Patent Docs

Nalproprion Pharmaceuticals, Inc. v. Actavis Laboratories FL, Inc. (Fed. Cir. 2019)

By Kevin E. Noonan --

Last week, the Federal Circuit reversed findings of non-obviousness and affirmed (over Chief Judge Prost's dissent) a finding that claims asserted in ANDA litigation were not invalid for failure to satisfy the written description requirement in Nalproprion Pharmaceuticals, Inc. v. Actavis Laboratories FL, Inc.

ANDA litigation arose over Nalproprion Pharma's Contrave^® extended-release tablets of the combination of naltrexone hydrochloride and buproprion hydrochloride, for treatment of obesity, and Orange Book-listed U.S. Patent Nos. 7,375,111; 7,462,626; and 8,916,195.  The following claims were at issue in this litigation:

Claim 11 of the '195 patent:

A method of treating overweight or obesity having reduced adverse effects comprising orally administering daily about 32 mg of naltrexone and about 360 mg of bupropion, or pharmaceutically acceptable salts thereof, to a person in need thereof, wherein the bupropion or pharmaceutically acceptable salt thereof is administered as a sustained release formulation, wherein the naltrexone or pharmaceutically acceptable salt thereof is ad- ministered as a sustained release formulation, and wherein said sustained release formulation of naltrexone has an in vitro naltrexone dissolution pro- file in a dissolution test of USP Apparatus 2 Paddle Method at 100 rpm in a dissolution medium of water at 37° C. of:
    a) between 39% and 70% of naltrexone re- leased in one hour;
    b) between 62% and 90% of naltrexone re- leased in two hours; and
    c) at least 99% in 8 hours;
    wherein about 16 mg of said sustained re- lease formulation of naltrexone or a pharmaceutically acceptable salt thereof is administered twice daily, and about 180 mg of said sustained release formulation of bupropion or a pharmaceutically acceptable salt thereof is administered twice daily.

Claim 1 of the '195 patent:

A composition for affecting weight loss comprising:
    (a) a sustained release formulation of bupropion or a pharmaceutically acceptable salt thereof in an amount effective to in- duce weight loss in an individual; and
    (b) a sustained release formulation of naltrexone or a pharmaceutically acceptable salt thereof in an amount effective to enhance the weight loss effect of the bupropion or salt thereof;
wherein said composition is in a single oral dosage form fixed combination.

Claims 26 and 31 of the '626 patent:

A method of treating overweight or obesity, comprising administering a weight loss effective amount of a first and second compound to an individual who has been diagnosed as suffering from overweight or obesity in order to treat said overweight or obesity, wherein said first compound is bupropion, or a pharmaceutically acceptable salt thereof, and said second compound is naltrexone, or a pharmaceutically acceptable salt thereof, and wherein the weight loss activity of said first and second compounds is enhanced compared to the administration of the same amount of either compound alone, wherein naltrexone and buproprion are administered together.

A method of treating overweight or obesity, comprising administering a weight loss effective amount of a first and second compound to an individual who has been diagnosed as suffering from overweight or obesity in order to treat said overweight or obesity, wherein said first compound is bupropion, or a pharmaceutically acceptable salt thereof, and said second compound is naltrexone, or a pharmaceutically acceptable salt thereof, and wherein the weight loss activity of said first and second compounds is enhanced compared to the administration of the same amount of either compound alone, wherein at least one of sad drugs are in a sustained release formulation and are administered in a single oral dosage form.

(where the italicized portions of these claims were recited in independent and/or dependent claims related to asserted claims 26 and 31).

The District Court found that defendant Actavis had not established that claim 11 of the '195 patent was invalid for failure to satisfy the written description requirement of 35 U.S.C. § 112(a) with regard to the claim limitation reciting USP dissolution methods ("USP1" versus "USP2").  The claims expressly recited the USP 2 Paddle Method, but Actavis argued that the specification disclosed only the UPS 1 Basket Method.  The District Court based its decision on the skilled worker not having a doubt that the inventors had possession of the invention based on the nature of the dissolution method disclosed in the specification.  The Court held that disclosure of a "substantially equivalent method" was sufficient to satisfy the requirement.

The District Court also rejected Actavis' arguments that claims 26 and 31 of the '626 patent and claim 1 of the '195 patent were obvious, on the grounds that "it would have been obvious for a person of skill to combine bupropion and naltrexone for treating overweight and obesity because both drugs were known to cause weight loss," holding that this argument amounted to "a classic case of hindsight bias."

The Federal Circuit reversed the District Court regarding its obviousness decision in an opinion by Judge Lourie, joined by Chief Judge Prost and Judge Wallach, and affirmed the District Court on its written description determination over Chief Judge Prost's dissent.  The majority's written description decision was based in part on the "peculiarity" of the structure of claim 11, which is directed to a method for treating obesity using specific amounts of the two drugs and reciting the method for determining the dissolution profile of what the majority termed "resultant in vitro parameters," which were not the "operative steps to treat overweight or obesity."  The majority found no clear error in the District Court's holding that "irrespective of the method of measurement used, the specification shows that the inventors possessed the invention of treating overweight or obesity with naltrexone and bupropion in particular amounts and adequately described it."  The majority noted that this determination by the District Court was supported by more credible testimony from Nalproprion Pharma's expert and "untrustworthy, self-serving statements by Actavis's expert."  The majority stated that it refused to disturb the District Court's weighing of witness credibility in the performance of its "fact-finding function."  The majority further recognized (in the face of the Chief Judge's dissent) that "[w]hile as a general matter written description may not be satisfied by so-called equivalent disclosure," under these facts the District Court had not clearly erred.

Turning to the District Court's non-obvious determination for claims 26 and 31 of the '626 patent and claim 11 of the '195, patent, the panel unanimously held these determinations to be error as a matter of law.  The opinion sets forth the teachings of the asserted references, characterizing them as disclosing the use of an opioid antagonist like naltrexone and "withdrawal attenuating agents," including buproprion for minimizing weight gain, inter alia, during smoking cessation, and bupropion or naltrexone alone in weight loss regimes.  The Federal Circuit disagreed with the District Court's conclusion of non-obviousness, stating that:

The prior art here discloses the claimed components of the composition claims and the steps of the method claims including the use claimed by the method.  . . .  The references teach that bupropion causes weight loss.  . . .  Likewise, the record indicates that naltrexone can cause weight loss.  . . .  Given that both drugs had shown weight loss effects, we conclude that a person of ordinary skill would have been motivated to combine them.  In fact, such persons did so.

The panel rejected as unpersuasive Nalproprion Pharma's argument that the FDA would not and had not approved buproprion for weight loss, saying that this was not dispositive for the question of whether the skilled worker would have had a motivation to combine the asserted references.  Further, the opinion states:

The inescapable, real-world fact here is that people of skill in the art did combine bupropion and naltrexone for reductions in weight gain and reduced cravings—goals closely relevant to weight loss.  Contrary to Nalpropion Pharma's view, persons of skill did combine the two drugs even without understanding bupropion's mechanism of action but with an understanding that bupropion was well-tolerated and safe as an antidepressant.  . . .  ("The precise mechanism for bupropion SR that is responsible for effects on weight loss is unknown.")  . . .  Thus, we conclude that skilled artisans would have been motivated to combine the two drugs for weight loss with a reasonable expectation of success [citations to the record omitted].

The Court found "every limitation of the claims at issue" was found in the asserted art, and rejected Nalproprion Pharma's purported evidence for secondary considerations (failure of others, unexpected results) to rebut their finding that these claims were obvious.  According to the Court, "the inventors only combined two drugs known to affect weight loss.  Both drugs were known to affect weight loss, and combining them for this known purpose as claimed in the patents yields no unpredictable result."  The Federal Circuit thus found claim 11 of the '195 patent and claims 26 and 31 of the '626 patent to be invalid for obviousness.

The Chief Judge's dissent on the written description question was based on the majority's reliance on "substantially equivalent disclosure" to support claim language not having clear and explicit support in the specification.  The Chief Judge characterizes the majority's decision as "add[ing] what appears to me to be a new rule to this court's long-standing written description jurisprudence."  She sets forth three reasons for her disagreement with the majority:

First, the USP 2 clause is limiting.  Second, the majority's "substantially equivalent" rule is inconsistent with this court's precedent.  Third, the district court clearly erred in finding that the '195 patent's written description includes a disclosure "substantially equivalent" to USP 2.

Important to the Chief Judge's reasoning, inter alia, were arguments from the prosecution history where the patentee appeared to rely on the dissolution profile (and the manner of determining it) to distinguish the claims from the prior art.  The Chief also disagreed with the District Court's (and the majority's) disregard for defendant's expert testimony and found his assertion that the USP1 an USP2 methods would not have produced the same dissolution profile results to have been relevant to the written description issue before each court.

Nalproprion Pharmaceuticals, Inc. v. Actavis Laboratories FL, Inc. (Fed. Cir. 2019)
Panel: Chief Judge Prost and Circuit Judges Lourie and Wallach
Opinion by Circuit Judge Lourie; dissenting in part opinion by Chief Judge Prost

Forum US, Inc. v. Flow Valve, LLC (Fed. Cir. 2019)

By Joshua Rich --

Every patent must include a written description of the invention sufficient to enable a person of ordinary skill in the art to make and use the invention.  A broadening reissue under 35 U.S.C. § 251 must meet a more exacting standard:  the claimed invention must be clearly and unequivocally disclosed in the original patent to justify grant of broadened claims.  The Forum US case illustrated the difference, where the Federal Circuit affirmed the District Court's grant of summary judgment of invalidity due to failure to comply with the reissue statute.

Flow Valve owned U.S. Patent No. 8,215,213, directed to supporting assemblies used in the machining of pipefittings.  The supporting assemblies would allow a machinist to manipulate the orientation and position of the pipefittings quickly and easily, expediting the use of various tools on the pipefittings.  As disclosed in the specification (both figures and text), the supporting assemblies included arbors along the axes of the pipe fitting for engagement of a machine, such as a lathe, that would turn the pipefitting for machining.  Two figures from the '213 patent illustrate the arbors (circled in red):

The '213 patent also claimed inventions expressly with arbors as part of the supporting assembly.  Claim 1, representative of the thirteen issued claims, covered:

    A workpiece machining implement comprising:
    a workpiece supporting assembly comprising:
    a body member having an internal workpiece channel, the body member having a plurality of body openings communicating with the internal workpiece channel;
    means supported by the body member for positioning a workpiece in the internal workpiece channel so that extending workpiece portions of the workpiece extend from selected ones of the body openings;
    a plurality of arbors supported by the body member, each arbor having an axis coincident with a datum axis of one of the extending workpiece portions; and
    means for rotating the workpiece supporting assembly about the axis of a selected one of the arbors.

'213 patent (emphasis added).  Flow Valve had sued Forum US for patent infringement on the '213 patent, and Forum US changed its design to eliminate arbors.  While that initial suit was pending, Flow Valve sought broadening reissue of the '213 patent and drafted claims to cover Forum US's new design.[1]  Specifically, Flow Valve sought -- and obtained -- additional claims 14-20 in U.S. Patent No. RE45,878 that did not require arbors as part of the supporting assemblies.  Claim 14 covers:

A workpiece supporting assembly for securing an elbow during a machining process that is performed on the elbow by operation of a workpiece machining implement, the workpiece supporting assembly comprising:
    a body having an internal surface defining a channel, the internal surface sized to receive a medial portion of the elbow when the elbow is operably disposed in the channel; and
    a support that is selectively positionable to secure the elbow in the workpiece supporting assembly, the body pivotable to a first pivoted position, the body sized so that a first end of the elbow extends from the channel and beyond the body so the first end of the elbow is presentable to the workpiece machining implement for performing the machining process, the body pivotable to a second position and sized so that a second end of the elbow extends from the channel beyond the body so the second end of the elbow is presentable to the workpiece machining implement for performing the machining process.

Rather than waiting for Flow Valve to sue it on the '878 reissue patent, Forum US brought a declaratory judgment suit arguing, among other things, that the new reissue claims were invalid for lack of compliance with § 251.[2]  Section 251 provides:

Whenever any patent is, through error, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent.  No new matter shall be introduced into the application for reissue.

Specifically, Forum US argued that the reissue claims were not "for the invention disclosed in the original patent" and moved for summary judgment on that basis.  Flow Valve responded, based on an expert declaration, that a person of ordinary skill in the art would understand that the patent disclosed multiple inventions, including embodiments with and without arbors.  This gambit didn't work; the District Court granted Forum US's motion for summary judgment, invalidating claims 14 through 20, because "no matter what a person of ordinary skill would recognize, the specification of the original patent must clearly and unequivocally disclose the newly claimed invention in order to satisfy the original patent rule."[3]

Upon appeal, the Federal Circuit reviewed the District Court's decision de novo, but employed the same reasoning in affirming the decision.  The Court relied on two cases -- both cited by the District Court -- separated by over seven decades:  U.S. Indus. Chems., Inc. v. Carbide & Carbon Chems. Corp., 315 U.S. 668 (1942), and Antares Pharma, Inc. v. Medac Pharma Inc., 771 F.3d 1354 (Fed. Cir. 2014).  The two cases stand for the same proposition, that for broadening reissue claims "it is not enough that an invention might have been claimed in the original patent because it was suggested or indicated in the specification."[4]  Instead, the face of the patent itself must show that what is covered by the reissue claims was intended to have been covered by the original patent.  As phrased by Antares, the original patent "must clearly and unequivocally disclose the newly claimed invention as a separate invention."[5]

Here, there was really no question that the broader reissue claims were not clearly and unequivocally disclosed in the original patent.  The original patent did not disclose an embodiment of the invention without an arbor.  Similarly, the abstract and summary of the invention described the invention as having a plurality of arbors.  For that reason, Flow Valve had relied on an expert declaration regarding what "a worker of ordinary skill would understand."  But while such a declaration might be sufficient to satisfy the written description requirement, it does not help illuminate the text of the original patent.  Simply put, the specification did not "clearly and unequivocally disclose the newly claimed invention as a separate invention," and the reissue claims failed the original patent requirement.

