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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
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`In re: OXYCONTIN ANTITRUST LITIGATION i
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`PURDUE PHARMA LP.,
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`THE P.F. LABORATORIES, INC., and
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`PURDUE PHARMACEUTICALS LP.,
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`-against-
`AMNEAL PHARMACEUTICALS~~~~dant. I
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`Plaintiffs,
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`I l : ! l ! l
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`04-Md-1603 (SHS)
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`13-Cv-3372 (SHS)
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`FINDINGS OF FACT AND CONCLUSIONS OF LAW
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`TABLE OF CONTENTS
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`TABLE OF ABBREVIATIONS ........................................................................................... v
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`PART 1. INTRODUCTION ...................................................................................... 1
`
`I.
`
`THE RECORD AND RELEVANT PROCEEDINGS ...................................................... 1
`
`A. The ‘888 Patent and Asserted Claims ......................................................... 1
`
`B. The 2013 Teva Trial ....................................................................................... 2
`
`C. Claim Construction ....................................................................................... 2
`
`D. The 2014 Trial................................................................................................. 3
`
`E. This Opinion .................................................................................................. 4
`
`II. LEGAL STANDARDS .............................................................................................. 4
`
`A. Procedural Context and the Hatch-Waxman Act ..................................... 4
`
`B. Claim Construction ....................................................................................... 6
`
`C. Claims of Patent Infringement .................................................................... 7
`
`D. The Affirmative Defense of Patent Invalidity ........................................... 8
`1. Novelty and Anticipation ........................................................................ 8
`2. Obviousness and Nonobviousness ........................................................ 9
`3. Definiteness.............................................................................................. 11
`
`E. Attorney’s Fees ............................................................................................ 12
`
`PART 2. FINDINGS OF FACT AND CONCLUSIONS OF LAW ..................... 13
`
`I. CLAIM CONSTRUCTION...................................................................................... 13
`
`A. Method of Testing Viscosity ...................................................................... 14
`1. The Viscosity Test Is Not Limited to Zero Shear Viscosity and
`Includes, at a Minimum, Shear Rates Ranging from .01 to 100 Reciprocal
`Seconds. ............................................................................................................ 15
`2. Tampering Temperature Is Not Limited to 25° C. and Includes
`Temperatures Above 45° C. ........................................................................... 19
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`3. Testing Temperature Is Not Limited to 25° C. but Does Not Extend
`to Temperatures at or Near Boiling. ............................................................. 20
`4. The viscosity test is conducted after a visual inspection confirms
`that the soluble components of the dosage form have dissolved,
`although insoluble particles may remain. ................................................... 23
`
`B. The Gelling Agent as a Whole May Confer the Requisite Viscosity.... 24
`
`II. FACTUAL BACKGROUND: ABUSE OF OXYCONTIN AND PURDUE’S RESPONSE . 28
`
`III.
`
`INFRINGEMENT .............................................................................................. 31
`
`A. Findings of Fact ........................................................................................... 31
`1. Amneal’s tablets meet the limitations of claim 1 because its gelling
`agents impart a viscosity of at least 10 cP. ................................................... 32
`2. Amneal’s tablets meet the limitations of claim 5 because they attain
`a viscosity of at least about 10 cP when dissolved in water. ..................... 33
`3. Amneal’s tablets meet the limitations of claim 7 because they obtain
`a viscosity of at least about 60 cP. ................................................................. 34
`4. Amneal’s tablets meet the limitations of claim 23 because they
`achieve the requisite viscosity when crushed and dissolved in water. ... 34
`5. Amneal’s tablets meet the limitations of claim 24 because they
`obtain the requisite viscosity when dissolved in water heated above
`45° C. ................................................................................................................. 35
`
`B. Conclusions of Law..................................................................................... 36
`
`IV.
