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`
`
`APPENDIX
`APPENDIX
`
`
`
`
`
`
`TABLE OF CONTENTS
`Court of Appeal Decision,
`May 15, 2019 .................................. 1a
`
`Appendix A:
`
`
`Appendix B: District Court Opinion,
`
`July 10, 2017................................ 33a
`
`Appendix C: District Court Final Judgment,
`
`July 21, 2017.............................. 113a
`
`Appendix D:
`
`
`Court of Appeals Judgment,
`May 15, 2019 ............................. 118a
`
`Appendix E:
`
`
`
`Court of Appeals Order on
`Petition for Rehearing En Banc,
`July 30, 2019.............................. 120a
`
`Appendix F:
`
`
`Court of Appeals Mandate,
`August 6, 2019 ........................... 123a
`
`Appendix G: U.S. Patent No. 6,926,907 ......... 125a
`
`Appendix H: U.S. Patent No. 8,557,285 ......... 196a
`
`
`
`1a
`
`APPENDIX A
`
`UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`
`
`NUVO PHARMACEUTICALS (IRELAND)
`DESIGNATED ACTIVITY COMPANY, HORIZON
`MEDICINES LLC,
`Plaintiffs-Cross-Appellants
`
`v.
`
`DR. REDDY’S LABORATORIES INC., DR.
`REDDY’S LABORATORIES, LTD., MYLAN, INC.,
`MYLAN PHARMACEUTICALS INC., MYLAN
`LABORATORIES LIMITED,
`Defendant-Appellants,
`
`LUPIN LTD., LUPIN PHARMACEUTICALS, INC.,
`Defendants-Appellees.
`
`
`2017-2473, 2017-2481, 2017-2484, 2017-2486,
`2017-2489, 2017-2491, 2017-2492, 2017-2493
`
`
`
`
`
`
`
`
`
`
`Appeals from the United States District Court for
`the District of New Jersey in Nos. 3:11-cv-02317-
`MLC-DEA, 3:13-cv-00091-MLC-DEA, 3:13-cv-04022-
`MLC-DEA, Judge Mary L. Cooper.
`
`
`
`
`
`2a
`
`
`DECIDED: May 15, 2019
`
`
`
`
`JAMES B. MONROE, Finnegan, Henderson,
`Farabow, Garrett & Dunner, LLP, Washington, DC,
`argued for plaintiffs-cross-appellants. Plaintiff-cross-
`appellant Horizon Medicines LLC also represented by
`CHARLES COLLINS-CHASE.
`
`STEPHEN M. HASH, Baker Botts, LLP, Austin,
`TX, for plaintiff-cross-appellant Nuvo Pharmac-
`euticals (Ireland) Designated Activity Company. Also
`represented by JEFFREY SEAN GRITTON.
`
`ALAN HENRY POLLACK, Windels Marx Lane &
`Mittendorf LLP, Madison, NJ, argued
`for all
`defendants-appellants. Defendants-appellants Dr.
`Reddy's Laboratories Inc., Dr. Reddy's Laboratories,
`Ltd. also represented by STUART D. SENDER.
`
`ANDREW DUFRESNE, Perkins Coie LLP,
`Madison, WI, argued for all defendants-appellants.
`Defendants-appellants Mylan,
`Inc., Mylan
`Pharmaceuticals Inc., Mylan Laboratories Limited
`also represented by AUTUMN N. NERO; DAN L.
`BAGATELL,
`Hanover,
`NH;
`SHANNON
`BLOODWORTH, Washington, DC.
`
`
`SAILESH K. PATEL, Schiff Hardin LLP,
`Chicago, IL, for defendants-appellees Lupin Ltd.,
`Lupin Pharmaceuticals, Inc.
`
`
`______________________
`
`
`
`
`
`3a
`
` Before PROST, Chief Judge, CLEVENGER and
`WALLACH, Circuit Judges.
`
`CLEVENGER, Circuit Judge.
`
`Inc., Mylan
`Laboratories,
`Dr. Reddy’s
`and Lupin Pharmaceuticals
`Pharmaceuticals,
`(collectively, “the Generics”) appeal from the final
`judgment of the United States District Court for the
`District of New Jersey following a bench trial
`upholding the asserted claims of U.S. Patent Nos.