The Forum US case is yet another reminder of the value of expert patent prosecution counsel.  Flow Valve might have been able to pursue its claims in a continuation application, if it had one pending (which experienced counsel would likely have suggested).  In doing so, it would not have had to meet the additional requirements of a broadening reissue.  But not knowing the quirky rules of reissue, including the original patent requirement, can prove fatal to the same claims if they do not appear clearly to be part of the invention in the original patent.

Forum US, Inc. v. Flow Valve, LLC (Fed. Cir. 2019)
Panel: Circuit Judges Reyna, Schall, and Hughes
Opinion by Circuit Judge Reyna

[1] See Forum US, Inc. v. Flow Valve, LLC, Civil Action No. 5:17-cv-00495-F (W.D. Okla.), Dkt. # 1 (Complaint).
[2] Id.
[3] Id., Dkt. #45, p. 10.
[4] Indus. Chems., 315 U.S. at 676.
[5] Antares, 771 F.3d at 1362.

Nuvo Pharmaceuticals (Ireland) Designated Activity Co. v. Dr. Reddy's Laboratories Inc. (Fed. Cir. 2019)

By Kevin E. Noonan --

There are provisions and interpretations of U.S. patent law that can be in tension depending on the circumstances under which they are argued, whether before an Examiner or during litigation.  One of these is the dichotomy between arguing that the prior art would provide insufficient expectation of success to render an invention obvious, while at the same time relying on what was known by a person of skill in the art to minimize the extent of the written description provided in a specification that satisfies the written description requirement of 35 U.S.C. § 112(a).  This tension proved fatal to the claims at issue in Nuvo Pharmaceuticals v. Dr. Reddy's Laboratories, decided by the Federal Circuit last week.

The case arose as ANDA litigation against Dr. Reddy's Labs (and Mylan and Lupin entities) over non-steroidal anti-inflammatory drugs (NSAIDs) formulated to diminish recognized gastrointestinal irritation side effects these drugs can cause, the formulations being claimed in Orange Book-listed U.S. Patent Nos. 6,926,907 and 8,557,285 and sold by Nuvo as Vimovo®.  The prior art disclosed efforts to avoid these side effects by co-administration of NSAIDs with proton pump inhibitors (PPIs), because stomach acid was believed to contribute to them.  These efforts were disadvantageous, inter alia, because stomach acid degraded the PPIs before they could be absorbed in the small intestine and have their acid-diminishing effect in the stomach.  The art showed attempts to remedy these shortcomings by enterically coating PPIs to resist stomach acid.  These efforts did not entirely fix the problem because the NSAID was degraded if released into the stomach before the PPI could reduce stomach acid (i.e., raising the pH by inhibiting the proton pump responsible for producing the acidic environment therein).

The inventor of the '907 patent invented a new formulation that "coordinated the release of an acid inhibitor and an NSAID in a single tablet, the formulation comprising a core of an NSAID, enterically coated so that the coating dissolves only at an elevated pH, and then providing an amount of a PPI sufficient to provide pH elevated to the enteric cost dissolving level."  Claim 1 of the '907 patent and claim 1 of the '285 patent are each set forth as representative in the Federal Circuit's opinion, respectively:

1.  A pharmaceutical composition in unit dosage form suitable for oral administration to a patient, comprising:
    (a) an acid inhibitor present in an amount effective to raise the gastric pH of said patient to at least 3.5 upon the administration of one or more of said unit dosage forms;
    (b) a non-steroidal anti-inflammatory drug (NSAID) in an amount effective to reduce or eliminate pain or inflammation in said patient upon administration of one or more of said unit dosage forms;
    and wherein said unit dosage form provides for coordinated release such that:
        i) said NSAID is surrounded by a coating that, upon ingestion of said unit dosage form by said patient, prevents the release of essentially any NSAID from said dosage form unless the pH of the surrounding medium is 3.5 or higher;
        ii) at least a portion of said acid inhibitor is not surrounded by an enteric coating and, upon ingestion of said unit dosage form by said patient, is released regardless of whether the pH of the surrounding medium is below 3.5 or above 3.5.

1.  A pharmaceutical composition in unit dosage form comprising therapeutically effective amounts of:
    (a) esomeprazole, wherein at least a portion of said esomeprazole is not surrounded by an enteric coating; and
    (b) naproxen surrounded by a coating that inhibits its release from said unit dosage form unless said dosage form is in a medium with a pH of 3.5 or higher;
    wherein said unit dosage form provides for release of said esomeprazole such that upon introduction of said unit dosage form into a medium, at least a portion of said esomeprazole is released regardless of the pH of the medium.

While the specification (according to the panel opinion) disclosed many features of the claimed invention, "[i]t is undisputed that there is no experimental data demonstrating the therapeutic effectiveness of any amount of uncoated PPI and coated NSAID in a single dosage form," nor is there any disclosure of formulations wherein uncoated PPI could be used to raise gastrointestinal pH.

The District Court found that Defendants had not shown the asserted claims to be obvious under 35 U.S.C. § 103 nor not enabled or inadequately described under 35 U.S.C. § 112, and that one of Dr. Reddy's generic products did not infringe the '907 patent (granting summary judgment to Dr. Reddy's on its noninfringement motion).  Specifically, the Court found that it would not have been obvious to use a PPI according to the asserted claims to prevent gastrointestinal injury from an NSAID, inter alia because the art would have discouraged attempting such formulations due to the known acid sensitivity of PPIs.  Moreover, the District Court held that the claims were enabled because the specification disclosed how to make and use the invention.  The Court relied on expert testimony in deciding that the skilled worker would have recognized the usefulness of the claimed formulations.

With regard to Dr. Reddy's written description challenges, the District Court found that the use of the transition term "comprising" in the '285 patent claims did not cause the claims to encompass (undisclosed) embodiments having uncoated, immediately released naproxen (an exemplified NSAID).  The Court also rejected a second challenge, that the claims encompass sustained-release as well as delayed-release NSAID formulations not supported by the specification, because the claims recited "inhibiting" rather than "preventing" NSAID release prior to achieving the claimed raised pH levels.  Finally, the District Court rejected Defendants' argument that "ordinarily skilled artisans would not have expected [the claimed formulation] to work and the specification provides no experimental data or analytical reasoning showing the inventor possessed an effective uncoated PPI."  The Court held that "experimental data and an explanation of why an invention works are not required, the specification adequately describes using uncoated PPI, and its effectiveness is necessarily inherent in the described formulation."

This appeal followed, limited to the District Court's findings on the first and third written description arguments; Nuvo cross-appealed on the District Court's grant of summary judgment of non-infringement by Dr. Reddy's second formulation.

The Federal Circuit reversed the District Court's decision and dismissed Nuvo's cross-appeal, in an opinion by Judge Clevenger, joined by Chief Judge Prost and Judge Wallach.  The opinion states that the panel's analysis "begins and ends" with Defendants' third written description argument related to a failure to show "efficacy" of the claimed formulation.  According to the Federal Circuit, the issue was raised by Nuvo's argument (related to Defendants' obviousness assertions) that "ordinarily skilled artisans would not have expected uncoated PPIs to be effective."  Inconsistently, "nothing in the specification would teach a person of ordinary skill in the art otherwise" and this failure to disclose what was not found in the art (and indeed, Nuvo affirmatively contended was not known in the art with regard to the obviousness issue) amounts to a failure to describe how the inventors were in possession of the claimed invention.  The District Court's error, according to the Federal Circuit, was that its written description analysis on this point "does not support it conclusions."  Because of the "clear error" standard of review imposed on the Federal Circuit on questions of fact (as the adequacy of disclosure sufficient to satisfy the written description requirement is), the opinion asserts that the panel "scour[ed] the record created below for evidence supporting the district court's written description finding."

To no avail.  In part, the panel came to this conclusion because they appreciated that Nuvo raised "at least five arguments" ("for the first time on appeal, and as its lead argument") directed to reading any effectiveness language or requirement from the asserted claims.  These arguments were, in the panel's view, contradicted by the plain language (and plain meaning thereof) of the claims (claim 1 of the '907 patent recites ". . . in an amount effective to raise the gastric pH of said patient to at least 3.5," and claim 1 of the '285 patent recites ". . . comprising therapeutically effective amounts of "the PPI"; emphasis in the opinion).  But the opinion sets forth and rejects each one.

First, Nuvo argued that the dosage form as a whole does not need to be effective in raising gastric pH; the Federal Circuit agreed but did not find any Defendants' argument to the contrary.

Second, Nuvo argued that the claims do not require the NSAID and PPI to be in a single dosage form, but "only amounts of each component effective on their own."  Defendants argued that the claim "requires coordinated release achieved by an effective amount of uncoated PPI that raises the gastric pH to at least 3.5 and an effective amount of naproxen that is released to treat pain when the pH reaches the desired level"; the panel held that Nuvo had not presented this argument below and thus it was forfeited.

Third, Nuvo contended that the claim didn't require the uncoated PPI to be effective to raise gastric pH, just that the formulation contained an effective amount of uncoated PPI.  In addition to holding Nuvo had also forfeited this argument by not raising it below, the panel termed it "nonsensical to read the claims to require effective amounts of uncoated PPI without specifying the result effectively achieved."

Fourth, Nuvo asserted that the claims encompassed "multiple dosage forms" and thus the specification did not need to expressly describe any particular effective dosage form.  Rather than summarily dismissing this argument, the opinion expressly disagreed with it:  the '285 patent "does not allow for more than one dosage form" and "[e]ven if it were true that the '907 patent allows more than one dosage form to effectively raise the gastric pH to at least 3.5 using uncoated PPI, the specification would still need to provide support for the notion that uncoated PPI is effective," according to the Court.

Finally, the panel rejected Nuvo's argument that the Examiner interpreted the claims in a manner consistent with their argument, that "the '907 patent claims [] merely require[d] certain amounts of PPI and NSAID effective on their own rather than requiring an overall efficacy for the combined drug."  The panel found Nuvo's argument relied in this regard on arguments the Court had already rejected and besides, in their view "the Examiner appears to have interpreted the claims to require an amount of PPI, whether coated or uncoated, effective to raise the gastric pH to the desired level" and that was the written description required (and lacking) in Nuvo's specification.

Having decided what the written description was required to be, the panel then reported its failure in finding support in the specification.  Nuvo's attempt to rely on expert testimony was unavailing, in part because this testimony was sufficiently particular that the Court was able to review and reject it.  Specifically, the opinion states that "[t]he statements [the expert] points to recite the claim limitation by simply calling generally for effective amounts of uncoated PPI, but our precedent clearly establishes that is not enough . . . .  We have expressly rejected the 'argument that the written description requirement . . . is necessarily met as a matter of law because the claim language appears in ipsis verbis in the specification'" according to the opinion, citing Enzo Biochem, Inc. v. Gen–Probe Inc., 323 F.3d 956, 968 (Fed. Cir. 2002).  Experimental evidence is not required, In re '318 Patent Infringement Litig., 583 F.3d 1317, 1324 (Fed. Cir. 2009), nor is there any requirement for a "theory or explanation of how or why a claimed composition will be effective," Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293, 1308 (Fed. Cir. 2015), nor does an invention need to be reduced to practice, Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 926 (Fed. Cir. 2004).  But here, "there is nothing in the specification of the patents-in-suit showing that the inventor actually invented the invention claimed,'" citing Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1348 (Fed. Cir. 2011) (emphasis in opinion).  The Court concluded that the specification is "fatally flawed" with regard to providing an adequate written description of the requisite efficacy recited in the claims, and reversed the District Court's finding that Defendants had not established that the '907 and '285 patents were invalid for failure to satisfy the requirements of 35 U.S.C. § 112.

Nuvo Pharmaceuticals (Ireland) Designated Activity Co. v. Dr. Reddy's Laboratories Inc. (Fed. Cir. 2019)
Panel: Chief Judge Prost and Circuit Judges Clevenger and Wallach
Opinion by Circuit Judge Clevenger

Supreme Court Denies Certiorari in Amgen v. Sanofi

By Kevin E. Noonan --

The Supreme Court denied certiorari last week in Amgen Inc. v. Sanofi, in a case that asked the Court to review the Federal Circuit's jurisprudence related to the written description requirement of 35 U.S.C. § 112(a).

To recap, the Federal Circuit overturned the "newly characterized antigen test" set forth in Noelle v. Lederman and brought treatment of the written description requirement for antibody claims in line with the Court's en banc decision in Ariad v. Eli Lilly.  The case arose when Amgen sued Sanofi and Regeneron for over its Praluent® (alirocumab) product that could compete with Amgen's Repatha™ (evolocumab); Amgen's asserted patents, inter alia, included U.S. Patent Nos. 8,829,165 ("'165 patent") and 8,859,741("'741 patent"), functionally claim a genus of antibodies that encompass Sanofi's Praluent® product.  As background, blood plasma contains low-density lipoproteins that bind cholesterol and are associated with atherosclerotic plaque formation.  Liver cells express receptors for LDL (LDL-R) wherein binding thereto reduces the amount of LDL cholesterol in blood and reduces the risk of plaque formation and cardiovascular disease.  PCSK9 (proprotein convertase subtilisin kexin type 9) is a molecule that binds to and causes liver cell LDL-R to be destroyed, thus reducing the capacity and effectiveness of the liver cell's ability to reduce serum LDL-cholesterol.  The antibodies at issue in this suit bind to PCSK9 and prevent PCSK9 from binding to LDL-R, causing their destruction.

Claim 2 of the '165 patent (dependent on claim 1, the limitations of which are included in italics) was asserted by Amgen in the litigation:

An isolated monoclonal antibody, wherein, when bound to PCSK9, the monoclonal antibody binds to at least one of the following residues: S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO:3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDL[-]R, wherein the monoclonal antibody binds to at least S153.