`
`INVALIDITY .................................................................................................... 36
`
`A. Novelty Pursuant to 35 U.S.C. § 102 ......................................................... 36
`1. Findings of Fact ....................................................................................... 36
`a) The ‘963 Patent does not disclose all the limitations of the ‘888
`Patent. ........................................................................................................... 36
`b) The ‘591 Application does not disclose all limitations of the
`asserted claims of the ‘888 Patent. ............................................................ 38
`2. Conclusions of Law ................................................................................ 40
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`B. Obviousness Pursuant to 35 U.S.C. § 103 ................................................ 40
`1. Findings of Fact ....................................................................................... 40
`a) Level of Ordinary Skill in the Art ..................................................... 40
`b) Scope and Content of the Prior Art .................................................. 41
`(1) The prior art teaches that gelling agents reduce abuse
`potential. ................................................................................................... 41
`(2) The prior art teaches that PEO functions as both a rate
`controlling agent and a gelling agent. .................................................. 43
`c) Differences Between the ‘888 Patent and the Prior Art ................. 44
`(1) The ‘888 Patent differs from the prior art by claiming
`oxycodone and requiring a quantitative level of viscosity. .............. 44
`(2) The ‘888 Patent does not represent a departure from the prior
`art in other significant ways. ................................................................. 45
`d) Objective Indicia of Nonobviousness .............................................. 47
`(1) There is insufficient evidence of the ‘888 Patent’s commercial
`success. ..................................................................................................... 47
`(2) Amneal’s alleged copying of the invention is not an indication
`of nonobviousness. ................................................................................. 50
`(3) The ‘888 Patent did not fulfill a long-felt but unmet need........ 50
`(4) Although Purdue received some acclaim for its invention,
`persons of skill in the art were not skeptical that the ‘888 Patent
`would work.............................................................................................. 51
`2. Conclusions of Law ................................................................................ 51
`a)
`It would have been obvious to respond to the oxycodone abuse
`crisis by creating a controlled release dosage form that utilizes PEO as
`a gelling and rate control agent. ................................................................ 51
`b) The remaining features of the claimed invention are obvious. .... 54
`c) All asserted claims of the ‘888 Patent are invalid as obvious. ...... 54
`
`Indefiniteness Pursuant to 35 U.S.C. § 112 .............................................. 55
`C.
`1. Findings of Fact ....................................................................................... 55
`a) Shear Rate ............................................................................................ 55
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`(1) Shear rate determines whether some accused products meet
`claim 5’s 60 cP viscosity limitation. ...................................................... 55
`(2) Specifying shear rate is standard practice among ordinarily
`skilled artisans. ........................................................................................ 56
`b) Tampering and Testing Temperature .............................................. 57
`c) Extent of Dissolution .......................................................................... 60
`2. Conclusions of Law ................................................................................ 61
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`PART 3. CONCLUSION AND RELIEF ................................................................ 63
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`
`‘060 Patent
`‘888 Patent
`‘963 Patent
`2014 Stip.
`
`ANDA
`API
`Bastin
`C.
`cP
`CPM
`FDA
`Hoffmeister
`HPMC
`Joshi
`
`NDA
`OROS
`PEO
`PTO
`Royce
`Shaw
`USP
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`TABLE OF ABBREVIATIONS
`
`U.S. Patent No. 8,309,060
`U.S. Patent No. 8,337,888
`U.S. Patent No. 6,488,963
`Stipulations or Agreed Statements of Fact or Law,
`Joint Pretrial Order, No. 04-Md-1603, Dkt. No.
`572, filed June 23, 2014
`Abbreviated New Drug Application
`active pharmaceutical ingredient
`International Application No. WO 95/20947
`Celsius
`centipoise
`chlorpheniramine maleate
`U.S. Food and Drug Administration
`U.S. Patent No. 4,070,494
`hypromellose K100M
`U.S. Patent Application Publication No. US
`2002/0187192
`New Drug Application
`osmotically controlled-release oral delivery system
`polyethylene oxide
`U.S. Patent and Trademark Office
`U.S. Patent No. 5,273,758
`U.S. Patent No. 3,980,766
`United States Pharmacopeia
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`SIDNEY H. STEIN, U.S. District Judge.
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`PART 1. INTRODUCTION
`
`This action concerns the infringement and validity of United States Patent
`No. 8,337,888 (“the ‘888 Patent”), which is associated with the opioid pain
`reliever OxyContin. The ‘888 Patent claims a controlled release oral dosage
`form containing oxycodone that forms a gel when dissolved in an aqueous
`liquid. The gelling properties of the invention enable it to resist abuse by
`injection, snorting, and oral ingestion.