`6,926,907 (“the ’907 patent”) and 8,557,285 (“the ’285
`patent”) as nonobvious under 35 U.S.C. § 103, enabled
`under 35 U.S.C. § 112, and adequately described
`under § 112. Nuvo Pharmaceuticals, Inc. and Horizon
`Pharma (collectively, “Nuvo”) cross-appeal from the
`district court’s grant of summary
`judgment of
`noninfringement to Dr. Reddy’s, concluding that one
`of its drug products will not infringe the claims of the
`’907 patent. For the reasons set forth below, we
`reverse the appeal and dismiss the cross- appeal.
`
`
`BACKGROUND
`
` I
`
`Non-steroidal anti-inflammatory drugs, also
`known as NSAIDs, control pain. Common NSAIDs
`include, among others, aspirin and naproxen. While
`NSAIDs control pain, they also have the undesirable
`side effect of causing gastrointestinal problems such
`as ulcers, erosions, and other lesions in the stomach
`and upper small intestine. Some theorize that the
`
`
`
`
`
`4a
`
`undesirable side effect is tied to the combination of
`NSAID with the presence of acid in the stomach and
`upper small intestine. So, to treat the side effect, some
`practitioners began prescribing acid inhibitors to be
`taken by a patient along with the NSAID. The NSAID
`treats the pain while the acid inhibitor reduces the
`acidity in the gastrointestinal tract, which is achieved
`by increasing the pH level in the tract. Common acid
`inhibitors include, among others, proton pump
`inhibitors (“PPIs”) like omeprazole and esomeprazole.
`
`The combination therapy had complications.
`First, stomach acid degraded the PPI before it could
`reach the small intestine. To fix that issue, an enteric
`coating that wears off after a certain amount of time
`has elapsed was placed around the PPI. Second, if the
`NSAID was released before the acid inhibitor had
`enough time to raise the pH level in the tract, patients
`would continue to suffer gastrointestinal damage. To
`address those complications, Dr. John Plachetka
`invented a new drug form that coordinated the
`release of an acid inhibitor and an NSAID in a single
`tablet. The tablet contained a core of an NSAID like
`naproxen in an amount effective to treat pain, an
`enteric coating around the NSAID that prevents its
`release before the pH increases to a certain desired
`level, and an acid inhibitor like PPI around the
`outside of the enteric coating that actively works to
`increase the pH to the desired level. Dr. Plachetka’s
`invention contemplates using some amount of
`uncoated PPI to allow for its immediate release into a
`patient’s stomach and upper small intestine. Dr.
`Plachetka recognized problems associated with
`uncoated PPI, namely that without a coating, the PPI
`
`
`
`
`
`5a
`
`is at risk of destruction by stomach acid—thereby
`undermining the therapeutic effectiveness of the PPI.
`
`Dr. Plachetka received the ’907 patent on his
`invention, which he assigned to Pozen Inc. He also
`received the ’285 patent, which is a division of an
`abandoned application that was a division of another
`application that itself was a continuation-in-part of
`the application that resulted in the ’907 patent. The
`’285 patent is also assigned to Pozen. The two patents
`bear the same title, “Pharmaceutical Compositions
`for the Coordinated Delivery of NSAIDs,” and have
`nearly identical specifications.
`
`Claim 1 of the ’907 patent and claim 1 of the ’285
`patent are representative. They read as follows:
`
`
`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
`aid 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;
`
`
`
`
`
`
`6a
`
`and wherein said unit dosage form provides for co-
`ordinated release such that:
`
`
`said NSAID is surrounded by a
`i)
`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.
`
`
`’907 patent col. 20 ll. 9–32.
`
`
`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;
`
`
`
`
`
`
`
`7a
`
`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.
`
`
`’285 patent col. 22 ll. 9–19.
`
`
`The shared specification discloses that the
`invention
`“is directed
`to a pharmaceutical
`composition in unit dosage form suitable for oral
`administration to a patient” that “contains an acid
`inhibitor present in an amount effective to raise the
`gastric pH of a patient to at least 3.5, preferably to at
`least 4, and more preferably to at least 5, when one or
`more unit dosage forms are administered.” ’907
`patent col. 3 ll. 19–25.1 It discloses exemplary acid
`inhibitors like PPIs, which the patents teach includes
`omeprazole and esomeprazole. It recites amounts of
`omeprazole between 5 and 50 mg and amounts of
`esomeprazole between 5 and 100 mg, “with about 40
`mg per unit dosage form being preferred.” Id. at col. 7
`ll. 9–13. The specification discloses that “[t]he
`pharmaceutical composition also contains a non-
`steroidal anti-inflammatory drug in an amount
`effective to reduce or eliminate pain or inflammation.”
