Patent Docs

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

Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc. (Fed. Cir. 2008)

    By Donald Zuhn --

Last week, 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 to encompass Plaintiff-Appellee Ortho-McNeil Pharmaceutical, Inc.'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 inequitable conduct, obviousness, and non-enablement, and (3) reset the effective date of Mylan's Abbreviated New Drug Application (ANDA).

Ortho-McNeil manufactures and sells TOPAMAX®, which is used to treat epilepsy and which comprises the active ingredient topiramate.  Ortho-McNeil researcher Dr. Bruce Maryanoff invented topiramate during a search for new antidiabetic drugs, discovering that the reaction intermediate topiramate had unexpected anticonvulsant properties.

Seeking approval to market generic topiramate, Mylan filed an Abbreviated New Drug Application (ANDA) with the FDA.  In response, Ortho-McNeil filed an infringement suit under 35 U.S.C. § 271(e)(2) in the District Court of New Jersey.

Following a Markman hearing, the District Court rejected Mylan's construction of claim 1 as excluding topiramate.  On summary judgment, the District Court also rejected Mylan's affirmative defenses of invalidity based on obviousness and non-enablement and unenforceability due to inequitable conduct.  As a result of these determinations, the District Court enjoined Mylan from infringing the '006 patent and reset the effective date of Mylan's ANDA.

On appeal, Mylan argued that the District Court improperly construed the word "and" in claim 1 of the '006 patent, which recites:

 

According to Mylan, the phrase "R2, R3, R4 and R5 are independently hydrogen or lower alkyl and R2 and R3 and/or R4 and R5 together may be a group of formula (II)" in claim 1 specifies two independent limitations:

[1] R2, R3, R4 and R5 are independently hydrogen or lower alkyl and
[2] R2 and R3 and/or R4 and R5 together may be a group of formula (II),

both of which must be met for a compound to infringe the claim.  In topiramate (at left), R2 and R3 and R4 and R5 together are a group of formula (II), and therefore, none of R2, R3, R4 and R5 are hydrogen or lower alkyl.  Mylan argues that when claim 1 is properly construed, it does not encompass topiramate.

The Federal Circuit disagreed with Mylan's construction, finding that the District Court properly interpreted claim 1.  According to the CAFC, the term "and appears in conjunction with the adverbs independently and together," and therefore, "links alternatives that occur under the different conditions of independence or togetherness."  In other words, R2, R3, R4 and R5 need not always be hydrogen or lower alkyl.

In support of this construction, the Federal Circuit noted that if the term "and" were construed to require a conjunctive meaning, dependent claims 2, 5, 9, and 10 would be rendered meaningless.  The CAFC also noted that the specification supported the above construction.  Finally, while stating that it need not consult extrinsic evidence, given the plain language of claim 1, the dependent claims, and the specification, the Federal Circuit pointed out that "dictionary definitions of [the term] and, while most often listing the additive sense as the most common usage of the term, also show usage of the term to connote alternatives."

With respect to the issue of unenforceability, the Federal Circuit rejected Mylan's argument that during prosecution of the '006 patent, Ortho-McNeil made statements about prior art compounds that were inconsistent with its own testing of those compounds.  Instead, the CAFC agreed with the District Court that Ortho-McNeil "merely accurately characterizes the references as claiming limited utility."

The Federal Circuit also rejected Mylan's arguments for invalidity.  As to obviousness, the CAFC stated that "this invention, contrary to Mylan's characterization, does not present a finite (and small in the context of the art) number of options easily traversed."  Moreover, "the ordinary artisan in this field would have had to (at the time of invention without any clue of potential utility of topiramate) stop at that intermediate and test it for properties far afield from the purpose for the development in the first place (epilepsy rather than diabetes)."  As to Mylan's assertion that claims 6-8 are not enabled, the Federal Circuit again agreed with the District Court, stating that it would not require undue experimentation to determine an "anticonvulsively effective amount" of topiramate.

Finally, with respect to Mylan's argument that the District Court's order resetting the effective date of Mylan's ANDA was inconsistent with 21 U.S.C. § 355(j)(5)(B)(iii), the Federal Circuit determined inter alia that 21 U.S.C. § 355 is directed to the FDA and does not limit a court's authority to reset the effective date of an ANDA that is approved before the court grants a preliminary injunction or finds infringement, as in the instant case.

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

Additional information regarding this case can be found at the Orange Book Blog and Patently-O.

Regents of the Univ. of California v. DakoCytomation California, Inc. (Fed. Cir. 2008)

    By Donald Zuhn --

On February 28th, the Federal Circuit, in Regents of the Univ. of California v. DakoCytomation California, Inc.:  (a) affirmed the denial by the District Court for the Northern District of California of a preliminary injunction sought by the Regents of the University of California, Abbott Molecular Inc., and Abbott Laboratories Inc. (Appellants), (b) affirmed in part the District Court's grant of summary judgment of noninfringement as to U.S. Patent No. 6,596,479, (c) reversed in part the District Court's grant of summary judgment of noninfringement as to U.S. Patent No. 5,447,841, (d) affirmed the District Court's construction of "heterogeneous mixture of labeled unique sequence nucleic acid fragments," (e) reversed the District's Court's construction of "morphologically identifiable cell nucleus," and (f) reversed the District Court's determination that Appellants were estopped from asserting that Dako's products meet a limitation of the '841 patent under the doctrine of equivalents.  The Federal Circuit remanded the case to the District Court.