`
`Plaintiffs, led by OxyContin manufacturer Purdue Pharma L.P., allege that
`defendant Amneal, which produces generic pharmaceutical products, has
`infringed several claims of the patent by seeking approval from the U.S. Food
`and Drug Administration (“FDA”) to sell a generic version of OxyContin.
`Amneal responds that its proposed product does not infringe plaintiffs’ patent
`and that even if it did, the asserted claims of the patent are invalid. The parties
`presented factual support for their contentions during a week-long bench trial
`before this Court.
`
`Applying the relevant legal standards to the evidence adduced at trial, the
`Court concludes that although Amneal has infringed the ‘888 Patent, the
`asserted claims are invalid as obvious and indefinite.
`
`I.
`
`THE RECORD AND RELEVANT PROCEEDINGS
`
`The ‘888 Patent and Asserted Claims
`
`A.
`The ‘888 Patent issued on December 25, 2012. (PTX 4002 [hereinafter “‘888
`Patent”] at (45).) It claims priority to a provisional application, Serial No.
`60/310,534, filed August 6, 2001. (Stipulations or Agreed Statements of Fact or
`Law, Joint Pretrial Order, No. 04-Md-1603, Dkt. No. 664, filed June 23, 2014, at
`¶ 24 [hereinafter “2014 Stip.”].)
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`Purdue1 alleges that Amneal’s proposed formulation infringes claims 5, 7,
`23, and 24 of the ‘888 Patent. Independent claim 1, from which all asserted
`claims depend, claims a controlled release oral dosage form containing the
`active pharmaceutical ingredient (“API”) oxycodone and a gelling agent
`comprising polyethylene oxide (“PEO”). (‘888 Patent at 40:22-29.) When the
`dosage form is dissolved in a small amount of aqueous liquid, it attains a
`viscosity of at least about ten centipoise (“cP”), thereby hindering attempts at
`injection, snorting, or swallowing. (Id. at 2:64-3:30, 40:22-29.) The dosage form
`of claim 1 also provides a therapeutic effect for at least about twelve hours
`when orally administered to a human patient. (Id. at 40:30-32.)
`
`The asserted dependent claims specify that the aqueous liquid is water
`(claim 5), that the dissolved dosage form achieves a viscosity of at least about
`60 cP (claim 7), and that tampering includes crushing (claim 23) or dissolution
`in an aqueous liquid with heating greater than 45° Celsius (“C.”) (claim 24).
`(‘888 Patent at 40:45-46, 40:51-52, 42:10-17.)
`
`The 2013 Teva Trial
`
`B.
`In September and October of 2013, the Court held a bench trial in the
`consolidated actions of Purdue Pharma L.P. et al. v. Teva Pharmaceuticals USA,
`Inc., Nos. 11-Cv-2037 and 12-Cv-5083; Purdue Pharma L.P. et al. v. IMPAX Labs.,
`Inc., No. 11-Cv-2400; and Purdue Pharma L.P. et al. v. Sandoz Inc., Nos. 11-Cv-
`4694 and 12-Cv-5082. Because the evidence presented at the 2013 trial relates
`to the claims and defenses at issue here, the parties have agreed to adopt the
`entire record as part of the factual record in this action. (Joint Pretrial Order,
`No. 4-Md-1603, Dkt. No. 664, filed June 23, 2014, at 20 ¶ 14.)
`
`Claim Construction
`
`C.
`After extensive briefing and a claim construction hearing, this Court
`issued a Claim Construction Opinion and Order in May 2014, which construed
`
`
`1 This Opinion refers to plaintiffs collectively as “Purdue.”
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`the patent claims at issue to resolve the parties’ disputes as to their meaning.
`See In re OxyContin Antitrust Litig., No. 04-Md-1603, 2014 WL 2198590 (S.D.N.Y.
`May 27, 2014) [hereinafter “Claim Construction”]. All parties to this action
`participated in litigating the claim constructions; consequently, for purposes of
`this trial, that Opinion and Order “define[s] the invention to which the
`patentee is entitled the right to exclude.” Phillips v. AWH Corp., 415 F.3d 1303,
`1312 (Fed. Cir. 2005) (en banc) (quotation marks omitted).