`Id. at col. 3 ll. 39–41. It provides that “[t]he most
`preferred NSAID is naproxen in an amount of
`between 50 mg and 1500 mg, and more preferably, in
`
`
`1 Because the ’907 and ’285 patents have nearly identical
`specifications, we cite to the ’907 patent only un- less stated
`otherwise.
`
`
`
`
`
`8a
`
`an amount of between 200 mg and 600 mg.” Id. at col.
`3 ll. 48–50.
`
`The specification teaches methods for preparing
`and making the claimed drug formulations, including
`in tablet dosage forms. It provides examples of the
`structure and ingredients of the drug formulations
`that comport with the invention. It 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.
`Appellant’s Opening Br. 23, 33; Appellee’s Resp. Br.
`35,
`43;
`Oral
`Arg.
`at
`34:08–40,
`http://oralarguments.cafc.uscourts.gov/default.aspx?f
`l=2017-2473.mp3. Furthermore,
`although
`the
`specification expressly provides that PPIs are “enteric
`coated to avoid destruction by stomach acid,” there is
`no alternative disclosure explaining that uncoated
`PPI could still be effective to raise pH. ’907 patent col.
`2 l.6; Oral Arg. at 34:08–39:28.
`
`Pozen ultimately sold its rights to the ’907 and
`’285 patents to Nuvo Pharmaceuticals, and Horizon
`Pharma maintained its previously obtained license
`under those patents. Nuvo makes and sells a drug
`called Vimovo®, which is a commercial embodiment
`of the ’907 and ’285 patents. The Generics want to
`market a generic version of Vimovo®. They submitted
`Abbreviated New Drug Applications (“ANDAs”) to the
`U.S. Food and Drug Administration (“FDA”) seeking
`approval to market products covered by the claims of
`the ’907 and ’285 patents. Dr. Reddy’s also submitted
`a second ANDA covering a product slightly different
`than Vimovo® because it contains a small amount of
`
`
`
`
`
`II
`
`9a
`
`uncoated NSAID in the outer layer of the tablet,
`which is separate from the enteric-coated NSAID that
`releases only when the pH rises to about 5.5.
`
`
`
`Nuvo sued the Generics in the United States
`District Court for the District of New Jersey to
`prevent their ANDA products from going to market, if
`approved, before the expiration of the ’907 and ’285
`patents. Nuvo alleged that all the Generics’ ANDA
`products will infringe claims 5, 15, 52, and 53 of the
`’907 patent and claims 1–4 of the ’285 patent.2 The
`Generics stipulated to infringement, except with
`respect to Dr. Reddy’s second ANDA product, which it
`alleged will not infringe the claims of either patent.
`The Generics defended against the infringement
`assertions by alleging that the asserted patents are
`invalid as obvious over the prior art under 35 U.S.C.
`§ 103 and for lack of enablement and an adequate
`written description under 35 U.S.C. § 112.
`
`Dr. Reddy’s moved for summary judgment of
`noninfringement, arguing that its second ANDA
`product does not infringe the asserted claims of the
`’907 patent. It argued that, because the claims of the
`’907 patent prevent “essentially any NSAID” from
`being released from the unit dosage form until the pH
`reaches at least 3.5, its second ANDA product
`containing some amount of NSAID in the outer layer
`that is released immediately, regardless of the pH,
`cannot infringe those claims. Nuvo countered that the
`
`2 All the asserted claims of the ’907 and ’285 patents are
`dependent on claim 1 of those respective patents.
`
`
`
`
`10a
`
`phrase “essentially any NSAID” in the claim language
`prevents only NSAID in the core of the tablet from
`being released before the pH rises to 3.5 or higher and
`that the claimed invention allows for a small amount
`of additional NSAID to be released immediately. The
`district court agreed with Dr. Reddy’s and granted its
`summary judgment motion.
`
`The court then held a six-day bench trial on the
`validity of the ’907 and ’285 patents, as well as Dr.