The '841 and '479 patents, which are owned by the Regents of the University of California and are exclusively licensed by Abbott, are directed to improved methods for identifying and classifying chromosomes in order to detect chromosomal abnormalities.  The improved methods of the '841 and '479 patents seek to overcome two problems that existed in the prior art:  (1) the requirement of prior art methods that chromosomes be in the metaphase stage of the cell-division cycle (when the chromosomes are condensed and microscopically visible) as opposed to the interphase stage (when the chromosomes are not condensed and therefore not microscopically visible), and (2) the nonspecificity of prior art methods that use nucleic acid probes to detect particular chromosomal sequences, which leads to unacceptable false-positive results.  This nonspecificity is caused by the hybridization of the nucleic acid probes to repetitive nucleotide sequences scattered throughout the chromosomes; in effect, the repetitive sequences "interfere" with the ability of the nucleic acid probes to hybridize only with particular chromosomal sequences.

The claimed methods of the '841 and '479 patents overcome the problems in the prior art by eliminating the "interference" caused by repetitive sequences.  In the methods of the '841 patent, the interference is eliminated by blocking repetitive sequences, and in the methods of the '479 patent, the interference is eliminated by removing the repetitive sequences.  In particular, in the methods of the '841 patent, "blocking nucleic acid . . . fragments which are substantially complementary to repetitive segments" are added to "labeled nucleic acid . . . fragments which are substantially complementary to nucleic acid segments within the chromosomal DNA for which detection is desired," and in the methods of the '479 patent, "a heterogeneous mixture of labeled unique sequence nucleic acid fragments which are substantially complementary to nucleic acid segments within the interphase chromosomal DNA for which detection is desired" is used.

In September of 2005, Appellants brought suit against Dako for patent infringement, and then in October of 2005 filed a motion for preliminary injunction seeking to enjoin Dako from manufacturing and selling its HER2 kit.  Based on the District Court's construction of the limitations "morphologically identifiable chromosome or cell nucleus" and "heterogeneous mixture of labeled unique sequence nucleic acid fragments" of the '479 patent, and its conclusion that Dako's product did not meet the "blocking nucleic acid" limitation of the '841 patent under the doctrine of equivalents, the District Court determined that Appellants had failed to show a likelihood of success on the merits with respect to their infringement claims, and therefore denied Appellants' motion.

The District Court subsequently issued a second order, amending the basis for its denial of Appellants' preliminary injunction motion.  In particular, the District Court maintained its rejection of Appellants' proposed construction of "heterogeneous mixture of labeled unique sequence nucleic acid fragments," but on the grounds that adopting such a construction would render the '479 patent invalid under the doctrine of obviousness-type double patenting (the District Court had previously determined that adopting Appellants' construction, which only appears in the '479 patent, would render the '479 patent invalid in view of the '841 patent, which the Court determined to be prior art to the '479 patent).  Appellants appealed both orders to the Federal Circuit.

While these appeals were pending, Dako moved for summary judgment of noninfringement.  Following a Markman hearing, the District Court granted summary judgment of noninfringement as to the '479 patent based on the Court's construction of the "heterogeneous mixture of labeled unique sequence nucleic acid fragments" limitation, and granted summary judgment of noninfringement as to the '841 patent based on the Court's conclusion that Appellants were barred from asserting that two of Dako's products met the "blocking nucleic acid" limitation under the doctrine of equivalents (the Court denied summary judgment as to the '841 patent for twenty other Dako products).  Following the District Court's order, the parties filed a joint motion to certify for immediate appeal, which the District Court granted, and the Federal Circuit then granted permission to appeal the interlocutory order.

On appeal, Appellants argued that the District Court had erred in:  (1) construing the limitation "heterogeneous mixture of labeled unique sequence nucleic acid fragments," (2) applying prosecution history estoppel to the "blocking nucleic acid" limitation, and (3) construing the limitation "morphologically identifiable cell nucleus."  With respect to the first issue, Appellants argued that the District Court erred in construing the limitation to mean that the heterogeneous mixture excludes repetitive sequences (Dako's kits contain repetitive sequences).  Appellants based their argument on the doctrine of claim differentiation (some of the patent's dependent claims require repetitive sequences) and the District Court's improper reliance on the prosecution history (Appellants asserted that the term "unique sequence" was added during prosecution to clarify that the claimed method was related to the detection -- and not necessarily use -- of unique sequences).