`
`During trial, several new issues of claim construction arose that the parties
`had not fully presented to the Court during its earlier claim construction
`hearing. The Court must resolve these claim construction disputes before
`analyzing the infringement and validity of the ‘888 Patent. See Rockwell Int’l
`Corp. v. United States, 147 F.3d 1358, 1362 (Fed. Cir. 1998).
`
`The 2014 Trial
`
`D.
`The bench trial in this action began on July 14, 2014. Over the course of
`five days, the Court heard live testimony from nine witnesses and admitted
`hundreds of exhibits. Purdue’s expert witnesses included Dr. Martyn Davies,
`an expert in drug delivery systems, including the development and testing of
`controlled-release formulations (Davies 2013 Tr. 683-842; Davies Tr. 326), and
`Dr. Jerry Hausman, an expert in economics and econometrics (Hausman Tr.
`272). Serving as expert witnesses for Amneal were Dr. Mohan Rao, an expert
`in economic analysis, including commercial success (Rao 2013 Tr. 1576; Rao Tr.
`657-58); Dr. Fernando Muzzio, an expert in the design, development, and
`analysis of pharmaceutical products and processes, as well as rheology and the
`measurement of viscosity (Muzzio Tr. 489); and Dr. Michael Maurin, an expert
`in pharmacy practice, the syringeability of drug products, and pharmaceutical
`formulation and testing, specifically in vivo and in vitro testing as related to
`therapeutic effect (Maurin Tr. 741).
`
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`2 Citations to “2013 Tr.” refer to the transcript of the 2013 trial, No. 04-Md-1603, Dkt. Nos.
`599-621.
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`Another defendant, Teva Pharmaceuticals USA, Inc., also participated in
`the 2014 trial but has since entered into a settlement with Purdue. Purdue
`accused Teva of infringing both the ‘888 Patent and U.S. Patent No. 8,309,060
`(“the ‘060 Patent”). The ‘060 Patent claims an abuse-proofed dosage form with
`a high breaking strength that prevents crushing; it may optionally contain
`additional abuse-deterring components, such as gelling agents. (PTX 4000 at
`6:24-48; 21:5-14, 21:37-46.) Purdue and Teva entered into a consent judgment
`after the conclusion of the trial. (No. 13-Cv-4606, Dkt. No. 92.) The Court
`therefore does not set forth findings of fact and conclusions of law regarding
`Teva’s alleged infringement of the ‘888 and ‘060 Patents or the validity vel non
`of the ‘060 Patent. However, the Court draws on the evidence presented at trial
`on those issues to the extent it relates to the validity of the ‘888 Patent and
`Amneal’s alleged infringement.
`
`This Opinion
`
`E.
`On the basis of the record established by the parties and the applicable
`law, the Court enters these findings of fact and conclusions of law pursuant to
`Rule 52(a) of the Federal Rules of Civil Procedure. To the extent that any
`findings of fact may be deemed conclusions of law, they shall also be
`considered conclusions of law; to the extent that any conclusions of law may
`be deemed findings of fact, they shall also be considered findings of fact. Cf.
`Miller v. Fenton, 474 U.S. 104, 113-14 (1985).
`
`II.
`
`LEGAL STANDARDS3
`
`Procedural Context and the Hatch-Waxman Act
`
`A.
`This litigation arises under the Drug Price Competition and Patent Term
`Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (codified at 21 U.S.C.
`
`
`3 Except where the law has evolved, the following discussion is taken largely from the
`Court’s findings of fact and conclusions of law resulting from the 2013 trial. See In re
`OxyContin Antitrust Litig., 994 F. Supp. 2d 367, 378-84 (S.D.N.Y. 2014).
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`§§ 301 et seq.) (“Hatch-Waxman Act”). The Hatch-Waxman Act provides a
`streamlined regulatory pathway for generic pharmaceutical companies to seek
`approval of their drugs, while giving branded pharmaceutical companies an
`opportunity to sue to defeat approval of the generic drugs.
`
`Pursuant to the Hatch-Waxman Act, a pharmaceutical company can seek
`FDA approval for a generic drug based on an already-approved branded drug
`by filing an Abbreviated New Drug Application (“ANDA”). 21 U.S.C.