`Reddy’s contention that its second ANDA product
`does not infringe the asserted claims of the ’285
`patent. It concluded that none of the asserted claims
`are obvious over the prior art because it was
`nonobvious to use a PPI to prevent NSAID-related
`gastric injury, and persons of ordinary skill in the art
`were discouraged by the prior art from using uncoated
`PPI and would not have reasonably expected it to
`work. It also determined that the asserted claims of
`both patents are enabled because the specification
`teaches how to make and use the invention and expert
`testimony demonstrated that an ordinarily skilled
`artisan would have accepted the usefulness of an
`NSAID–PPI combination therapy for treating pain.
`
`The district court went on to reject all three of the
`Generics’ written description arguments. First, the
`court rejected the “comprising” written description
`argument. The Generics argued that, because of the
`“comprising” language in the ’285 patent’s claims,
`they allow for the drug formulation to include some
`uncoated naproxen that is released immediately
`regardless of the pH, which is not supported by the
`specification and goes against the concept of
`
`
`
`
`
`11a
`
`coordinated release that is at the heart of the patent’s
`invention. The court disagreed because it viewed
`uncoated naproxen as a less preferred embodiment of
`the claimed invention and thus found that the
`invention was supported by the general disclosure in
`the specification.
`
`Second, the district court rejected the “inhibit”
`written description argument. The Generics
`contended that, although the patent discloses only
`delayed release formulations, the claims of the ’285
`patent recite a broader undescribed invention,
`namely sustained release as op- posed to coordinated
`release of naproxen. That is because the claims cover
`any formulation having a coating that merely
`“inhibits” the release of naproxen before the pH
`reaches 3.5 or higher, which would include sustained
`release drugs that immediately discharge naproxen
`albeit at a slower rate than is typical. The court
`disagreed that the word “inhibits” meant that the
`claims
`contemplated
`sustained
`release drug
`formulations and thus concluded that the claims do
`not lack written description support on that basis.
`
`Third, the district court rejected the “efficacy”
`written description argument. The Generics argued
`that, if they lose on their obviousness contention, then
`the claims lack written description support for the
`claimed effectiveness of uncoated PPI because
`ordinarily skilled artisans would not have expected it
`to work and
`the
`specification provides no
`experimental data or analytical reasoning showing
`the inventor possessed an effective uncoated PPI.
`Nuvo responded that experimental data and an
`
`
`
`
`
`12a
`
`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. The court
`rejected the notion that effectiveness does not need to
`be described because it is necessarily inherent in the
`claimed drug formulation. It also held that the
`specification of the ’907 and ’285 patents did not
`disclose
`information regarding
`the efficacy of
`uncoated PPI. But the court nonetheless concluded
`that the claims were adequately described because
`the specification described the immediate release of
`uncoated PPI and the potential disadvantages of
`coated PPI, namely
`that enteric-coated PPI
`sometimes works too slowly to raise the intragastric
`pH. The district court did not explain why the mere
`disclosure of
`immediate release uncoated PPI,
`coupled with the known disadvantages of coated PPI,
`is relevant to the therapeutic effectiveness of
`uncoated PPI, which the patent itself recognized as
`problematic for efficacy due to its potential for
`destruction by stomach acid.
`
`Finally, the district court held that Dr. Reddy’s
`second ANDA product infringes the claims of the ’285
`patent because it satisfies all the limitations recited
`in those claims.
`
`The Generics now appeal the first “comprising”
`and third “efficacy” written description rulings. They
`do not appeal
`the obviousness holding,
`the
`enablement decision, or the second “inhibit” written
`description issue. Nuvo cross-appeals the district
`court’s
`grant
`of
`summary
`judgment
`of
`
`
`
`
`
`13a
`
`noninfringement. We have jurisdiction to decide the
`appeals under 28 U.S.C. § 1295(a)(1).