It is important to note that, while reciting the structure of the residues on PCSK9 that are bound by the claimed antibody, the claim does not recite any structural limitations of the antibody.  The only antibody characteristics recited as limitations are functional, i.e., the ability to bind to at least one of the recited PCSK9 residues and block binding of PCSK9 to LDLR.

The panel decision, by Chief Judge Prost, joined by Judges Taranto and Hughes, held that an adequate written description of a genus requires the specification to disclose "a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus."  The panel held that the jury instructions, which relied on Noelle v. Lederman for the proposition that characterizing a new antigen was sufficient to satisfy the statute for claims encompassing a broad genus of antibodies that could bind to the new antigen, "is not legally sound and [] not based on any binding precedent" and provided its legal analysis of Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed. Cir. 2002), Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004), and Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341 (Fed. Cir. 2011) in support of its conclusion.  The panel held this instruction to be improper because it effectively eliminated the written description requirement from the statute in favor of enablement, contrary to the Court's en banc Ariad decision, stating that "[b]y permitting a finding of adequate written description merely from a finding of ability to make and use, the challenged sentence of the jury instruction in this case ran afoul of what is perhaps the core ruling of Ariad."  And the panel found that whether the relationship between the structure of the antigen, no matter how fully characterized, and any of its cognate antibodies is (here and hitherto) "hotly contested" which precluded the Court from making any definitive finding.  The panel recited its abrogation of the "fully characterized antigen" test more directly:

Further, the "newly characterized antigen" test flouts basic legal principles of the written description requirement.  Section 112 requires a "written description of the invention."  But this test allows patentees to claim antibodies by describing something that is not the invention, i.e., the antigen.  The test thus contradicts the statutory "quid pro quo" of the patent system where "one describes an invention, and, if the law's other requirements are met, one obtains a patent."  Indeed, we have generally eschewed judicial exceptions to the written description requirement based on the subject matter of the claims [citations omitted].

In its certiorari petition, Amgen submitted this Question Presented:

Whether the standard for determining the adequacy of the "written description of the invention" should be as the statute says—that the description must be "in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains . . . to make and use the same"—or whether court-created standards should control instead.

Amgen asserted a number of reasons for the Court's review.  Amgen argued that the Federal Circuit's "possession" test for satisfying the written description requirement is contrary to the statutory language, the statute's history, and Supreme Court and lower court precedent.  The petition analyzed the statutory test, finding that the statute's structure mandates that the statute requires a written description of the invention in a manner that discloses how to make and use it.  The brief argued that the Federal Circuit's "'possession' jurisprudence has strayed too far from the statutory standard, imposes extra-statutory barriers to patent protection, and has resulted in a shifting array of uncertain sub-tests and evidentiary considerations that destabilize the incentives and certainty needed to drive the development of breakthrough inventions."  In Amgen's view, the statute contains a single written description requirement that the Federal Circuit has split into two, separating the "written description" requirement from the "enablement" requirement, each having different standards.  This bifurcation "defies the statute and precedent," according to the petition.  Throughout the brief, Amgen contrasted the relatively certain methodology to ascertain whether the enablement requirement has been satisfied with the more "nebulous" requirement for satisfying written description (caused by the factual nature of the written description inquiry).  Using the Federal Circuit's own precedent, the petition called out a number of "subtests" used by the Federal Circuit to address this question, including the "representative-species" test, "structure-function" test, and "common-structural-features" test, none of which, Amgen argued, can be reconciled with the statutory text.  The brief also relied on a number of dissenting opinions by Federal Circuit judges (including in the en banc Ariad decision) and academic criticism to support its allegations that the Federal Circuit erred in its application of the written description requirement of § 112(a).  The brief also pointed to the "ever-shifting" nature of the Court's decisions, culminating in overturning the Noelle v. Lederman test in the case at bar, arguing that:

The Federal Circuit's departure from § 112(a)'s standard—and the bargain the Patent Act provides—has become intolerable.  It does not promote research and investment required for the breakthrough inventions most deserving of patent protection; instead, incentives are shifted to narrow advances for which narrow patents can be obtained under the Circuit's sub-tests.  The ever-evolving application of the "possession" standard has produced jurisprudential anarchy, leaving inventors uncertain whether disclosures are sufficient.

The petition also contained a section directed to the purported importance (on policy grounds) of the question presented, putative negative effects on innovation, dissension amongst Federal Circuit judges over the recognition of a separate written description requirement, and the disparate effects on biotechnology inventions.

Sanofi's responsive brief provided several reasons why the Supreme Court should not grant cert.  First, the brief argued that this case was an "exceptionally poor candidate for certiorari," at least because the issue underlying the Question Presented was not raised by the parties below or addressed by the Federal Circuit (the Supreme Court is "a court of review, not of first view," according to the brief, citing Byrd v. United States, 138 S. Ct. 1518, 1527 (2018)).  This argument was supported by Amgen's positions, in this case and as amicus in, inter alia, the Federal Circuit's Ariad decision, supporting the Federal Circuit's decisions on written description.  Under these circumstances, Sanofi argued that the Court should consider the issue waived by Amgen.  Raising judicial economy principles, the brief also argued that even if the Court granted certiorari and decided the case, its judgment was not dispositive (because the Federal Circuit remanded for the District Court to reconsider Sanofi's enablement challenge based on post-arising evidence the District Court "improperly excluded") and that the case remained ongoing below.  Turning to stare decisis, the brief argued that there was no reason for the Court to "disrupt more than fifty years of settled precedent" by reviewing the Federal Circuit's written description case law.  Sanofi asserted that the Federal Circuit had come to the right conclusions in how its written description jurisprudence had developed, and again asserted to the Court that Amgen had "vastly overstate[d]" the importance of the Question Presented.

It is impossible to know, of course, why the Supreme Court decides whether or not to grant cert.  Whether this decision signals a lessening of the Supreme Court's interest in deciding patent law cases, what we do know is that the Court will not yet be reviewing how the Federal Circuit applies the written description requirement to antibody claims.

In re Tropp (Fed. Cir. 2018)

By Donald Zuhn --

Today, in In re Tropp, the Federal Circuit vacated and remanded a decision by the U.S. Patent and Trademark Office's Patent Trial and Appeal Board affirming the Examiner's rejection of claims 29-53 of U.S. Application No. 13/412,233 for lack of sufficient written description under 35 U.S.C. § 112.  In vacating the Board's determination, the Court found that the Board had erred in its analysis.

The claims of the '233 application are directed to a set of locks for securing luggage and methods of using that set of locks, wherein the locks have two components:  a combination lock portion for use by travelers, and a master key portion for use by a luggage-screening entity, and wherein the set of locks has at least two subsets with a different number of dials on the combination lock portion.

Representative claim 29 recites:

29.  A set of locks for securing travelers' luggage while facilitating an entity’s authorized luggage-screening of luggage that the travelers have locked with said locks, without breaking the locks or the luggage, wherein the set comprises at least a first subset and a second subset each comprising plural locks, each lock in each of the first and second subsets having a combination lock portion for use by the travelers to lock and unlock the lock and in addition having a master key portion for use by the luggage-screening entity to unlock and re-lock the lock while the combination lock portion of the same lock remains in a locked state, wherein the same master key unlocks the master key portion of each lock in the first and second subsets, and different locks of the first and second subsets have combination lock portions with different plural numbers of dials, wherein:

the master portion of each lock in the first and second subsets of locks is configured for the same master key to unlock and re-lock the lock for the authorized luggage-screening independently of a locked state of the combination lock portion of the same lock;

the combination lock portion of each lock in the first and second subsets of locks is configured to unlock and re-lock the lock independently of a locked state of the master key portion of the same lock, using respective different combination dial settings of the plural number of dials as selected by of for the travelers;

each lock of a first subset of plural locks and a second subset of plural locks of the locks in the set has two or more combination lock dials; the number of dials in each lock of the first subset differs from the number of dials in each lock of the second subset; and

each lock in the set has the same prominent indicia configured to uniquely differentiate the locks of the set from locks that are not configured for the luggage-screening entity to unlock and re-lock with the same master key for said authorized luggage-screening by said entity.

The '223 application is a continuation of U.S. Application No. 10/756,531, which is a continuation-in-part of U.S. Application No. 10/706,500.  Both the '223 and '500 applications describe:

[A] special lock having a combination lock portion and having a master key lock, the master key lock portion for receiving a master key that can open the master key lock portion of any special lock of this type, the special lock designed to be applied to an individual piece of airline luggage.

However, the '223 application (but not the '500 application) also discloses that "[t]he phrase 'any special lock of this type' is intended to include special locks having a multiplicity of sub-types, such as different sizes, different manufacturing designs or styles, etc."

Before the Board, the Appellant relied on the language only found in the '233 application.  The Board, however, determined that the specification failed to provide sufficient written description support for the claims because it did not describe a "set of locks" with various "subsets," and only described a single special lock with different embodiments.

In vacating the Board's decision, the Federal Circuit noted that the Board's entire discussion of the additional language found only in the '233 application was contained in a footnote in the Board's decision that reads as follows:

Priority Application 10/756,531, now US 8,145,576, does describe "'any special lock of this type' is intended to include special locks having a multiplicity of sub-types, such as different sizes, different manufacturing designs or styles, etc."  (Col. 4, ll. 21-24), but Application 10/756,531 is a [continuation-in-part] of US'537.  We find this description constitutes at least part of the added new matter of the continuation-in-part application.

The Appellant argued that the footnote demonstrated that the Board had disregarded the additional language because it mistakenly concluded that the additional language constituted new matter.  Although the Court found the footnote to be confusing "at best," it determined that the Appellant's "interpretation is the most plausible one" for the Board's decision, and the Court pointed out that "[e]ven if [the additional language] is new matter, the language in the '233 application as filed is relevant to assessing compliance with the written description requirement."  The Court concluded that the Board failed to consider the additional language in its written description analysis, and therefore erred in its analysis.  The Court therefore vacated the Board's decision and remanded for consideration of written description in light of the entire '233 specification.

In re Tropp (Fed. Cir. 2018)
Nonprecedential disposition
Panel: Chief Judge Prost and Circuit Judges Clevenger and Moore
Opinion by Circuit Judge Moore

FWP IP ApS v. Biogen MA, Inc. (Fed. Cir. 2018)

By Donald Zuhn –-

Last month, in FWP IP ApS v. Biogen MA, Inc., the Federal Circuit affirmed a decision by the U.S. Patent and Trademark Office's Patent Trial and Appeal Board granting Biogen's motion that FWP's U.S. Application No. 11/576,871 did not provide an adequate written description under 35 U.S.C. § 112 for claims directed to a method for treating multiple sclerosis.  The MS treatment at dispute involves administering a specific daily dosage (480 mg) of fumarates, specifically dimethyl fumarate (DMF) and/or monomethyl fumarate (MMF), to a subject.

The appeal arose from an interference proceeding involving the above method for treating multiple sclerosis.  U.S. Patent No. 8,399,514, owned by Biogen, describes and claims such a method.  The '871 application, which was assigned to FWP by original Appellant Forward Pharma A/S after the appeal was docketed, discloses controlled release compositions of fumarates.  In the interference proceeding, Forward argued that the '871 application describes the treatment method in dispute.  Although the Board determined that the '871 application had an earlier priority date than the '514 patent, it granted Biogen's motion that the MS treatment method Forward sought to claim was not supported by an adequate written description.

The '871 application is a U.S. national phase filing of a PCT application that was filed on October 7, 2005, and which claims priority to a Danish patent application filed on October 8, 2004.  The '514 patent claims priority to a U.S. provisional patent application filed on February 8, 2007.  During prosecution of the '871 application, Forward cancelled all pending claims and added claims that closely tracked the claims that issued in the '514 patent.  The Board declared an interference between the '871 application and '514 patent, designating Forward as the senior party with a constructive reduction to practice date of October 8, 2004.

Finding that the focus of the '871 application was on "controlled release fumarate compositions" and that "general teaching of applicability of the fumarates to [the] treatment of a variety of possible disease or conditions and the teaching of a broad range of possible dosages would not have conveyed possession or description of the specific treatment of MS that [Forward] now claims," the Board granted Biogen's motion that the claims of the '871 application were not supported by an adequate written description.  The Board pointed to claim 69 of the '871 application as representative:

69.  A method of treating a subject in need of treatment for multiple sclerosis comprising
    (a) a therapeutically effective amount of dimethyl fumarate and
    (b) one or more pharmaceutically acceptable excipients, wherein the therapeutically effective amount of dimethyl fumarate is about 480 mg per day.

Looking to claim 69, the Board distilled the claimed treatment method at issue into three limitations: (1) an MS treatment, (2) by oral administration of a therapeutically effective amount of DMF and/or MMF, at (3) a dosage of 480 mg per day.  With respect to the first limitation, the Board determined that the '871 application lists over twenty diseases and conditions, that MS is not identified as a disease or condition of particular interest, and that the application instead focuses on psoriasis and conditions associated with psoriasis.  Regarding the third limitation, the Board determined that while the 480 mg/day dosage is expressly mentioned in the specification, there "is no discussion that would guide one skilled in the art to treat MS with a therapeutically effective dose of 480 mg/day, or any other therapeutically effective dose within the ranges disclosed."

The Board also rejected Forward's arguments based on Snitzer v. Etzel, 465 F.2d 899 (CCPA 1972); Falkner v. Inglis, 448 F.3d 1357 (Fed. Cir. 2006); and Streck, Inc. v. Research & Diagnostic Sys., Inc., 665 F.3d 1269 (Fed. Cir. 2012).  The Board determined that unlike the invention in Snitzer, Forward's case required the selection and combination of claim elements from more than a single limited list, and that unlike Falkner and Streck, the '871 application did not provide the blaze marks necessary to guide a skilled artisan to the claimed invention.  The Board concluded that even though each required claim element is mentioned separately in the '871 application, the specification did not disclose the claimed invention in a manner that adequately describes the claimed MS treatment to a skilled artisan, and therefore, that the claims of the '871 application failed to meet the written description requirement.

