  one by Judge Moore, joined by Chief Judge Rader, and another by Judge O'Malley.  Judge Moore's dissent characterized claim construction as "the single most important event in the course of a patent litigation."  However, the Federal Circuit's rules for making claim construction determinations remain "ill-defined and inconsistently applied," even by the Court in her view.  While citing commentators to support this conclusion, this dissent focused on the question at issue in Retractable Technologies and, according to Judge Moore, arose generally from a deficiency in the Court's application of the law:  where to draw the "fine line" between "construing the claims in light of the specification and improperly importing a limitation from the specification into the claims."  Her dissent contended that this was the case to consider the issues of "the role of the specification in construing the claims and whether deference should be given to the district court in the claim construction process."

Judge Moore relied principally on Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc), and the "bedrock principle" that "the claims of a patent define the invention to which the patentee is entitled the right to exclude."  She discounted the concerns voiced by the Retractable Technologies majority, including that "the metes and bounds of what the inventor claims extend beyond what he has invented or disclosed in the specification."  In that case, the question would be one of validity rather than claim construction, she stated, and it is not the role of the court to "tailor the claim language to the invention disclosed."  Citing Phillips, the dissent relies on the mantra that the "plain meaning" of the clams controls (and the dissent voiced surprise that this question was not resolved in Phillips).  Judge Moore stated her (stringent) standard for the relationship between the claims and the specification:  "the specification cannot be used to narrow a claim term -- to deviate from the plain and ordinary meaning -- unless the inventor acted as his own lexicographer or intentionally disclaimed or disavowed claim scope," citing Phillips and Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1327 (Fed. Cir. 2002).  Any deviation from this procedure should be applied narrowly, in her opinion, and specifically, her dissent opined that the choice of an overbroad term may affect validity but should not be considered for claim construction.  Following a detailed recitation of the facts and legal principles enunciated in Phillips, the dissent contrasted the majority decision in Phillips with the panel decision here:  in the absence of "disclaimer or special lexicography," the plain meaning standard must be applied.  And the evidence, according to this dissent, failed to support a claim limited to single-body embodiments.

Judge Moore identified the problem with the panel decision with particularity:

The error in Retractable is the majority's attempt to rewrite the claims to better conform to what it discerns is the "invention" of the patent instead of construing the language of the claim.  Indeed, the majority candidly explained that its construction, limiting "body" to a one-piece body, "is required to tether the claims to what the specifications indicate the inventor actually invented."

While agreeing that the specification and claims must comply with the requirements of 35 U.S.C. § 112, her dissent stated simply that the Court "does not rewrite claims"; this is not a case, Judge Moore contended, where "the majority is choosing between two equally plausible plain meanings and adopting the one that comports with the disclosure in the specification."  Rather, this case was illustrative that there is "a fundamental split within the court as to the meaning of Phillips and Markman as well as the proper approach to claim interpretation."  That was enough to convince Judge Moore and Chief Judge Rader that claim construction required reconsideration by the court en banc.  Judge Moore also wrote that this case had a procedural posture that would permit the court to set forth the extent to which the "mongrel practice" of claim construction would permit or require deference to a district court's factual determinations under Markman v.Westview Instruments, Inc., 517 U.S. 370, 378 (1996).

Judge O'Malley dissented separately, a posture reflecting her singular experience as a district court judge tasked with performing factual determinations in support of claim construction decisions.  She was forthright:  "[i]t is time to revisit and reverse our decision in Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998) (en banc)," if only because "the court's decision necessarily would change if even minimal deference were afforded to the trial judge's claim construction."  Her dissent noted that the Court's decision to give no deference to district court factual determinations was not required by the Supreme Court in Markman, and indeed the High Court "did not affirm this court's earlier conclusion that resort to a jury was unnecessary because claim construction is a pure question of law."  She believes the appellate court's decision to be "ill considered" when it was enunciated thirteen years ago and that it has not proven "beneficial" to patent jurisprudence "in the long run."

Reflecting her own experience, Judge O'Malley opined that:

[D]istrict judges have been trained to -- and do -- engage in detailed and thoughtful analysis of the claim construction issues presented to them.  They conduct live hearings with argument and testimony, sometimes covering several days, and certainly always extending beyond the mere minutes that courts of appeals have to devote to live exchanges with counsel.  Simply, "the trial court has tools to acquire and evaluate evidence that this court lacks."  Cybor, 138 F.3d at 1477 (Rader, J., dissenting).

She went on to say that "[w]hile no one would urge deference to cryptic, unthinking rulings born of little or no real inquiry, where, as here, the trial court has thoroughly vetted all relevant aspects of the claim constructions at issue, 'careful consideration of the institutional advantages of the district court would counsel deference.'"  Reciting the history of the case, she noted that these claims had been construed by two separate district court judges and that the asserted "wrongdoing" reversed by the panel decision "did not promote the consistency and uniformity in patent law that Cybor was intended to foster; the decision here accomplished the opposite."

In Judge O'Malley's view, the panel did not misapply the claim construction canons in Phillips; rather, she merely disagreed with their application.  But this fact, and the experience of the panel members that they "could not agree on the proper claim construction in this case, despite careful consideration of their respective obligations under Phillips," strongly suggested to Judge O'Malley that the "complicated and fact-intensive nature of claim construction" mandates "the need to rethink our approach to it."  For her, the "review of extensive documentary evidence" and possibly expert testimony suggest factual, not legal questions are being posed to the Court.  And:

Where, as here, there is fair debate about the scope of the invention after application of Phillips's principles, we should defer to reasoned district court choices.  Reasonable minds can -- and do -- differ over the correct interpretation of the term "body" as used in the patent in suit.  These are not the circumstances under which we should be reversing carefully reasoned claim constructions and putting aside years of litigation in the process.

Against this backdrop, the Solicitor General's brief concluded that, first, "Petitioners identify no unsettled question of claim construction methodology warranting this court's review," and second, "[t}his case is not an appropriate vehicle for determining what standard of appellate review should apply to a district court's subsidiary factual findings in claim construction."  The brief based its first argument, that there is no unsettled question, on the majority's reliance on Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc), cert. denied, 546 U.U. 1170 (2006).  There is no dispute between the Federal Circuit judges and thus nothing for the Court of review, according to the brief, because there is "broad agreement" in the Federal Circuit that both plain meaning and specification should be considered.  The brief characterizes a patent as an "integrated legal document," and thus, although the claims are what defines the scope of the right to exclude, claims must be interpreted according to the specification, citing United States v. Adams, 383 U.S. 39 (1966); Schriber-Schroth Co. c. Cleveland Trust Co., 311 U.S. 211 (1940); Brooks v. Fiske, 56 U.S. 212 (1854).  "At bottom, then, the task of claim construction is to ascertain the meaning of the actual claim language approved by the U.S. Patent and Trademark Office, as "explained by and read in connection with the specification" in the Solicitor's view, citing Carnegie Steel Co. v. Cambria Iron Co., 185 U.S. 403, 432 (1902).  Again citing Phillips, the Solicitor General asserts that "[t]he Federal Circuit has faithfully implemented those principles in considering questions of claim construction."  Curiously, the brief accentuates the near unanimity achieved by the Federal Circuit in Phillips, ignoring the different views enunciated by the Federal Circuit in this case (and ignoring the changed composition of the lower court in the intervening time since Phillips).  Instead of different doctrinal camps, the Solicitor General sees the differing results as merely reflecting the "case-by-case" nature of claim construction.  Turning to the case at bar, although acknowledging that the question is "close," the brief maintains that the Federal Circuit came to the right decision in this case.

Even if the Court believes that Federal Circuit jurisprudence in this area is in need of reconciliation by the Court, the Solicitor General asserts that "[t}his case is not an appropriate vehicle for determining what standard of appellate review should apply to a district court's subsidiary factual findings in claim construction."  The reason is simple:  there is no factual determination by the district court at issue here.  Indeed, "[i]n an appropriate case, this court's intervention might be warranted to determine the proper standard of appellate review of district court factual determinations that bear on the interpretation of disputed patent claims" according to the Solicitor General's brief.  But this is not that case.  Here, the District Court relied "solely" on the parties' legal arguments, thus not raising the issue the petitioners ask the Court to resolve.  Moreover, the Federal Circuit's decision in Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998), that factual determinations by a district court were due no deference on review, is "amply support[ed]" by the Court's Markman decision in the Solicitor's view.  The brief engages in the fiction that Cybor does not preclude deference to a district court's factual findings, but maintains its position that, regardless of the Federal Circuit's treatment in other cases there is no basis warranting review on this question in this case.

The Solicitor General maintains that "the question whether deferential review is appropriate in those circumstances is of substantial and ongoing importance in patent law" but "[t]hat issue is not properly presented in this case, however, because the district court did not make any factual findings or resolve any evidentiary disputes in interpreting the patent claims at issue here."

Taking into account the five "active" judges who voted to grant rehearing in Amgen Inc. v. Hoechst Marion Rousell, Inc., 469 F.3d 1039 (Fed. Cir. 2006), and contrary to the Solicitor General's views on the matter, the evidence suggests that the active members of the Federal Circuit are almost evenly split on the question of whether to grand en banc review, and by implication revisit the Court's decision in Cybor.  And an honest assessment of the Federal Circuit's jurisprudence supports the Petitioner's view that the Federal Circuit is split, at least loosely, into those judges who believe that claims must be strictly construed according to the specification in order to limit their scope to "what the inventor has invented," and those judges who believe that the plain meaning of the claim language is the primary determinant of the scope and meaning of the claims.  The Solicitor General discounts this evidence in encouraging the Supreme Court not to grant cert.  In view of the cases where the Supreme Court has already granted certiorari this term, and the continuing pattern of the Court to ignore the recommendations of the Solicitor General's Office, and the apparently unsettled posture of the question of claim construction in the Federal Circuit, there is a fair likelihood that the Supreme Court will decide that its supervision is required in yet another area of patent law.

Marine Polymer Technologies, Inc. v. Hemcon, Inc. (Fed. Cir. 2012) (en banc)

By Kevin E. Noonan --

In a decision ripe for Supreme Court review (appropriately, this time), a fractured Federal Circuit delivered a plurality opinion in Marine Polymer Technologies, Inc. v. Hemcon, Inc. (Fed. Cir. 2012) (en banc).  The case revealed a deep division between judges taking a strict constructionist view of the patent statute (in this case, 35 U.S.C. § 152 regarding intervening rights), and another cohort of judges who are apparently willing to adopt a more outcome-determinative view of the matter.

The case involved claims of U.S. Patent No. 6,864,245 directed to poly-N-acetyl glucosamine polymer used for treating trauma and other uses, purified from arthropods, fungi, and microalgae.  The claims recited "biocompatible" preparations, based on four tests set forth in specification.  A substance passes the test if the reaction is only mild or slight reactivity (<++), but some language in the specification indicated that truly biocompatible embodiments falling within the scope of the claim must be (< +), i.e., having "no detectable biological reactivity."  The claims, on the other hand, recited biocompatible "generically," with no distinction based on degree (although some dependent claims recite values of 0).

During a Markman heating at the District Court, Marine Polymer argued that "biocompatible" p-GlcNAc should be construed to mean "biomedically pure [p-GlcNAc] that reproducibly exhibits acceptably low levels of adverse bioreactivity, as determined by biocompatibility tests."  HemCon countered that "biocompatible" should be read as limiting the claims to p-GlcNAc that had been "harvested from plant microalgae," or in the alternative, should be interpreted broadly to mean "suited for biomedical applications."  The District Court concluded that "biocompatible" p-GlcNAc, as claimed in the '245 patent, means p-GlcNAc "with low variability, high purity, and no detectable biological reactivity as determined by biocompatibility tests."  The District Court granted summary judgment of infringement, and a jury entered a verdict of no invalidity and damages of ~$29M.  In addition, the District Court granted Marine Polymer a permanent injunction.

While the District Court was pending, HemCon filed an ex parte request for re-examination, basing the "substantial new question of patentability" on District Court's claim construction.  The examiner adopted a claim construction that differed from the District Court, concluding that "biocompatible" means "low variability, high purity, and little or no detectable reactivity" because (according to the examiner) independent claim 1 could not be construed to mean "no detectable bioreactivity" because there were dependent claims that recited low level of bioreactivity.  Because this interpretation was broader than the District Court's claim construction, the examiner rejected all 22 claims on obviousness grounds.  In response, the patentee canceled the dependent claims that recited little or no detectable reactivity, and argued that the District Court's construction should prevail.  The examiner agreed and withdrew the rejections and issued the reexamination certificate.

A merits panel reversed the District Court on grounds that HemCon was entitled to intervening rights under Section 252.  (Intervening rights apply to reexaminations under Sections 307(b) and 316(b).)  In the Federal Circuit's en banc decision, written by Judge Lourie (joined by Chief Judge Rader and Judges Newman, Bryson and Prost in full, and Linn in part), with a dissent written by Judge Dyk (joined by Gajarsa, Reyna, and Wallach in full and Linn in part) (Judges O'Malley and Moore took no part in the decision), the Court "affirmed" (because the Federal Circuit was equally divided and hence there was no basis to reverse).  The issue dividing the Court was whether a claim must be amended during reexamination (as opposed to merely changed in scope) for intervening rights to arise.

The "majority" opinion upheld the District Court's claim construction as being supported by intrinsic evidence (ignoring inconsistent portions of the specification), and determined that the claims did not define the term "biocompatible."  Accordingly, the District Court was correct in interrogating the specification to ascertain the proper meaning of the term in the claim.

The opinion characterized the issue as "a conflict between teachings in the specification and the doctrine of claim differentiation," because the presence of dependent claims reciting the "little or no bioreactivity" limitation implied that the independent claim encompassed embodiments having a greater degree of bioreactivity).  But the Court opined that the doctrine of claim differentiation was not controlling (not a "hard and fast rule") while claim construction based on the written description is, citing Seachange Int'l, Inc. v. C-Cor, Inc., 413 F.3d 1361, 1369 (Fed. Cir. 2005).

The issue of whether intervening rights arose as a consequence of the reexamination is where the Court split 5 to 5.  HemCon's position was that cancellation of the dependent claims effectively changed the scope of the independent claim, and that this was enough to confer intervening rights.  The majority rejected this contention, saying that the statute requires that the claims be "amended or new" to raise intervening rights, and here the independent claim was not amended.  The opinion considered two types of intervening rights:  absolute intervening rights and equitable intervening rights.  Intervening rights do not accrue, according to the opinion, where the accused product or activity infringes a claim that existed in the original patent and remains "without substantive change" after reissue, citing Seattle Box Co. v. Indus. Crating & Packing, Inc., 731 F.2d 818, 827–28 (Fed. Cir. 1984).  The opinion holds that the threshold inquiry is whether the claims were "amended or new"; only thereafter does the question become was there a substantive change.  Accordingly, "HemCon ignores this threshold statutory requirement [that a claim be amended] and asks that we proceed directly to the subsidiary 'substantive change' analysis, which derives from § 252."  While the plurality opinion recognizes that the amendments made during the reexamination changed claim scope, this is not the same as amending the claims, and HemCon's position that the equivalence of the effect should lead to an equivalent outcome (i.e., to raise intervening rights) "goes too far."  Thus:

Section 307(a) identifies three categories of claims in a reexamined patent:  (1) claims that existed in the original patent but have been cancelled as unpatentable, (2) claims that existed in the original patent and have been confirmed as patentable, and (3) amended or new claims that did not exist in the original patent but have been found to be patentable and will be incorporated into the patent by the PTO.

Intervening rights apply only to category #3 says the Court, if only because "[a]ny interpretation of 'amended' that includes disavowal or disclaimer by argument alone, as advocated by HemCon, would conflict with the rest of § 307, for it is difficult to envision how arguments about claim meaning could be 'incorporated into a patent' by the Director of the PTO."

The plurality addresses the concern raised by the dissent that their decision creates a "loophole" fraught with the potential for gamesmanship by patentees; the plurality does not believe the potential for a "loophole" is likely, because invalid claims will need amendment to be allowed.  "Thus, the fear of gamesmanship does not persuade us to rule contrary to the plain meaning of the statute."

In sum, the plain directive of the governing statute before us does not permit HemCon to invoke intervening rights against claims that the PTO confirmed on reexamination to be patentable as originally issued.  To be sure, patent applicants' actions and arguments during prosecution, including prosecution in a reexamination proceeding, can affect the proper interpretation and effective scope of their claims.  But in rejecting HemCon's request for intervening rights, we are not here interpreting claims.  Rather, we are interpreting a statute that provides for intervening rights following reexamination only as to "amended or new" claims.  The asserted claims of the '245 patent are neither.

The dissent contends that the Court failed to address the issue except by dicta, and that the possible existence (or creation) of strategic advantages would only increase under the expanded post-grant review provisions of the Leahy-Smith America Invents Act (LS-AIA).  For the dissenting judges, "[t]he starting point for an intervening rights determination is the meaning of the original claim language" as opposed to the plain meaning of the statute.  These judges disagreed with District Court's claim construction, being more convinced by the claim differentiation argument that the meaning of the term "biocompatible" was broader than it was interpreted by the District Court's claim construction.  It was also an important issue for these judges that whether the "product of nature" polymer was patent-eligible depends on the meaning of the term "biocompatible."

This case illustrates the continuing difficulties with the Federal Circuit's claim construction jurisprudence; the dissent says "[o]ne might at the outset be somewhat skeptical of this construction because it was not proposed by either party and was indeed contrary to the patentee's own proposed construction."  This sentiment is in direct opposition to other pronouncements of the Federal Circuit, to the effect that a district court should not adopt either party's claim construction position but should instead come to an independent determination.  (See, for example, Exxon Chemical Patents v. Lubrizol).  Here, however, the dissenting judges think the District Court construction is contrary to the specification and prosecution history (and which is entitled to no deference), and also put more emphasis on the claim differentiation doctrine (saying it is ignored only if "compelled" by the intrinsic evidence).  Thus:

Judge Lourie's new approach to claim construction would enable patentees to eliminate questions of validity by narrowing claims in accordance with a preferred embodiment or single example, while also allowing alleged infringers to narrow claims beyond their valid scope to avoid infringement.  That approach cannot be correct.

The dissent also disagrees with the plurality's claim construction, relying on those portions of the specification that appear to indicate that "biocompatible" may be entitled to a broader interpretation that was given it by the District Court:

In other words, under the district court's incorrect claim construction, now binding on the parties as a result of the affirmance of the district court's judgment, the original and reexamined claims are identical in scope, and there is thus no issue of intervening rights and no need for the majority to offer "an alternative ground for decision."

The dissenting opinion equates "new or amended" = "substantially identical" ("clearly intended to have the same meaning"), relying on Laitram Corp. v. NEC Corp., 163 F.3d 1342, 1346 (Fed. Cir. 1998) ("Reexamined claims are "identical" to their original counterparts if they are 'without substantive change'") (this portion of the dissent is rebutted by the plurality on the grounds that the claims in Laitram were amended).  Because "[t]he effect [of canceling claims] was to narrow the claims and protect them from a finding of invalidity," the dissenting judges believe that "[h]ere, although identical in language, the claims of the patent after reexamination were not identical in scope for purposes of intervening rights because they were "substantively changed" during reexamination."  In perhaps their strongest argument, the dissenting judges note that the Supreme Court recognized that the scope of patents could be changed by an amendment to the specification where there is no formal amendment to the claim, citing Russell v. Dodge, 93 U.S. 460, 463 (1876) (noting that a specification might "be substantially changed, either by the addition of new matter or the omission of important particulars, so as to enlarge the scope of the invention as originally claimed").