`
`
`DISCUSSION
`
`The Generics’ appeal and Nuvo’s cross-appeal
`present three main issues. First, the Generics argue
`that the district court clearly erred when it concluded
`that the specification of the ’907 and ’285 patents
`adequately describes the claimed effectiveness of
`uncoated PPI. The Generics emphasize
`the
`circumstances in which the written description issue
`arises in this case. The asserted claims recite the
`therapeutic effectiveness of uncoated PPI, but the
`prior art taught away from such effectiveness. In
`those circumstances, the Generics argue that
`satisfaction of the written description requirement
`requires either supporting experimental data, or
`some reason, theory, or alternative explanation as to
`why the claimed invention is possessed by the
`inventor, and that mere recitation of claim language
`in the specification cannot suffice. Second, the
`Generics argue that the district court clearly erred
`when it concluded that the specification of the ’907
`and ’285 patents adequately describes uncoated
`naproxen. Finally, Nuvo argues that the district court
`should not have granted summary judgment of
`noninfringement in favor of Dr. Reddy’s because it
`incorrectly construed the term “essentially any
`NSAID” in the claims of the ’907 patent to prevent
`even small amounts of uncoated NSAID in the unit
`dosage form.
`
`
`
`
`
`
`14a
`
`Whether a claim satisfies the written description
`requirement is a question of fact. Allergan, Inc. v.
`Sandoz Inc., 796 F.3d 1293, 1308 (Fed. Cir. 2015).
`Therefore, on appeal from a bench trial, we review a
`written description determination for clear error. Id.
`“Under the clear error standard, the court’s findings
`will not be overturned in the absence of a ‘definite and
`firm conviction’ that a mistake has been made.”
`Scanner Techs. Corp. v. ICOS Vision Sys. Corp. N.V.,
`528 F.3d 1365, 1374 (Fed. Cir. 2008) (quoting Pfizer,
`Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 1366
`(Fed. Cir. 2008)).
`
`Our analysis begins and ends with the “efficacy”
`written description issue.
`
`
`I
`
`The written description requirement of 35 U.S.C.
`§ 112, ¶ 1 provides, in pertinent part, that “[t]he
`specification shall contain a written description of the
`invention.”3 That requirement is satisfied only if the
`inventor “convey[s] with reasonable clarity to those
`skilled in the art that, as of the filing date sought, he
`or she was in possession of the invention,’ and
`demonstrate[s] that by disclosure in the specification
`of the patent.” Centocor Ortho Biotech, Inc. v. Abbott
`Labs., 636 F.3d 1341, 1348 (Fed. Cir. 2011) (quoting
`Carnegie Mellon Univ. v. Hoffmann–La Roche Inc.,
`541 F.3d 1115, 1122 (Fed. Cir. 2008)). “The essence of
`
`3 Because the applications resulting in the ’907 and ’285 patents
`were filed before the enactment of the Leahy–Smith America
`Invents Act (“AIA”), Pub. L. No. 112–29, § 4(c), 125 Stat. 284,
`296–97 (2011), we apply the pre-AIA version of 35 U.S.C. § 112.
`
`
`
`
`15a
`
`the written description requirement is that a patent
`applicant, as part of the bargain with the public, must
`describe his or her invention so that the public will
`know what it is and that he or she has truly made the
`claimed invention.” AbbVie Deutschland GmbH & Co.
`v. Janssen Biotech, Inc., 759 F.3d 1285, 1298 (Fed.
`Cir. 2014).
`
`The Generics argue that the district court clearly
`erred when
`it
`concluded
`that
`the
`claimed
`effectiveness of uncoated PPI in the ’907 and ’285
`patents is supported by adequate written description.
`Their argument is straightforward. The ’907 and ’285
`patents claim uncoated PPI effective to raise the
`gastric pH to at least 3.5, the district court found upon
`Nuvo’s insistence as part of its obviousness analysis
`that ordinarily skilled artisans would not have
`expected uncoated PPIs to be effective, and nothing in
`the specification would teach a person of ordinary
`skill in the art otherwise.
`
`Nuvo counters that the district court correctly
`concluded that the claimed uncoated PPI is supported
`by adequate written description. It argues that the
`claims do not require any particular degree of efficacy
`of the uncoated PPI itself, it is enough that the
`specification discloses making and using drug
`formulations containing effective amounts of PPI and
`NSAID, and experimental data and additional
`explanations demonstrating the invention works are
`unnecessary.
`
`The district court held that the Generics failed to
`prove by clear and convincing evidence that the
`
`
`
`
`
`16a
`
`asserted claims of the ’907 and ’285 patents are
`invalid for lack of written description. But its analysis
`does not support its conclusion. The district court,
`after finding that the specification lacks “information
`regarding the efficacy of uncoated PPIs,” said it was
`enough
`that
`the
`specification described
`the
`immediate release of uncoated PPI and the potential
`disadvantages of enteric-coated PPI formulations.