On appeal, Forward argued that the interference count was disclosed in an up-scale table in the '871 application, which Forward argued (1) discloses a 480 mg/day dosage, (2) is reasonably directed at using DMF to treat the listed conditions, and (3) is linked to the treatment of MS.  The up-scale table describes scaling up the daily dosage level of fumerates over a nine-week period, with the 480 mg/day dosage occurring during week seven, and is designed to minimize the side-effects of ingesting fumarates by increasing the dose gradually over time to allow the patient to acclimate.  The Federal Circuit, however, stated that it was not persuaded by Forward's argument, and agreed with the Board that "the '871 application does not disclose the now-claimed MS treatment as a unified whole."

With respect to the 480 mg/day dosage, the Federal Circuit noted that this dosage is an interim dosage, and that Forward failed to present persuasive evidence as to why a skilled artisan would have understood the week seven interim dosage to be therapeutically effective.  The Court also noted that Biogen's expert testified that because MS is a chronic disease, a skilled artisan would not have viewed a one week, interim dosage in the middle of a nine week up-scale schedule as an adequate treatment dosage, let alone one for a particular disease such as MS.

In affirming the Board's decision, the Federal Circuit stated that "[g]iven the brief references to MS and the lack of recognition of 480 mg/day as a therapeutically effective daily dosage, we agree with the Board’s finding that there 'is no discussion [in the '871 application] that would guide one skilled in the art to treat MS with a therapeutically effective dose of 480 mg/day. . . .'"  The Court was also unpersuaded by Forward's attempt to use the prior art to supply the link between the therapeutically effective dose of 480 mg/day and MS, noting that "even if we allow Forward to rely on the prior art for establishing a prior, known link between MS and fumarates, the prior art does not teach the key limitation of the count: the 480 mg daily dosage."

The Federal Circuit also rejected Forward's argument that the original claims of the '871 application adequately describe the MS treatment that it was seeking to claim.  According to the Court, "Forward's argument is premised on piecing together elements of several of the claims."  In rejecting this argument, the Court explained that:

Th[e original] claims are mainly directed to controlled release compositions of numerous fumarates and pharmaceutically acceptable salts.  Some claims recited numerous possible dosing schedules (claims 30–32) and dosages (claims 33–38).  And others replicate the laundry list of diseases and conditions enumerated in the specification (claims 44 and 45).  This large number of disease conditions, dosages, dosing schedules, active ingredients, pharmaceutical formulations for controlled release, and combinations thereof covered by the original claims detracts from Forward's argument that it possessed and invented the now-claimed, specific MS treatment.  . . .  Rather, what the scale of the claims demonstrate is that Forward possessed, as of the 2004 critical date, a mere wish for obtaining some type of fumarate formulation to treat any one of a number of diseases and conditions, one of which was MS, using almost any possible daily dosage.

Finding that "the '871 application does not disclose 480 mg of fumarates per day as a therapeutically effective dose for treating MS," the Federal Circuit determined that substantial evidence supported the Board's finding that the MS treatment Forward sought to claim was not supported by an adequate written description under 35 U.S.C. § 112.  The Federal Circuit therefore affirmed the Board's decision.

FWP IP ApS v. Biogen MA, Inc. (Fed. Cir. 2018)
Nonprecedential disposition
Panel: Chief Judge Prost and Circuit Judges Wallach and Chen
Opinion by Circuit Judge Chen

Patenting Repurposed Drugs

By John E. Conour --

Even with billions of dollars of funding and the cumulative knowledge and experience of over a hundred years of experimental pharmacology, de novo discovery of effective and safe therapeutics remains a costly and risky endeavor.  The number of unsuccessful attempts to obtain Food and Drug Administration (FDA) approval of drugs for specific indications is far greater than the number of successes.  As a result, there is an extensive and ever growing list of "failed" drugs, most of which are ultimately abandoned by pharmaceutical companies.

More recently, failed drugs previously considered to be lost causes are being reconsidered as possible therapies for different indications than those for which they had originally been considered.  Such drug "repurposing" provides researchers and clinicians with a cost-effective way to identify potential new therapies without needing to start from scratch.  Many failed drugs have already established their relative safety in Phase I clinical trials, which can simplify and reduce the cost of obtaining FDA approval should a new indication be found.  Drug repurposing is not limited to failed drugs but is also being considered for currently marketed drugs as well as "off patent" generic compounds to expand and extend their usefulness.

But because drug repurposing primarily concerns previously-known drugs, obtaining patent protection can be challenging.  In some cases, a drug to be repurposed is still protected by a patent that can be acquired and/or in-licensed, but often the drug itself is not protected by patent.  Without patent protection, commercialization of a repurposed drug (i.e., maximizing the potential beneficial impact of the drug) is not realistic.  This article discusses certain issues to be considered when trying to obtain new patent protection for repurposed drugs.  It should be expected that each attempt to patent a repurposed drug will have its own factspecific challenges.  Accordingly, the concepts discussed here are generalized and nonexhaustive.

The foundational inquiry for determining whether a repurposed drug can be patented in the United States is to consider whether, under 35 U.S.C. § 101, the drug constitutes patentable subject matter.  Section 101, in relevant part, provides: "[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor . . . ."[1]  Repurposed drugs are often non-nature-based compositions of matter (i.e., synthetic compounds that are not naturally occurring) that can be used in useful processes (e.g., methods of treating a disease by administering to a patient in need thereof a therapeutically effective dose of a drug).  Therefore, claims directed to repurposed drugs and methods of their use should not typically run afoul of § 101.  Even repurposed drugs that are nature-based compositions of matter may still be patentable, for example, if recited in a method of treatment claim.  Indeed, method of treatment claims reciting nature-based compositions of matter seem to be on more secure footing under § 101 in light of the recent decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals,[2] at least because the United States Patent and Trademark Office has issued a recent memorandum to the Patent Examining Corps advising that the Patent Office intends to follow the legal reasoning in this case.[3]  Nevertheless, care must be taken when drafting claims to avoid § 101 issues.

Another significant hurdle to overcome with respect to patenting repurposed drugs is 35 U.S.C. § 102.  Section 102, as applied to a repurposed drug, requires that it was not previously patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before a patent application is filed to cover the repurposed drug.  In other words, a claim to the repurposed drug itself must be novel, in that it must recite something not previously publicly known.  Practically speaking, most composition of matter claims reciting only the repurposed drug will be excluded from patentability under § 102, because (almost by definition for a "repurposed" drug) the drug was previously known and thus its earlier public disclosure would be prior art to any subsequent patent filing.  Accordingly, composition claims directed to the repurposed drug itself will likely be anticipated because they are not reciting anything new.  Yet there are ways to overcome § 102 to obtain composition claims on repurposed drugs.

One useful approach for overcoming a § 102 rejection is to incorporate the repurposed drug into a composition that includes one or more other compounds to form a novel combination not previously known.  Importantly, the claimed combination can be any practical combination that is novel for purposes of overcoming § 102.  However, as discussed below, claims to pharmaceutical compositions that recite combinations with more than one key constituent (e.g., a therapeutically effective amount of a repurposed drug and a therapeutically effective amount of a second drug) are more likely to be patentable.  Additional details regarding specific amounts of drugs included in combinations or ratios between the drugs in the combination can add further grounds for finding such claims patentable over what was previously known in the prior art.

A further approach to obtaining claims directed to previously known drugs that are patentable in a § 102 context is to draft claims to novel pharmaceutical dosage forms.  Pharmaceutical dosage forms can be, for example, solids, liquids, delayed or extended release forms, and/or for a specific type of administration (e.g., oral, parenteral, intramuscular, etc.).  Many types of variations are possible with pharmaceutical dosage forms, which lend themselves to drafting novel claims.  For example, desired release characteristics and/or routes of administration may differ for the new use of the repurposed drug compared to its previous use, which would provide the basis of a novel claim.

As a final and particularly important example, a method claim reciting a repurposed drug may more easily overcome § 102 rejections.  Repurposing a drug for a new indication is typically a novel use of the drug.  Therefore, a method-of-use claim that recites a repurposed drug for treating a subject with the new indication should also be novel.  Such method claims are particularly useful because they are difficult for competitors to design around, and they are also available in many foreign jurisdictions (though with potentially different formats).

What is often more challenging for patenting a repurposed drug is overcoming an obviousness rejection.  Obviousness (or lack of inventive step) falls under 35 U.S.C. § 103, which states, in relevant part, that:

A patent for a claimed invention may not be obtained . . . , if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.[4]

Here, the basic calculus is that if a skilled artisan (e.g., a clinician or researcher in the same field of practice or study as the person seeking to repurpose a drug and with the average skill level of such clinicians or researchers) who understands the prior art would have reasonably expected the drug to be useful for the new indication, then a claim to a repurposed drug for the new indication may be obvious.  Obviousness rejections of claims to repurposed drugs can be very complex and can be based on a combination of several prior art references, each teaching one or more aspects of the rejected claims.

Unfortunately, the relatively straightforward strategies for overcoming a § 102 rejection are mostly ineffective for overcoming obviousness rejections.  Simple chemical combinations of repurposed drugs with other drugs that may make a novel composition are arguably obvious if they are nothing more than a routine exercise for a skilled pharmacologist.  Fortunately, there are ways to overcome obviousness rejections, but they can require planning well before filing a patent application, and indeed, experiments to investigate the usefulness of a repurposed drug should be designed with obviousness rejections in mind.  This is because one of the most powerful arguments against an obviousness rejection of claims directed to a repurposed drug is a showing of unexpected results.[5]  In this context, a showing of unexpected results can be a presentation of scientific data (often in the patent application, but data can also be presented after filing) that, for example, show a surprising effect of a drug that would not have been expected based on what was known at the time.  Examples of unexpected results can include that a drug surprisingly works as intended for a new indication, or that a drug works at the dose used (e.g., a surprisingly low dose), or that a combination of drugs demonstrates synergy when used together (their combined effect being greater than each drug acting alone), among others.[6]  Another powerful example of unexpected results is the discovery that the drug acts via a different target or has a different mechanism of action for the new use than for its previous use.  Such examples of unexpected results can overcome obviousness rejections for claims directed to method of use, or pharmaceutical dosage forms, or pharmaceutical compositions comprising a combination of drugs, respectively.  Therefore, care should be given to experimental design and the types of data that are collected in support of such evidence of non-obviousness.

Finally, a patent for a repurposed drug must satisfy 35 U.S.C. § 112, which requires that a patent application include:

[A] written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.[7]

Section 112 also requires an application to have one or more claims "particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention."[8]  Basically, § 112 requires that, at the time of filing, the written description must enable a skilled artisan to replicate the invention (much like a scientific paper should enable a researcher to replicate the experiments and data presented in the paper) and that the claims must be fully supported by the written description.

Careful patent application planning and drafting can avoid or overcome § 112 rejections.  At a minimum, literal support for each claim should be provided, examples of various embodiments of the invention described (e.g., the repurposed drugs and indication, possible drug substitutions and/or derivatives, dosing amounts, dosage forms, excipients, dosing regimens, methods of treatment, etc.), and experimental data establishing drug effectiveness included.  The written description should also be drafted with sufficient detail and distinct variations of the invention to permit claim amendments that can dispose of a prior art rejection (under either § 102 or 103).  Indeed, all important details and variations of the invention envisioned must be included before filing because § 112 prohibits addition of "new matter" after filing.

In conclusion, patent protection is possible for previously known drugs being repurposed for new indications.  The best chances for patenting repurposed drugs occur when care is given to initial experimentation to establish the usefulness of the drugs and for identifying any unexpected properties of the drugs.  By combining robust invention disclosures with thoughtful and detailed application preparation, patent applications directed to repurposed drugs will be better prepared to successfully navigate the rigors of the Patent Office.

[1] 35 U.S.C. § 101.

[2] 887 F.3d 1117 (Fed. Cir. 2018).

[3] See Memorandum from Robert W. Bahr, Deputy Comm'r for Patent Examination Policy, to Patent Examining Corps (Jun. 7, 2018), available at https://www.uspto.gov/sites/default/files /documents/memo-vanda-20180607.PDF.

[4] 35 U.S.C. § 103.

[5] Other important objective evidence of non-obviousness, also known as "secondary considerations," includes evidence of commercial success, long-felt but unsolved needs, and failure of others.  See Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17 (1966).

[6] See Manual of Patent Examining Procedure §§ 716.02, 2145.

[7] 35 U.S.C. § 112(a).

[8] Id. § 112(b).

General Hospital Corp. v. Sienna Biopharmaceuticals, Inc. (Fed. Cir. 2018)

By Kevin E. Noonan --

The application of the written description requirement under 35 U.S.C. § 112(a) with regard to disclosed ranges is not always entirely straightforward or intuitively obvious, and this can particularly be the case when the question is involved with another notoriously arcane species of patent law, interferences.  (Interference practice was abolished, to the joy of many, with passage of the Leahy-Smith America Invents Act in 2012.)  Whether claims designated as corresponding to a count in an interference satisfy the written description requirement is a threshold issue which can lead to the interference being dismissed without the Patent Trial and Appeal Board (PTAB) rendering a decision on which claimant has proper priority, as well as finding said claims invalid.  Such was the decision against an applicant who had provoked an interference against claims of a granted patent, in General Hospital Corp. v. Sienna Biopharmaceuticals, Inc., where the Federal Circuit in a precedential decision took the opportunity to reiterate the proper application of this requirement to the claims at issue and overturn the Patent Office's decision to terminate the interference.