Once again, this case illustrates one of the consequences of the difficulties inherent in applying the Federal Circuit's rubrics regarding whether the claims are being construed in light of the specification or the majority is importing limitations from the specification into the claims.  The decision is also reminiscent of the differences on opinion that arose in Retractable Techs., Inc. v. Becton, Dickinson & Co.,  There, Judge Lourie wrote for the majority (reversing the District Court's construction) that:

There is a fine line between construing the claims in light of the specification and improperly importing a limitation from the specification into the claims.  See Phillips, 415 F.3d at 1323.  In reviewing the intrinsic record to construe the claims, we strive to capture the scope of the actual invention, rather than strictly limit the scope of claims to disclosed embodiments or allow the claim language to become divorced from what the specification conveys is the invention.  Id. at 1323–24.

This sentiment was espoused even more strongly by Judge Plager, whoe wrote in a concurring opinion that:  "the claims cannot go beyond the actual invention that entitles the inventor to a patent" and that "the [patentee's] obligation [was] to make full disclosure of what is actually invented, and to claim that and nothing more."

On the contrary, Chief Judge Rader, dissenting-in-part, argued the primacy of the claim language, and that it is impermissible to read limitations from the specification into the claims.  He also joined in Judge Moore's dissenting opinion, which focused on a deficiency in the Court's application of the law:  where to draw the "fine line" between "construing the claims in light of the specification and improperly importing a limitation from the specification into the claims."  Relying principally on Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc), and the "bedrock principle" that "the claims of a patent define the invention to which the patentee is entitled the right to exclude,"  Judge Moore discounted the concerns voiced by the majority in Retractable Technologies, including that "the metes and bounds of what the inventor claims extend beyond what he has invented or disclosed in the specification."  In that case, the question is one of validity rather than claim construction, she wrote, and it is not the role of the court to "tailor the claim language to the invention disclosed."  Citing Phillips, Judge Moore's dissent relied once again on the mantra that the "plain meaning" of the clams controls (and the dissent voices surprise that this question was not resolved in Phillips).  Judge Moore states her (stringent) standard for the relationship between the claims and the specification:  "the specification cannot be used to narrow a claim term -- to deviate from the plain and ordinary meaning -- unless the inventor acted as his own lexicographer or intentionally disclaimed or disavowed claim scope," citing Phillips and Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1327 (Fed. Cir. 2002).  Judge Moore identified the problem with the panel decision with particularlty:

The error in Retractable is the majority's attempt to rewrite the claims to better conform to what it discerns is the "invention" of the patent instead of construing the language of the claim.  Indeed, the majority candidly explained that its construction, limiting "body" to a one-piece body, "is required to tether the claims to what the specifications indicate the inventor actually invented."

HemCon's position is supported by amici curiae Hewlett-Packard Co., Broadcom Corp., Cisco Systems, Inc., Dell, Inc., eBay, Inc., Facebook, Inc., Google Inc., and SAP America, Inc.; and GEICO Corp., FedEx Corp., and Macy's, Inc.

Marine Polymer's position is supported by amici curiae Jan K. Voda; Intellectual Ventures Management LLC; the Biotechnology Industry Association and Phar- maceutical Research and Manufacturers of America; Soverain Software LLC and Tessera, Inc.; and Sealy Corp.

Marine Polymer Technologies, Inc. v. Hemcon, Inc. (Fed. Cir. 2012) (en banc)
Panel: Chief Judge Rader and Circuit Judges Newman, Lourie, Bryson, Gajarsa, Linn, Dyk, Prost, Reyna, and Wallach
Opinion for the court by Circuit Judge Lourie, joined by Chief Judge Rader and Circuit Judges Newman, Bryson, and Prost in full, and by Circuit Judge Linn as to part II; dissenting opinion by Circuit Judge Dyk, joined by Circuit Judges Gajarsa, Reynam and Wallach in full, and by Circuit Judge Linn as to parts I-II.

News from Abroad: Construction of "Swiss" Medical Use Claims in Europe

By Christopher Bond --

In Ranbaxy (UK) Ltd v AstraZeneca AB, the England and Wales High Court considered the scope of "Swiss" medical use claims.  This important decision clarifies how these types of claims can be infringed.

Background: "Swiss" Claims

The European Patent Convention (EPC) expressly excludes methods of treatment from being patentable.  The reason for this is that healthcare professionals should not be prevented by patents from treating patients.  This exclusion is a major difference between the European and U.S. patent systems.

New and inventive pharmaceuticals are patentable, provided they are novel and inventive in their own right.  Under the original EPC, the first medical use of a known compound is also patentable, using a claim worded "Compound X for use in therapy."  However the original EPC only included the first medical use under this provision.

An early decision (G5/83) of the Enlarged Board of Appeal of the European Patent Office (EPO) considered the claim form that might protect a further inventive therapeutic use of a compound.  It decided that the wording "Compound X for the manufacture of a medicament for [the therapy]" would be valid.  This is known as a "Swiss" claim, and under the original EPC was used to patent a second medical use of a known pharmaceutical.

The Claims

AstraZeneca owned a patent (EP1020461) which contained a "Swiss" claim to the use of high purity magnesium esomeprazole for the inhibition of gastric acid secretion.

Proposed Importation

AstraZeneca was the only supplier of esomeprazole in the UK.  Ranbaxy sought a declaration that their generic product for the inhibition of gastric acid secretion would not infringe the patent.

Ranbaxy's product was to be manufactured in India and imported into the UK.  Neither side disputed that one of the starting materials for the product was magnesium omeprazole with the claimed purity, or that Ranbaxy's final product (which it wanted to import into the UK) did not have the claimed purity.

Construction of "Swiss" claims

The court considered whether, either:

• Ranbaxy infringed, because their product was the direct product of a process which used high purity magnesium esomeprazole to make a medicament; or,
• Ranbaxy did not infringe, because their product did not contain magnesium esomeprazole of the claimed purity.

The UK courts construe a patent claim by asking what meaning a skilled person would have given to the terms in the claim, in the context of the patent.

The High Court judge decided that the teaching of the whole specification was to the production of optically pure esomeprazole and its use in inhibiting gastric acid secretion.  As a result, the judge interpreted the "Swiss" claim as directed to the use of the pure magnesium esomeprazole in the manufacture of a medicament, which medicament contains the active ingredient at that level of purity.

The High Court declared that Ranbaxy would not infringe the "Swiss" claim, because the product it intended to import did not have the claimed purity.

This case provides interesting guidance on the scope of "Swiss" medical use claims in the UK.  The courts will construe these claims as covering a medicament, containing the claimed active ingredient, packaged for use in the claimed therapy.

The EPC 2000 came into force in 2007.  This updated European Patent Convention allows the previous "first medical use" claim form to protect any subsequent medical uses of a known pharmaceutical. We recently reported an EPO decision (G2/08), which stated that "Swiss" claims are redundant under EPC 2000.  We wait to see if the UK court interprets "Swiss" claims and the new "medical use" claims as having the same scope.

This article was reprinted with permission from the Forresters "Life sciences update" for Winter 2011.

Federal Circuit Continues to Avoid En Banc Review of Claim Construction

By Kevin E. Noonan --

Sometimes it is what a court doesn't do that points to what needs to be done.  That appears to be the case for claim construction and the Federal Circuit's standard, since Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998), that the appellate court should review claim construction de novo with no deference to the factual determinations underlying claim construction by a district court.  Even Cybor (decided en banc in the days just after the Supreme Court's decision in Markman v.Westview Instruments, Inc.), holding that claim construction was a question for a judge rather than a Seventh Amendment right to trial by jury, had its detractors (including Chief Judge Rader) and its skeptics (including Judge Plager, who suggested that the consequences of the court's "no deference" standard would need time to be appreciated).  Now, in a decision by the court not to review this policy en banc in Retractable Techs., Inc. v. Becton, Dickinson & Co., the dissents by three judges illustrate most clearly the deficiencies of the policy decision by the court not to permit any deference in its claim construction jurisprudence.

The panel decision, by Judge Lourie joined by Judge Plager and (in part) by Chief Judge Rader, reversed the District Court's claim construction as to one claim term and affirmed as to another, remanding for consideration of infringement under the Doctrine of Equivalents.  The claims were directed to syringes configured to retract the needle into the body of the syringe after use, to reduce the likelihood of needle-stick injury.  The claim term at issue was "body," specifically whether the term should be construed to be limited to single-piece versus multiple piece embodiments.  The District Court construed "body" as "a hollow outer structure that houses the syringe's components," and concluded that the term "body" was not limited to a one-piece structure.

The panel reversed the District Court with regard to meaning of "body," finding that the term should be limited to a one-piece structure.  The panel found that the claim language was not determinative, and disclosure in the specification supported its one-piece construction.  The specification described the claimed invention as comprising a one-piece body, all the figures illustrated syringes comprising a one-piece body, and the specification disparaged prior art syringes made of multiple piece bodies.  Moreover, there was no disclosure of a multiple piece syringe body in specification.  In reversing the District Court's construction, the majority said:

There is a fine line between construing the claims in light of the specification and improperly importing a limitation from the specification into the claims.  See Phillips, 415 F.3d at 1323.  In reviewing the intrinsic record to construe the claims, we strive to capture the scope of the actual invention, rather than strictly limit the scope of claims to disclosed embodiments or allow the claim language to become divorced from what the specification conveys is the invention.  Id. at 1323–24.

Judge Plager filed a concurring opinion expanding on this theme, saying that "the claims cannot go beyond the actual invention that entitles the inventor to a patent" and that "the [patentee's] obligation [was] to make full disclosure of what is actually invented, and to claim that and nothing more."  Chief Judge Rader, dissenting-in-part, argued the primacy of the claim language, and that it is impermissible to read limitations from the specification into the claims.

There were two dissents filed in the court's decision not to hear the claim construction decision en banc:  one by Judge Moore, joined by Chief Judge Rader, and another by Judge O'Malley.  Judge Moore's dissent characterizes claim construction as "the single most important event in the course of a patent litigation."  However, the Federal Circuit's rules for making claim construction determinations are "still ill-defined and inconsistently applied," even by the Court.  While citing commentators to support this conclusion, the dissent focuses on the question at issue in Retractable Technologies and, according to Judge Moore, comprising generally a deficiency in the Court's application of the law:  where to draw the "fine line" between "construing the claims in light of the specification and improperly importing a limitation from the specification into the claims."  The dissent contends that this is the case to consider the issues of "the role of the specification in construing the claims and whether deference should be given to the district court in the claim construction process."

Judge Moore relies principally on Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc), and the "bedrock principle" that "the claims of a patent define the invention to which the patentee is entitled the right to exclude."  She discounts the concerns voiced by the majority in Retractable Technologies, including that "the metes and bounds of what the inventor claims extend beyond what he has invented or disclosed in the specification."  In that case, the question is one of validity rather than claim construction, and it is not the role of the court to "tailor the claim language to the invention disclosed."  Citing Phillips, the dissent relies once again on the mantra that the "plain meaning" of the clams controls (and the dissent voices surprise that this question was not resolved in Phillips).  Judge Moore states her (stringent) standard for the relationship between the claims and the specification:  "the specification cannot be used to narrow a claim term -- to deviate from the plain and ordinary meaning -- unless the inventor acted as his own lexicographer or intentionally disclaimed or disavowed claim scope," citing Phillips and Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1327 (Fed. Cir. 2002).  Any deviation from this procedure should be applied narrowly, and specifically, the dissent opines that the choice of an overbroad term may affect validity but should not be considered for claim construction.  Tellingly, she recites that "[w]e [the court] are not lexicographers."  Following a detailed recitation of the facts and legal principles enunciated in Phillips, the dissent here contrasts the majority decision in Phillips with the panel decision here:  in the absence of "disclaimer or special lexicography," the plain meaning standard must be applied.  And the evidence, according to the dissent, fails to support a claim limited to single-body embodiments.

Judge Moore identifies the problem with the panel decision with particularlty:

The error in Retractable is the majority's attempt to rewrite the claims to better conform to what it discerns is the "invention" of the patent instead of construing the language of the claim.  Indeed, the majority candidly explained that its construction, limiting "body" to a one-piece body, "is required to tether the claims to what the specifications indicate the inventor actually invented."

While the dissent then explicates why Judge Moore believes that this construction isn't supported by the specification, more particularly she illustrates the subjectivity and difficulty an appellate court can be expected to encounter in reviewing claim construction without deference to a district court's fact finding.  And "[c]hanging the plain meaning of a claim term to tailor its scope to what the panel believes was the 'actual invention' is not consistent with the standard enunciated by Phillips."  While agreeing that the specification and claims must comply with the requirements of 35 U.S.C. § 112, the dissent states simply that the Court "does not rewrite claims"; this is not a case, Judge Moore contends, where "the majority is choosing between two equally plausible plain meanings and adopting the one that comports with the disclosure in the specification."  Rather, this case is illustrative that there is "a fundamental split within the court as to the meaning of Phillips and Markman as well as the proper approach to claim interpretation."  That is enough to convince Judge Moore and Chief Judge Rader that claim construction requires reconsideration by the court en banc.  Judge Moore also writes that this case has a procedural posture that would permit the court to set forth the extent to which the "mongrel practice" of claim construction permits or requires deference to a district court's factual determinations under Markman v. Westview Instruments, Inc., 517 U.S. 370, 378 (1996).

Judge O'Malley dissents separately, a posture reflecting her singular experience as a district court judge tasked with performing factual determinations in support of claim construction decisions.  She is forthright:  "[i]t is time to revisit and reverse our decision in Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998) (en banc)," if only because "the court's decision necessarily would change if even minimal deference were afforded to the trial judge's claim construction."  Her dissent notes that the Court's decision to give no deference to district court factual determinations is not required by the Supreme Court in Markman, and indeed the High Court "did not affirm this court's earlier conclusion that resort to a jury was unnecessary because claim construction is a pure question of law."  She sees the appellate court's decision to be "ill considered" when it was enunciated thirteen years ago and that it has not proven "beneficial" to patent jurisprudence "in the long run."

Reflecting her own experience, Judge O'Malley opines that:

[D]istrict judges have been trained to -- and do -- engage in detailed and thoughtful analysis of the claim construction issues presented to them.  They conduct live hearings with argument and testimony, sometimes covering several days, and certainly always extending beyond the mere minutes that courts of appeals have to devote to live exchanges with counsel.  Simply, "the trial court has tools to acquire and evaluate evidence that this court lacks."  Cybor, 138 F.3d at 1477 (Rader, J., dissenting).

She goes on to say that "[w]hile no one would urge deference to cryptic, unthinking rulings born of little or no real inquiry, where, as here, the trial court has thoroughly vetted all relevant aspects of the claim constructions at issue, 'careful consideration of the institutional advantages of the district court would counsel deference.'"  Reciting the history of the case, she notes that these claims had been construed by two separate district court judges and that the asserted "wrongdoing" reversed by the panel decision "did not promote the consistency and uniformity in patent law that Cybor was intended to foster; the decision here accomplished the opposite."

In Judge O'Malley's view, the panel did not misapply the claim construction canons in Phillips; more pedestrianly, she states that she merely disagrees with their application.  But this fact, and the experience of the panel members that they "could not agree on the proper claim construction in this case, despite careful consideration of their respective obligations under Phillips," strongly suggests to Judge O'Malley that the "complicated and fact-intensive nature of claim construction" mandates "the need to rethink our approach to it."  For her, the "review of extensive documentary evidence" and possibly expert testimony suggest factual, not legal questions are being posed to the Court.  And:

Where, as here, there is fair debate about the scope of the invention after application of Phillips's principles, we should defer to reasoned district court choices.  Reasonable minds can -- and do -- differ over the correct interpretation of the term "body" as used in the patent in suit.  These are not the circumstances under which we should be reversing carefully reasoned claim constructions and putting aside years of litigation in the process.

Taking into account the five "active" judges who voted to grant rehearing in Amgen Inc. v. Hoechst Marion Rousell, Inc., 469 F.3d 1039 (Fed. Cir. 2006), Judge O'Malley's dissent suggests that the active members of the Court are almost evenly split on the question of whether to grand en banc review.  Although her call to arms ("[i]t is time we stop talking about whether we should reconsider the standard of review we employ when reviewing claim construction decisions from district courts; it is time we do so") is stirring, the question won't be put to the en banc Court until either its composition changes or an even more compelling case is presented to it.

Is Claim Construction the Key to Patent-eligibility of Isolated DNA?

By Kevin E. Noonan --

Judge Giles Sutherland Rich famously said that, in patent law, "the name of the game is the claim."  One of the weaknesses in the "gene patenting" debate, as well as in the District Court's opinion in AMP v. USPTO (the Myriad case), is the lack of clarity about the scope and meaning of the claims of the challenged patents.  The District Court did not bother to hold a Markman hearing to construe the claims, and thus neither that Court nor the Federal Circuit in reviewing Judge Sweet's decision brought any clarity to what the parties were arguing about, instead drawing generally inapt analogies to what other claims in other patents might claim.  The type and number of claims at issue are sufficiently similar, having generally the same structure and using the same language that claim construction might help, and the language used is certainly no more arcane than in any other patent case.

Construing claim language to determine the scope and meaning of the claims is a matter of law for the district court in the first instance (Markman v. Westview Instruments, Inc., 52 F.3d 1321 (Fed. Cir. 1995) (en banc), aff'd 517 U.S. 370 (1996)).  The Federal Circuit reviews claim construction de novo, giving no deference to either the district court's ultimate construction of claim terms or any factual determinations underlying the court's legal determination of claim scope (Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998) (en banc)).  The way courts are to perform claim construction was set forth (most recently) by the en banc Federal Circuit in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc).  This procedure can be summarized in a few simple rules.  First, claim terms are to be given their "ordinary and customary" meaning as understood by those with skill in the art.  Id. at 1313.  Next, the specification is consulted to determine whether the patent applicant has acted as his or her own lexicographer, a capacity recognized as black letter patent law (see Autogiro Co. Amer. v. U.S., 384 F.2d 391 (Ct. Claims 1967).  This ability to define terms is limited only insofar as the applicant attempts to define a commonly accepted term in a way that is "repugnant" to its meaning in the art.  In re Hill, 161 F.2d 367 (CCPA 1947).  In the event that there is any ambiguity about the "ordinary and customary" meaning of a claim term, resort to the specification is preferred under Phillips as "the single best guide to the meaning of a disputed term."  Id. at 1315 (citing Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).  Finally, the prosecution file history should be consulted to ensure that a patentee cannot advance a narrow construction of a term during patent prosecution, only to argue a broader construction in an infringement action.  Phillips at 1317.

With these concepts and principles in mind, generally two types of claims were at issue in the Myriad case:

1.  Isolated DNA claims (as well as claims to oligonucleotides); and
2.  Diagnostic method claims.

(The one other claim at issue, claim 20 of U.S. Patent No. 5,474,282, is in some ways sui generis to the other claims, being directed to methods for screening chemical compounds for anti-cancer properties.)  Claim 1 of U.S. Patent No. 5,837,492 is representative of the first type of claim:

An isolated DNA molecule coding for a BRCA2 polypeptide, said DNA molecule comprising a nucleic acid sequence encoding the amino acid sequence set forth in SEQ ID NO:2.