`J.A. 82–83. But that disclosure it pointed to in no way
`provides support for the claimed efficacy of uncoated
`PPI. Even if the district court thought that it was
`enough that the patents taught how to make and use
`drug formulations containing uncoated PPI, it flatly
`rejected Nuvo’s argument “that the efficacy of
`uncoated PPIs need not be described because it is
`‘necessarily inherent’ in a formulation.” J.A. 83.
`Nevertheless, because we review the district court’s
`decision for clear error, we will scour the record
`created below for evidence supporting the district
`court’s written description finding.
`
`
`A
`
`At trial, the parties and the district court
`understood that the plain words of the patents claim
`effectiveness of uncoated PPI. Beyond the plain
`language of the claims, the district court was not
`asked to define further the effectiveness limitation.
`The parties and the district court also understood that
`written description of effective uncoated PPI is
`required. Nuvo nonetheless for the first time on
`appeal, and as its lead argument, contends that we
`can affirm the district court’s written description
`finding because the claims do not recite an efficacy
`
`
`
`
`
`17a
`
`requirement for uncoated PPI. The Generics of course
`disagree. We read Nuvo’s appellate brief as
`presenting at least five arguments aimed at either
`recharacterizing the written description dispute or
`rewriting the claim language. We reject them all as
`meritless.
`
`“[a]
`’907 patent recites
`the
`Claim 1 of
`pharmaceutical composition in unit dosage form
`suitable
`for oral administration to a patient,
`comprising:… 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” and wherein “at least a
`portion of said acid inhibitor is not surrounded by an
`enteric coating:…” ’907 patent col. 20 ll. 9–29
`(emphasis added). Claim 1 of the ’285 patent recites
`“[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 “wherein said unit dosage form provides for
`release of said esomeprazole such that upon intro-
`duction of said unit dosage form into a medium, at
`least a portion of said esomeprazole is released
`regardless of the pH of the medium.” ’285 patent col.
`22 ll. 9–19 (emphasis added). The claim also recites
`“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,” which
`means the esomeprazole must be acting to raise the
`pH to effect the release of the naproxen from the
`dosage form. Id. at col. 22 ll. 13–15. Both patents-in-
`suit therefore recite claims requiring amounts of
`
`
`
`
`
`18a
`
`uncoated PPI effective to raise the gastric pH to at
`least 3.5. No argument was made below that the
`claims of the ’907 patent should be treated any
`differently than those of the ’285 patent with respect
`to the efficacy limitation. And the district court
`treated the claims the same with respect to that lim-
`itation. So we do not treat them differently on appeal
`either.
`
`First, Nuvo argues that there is no requirement
`that the dosage form as a whole be effective to raise
`the gastric pH. While we agree, we do not understand
`the Generics to be arguing that the claims require the
`entire drug to be effective to raise the gastric pH to a
`certain level. Instead, the uncoated PPI must
`effectively do so.
`
`Second, Nuvo contends that the claims do not
`require an effective amount of the combined uncoated
`PPI and coated naproxen in a single dosage form, but
`only amounts of each component effective on their
`own. The Generics respond that Nuvo’s argument is
`divorced from the claim as a whole, which 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. Nuvo’s argument was not raised below
`and thus is forfeited. See TVIIM, LLC v. McAfee, Inc.,
`851 F.3d 1356, 1363 (Fed. Cir. 2017) (“[A] party may
`not introduce new claim construction arguments on
`appeal or alter the scope of the claim construction
`positions it took below. Moreover, litigants waive
`
`
`
`
`
`19a
`
`their right to present new claim construction disputes
`if they are raised for the first time after trial.”).
`
`Third, Nuvo argues that the claims do not require
`that the uncoated PPI be effective to raise the gastric
`pH to a certain level, but only that the dosage forms
`contain an effective amount of uncoated PPI. The
`Generics disagree. Nuvo forfeited the argument by
`not raising it below. Additionally, it is nonsensical to
`read the claims to require effective amounts of
`uncoated PPI without specifying the result effectively
`achieved. Claim 1 of the ’907 patent expressly states
`that the PPI, which is uncoated, must be effective to
`raise the gastric pH to at least 3.5. Claim 1 of the ’285
`patent at least impliedly requires the same since the
`naproxen is only released when the pH reaches at
`least 3.5 and the uncoated esomeprazole is the only
`other agent available in the dosage form to achieve
`that goal.