`§ 355(j)(2)(A), (8)(B). As the name suggests, an ANDA does not require the
`detailed showings necessary for the pioneer New Drug Application (“NDA”),
`such as proof of safety and effectiveness. See id. Where a branded
`manufacturer’s patent has not yet expired but a generic manufacturer
`nonetheless wants to enter the market, the generic must file a pre-expiration
`challenge (known colloquially as a “Paragraph IV” certification, after the
`relevant paragraph number in the legislation). Id. § 355(j)(2)(A)(vii)(IV). A
`generic firm’s Paragraph IV certification must establish bioequivalence of the
`proposed generic version with the approved branded version of the drug. See
`21 C.F.R. § 314.94(a)(9). The Paragraph IV certification must also state and
`explain at least one of the following claims: that the generic product would not
`infringe the branded firm’s patent, or that the branded firm’s patent is invalid.
`See 21 U.S.C. § 355(j)(2)(B)(iv)(II).
`
`As the U.S. Court of Appeals for the Second Circuit has explained, the
`mere filing of “[a]n ANDA-IV certification itself constitutes an act of
`infringement, triggering the branded manufacturer’s right to sue.” Ark.
`Carpenters Health & Welfare Fund v. Bayer AG, 604 F.3d 98, 101 (2d Cir. 2010)
`(citing 35 U.S.C. § 271(e)(2)(A)). When a branded manufacturer files suit
`pursuant to that right within 45 days of receiving notice of the Paragraph IV
`certification, the litigation automatically stays the generic’s entry to the market.
`21 U.S.C. § 355(j)(5)(B)(iii). At its core, then, the Hatch-Waxman Act
`“redistributes the relative risks between the patent holder and the generic
`manufacturer, allowing generic manufacturers to challenge the validity of the
`patent without incurring the costs of market entry or the risks of damages from
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`infringement.” Ark. Carpenters Health & Welfare Fund, 604 F.3d at 101. More
`significantly for purposes of this litigation, this structure allows the parties to
`try the dueling issues of patent infringement and patent invalidity
`simultaneously.
`
`Claim Construction
`
`B.
`“[T]he claims of a patent define the invention to which the patentee is
`entitled the right to exclude.” Phillips, 415 F.3d at 1312 (quotation marks
`omitted). “Generally, a claim term is given the ordinary and customary
`meaning as understood by a person of ordinary skill in the art at the time of
`invention.” InTouch Techs., Inc. v. VGO Commc’ns, Inc., 751 F.3d 1327, 1339 (Fed.
`Cir. 2014).
`
`Because ordinary and customary meaning cannot be determined “in a
`vacuum,” the Federal Circuit has stressed “the importance of intrinsic
`evidence” to claim construction. Phillips, 415 F.3d at 1313, 1317 (quotation
`marks and citations omitted). The analysis “must begin and remain centered
`on the claim language itself.” Innova/Pure Water, Inc. v. Safari Water Filtration
`Sys., Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004) (quotation marks and alterations
`omitted). “Claims, however, must be construed in light of the appropriate
`context in which the claim term is used.” Aventis Pharm. Inc. v. Amino Chems.
`Ltd., 715 F.3d 1363, 1373 (Fed. Cir. 2013). That context includes the specification,
`which “is always highly relevant to the claim construction analysis. Usually, it
`is dispositive; it is the single best guide to the meaning of a disputed term.”
`Phillips, 415 F.3d at 1315 (quotation marks and citation omitted).
`
`The prosecution history also constitutes intrinsic evidence and “has an
`important role in claim construction by supplying context to the claim
`language.” Aventis, 715 F.3d at 1373. Because the prosecution history
`“represents an ongoing negotiation between the PTO and the applicant, rather
`than the final product of that negotiation,” it is often less helpful than the
`specification for purposes of claim construction. Phillips, 415 F.3d at 1317.
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`Nonetheless, the prosecution history may “provide[] evidence of how the PTO
`and the inventor understood the patent.” Id.