(Claims 1 and 7 of the '282 patent; claims 6 and 7 of the '492 patent; and claim 1 of U.S. Patent No.  5,693,473 are variants of this general claim type.)  The italicized words and phrases in the exemplary claim need construing, the other terms being expressly defined with regard to other terms in the claims (e.g., the amino acid sequence of the BRCA2 polypeptide is defined as SEQ ID NO: 2; as a consequence, any ambiguity in the meaning of this term devolves to any ambiguity in the nature of the expressly recited sequence).

Of the italicized terms, the parties and the Federal Circuit focused most attention on the term "isolated."  This term has a meaning accepted by the Patent Office (and in the biotechnology arts) with regard to nucleic acids, wherein the term means "isolated from its natural state and processed through purifying steps that separate the gene from other molecules naturally associated with it."  Utility Examination Guidelines, 66 Fed. Reg. 1094 (2001).  An associated definition is found in the specification of the patents in suit:

"Isolated" or "substantially pure".  An "isolated" or "substantially pure" nucleic acid (e.g., an RNA, DNA or a mixed polymer) is one which is substantially separated from other cellular components which naturally accompany a native human sequence or protein, e.g., ribosomes, polymerases, many other human genome sequences and proteins.  The term embraces a nucleic acid sequence or protein which has been removed from its naturally occurring environment, and includes recombinant or cloned DNA isolates and chemically synthesized analogs or analogs biologically synthesized by heterologous systems.

Some in the gene patenting debate have characterized this meaning as encompassing isolation of total genomic DNA as falling within the scope of the claim; indeed this interpretation is one of the bases for the argument that Myriad's claims may inhibit "whole genome sequencing" methods, as Chris Hansen of the ACLU argued during oral argument in Myriad (see "AMP v. USPTO: Oral Argument at the Federal Circuit").  This interpretation is only persuasive, however, if the phrase "many other human genome sequences" is eliminated from the list of cellular components from which the BRCA-encoding DNA is separated.  Thus, the ordinary and customary meaning of the term "isolated" is reinforced by the express meaning of the term as recited in the specification.  And as interpreted using this meaning, the distinctions drawn in the majority and concurring opinions in Myriad, between what is isolated and what is "merely" purified, become less relevant, since DNA is understood both to be "purified" from other cellular components and "isolated" from other human genome sequences.

In addition, since claims must be construed as a whole, giving each limitation meaning and avoiding surplusage, what is "isolated" is a nucleic acid encoding an amino acid sequence "set forth" in the specification as SEQ ID NO: 2.  Thus, properly interpreted, the claim is limited to DNA molecules that encode the BRCA 2 polypeptide.  The only other claim term that could expand the scope of these claims to extend to nucleic acids other than those encoding the BRCA proteins (and only those having the specifically recited amino acid sequences) is the word "comprising."  However, using another well-recognized rubric of claim construction, this word cannot be used to expand the scope of the claim to extend to human genomic DNA per se:  first, because "claims should be so construed, if possible, as to sustain their validity," Rhine v. Casio, Inc., 183 F.3d 1342, 1345 (Fed Cir. 1999); see also Klein v. Russell, 86 U.S. (19 Wall.) 433, 466, 22 L. Ed. 116 (1873), but also because claims are interpreted in light of the specification, United States v. Adams, 383 U.S. 39, 49, 15 L. Ed. 2d 572, 86 S. Ct. 708, 174 Ct. Cl. 1293 (1966).  The specification of the Myriad patents claiming DNA encoding BRCA1 and BRCA2 disclose the patentees' efforts to identify, isolate, and purify BRCA-encoding DNA.  Thus, the proper interpretation of these claims is directed to DNA (and in particular, cDNA) encoding the BRCA proteins.

Turning to the diagnostic method claims, claim 1 of U.S. Patent No. 5,753,441 is representative:

A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.

(Claims 1 of U.S. Patent No. 5,709,999; claim 1 of U.S. Patent No. 5,710,001; and claims 1 and 2 of U.S. Patent No. 6,033,857 are variants of this general claim type.)  Here, the claim term "comparing" has no specific definition in the specification; however, Example 9, entitled "Analysis of BRCA 1 Mutations" sets forth the general method for extracting DNA from blood or tumor samples from patients with breast or ovarian cancer to detect mutations.  The relevant claim term to be construed is thus from a tissue sample from said subject, and whether this implies a necessary transformation step to ascertain the individual patient's BRCA gene sequence.  Both the District Court and the Federal Circuit treated this claim as if it had been construed to encompass mere inspection of and comparison between two sequences (i.e., printouts of the germline and patient sample sequences) that did not require a patient sample to be assayed to obtain the sequence.  While not a necessarily unreasonable interpretation (since these claims do not expressly recite limitations drawn to obtaining a sample and determining the BRCA gene sequence therefrom), it is not the only interpretation.  What is missing from any judicial analysis of the diagnostic method claims at issue is whether the skilled worker would understand the claim not to require these steps, and whether the specification mandates interpretation of the claim to include these steps.  (The prosecution file history may also be informative as to what the patentee understood the invention to be and, more importantly, represented that understanding to the patent examiner, with regard to the scope of these claims.)

The danger in ignoring and failing to perform the fundamental and threshold exercise of construing the claims at issue in patent litigation is clearly illustrated in the briefs (both from the parties and the amici) and the decisions of both the District Court and the Federal Circuit.  The Courts' analyses are understandably adrift without the anchor of having decided what the claims mean, turning them into a "nose of wax" to be susceptible to whatever argument is being advanced.  Although it is perhaps too late to do so now, if the Federal Circuit grants rehearing or en banc review, it would be well if the Court mandated that the parties provide the equivalent of their Markman briefs, to enable the Court as a threshold matter to determine what the claims mean as a matter of law.  Without that, it is hard to see how the Federal Circuit, or the Supreme Court if it grants certiorari, will have any reasoned basis for coming to a decision as to whether these claims recite patent-eligible subject matter.  That outcome may be good for arguments based on emotion and rhetoric, but it won't be good for deciding this fundamental question of patent law.

Adams Respiratory Therapeutics, Inc. v. Perrigo Co. (Fed. Cir. 2010)

By Donald Zuhn --

In Adams Respiratory Therapeutics, Inc. v. Perrigo Co., decided last Thursday, the Federal Circuit vacated and remanded a determination by the District Court for the Western District of Michigan that the guaifenesin product described in Defendants-Appellees' ("Perrigo") Abbreviated New Drug Application (ANDA) would not infringe the asserted claims of Plaintiffs-Appellants' ("Adams") U.S. Patent No. 6,372,252.  The panel's decision to vacate was based in part on the District Court's erroneous claim construction.

The '252 patent relates to controlled-release formulations of guaifenesin (at left), an expectorant used to thin, loosen, and help expel mucus that causes congestion.  The preferred embodiment of the '252 patent is Mucinex®, an extended release guaifenesin tablet that contains an immediate release (IR) portion and a sustained release portion.  Seeking approval to market 600 mg guaifenesin extended-release tablets, Perrigo filed an ANDA with the FDA.  In response to Perrigo's ANDA filing, Adams brought suit against Perrigo for infringement of claims 26, 33, 34, and 39 of the '252 patent.

After construing the claims, the District Court granted summary judgment of noninfringement to Perrigo.  At issue before the District Court was the meaning of the term "equivalent" in claim 24, from which each of the asserted claims depends.  Claim 24 recites (emphasis added):

24.  A modified release product having two portions, wherein a first portion comprises a first quantity of guaifenesin in an immediate release form which becomes fully bioavailable in the subject's stomach and a second portion comprises a second quantity of guaifenesin in a sustained release form wherein the ratio of said first quantity to said second quantity provides a Cmax in a human subject equivalent to the Cmax obtained when the first of three doses of a standard immediate release formulation having one third the amount of guaifenesin is dosed every four hours over a 12 hour period and wherein said product also provides therapeutically effective bioavailability for at least twelve hours after a single dose in a human subject according to serum analysis.

The District Court construed "equivalent" as "within 80% to 125% of the value with which it is being compared, at a 90% confidence interval," basing its construction on statements made by Adams during reexamination proceedings on the '252 patent.  According to the Court, "Adams explicitly stated during reexamination that 'equivalent' meant 'the FDA bioequivalence guidelines' [i.e., the FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations," which reflect both an 80 to 125% range and a 90% confidence interval]."  In addition, the Court noted that a declaration submitted by Adams during reexamination indicated that one of ordinary skill in the art would understand the term "equivalent" to mean within the FDA bioequivalent range of 80 to 125%.

On appeal, Adams challenged the requirement of a 90% confidence interval, noting that the '252 patent does not require or mention such an interval.  While acknowledging that it defined "equivalent" to mean within the 80 to 125% range, Adams argued that a 90% confidence interval was never included in that definition.  Adams asserted that the 90% confidence made sense in the context of drug approval, but not in the context of proving infringement, and that by requiring a 90% confidence interval, the District Court was requiring Adams to prove that Perrigo's guaifenesin product would infringe the '252 patent 90% of the time (rather than simply showing that it was more likely than not that Perrigo's ANDA, if approved, would permit Perrigo to market a product that infringes the '252 patent).  Perrigo countered that Adams "expressly defined 'equivalent' as FDA's bioequivalence guidelines, i.e., 'within 80% to 125% of the value with which it is being compared, at a 90% confidence interval."

In vacating the District Court's summary judgment of noninfringement, the Federal Circuit construed "equivalent" to require a Cmax that is 80% to 125% of the value to which it is being compared, adding that "[c]ontrary to Perrigo's assertion, Adams did not define equivalent as meeting all of the requirements of the FDA’s bioequivalence guidelines," but rather referred specifically to the 80 to 125% range of the FDA guidelines.  The panel noted that "[t]he range and the confidence interval are independent concepts," explaining that "[t]he range reflects 'a medical decision that, for most drugs, a -20%/+25% difference in the concentration of the active ingredient in blood will not be clinically significant,'" and that "the 90% confidence interval reflects the FDA's concern that a generic drug consistently match the performance of the branded drug."  With respect to the District Court's construction, the panel stated that:

Patent infringement does not require bioequivalence, and Adams did not import the 90% confidence interval into its claim.  Requiring a 90% confidence interval would inappropriately raise the bar for establishing infringement.  Adams must show that it is more likely than not that Perrigo's ANDA product will have a Cmax within the 80 to 125% range.  Adams is not required to show that Perrigo's product will meet this requirement 9 times out of 10.

Turning to the issue of equivalence, the panel noted that before the lower court, Adams had failed to present evidence of equivalence sufficient to create a genuine issue of material fact of infringement.  In particular, Adams had attempted to show that Perrigo's ANDA product would have a Cmax equivalent to a standard IR product by showing that Perrigo's ANDA product was bioequivalent to Mucinex® and that Mucinex® was bioequivalent to a standard IR product.  The District Court found fault with Adams' comparison, in particular because Adams had compared Perrigo's ANDA product to Adams' commercial embodiment.  The lower court determined that equivalence must be shown by a two-way crossover study comparing Perrigo's ANDA product and a standard IR product, as required by the FDA to establish bioequivalence (a study that Adams had not performed).

The Federal Circuit agreed with Adams that a two-way crossover study was unnecessary and that Adams had provided sufficient evidence of infringement to create a genuine issue of material fact.  With respect to Adams' comparison of Perrigo's ANDA product to Adams' commercial embodiment, the panel stated that "[o]ur case law does not contain a blanket prohibition against comparing the accused product to a commercial embodiment," and added that "when a commercial product meets all of the claim limitations, then a comparison to that product may support a finding of infringement."

Perrigo also argued that one could not establish infringement based on the available data.  However, the panel noted that while Perrigo's argument appears to assume that the claim requires a 90% confidence interval, Perrigo had offered no explanation why Adams' evidence failed to establish infringement under the correct construction of "equivalent."  In addition, the Court noted that Adams presented more than just the fact of bioequivalence of the two sets of products (i.e., Perrigo's ANDA product and Mucinex®; Mucinex® and a standard IR product), explaining that:

If Adams had relied on the mere fact of bioequivalence of the two sets of products (and no PK data or Cmax values), that would not be enough to survive summary judgment.  If product A is bioequivalent to B, and B is bioequivalent to C, then it is entirely possible that A is not equivalent to C because bioequivalence indicates a range of values (80 to 125%).  Bioequivalence values on the low or high end of the range would not indicate equivalence (e.g., if A is consistently 80% of B, and B is consistently 80% of C, then A is likely to be 64% of C).  However, here, in addition to its evidence of bioequivalence, Adams presented actual PK data and Cmax values.  In light of this evidence, a fact-finder could reasonably conclude that it is more likely than not that Perrigo's ANDA product will have a Cmax equivalent to that of a standard IR product.  Therefore, Adams has raised a genuine issue of material fact on infringement under the proper construction of the term equivalent, sufficient to preclude summary judgment.

The Federal Circuit also rejected Perrigo's alternative basis for affirming the District Court's finding of noninfringement:  that Adams cannot establish that Perrigo's ANDA product has an IR portion of guaifenesin that becomes "fully bioavailable in the subject's stomach" as required by claim 24.  On appeal, Perrigo asserted that "bioavailable" means absorption, and Adams contended that it means release into the stomach, rather than absorption into the body.  In support of its position, Adams pointed to the specification, which repeatedly states that the IR portion of guaifenesin is released in the stomach, but never states that it is absorbed in the stomach.  While acknowledging that "Perrigo and Adams each proposed a reasonable construction of the term bioavailable in the abstract," the panel concluded that:

Adams' construction is consistent with the use of this term in the specification; Perrigo’s is not.  Claim terms are not construed in a vacuum divorced from the specification.  Although the specification never expressly defines bioavailable, it uses the term when describing the availability of the drug for absorption, not the actual absorption.

. . .

Adams' construction -- requiring release and availability for absorption -- covers the preferred embodiment.  Perrigo's construction -- requiring both release and actual absorption -- excludes the preferred embodiment and essentially all guaifenesin formulations, as the specification explains that absorption occurs in the intestinal tract.

The last section of the opinion addresses Adams argument that it should be allowed to establish infringement of claim 34 under the doctrine of equivalents.  According to the panel, claim 34 recites:

34.  The modified release product of claim 26 [which claims the modified release product of claim 24 wherein the total quantity of guaifenesin is 600 mg] wherein the Cmax of said product is at least 1000 ng/mL and said product has an AUCinf of at least 3500 hr*ng/mL.

Adams noted that the highest AUCinf (the area under a plasma concentration versus time curve, i.e., the total amount of guaifenesin absorbed by the subject) for Perrigo's ANDA product was 3493.38 hr*ng/mL, which was within 0.189% of the recited value.  Citing Abbott Labs. v. Dey, L.P., 287 F.3d 1097, 1100, 1105-08 (Fed. Cir. 2002), Adams argued that the Federal Circuit had previously concluded that infringement under the doctrine of equivalents could apply to claims requiring a specific numeric range.  The District Court, however, had determined that the term "at least" in claim 34 indicates an absolute lower limit of the range (citing Quantum Corp. v. Rodime, PLC, 65 F.3d 1577 (Fed. Cir. 1995)), and that allowing Adams to show infringement under the doctrine of equivalents would vitiate the 3500 hr*ng/mL limitation.

The panel noted that the limitation "at least 3500 hr*ng/mL" was comparable to the specific numerical ranges in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc); Abbott Labs. v. Dey, L.P.; and Jeneric/Pentron, Inc. v. Dillon Co., 205 F.3d 1377 (Fed. Cir. 2000), and that these cases indicate that "[t]he recitation of a specific numerical value does not by itself foreclose the application of the doctrine of equivalents."  Determining that "[t]he addition of 'at least' in this case does not change this analysis," and further that "[t]he fact that the claim does not contain words of approximation (i.e., 'about at least 3500 hr*ng/mL') does not affect the analysis," the Court stated that the proper inquiry is whether the accused value is insubstantially different from the claimed value.  The panel concluded that Adams had introduced sufficient evidence from which a reasonable fact-finder could conclude that an AUC value of 3493.38 hr*ng/mL is insubstantially different from a value of 3500 hr*ng/mL, and therefore vacated the District Court's grant of summary judgment of noninfringement of claim 34 under the doctrine of equivalents.

Adams Respiratory Therapeutics, Inc. v. Perrigo Co. (Fed. Cir. 2010)
Panel: Circuit Judges Linn, Moore, and Friedman
Opinion by Circuit Judge Moore

Intervet Inc. v. Merial Ltd. (Fed. Cir. 2010)

Claim Construction of DNA-reciting Claims

By Kevin E. Noonan --

The Federal Circuit considered claims to isolated DNA sequences encoding portions of the genome of a porcine circovirus in Intervet Inc. v. Merial Ltd. last week, remanding the case to the District Court based on disagreements with the lower court's construction of three claim terms.  The Federal Circuit also took the occasion to opine on the extent of subject matter surrendered by amendment of these claims during prosecution.  The greatest interest in the opinion has arisen from the dissent, by Judge Dyk, who sua sponte raised the issue of patent-eligibility for isolated DNA molecules.  Although his concern with the decision in AMP v. USPTO seemingly turns the jurisprudential pyramid on its head, discussion of the dissent, and its departures from both factual and legal realities will await a later post.

The case arose as a declaratory judgment action, with Intervet asking the District Court to declare that its porcine vaccines did not infringe the claims of Merial's U.S. Patent No. 6,368,601.  Merial's claims were related to particular strains of porcine circovirus that cause postweaning multisystemic wasting syndrome (PMWS), a disease of livestock pigs.  While viruses of this type were known in the art (termed "Type I" or "PVS-1" strains in the opinion), none of them were pathogenic.  Patentees discovered novel strains of these viruses that were associated with PMWS (termed "Type II" or "PVS-2" in the opinion), and disclosed five separate strains.  Samples of all five strains were deposited, and the complete nucleotide sequence of four of them included in the specification.  These four strains showed 96% nucleotide sequence "homology" (although as used by the Court this term is equivalent to "sequence identity"), compared with Type 1 strains, to which the Type II strains showed 76% nucleotide sequence identity.  The specification also identified thirteen open reading frames (ORFs), nine of which were specific for Type II viruses and four in common between Type I and Type II viruses.

Two groups of claims were at issue in the litigation:

9.  A vector comprising an isolated DNA molecule comprising a sequence selected from the group consisting of ORFs 1 to 13 of porcine circovirus type II.

32.  An isolated DNA molecule comprising a nucleotide sequence encoding an epitope which is specific to PCV-2 and not specific to PCV-1.

The District Court construed several claim terms, three of which were considered by the Federal Circuit and are germane it its opinion:

• "porcine circovirus type II" was construed as consisting of the five nucleotide sequences that the patentee placed on deposit with the USPTO.

• "ORFs 1-13" were construed as the DNA sequences of the thirteen ORFs of SEQ ID 4 listed in a table under Example 13 of the patent.

• Claim 32 was construed as a whole to be a construct comprising at least one DNA molecule that is unique to one of the five sequences on deposit with the PTO.

Based on this claim construction, the District Court granted summary judgment of noninfringement to Intervet.  The Court said it was undisputed that the accused infringing vaccine contained a DNA molecule 99.7% homologous to one of the deposited sequences, and thus, outside the literal scope of the claims, "which required strict identity to one of the five deposited sequences."  Merial appealed.