`
`Fourth, Nuvo contends that the ’907 patent allows
`multiple dosage forms rather than a single dosage
`form to satisfy any perceived efficacy requirement, so
`the specification does not need to show an effective
`amount of uncoated PPI in one dosage form. We
`disagree. As stated above, Nuvo forfeited any
`argument that the ’907 and ’285 patents should be
`treated differently with respect to the efficacy
`requirement by not raising it to the district court. And
`the ’285 patent does not allow for more than one
`dosage form. Even 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
`
`
`
`
`
`20a
`
`specification would still need to provide support for
`the notion that uncoated PPI is effective.
`
`Last, Nuvo argues that the Examiner interpreted
`the ’907 patent claims as merely requiring certain
`amounts of PPI and NSAID effective on their own
`rather than requiring an overall efficacy for the
`combined drug. The Generics counter that the
`Examiner never considered the effectiveness of
`uncoated PPI because it was not a claim limitation at
`the time of the initial rejection. We already rejected
`Nuvo’s argument that the difference between a
`dosage form as a whole containing an effective
`amount of uncoated PPI and an effective amount of
`uncoated PPI as a component meaningfully impacts
`the written description analysis. And we also already
`rejected
`its argument that the Generics were
`contending that Nuvo had to demonstrate the overall
`effectiveness of
`the entire drug combination.
`Furthermore, the argument is forfeited because it was
`not presented below. Finally, 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. We agree with that
`understanding and written description support must
`be provided for that limitation.
`
`In sum, the parties appear to have assumed
`before the district court that the claims require a
`therapeutically effective amount of uncoated PPI that
`can raise the gastric pH to at least 3.5. We see no
`reason to change course on appeal. Because the
`parties’ assumption at the trial court is a fair reading
`of the claim language, we will proceed as everyone did
`
`
`
`
`
`21a
`
`before the district court and search the specification
`for written description support for the efficacy of
`uncoated PPI.
`
`
`B
`
`Nuvo argues that credible expert testimony from
`its witness, Dr. Williams,
`identified written
`description support in the specification for the
`claimed dosage forms comprising an effective amount
`of uncoated PPI. Specifically, Nuvo points to Dr.
`Williams’s testimony that every limitation of the
`asserted claims in the ’907 and ’285 patents has
`adequate written description support in the shared
`specification.
`
`four parts of the
`identified
`Dr. Williams
`specification
`that he
`thought provide written
`description support for amounts of uncoated PPI, and
`specifically esomeprazole, effective to raise the gastric
`pH of a patient to at least 3.5. He pointed to the
`specification’s statement that “[t]he composition
`contains an acid inhibitor present in an amount
`effective to raise the gastric pH of a patient to at least
`3.5.” See J.A. 10787 (quoting ’907 patent col. 3 ll. 21–
`23), 10797 (similar). He also pointed to the claims
`themselves for written description support. See J.A.
`10787 (citing ’907 patent col. 20 ll. 9–32, 42–45),
`10798 (similar). He then said the sixth example in the
`specification provides support for uncoated PPI
`because it includes “omeprazole immediate release” in
`the title and provides that a layer of the composition
`embodied in the example “contains an acid inhibitor
`in an effective amount which is released from the
`
`
`
`
`
`22a
`
`dosage form as soon as the film coat dissolves,” where
`the acid inhibitor is the PPI omeprazole. J.A. 10788–
`89 (quoting ’907 patent col. 14 ll. 40–41, col. 15 ll. 1–
`3). His last piece of support from the specification was
`its statement that “[p]roton pump inhibitors will
`typically be present at about 5 milligrams to 600
`milligrams per dose” and “[e]someprazole is 5 to 100
`milligrams.” J.A. 10798 (quoting ’907 patent col. 7 ll.
`7–13).
`
`The Generics argue that the parts of the
`specification Dr. Williams identified are not enough
`to satisfy the written description requirement. They
`argue that the specification provides only typical
`dosage amounts of uncoated PPI and the use of
`uncoated PPI in a drug formulation, but it never
`discusses or explains its efficacy. We agree with the
`G
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