`
`Courts may also look to extrinsic evidence—“all evidence external to the
`patent and prosecution history, including expert and inventor testimony,
`dictionaries, and learned treatises.” Phillips, 415 F.3d at 1317 (quotation marks
`and citations omitted). Such evidence, however, may not be used “to contradict
`claim meaning that is unambiguous in light of the intrinsic evidence.” Id. at
`1324. “Ultimately, the construction that stays true to the claim language and
`most naturally aligns with the patent’s description of the invention will be, in
`the end, the correct construction.” Takeda Pharm. Co. Ltd. v. Zydus Pharm. USA,
`Inc., 743 F.3d 1359, 1363 (Fed. Cir. 2014) (quotation marks, citations, and
`alterations omitted).
`
`Although claim construction is a question of law, it often presents
`subsidiary factual issues where, as here, the court must consult extrinsic
`evidence to understand the underlying science or the meaning of a term of art.
`See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841 (2015).
`
`Claims of Patent Infringement
`
`C.
`Patent infringement “is an issue of fact, which the patentee must prove by
`a preponderance of the evidence.” Siemens Med. Solutions USA, Inc. v. Saint-
`Gobain Ceramics & Plastics, Inc., 637 F.3d 1269, 1279 (Fed. Cir. 2011). “In order
`to prove infringement, a patentee must show that every limitation of the claims
`asserted to be infringed is found in the accused device.” Glaxo, Inc. v.
`Novopharm, Ltd., 110 F.3d 1562, 1565 (Fed. Cir. 1997).
`
`The infringement inquiry involves two steps: (1) “the claim must be
`properly construed to determine its scope and meaning” and (2) “the claim as
`properly construed must be compared to the accused device or process.”
`Absolute Software, Inc. v. Stealth Signal, Inc., 659 F.3d 1121, 1129 (Fed. Cir. 2011)
`(quotation marks omitted). The Court’s Claim Construction Opinion and
`Order of May 27, 2014, as well as the Court’s resolution of other outstanding
`claim construction disputes infra, embody the first step.
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` “The second step in [this two-step] analysis is to apply the claims to the
`accused device.” Allen Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1345
`(Fed. Cir. 2002). Because the allegedly infringing product in a Hatch-Waxman
`Act case is not yet on the commercial market, the infringement inquiry focuses
`on what is likely to be sold following FDA approval. See Abbott Labs. v.
`TorPharm, Inc., 300 F.3d 1367, 1373 (Fed. Cir. 2002). The accused device
`infringes a claim “when each of the claim limitations ‘reads on,’ or in other
`words is found in, the accused device.” Id. A patentee may prove infringement
`by either direct or circumstantial evidence. Vita-Mix Corp. v. Basic Holding, Inc.,
`581 F.3d 1317, 1326 (Fed. Cir. 2009).
`
`The Affirmative Defense of Patent Invalidity
`
`D.
`A defendant “in any action involving . . . infringement of a patent” may
`plead as an affirmative defense that the asserted patent is invalid. 35 U.S.C.
`§ 282(b)(2)-(3); see also Microsoft Corp. v. i4i L.P., 131 S. Ct. 2238, 2242 (2011).
`Because “[a] patent shall be presumed valid,” “[t]he burden of establishing
`invalidity . . . rest[s] on the party asserting such invalidity.” 35 U.S.C. § 282(a).
`A defendant asserting patent invalidity must demonstrate invalidity by clear
`and convincing evidence. Microsoft Corp., 131 S. Ct. at 2242.
`
`Novelty and Anticipation
`
`1.
`An invention must be novel in order to receive a valid patent. 35 U.S.C.
`§ 102(a) (2006). “Invalidity based on lack of novelty (often called ‘anticipation’)
`requires that the same invention, including each element and limitation of the
`claims, was known or used by others before it was invented by the patentee.”
`Hoover Grp., Inc. v. Custom Metalcraft, Inc., 66 F.3d 299, 302 (Fed. Cir. 1995). A
`patent is therefore invalid due to anticipation when “a single prior art reference
`. . . expressly or inherently disclose[s] each claim limitation.” Finisar Corp. v.
`DirecTV Grp., Inc., 523 F.3d 1323, 1334 (Fed. Cir. 2008). The doctrine’s
`application is encapsulated in the old chestnut: “[t]hat which infringes, if later,
`would anticipate, if earlier.” Upsher-Smith Labs., Inc. v. Pamlab, LLC, 412 F.3d
`
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`1319, 1322 (Fed. Cir. 2005) (quoting Peters v. Active Mfg. Co., 129 U.S. 530, 537
`(1889) (internal quotation marks omitted)).