The Federal Circuit reversed the District Court's construction of the first two of these claim terms, in an opinion by Judge Prost and joined by Judge Bryson and Judge Dyk (in part).  The Court independently construed the claim term "porcine circovirus type II," which the District Court had limited to the specific deposited sequences.  The Federal Circuit began its analysis with reference to the patent specification, which "states that the five deposited strains and listed sequences are 'representative of' a 'type of porcine circovirus,' and thus do not constitute the entire scope of the invention" (emphasis in original).  Accordingly, the Court cited Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 967 (Fed. Cir. 2002), and In re Smythe, 480 F.2d 1376, 1383 (C.C.P.A. 1973), for the proposition that a claimed genus can be broader than the species disclosed to represent the genus.  (The majority opinion also states in a footnote that it does not reach validity issues not raised by the parties, suggesting that on remand Merial will need to contend with sufficiency of disclosure grounds of invalidity under § 112.)  The opinion cites the specification as not disclosing any "quantitative threshold" to distinguish type I and type II strains, stating that the distinction is based on serological similarities and differences as well as pathogenicity, and that "[t]his conclusion comports with the way that viruses are typically classified in the relevant art."  According to the opinion, "the pathogenicity and homology patterns are the defining properties of the new type of virus.  The claim construction of 'porcine circovirus type II' is therefore properly limited to porcine circoviruses that have these two defining properties."

In view of the disclosure, and the relatedness of the different strains of type II virus disclosed, the Federal Circuit construed the term "porcine circovirus type II" as "a pathogenic pig virus having a circular genome that is at about 96% or more homologous with the four sequences disclosed in the present specification, and about 76% or less homologous with the [Type I] sequence."  The opinion states that this claim construction is "not inconsistent with the other descriptive language in the specification."

The Federal Circuit found that the accused infringing vaccines, comprising nucleotide sequences having 99.7% sequence identity, were not entitled to summary judgment of noninfringement in view of its claim construction, and remanded to the District Court for further proceedings based on the panel's interpretation of this claim term.

The Federal Circuit next construed the term "ORFs 1-13," saying this term was also improperly construed by the District Court.  In the CAFC's opinion "the court erred in confining the scope of the term to the precise limits of the representative ORFs listed in Example 13, and the exact DNA sequence of SEQ ID 4."  Once again, the Court found the claim term to be representative of type II sequences, and thus that the genus was broader than the recited species.  In part this was due to explicit disclosure of variation in the ORF sequences in the specification, although the extent of that variation in the specification was described merely as "slight natural variation" that the skilled worker could expect.  Salient to the Federal Circuit's determination that the District Court had too narrowly construed this claim term was the observation that "[i]ndeed, limiting the construction of the term to the exact ORF sequences of SEQ ID 4 would even exclude from the claimed ORFs two of the four sequenced strains of PCV-2, the ORF variations for which sequences are expressly disclosed following the table in Example 13."  And, the opinion notes, "[w]e have already construed that set of circovirus strains to be broader than just the four sequenced strains, so it would be incongruous to selectively impose the narrower construction here, as the dissent suggests."

The opinion held that "the term ORFs 1-13 is properly construed as 'lengths of translatable DNA between pairs of start and stop codons, corresponding to the 13 ORFs identified in the patent specification,'" reversed summary judgment, and remanded to the District Court for further proceedings based on the Federal Circuit's interpretation of this claim term.

The District Court properly construed claim 32 to mean "an isolated DNA molecule that includes, but is not necessarily limited to, a DNA sequence which codes for an immunodominant region of a protein, wherein the sequence is from the genome of a PCV-2 circovirus, and not from the genome of a PCV-1 circovirus," according to the Federal Circuit's opinion.  The District Court found that this claim could read on sequences in common between the two types of PCV, so long as there was at least one nucleic acid that was not in common.

However, the basis for Merial's challenge to the District Court's decision regarding this claim was in how the lower court applied it.  The District Court determined that the "from" the genome language "excluded sequences that were physically derived from a non-PCV-2 source."  Merial argued that including such a "manufacturing" or process limitation was improper, and the Federal Circuit agreed; in its analysis, the panel focused on the term "specific to," "since it appears that this term is the hook for the requirement that the sequence be unique to and derived from PCV-2."

Merial argued the term "specific to" was a term of art in the immunological arts, referring to the propensity of an antibody to bind an antigen.  While the Federal Circuit recognized this specialized meaning, "epitope is thus bound by antibodies that are 'specific to' PCV-2" as recited in the claim.  "In light of the patent description and a general understanding of the relevant art," according to the opinion, "the claim would be understood by one of skill in the art to be using the term 'specific to' in a colloquial or non-technical sense."

The Federal Circuit then construed the relevant language of claim 32 as:

[A] nucleotide sequence encoding an epitope that is specific to PCV-2 and not specific to PCV-1, as that term is used in claim 32, is a nucleotide sequence that encodes part of a polypeptide sequence of PCV-2, but not part of a polypeptide sequence of PCV-1.  More specifically, it encodes at least one epitope found on the PCV-2 virus, but not found on the PCV-1 virus.

Insofar as the District Court's construction required the encoded epitope to be unique to PCV-2 among all possible antigens, it is in error, according to the opinion, because "[i]f the term 'specific to PCV-2' meant that the epitope must be found only on PCV-2 and no other antigen, then the subsequent limitation 'and not specific to PCV-1' would be redundant."

Turning to the doctrine of equivalents, the Federal Circuit found that the District Court had erred in its application of prosecution history estoppel to limit the extent to which Merial was entitled to rely on the doctrine.  "The district court erred . . . in applying controlling Federal Circuit and Supreme Court law to the prosecution history of the '601 patent.  As a result, the scope of the district court's bar on Merial's ability to invoke the doctrine of equivalents was overly broad."

What raised the estoppel were amendments to claim 9.  As originally draft the claim read:

9.  A vector comprising an isolated DNA molecule comprising a sequence selected from the group consisting of ORFs 1-13.

This claim was rejected, on the grounds that while "[t]he ORFs are assumed to be derived from porcine circovirus . . . as written, the claims could encompass ORFs from any organism," specifically the prior art Type I sequences.  Although the inventors submitted argument that these ORFs could not be derived from any other organism, being specifically defined by sequence in the specification, they nevertheless amended claim 9 by adding the limitation that the ORFs were "of porcine circovirus type II," which resulted in allowance of the claim.

The opinion found no fault with the District Court's determination that this was a narrowing amendment, and that the amendment was substantially related to patentability.  Where the District Court erred, according to the opinion, was in the scope of the resulting estoppel.  The proper extent of this estoppel, according to the Federal Circuit, was that:

Merial is thus estopped from arguing that ORFs of pathogenic circoviruses found in other organisms are equivalent to ORFs of PCV-2.  It is also estopped from arguing that ORFs of a pathogenic strain of PCV-1 are equivalent to ORFs of PCV-2, despite the strain having strong homology with [Type I virus] and weak homology with the representative strains disclosed in the patent.

However:

Merial is not, however, estopped from arguing that a pathogenic porcine viral sequence with over 99% nucleotide homology with one of the five representative strains is equivalent to that strain.  Such a draconian preclusion would be beyond a fair interpretation of what was surrendered.

The opinion directed that on remand the District Court consider the extent to which Merial could show infringement under the doctrine of equivalents.

An analysis of the dissent, both on its "merits" and with regard to recent efforts by groups representing the plaintiffs in the AMP v. USPTO case to influence the makeup of the panel that hears the Federal Circuit appeal, will follow in a later post.

Intervet Inc. v. Merial Ltd. (Fed. Cir. 2010)
Panel: Circuit Judges Bryson, Dyk, and Prost
Opinion by Circuit Judge Prost; opinion concurring-in-part and dissenting-in-part by Circuit Judge Dyk

Scantibodies Laboratory, Inc. v. Immutopics, Inc. (Fed. Cir. 2010)

    By Andrew Williams --

Last week, in Scantibodies Laboratory, Inc. v. Immutopics, Inc., the Federal Circuit affirmed a claim construction decision and corresponding summary judgment of non-infringement rendered by the U.S. District Court for the Central District of California.  The patent at issue was U.S. Patent No. 6,689,566 ("the '566 patent"), "Methods, Kits, and Antibodies for Detecting Parathyroid Hormone."  Claim 5, the only claim addressed on appeal, reads (with the claim terms at issue underlined):

5.  A method for measuring an amount of whole parathyroid hormone in a sample comprising:

    a)  adding to a sample a labeled antibody or antibody fragment specific for an initial peptide sequence of whole parathyroid hormone wherein said initial peptide sequence consists of VAL-SER-GLU-ILE-GLN-LEU-MET (SEQ ID NO:3), and wherein at least four amino acids in said initial peptide sequence are part of a reactive portion to said labeled antibody;

    b)  allowing said labeled antibody to bind to whole parathyroid hormone present, thereby forming a complex; and

    c)  measuring the amount of said labeled complex to measure the amount of whole parathyroid hormone in said sample while not detecting an interfering non-(1-84) parathyroid hormone fragment.

The District Court construed these terms to mean:

• "specific for" = having a measurable affinity for and detectable binding to an epitope having at least four amine acids of the seven in SEQ ID No. 3 (VAL-SER-GLU-ILE-GLN-LEU-MET)

• "not detecting an interfering non-(1-84) parathyroid hormone fragment" = having no detectable binding to an interfering non-(1-84) parathyroid hormone fragment

Because Scantibodies conceded that the accused Immutopics antibody did not meet the later limitation, the District Court granted summary judgment of non-infringement.

The application that issued as the '566 patent was filed January 14, 1999.  The application described antibodies, methods of use, and kits for detecting whole or non-fragmented parathyroid hormone ("w-PTH") in a biological sample.  Measuring serum levels of PTH in patients is important for a large number of diseases, including familial hypocalciuric, osteoporosis, and Paget's bone disease.  However, measuring biologically active levels of PTH in humans has been challenging.  One problem is that PTH circulates at extremely low levels.  In addition, these circulating levels of protein are heterogeneous due to the large number of PTH fragments, which leads to interference when attempting to measure the biologically active form ("the (1-84) PTH fragment").  In order to overcome this fragment interference, two-site immunoradiometric assays had previously been developed, which allow for the measurement of intact PTH ("I-PTH").  A measurement of I-PTH, however, includes w-PTH and a large PTH fragment cleaved at amino acids 5 to 8.  In fact, patients with hyperparathyroid or renal failure have significant concentrations of these large, non-whole PTH fragments, which can give inaccurate measurements of the biologically active form.  To overcome this problem, the Scantibodies scientists discovered methods for detecting w-PTH in a biological sample while not detecting this non-(1-84) large PTH fragment component of I-PTH.  They also developed antibodies for use with such methods.  The Scantibodies method used an antibody "specific for" at least four amino acids of seven amino acids disclosed from the N-terminal end of the protein.  Use of such an antibody was important, because it would not react with the interfering non-(1-84) parathyroid hormone fragment.

The originally filed claims in the application that lead to the '566 patent did not contain the limitation "not detecting an interfering non-(1-84) parathyroid hormone," even though the necessity of not detecting this fragment was described in the specification.  During prosecution, however, the examiner cited to several pieces of art in both novelty (§ 102) and obviousness (§ 103) rejections.  The most significant art described the methodology of the measurement of I-PTH.  In order to obtain allowable claims, therefore, the applicant amended the claims to include the "not detecting" limitation, because apparently all of the prior art methods couldn't differentiate w-PTH from this interfering non-(1-84) parathyroid hormone.

Scantibodies filed the present lawsuit on October 26, 2004.  Subsequently, both parties filed reexamination requests, which eventually resulted in a reexamination certificate that altered the antibody and kit claims, but apparently did not change the method of use claims.  This may be the reason that the parties focused on claim 5 during the appeal.  The District Court determined that it needed to construe the claims before it could issue a non-infringement summary judgment order.  And, after two claim construction orders, the Court did just that.  Scantibodies appealed.

The Federal Circuit recognized that the District Court's construction of "not detecting" to mean "no detectable binding" created a difficult, although not insurmountable, hurdle for finding infringement.  Apparently, Scantibodies argued that such a definition would exclude all antibodies, because it was impossible not to have some cross-reactivity.  However, the specification of the '566 patent apparently touted the fact that no cross-reactivity could be achieved.  Moreover, the Federal Circuit pointed out that this construction was based on another limitation that Scantibodies did not challenge ("does not specifically bind to an interfering non-(1-84) parathyroid hormone fragment").  The Court did not give much weight to the testimony of one of the patentees, nor did the Court find it relevant that Scantibodies' product literature defined "no cross-reactivity" as "no significant cross-reactivity."  Scantibodies argued that no PTH assay can absolutely detect PTH without detectable cross-reactivity.  However, the Court pointed out a 2001 reference from Gao et al., which included the inventors as authors, disclosing that an N-terminal PTH antibody that bound to the first few amino acids, and did not have detect the (7-84) PTH fragment at concentrations of 10,000 pg/ml.  The Federal Circuit used this as proof that it was possible to meet the limitations of the claim as construed by the District Court.

Finally, the Federal Circuit noted that the error should be assigned to the patent drafters, because if they had wanted "not detecting" to mean something else, they could have either used different claim language, or provided a different definition in the specification.  This analysis ignores the reality that this claim limitation was required to overcome prior art cited during prosecution.  Moreover, it ignores the fact that the specification highlighted the criticality of not detecting an interfering non-(1-84) parathyroid hormone fragment.  In fact, it is possible that if the claims had issued without the "not detecting" limitation, Scantibodies could have had a written description problem.  Therefore, the Federal Circuit is correct in pointing out that claim drafters need to be careful in choosing the language of claim limitations, but claim drafters also need to mindful of the invention that is actually disclosed in the specification.

Scantibodies Laboratory, Inc. v. Immutopics, Inc. (Fed. Cir. 2010)
Nonprecedential disposition
Panel: Chief Judge Michel and Circuit Judges Plager and Moore
Opinion by Chief Judge Michel

Image of parathyroid hormone (above) by Emw, from the Wikipedia Commons under the Creative Commons license.

In re Suitco Surface, Inc. (Fed. Cir. 2010)

    By Kevin E. Noonan --

It is a bedrock principle of patent practice that the U.S. Patent and Trademark Office gives the terms of claims under examination their broadest reasonable construction.  The rationale is that, in this way, the applicant has the opportunity to argue or amend the claims to be as broad as the prior art permits, and precludes the applicant from expanding beyond these limits the scope of granted claims it asserts against accused infringers.  Regardless of the soundness of this practice as a policy matter, as applied by the Office it can (and frequently does) exceed the boundaries of reasonableness:  the Office frequently takes a position regarding the scope of a claim term that is completely unreasonable.  As one example, the Office has, on occasion, determined that essentially any nucleic acid can hybridize with any other, since the complexity of almost any sequence contains short stretches of sequence found in many other sequences; such reasoning is then applied to reject any claim depending on specific hybridization.

The practice of construing claim terms unreasonably arose in an opinion handed down from the Federal Circuit today, In re Suitco Surface, Inc.  Patentees appealed final rejection in an ex parte reexamination based on anticipation.  The Federal Circuit, in an opinion by Judge Rader joined by Judges Prost and Moore, vacated and remanded the Office's grounds of rejection based, in part, on the unreasonable construction of claim terms that expanded their scope to encompass the prior art.

Reexamination was on U.S. Patent No. 4,994,514, which claimed a "floor finishing material" used on "floor surfaces [made] of wood, linoleum, terrazzo, [or] concrete," particularly as used on bowling lanes and athletic courts.  Representative claim 4 is in Jepson claim format (with emphasis added):

4.  On a floor having a flat top surface and an improved material for finishing the top surface of the floor, the improvement comprising:
    at least one elongated sheet including a uniform flexible film of clear plastic material having a thickness between about one mil and about twenty-five mils and
    a continuous layer of adhesive material disposed between the top surface of the floor and the flexible film, the adhesive layer releasably adhering the flexible film onto the top surface of the floor.

The opinion notes that the underlined claim terms had been construed during a prior litigation:  "material for finishing" to mean "a material that makes more durable the underlying surface of the floor, and is applied for that purpose," and "uniform flexible film" to mean "the material must be of a uniform thickness, and excludes material in which there are any variations in thickness."  The Federal Circuit in an appeal from grant of summary judgment against the patentee, disagreed, saying:

The text of claim 4 leaves little ambiguity as to the meaning of "material" - namely, at least one elongated sheet of a uniform flexible film of clear plastic having a thickness between about one and about twenty-five mils.  What remains in dispute is the precise meaning of the phrase "for finishing."  In the context of claim 4, "finishing" clearly refers to providing a clear, uniform layer on the top surface of a floor.  Significantly, there is no indication in claim 4 as to what level of durability, if any, the "finish" layer must have.  Thus, claim 4 implies a broad meaning for the term "finishing," which is consistent with the dictionary definition of "finish."  See, e.g., Webster's Ninth New Collegiate Dictionary 464 (1984) (defining "finish" as "the final treatment or coating of a surface," but not identifying any specific properties).

The District Court granted summary judgment a second time on remand, based on the "uniform flexible film" limitation.  The Federal Circuit again disagreed, based on whether the accused infringing article was required to have a uniform thickness throughout.  During the second remand, the defendant 3M (an amicus here) filed the ex parte reexamination request which resulted in a stay of the remand litigation and, ultimately, this appeal.  Claims 4-8 were finally rejected as being anticipated by U.S. Patent No. 3,785,102 to Amos and U.S. Patent No. 4,543,765 to Barrett, these rejections being the subject matter of this appeal.  (A third rejection, based on U.S. Patent No. 4,328,274 to Tarbutton was not appealed.)

Briefly, the Amos reference teaches "a floor covering pad comprising a plurality of plastic sheets connected together by a plurality of adhesive layers . . . designed to be used right before entry into a clean room or a hospital bay to remove dirt from the shoes or wheels of incoming traffic."  Each of the plurality of sheets is exposed one at a time and allowed to function to remove dirt until the adhesive on the sheet is filled, and then the sheet is removed and the next sheet is exposed and so forth.  The Barrett reference teaches "the use of a clear plastic film connected to a floor with an adhesive layer" to "temporarily protect a floor during construction."

During the reexamination, the examiner asserted rejections based on anticipation by these references, and the Board affirmed.  The Board construed the two relevant claim terms more broadly that the District Court:  the term "material for finishing the top surface of a floor" was construed to mean "requiring a material that is structurally suitable for placement on the top surface of a floor."  Thus, any layer placed above a floor fulfilled this requirement, "regardless of whether it was the top or final layer."  The term "uniform flexible film" was construed by the Board to mean "including, for example, a flexible film having the same thickness throughout, as well as a flexible film having the same textured surface throughout."  Suitco challenged the Board's decision affirming the asserted rejections based on these constructions, particularly asserting that none of the prior art cited the "uniform" limitation.

The Federal Circuit's opinion acknowledged the practice before the Office that claim terms are to be given "their broadest reasonable construction consistent with the specification," citing In re ICON Health & Fitness, Inc., 496 F.3d 1374, 1379 (Fed. Cir. 2007), saying that its inquiry was thus whether the Board's construction was "reasonable," citing In re Morris, 127 F.3d 1048, 1055 (Fed. Cir. 1997).  Applying these principles, the Court directly held that the Office's construction of the term "material for finishing" was unreasonable:

The express language of the claims requires a "material for finishing the top surface of the floor."  '514 patent col.7 ll.67-68 (emphases added).  A material cannot be finishing any surface unless it is the final layer on that surface.  Otherwise, the material would not be "finishing" the surface in any meaningful sense of the word.