Despite finding that the District Court erred in first concluding that the '841 patent was prior art to the '479 patent and then concluding that the '479 patent would be rendered invalid due to obviousness-type double patenting, the Federal Circuit affirmed the District Court's construction of the heterogeneous mixture limitation as well as the District Court's determination that some of Dako's kits contain repetitive sequences, and therefore, do not infringe the '479 patent.  The basis of the Federal Circuit's affirmance was Appellants' ability to overcome an enablement rejection (the examiner argued that a mixture containing repetitive sequences would not work due to nonspecific hybridization) by limiting the heterogeneous mixture's composition to unique sequences.  As for Appellants' claim differentiation argument, the Federal Circuit noted that "the presumption created by the doctrine of claim differentiation is 'not a hard and fast rule and will be overcome by a contrary construction dictated by the written description or prosecution history.'"

With respect to the "blocking nucleic acid" limitation, Appellants argued that the District Court erred in barring them from asserting that the peptide nucleic acids (PNAs) used in Dako's kits were an equivalent of the blocking nucleic acids recited in the claims (the parties had stipulated that the "nucleic acid" portion of the term was limited to DNA and RNA).  In particular, Appellants asserted that since the "blocking nucleic acid" limitation was never narrowed during prosecution, the District Court improperly applied the doctrine of prosecution history.

The Federal Circuit concluded first that "[b]ecause the prosecution history suggests that the patentees limited the claim to the blocking method at least in part to overcome the examiner's rejections, the patentees presumptively surrendered all equivalents of the 'blocking nucleic acid' limitation."  The CAFC then concluded that Appellants "met their burden of showing that the amendment did not surrender the equivalent in question because the narrowing amendment was only tangential to the accused PNA equivalent," and therefore, determined that the District Court erred in finding that Appellants were estopped from asserting that Dako's products infringe under the doctrine of equivalents.  The Federal Circuit based its conclusion on the fact that when the patentees amended the claims to add the "blocking nucleic acid" limitation, they  "argued that that the invention was new and nonobvious because it used the blocking method in connection with in situ hybridization for the detection of unique sequences" (emphasis added).  Thus, the CAFC concluded that Appellants' narrowing amendment focused on the "blocking" aspect and not on the "nucleic acid" aspect of the limitation.  The Federal Circuit, therefore, reversed the District Court's determination that Appellants were barred from asserting that Dako's PNA-containing kits infringed under the doctrine of equivalents.

Finally, with respect to the "morphologically identifiable cell nucleus" limitation, Appellants argued that the District Court erred in construing the term to mean "a single cell nucleus that contains the full complement of chromosomal DNA."  Appellants asserted that the limitation "merely requires that the nucleus be 'capable of being identified by its form or function' and does not require the full set of DNA."  The Federal Circuit agreed with Appellants, stating that "[s]ignificantly, nowhere in the prosecution history, or the specification for that matter, do we find any indication that the 'morphologically identifiable' language was added to impose a requirement that the cell nucleus must retain its full complement of chromosomal DNA."  The CAFC, therefore, determined that the District Court erred in construing this limitation.

Judge Prost dissented with respect to the portion of the majority opinion that holds that the doctrine of equivalents is not precluded by prosecution history estoppel because the tangential exception applies, writing that the majority's finding "is contrary to this court's precedent and to the proper application of prosecution history estoppel as set forth by the Supreme Court."  Citing Norian Corp. v. Styker Corp., Judge Prost noted that:

[I]t frequently happens that patentees surrender more through amendment than may have been absolutely necessary to avoid particular prior art.  In such cases, we have held the patentees to the scope of what they ultimately claim, and we have not allowed them to assert that claims should be interpreted as if they had surrendered only what they had to.

Observing that the patentees narrowed the scope of the claims from any method of eliminating interference from repetitive sequences to just the use of "blocking nucleic acid," Judge Prost stated that:

It is irrelevant to the determination of the scope of the surrendered territory that to overcome the prior art references the patentee did not need to amend the claims to a method of disabling the hybridization capacity of repetitive sequences by blocking with a "blocking nucleic acid," but instead could have amended the claims to a method of disabling repetitive sequences by blocking.

Judge Prost concluded that:

To overcome the presumption of prosecution history estoppel "[t]he patentee must show that at the time of the amendment one skilled in the art could not reasonably be expected to have drafted a claim that would have literally encompassed the alleged equivalent."  Here, the appellants could reasonably have been expected to have drafted a claim that encompassed blocking repetitive sequences using PNA.  The appellants should, therefore, be estopped from asserting that PNA is an equivalent to "blocking nucleic acid" in the '841 patent.

Regents of the Univ. of California v. DakoCytomation California, Inc. (Fed. Cir. 2008)
Panel: Circuit Judges Mayer, Lourie, and Prost
Opinion by Circuit Judge Lourie; opinion dissenting-in-part by Circuit Judge Prost

Additional information regarding this case can be found at Patently-O.

In re Gabapentin Patent Litigation (Fed. Cir. 2007)

    By Donald Zuhn --

Last Friday, the Federal Circuit reversed a District Court's finding on summary judgment that eight generic drug manufacturers did not infringe U.S. Patent No. 6,054,482 (the '482 patent), and affirmed the District Court's construction of two disputed claim limitations.