The appeal arose over interference proceedings provoked by GHS between its U.S. Application No. 13/789,575 and Sienna's U.S. Patent No. 8,821,941.  The PTAB dismissed the interference on the grounds that GHC's claims failed to satisfy the written description requirement under 35 U.S.C. § 112(a) under § 41.202(a).  The technology at issue involved hair removal using nanoparticles to damage hair follicles.  The interference was declared on the basis of claim 1 of the '941 patent as the only count:

1.  A method of localizing thermal damage to a hair follicle, comprising: applying a composition to a skin surface, wherein said composition comprises a plurality of unassembled plasmonic nanoparticles, wherein the unassembled plasmonic nanoparticles comprise a conductive metal portion, wherein the conductive metal portion comprises at least one of gold or silver, wherein the unassembled plasmonic nanoparticles have a size in a range of 10 nm to 300 nm, wherein the unassembled plasmonic nanoparticles comprise a coating that coats the conductive metal portion, wherein said coating facilitates selective removal from the skin surface; wherein the coating comprises at least one of silica or polyethylene glycol (PEG), wherein the unassembled plasmonic nanoparticles have a concentration of 10⁹ to 10²³ particles per ml of the composition, wherein said concentration is sufficient to, after exposure to irradiation, induce thermal damage in the hair follicle; distributing the composition from the skin surface to the hair follicle to target the hair follicle; selectively removing the composition from the skin surface, while leaving the composition localized within the hair follicle; and irradiating the composition with an infrared light source thereby inducing a plurality of surface plasmons in said unassembled plasmonic nanoparticles, wherein the induction of the surface plasmons generates thermal damage to the hair follicle for at least one of hair removal or hair growth reduction.

(the limitation relevant to the issues before the Court is italicized).  Among the claims of Sienna's application corresponding to the count is claim 65:

65.  A method of localizing thermal damage to a hair follicle, comprising:
    applying a composition to a skin surface
    wherein said composition comprises a plurality of unassembled plasmonic nanoparticles,
    wherein the unassembled plasmonic nanoparticles comprise a conductive metal portion,
    wherein the conductive metal portion comprised gold,
    wherein the unassembled plasmonic nanoparticles have a diameter of about 150 nm,
    wherein the unassembled plasmonic nanoparticles comprise a coating that coats the conductive metal portion, wherein said coating facilitates selective removal from the skin surface,
    wherein the coating comprises polyethylene glycol (PEG),
    wherein the unassembled plasmonic nanoparticles have a concentration of about 6.6 x 10¹¹ particles per ml of the composition, wherein said concentration is sufficient to, after exposure to irradiation, induce thermal damage in the hair follicle;
    distributing the composition from the skin surface to the hair follicle to target the hair follicle;
    selectively removing the composition from the skin surface, while leaving the composition localized within the hair follicle; and
    irradiating the composition with an infrared light source thereby inducing a plurality of surface plasmons in said unassembled plasmonic nanoparticles,
    wherein the induction of the surface plasmons generated thermal damage to the hair follicle for at least one of hair removal or hair growth reduction.

(as with Sienna's claim, the limitation relevant to the issues before the Court is italicized).

The Board construed the word "about" in GHC's claims to mean "within 10%" of the value recited, equivalent to between 5.94 x 10¹¹ and 7.26 x 10¹¹ particles per mL of the composition, under which construction Sienna argued the claims failed to satisfy the written description requirement.  The specification of GHC's '575 application defined nanoparticle concentration with regard to optical density rather than in particles per mL.  Under the conversion coefficient proffered by Sienna's expert and accepted by the Board, there was no disclosure in GHC's '575 application of nanoparticle concentrations between 5.94 x 10¹¹ and 7.26 x 10¹¹ particles per mL of the composition.  Hence, the Board found  GHC's claims corresponding to the count to be unpatentable for failure to satisfy the written description requirement.

GHC also moved the Board for leave to add a new claim that would fall within the scope of the count in the interference.  The Board denied this motion because GHC failed to show that there was an interference-in-fact between the claims, and for failing to provide evidence that this claim was patentable.

The Federal Circuit vacated the Board's decision to terminate the interference in a decision by Judge Moore, joined by Judges Reyna and Taranto.  With regard to its written description decision, the Court affirmed the Board's construction of the term "about," reviewing claim construction de novo and the factual question of whether GHC's claims satisfied the written description requirement for substantial evidence.  In applying the written description requirement, the panel noted that GHC's claims-in-interference were not original claims (and thus, albeit unspoken, recognized that these claims were not entitled to the presumption that original claims get that they satisfy the written description requirement).  Converting GHC's disclosure into nanoparticles per mL the Board found that GHC's specification disclosed species having "4.10 x 10¹¹, 4.46 x 10¹¹, 7.77 x 10¹¹, 8.44 x 10¹¹, 9.32 x 10¹¹, 22 x 10¹¹, and 24 x 10¹¹ [nano]particles per ml."  Citing Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000), the panel noted that "[t]he disclosure of a broad range of values does not by itself provide written description support for a particular value within that range.  Instead, where a specification discloses a broad range of values and a value within that range is claimed, the disclosure must allow one skilled in the art to 'immediately discern the limitation at issue in the claims.'"  In this case, the panel stated that GHC's specification disclosed a minimum concentration of 1 x 10¹¹ nanoparticles per mL and no maximum concentration other than "some value greater than 9.31 x 10¹¹ nanoparticles per ml" (with, as set forth above, some specific values even greater than that).  This is not enough to satisfy the written description requirement, however, because (again citing Purdue Pharma, "'one cannot disclose a forest in the original application, and then pick a tree out of the forest and say here is my invention.'"  And even though there was "minimal overlap[]" between the range claimed in Sienna's claims and the range disclosed in GHC's specification this also was not enough, the panel citing  analogous facts in Eiselstein v. Frank, 52 F.3d 1035, 1040 (Fed. Cir. 1995), in support of its conclusion.

The Board erred however, according to the Federal Circuit, by denying GHC's motion to add a claim corresponding to the count.  This decision was arbitrary and capricious because the Board "did not engage in a substantive analysis of the claim's patentability or identify any particular ground on which GHC failed to establish patentability."  Pursuant to the Board's Standing Order (SO) governing interferences, the panel held that GHC had made the required certifications that its new claim was patentable.  The Board did not identify any inconsistency from the prosecution history upon which to base its unpatentability determination to the contrary, as required by the SO.  The Court also found error in the Board's finding regarding there being no interference-in-fact, based on the principle that "[w]here a prior art patent discloses a range of values, showing a claimed value falls within that range meets a party's burden of establishing the narrower claim would have been obvious where there is no reason to think the result would be unpredictable," citing Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013); Alcon Research, Ltd. v. Apotex Inc., 687 F.3d 1362, 1368 (Fed. Cir. 2012); In re Applied Materials, Inc., 692 F.2d 1289, 1295 (Fed. Cir. 2012); and In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003).  "It is not disputed that the values in the proposed claim fall within the ranges in claim 1 of the '941 patent.  Under the circumstances of this case, GHC has put forth sufficient evidence to establish proposed claim 74 would have been rendered obvious by claim 1 of the '941 patent," the panel concluded.  Thus the matter was remanded to the Board for continued interference proceedings, depending on whether the panel can find a basis for deciding that the new claim is patentable to GHC.

General Hospital Corp. v. Sienna Biopharmaceuticals, Inc. (Fed. Cir. 2018)
Panel: Circuit Judges Moore, Reyna, and Taranto
Opinion by Circuit Judge Moore

USPTO Issues Memo Clarifying Written Description Guidance

By Donald Zuhn –-

In a memorandum distributed last week to the U.S. Patent and Trademark Office patent examining corps, Robert Bahr, the Deputy Commissioner for Patent Examination Policy, sought to clarify the Office's guidance regarding the written description requirement of 35 U.S.C. § 112(a), and in particular, the examination of claims directed to antibodies for compliance with the written description requirement.  The memorandum, entitled "Clarification of Written Description Guidance For Claims Drawn to Antibodies and Status of 2008 Training Materials," is divided into three sections, which address the Federal Circuit's recent decision in Amgen Inc. v. Sanofi, the Written Description Training Materials released by the Office in 2008, and the Office's current guidance on the written description requirement.

In the first section of the memorandum, Deputy Commissioner Bahr discusses the Federal Circuit's clarification in Amgen Inc. v. Sanofi of the written description requirement as applied to antibodies.  In that case, the Federal Circuit clarified how the Court (and U.S. Patent and Trademark Office) should apply the written description requirement in 35 U.S.C. § 112(a) to properly circumscribe the scope of claims to monoclonal antibodies.  Perhaps the most significant portion of the opinion involved the jury instructions, which relied on Noelle v. Lederman for the proposition that characterizing a new antigen was sufficient to satisfy the statute for claims encompassing a broad genus of antibodies that could bind to the new antigen.  The Federal Circuit determined that this instruction "is not legally sound and . . . not based on any binding precedent," finding the instruction to be improper because it effectively eliminated the written description requirement from the statute in favor of enablement, contrary to the Court's en banc Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. decision, stating that "[b]y permitting a finding of adequate written description merely from a finding of ability to make and use, the challenged sentence of the jury instruction in this case ran afoul of what is perhaps the core ruling of Ariad."  In setting forth its abrogation of the "fully characterized antigen" test more directly, the Federal Circuit declared that:

[T]he "newly characterized antigen" test flouts basic legal principles of the written description requirement.  Section 112 requires a "written description of the invention."  But this test allows patentees to claim antibodies by describing something that is not the invention, i.e., the antigen.  The test thus contradicts the statutory "quid pro quo" of the patent system where "one describes an invention, and, if the law's other requirements are met, one obtains a patent."  Indeed, we have generally eschewed judicial exceptions to the written description requirement based on the subject matter of the claims [citations omitted].

The Office's memorandum explains that "[t]he Amgen court expressly stated that the so-called 'newly characterized antigen' test, which had been based on an example in USPTO-issued training materials and was noted in dicta in several earlier Federal Circuit decisions, should not be used in determining whether there is adequate written description under 35 U.S.C. § 112(a) for a claim drawn to an antibody."  The memorandum states that "[i]n view of the Amgen decision, adequate written description of a newly characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen."  The memorandum also notes that the Manual of Patent Examining Procedure (MPEP) will be updated to incorporate the Amgen decision in due course.

The second section of the memorandum indicates that Written Description Training Materials that were made available by the Office in March of 2008 are now considered by the Office to be outdated.  In a series of articles published in 2008 and 2009, we reported on the Training Materials (albeit not on Examples 13 and 14, which concern antibodies to a single protein and antibodies to a genus of proteins, respectively).  According to the Office's memorandum, the Written Description Training Materials "are outdated and should not be relied upon as reflecting the current state of the law regarding 35 U.S.C. §§ 101 and 112."  The memorandum also notes that the Office is currently preparing written description training materials containing examples that will reflect recent developments in the law regarding 35 U.S.C. §§ 101 and 112.

The memorandum concludes by providing the examining corps with a list of currently available guidance on the examination of claims for compliance with the written description requirement.  According to the memorandum, "USPTO personnel should continue to follow the guidance in the MPEP regarding written description (see, e.g., MPEP 2161.01 and 2163), except insofar as MPEP 2163 indicates that disclosure of a fully characterized antigen may provide written descriptive support of an antibody to that antigen."  The memorandum notes that the following materials "remain applicable and should be followed by USPTO personnel":

• The 2015 training module entitled "Examining Claims for Compliance with 35 USC 112(a) : Overview & Part I - Written Description";
• The 2015 Written Description Workshop materials; and
• The 2015-16 training slide set entitled "Antibody Decisions and Their Compliance with the Written Description Requirement."

Top Stories of 2017: #10 to #14

By Donald Zuhn –-

After reflecting upon the events of the past twelve months, Patent Docs presents its 11th annual list of top patent stories.  For 2017, we identified nineteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and applicants.  Yesterday, we counted down stories #19 to #15, and today we count down stories #14 to #10 as we work our way towards the top five stories of 2017.  As with our other lists (2016, 2015, 2014, 2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.  In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2017" on January 17, 2018 from 10:00 am to 11:15 am (CT).  Details regarding the webinar, which will focus on a handful of the most important stories on this year's list, can be found here.

14.  Federal Circuit: PTAB and District Court Can Reach Different Conclusions on Same Evidence

In April, the Federal Circuit determined in Novartis AG v. Noven Pharmaceuticals Inc. that the U.S. Patent and Trademark Office's Patent Trial and Appeal Board (PTAB) did not have to take into account a final district court determination of non-obviousness of the same claims based on the same prior art in an inter partes review proceedings.  The Federal Circuit based its decision on the different burdens of proof required in the two different types of proceedings, citing to Cuozzo Speed Techs., LLC v. Lee, wherein the Supreme Court which noted that the "different evidentiary burdens mean that the possibility of inconsistent results is inherent to Congress' regulatory design."  Cuozzo, 136 S. Ct. 2131, 2146 (2016).

For information regarding this and other related topics, please see:

• "Novartis AG v. Noven Pharmaceuticals Inc. (Fed. Cir. 2017)," April 4, 2017

13.  Patent Associations Propose Changes to § 101

In the aftermath of the Supreme Court's decision in 2016 not to grant certiorari in Sequenom v. Ariosa, many voiced the opinion that only Congress could resolve the acknowledged uncertainty that recent Supreme Court decisions have created in the law of patent subject matter eligibility.  In February, the Intellectual Property Owners Association was the first of three patent associations to propose an amendment to 35 U.S.C. § 101.  In March, the Intellectual Property Law Section of the American Bar Association (ABA-IPL) sent its proposal for revising § 101 to U.S. Patent and Trademark Office Director Michelle Lee.  Finally, in May, the American Intellectual Property Lawyers Association (AIPLA) announced its proposal to amend § 101.  The three proposals can be found in the posts listed below.  Many in the patent community are hopeful that the three patent associations will be able to come together on a consensus proposal in 2018 and have a bill to change § 101 introduced in Congress.