The PTO's proffered construction ignores this reality by allowing the finishing material to fall anywhere above the surface being finished regardless of whether it actually "finishes" the surface.  Indeed, according to the PTO, the finishing surface need only be "structurally suitable for placement on the top surface of the floor" -- i.e., several layers can be placed on top of the "finishing" layer.  If the PTO's construction were accepted, a prior art reference with carpet on top of wood, on top of tile, on top of concrete, on top of a thin adhesive plastic sheet anticipates the claims in question because an adhesive plastic sheet falls at some point in the chain of layers.  This construction does not reasonably reflect the plain language and disclosure of the '514 patent.

The problem, according to the Court, is that the Office has ignored the part of the standard that limits the bounds of what is "reasonable" to what is consistent with the specification:  the rubric is not merely that claims must be given "their broadest reasonable construction" but that they be given "their broadest reasonable construction consistent with the specification" (emphasis added).  Moreover, claims are to be read "in light of the specification as it would be interpreted by one of ordinary skill in the art," citing In re Bond, 910 F.2d 831, 833 (Fed. Cir. 1990).

The opinion particularly rejects the Office's reliance upon and justification of its construction because the patentee used the term "comprising" in the claim.  "The broadest-construction rubric coupled with the term 'comprising' does not give the PTO an unfettered license to interpret claims to embrace anything remotely related to the claimed invention," according to the opinion.  Citing Schriber-Schroth Co. v. Cleveland Trust Co., 311 U.S. 211, 217 (1940) (perhaps on the panel's mind after its extensive citation in the en banc Ariad v. Eli Lilly appeal), the Court held that the Office must always construe claims "in light of the specification and the teachings of the underlying patent."  Here, both the "express language of the claim and the specification" mitigated against the Office's construction, and "require the finishing material to be the top and final layer on the surface being finished."

This opinion certainly provides ammunition for applicants facing unreasonable interpretations of claim terms during prosecution.  It will be interesting to see whether the Office adopts the Federal Circuit's restrictions on unfettered claim interpretation, or continues with its occasional flights of fancy in construing claim terms during prosecution.

In re Suitco Surface, Inc. (Fed. Cir. 2010)
Panel:  Circuit Judges Rader, Prost, and Moore
Opinion by Circuit Judge Rader

Applera Corp. v. Illumina, Inc. (Fed. Cir. 2010)

    By Kevin E. Noonan --

The Federal Circuit waded into the question of patent ownership in a dispute between a patent attorney and Applera-Applied Biosystems over patents involving nucleic acid sequencing technology in Applera Corp. v. Illumina, Inc.  The case is unusual in at least three respects:  the inventor is a lawyer, not a scientist; the patents are substantially prophetic in a technology that is heavily dependent on experimental results; and the dispute was resolved not on the basis of a patent law issue but with the Federal Circuit interpreting the provisions of California employment law.  The result, while nonprecedential, does shed some light on how these issues are intimately dependent on the underlying facts of the inventor's employment as well as the provisions of state law (which, in view of its variability, prevents there being any definite rubrics from this decision for resolving these issues).

The patents at issue were U.S. Patent Nos. 5,750,341; 5,969,119; and 6,306,597 (all three patents are related).  All three name Stephen Macevicz, Ph.D. as inventor.  While employed as a patent attorney for Applera, Dr. Macevicz developed a method for nucleic acid sequencing based on "repeated rounds of ligation and cleavage of oligonucleotide probes."  Claim 1 of the '597 patent is illustrative of these methods:

1.  A method for identifying a sequence of nucleotides in a polynucleotide, the method comprising the steps of:
    (a)  extending an initializing oligonucleotide along the polynucleotide by ligating an oligonucleotide probe thereto to form an extended duplex;
    (b)  identifying one or more nucleotides of the polynucleotide; and
    (c)  repeating steps (a) and (b) until the sequence of nucleotides is determined.

It is undisputed that Dr. Macevicz did not inform Applera of these applications while they employed him.  It is also undisputed that these patents stemmed from related but distinct technology developed by Sydney Brenner, a Nobel Prize-winning biologist for whom Dr. Macevicz had prepared and prosecuted patents for the technology.  (Curiously, he performed this patent prosecution work for Dr. Brenner while being employed by Applera, who apparently had a policy of allowing their patent professionals to take on "outside work.")  Finally, it is undisputed that Applera was given the opportunity to license Dr. Brenner's patents but declined based on its determination that the technology was "'far too expensive' and 'complex and thus not a 'viable commercial product' for Applera."  Thereafter, Applera acquired Agencourt Personal Genomics, which had developed its own "ligation-and-cleavage" sequencing technology and formed the basis of Applera's "SOLiD™ System DNA sequencing technology."  Dr. Macevicz had moved on to Solexa by this time, which licensed both Dr. Brenner's patents as well as Dr. Macevicz's.  The instant lawsuit resulted from Applera filing a declaratory judgment action claiming ownership of Dr. Macevicz's patents, as well as non-infringement and invalidity.

Solexa won jury verdicts in its favor on the ownership issues and that claim 1 of the '119 patent was not invalid, but the jury also determined that this claim was not infringed by Applera.  The District Court denied the parties' motions for JMOL.

The Federal Circuit, in an opinion by Judge Moore joined by Judges Lourie and Gajarsa, considered three contested issues:  patent ownership, non-obviousness of claim 1 of the '119 patent, and claim construction of claim 1 of the '597 patent (which the parties stipulated was not infringed under the District Court's interpretation).  On the ownership issue, the Federal Circuit construed the provisions of Dr. Macevicz's employment agreement with Applera, which provided that Dr. Macevicz was obligated to assign any inventions he developed while employed by Applera unless:

(1)  the invention was developed entirely on his own time;
(2)  "no equipment, supplies, facility, or trade secret of the Company was used in its development"; and
(3)  "(i) it does not relate to the business or actual or demonstrably anticipated research or development of the Company, or (ii) it does not result from any work performed by [him] for the Company."

The jury by special verdict found that Dr. Macevicz satisfied all three of these provisions.  According to the opinion, the first provision was not in dispute.  Dr. Macevicz's satisfaction of the second provision stemmed from the singular nature of his invention -- it was purely prophetic and there was no experimental verification in the specification -- as well as from Dr. Macevicz's sagacity in "detail[ing] his inventions in a laboratory notebook he purchased himself."  There was a secondary issue of whether Dr. Macevicz had utilized any of Applera's trade secrets, specifically the work of an Applera scientist (Dr. Fung), but there was substantial evidence that Dr. Fung's work was unrelated to conception of Dr. Macevicz's invention.

The question to be decided by the panel was whether the jury's determination that the third criterion was satisfied was supported by substantial evidence.  The parties disagreed on whether Dr. Macevicz needed to satisfy only one (Solexa) or both (Applera) provisions of this criterion, i.e., whether Dr. Macevicz's invention did not "relate to the business or actual or demonstrably anticipated research or development of the Company," or did not "result from any work performed by [him] for the Company."  This question came down to a matter of contract interpretation, which the Federal Circuit said was a state law question, subject to the Court's de novo review.  In analyzing this issue, the Court cited a California Court of Appeals case, Cubic Corp. v. Marty, and how that court construed the provisions of a "similar provision" (§ 2870) of the California Labor Code, which reads as follows:

Any provision in an employment agreement which provides that an employee shall assign or offer to assign any of his or her rights in an invention to his or her employer shall not apply to an invention for which no equipment, supplies, facility, or trade secret information of the employer was used and which was developed entirely on the employee's own time, and
    (a)  which does not relate
        (1)  to the business of the employer or
        (2)  to the employer's actual or demonstrably anticipated research or development, or
    (b)  which does not result from any work performed by the employee for the employer.
    Any provision, which purports to apply to such an invention, is to that extent against the public policy of this state and is to that extent void and unenforceable.  Cal. Lab. Code § 2870 (West 1979).

In the Cubic case, the California court held that unless both conditions (a) and (b) were met, the contract was enforceable under California law.  Here, the Federal Circuit distinguished Cubic, deciding that the better view (and one that the panel was not convinced the California Supreme Court would dispute) was to construe the language of the employment agreement according to the plain meaning of its terms.  Thus, the CAFC held that the provisions of the third criterion were in the alternative, i.e., disjunctive not conjunctive, and that if Dr. Macevicz satisfied either provision, then there was substantial evidence to support the jury's determination that he was not obligated to assign his rights to Applera.  The panel found that there was substantial evidence that Dr. Macevicz's inventions did not result from any work he performed for Applera.  This conclusion was supported by the existence of another patent on nucleic acid sequencing Dr. Macevicz obtained before he began working for Applera, refuting Applera's contention that his work for them was the basis for conception of the inventions disclosed and claimed in the patents-in-suit.

The non-obviousness question regarded claim 1 of the '119 patent:

1.  An oligonucleotide probe of the formula:

HO—(3')(B)j(5')—OP(=O)(O—)NH—(B)k-Bt*

wherein:
B is a nucleotide or an analog thereof;
j is in the range of from 1 to 12;
k is in the range of from 1 to 12, such that the sum of j and k is less than or equal to 12;
Bt* is a labeled, nonextendable chain terminating moiety.

It was not disputed that the prior art disclosed every aspect of the oligonucleotide recited in this claim except that the chain-terminating moiety, Bt, comprised a label.  Also undisputed was that labeled oligonucleotides were known in the prior art.  The question of whether the skilled worker would have been motivated to combine these references (or, in the language of KSR v. Teleflex, whether there would have been a reasoned basis to do so) was presented to the jury as a factual question, with each parties' contentions supported by expert testimony.  According to the Federal Circuit, "[t]he jury apparently found the testimony of Solexa's expert more credible.  We will not disturb its verdict."

Finally, regarding construction of claim 1 of the '597 patent (set forth above), the issue before the Court was the meaning of the following terms:

• "extending an initializing oligonucleotide along the polynucleotide by ligating an oligonucleotide probe thereto to form an extended duplex" in step (a);
• "identifying" in step (b) and
• "repeating steps (a) and (b) until the sequence of nucleotides is determined" in step (c).

Solexa argued that the first term must be interpreted to mean that "each oligonucleotide probe must be ligated to an initializing nucleotide during repetition of the cycle" rather than that "the oligonucleotide probe can be ligated to an extended duplex (an initializing probe that has already been extended by an oligonucleotide probe)."  The District Court disagreed, interpreting the claim to require that "step (a) includes an extension process, whereby, with each repetition, an additional probe is added to what is already there, so that the chain gets longer and longer."  In construing the claim in agreement with the District Court, the Federal Circuit referenced the specification, "which repeatedly describes regenerating an extendable end on the extended duplex to allow for successive cycles of ligation."

Regarding the meaning of the term "identifying" in step (b) of the claimed method, the District Court construed the term to mean that "at least one nucleotide [is] identified during step (b), that is, its identity as an A, G, C or T must be determined."  The Court also construed step (c) as requiring such identification to occur during each cycle of repeating steps (a), (b) and (c).  Solexa argued that the use of the word "comprising" meant that the method could be practiced in such a way that the identifying step was "skipped" in some iterations of the method, and then multiple nucleotides identified by the end of the process.

The Federal Circuit disagreed with Solexa's interpretation, citing Dippin' Dots, Inc. v. Mosey, 476 F.3d 1337, 1343 (Fed. Cir. 2007) that "'[c]omprising' is not a weasel work with which to abrogate claim limitations."  Again consulting the specification, the panel held that the invention was described as comprising repeated cycles of the steps (a), (b) and (c), and that "in order to repeat steps (a) and (b)" (as required in step (c)), "one must actually perform step (b)."  Moreover, the Court cited the prosecution history of the '597 patent to reject Solexa's construction of step (c), affirming the District Court's construction giving the words of claim step (c ) their ordinary and customary meaning.

Applera Corp. v. Illumina, Inc. (Fed. Cir. 2010)
Nonprecedential diposition
Panel: Circuit Judges Lourie, Gajarsa, and Moore
Opinion by Circuit Judge Moore

District Court Judge Provides Another Reminder of Dysfunctional State of the Federal Circuit's Claim Construction Jurisprudence

Trading Technologies Int'l. Inc.  v. eSpeed Inc. (Fed. Cir. 2010)

    By Kevin E. Noonan --

In an otherwise unremarkable affirmance of jury verdicts and district court decisions on claim construction, the nascent Chief Judge of the Federal Circuit, Randall Rader, and District Court Judge Ron Clark (E.D Tex.) sitting by designation, provided remarkably similar views on the negative consequences of the de novo review standard for claim construction enunciated 13 years ago by the en banc court in Cybor Corp. v. FAS Technologies, Inc.  That standard, whereby the appellate court gives no deference to the underlying factual determinations made by the district court in construing claims, is widely recognized as resulting in less than optimal administration or development of U.S. patent jurisprudence.

In the majority opinion, written by Judge Rader (at left), the panel reviews the development of the standard by the Federal Circuit stemming from the Supreme Court's decision in Markman v. Westview Instruments, Inc.  "The Supreme Court recognized that claim construction 'falls somewhere between a pristine legal standard and a simple historical fact,' Id. at 388 (quoting Miller v. Fenton, 474 U.S. 104, 114 (1985))" said the CAFC.  In addition, the opinion noted that the Supreme Court characterized claim construction as "not a purely legal matter," but "found 'sufficient reason to treat construction of terms of art like many other responsibilities that we cede to a judge in the normal course of trial, notwithstanding its evidentiary underpinnings.' Id. at 390."  Nevertheless, however, the Federal Circuit "interpreted Markman as holding that claim construction was solely a question of law, which this court should review without deference," citing Cybor Corp. v. FAS Technologies, Inc., 138 F.3d 1448, 1451 (Fed. Cir. 1998) (en banc).  The opinion restates the question presented to the Supreme Court in Markman as involving whether a litigant had a Seventh Amendment right to a jury determination of claim scope as the "the meaning of any disputed term of art about which expert testimony is offered."  The opinion states that the Federal Circuit, in responding to Markman, understood the Supreme Court to have determined whether claim construction was a matter of fact or law, and rejected the view that "the Court endorsed a silent, third option -- that claim construction may involve subsidiary or underlying questions of fact," that may permit some deference to be given to factual determinations made by the district court judge.

The opinion then dissects the Supreme Court's Markman opinion with regard to the "factual components of claim construction:"

• "[C]onstruing a term of art following receipt of evidence" is "a mongrel practice."  Id. at 378.
• Claim construction "falls somewhere between a pristine legal standard and a simple historical fact."  Id. at 388.
• "We accordingly think there is sufficient reason to treat construction of terms of art like many other responsibilities that we cede to a judge in the normal course of trial, notwithstanding its evidentiary underpinnings."  Id. at 390.

"These references in the Supreme Court opinion," according to Judge Rader, "leaves this court stranded between the language in the Court's decision and the language in this court's Cybor decision."

Turning to the case before it, the panel reviewed the factual findings made by the District Court, including the "technical background of the invention," the meaning of the claim terms at issue as understood by the "ordinary artisan," and the way that artisan would "interpret the patent applicant's statements made to the PTO examiner during [patent] prosecution."  "In sum," the court opined, "claim construction involves many technical, scientific, and timing issues that require full examination of the evidence and factual resolution of any disputes before setting the meaning of the disputed terms."  However,

[d]espite the Supreme Court's emphasis on the trial court's central role for claim construction, including the evaluation of expert testimony, this court may not give any deference to the trial court's factual decisions underlying its claim construction.  This court's prior en banc decision requires a review of the district court's claim construction without the slightest iota of deference.  See Cybor, 138 F.3d at 1451.

With that introduction, the opinion reviewed and affirmed the District Court's claim construction.

Judge Clark provided a district court's perspective in a separate concurring opinion.  While agreeing with the result, Judge Clark states his purpose in writing separately was "to respectfully suggest that the current de novo standard of review for claim construction may result in the unintended consequences of discouraging settlement, encouraging appeals, and, in some cases, multiplying the proceedings."  The task of construing a claim frequently requires a district court to determine "crucial facts" and may depend on the weight given conflicting evidence and sometimes evaluating the credibility of expert testimony.  The standard of review, according to Judge Clark, "sets one of the important benchmarks against which competent counsel evaluates decisions regarding settlement and appeal," uniquely addressing consequences of the Federal Circuit's de novo review standard on litigation behavior (rather than merely litigation strategy).

The Judge sets forth two "practical" results of this standard, neither of which "furthers the goal of the 'just, speedy, and inexpensive determination of every action and proceeding.' Fed. R. Civ. P. 1."  The first of these is that settlement becomes more difficult to negotiate, and appeal "almost compelled," when it is even "debatable" that a client's position on claim construction is valid.  The Judge says it is "a natural reaction" to believe that the Federal Circuit, having generally more experience with patent cases, will better understand the facts underlying a party's claim construction arguments, and under the court's "own authoritative rule" will review claim construction "without regard to any determination the lower court has made."  "What public policy," Judge Clark asks, "is advanced by a rule requiring the determination of underlying facts by more than one court?"

A second consequence of the Court's refusal to give any deference to the district court in claim construction (albeit less common according to Judge Clark) is that a party may "present [its] case with an eye towards appeal rather than the verdict."  This may occur, for example, when "[s]killed counsel" recognize that her client "may not be well received by a jury," and hence may be motivated to introduce error into claim construction at the district court or limit the extent of argument she presents to the district court during claim construction.  This would permit a litigant to present the "most sharply focused argument" on appeal rather than in the district court.  These tactics, constituting some measure of gaming the system and introducing inefficiencies to that system, would be "less inviting if the district court's claim construction was officially accorded some measure of deference," even only if applied to the relatively rare cases where reference to extrinsic evidence was required.

These sentiments are reminiscent of the dissenting opinion of District Court Judge Vaughn R. Walker, Chief Judge, U.S. District Court for the Northern District of California, sitting by designation, in Medegen MMS, Inc. v. ICU Medical Inc. (Fed, Cir. 2008) (see "Claim Construction at the Federal Circuit: A District Court Judge's View").  In that case, Judge Walker pointed out rather more sharply than Judge Clark the "conundrum" faced by district courts arising from the "twin axioms" of claim construction:  "[o]n the one hand, claims 'must be read in view of the specification'," citing Markman, while "[o]n the other hand, it is improper to read a limitation from the specification into the claims," citing Arlington Indus. Inc. v. Bridgeport Fittings, Inc.  Judge Walker reminded the Court that these axioms "themselves seldom provide an answer, but instead merely frame the question to be resolved."  While recognizing the sound policy reasons for a patent drafter to be required to include "all claim limitations in the claims of a patent," he also admonished that "patents must be read as well as written."  Citing Phillips, he asserted that this analysis must be performed with due consideration of a term's "ordinary and customary meaning" informed by the "context of the entire patent, including the specification."

Both Judge Walker's dissent and Judge Clark's concurrence remind the Federal Circuit of the essential paradox of its practice under Cybor:  by giving no deference to factual determinations by district courts in claim construction, the Federal Circuit must substitute its judgment for that of trial court judges more accustomed to make factual determinations "not well suited to appellate review."