Plaintiffs-Appellants Warner Lambert Co., Pfizer Inc., and Gödecke Aktiengesellschaft (Warner Lambert) manufacture and sell Neurontin®, which is used to treat cerebral disorders such as epilepsy and which comprises the active ingredient gabapentin.  Warner Lambert discovered that under certain manufacturing conditions, gabapentin can form a lactam.  To minimize the formation of the lactam, which is twenty-five times more toxic than gabapentin and which causes - rather than prevents - seizures, Warner Lambert developed a process for preparing stable and safe gabapentin formulations.  The '482 patent is directed towards this process as well as to gabapentin compositions that are substantially free from a lactam contaminant.

Seeking approval to market generic gabapentin, Defendants-Appellees Purepac Pharmaceutical Co., Faulding Inc., Teva Pharmaceutical Industries, Inc., Teva Pharmaceuticals USA, Inc., Zenith Laboratories, Inc. (now IVAX Pharmaceuticals NV, Inc.), Zenith Goldline Pharmaceuticals, Inc. (now IVAX Pharmaceuticals, Inc), IVAX Corp., and Eon Labs Manufacturing, Inc. (Appellees) filed Abbreviated New Drug Applications (ANDAs) with the FDA.  In response, Warner Lambert brought number of infringement actions against the Appellees; the suits were consolidated in the District Court of New Jersey.

In pretrial proceedings, the Appellees moved for summary judgment of noninfringement and invalidity of the '482 patent.  The District Court granted Appellees' motion for summary judgment of noninfringement, determining that Warner Lambert had failed to establish that the accused products contained no more than 20 parts per million (ppm) of anions of mineral acid as required by the asserted claims (more anions of mineral acid indicates the presence of gabapentin hydrochloride - the salt form of gabapentin, which in turn indicates that the gabapentin sample is less pure, and therefore, less stable; less stable formulations of gabapentin contain lactam contaminant).  In addition, the District Court construed two claim terms in Warner Lambert's favor.  In particular, the District Court construed the term "anion of a mineral acid" as an "anion derived from a mineral acid" and the term "adjuvant" as a "subset of [eight particular] inactive ingredients that is intimately mixed with gabapentin to form the drug mixture, and thus [does not] refer to the ingredients of capsule shells or tablet coatings."

On appeal, Warner Lambert argued that the District Court, in granting summary judgment of noninfringement, erred by resolving factual disputes.  In opposing the Appellees' motion for summary judgment, Warner Lambert had submitted the results of a comparative pH test that established that four of five of the Appellees' samples tested contained not more than 17 ppm of anions of mineral acid.  In response, the Appellees challenged the accuracy and reliability of Warner Lambert's comparative pH test.

The Federal Circuit, however, noted that the Appellees had "waived any argument challenging the validity, including challenges to the accuracy or reliability, of the pH testing method for purposes of summary judgment," and were therefore confined to arguing against "the undisputed limits of the test's precision" (i.e., a ± 5 ppm margin of error).  When so confined, the CAFC concluded that the Appellees could not counter Warner Lambert's demonstration that the Appellees' gabapentin (at left) samples contained less than 20 ppm of anions of a mineral acid, as recited in the claims.  Thus, the Federal Circuit concluded that "the district court erred in granting summary judgment of noninfringement based on Warner Lambert's purported failure to meet its burden of proof" since "[t]he record shows that Warner Lambert proffered sufficient evidence to create a genuine issue of material fact regarding whether the accused products met the 20 ppm claim limitation of the '482 patent."

With respect to the District Court's construction of the term "anion of a mineral acid," the Appellees argued that the term refers to total chloride content and is not limited to acid-derived chloride ions. The Appellees also argued that the term "adjuvant" refers to any ingredient other than the active ingredient, and thus encompasses ingredients included in the capsule shell or tablet coating.

In affirming the District Court's construction of the first disputed claim term, the Federal Circuit determined that "the construction adopted by the district court gives full meaning to every word of the entire claim term," and that "[h]ad the patentees intended the anion to refer to any anion, regardless of its source, the patentees could have simply claimed 'anions' and omitted the phrase 'of a mineral acid.'"  With respect to the second disputed claim term, the CAFC noted that the District Court had "found nothing in the patent or prosecution history indicating that ingredients found in the capsule shell or coating affects stability, and also relied on several dictionary definitions in support of its construction."  As a result, the Federal Circuit concluded that the District Court also did not err in construing the term "adjuvant."

In re Gabapentin Patent Litigation (Fed. Cir. 2007)
Panel: Circuit Judges Lourie, Lyn, and Moore
Opinion by Circuit Judge Lourie

Additional information regarding this case can be found at the Orange Book Blog and Patently-O.