`
`The anticipating reference need not explicitly spell out each element of the
`anticipated patent claim, but rather can teach a claim limitation if the “teaching
`is inherent in the [] prior art reference.” Corning Glass Works v. Sumitomo Elec.
`USA, Inc., 868 F.2d 1251, 1262 (Fed. Cir. 1989). To show inherent anticipation,
`a defendant must demonstrate clearly and convincingly that a claim limitation
`not disclosed in the anticipating reference will always be present when the
`prior art is practiced as taught in that reference. Glaxo Inc. v. Novopharm Ltd., 52
`F.3d 1043, 1047-48 (Fed. Cir. 1995). “Inherent anticipation requires that the
`missing descriptive material is ‘necessarily present,’ not merely probably or
`possibly present” in the anticipating reference. Trintec Indus., Inc. v. Top-U.S.A.
`Corp., 295 F.3d 1292, 1295 (Fed. Cir. 2002).
`
`Anticipation and its subsidiary issues are questions of fact. Amkor Tech.,
`Inc. v. Int’l Trade Comm’n, 692 F.3d 1250, 1254 (Fed. Cir. 2012) (anticipation);
`Telemac Cellular Corp. v. Topp Telecom, Inc., 247 F.3d 1316, 1328 (Fed. Cir. 2001)
`(inherency).
`
`Obviousness and Nonobviousness
`
`2.
`A patent for an invention may not be obtained “if the differences between
`the subject matter sought to be patented and the prior art are such that the
`subject matter as a whole would have been obvious at the time the invention
`was made to a person having ordinary skill in the art to which said subject
`matter pertains.” 35 U.S.C. § 103(a) (2006). “The ultimate judgment of
`obviousness is a legal determination.” KSR Int’l Co. v. Teleflex Inc., 550 U.S.
`398, 427 (2007). That legal determination rests on “underlying factual
`inquiries including: (1) the scope and content of the prior art, (2) the
`differences between the claimed invention and the prior art, (3) the level of
`ordinary skill in the art, and (4) objective indicia of nonobviousness.” Pregis
`Corp. v. Kappos, 700 F.3d 1348, 1354 (Fed. Cir. 2012); see also Graham v. John
`Deere Co. of Kansas City, 383 U.S. 1, 17-18 (1966).
`
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`For purposes of obviousness, the hypothetical person of skill in the art is
`presumed to know all of the teachings of the prior art in the field of the
`invention at the time of the patent’s priority date. See, e.g., In re Rouffet, 149 F.3d
`1350, 1357 (Fed. Cir. 1998). Moreover, “[a] reference is reasonably pertinent if,
`even though it may be in a different field from that of the inventor’s endeavor,
`it is one which, because of the matter with which it deals, logically would have
`commended itself to an inventor’s attention in considering his problem.” In re
`ICON Health & Fitness, Inc., 496 F.3d 1374, 1379-80 (Fed. Cir. 2007) (quotation
`marks and citation omitted).
`
`“Generally, a party seeking to invalidate a patent as obvious must
`demonstrate by clear and convincing evidence that a skilled artisan would
`have been motivated to combine the teaching of the prior art references to
`achieve the claimed invention, and that the skilled artisan would have had a
`reasonable expectation of success in doing so.” OSRAM Sylvania, Inc. v. Am.
`Induction Techs., Inc., 701 F.3d 698, 706 (Fed. Cir. 2012) (quotation marks
`omitted). The court may “look to interrelated teachings of multiple patents; the
`effects of demands known to the design community or present in the
`marketplace; and the background knowledge possessed by a person having
`ordinary skill in the art, all in order to determine whether there was an
`apparent reason to combine the known elements in the fashion claimed by the
`patent at issue.” KSR, 550 U.S. at 418. The overall obviousness inquiry must
`remain “expansive and flexible,” and “a court can take account of the
`inferences and creative steps that a person of ordinary skill in the art would
`employ.” Id. at 415, 418.
`
`In assessing obv