In his dissent from the en banc opinion in Cybor, Judge Rader performed a rough calculus on the fate of district court claim construction determinations at the Federal Circuit in 1997.  He found that the Court reversed claim construction 53% of the time (27% reversed completely, 26% reversed-in-part).  Current academic research suggests that Federal Circuit reversal rates of district court claim construction has "improved" to 30-40%.  This may reflect the vagaries of district court claim construction determinations, being done by courts having various levels of experience in patent cases.  On the other hand, each panel of the Federal Circuit resolves claim construction issues idiosyncratically (depending, as it must, on the particular terms that must be construed in each case and the intrinsic evidence available to the Court in each case).  While there may be some degree of consistency that arises from having the Federal Circuit make the final decision on claim construction, there are also inconsistencies and inefficiencies produced by the Court's review standard, as set forth by Judge's Walker and Clark.  Judge Lourie has suggested a middle ground, that rather than giving any formal deference to district court claim construction the CAFC should exercise judicial restraint from reversing the district court unless there is "strong conviction of error."  Phillips v. AWH Corp.  It may be time for the Federal Circuit to consider again this option.

Sanofi-Aventis U.S. LLC v. Sandoz, Inc. (Fed. Cir. 2009)

More Claim Construction Confusion from the Federal Circuit

    By Kevin E. Noonan --

The Federal Circuit demonstrated once again the quagmire that can exist when lower courts attempt to apply the CAFC's rather quixotic jurisprudence on claim construction.

The case, Sanofi-Aventis U.S. LLC v. Sandoz, Inc.⁽¹⁾, arose as the result of ANDA filings by several Defendants for oxaliplatin, the active ingredient in Sanofi's Eloxatin® colorectal cancer drug.  Two claims of the patent at issue, U.S. Patent No. 5,338,874, were asserted against the Defendants:

1.  Optically-pure cis-oxalato(trans-l-1,2-cyclohexanediamine) Pt(II) having the general formula of Formula (1).

(Dependent claim 2 merely added a melting point limitation and was not further at issue in the case.)  The question decided by the Federal Circuit on appeal was whether the claim term "optically pure" included an affirmative limitation that "optically pure oxaliplatin" had been "resolved by means of the HPLC method described" in the specification of the '874 patent.

The District Court had decided that this term did include the limitation.  While admitting that "[t]here was no dispute that nothing on the face of the claims of the '874 patent limit[ed] the claims to 'optically pure oxaliplatin that is produced through the use of HPLC," the District Court identified statements in the prosecution history and disclosure in the specification that supported its interpretation.  Specifically, the District Court was persuaded that Sanofi had distinguished an asserted prior art reference (Kidani et al.) that purported to disclose "a single isomer [of oxaliplatin] useful as an antitumor agent" by arguing that the optical purity of the oxaliplatin in the reference was only 90%.  According to the District Court, Sanofi stated during prosecution that "[o]nly after HPLC resolution (in accordance with the teachings of the present application) was optical purity obtained."  In addition, the District Court pointed to portions of the specification that compared the optical purity of oxaliplatin prepared according to prior art methods contained in the asserted reference with the optical purity of Sanofi's molecule after resolution by HPLC.  To the District Court, these distinctions were sufficient to require that the claim term "optically pure oxaliplatin" describe only oxaliplatin resolved to optical purity by HPLC.  Accordingly, since the Defendants did not use HPLC to resolve oxaliplatin to optical purity, the District Court granted summary judgment of non-infringement.

The Federal Circuit disagreed with the lower court's claim construction.  In a unanimous (albeit nonprecedential) opinion by Judge Moore, joined by Judges Linn and Prost, the Court found that the patentee had not disclaimed all embodiments of optically pure oxaliplatin except those resolved by HPLC.  The Court opined as follows:

We have repeatedly warned of "the danger of reading limitations from the specification into the claim."  See, e.g., Phillips, 415 F.3d at 1323.  "Absent a clear disavowal or contrary definition in the specification or the prosecution history, the patentee is entitled to the full scope of its claim language."  Home Diagnostics, Inc. v. Lifescan, Inc., 381 F.3d 1352, 1358 (Fed. Cir. 2004).  To narrow the plain language of a claim, a disclaimer must be clear and unmistakable.  Cordis Corp. v. Boston Scientific Corp., 516 F.3d 1319, 1329 (Fed. Cir. 2009).  We see no such disclaimer in the specification or prosecution history of the '874 patent.

The Court also disagreed that claim 1 of the '874 patent was a product-by-process claim:

The district court relied on Andersen Corp. v. Fiber Composites, L.L.C., 474 F.3d 1361 (Fed. Cir. 2007), when construing claim 1 as a product-by-process claim.  In Andersen, this court held that claims to composite structures included a pelletizing process limitation where the patentee relied on that process both to define the invention and to distinguish the prior art.  . . .  We determined that the specification attributed the claimed physical properties to the process and that the specification indicated that the pelletizing step was a requirement, not a preference, of the invention.  . . .  We further determined that the patentee had clearly disavowed other processes during prosecution.  . . . [emphasis added]

By contrast, here, the patent specification and prosecution history focus on the property of the composition (optical purity) and not the process used to obtain that property.  . . .  The specification never asserts that HPLC is required to obtain optically pure oxaliplatin.  It characterizes HPLC as an "illustrative method" and a "representative process" by which the claimed compound "may be prepared".  . . .  Moreover, the specification does not define the property (optical purity) by reference to the process of purification by HPLC.  Thus nothing in the specification limits the invention to optically pure oxaliplatin purified using HPLC.

The prosecution history also illustrates that it is the optical purity of oxaliplatin that distinguished it from the prior art, not the process used to obtain that purity.  The Examiner rejected the initially filed claims to oxaliplatin "of optically high purity" as anticipated or rendered obvious by Kidani.   The Examiner stated that Kidani disclosed "a single isomer [oxaliplatin] useful as an antitumor agent.  Note that since the single isomer complex was prepared, the optical purity of such material is very high or almost pure isomer."  In response, the applicant . . . explained that it had repeated Kidani's process "using identical reactant materials and the subsequent testing thereof. . . . The resultant material was tested and found to be 90% [oxaliplatin] not optically pure . . . ."  Sanofi explained that "[o]nly after HPLC resolution (in accordance with the teachings of the present application) was optical purity obtained."  Sanofi further asserted that the products prepared using Kidani's method "do not have the presently claimed optical purity."  Therefore, Sanofi argued that the claimed oxaliplatin "having high optical purity[] is not found or taught in the prior art either by inherency or by being obvious thereover."  Following a telephone interview, Sanofi agreed to amend the claims to "optically pure" oxaliplatin, rather than oxaliplatin "of high optical purity."  The Examiner entered the amendment and allowed the claims, stating that "[t]he Examiner agrees with applicants that Kidani et al. does not teach[] the cis-oxalato(trans-l-1,2-cyclohexanediamine)Pt(II) as an optically pure isomer.  It is clear from Kidani et al. that also other isomers can be in the final product."  Thus, Sanofi argued that the defining feature of the claimed oxaliplatin was its optical purity, not the HPLC process.  Nothing in the prosecution history amounts to a clear and unmistakable disclaimer of optically pure oxaliplatin prepared using other (non-HPLC) processes.  [emphasis added].

The Federal Circuit vacated the District Court judgment of non-infringement and remanded the case to the lower court.

The panel's opinion illustrates how difficult it is for a district court to implement supposedly straightforward rubrics such as those enunciated by the en banc court in Phillips v. AWH Corp.  The District Court's reasoning was based on understanding the plain meaning of the term "optically pure," a phrase that has no plain meaning outside its specialized meaning in the chemical arts.  The District Court looked to the specification and the prosecution history to identify how the patentee defined the term, and in the absence of an express definition used the examples in the specification and the arguments and amendments made during prosecution to construe the claim term "optically pure" to require that optical purity must be achieved using HPLC.  The Federal Circuit disagreed and substituted its judgment for the lower court's, a commonplace occurrence.

The outcome brings to mind the dissenting opinion of District Court Judge Vaughn R. Walker, Chief Judge, U.S. District Court for the Northern District of California, sitting by designation, in Medegen MMS, Inc. v. ICU Medical Inc. (Fed, Cir. 2008) (see "Claim Construction at the Federal Circuit: A District Court Judge's View").  In that case, Judge Walker asserted that claim construction presented "a conundrum" to district courts.  This conundrum arose from these "twin axioms" of claim construction:  "[o]n the one hand, claims 'must be read in view of the specification'," citing Markman, while "[o]n the other hand, it is improper to read a limitation from the specification into the claims," citing Arlington Indus. Inc. v. Bridgeport Fittings, Inc.  The problem with these axioms, according to Judge Walker, is that "the axioms themselves seldom provide an answer, but instead merely frame the question to be resolved."  While recognizing the sound policy reasons for a patent drafter to be required to include "all claim limitations in the claims of a patent," he also admonished that "patents must be read as well as written."  Citing Phillips, he asserted that this analysis must be performed with due consideration of a term's "ordinary and customary meaning" informed by the "context of the entire patent, including the specification."

Judge Walker's dissent raised the essential paradox of the Federal Circuit's practice under Cybor Corp. v. FAS Technologies, Inc. of giving no deference to claim construction by district courts:  "[a]s a jurist more accustomed to working on the front lines of patent litigation than reviewing decisions from above, it is my experience that claim construction -- determining how one of ordinary skill in the art would understand the patent at the time of invention -- often requires making fact-like determinations not well suited to appellate review."  The "uniformity and predictability" desired by the CAFC as a general, guiding principle is not always best served in the individual determinations necessary to construe claim terms.  In this he cited with approval Judge Lourie's point in Phillips, that while there is (and perhaps cannot be) formal deference by the CAFC to a district court's claim construction, it is better policy for the Federal Circuit to affirm "in the absence of a strong conviction of error."

Current academic research suggests that Federal Circuit affirmance rates of district court claim construction has "improved" to from 60-70%.  However, each Federal Circuit panel addresses, and resolves, specific claim construction issues in any particular case in its own way, introducing the kind of uncertainty that the Federal Circuit was created to curtail.  The inconsistencies resulting from the Federal Circuit's "no deference" standard of review can be expected to continue to produce the type of results decried by Judge Walker in Medegen and, arguably, that were obtained in Sanofi-Aventis v. Sandoz.

⁽¹⁾ Additional defendants included Teva Parenteral Medicines, Inc., Teva Pharmaceuticals USA, Inc., and Pharmachemie BV; Mayne Pharma Ltd., Mayne Pharma (USA) Inc,, Hospira Australia Pty Ltd., and Hospira, Inc.; W.C. Heraeus GMBH; APP Pharmaceuticals, Inc. and Abraxis Bioscience, Inc.; Actavis Totowa LLC, Actavis, Inc. and Actavis Group HF; Fresenius Kabi Oncology PLC and Fresenius Kabi Pharma Ltd.; Sun Pharmaceutical Industries Ltd. and Caraco Pharmaceutical Laboratories, Ltd.; Ebewe Pharma GES.M.B.H. NFG HG; and Mustafa Nevzat Ilac Sanayii A.S., Par Pharmaceutical Companies, Inc. and Par Pharmaceutical, Inc.

Sanofi-Aventis U.S. LLC v. Sandoz, Inc. (Fed. Cir. 2009)
Nonprecedential disposition
Panel: Circuit Judges Linn, Prost, and Moore
Opinion by Circuit Judge Moore

University of Pittsburgh v. Hedrick (Fed. Cir. 2009)

For Stem Cells, It Seems That Conception Is Enough

    By Kevin E. Noonan --

On Thursday, the Federal Circuit affirmed a District Court determination that the University of Pittsburgh had established, by clear and convincing evidence, that four inventors had been improperly named in U.S. Patent No. 6,777,231 and granting judgment correcting inventorship under 35 U.S.C. § 256.  In doing so, the Court's decision raised a paradox with regard to conception of biological inventions (albeit while not making any new law in the process).

The facts of the case, as set forth in the Patent Docs report on the District Court decision, illustrate the influence patenting can have on academic collaboration.  As granted, the '231 patent named Adam J. Katz, Ramon Llull, William J. Futrell, Marc H. Hedrick, Prosper Benhaim, Hermann Peter Lorenz, and Min Zhu as inventors, with Katz, Llull, and Futrell having assigned their rights to the University of Pittsburgh and the remaining named inventors assigning their rights to the Regents of the University of California.

The District Court found that Dr. Katz had isolated adipose-derived stem cells, and that Drs. Katz and Llull conceived that these cells could be induced to differentiate into cells from multiple mesodermal lineages, "including bone, cartilage, fat and muscle."  The Court credited evidence from laboratory notebooks that Drs. Katz and Llull showed their adipose-derived stem cells could differentiate into several different cell types, including adipose cells, nerve cells, and muscle cells.  According to the District Court's Findings of Fact, Dr. Katz also "appreciated" the capacity of these adipose-derived stem cells for self-renewal.  The Court found that the earliest date of conception for the invention claimed in the '231 patent was 1996, a date several years before work began at UCLA.

The Federal Circuit recited the following facts which are relevant to the panel decision:

• The Pittsburgh inventors (Katz and Llull) discovered in 1996 that certain cells from adipose tissue could de-differentiate into fibroblast-like cells and back again to adipose-like cells.

• In 1997, these researchers "explored the idea" that these cells could "transdifferentiate" into other cell types, including bone, cartilage, and muscle, and that Dr. Katz's laboratory notebooks showed experiments on different media formulations that could induce adipose-derived cells to differentiate into bone, muscle, fat, cartilage, and nerve cells; however, these notebooks also established that this differentiation was "not scientifically certain," but the cells were observed to change into muscle and fat cells and maybe into nerve cells.

• At that time, they recognized from the work of others that mesenchymal stem cells can do this too, but these isolated by others from bone marrow.

• "By April 1997, they [the Pittsburgh inventors] had the firm and definite idea that the cells were human, could be genetically modified, secreted hormones, and contained cell-surface bound intracellular signaling moieties, all properties known at the time to scientists in the field."

• A UCLA scientist (Hedrick) was on a one-year fellowship to Dr. Katz's laboratory in 1997, but was not named on a grant proposal on adipose-derived stem cells submitted at that time or in laboratory notebooks on these stem cells.

• Dr. Hedrick did write his own proposal on using these cells.

• An invention disclosure was submitted to the University of Pittsburgh naming the Pittsburgh inventors and Hedrick, stating the invention was isolated cells that could be induced to transform into fat, bone, cartilage, and muscle cells.

• When Dr. Hedrick returned to UCLA after his fellowship in Dr. Katz's lab, he formed the Regenerative Bioengineering and Research ("REBAR") laboratory with the other UCLA inventors.

• Dr. Hedrick and the REBAR group worked on the same cells as the Pittsburgh group, and "determined that the adipose-derived cells were distinct from the prior art bone marrow-derived mesenchymal stem cells because they responded differently to induction media.  They also identified various media to induce differentiation in the cells, and identified the presence of an enzyme that is indicative of stem cells in a heterogeneous stromal vascular fraction population.  In late 1999 and early 2000, the REBAR lab successfully cloned single adipose-derived cells."

• In March 1999, a provisional patent application was filed by the University of Pittsburgh that named Hedrick as well as the Pittsburgh inventors; a second provisional application was filed in October 1999 naming the same inventors.

• In February 2000, Dr. Hedrick submitted an invention disclosure to UCLA for adipose tissue-derived stem cells, and included the nerve cell embodiments even though he "had not conducted any nerve differentiation experiments."

• In March 2000, an International Patent Application was filed by Pittsburgh naming all the Pittsburgh and UCLA inventors; this is the application that issued as USP 6,777,231.

The '231 patent was granted with the following claims:

1.  An isolated adipose-derived stem cell that can differentiate into two or more of the group consisting of a bone cell, a cartilage cell, a nerve cell, or a muscle cell.

2.  An isolated, adipose-derived multipotent cell that differentiates into cells of two or more mesodermal phenotypes.

3.  An isolated adipose-derived stem cell that differentiates into two or more of the group consisting of a fat cell, a bone cell, a cartilage cell, a nerve cell, or a muscle cell.

4.  An isolated adipose-derived stem cell that differentiates into a combination of any of a fat cell, a bone cell, a cartilage cell, a nerve cell, or a muscle cell.

5.  A substantially homogeneous population of adipose-derived stem cells, comprising a plurality of the stem cell of claim 1, 3 or 4.

6.  The adipose-derived stem cell of claim 1, 3 or 4 which can be cultured for at least 15 passages without differentiating.

7.  The adipose-derived stem cell of claim 1, 3 or 4 which is human.

8.  The cell of any of claim 1, 3 or 4 which is genetically modified.

9.  The cell of any of claim 1, 3 or 4, which has a cell-surface bound intercellular signaling moiety.

10.  The cell of any of claim 1, 3 or 4, which secretes a hormone.

The Federal Circuit's opinion, by Judge Mayer joined by Judges Rader and Bryson, considered two questions:  claim construction and inventorship.  Regarding claim construction, the Court affirmed the District Court's determination that the claim term "adipose-derived" had its plain meaning as "derived from fat tissue," and rejected the construction proposed by the REBAR inventors that the term should mean "species of stem cell distinct from the mesenchymal stem cell that is obtainable from bone marrow tissue."  The REBAR inventors had determined that adipose-derived stem cells were distinct from mesenchymal stem cells from bone marrow, and thus their construction excluded such bone-marrow derived stem cells that may have migrated to adipose tissue.  The District Court had agreed that the specification distinguished bone marrow from adipose tissue derived stem cells, but only with regard to culture conditions and not that the cells represent "separate species."  The District Court was not persuaded that the different culture and isolation conditions necessitated that the adipose derived stem cells are different from bone marrow-derived mesenchymal stem cells.  The Federal Circuit agreed, and opined that neither the specification (where the term was not expressly defined) nor the prosecution file history supported REBAR inventors' construction.  Specifically with regard to the file history argument, the REBAR inventors contended that an amendment proposed by the Pittsburgh inventors (to recite "adipose-derived" in the claims) was a disclaimer of mesenchymal stem cells isolated from fat that would read on prior art stem cells.  The panel noted, however, that this amendment was never submitted, since the inventors submitted instead a paper from the REBAR group showing that the cells were different.  The panel refused to find a disavowal of subject matter under these circumstances:

A wide chasm exists between the weak inference from the summary that adipose-derived stem cells in this invention must be a different species from mesenchymal stem cells and a clear and unmistakable disavowal as required to limit a claim term.

Turning to inventorship, the panel recited the following fundamental principles:

An inventor need not know that his invention will work for conception to be complete.  Price v. Symsek, 988 F.2d 1188, 1196 (Fed. Cir. 1993).  . . .  He need only show that he had the complete mental picture and could describe it with particularity; the discovery that the invention actually works is part of its reduction to practice.  Id.  In a joint invention, each inventor must contribute to the joint arrival at a definite and permanent idea of the invention as it will be used in practice.  Burroughs Wellcome Co. v. Barr Labs, Inc., 40 F.3d 1223, 1229 (Fed. Cir. 1994).