Trying to Understand What's Not Obvious about What's "Obvious to Try"

    By Kevin E. Noonan --

The Supreme Court's recent KSR Int'l Co. v. Teleflex Inc. decision is stunning in the amount of dicta it contains (and confusing dicta at that).  The Court succumbed to imprecise language (albeit not quite gobbledygook) even when addressing the merits of the case, particularly its reasoning for reversing the Federal Circuit's opinion.  Nowhere is this more evident than in its foray into the question of when something that is "obvious to try" is also obvious under 35 U.S.C. § 103.

This portion of the Court's opinion consists of a mere 124 words, but has raised the temperature of commentators and less measured members of the patent bar, who opine that it somehow lowers the bar for courts (and more fearfully, the Patent and Trademark Office) to find inventions obvious:

The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was "obvious to try."  Id., at 289 (internal quotation marks omitted).  When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.  If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.  In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.

The take-home message for many are the words "error" in conjunction with "that a patent claim cannot be proved obvious merely by showing that the combination of elements was 'obvious to try.'"  Having created the impression that something that is "merely . . . obvious to try" can be obvious, the Court then contradicts its own statement by qualifying it:  something that is "[m]erely . . . obvious to try" is also obvious only when there is a design need or market pressure (or, in the words of the TSM test, "motivation") and "a finite number of identified, predictable solutions" that "leads to the anticipated success."

Part of the difficulty in explicating the KSR text is the Court's penchant (not limited, of course, to patent law) in reciting established legal principles as if newly-minted by the Court.  In this case, a close reading of the text reveals the not surprising (and close to mundane) conclusion that things that are obvious can also be obvious to try, and that under limited circumstances (i.e., a limited – "finite" – number of "identified, predictable solutions" that "lead to the anticipated success") things that are "obvious to try" are also obvious.  This is consistent with twenty years of Federal Circuit precedent, as illustrated by two cases: In re O'Farrell (Fed. Cir. 1988) and Pfizer, Inc. v. Apotex, Inc. (Fed. Cir. 2007).

In O'Farrell, the Federal Circuit had this to say about the relationship between obviousness and what is "merely obvious to try":

It is true that this court and its predecessors have repeatedly emphasized that "obvious to try" is not the standard under §103.  However, the meaning of this maxim is sometimes lost.  Any invention that would in fact have been obvious under §103 would also have been, in a sense, obvious to try.  The question is: when is an invention that was obvious to try nevertheless nonobvious?

The admonition that "obvious to try" is not the standard under § 103 has been directed mainly at two kinds of error.  In some cases, what would have been "obvious to try" would have been to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful.  In others, what was "obvious to try" was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it.

Obviousness does not require absolute predictability of success.  Indeed, for many inventions that seem quite obvious, there is no absolute predictability of success until the invention is reduced to practice.  There is always at least a possibility of unexpected results, that would then provide an objective basis for showing that the invention, although apparently obvious, was in law nonobvious.  For obviousness under § 103, all that is required is a reasonable expectation of success.  (Citations omitted).

And in Pfizer v. Apotex:

Parties before this court often complain that holdings of obviousness were based on the impermissible "obvious to try" standard, and this court has accordingly struggled to strike a balance between the seemingly conflicting truisms that, under 35 U.S.C. § 103, "obvious to try" is not the proper standard by which to evaluate obviousness, but that, under O'Farrell and other precedent, absolute predictability of success is not required.  Reconciling the two is particularly germane to a situation where, as here, a formulation must be tested by routine procedures to verify its expected properties.  The question becomes then, when the skilled artisan must test, how far does that need for testing go toward supporting a conclusion of non-obviousness?

First, this is not the case where there are "numerous parameters" to try.  Rather, the only parameter to be varied is the anion with which to make the amlodipine acid addition salt.  Although we recognize some degree of unpredictability of salt formation, the mere possibility that some salts may not form does not demand a conclusion that those that do are necessarily non-obvious.  This is especially true here, where (1) as noted above, the skilled artisan had a reasonable (although not guaranteed) expectation that amlodipine besylate would form; (2) Pfizer conceded in prior litigation that the type of salt had no effect on the therapeutic effect of the active ingredient, amlodipine, and was practically interchangeable, and (3) numerous other publications (described above) clearly directed the skilled artisan to a pharmaceutically-acceptable acid addition salt made from benzene sulphonate, including, significantly, the Carabateas patent which taught the besylate acid addition salt form of another dihydropyridine pharmaceutical compound.

Second, this is not the case where the prior art teaches merely to pursue a "general approach that seemed to be a promising field of experimentation" or "gave only general guidance as to the particular form of the claimed invention or how to achieve it."  Here, as admitted by Mr. Davison, in selecting an acid addition salt formulation, one skilled in the art looked to pharmacopoeias and compendia to find a salt that was previously approved by the FDA and used successfully within the pharmaceutical industry.  Berge clearly pointed the skilled artisan to 53 anions that, as of 1974, were pharmaceutically acceptable.  As Dr. Wells' testimony and the Carabateas patent demonstrated, one of ordinary skill in the art was capable of further narrowing that list of 53 anions to a much smaller group, including benzene sulphonate, with a reasonable expectation of success.