For information regarding this and other related topics, please see:

• "AIPLA Proposes Legislative Changes to 35 U.S.C. § 101," May 16, 2017
• "ABA IP Law Section Sends Section 101 Revision Proposal to USPTO Director Lee," March 29, 2017
• "What to Do about Section 101? IPO Provides Its Answer," February 9, 2017

12.  Federal Circuit Narrows Enfish & McRO in Recognicorp

Since September of 2016, when the Federal Circuit issued its decision in McRO, Inc. v. Bandai Namco Games America Inc., it had been understood that an invention that improves the operation of a computer or another technology is not abstract under § 101, and that a court should review the specification to make this determination.  While Recognicorp, LLC v. Nintendo Co. did not exactly throw that notion under the bus, it did serve to possibly narrow the holdings of Enfish, LLC v. Microsoft Corp., decided in May of 2016, and McRO.  In deciding Recognicorp, the Federal Circuit refused to acknowledge the possibility that the claimed invention resulted in such an improvement, and did not analyze the specification in detail.  As we reported shortly after Recognicorp was decided in April, the disconnect between the Federal Circuit's characterization of the claims under part one of the Alice two-part test (to determine whether claims are directed to patent-eligible subject matter) and the actual claimed invention was remarkable.  In the Court's view, there was no substantive difference between claim 1 and "Morse code, ordering food at a fast food restaurant via a numbering system, and Paul Revere's one if by land, two if by sea signaling system."  As many have noted, evaluating claims at such a high level does violence to the actual invention, which is the specific method recited by the claim.  Indeed, Enfish and McRo specifically warned against over-generalizing claims and reducing them to a subjective "gist" in part one of the Alice analysis.

For information regarding this and other related topics, please see:

• "Recognicorp, LLC v. Nintendo Co. -- Petition for En Banc Rehearing and Amicus Briefs," June 22, 2017
• "Recognicorp -- A Miscarriage of Justice Calling for En Banc Reconsideration," May 10, 2017
• "Recognicorp, LLC v. Nintendo Co. (Fed. Cir. 2017)," May 1, 2017

11.  Federal Circuit Eschews "Newly Characterized Antigen" Test for Antibodies

In October, the Federal Circuit rendered a decision in Amgen Inc. v. Sanofi that brought clarity to how the Court (and U.S. Patent and Trademark Office) should apply the written description requirement in 35 U.S.C. § 112(a) to properly circumscribe the scope of claims to monoclonal antibodies.  Perhaps the most significant portion of the opinion involved the jury instructions, which relied on Noelle v. Lederman for the proposition that characterizing a new antigen was sufficient to satisfy the statute for claims encompassing a broad genus of antibodies that could bind to the new antigen.  The Federal Circuit determined that this instruction "is not legally sound and [] not based on any binding precedent," finding the instruction to be improper because it effectively eliminated the written description requirement from the statute in favor of enablement, contrary to the Court's en banc Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. decision, stating that "[b]y permitting a finding of adequate written description merely from a finding of ability to make and use, the challenged sentence of the jury instruction in this case ran afoul of what is perhaps the core ruling of Ariad."  In setting forth its abrogation of the "fully characterized antigen" test more directly, the Federal Circuit declared that:

[T]he "newly characterized antigen" test flouts basic legal principles of the written description requirement.  Section 112 requires a "written description of the invention."  But this test allows patentees to claim antibodies by describing something that is not the invention, i.e., the antigen.  The test thus contradicts the statutory "quid pro quo" of the patent system where "one describes an invention, and, if the law's other requirements are met, one obtains a patent."  Indeed, we have generally eschewed judicial exceptions to the written description requirement based on the subject matter of the claims [citations omitted].

For information regarding this and other related topics, please see:

• "Amgen Inc. v. Sanofi (Fed. Cir. 2017), November 19, 2017

10.  Supreme Court to Decide Whether Board Must Address Every Claim Raised in IPR Petition

In November, the Supreme Court heard oral argument in SAS Institute, Inc. v. Complementsoft, LLC (immediately after the Supreme Court heard oral argument in Oil States Energy Services, LLC. v. Greene's Energy Group, LLC -- which, as most readers may surmise, will make a subsequent appearance on our top stories list for 2017).  As for SAS Institute, the case arose in litigation over a patent assigned to Complementsoft.  SAS filed its inter partes review petition on claims 1-16 of that patent, and the Board instituted as to claims 1 and 3-10 on obviousness grounds.  The PTAB found all instituted claims but claim 4 obvious and issued a final written decision on these claims.  SAS appealed, arguing that "the Board's final written decision is deficient for failing to address the patentability of all claims SAS included in its IPR petition, including those for which the Board did not institute IPR."  On appeal, the Federal Circuit held that the Board was not required to render a decision as to claims for which it did not institute the IPR, and that its decision in Synopsys, Inc. v. Mentor Graphics Corp., 814 F.3d 1309 (Fed. Cir. 2016) was controlling.  At least one basis for the Federal Circuit's decision was the differences between the statutory language in 35 U.S.C. § 318(a), which recited "claims challenged by the petitioner," and the language in 35 U.S.C. § 314, in which the language "claims challenged in the petition" was used to describe the institution decision.  SAS's petition for certiorari set forth the following Question Presented:

Whether 35 U.S.C. § 318(a), which provides that the Patent Trial and Appeal Board in an inter partes review "shall issue a final written decision with respect to the patentability of any patent claim challenged by the petitioner," requires that Board to issue a final written decision as to every claim challenged by the petitioner, or whether it allows that Board to issue a final written decision with respect to the patentability of only some of the patent claims challenged by the petitioner, as the U.S. Court of Appeals for the Federal Circuit held.

For information regarding this and other related topics, please see:

• "Supreme Court Hears Argument in SAS Institute, Inc. v. Complementsoft, LLC," December 5, 2017

Amgen Inc. v. Sanofi (Fed. Cir. 2017)

By Kevin E. Noonan --

Last month, the Federal Circuit rendered a decision in Amgen Inc. v. Sanofi that brought clarity to how the Court (and U.S. Patent and Trademark Office) should apply the written description requirement in 35 U.S.C. § 112(a) to properly circumscribe the scope of claims to monoclonal antibodies.  As a bonus, the panel opined on the relationship between the various requirements for a court to grant a permanent injunction when the infringing article comprises a medicine or other therapeutic agent.

Prior to the Supreme Court's recent focus on patent law questions (and the uncertainty and jurisprudential chaos that has arisen as a consequence), the Federal Circuit spent almost a decade refining the application of the written description requirement to biotechnology patent claims.  Arguably beginning with Amgen v. Chugai and Fiers v. Revel, the Court spoke most clearly in University of California v. Eli Lilly & Co.; this jurisprudence matured in University of Rochester v. G.D. Searle and Enzo Biochem v. GenProbe, culminating in the Court's Ariad v. Eli Lilly en banc decision that the written description and enablement requirements of 35 U.S.C. § 112, first paragraph (now, 35 U.S.C. § 112(a)), were separate and distinct and could be differentially satisfied on the same disclosure (i.e., enablement could be satisfied even though the written description requirement was not).

These cases arose from the complexities of assessing the sufficiency of disclosure for claims to isolated nucleic acids (including cDNA molecules that remain patent-eligible after AMP v. Myriad Genetics).  Another complex class of important biomolecules, antibodies and, in particular, monoclonal antibodies, have had a more murky course through § 112 jurisprudence; the issue in the few decided cases related to the requirements for producing humanized and ultimately human antibodies from (typically) mouse monoclonal progenitors rather than the scope of antibody claims as they relate to antigenic specificity.  The Federal Circuit's decision in this case provides some clarity in this regard.

The case arose when Amgen sued Sanofi over its sales of Praluent® (alirocumab) in competition with Amgen's Repatha™ (evolocumab); Amgen's asserted patents, U.S. Patent Nos. 8,829,165 ("'165 patent") and 8,859,741 ("'741 patent"), claim a genus of antibodies that encompass Sanofi's Praluent® product.  As background, blood plasma contains low-density lipoproteins that bind cholesterol and are associated with atherosclerotic plaque formation.  Liver cells express receptors for LDL (LDL-R) wherein binding thereto reduces the amount of LDL cholesterol in blood and reduces the risk of plaque formation and cardiovascular disease.  PCSK9 (proprotein convertase subtilisin kexin type 9) is a molecule that binds to and causes liver cell LDL-R to be destroyed, thus reducing the capacity and effectiveness of the liver cell's ability to reduce serum LDL-cholesterol.  The antibodies at issue in this suit bind to PCSK9 and prevent PCSK9 from binding to LDL-R, causing their destruction.

Claim 1 of the '165 patent is representative:

An isolated monoclonal antibody, wherein, when bound to PCSK9, the monoclonal antibody binds to at least one of the following residues: S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO:3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDL[-]R.

It is important to note that, while reciting the structure of the residues on PCSK9 that are bound by the claimed antibody, the claim does not recite any structural limitations of the antibody.  The only antibody characteristic recited as a limitation is a functional one, i.e., the ability to bind (and not even specifically bind) to at least one of the recited PCSK9 residues.

Evidence at trial showed that Amgen had produced a plurality of anti-PCSK9 antibodies and screened them for the ability to inhibit PCSK9 binding to LDL-R in liver.  This screening was done using a "trial and error" process that reduced 3,000 human monoclonal antibodies down to 85 antibodies that "blocked interaction between the PCSK9 . . . and the LDLR [at] greater than 90%," of which the specification illustrated the three-dimensional binding arrangement for two (one of which became the Repatha™ antibody) by x-ray crystallography.  The specification of the Amgen patents in suit disclose amino acid sequence information for twenty-two human anti-PCSK9 antibodies able to compete for PCSK9 binding with these two more fully characterized antibodies.  Regeneron's patents (not at issue here) recited antibody-specific amino acid sequences for its claimed anti-PCSK9 antibodies.

The jury found Amgen's patents not to be invalid; Sanofi stipulated to infringement.  The District Court excluded Sanofi evidence relating to written description and enablement based on Praluent® and other post-priority-date antibodies (i.e., that were produced after Amgen's earliest priority date).  The District Court, relying on Noelle v. Lederman as precedent, instructed the jury that an applicant can be entitled to claim scope encompassing generically described antibodies (as was the case for Amgen's claims) provided that the applicant provided a full characterized, novel antigen:

In the case of a claim to antibodies, the correlation between structure and function may also be satisfied by the disclosure of a newly characterized antigen by its structure, formula, chemical name, or physical properties if you find that the level of skill and knowledge in the art of antibodies at the time of filing was such that production of antibodies against such an antigen was conventional or routine.

The District Court denied Sanofi's post-trial motion for judgment as a matter of law (JMOL) that Amgen's claims were invalid for failing the written description and enablement requirements of 35 U.S.C. § 112(a), and granted Amgen's motion for JMOL that the claims were non-obvious.  On this record, the District Court also granted Amgen a permanent injunction preventing Sanofi from selling Praluent® (which was stayed pending Sanofi's appeal).

The Federal Circuit reversed in part, affirmed in part, vacated in part, and remanded, in an opinion by Chief Judge Prost, joined by Judges Taranto and Hughes.  The opinion distinguishes two bases for a court to consider post-priority date evidence of failure to satisfy the written description requirement, and finds that the District Court misapplied the law in excluding Sanofi's evidence.  The first basis for considering evidence regarding written description is when the evidence is proffered to show whether there was sufficient disclosure in the specification as filed and for this purpose the panel states that post-priority date evidence is improper.  Here, Sanofi's evidence was proffered under the second basis, which is whether the specification discloses a representative number of species in a claimed genus.  For such purposes, the opinion held that post-priority evidence is admissible, because such evidence can show that the genus is sufficiently diverse that the number of species disclosed in the specification is not representative.  As set forth in Ariad, an adequate written description of a genus requires the specification to disclose "a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus."  The panel distinguished prior precedent cited by Amgen, including In re Koller, 613 F.2d 819, 825 (CCPA 1980), and In re Hogan, 559 F.2d 595, 605 (CCPA 1977), because those cases were directed to the first basis for evaluating whether a specification satisfies the written description requirement.  (Another reason is that the second basis recognized by the opinion is arguably a creation of the Federal Circuit's more recent written description jurisprudence.)

The opinion acknowledges that the Court has not directly addressed this application of the law to date, but finds it to be consistent with the Court's earlier decision in AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285 (Fed. Cir. 2014).  In AbbVie, the accused infringer used evidence from its own, later-developed antibodies to show that patentee AbbVie's claims were not supported by an adequate written description of a representative number of species within the claimed antibody genus (although, as the opinion admits, defendant's antibody "was a basis for the unrepresentativeness ruling without regard to whether it postdated the patent's priority date").  With regard to the Hogan precedent (which is binding on Federal Circuit panel opinions unless overturned by the en banc Court), the opinion states that "Appellees misread In re Hogan by conflating the difference between post-priority-date evidence proffered to illuminate the post-priority-date state of the art, which is improper, with post-priority-date evidence proffered to show that a patent fails to disclose a representative number of species.  In re Hogan prohibits the former but is silent with respect to the latter."  Hogan was based on the USPTO requiring an applicant to disclose at an application's filing date species that did not exist at that time.  The panel understood that not to be analogous to the case before it, and stated that as a consequence, the District Court's exclusion of Sanofi's evidence relating to whether Amgen's specification disclosed a representative number of species was error.  The Court remanded the matter to the District Court for a new trial on this issue.

The Court also found it to be error for the District Court to have excluded evidence regarding enablement on the same grounds.  This evidence related to the "lengthy and potentially undue experimentation" Amgen needed to employ to arrive at its antibodies that fell within the scope of the claims of the '165 and '741 patents.  This was relevant evidence not barred by its post-priority date origins, and the panel remanded for a new trial on enablement in light of this evidence.

Perhaps the most significant portion of the opinion involves the jury instructions, which relied on Noelle v. Lederman for the proposition that characterizing a new antigen was sufficient to satisfy the statute for claims encompassing a broad genus of antibodies that could bind to the new antigen.  The panel found that this instruction "is not legally sound and [] not based on any binding precedent" and then provided its legal analysis of Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed. Cir. 2002), Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004), and Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341 (Fed. Cir. 2011) in support of its conclusion.