In this panel's view, the district court had applied these principles properly:

The district court correctly applied this law, finding clear and convincing evidence that Katz and Llull conceived of each claim of the invention through contemporaneous corroboration before the arrival of Hedrick at Pittsburgh in July 1997.  It found that they had recorded that their cells could transdifferentiate into multiple mesodermal lineages including bone, cartilage, fat and muscle in laboratory notebooks, letters, a January 1997 invention disclosure for their Auto-Cell Separator, the February 1997 document "What's So Great About Fat?," and the inference that Katz would have only conducted his muscle induction experiment on the cells to confirm his belief that they could differentiate into muscle instead of adipocytes.  They had recorded that their isolated cells transdifferentiated into cells resembling a nerve cell in April 1997, as was recorded in a letter to a colleague requesting his help with electrophysiological techniques.  While not scientifically certain that they were observing a nerve cell, they did have the firm and definite idea that nerve cells were present, and ordered further confirming tests.  Claims 1, 2, 3, and 4 require an isolated adipose-derived stem cell that can differentiate into two or more mesodermal phenotypes, including specifically a fat cell, a bone cell, a cartilage cell, a nerve cell, a muscle cell, or a combination of these.  Thus, the entire invention as described by claims 1, 2, 3, and 4 had been conceived and corroborated through these disclosures.

The panel also opined that other limitations recited in the claims, such as the requirement for a substantially homogeneous population of cells (claim 5), the capacity of the cells for self-renewal (claim 6), that the cells must be human (claim 7), could be genetically-modified (claim 8), secreted hormones (claim 9), and contained cell-surface bound intracellular signaling moieties (claim 10) were all "grasped" by Drs. Katz and Llull by April 1997 (at a time prior to Dr. Hedrick beginning his fellowship), at least in part because the scientists in the field recognized that stem cells had these features and capacities.

The panel rejected the REBAR inventors' contentions that the Pittsburgh inventors' research was "inconclusive," "highly speculative," and not fully realized until their owen contribution to the work.  Citing Coleman v. Dines, 754 F.2d 353 (Fed. Cir. 1985), the REBAR inventors argued that an inventor must "know" that the invention contained every limitation of each claim at the time of conception.  The panel characterized these assertions as a "misapprehension of what it means to 'know' the limitations of the claims."  The District Court found that Katz's laboratory notebooks sufficiently described to those skilled in the art how to isolate the cells from adipose-tissue, at which point they would be in possession of the invention, and the Federal Circuit agreed.  Specifically, the Court stated that:

Knowledge in the context of a possessed, isolated biological construct does not mean proof to a scientific certainty that the construct is exactly what a scientist believes it is . . . .  Proof that the invention works to a scientific certainty is reduction to practice . . . .  The determinative inquiry is not whether [the inventor's] disclosure was phrased certainly or tentatively, but whether the idea expressed therein was sufficiently developed to support conception of the subject matter.  In re Jolley, 308 F.3d 1317, 1324 (Fed. Cir. 2002).  . . .  Evidence need not always expressly show possession of the invention to corroborate conception, and a court may properly weigh evidence that a claimed attribute is merely an obvious property of a greater discovery at issue.  Burroughs Wellcome Co. v. Barr Labs, Inc., 40 F.3d 1223, 1231 (Fed. Cir. 1994).

This determination is consistent with well-established law regarding conception.  For example, in Burroughs Wellcome Co. v. Barr Labs, Inc., the Burroughs Wellcome defendants argued that for an invention in an "uncertain or experimental discipline, where the inventor cannot reasonably believe an idea will be operable until some result supports that conclusion," conception occurs only when there is experimental confirmation that the invention works for its intended purpose.  The Federal Circuit was clear, stating: "[b]ut this is not the law.  An inventor's belief that his invention will work or his reasons for choosing a particular approach are irrelevant to conception.  Id., citing MacMillan v. Moffett, 432 F.2d 1237, 1239, 167 U.S.P.Q. 550, 552 (CCPA 1970)."  This is sufficient for conception, unless there is evidence of subsequent experimental failure:  "[a] conception is not complete if the subsequent course of experimentation, especially experimental failures, reveals uncertainty that so undermines the specificity of the inventor's idea that it is not yet a definite and permanent reflection of the complete invention as it will be used in practice.  Id. at 1229, citing Rey-Bellet v. Engelhardt, 493 F.2d 1380, 1387, 181 U.S.P.Q. 453, 457-58 (CCPA 1974)."

However, this decision, and the well-established reasoning behind it, does lead to at least an anomaly if not an outright paradox when it comes to biological inventions.  Here, the inventors "conceived" of a stem cell derived from adipose tissue that could be induced to differentiate into bone, muscle, fat, and nerve tissue on the basis of (1) isolating cells that could de- and transdifferentiate; (2) some but admittedly inconclusive evidence that these cells could be induced to differentiate under certain experimental conditions; and (3) the "a definite and permanent idea" of adipose-derived stem cells.  In contrast, other biological inventions, such as nucleic acids, have been held to require simultaneous conception and reduction to practice, in view of their inherent complexity (see Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200 (Fed. Cir. 1991)).  It seems anomalous that cells, which are inherently more complex than nucleic acids should be capable of being conceived more easily and to require less knowledge about their properties (except what can be "definitely and permanently" fixed in the mind of the inventor (and corroborated by documentary evidence).  Perhaps an answer to the paradox is that this case is limited to determining who should be named as inventors, i.e., who conceived of the invention.  Unlike the situation in an interference, neither the District Court nor the Federal Circuit address when the Pittsburgh inventors could describe the cells sufficiently or produce and differentiate them reliably, activities both courts classified as being part of reduction to practice and hence irrelevant to the question before them (see, e.g., Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326 (Fed. Cir. 2005)).  The Federal Circuit's decision made abundantly clear that the rubrics for deciding inventorship in the relatively complex biological arts are no different than for any other art, and that conceiving the existence of a cell like a stem cell is enough (so long as subsequent attempts to reduce the invention to practice do not contradict this presumption).

University of Pittsburgh v. Hedrick (Fed. Cir. 2009)
Panel: Circuit Judges Mayer, Rader, and Bryson
Opinion by Circuit Judge Mayer

Agilent Technologies, Inc. v. Affymetrix, Inc. (Fed. Cir. 2009)

    By Kevin E. Noonan --

The Federal Circuit clarified the role of the written description requirement in interference practice today in an opinion by Judge Rader, one of the Court's most severe critics of its written description jurisprudence.  Unlike the situation where the written description requirement is used to invalidate patents (which is the subject of a petition for en banc review in Ariad v. Eli Lilly), Judge Rader's decision confirms that the written description requirement is particularly relevant to the essential interference question of inventive priority.

The interference at issue was declared against U.S. Patent No. 6,513,968 to Schembri and assigned to Agilent, and U.S. Patent Application Serial No. 10/619,244 to Besemer and assigned to Affymetrix.  Affymetrix provoked the interference by copying claims from the '968 patent; because Affymetrix's application was awarded the earliest priority date, Besemer was declared the senior party, placing the burden of establishing priority on Agilent.

The interference count was identical to claim 20 of the Schembri patent and claim 66 of the Besemer application:

A method comprising:
    providing a first substrate and a second substrate having inner surfaces that define a closed chamber therebetween, said chamber adapted to retain a quantity of fluid so that the fluid is in contact with both inner surfaces, and wherein at least one of said inner surfaces is functionalized with polynucleotides, polypeptides, or polysaccharides;
    introducing a fluid containing a plurality of components into the closed chamber so as to provide a quantity of fluid therein in contact with both inner surfaces;
    providing a bubble in the fluid; and
    moving a bubble within the fluid to result in mixing.

As explained in the opinion, Agilent's Schembri patent disclosed a microarray hybridization method performed in a closed chamber in which probe sequences were attached to one or both of two opposing surfaces on the interior of the chamber.  Because of the small volumes of fluid used for hybridization, mixing was effected by producing  bubbles in the fluid (by heating) and using motion of the bubbles in response to a temperature gradient to "cause the bubble to move and mix the fluid sample in the closed chamber," as illustrated in Figures 1 and 4 of the '968 patent:

The Besemer application, on the other hand, disclosed microarrays contained in a chamber operably linked to "circulator" embodiments comprising reservoirs from which hybridization fluid was pumped through the hybridization chamber to effect mixing, as illustrated in Figure 28 (at right).

Alternatively,  the microarrays were contained in a chamber that was agitated at 3000 cycles per minute as shown in Figure 29 (at left).

During interference proceedings in the Patent Office, Agilent challenged the Besemer claim in interference for failure to satisfy the written description requirement of 35 U.S.C. § 112, first paragraph.  The Board disagreed on the grounds that "Schembri had not advanced any 'meaningful evidence' to show that one of ordinary skill in the art would not have understood Besemer's specification to inherently disclose using bubbles to mix fluid in a closed chamber, as required by Besemer's claim 66.  Board Decision, slip op. at 28," awarded priority to the Besemer application and cancelled Schembri's '968 patent.  Agilent appealed, filing an action in the District Court for the Northern District of California pursuant to 35 U.S.C. § 146.  In that action, both parties submitted new expert reports concerning the disclosures of the '968 Schembri patent and the Besemer application.  After holding a claim construction hearing and considering summary judgment motions from both parties, the District Court affirmed the Board's decision that the Besemer application satisfied the written description requirement.  Agilent then appealed to the Federal Circuit, challenging the District Court's claim construction and written description determinations.

The opinion, written by Judge Rader and joined by Judge Mayer and 7th Circuit Judge Richard Posner, sitting by designation, began by considering the question of which specification was to be used to construe Besemer's claim 66.  The District Court had used the disclosure of the Besemer application (termed "the host application" in the opinion), and Agilent contended that the proper reference was the Schembri patent specification.  Judge Rader framed the question in terms of which of the Court's precedents were controlling:  In re Spina or Rowe v. Dror.  In the Spina case, as here, an applicant copied a claim from an issued patent to provoke an interference.  The Board, in determining whether the copier's specification satisfied the written description requirement, construed the copied claim in light of the specification of the granted patent, an approach affirmed by the Federal Circuit:  "'[w]hen interpretation is required of a claim that is copied for interference purposes, the copied claim is viewed in the context of the patent from which it was copied.'  Spina, 975 F.2d at 856."

In the Rowe case, junior party Rowe copied claims from the Dror patent to provoke an interference.  In that case, senior party Dror moved for judgment on the grounds that a third-party patent anticipated certain of Rowe's claims corresponding to the count.  In deciding the subsequent appeal, the Federal Circuit held that the specification of Rowe's application should be used to construe the claim term at issue -- in other words, precisely the opposite result from the rule laid down in Spina.  That panel recognized the inconsistency with the Spina panel's rule, and distinguished the cases as follows:

In Spina, this court considered whether an applicant was eligible to copy a patentee's claim and thereby challenge priority of invention, a question that turned on whether the copying party's specification adequately supported the subject matter claimed by the other party.  This court held, in that context, that a copied claim is interpreted in light of its originating disclosure.  This Spina rule sought to ensure that the PTO would only declare an interference if both parties had a right to claim the same subject matter.  However, that rule does not apply in cases, such as this one, where the issue is whether the claim is patentable to one or the other party in light of prior art.  In this posture, the PTO and this court must interpret the claim in light of the specification in which it appears.  Rowe, 112 F.3d at 479.

In this case, the Federal Circuit held that the rule in Spina applies, because the question was whether "Besemer ha[s an] adequate basis to copy Schembri's claim and thereby challenge Schembri's priority of invention . . . .  This case does not present the Rowe situation, 'where the issue is whether the claim is patentable to one or the other in light of prior art.'"  In making this determination, the Court expressly rejected Affymetrix's contention that it would be contrary to 37 C.F.R. § 41.200(b), stating that "administrative regulations cannot trump judicial directives . . . .  Judicial precedent is as binding on administrative agencies as are statutes" (citing Rowe at 479 n.2).  The Court summarized its holding on this question as follows:

To be clear, as this court explained in Rowe, when a party challenges written description support for an interference count or the copied claim in an interference, the originating disclosure provides the meaning of the pertinent claim language.  When a party challenges a claim's validity under § 102 or § 103, however, this court and the Board must interpret the claim in light of the specification in which it appears.  Thus, the district court erred in construing claim language in light of the host Besemer application, rather than the originating Schembri disclosure.

Turning to the District Court's claim construction, the panel disagreed with two aspects that were dispositive.  First, the panel disagreed with the District Court's construction of the claim term "a closed chamber . . . adapted to retain a quantity of clued" to mean "an enclosed cavity, or some other enclosure or system of enclosures, which is capable of being sealed or set apart from its surroundings to retain a quantity of fluid."  Under the District Court's construction, the configuration set forth in Figure 28 of the Besemer application provided an adequate written description of a "closed chamber," as illustrated at left.

The Federal Circuit held that this construction was "dubious" since it ran counter to the plain meaning of the phrase "a closed chamber" considered in the context of the rest of the claim, which recited that the closed chamber was "'define[d by] a first substrate and second substrate having inner surfaces."  The Court contrasted the chamber thus recited as being "bounded by two discrete substrates" with "a nebulous space that could ambiguously span 'a system of enclosures.'"  The panel's contrary construction of the term was supported by the Schembri specification, rather than the Besemer specification used by the District Court.  As might be expected, the definition of "a closed chamber" in the Schembri specification provided no support for the embodiments disclosed in the Besemer specification.  The Federal Circuit also found functional as well as structural distinctions, including that the "closed chamber" disclosed in the Schembri specification was configured so that nucleated bubbles would be formed that would move in response to an induced temperature gradient to facilitate mixing, in contrast to the embodiments disclosed in the Besemer specification that used fluid flow from external reservoirs to mix hybridization fluid over the microarray surfaces.  The Court's opinion also noted that construing "a chamber" to comprise "several chambers" (as would be required to encompass the Besemer embodiments) would "provide no guidance as to where, amongst the several chambers, the first and second substrates [comprising the probe sequences] are located."  In this regard, the CAFC also held that the District Court's construction was faulty for rendering the word "closed" to be superfluous, finding that the term "closed" was synonymous with "sealed," a quality the embodiments disclosed  by Besemer did not have.

Turning to the written description issue, the panel agreed with Agilent that there was no support in the Besemer specification for the count corresponding to Besemer's copied claim 66.  Summarizing, the opinion states that:

[T]he "circulator" embodiments (illustrated in Figures 28 and 30) do not describe a method that takes place in a "closed chamber," whereas the "vortexer" embodiment (Figure 29) does not describe bubble mixing at all.  Thus, as per Agilent, Besemer cannot show possession of the claimed invention because no embodiments describe a method of both introducing fluid into a closed chamber and using bubbles to mix the fluid.

The panel eliminated the embodiments disclosed in Figures 28 and 30 for failure to describe a closed chamber, and then eliminated the embodiment disclosed in Figure 29 for failure to disclose bubbles to facilitate mixing.  The panel's conclusions were based on the Court's reading of portions of the Besemer specification as well as expert testimony, which the opinion termed "a critical admission" that the vortexer embodiment described in Figure 29 did "not necessarily" generate bubbles in operation, testimony that the Court opined vitiated any inherency argument asserted by Affymetrix.

The Federal Circuit also held that the District Court had improperly failed to consider new evidence presented by Agilent pursuant to the provisions of 35 U.S.C. § 146, directed at supplying what the Board found it had failed to supply during the interference:

Meaningful evidence in this case might, for example, have included an expert declaration stating that one of ordinary skill in the art would not have had the requisite knowledge or skills to conclude from the Besemer '224 specification that the inventor was in possession of the invention as claimed.  Board decision, at 28.

The District Court erred in not considering Agilent's new evidence and thus deferring to the Board's factual determinations.  Accordingly, the panel held that there was "no dispute of material fact that the Besemer application does not teach the claimed method" and thus the Besemer application was entitled to a priority date no earlier than its filing date.  Accordingly, the Federal Circuit held that Agilent was entitled to priority without remand to the District Court.

Agilent Technologies, Inc. v. Affymetrix, Inc. (Fed. Cir. 2009)
Panel: Federal Circuit Judges Mayer and Rader and Seventh Circuit Judge Posner
Opinion by Circuit Judge Rader

Digene Corp. v. Third Wave Technologies, Inc. (Fed. Cir. 2009)

    By Donald Zuhn --

On April 1st, the Federal Circuit affirmed the judgment of the District Court for the Western District of Wisconsin that Defendant-Cross Appellant Third Wave Technologies, Inc. did not infringe U.S. Patent No. 5,643,715, owned by Plaintiff-Appellant Digene Corp.  The panel also affirmed the District Court's grant of summary judgment dismissing Third Wave's antitrust counterclaims.

The '715 patent relates to the diagnosis of human papillomavirus (HPV) type 52, which is one of several HPV strains known to cause cervical cancer.  The '715 patent describes the differentiation of HPV type 52 from other HPV types using "nucleic acid hybridization probes which are specific for HPV type 52."  Both Digene and Third Wave make HPV testing systems; Third Wave's system utilizes a nucleic acid molecule that includes a sequence that is homologous to HPV type 52 and an additional sequence that serves as "an indicator of the HPV's presence."

In January 2007, Digene brought suit against Third Wave for infringement of claims 8, 10-12, and 18-27 of the '715 patent.  Asserted claims 18 and 21 include all of the limitations that were contested on appeal (contested limitations are underlined):

18.  An HPV 52 hybridization probe comprising a member selected from the group consisting of
    (i)  HPV 52 DNA labelled with a detectable label, and
    (ii)  HPV 52 RNA labelled with a detectable label,
    wherein the length of the HPV 52 DNA or HPV 52 RNA is between approximately 15 and 8000 nucleotide bases,
    wherein the HPV 52 DNA consists of all or a fragment of an HPV DNA, wherein the HPV DNA cross-hybridizes to the HPV portion of clone pCD15 to greater than 50% under moderately stringent conditions,
    wherein the HPV 52 RNA consists of all or a fragment of an HPV RNA, wherein the HPV RNA cross-hybridizes to the HPV portion of clone pCD15 to greater than 50% under moderately stringent conditions, and
    wherein the HPV 52 DNA and HPV 52 RNA do not hybridize to DNA from HPV types 1 through 51 under stringent conditions.

21.  An HPV hybridization probe composition comprising
    (a)  a member selected from the group consisting of
        (i)  HPV 52 DNA labelled with a detectable label and
        (ii)  HPV 52 RNA labelled with a detectable label,
    wherein the length of the HPV 52 DNA or HPV 52 RNA is between approximately 15 and 8000 nucleotide bases,
    wherein the HPV 52 DNA consists of all or a fragment of an HPV DNA, wherein the HPV DNA cross-hybridizes to the HPV portion of clone pCD15 to greater than 50% under moderately stringent conditions,
    wherein the HPV 52 RNA consists of all or a fragment of an HPV RNA, wherein the HPV RNA cross-hybridizes to the HPV portion of clone pCD15 to greater than 50% under moderately stringent conditions, and
    wherein the HPV 52 DNA and HPV 52 RNA do not hybridize to DNA from HPV types 1 through 51 under stringent conditions, and
    (b) DNA or RNA of at least one other HPV type labelled with a detectable label.

The District Court construed the contested limitations as follows:

• "HPV 52 hybridization probe" (claim 18) means a "nucleic acid molecule that is specific for HPV 52 DNA and that differentiates HPV 52 DNA from DNA of all other types";

• "HPV 52 DNA labelled with a detectable label" (claims 18 and 21) means "HPV 52 DNA that has a detectable label that is not DNA" (since, given the Court's other constructions, the label could not be DNA);

• "between approximately 15 and 8000 nucleotide bases" (claims 18 and 21) means "between 15 and approximately 8000 nucleotide bases" (since the applicant disavowed fewer than 15 bases during prosecution);

• "HPV hybridization probe" (claim 21) means a "nucleic acid molecule that is specific for the DNA of any one type of HPV and differentiates the DNA of that type from DNA of all other HPV types"; and

• "HPV 52 DNA consists of all or a fragment of an HPV DNA" (claim 21):  "HPV 52 DNA" means "a DNA molecule that is only type 52 HPV" (since the applicant disclaimed a molecule including fragments of later-discovered HPV types by stating during prosecution that "the claimed HPV 52 DNA must be derived from only type 52 HPV DNA") and "consists of all or a fragment of an HPV DNA" means "consists of all or a fragment of one HPV DNA that does not contain any other DNA" (since "an" means "one and only one" when following the transitional phrase "consists of").