Finally, Pfizer protests that a conclusion that amlodipine besylate would have been obvious disregards its "discovery" because it was obtained through the use of trial and error procedures.  While the pharmaceutical industry may be particularly adversely impacted by application of an "obvious to try" analysis, that Pfizer had to verify through testing the expected traits of each acid addition salt is of no consequence because it does not compel a conclusion of non-obviousness here.  In coming to this conclusion, we have not ignored the fact that "[p]atentability shall not be negatived by the manner in which the invention was made."  35 U.S.C. § 103(a).  Nor are we ignorant of the fact that reference to "routine testing" or "routine experimentation" is disfavored.

*  *  *

However, on the particularized facts of this case, consideration of the "routine testing" performed by Pfizer is appropriate because the prior art provided not only the means of creating acid addition salts but also predicted the results, which Pfizer merely had to verify through routine testing.

Thus, while patentability of an invention is not negated by the manner in which it was made, "the converse is equally true: patentability is not imparted where 'the prior art would have suggested to one of ordinary skill in the art that this process should be carried out and would have a reasonable likelihood of success.'"  (Citations omitted).

Taken in the context of established Federal Circuit (and C.C.P.A. precedent), the Supreme Court's latest assertion of the relationship between obviousness and what it "obvious to try" accomplishes nothing other than to create the (false) impression that new law, or a new interpretation of the law, has been made.  Not so:  it remains the case that what is obvious is also frequently "obvious to try," because there are a limited number of parameters to be varied or new technological methods are applied to an old problem.  And what is merely "obvious to try," without more (i.e., the limited number of finite and predictable solutions that lead to a predictably successful result) is frequently nonobvious, particularly when the result is unpredictable or indeed, suprising and unexpected.  Perhaps it would have been better had the Supreme Court heeded the cautionary note sounded by the Federal Circuit in DyStar Textilfarben GmbH v. C.H. Patrick Co. (Fed. Cir. 2006):

Obviousness is a complicated subject requiring sophisticated analysis, and no single case lays out all facets of the legal test.  [There is] danger inherent in focusing on isolated dicta rather than gleaning the law of a particular area from careful reading of the full text of a group of related precedents for all they say that is dispositive and for what they hold.  When parties . . . do not engage in such careful, candid, and complete legal analysis, much confusion about the law arises and, through time, can be compounded.

For additional information and commentary regarding the KSR decision, please see:

• "Like a Penny Saved for a Rainy Day (Albeit, Unintentionally): The Renewed Relevance of 35 U.S.C. § 103(b)," May 13, 2007
• "BIO's Reaction to KSR v. Teleflex," May 8, 2007
• "Implications of the Supreme Court's KSR v. Teleflex Decision for Biotechnology," May 4, 2007
• "The Patent Office Reacts to KSR: A First Look," May 3, 2007
• "KSR Int'l Co. v. Teleflex Inc. (2007)," April 30, 2007
• "Conference & CLE Calendar," which provides an updated list of upcoming KSR CLE's

Supreme Court Denies Amgen Certiorari Petition to Reverse Cybor

    By Kevin E. Noonan --

The U.S. Supreme Court today denied without comment Amgen's petition for certiorari to review the Federal Circuit's reversal (for the second time) of the District Court's construction of the term "therapeutically effective amount" in its patent infringement suit against Sanofi-Aventis over erythropoietin (EPO).

This lawsuit has been reviewed twice by the Federal Circuit from a bench trial in the Massachusetts District Court (before Judge Young), and each time the Federal Circuit has disagreed with the District Court's interpretation of the term "therapeutically effective amount" in claim 1 of U.S. Patent No. 5,955,422:

A pharmaceutical composition comprising a therapeutically effective amount of human erythropoietin and a pharmaceutically acceptable diluent, adjuvant, or carrier, wherein said erythropoietin is purified from mammalian cells grown in culture.

(emphasis added).  The meaning of this term is important, because the validity of the claim rests upon whether the term requires that the claimed erythropoietin be capable of treating or curing anemia (see "Amgen Asks Supreme Court to Reverse Cybor").  According to the Federal Circuit, the District Court's interpretation of the term was flawed because the District Court improperly focused on the ability of EPO to cause an increase in hematocrit, which is one of EPO's biological properties recited in the specification, to the exclusion of several others.  Since prior art EPO formulations existed that did not have the capacity to increase hematocrit or cure anemia, the District Court used this distinction for finding that said prior art did not anticipate Amgen's claim.

The Federal Circuit disagreed.  It considered causing an increase in hematocrit to be only one of EPO's biological properties, and remanded to the District Court to consider the prior art in light of its construction of the claim term.