The basis for the instruction, according to the opinion, is in Guidelines from the USPTO discussed by the Court in the Enzo opinion.  There, the Court noted (in dicta, as characterized in this opinion), that the PTO would find claims to an antibody in compliance with Section 112 "notwithstanding the functional definition of the antibody, in light of the well-defined structural characteristics for the five classes of antibody, the functional characteristics of antibody binding, and the fact that the antibody technology is well developed and mature."  The decision in Noelle was actually contrary (the claims were not entitled to priority to an earlier application because that application did not disclose "the structural elements of the antibody or antigen") but (again in dicta) stated that "as long as an applicant has disclosed a 'fully characterized antigen,' either by its structure, formula, chemical name, or physical properties, or by depositing the protein in a public depository, the applicant can then claim an antibody by its binding affinity to that described antigen" based on the Court's Enzo decision.  Finally, in Centocor, the Court questioned the interpretation of its precedent that, as Amgen did here, an applicant was entitled to a broad claim based solely on functional properties (e.g., binding affinity or specificity) provided that the applicant provided a fully characterized, novel antigen.  As expressed in Centocor, one basis for skepticism over the "fully characterized antigen" test advocated there and here (by Amgen) was that instead of "analogizing the antibody-antigen relationship to a 'key in a lock,' it was more apt to analogize it to a lock and 'a ring with a million keys on it" (italics in opinion).  The panel emphasized that because the written description requirement is a question of fact, the value of these cases as precedent is "extremely limited."

The panel held this instruction to be improper because it effectively eliminated the written description requirement from the statute in favor of enablement, contrary to the Court's en banc Ariad decision, stating that "[b]y permitting a finding of adequate written description merely from a finding of ability to make and use, the challenged sentence of the jury instruction in this case ran afoul of what is perhaps the core ruling of Ariad."  And the panel found that whether the relationship between the structure of the antigen, no matter how fully characterized, and any of its cognate antibodies is (here and hitherto) "hotly contested" which precluded the Court from making any definitive finding.  The panel recited its abrogation of the "fully characterized antigen" test more directly:

Further, the "newly characterized antigen" test flouts basic legal principles of the written description requirement.  Section 112 requires a "written description of the invention."  But this test allows patentees to claim antibodies by describing something that is not the invention, i.e., the antigen.  The test thus contradicts the statutory "quid pro quo" of the patent system where "one describes an invention, and, if the law's other requirements are met, one obtains a patent."  Indeed, we have generally eschewed judicial exceptions to the written description requirement based on the subject matter of the claims [citations omitted].

For the same reasons the opinion affirmed the District Court's denial of JMOL that Amgen's claims lack written description and enablement, in favor of those questions being decided on remand based on the facts properly permitted to be considered by the jury.

Turning to the grounds for granting Amgen a permanent injunction, the panel found error in how the District Court applied the standards enunciated by the Supreme Court in eBay, Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006):

[A] plaintiff seeking a permanent injunction must satisfy a four-factor test before a court may grant such relief.  A plaintiff must demonstrate: (1) that it has suffered an irreparable injury; (2) that remedies available at law, such as monetary damages, are inadequate to compensate for that injury; (3) that, considering the balance of hardships between the plaintiff and defendant, a remedy in equity is warranted; and (4) that the public interest would not be disserved by a permanent injunction.  Id. at 391 (emphases added).

Here, the District Court granted the injunction despite finding that an injunction would "disserve" the public interest in the absence of plaintiff Amgen refuting this conclusion.  The panel's plain reading of the Supreme Court's mandate held this to be error.  In addition, the panel held to be error the District Court's finding that the public interest would be disserved because the effect of the injunction would be to ""tak[e] an independently developed, helpful drug off the market."  According to the opinion, using this standard a court would never be able to enjoin an infringing drug product because that would always involve taking a helpful drug off the market, contrary to both eBay and 35 U.S.C. § 271(e)(4)(B), citing WBIP, LLC v. Kohler Co., 829 F.3d 1317 (Fed. Cir. 2016).

This case is the latest application of the Federal Circuit's written description doctrine, which is one of the few areas that the Supreme Court has not found it fit to question the Court's application of U.S. patent law.  On the one hand this is curious, because written description is perhaps the preeminent example of the Federal Circuit exercising its special expertise and Congressional mandate to provide a harmonized interpretation of patent law.  On the other hand, how the Federal Circuit has developed this area of the law has (generally) limited the scope of biotechnology patent claims, consistent with the Supreme Court's penchant for treating the patent grant parsimoniously.  In any case, this decision makes the application of the written description requirement as applied to antibody claims more consistent with how the Court has applied § 112 to other biotechnological inventions and thus is in keeping with past twenty years of the Court's jurisprudence.  It is also more congruent with how the technology has developed since monoclonal antibodies were first disclosed (but not patented) by Kohler and Milstein in 1973.  If such consistency is the proper role of the Federal Circuit, then this decision is an exemplar of it fulfilling that role.

Amgen Inc. v. Sanofi (Fed. Cir. 2017)
Panel:  Chief Judge Prost and Circuit Judges Taranto and Hughes
Opinion by Chief Judge Prost

Board of Trustees of the Leland Stanford Junior University v. Chinese University of Hong Kong (Fed. Cir. 2017)

By Kevin E. Noonan --

Detection of paternal cell-free fetal DNA (cffDNA) in maternal blood (the technology at issue in Ariosa v. Sequenom) was in a different incarnation the subject of an interference between professors at two universities; the decision of the U.S. Patent and Trademark Office Patent Trial and Appeal Board in favor of Dennis Lo and the Chinese University of Hong Kong was reversed last week and remanded for further proceedings, in Board of Trustees of the Leland Stanford Junior University v. Chinese University of Hong Kong.

This embodiment of the technology was directed to detecting aneuploidies, or an abnormal number of chromosomes in a cell; noted examples include Downs Syndrome (trisomy 21) and Turner's syndrome (XO).  While the opinion recognizes Dr. Lo as the discoverer of cffDNA in 1996, Stanford's professor (Dr. Stephen Quake) developed a new method for detecting small changes in the number of chromosomes characteristic of aneuploidy, employing a technology the Court terms "digital analysis," which did not distinguish between paternal and maternal sources of DNA.  There were four steps to Dr. Quake's claimed method as set forth in the opinion:

(1) obtaining a maternal tissue sample, preferably blood; (2) distributing single DNA molecules from this sample to a number of discrete reaction samples; (3) "[d]etecting the presence of the target in the DNA in a large number of reaction samples"; and (4) performing "[q]uantitative analysis of the detection of the maternal and fetal target sequences."

The opinion also sets forth disclosure from Dr. Quale's specification relating to the use of "second generation massively parallel sequencing [(MPS)] methods and PCR amplification of chromosome DNA as being useful in the practice of the invention.

Dr. Lo's invention, according to the opinion, was claimed in U.S. Patent Application Nos. 12/178,181; 13/070,275; 13/070,240; 12/614,350; 13/070,251; and 13/417,119.  The claims of these applications were directed to "random sequencing" of cffDNA followed by sequence alignment to a reference human genome sequence to detect DNA sequence fragments specific for each chromosome, using MPS methods as in Dr. Quake's patents and application.  Aneuploidies for each chromosome where they exist are detected by finding a greater frequency of aligned fragments for particular chromosomes than others.

At issue in the interference were Stanford U.S. Patent Nos. 7,888,017 and 8,008,018 and U.S. Application No. 12/393,833.  The CUHK application in interference was U.S. Application No. 13/070,275.  Three interferences were declared: Quake v. Lo, No. 105,920 (P.T.A.B. Apr. 7, 2014); Lo v. Quake, No. 105,923 (P.T.A.B. Apr. 7, 2014); and Lo v. Quake, No. 105,924 (P.T.A.B. Apr. 7, 2014).  In a footnote, the Federal Circuit opinion notes that the Board's opinion in all three interferences "contained largely the same findings" and to the opinion cited the '920 interference throughout as being applicant to all three interferences.  Dr. Quakes was accorded the benefit of his earliest provisional filing, February 2, 2007; Dr. Lo's priority date as disclosed in the Declaration of Interference was July 3, 2007.  Thus, Dr. Lo and CUHK were designated as the Junior Party and would have the burden of establishing an earlier date of invention should the interference reach the priority phase.

Both parties requested the PTO declare the interferences, which were all declared in 2013, and during each of the proceedings, CUHK filed preliminary motions that Stanford's '018 patent and '833 application were invalid for failure to satisfy the written description requirement of 35 U.S.C. § 112(a) (this posing a threshold question in the interference wherein Junior Party Lo would prevail if its motion was persuasive to the Board).  At least part of the basis for this allegation was that Dr. Quake changed the claims pending in the application that matured into the '018 patent to more closely parallel Dr. Lo's claims; indeed, Junior Party Lo contended that Senior Party Quake had copied the pending claims of CUHK's '181 application.  These motions were supported by expert testimony, as were Stanford's rebuttals to these motions.  The Board was persuaded by CUHK's motions and granted them, thus ending the interference and invalidating Stanford's patents.  In these decisions, the Board (according to the panel opinion) "repeatedly credited the testimony of [CUHK's expert] Dr. Gabriel, including in finding that (1) the specification of the '018 patent is directed to the use of 'digital analysis' of predetermined targeted sequences in a sample, and (2) the language relied upon by Quake could have related to either random or targeted sequencing but that, because 'the main focus of the Quake '018 patent [was] on diagnosing aneuploidy with digital PCR, those of skill in the art would have understood the discussion of massively parallel sequencing to refer to sequencing targeted, predetermined portions of the DNA in a sample, not sequencing of random DNA'" (and was not persuaded by Stanford's attacks on that testimony).  In summary, the Board stated that:

Though the Quake inventors may have possessed parts of such a method, including massively parallel sequencing, randomly fragmenting DNA, and aligning sequences to genomic sequences, the facts do not indicate that those of ordinary skill in the art would have understood the inventors had put these pieces together into a complete method of sequencing random DNA fragments and identifying the sequenced fragments to determine aneuploidy.

Stanford appealed this decision to the District Court under 35 U.S.C. § 146 in the Northern District of California (Judge Susan Illston of Sequenom fame).  However, based on its decision in Biogen MA, Inc. v. Japanese Found. for Cancer Research, 785 F.3d 648 (Fed. Cir. 2015), that the provisions of the Leahy-Smith America Invents Act precluding appeals to the district courts should apply, the parties jointly asked the District Court to transfer the appeal to the Federal Circuit, and this opinion followed.

The Federal Circuit reversed, in an opinion by Judge O'Malley, joined by Judges Reyna and Chen.  The panel rejected Stanford's invitation to "rethink" its Biogen decision regarding whether appeals from interferences could no longer be brought before the district courts under § 146.  On that question the opinion states that Biogen is the law in this circuit and "we, as a panel, will not revisit it."  Similarly, the panel refused to consider the evidence adduced during the brief discovery period before the California District Court and the Biogen decision, because the District Court did not have subject matter jurisdiction under the panel's appreciation of the law after Biogen ("the activities in the district court are a nullity when the district court lacks subject matter jurisdiction to consider a matter," citing Ruhrgas AG v. Marathon Oil Co., 526 U.S. 574, 577 (1999)) and CUHK cannot waive lack of subject matter jurisdiction.  Having made this decision, the Federal Circuit's review was limited to the "four corners" of the record before the PTAB, and the panel agreed with CUHK that it would "treat the district court proceedings as if they never occurred."

Turning to the merits (which the Court reviewed for substantial evidence as the question of written description is one of fact; In re Gartside, 203 F.3d 1305, 1314 (Fed. Cir. 2000)), the panel held that the PTAB had erred in invalidating Stanford's patents.  The basis for this determination was found in CUHK's expert's testimony and some of the references upon which her conclusions had been based.  The deficiency arose based on the lack of correspondence between what was expressly disclosed in Stanford's patents and applications and what the references relied upon by CUHK's expert disclosed (and upon which she based her conclusion on the adequacy of disclosure question).  According to the opinion:

All of the published references on which the Board relies focus on the Roche 454 platform, not the Illumina platform actually referenced in the specification.  The Board did not cite evidence to connect targeted sequencing on the Roche 454 platform to targeted sequencing on the Illumina system, nor has the Board explained what it found persuasive about the Roche 454 platform references.

The evidence put forward by Stanford was that its disclosure related to a so-called "second generation" (Illumina) sequencing apparatus and that CUHK's expert relied on references directed to a "first generation" (Roche 454) machine.  In addition (and perhaps providing the panel's best support for its opinion), "Dr. Gabriel and the Board failed to cite to the Roche 454 references with specificity, leaving us with no reviewable record to conclude that the disclosed methods or platform would have been applicable to Illumina on Quake's priority date."  It is one thing to give deference to the PTAB and apply the substantial evidence standard; it is apparently another thing not to provide a reviewing court (or at least the Federal Circuit) with sufficient evidence for the substantiality thereof to be assessed.

The panel was also unimpressed with the distinctions raised by CUHK's expert regarding targeted versus random MPS:

The Board's finding that the '018 specification's language does not preclude targeted MPS ignores the fact that the same description might be able to disclose both random and targeted sequencing.  Put another way, even if the '018 specification could indicate targeted sequencing, it could also disclose random sequencing, or it could disclose both random and targeted sequencing.  The Board frames its finding in terms of an erroneous premise: the Board's task was to determine whether the '018 patent's written description discloses random MPS sequencing, as recited by the later-added claims, not whether the description does not preclude targeted MPS sequencing.

In addition, this was another instance where the Federal Circuit believed the PTAB had not properly explained its reasoning:  "The Board's error on this issue is compounded by its failure to explain the meaning of key sentences and phrases in the specification's discussion of the sequencing process, and its failure to compare these statements to the claim limitations."

On remand, the panel directed the PTAB to "examine whether a person of ordinary skill in the art would have known, as of the priority date, that the '018 specification's reference to Illumina products meant random MPS sequencing as recited in the claims," based on the understanding in the art at the priority date, and should "examine whether a person of ordinary skill would have understood that the '018 patent's specification disclosed random MPS sequencing, as opposed to whether the specification did not preclude targeted MPS sequencing."  Of course, should the Board find that the evidence does not support invalidating any or all of Stanford's patents or application, the interference should proceed to address other motions and ultimately put CUHK to its priority proofs regarding who was the first inventor of the claimed technology.