On appeal, Digene argued that the District Court misconstrued the phrase "HPV 52 DNA consists of all or a fragment of an HPV DNA" by disregarding the inventor's definition of "HPV 52 DNA" in the prosecution history and claims themselves.  In particular, Digene argued that in the context of the '715 patent, "HPV 52 DNA" is defined by length (approximately 15 and 8000 nucleotides), cross-hybridization with a deposited clone under moderately stringent conditions, and failure to cross-hybridize with HPV types 1-51 under stringent conditions (as opposed to being defined by nucleotide sequence).  In other words, Digene contended that HPV 52 sequences in which "certain" nucleotides had been replaced were still HPV 52 DNA sequences.  As for the statement made during prosecution (i.e., "the claimed HPV 52 DNA must be derived from only type 52 HPV DNA"), Digene argued that it referred to the origin of the DNA and not its specific structure.

Digene also argued that the District Court erroneously limited the term "an HPV DNA" in the contested claim 21 limitation "HPV 52 DNA consists of all or a fragment of an HPV DNA" to "one HPV DNA that does not contain any other DNA."  With respect to this claim term, Digene contended that the overall transitional phrase in the claim was "comprising," and therefore, the term "an" in "an HPV DNA" should have been construed as "one or more."  Digene also argued that the District Court's construction would result in the exclusion of mutations, subtypes, and synthesized DNA.

Third Wave, not surprisingly, took an opposite position with respect to each of Digene's arguments.  In addition, Third Wave asserted that because claim 21 recites both "HPV 52 DNA" and "DNA . . . of at least one other HPV type," the term "HPV 52 DNA" must be limited to DNA of only type 52 and not include DNA of another HPV type.

Siding with Third Wave, the Federal Circuit found that the District Court reasonably construed the phrase "HPV 52 DNA consists of all or a fragment of an HPV DNA."  In particular, the panel agreed that by reciting both "HPV 52 DNA" and "DNA . . . of at least one other HPV type" in claim 21, Digene distinguished HPV 52 DNA from the DNA of other HPV types, thereby supporting Third Wave's position that "HPV 52 DNA" means "a DNA molecule that is only type 52 HPV."  The Court also found that applicant's statement that "the claimed HPV 52 DNA must be derived from only type 52 HPV DNA" indicated that applicant had disclaimed a meaning of "HPV 52 DNA" that was derived from anything but HPV 52 DNA.  In addition, the panel noted that the District Court had been correct in construing "an" after the transitional phrase "consisting of" as meaning "one," stating that "[i]f the term 'consists of' appears in the body of a claim, it does not limit the entire claim as such, but it does limit the clause for which it acts as a transition to only those elements found in that particular clause."  Finally, the Court agreed with Third Wave that the District Court's construction did not exclude possible mutations or subtypes.  With respect to the other claim terms, the panel noted that because "Digene candidly conceded that it could not prove infringement under the district court's claim constructions of 'HPV 52 DNA consists of all or a fragment of an HPV DNA'" at oral argument, the panel did not need to address the remaining terms in light of Digene's concession."

Digene Corp. v. Third Wave Technologies, Inc. (Fed. Cir. 2009)
Nonprecedential disposition
Panel: Circuit Judges Lourie, Rader, and Prost
Opinion by Circuit Judge Lourie

For additional information regarding this case, please see:
• "Digene Files Infringement Suit against Third Wave Technologies," January 17, 2007

Claim Construction at the Federal Circuit: A District Court Judge's View

Medegen MMS, Inc. v. ICU Medical, Inc. (Fed. Cir. 2008)

    By Kevin E. Noonan --

The Federal Circuit recently had the opportunity to appreciate firsthand the frustrations of district court judges with its review of claim construction under Markman v. Westview Instruments, Inc.  This teaching came in a dissenting opinion from the Honorable Vaughn R. Walker, Chief Judge, U.S. District Court for the Northern District of California, sitting by designation in Medegen MMS, Inc. v. ICU Medical, Inc. decided November 20, 2008.

The case involves "needle-free valve[s] for intravenous (I.V.) therapy used to administer fluids to a medical patient."  The claimed devices are used to connect a syringe to a catheter, without suffering from "retrograde flow."  The opinion characterizes retrograde flow as being "the reverse flow of fluid out of the patient's body and back into the catheter tubing, the connector, and the syringe, caused by the negative pressure suction that occurs as the syringe is withdrawn from the connector."  Such retrograde flow can result in blood fouling the catheter, with clotted blood necessitating flushing or replacement of the catheter.  Positive pressure produced using a plug counteracts the negative pressure that produces retrograde flow.

After a Markman hearing construing several claim terms, including "plug," ICU filed and the District Court granted a motion for summary judgment of non-infringement.  The basis for this judgment was that the ICU product embodied a rigid, inflexible plug, while the District Court's construction of plug required a flexible, elastomeric plug.

According to the majority opinion, written by Judge Dyk and joined by Judge Rader, this construction of the term "plug" was error.  The opinion characterized the construction as "relying heavily" on the fact that the specification consistently described the plug as having an elastomeric character, and that the specification "nowhere describe[d] a non-elastomeric or rigid plug."  The CAFC agreed with Medegen, that the term "plug" should be given "its ordinary meaning" as "a moveable member between an open and closed position."  The bases of the Court's opinion included that the term "plug" was claimed "broadly"; that the term was "not expressly limited by the language of the claims"; that there was "no contention that the ordinary meaning of the term 'plug' does not include a rigid plug or that it has a special meaning in the medical field that requires elastomericity"; and that there was no "clear disclaimer of non-elastomeric plugs in the specification."

The opinion expressly disagreed with ICU's contention that the skilled worker "would read the specification as limited to elastomeric plugs," and characterized elastomeric plugs as being "merely an example" of how to practice the invention.  The Court reached its determination even though the Detailed Description section of the patent disclosed elastomeric or "rubber" plugs twenty-one times (and never discussed non-elastomeric or rigid plugs).  This disclosure merely reflects "preferred embodiments," and limiting the claims to preferred embodiments is improper.  According to the opinion, ICU's construction "relies on a single embodiment theory," a construction "specifically rejected" in Phillips v. AWH Corp.  In view of this disagreement on the proper construction of the term "plug," the Federal Circuit vacated and remanded to the District Court for trial using this more expansive construction of plug.

Judge Walker (at left) dissented.  He asserted that the issues before the CAFC presented "a conundrum often faced by district courts when construing" claim terms.  He cited the "twin axioms" of claim construction that produced the conundrum:  "[o]n the one hand, claims 'must be read in view of the specification'," citing Markman, while "[o]n the other hand, it is improper to read a limitation from the specification into the claims," citing Arlington Indus. Inc. v.  Bridgeport Fittings, Inc.  The problem with these axioms, according to Judge Walker, is that "the axioms themselves seldom provide an answer, but instead merely frame the question to be resolved."  Here, Judge Walker contended that the majority based its decision to overrule the District Court's construction on the second axiom without properly assessing the term by taking both axioms into consideration.  While recognizing the sound policy reasons for a patent drafter to be required to include "all claim limitations in the claims of a patent," he also admonished that "patents must be read as well as written."  Citing Phillips, this analysis must be performed with due consideration of a term's "ordinary and customary meaning" informed by the "context of the entire patent, including the specification."  The majority's construction gave too little weight to the specification, in Judge Walker's view, in favor of "broad dictionary definitions."

In contrast, the "very able district court . . . looked first to the patent" in performing its construction of the term "plug," basing its decision on the "repeated" description of the plug as having "elastomeric, pivoting and buckling limitations" that the District Court included in its construction.  Moreover, the claimed invention would not work using a rigid, non-elastomeric plug, and for this reason alone, Judge Walker contended that the District Court's construction of the term was more consistent with an elastomeric plug being "an essential element" of the invention.  In addition to the intrinsic evidence, the District Court also relied on extrinsic evidence from expert witnesses, including evidence that Medegen's expert could not explain how a rigid plug would be operable in the claimed invention.

Judge Walker raises the essential paradox of the Federal Circuit's practice under Cybor Corp. v. FAS Technologies, Inc. of giving no deference to claim construction by district courts:  "[a]s a jurist more accustomed to working on the front lines of patent litigation than reviewing decisions from above, it is my experience that claim construction -- determining how one of ordinary skill in the art would understand the patent at the time of invention -- often requires making fact-like determinations not well suited to appellate review."  The "uniformity and predictability" desired by the CAFC as a general, guiding principle is not always best served in the individual determinations necessary to construe claim terms.  In this he cites with approval Judge Lourie's point in Phillips, that while there is (and perhaps cannot be) formal deference by the CAFC to a district court's claim construction, it is better policy for the Federal Circuit to affirm "in the absence of a strong conviction of error."  Despite the fact that current academic research suggests that Federal Circuit affirmance rates of district court claim construction has "improved" to from 60-70%, these broad statistics do not inform how each Federal Circuit panel addresses, and resolves, specific claim construction issues in any particular case.  And so long as a majority of the Federal Circuit judges continue to resist en banc reconsideration of Cybor, and the Supreme Court appears singularly disinterested in the issue, the inconsistencies resulting from the Federal Circuit's "no deference" standard of review will continue to produce the type of results decried by Judge Walker in Medegen.

Medegen MMS, Inc. v. ICU Medical, Inc. (Fed. Cir. 2008)
Panel: Circuit Judges Rader and Dyk and Chief District Judge Walker
Opinion by Circuit Judge Dyk

General Atomics Diazyme Lab. Division v. Axis-Shield ASA (Fed. Cir. 2008)

    By Kevin E. Noonan --

In the non-precedential General Atomics case decided earlier this month, the Federal Circuit applied its Markman claim construction practice to a Jepson claim, a venerable claim format seen more frequently in the mechanical and electrical arts than in the chemical or biotechnology arts (1).  The case illustrates the tendency for the CAFC to parse claim language very finely and almost hyper-technically, and the prevailing attitude on the Federal Circuit that patentees should and must pay the price for claim language that does not adequately protect their technology from being practiced in a non-infringing manner.

The case involved a diagnostic assay for homocysteine, an amino acid derivative normally found in trace amounts in blood and urine.  Elevated levels have been associated with a variety of ailments, including cardiocascular disease.  Axis-Shield, the patentee, asserted two patents, U.S. Patent Nos. 5,631,127 and 5,958,717, in its countersuit to General Atomics' declaratory judgment action.  Claim 1 of the '127 patent reads:

1.  In a method for assaying homocysteine in a sample, said method comprising the steps of:

    (i) contacting said sample with a homocysteine converting enzyme and at least one substrate for said enzyme other than homocysteine, and

    (ii) assessing an analyte which is a substrate for said enzyme,

    wherein the improvement comprises in step (i) contacting said sample with a said substrate other than homocysteine and in step (ii) without chromatographic separation assessing a non-labelled analyte selected from the group consisting of a homocysteine co-substrate and the homocysteine conversion products of the enzymic conversion of homocysteine by said enzyme.

Claim 1 of the '717 reads:

1.  In a method for assaying homocysteine in a sample, said method comprising the steps of:

    (i) contacting said sample with a homocysteine-converting enzyme and

    (ii) assessing an analyte,

    wherein the improvement comprises in step (ii) without chromatographic separation assessing a non-labelled analyte selected from the group consisting of the homocysteine conversion products of the enzymic conversion of homocysteine by said enzyme.

(underlining was added in the case as reported, to identify the limitations that were the focus of the Federal Circuit's determinations).

Consistent with Jepson claiming, the novel aspects of these claims are the limitations following the word "improvement" in each claim; the recitations prior to "improvement" are in the prior art.

The accused assays detected homocysteine using an assay having the following steps:

1) a co-substrate referred to as S-adenosyl-L-methionine ("SAM") is added to the sample;
2) an enzyme referred to as homocysteine-methionine methyl transferase ("HMTase") is then added;
3) the HMTase acts to remove a methyl group from the co-substrate SAM and attach it to the homocysteine, converting the homocysteine into methionine and SAM into S-adenosyl-L-homocysteine ("SAH");
4) simultaneously, a second enzyme is added, SAH-hydrolase, which catalyzes a reaction that converts SAH to adenosine and non-sample homocysteine;
5) additional steps occur, involving adenosine deaminase and spectrophotometric monitoring, to determine the level of SAH produced.

The assay took advantage of the following reaction pathway:

The basis for General Atomics' assay was that the amount of SAH was proportional to the levels of homocysteine in a sample; the assay assessed the amount of SAH by spectrophotometry.

Axis-Shield asserted two theories of infringement:  that sample homocysteine was coverted by HMTase (the "homocysteine converting enzyme") by combination with SAM (the "homocysteine co-substrate").  The assay produced two "homocysteine conversions products," SAH and methionine, and the assay detected SAH without chromatographic separation.  In its alternative theory, Axis-Shield asserted that SAH hydrolase was the homocysteine converting enzyme, adenosine was the homocysteine co-substrate, and SAH was the homocysteine conversion product.

The case turned, as is frequently the case, on the meaning of the claim terms (underlined above).  In order to infringe, according to the District Court, the analyte detected ("assessed") in the General Atomics assay must either be a homocysteine co-substrate or a homocysteine conversion product.  And the District Court found the analyte assessed in the accused assay (SAH) was neither, based on either of Axis-Shield's infringement theories.

The Federal Circuit, in a unanimous decision written by Judge Lourie (Judges Gajarsa and Dyk concurring) construed the claims de novo in the face of Axis-Shield's contention that the District Court had misconstrued the claims, specifically the terms "homocysteine conversion product," "homocysteine converting enzyme," and "homocysteine co-substrate."  Judge Lourie reviewed the District Court's definition of the term "homocysteine conversion product" as a product that must be derived from homocysteine, and agreed with this construction based on the plain meaning of the claim language.  Specifically, the claim itself recites that the homocysteine conversion products are products of "enzymic conversion of homocysteine by said enzyme."  Judge Lourie made a distinction between the language of the claim and hypothetical language more in keeping with the construction Axis-Shield argued on appeal, "homocysteine conversion reaction products."  In Judge Lourie's view, this language would permit the claim to be construed to encompass detection of "any product" produced by the homocysteine conversion reaction.  In contrast, according to Judge Lourie, the actual claim language specifically recited a homocysteine conversion product, which would include methionine but not SAH.  SAH, in the CAFC's opinion, is a conversion product of SAM, not homocysteine.  The opinion finds support in the specification as well, citing the "first embodiment" of the invention disclosed therein as being the production of SAH by SAH hydrolase.  In this reaction, according to the Federal Circuit, adenosine is the homocysteine co-substrate, SAH hydrolase is the homocysteine converting enzyme, and SAH is the homocysteine conversion product.

The CAFC also rejected Axis-Shield's contention that the specification disclosed embodiments wherein homocysteine acted as an inhibitor of SAH hydrolase, so that detection of the adenosine content of the reaction is a measure of the amount of homocysteine in the sample.  The Federal Circuit noted that claims do not always (and are not required to) encompass all disclosed embodiments, particularly in view of prosecution strategies.  In this case, Axis-Shield had originally asserted another patent, No. 6,063,581, having claims to the inhibitor embodiments, and the Federal Circuit characterized as "inapt" Axis-Shield's claim construction arguments to have these embodiments fall within the scope of either the '717 or '127 claims.

The CAFC also affirmed the District Court's construction that General Atomics' assay did not infringe under Axis-Shield's alternative infringement theory, because it "cannot differentiate between SAH produced from SAH hydrolase reaction and from the HMTase reaction.

Besides the rarity of having the Federal Circuit construe a Jepson claim in a biotechnology patent, this case is another example of the CAFC's propensity to place the burden of an unfavorable claim construction on the patentee (at least with regard to constructions that do not support a finding of infringement); see Sage Products Inc. v. Devon Indust. Inc.  This has some logic as policy, since the patentee is in the best position to claim her invention as broadly as her disclosure and the prior art permit.  In addition, it provides incentives (if not rewards) for third parties to design around the patentee's claims, especially when the construction is based on the "plain meaning" of the claim language.  But it also requires something akin to a crystal ball for patent prosecutors and inventors to craft claim language that adequately protects technology, and it is not yet clear whether the Federal Circuit is balancing these competing interests to provide the optimum amounts of both incentive and certainty.

(1)  For example, the term "nucleic acid" yields 20,706 granted patents as a claim term, while the term "improvement" occurs in only 265 (1.3%) of them.  In contrast, the term "attached" occurs 380,895 times, while the term "improvement" occurs in 21,409 (5.6%) of them.

General Atomics Diazyme Lab. Division v. Axis-Shield ASA (Fed. Cir. 2008)
Panel: Circuit Judges Lourie, Gajarsa, and Dyk
Opinion by Circuit Judge Lourie

Ortho-McNeil Pharmaceutical, Inc. v. Cobalt Pharmaceuticals Inc. (Fed. Cir. 2008)

    By Donald Zuhn --

Last week, the Federal Circuit issued an opinion in Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc.  In Mylan Laboratories, the Federal Circuit determined that the District Court for the District of New Jersey properly construed claim 1 of U.S. Patent No. 4,513,006, owned by Plaintiff-Appellee Ortho-McNeil Pharmaceutical, Inc., to encompass Ortho-McNeil's epilepsy drug topiramate, and affirmed the District Court's decision to (1) permanently enjoin Defendants-Appellees Mylan Laboratories, Inc. and Mylan Pharmaceuticals, Inc. (Mylan) from infringing the '006 patent, (2) dismiss Mylan's invalidity defenses based on obviousness, inequitable conduct, and non-enablement, and (3) reset the effective date of Mylan's Abbreviated New Drug Application (ANDA).  A full discussion of Mylan Laboratories can be found here.

On the same day that the Federal Circuit issued its decision in Mylan Laboratories, it also issued a nonprecedential opinion in a companion case: Ortho-McNeil Pharmaceutical, Inc. v. Cobalt Pharmaceuticals Inc.  In this case, Defendant-Appellant Cobalt Pharmaceuticals Inc. (Cobalt) stipulated that it would be bound by the District Court's final judgment order in Mylan Pharmaceuticals.  Although Cobalt retained its right to appeal, it also stipulated that the appeal would be based on the record in Mylan Pharmaceuticals.  Thus, in affirming the District Court's judgment against Mylan, the Federal Circuit affirmed the District Court's judgment against Cobalt.

Cobalt attempted to present an additional argument on appeal; namely, that claim 1 is rendered indefinite by the use of the term "may be."  The Federal Circuit, however, declined to consider this argument in view of Cobalt's stipulation that its appeal be based on the record in Mylan Pharmaceuticals.

Ortho-McNeil Pharmaceutical, Inc. v. Cobalt Pharmaceuticals Inc. (Fed. Cir. 2008)
Nonprecedential disposition
Panel: Chief Judge Michel and Circuit Judges Rader and Linn
Opinion by Circuit Judge Rader