In response, Amgen first petitioned for rehearing en banc, which was denied.  However, the published decision denying rehearing en banc illustrated the fractured consensus on the Federal Circuit over its decision, in Cybor Corp. v. FAS Technologies, Inc., that the court would show no deference to lower courts' claim construction decisions, and would review claim construction (both the legal determinations and the underlying factual findings) de novo.  In its petition, Amgen cited the specific deficiencies of the Federal Circuit in its construction of the claim term relative to the trial court (which Amgen asserted "had received tutorials from an M.I.T. scientist, listened to 32 days of testimony from 35 scientists, and read countless pages of written submissions").  Amgen also based its petition on misappropriation of judicial resources, usurpation of the trial court's duty of assessing the evidence firsthand, and the litany of:

(1) a steadily high reversal rate; (2) a lack of predictability about appellate outcomes, which may confound trial judges and discourage settlements; (3) loss of the comparative advantage often enjoyed by the district judges who heard or read all of the evidence * * * ; and (4) inundation of our court with the minutia of * * * disputed claim terms * * * in nearly every patent case,

citing Judge Michel's dissent from the Federal Circuit's denial of rehearing en banc.

In view of its penchant recently to review (and reverse) Federal Circuit precedent, the Supreme Court's decision to decline this opportunity is both surprising and puzzling.  Perhaps the Court believes it may be time to step back from its more aggressive oversight of the Federal Circuit, particularly since that court seems to "gotten the message" and adapted its recent jurisprudence to Supreme Court mandates (see "Is It Time for the Supreme Court to Stop Flogging the Federal Circuit?" and "Syngenta Seeds, Inc. v. Monsanto Co. (Fed. Cir. 2007)").  Also possible is that the Supreme Court agrees with the Federal Circuit's approach as being consistent with its own thinking in Markman v. Westview Instruments, Inc.  Finally, since a significant minority of the Federal Circuit judges have, in dissent of the en banc rehearing decision, indicated that the application of the Cybor doctrine has not worked well in practice and was ripe for review, the Supreme Court may be content to permit the Federal Circuit to come to its own consensus before stepping in.

Notwithstanding the Supreme Court's decision to deny Amgen's petition, Amgen's EPO franchise would appear to be safe no matter what the District Court decides.  There were four other patents-in-suit in this litigation, and Amgen has prevailed on validity and infringement with respect to two of them.

For additional information regarding this case, please see:

• "Amgen Inc. v. Hoeschst Marion Roussel, Inc. (Fed. Cir. 2006)," October 27, 2006

Amgen Asks Supreme Court to Reverse Cybor

    By Kevin E. Noonan ---

Since the Federal Circuit's en banc decision in Cybor Corp. v. FAS Technologies, Inc. that no aspect of a district court's claim construction was entitled to any deference, courts, commentators, and other critics have disagreed with the Federal Circuit.  Today, Amgen has enlisted the aid of the Supreme Court to rein in what it termed a "power grab" by the Federal Circuit in its petition for certiorari in Amgen Inc. v. Hoechst Marion Roussel, Inc.

This case has gone back and forth from the Massachusetts District Court to the Federal Circuit twice, and each time the Federal Circuit has disagreed with the District Court's interpretation of the term "therapeutically effective amount" in claim 1 of U.S. Patent No. 5,955,422:

A pharmaceutical composition comprising a therapeutically effective amount of human erythropoietin and a pharmaceutically acceptable diluent, adjuvant, or carrier, wherein said erythropoietin is purified from mammalian cells grown in culture.

The meaning of this term is important, because the validity of the claim rests upon whether the term requires that the claimed erythropoietin (EPO) be capable of treating or curing anemia.  EPO is a naturally-occurring hormone that stimulates the body to produce red blood cells, and its absence (or insufficiency) causes anemia.  The standard clinical measure of anemia is the hematocrit, or the percent of whole blood comprised of red blood cells.  In construing the term "therapeutically-effective amount," the District Court had required that EPO falling within the scope of claim 1 increase hematocrit and have any other biological properties of naturally-occurring EPO.  Prior art EPO formulations existed that did not have the capacity to increase hematocrit or cure anemia, and this distinction was the basis for the District Court's finding that said prior art did not anticipate Amgen's claim.

The Federal Circuit disagreed.  Under the Court's interpretation, the District Court had improperly focused on hematocrit, which is one of EPO's biological properties recited in the specification, to the exclusion of several others, including increasing stimulation of reticulocyte response, development of ferrokinetic effects, erythrocyte mass changes, and stimulation of hemoglobin.  The CAFC noted in particular that the specification recited that the therapeutic properties of recombinant EPO "included" all of these, and that the specification further stated that recombinant EPO was therapeutically useful even if it lacked some but not all of these properties.  For the second time, the Federal Circuit remanded to the District Court for further proceedings based on its more expansive construction of the term "therapeutically effective amount." 

In its petition, Amgen focused on the differences in understanding between the trial court judge (who Amgen asserted "had received tutorials from an M.I.T. scientist, listened to 32 days of testimony from 35 scientists, and read countless pages of written submissions") and the Federal Circuit.  According to Amgen, the Federal Circuit's de novo review jurisprudence misappropriated judicial resources and usurped the trial court's duty of assessing the evidence firsthand.  Amgen cleverly analogized to the Supreme Court's Daubert jurisprudence, where the Court has commented on its confidence in district court judges' ability to understand complex scientific and factual evidence.  In the Daubert analysis, the Supreme Court has directed appellate courts to defer to such factual findings by the district courts, the outcome Amgen advocates here.