Board of Trustees of the Leland Stanford Junior University v. Chinese University of Hong Kong (Fed. Cir. 2017)
Panel: Circuit Judges O'Malley, Reyna, and Chen
Opinion by Circuit Judge O'Malley

Yeda Research and Development Co. v. Abbott GmbH & Co. (Fed. Cir. 2016)

By Kevin E. Noonan --

Before the Supreme Court's recent forays into the topic of subject matter eligibility in patent law, the most contentious line of cases (from the Federal Circuit) concerned the written description requirement of Section 112.  Indeed, some (like former Chief Judge Rader) believed that the statute does not contain a separate written description requirement, an opinion firmly shut down by the Court's en banc decision in Ariad v. Eli Lilly & Co.  That case established not only the existence of a requirement separate from enablement that a specification provide an adequate written description, but affirmed the decision from Regents of the University of California v. Eli Lilly & Co. that the requirement was satisfied if the person of ordinary skill in the art would have understood the inventor to have possessed the invention throughout its full scope when the application was filed.

Although the principles seem to be settled (a dangerous assumption with this or perhaps any Supreme Court decision) the application of the law still leaves room for surprise.  One such surprise was enunciated by the Federal Circuit in its decision upholding a district court's finding that disclosure and possession can be satisfied inherently, in Yeda Research and Development Co. v. Abbott GmbH & Co.  The case came to the Court after two adverse decisions before the District Court (for the District of Columbia) and the U.S. Patent and Trademark Office's Patent Trial and Appeal Board (PTAB).  Yeda and Abbott were in an interference involving Abbott's U.S. Patent No. 5,344,915 in which Yeda originally prevailed.  The basis for the initial PTAB decision was that the '915 patent was not entitled to an earlier priority date based on a German patent application.  Without that priority claim, it was undisputed that an intervening prior art reference (Engelmann) anticipated the claims.  The question was whether the original German patent, which disclosed isolation but not amino acid sequence characterization of a tumor necrosis factor binding protein, named TBP-II, inherently disclosed the amino acid sequence of the amino terminus, as recited in representative claim 1 of the '915 patent:

A purified and isolated TNFα-binding protein which has a molecular weight of about 42,000 daltons and has at the N terminus the amino acid sequence
    Xaa Thr Pro Tyr Ala Pro Glu Pro Gly Set Thr Cys Arg Leu Arg Glu
    where Xaa is hydrogen, a phenylalanine residue (Phe), or the amino acid sequences Ala Phe, Val Ala Phe, Gln Val Ala Phe, Ala Gln Val Ala Phe, Pro Ala Gln Val Ala Phe or Leu Pro Ala Gln Val Ala Phe.

The disclosure of the priority applications was limited to "a partial N-terminus sequence, a protocol for obtaining the protein from its biological source, and additional properties of the protein, such as molecular weight, biological activity, and degradation characteristics when exposed to trypsin."  The parties also agreed, according to the Federal Circuit opinion, that the (partial) N-terminal amino acid sequence set out in the priority document(s) were only present in TBP-II, the same protein disclosed and claimed in the '915 patent.

The PTAB found the '915 patent to be invalid for anticipation buy the Engelmann reference in original interference (No. 103,625) and Abbott brought suit in district court challenging that decision.  The District Court granted summary judgment for Abbott, agreeing that the priority application "inherently discloses the TBP-II protein and provides an adequate written description of the invention claimed in the '915 application" and remanded to the PTAB.  The PTAB found on remand that the '915 specification satisfied the written description requirement and Yeda filed its own district court action challenging that result.  Again, the District Court found that the '915 specification satisfied the written description requirement and granted summary judgment to Abbott.  This appeal followed.

The Federal Circuit affirmed, in an opinion by Judge Reyna joined by Judges Wallach and Hughes.  Relevant to its decision, the panel noted that it was undisputed that the protein disclosed in the priority applications was the same protein disclosed in the '915 patent and in the Engelmann reference, and that this is the only protein having that amino acid sequence.  Under the doctrine of inherent disclosure," when a specification describes an invention that has certain undisclosed yet inherent properties, that specification serves as adequate written description to support a subsequent patent application that explicitly recites the invention's inherent properties" according to the opinion, citing Kennecott Corp. v. Kyocera Int'l, Inc., 835 F.2d 1419, 1421 (Fed. Cir. 1987) (a pre-Ariad case now seeming to have the imprimatur of the Federal Circuit as remaining good law).  Here, under the circumstances of this case, the Federal Circuit held that the priority application inherently disclosed the N-terminal amino acid sequence of TBP-II.  Specifically, the Court said that "[i]t is not necessary for an application to disclose a protein's complete N-terminus sequence in order to provide an adequate written description of that protein."  In distinguishing this case from precedent cited by Yeda (Hyatt v. Boone, 146 F.3d 1348 (Fed. Cir. 1998) and In re Wallach, 378 F.3d 1330 (Fed. Cir. 2004)), the importance of the circumstances is clear:  "[n]either Hyatt nor Wallach involved the situation present in this case, where it is undisputed that the invention described in an earlier application was the exact invention claimed by the later patent."

The opinion also rejected Yeda's argument that inherent limitations cannot be relied upon in a priority determination if the limitations are material to patentability, citing Hitzeman v. Rutter, 243 F.3d 1345, 1355 (Fed. Cir. 2001).  Yeda supported its position that the specific amino acid sequences were material on the basis that Abbott had distinguished its claims from prior art "that disclosed a protein with the same source, weight, and function as the protein claimed in the '915 patent."  In the panel's view, the prosecution history did not corroborate Yeda's reading of the prior art disclosure, stating that "the cited art concerned only TBP-I, and that TBP-II includes a sequence of five amino acids not present in TBP-I that match the chain recited in the '915 patent claims."  And 3 of the 5 distinguishing amino acids disclosed in the Engelmann reference were also disclosed in the priority applications for the '915 patents and "were themselves sufficient to distinguish TBP-I from TBP-II."

The apparent liberality applied by the Court in finding that the disclosure of the priority applications satisfied the written description requirement is in stark contrast to how stringently the requirement has been applied over the past twenty years in the USPTO, particularly in a variety of Guidances and Training Materials promulgated during that time.  But while certainly constrained by the particular facts set forth in the opinion, in some ways perhaps how the Court applied the requirement is consistent with Judge Lourie's formulation of how Section 112 should be interpreted in the Lilly case that in many ways was the beginning of modern written description jurisprudence:

A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus.

Here, the "members of the genus" was in fact TBP-II itself, and the "structural features" comprised the partial amino acid sequence disclosed plus the protein itself from which the remaining amino acids comprising the N-terminus of the protein could be determined.  The situation here in many ways was the opposite of what Judge Lourie prescribed against:  not a broad genus defined purely by function, but a particular protein that inherently had an N-terminal amino acid sequence that need not be expressly recited in order to support a priority claim.

Yeda Research and Development Co. v. Abbott GmbH & Co. (Fed. Cir. 2016)
Panel: Circuit Judges Reyna, Wallach, and Hughes
Opinion by Circuit Judge Reyna

Driessen v. Sony Music Entertainment (Fed. Cir. 2016)

By Joseph Herndon --

On February 10, 2016, the Federal Circuit issued a nonprecedential opinion in a case captioned Driessen v. Sony Music Entertainment, Best Buy Stores, Fye, & Target Corp. addressing issues related to means-plus-function claims and written description.  While the decision is nonprecedential, it serves as a reminder to provide detailed descriptions of claim terms and to use means-plus-function terms sparingly.

James L. Driessen is the named inventor on U.S. Patent Nos. 7,003,500 ("the '500 patent"), 7,636,695 ("the '695 patent"), and 7,742,993 ("the '993 patent").  Mr. Driessen and his wife sued Sony Music Entertainment, Best Buy Stores, FYE, and Target (collectively "Sony"), alleging infringement of these patents in the U.S. District Court for the District of Utah.  The District Court granted Sony's motions for summary judgment, finding some of the asserted claims of the '500 patent invalid as indefinite, and some of the asserted claims of the '500 patent, all claims of the '695 patent, and all claims of the '993 patent invalid for lack of written description.

All three patents have virtually the same specification and relate to systems and methods of purchasing downloadable content from the Internet.  Rather than purchasing the content directly through the Internet, the buyer goes to a retail store to pay for the item in person.  At the retail store, the buyer obtains a ticket or other "physical medium" proof of sale containing a web address specific to the item sold and a unique password that will enable its download.  The buyer can then anonymously download the media content from any computer with Internet access by going to the web address and inputting the unique password provided.

Indefinite Claims

Claim 1 of the '500 patent, which contains several means-plus-function elements, provides,

1.  A payment system for itemized Internet merchandise or itemized downloadable media material objects, comprising:
    a retail point of sale establishment;
    a customer access point at said retail point of sale establishment;
    URL information that is an Internet transaction location of said itemized Internet merchandise or itemized downloadable media material objects;
    means for accepting payment through an in person transaction with a customer wherein said payment is designated for purchase of said itemized Internet merchandise or itemized downloadable media material objects;
    means for storing and retrieving a record on or in a physical medium corresponding to said URL information that is an Internet transaction location of said itemized Internet merchandise or itemized downloadable media material objects;
    means for transfer of said physical medium from said retail point of sale establishment to said customer; and
    means for Internet transaction authorization on, in, or actuated from said physical medium wherein ownership rights in said itemized Internet merchandise or itemized downloadable media material objects are preselected and transferred to said customer through said transfer of said physical medium.

Primarily at issue in the case is the "means for storing and retrieving a record on or in a physical medium" limitation.  This claim element was construed pursuant to 35 U.S.C. § 112(f), in which the function is identified and then the specification is analyzed to determine what is described as performing the identified function.  The District Court found that the function of this element is "storing and retrieving a record on or in a physical medium".  Specific terms of this element were then construed in which "storing" was construed to mean "both putting into storage and holding in storage," "retrieving" was construed to mean "taking out of storage for the purpose of presenting authentication to prove purchase," "record" was construed to mean a "unique URL corresponding to specific web merchandise or content," and "on or in a physical medium" was construed to mean the location where "the record is stored and from where it may be retrieved."

A means-plus-function claim is indefinite unless structure to perform the function is identified in the specification.  Here, the District Court rejected the Driessens' contention that Figure 5 (a portion of which is reproduced below) -- which depicts an "Admit One" ticket and a floppy disk -- provides the necessary structure to correspond with the above function.

The District Court explained that while Figure 5 perhaps discloses examples of "physical media," it does not disclose a structure that "stor[es] and retriev[es] a record on or in a physical medium."  The disk lacks structure for retrieving any record.  Thus, because the specification failed to disclose any such associated structure for "storing" and "receiving" the record in a physical medium, the claims were held invalid as indefinite.

The Federal Circuit agreed with the District Court, and noted that in the context of storing "a record on or in a physical medium," it is apparent that "store" implies not only maintaining the record in a physical medium, but also getting it there to begin with.  The fact that necessary structures for performing a "means for storing and retrieving a record on or in physical medium" were known in the art does not save the claims.  For means-plus-function claim terms, the inquiry is whether one of skill in the art would understand the specification itself to disclose a structure, not simply whether that person would be capable of implementing a structure.  Accordingly, a bare statement that known techniques or methods can be used does not disclose structure.

Lack of Written Description

A portion of claim 10 of the '500 patent provides:

10.  A method of merchandise transfer on a computer network comprising at least one buyer computer on a network for operation by a user desiring to buy at least one product and at least one selling computer on said network operating for a purpose to sell said product, the method comprising the steps of: . . .
    sending a payment message as a response to said in person transaction either directly or through other computers on said network to said selling computer on said network;
    causing an authorization message to be created on said selling computer in or as a result of said payment message that comprises at least said specification of said product and authentication based on cryptographic key(s), said selling computer being programmed to receive said authorization message for verification of said authentication; . . .

The three terms "selling computer," "payment message," and authorization message," which first appeared when Mr. Driessen added new claims by amendment more than four years after filing the original application that became the '500 patent, also appear in all asserted claims of the '695 and '993 patents.

The District Court found that no written description for "selling computer," "payment message," or "authorization message" is provided anywhere in the specification or original application.  The Driessens argued that the terms were implicitly present in the original application, but the District Court held that the asserted description of "secure web transactions" and "public key infrastructure" in these patents did not necessarily provide for "payment messages" or "authorization messages," let alone require such messages to be sent to or from "selling computers."

The Federal Circuit agreed with the District Court and cautioned that when a patent applicant adds new claims after the original filing date, the new claims must find support in the original specification.  The question becomes whether one of ordinary skill in the art would consider the added claim terms to be supported by the specification as originally filed.

Here, the terms added by amendment of "selling computer," "payment message," and "authorization message" are not present anywhere in the specification or original provisional application.  The fact that the words "payment," "message," "authorization," and "computer" appear individually numerous times in the specification does not provide adequate written description for the terms "selling computer," "payment message," and "authorization message" as defined in the claims.  The Federal Circuit cited LizardTech and noted that the mere presence of these words in isolation does not suffice to show that the "patentee had possession of" the "selling computer," "payment message," and "authorization message" elements of the claimed invention at the time of the application, as 35 U.S.C. § 112(a) requires.

Thus, the Federal Circuit affirmed the District Court's conclusion that such claims are invalid for lack of written description.

This case serves as a lesson for using means-plus-function terms sparingly and carefully, and for having clear support in the specification for all amendments entered during prosecution.  From a point of personal experience, recently, it feels like U.S. patent examiners seemingly have been told to have a heightened scrutiny with respect to section 112 issues requiring very specific support in the specification for all claim terms.  While the requirements in the U.S. Patent Office are not as strict as seen in foreign jurisdictions (e.g., the EPO requires near verbatim or one-to-one use of terminology in the claims as seen in the specification), it does appear that the standards at the U.S. Patent Office have been raised somewhat.

Driessen v. Sony Music Entertainment (Fed. Cir. 2016)
Nonprecedential disposition
Panel: Circuit Judges Dyk, Mayer, and Hughes
Opinion per curiam