Amgen also recites the now-familiar litany of negative consequences of the Federal Circuit's de novo review standard, including "(1) a steadily high reversal rate; (2) a lack of predictability about appellate outcomes, which may confound trial judges and discourage settlements; (3) loss of the comparative advantage often enjoyed by the district judges who heard or read all of the evidence . . .; and (4) inundation of our court with the minutia of . . . disputed claim terms . . . in nearly every patent case," citing Judge Michel's dissent from the Federal Circuit's denial of rehearing en banc.  Finally, Amgen stresses that this issue is ripe for Supreme Court review in light of the disagreement between the Federal Circuit judges, reminding the Supreme Court that it used this rationale for granting certiorari in Warner-Jenkinson and Festo.

Amgen also asked the Supreme Court to review the Federal Circuit's determination that prosecution history estoppel prevented it from prevailing on another of its claims in suit.  This claim recites recombinant EPO containing 166 amino acids, as determined from the predicted amino acid sequence encoded by the EPO cDNA.  In fact, human EPO as it is found in nature contains only 165 amino acids, since the 166th amino acid is cleaved during the protein's maturation process.  The District Court twice found that prosecution history estoppel did not prevent Amgen from asserting this claim against the defendants under the doctrine of equivalents, and twice the Federal Circuit disagreed.  In its certiorari petition, Amgen contends that the manner in which the Federal Circuit is implementing the Supreme Court's edicts regarding the application of the prosecution history estoppel doctrine is tantamount to the Federal Circuit's own, draconian, and Supreme Court-repudiated "no equivalents" standard for any claim amended during prosecution.  In Festo, the Supreme Court had explicitly rejected this approach, mandating that the Federal Circuit's analysis consider whether the amendment was unforeseeable, was tangential to patentability, or for some other reason should not raise an estoppel.  Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 740-41 (2002).  By including the prosecution history estoppel issue in its certiorati petition, Amgen has significantly increased its chances of having the petition granted, since the Supreme Court has been diligent in the past ten years in defending the doctrine of equivalents from a consistent effort by the Federal Circuit to minimize or eliminate application of the doctrine.

Supreme Court review of the Federal Circuit's application in Cybor of the principles it set forth in Markman has been anticipated and welcomed by many.  A significant minority of the Federal Circuit judges have, in dissent, indicated that the Court's application of the Cybor decision (i.e., that the Court owes the District Court no deference even for factual matters related to claim construction) did not work well in practice and was ripe for review.  The Court might have lost its opportunity to address these issues itself, and inadvertently provided the Supreme Court with another opportunity to overturn Federal Circuit precedent, a pastime it has become accustomed to in the last few years.

Roche Diagnostics Corp. v. Home Diagnostics, Inc. (S.D. Ind. 2007)

Court Finds That HDI's Glucometer Does Not Infringe Roche Patent

    By Robert Dailey

A District Court in Indianapolis ruled last week that Home Diagnostics' TrueTrack® and TrackEASE® blood glucose monitoring systems do not infringe U.S. Patent No. 5,366,609, owned by Roche.  The lawsuit had pitted Roche, one of the leaders in the medical diagnostics industry, against a discount seller of competing products.

The Roche patent is directed to a biosensing meter that has a pluggable ROM key.  The pluggable key contains data that enable the meter to perform certain test functions.  The asserted claim contained several means-plus-function elements.  The case largely turned on the District Court's construction of these elements (see Court's Order on Claim Construction).

In typical claim construction, courts should resist reading limitations from the specification into the claims.  The text of the claims establishes their scope.  If the accused device falls within the scope of the claim's periphery, the device infringes.

But the infringement analysis differs for means-plus-function claims.  "Literal infringement of a means-plus-function claim limitation requires that the relevant structure in the accused device perform the identical function recited in the claim and be identical or equivalent to the corresponding structure in the specification."  Even for doctrine of equivalents (DOE) infringement of a means-plus-function limitation, the accused device must "perform the identical function in substantially the same way, with substantially the same result."

Means-plus-function claims can ease some of the headaches of patent prosecution, but they can come back to bite patentees when they try to enforce the claims against an accused infringer.  In drafting means-plus-function claims, patentees should be careful to:  (i) define the function very broadly, and (ii) provide a wealth of embodiments that can serve as corresponding structures.  Otherwise, would-be licensees may find little difficulty designing around the claimed invention.

In this instance, the Court's claim construction left Roche with relatively narrow claims that had little power to exclude potential infringers.

    Roche Diagnostics Corp. v. Home Diagnostics, Inc., 04-cv-1187-LJM-JMS (S.D. Ind. 2007).

    Robert Dailey, Ph.D., is a physical chemist and a third-year law student at the University of North Carolina at Chapel Hill.  Dr. Dailey was a member of MBHB's 2006 class of summer associates, and is a regular Patent Docs contributor.