458
`
`the ALJ’s summary is brief, such discus-
`sion along with the analysis of plaintiff’s
`daily activities and testimony, suffices to
`support the ALJ’s RFC determination.9
`The ALJ considered all the relevant evi-
`dence and adequately discussed the bases
`for her RFC determination in her findings
`and evaluation of the evidence. The court
`concludes that a careful review of the en-
`tire record provides substantial evidence,
`sufficient to support the ALJ’s finding that
`plaintiff could perform a limited range of
`light work and that jobs existed in signifi-
`cant numbers in the national economy that
`he could have performed, and that he was
`not disabled as of May 25, 2010.
`
`V. CONCLUSION
`For the reasons stated, plaintiff’s motion
`for summary judgment will be denied and
`defendant’s motion for summary judgment
`will be granted. An appropriate order
`shall issue.
`
`ORDER
`At Wilmington this 22nd day of October,
`2014, consistent with the memorandum
`opinion issued this same date;
`IT IS ORDERED that:
`1. Plaintiff’s motion for summary judg-
`ment (D.I. 13) is denied.
`2. Defendant’s motion for summary
`judgment (D.I. 15) is granted.
`3. The Clerk of Court is directed to
`enter judgment in favor of defendant and
`against plaintiff.
`
`,
`
`
`
`71 FEDERAL SUPPLEMENT, 3d SERIES
`
`PFIZER INC., Pharmacia & Upjohn
`Company, Pharmacia & Upjohn Com-
`pany LLC, Sugen, Inc., C.P., Pharma-
`ceuticals International C.V., Pfizer
`Pharmaceuticals LLC, and PF Prism
`C.V., Plaintiffs,
`
`v.
`
`MYLAN PHARMACEUTICALS
`INC., Defendant.
`
`C.A.No. 10–528–GMS
`
`United States District Court,
`D. Delaware.
`
`Signed October 22, 2014
`Background:
` Patentees brought action
`against competitor, alleging infringement
`of patents related to cancer treatment
`drugs that operated by blocking angiogen-
`esis. Following bench trial, parties moved
`and cross-moved for judgment on partial
`findings with respect to issue of validity.
`Holdings: The District Court, Gregory M.
`Sleet, J., held that:
`(1) asserted claims were not obvious based
`on prior patent application disclosing
`approximately 1,200 drug combina-
`tions;
`(2) potential ‘‘lead compounds’’ proposed
`by competitor would not have been
`selected by one skilled in art;
`(3) even if competitor had identified ap-
`propriate ‘‘lead compound,’’ it failed to
`establish that modifications to yield
`claimed compound were obvious; and
`(4) even if competitor had established pri-
`ma facie case of obviousness, second-
`
`9. To the extent plaintiff relies on the GAF
`score to require a finding of disablement,
`plaintiff’s therapist Jake Wayne is considered
`an ‘‘other source’’ and his report alone can
`not
`establish
`disability.
` 20
`C.F.R.
`§§ 404.1513(d)(1), 416.913(d)(1); SSR 06–
`
`03p (‘‘Information from these ‘‘other sources’’
`cannot establish the existence of a medically
`determinable impairment, [but] TTT may pro-
`vide insight into the severity of the impair-
`ment(s) and how it affects the individual’s
`ability to function’’).
`
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`

`PFIZER INC. v. MYLAN PHARMACEUTICALS INC.
`Cite as 71 F.Supp.3d 458 (D.Del. 2014)
`
`459
`
`ary considerations weighed against
`finding of obviousness.
`Patentees’ motion granted.
`
`1. Patents O681, 683, 701, 709(1), 800
`Obviousness of a patent claim is a
`question of law that is predicated on sever-
`al factual inquires; specifically, the trier of
`fact is directed to assess four consider-
`ations, including (1) the scope and content
`of the prior art, (2) the level of ordinary
`skill in the art, (3) the differences between
`the claimed subject matter and the prior
`art, and (4) secondary considerations of
`non-obviousness, such as commercial suc-
`cess, long felt but unsolved need, failure of
`others, acquiescence of others in the indus-
`try that the patent is valid, and unexpected
`results. 35 U.S.C.A. § 103(a).
`
`2. Patents O794
`Party seeking to challenge the validity
`of a patent based on obviousness must
`demonstrate by clear and convincing evi-
`dence that the invention described in the
`patent would have been obvious to a per-
`son of ordinary skill in the art at the time
`the
`invention was made.
` 35 U.S.C.A.
`§ 103(a).
`
`3. Patents O720
`When the validity of a patent is chal-
`lenged based on obviousness, the use of
`hindsight is not permitted in determining
`what would have been obvious to one of
`ordinary skill in the art. 35 U.S.C.A.
`§ 103(a).
`
`4. Patents O687
`Finding of a patent’s obviousness does
`not require absolute predictability of suc-
`cess, but rather requires a reasonable ex-
`pectation of success. 35 U.S.C.A. § 103(a).
`
`5. Patents O687
`Patent’s obviousness cannot be avoid-
`ed simply by a showing of some degree of
`unpredictability in the art, so long as there
`
`was a reasonable probability of success.
`35 U.S.C.A. § 103(a).
`
`6. Patents O768
`Asserted claims of patents related to
`cancer treatment drugs that operated by
`blocking angiogenesis, specifically with re-
`spect to synthesizing sunitinib malate,
`were not obvious on basis of prior patent
`application that disclosed approximately
`1,200 drug combinations; process of going
`from dimethyl sunitinib to sunitinib to sun-
`itinib malate would have required signifi-
`cant guesswork and variation of parame-
`ters to achieve end result, and application
`did not indicate that these steps would
`yield better angiogenesis inhibition, in ab-
`sence of data to support taking these steps
`and in light of sheer volume of possible
`combinations and additional subsequent
`chemical alterations necessary to arrive at
`claimed compound. 35 U.S.C.A. § 103(a).
`
`7. Patents O750
`To establish a prima facie case of pat-
`ent obviousness based on a ‘‘lead com-
`pound,’’ i.e., one known in the art that
`would have served as a logical starting
`points for further development efforts, the
`party asserting obviousness must first es-
`tablish that one skilled in the art would
`have selected a given ‘‘lead compound,’’
`and, if one skilled in the art would have
`chosen the ‘‘lead compound,’’ that party
`must then prove that the modification of
`the
`‘‘lead compound’’ to arrive at the
`claimed compound would have been obvi-
`ous to one skilled in the art. 35 U.S.C.A.
`§ 103(a).
`See publication Words and Phrases
`for other judicial constructions and
`definitions.
`
`8. Patents O750
`To avoid the possibility of hindsight
`bias on a claim of patent obviousness
`based on a
`‘‘lead compound,’’ i.e., one
`known in the art that would have served as
`
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`

`460
`
`71 FEDERAL SUPPLEMENT, 3d SERIES
`
`a logical starting points for further devel-
`opment efforts, the party asserting obvi-
`ousness must point to more than mere
`structural similarity as a reason to select a
`compound as a lead. 35 U.S.C.A. § 103(a).
`See publication Words and Phrases
`for other judicial constructions and
`definitions.
`
`9. Patents O768
`Potential ‘‘lead compound’’ proposed
`by competitor would not have been select-
`ed as such for further development by one
`skilled in art, precluding any finding of
`obviousness based on this compound with
`respect to patentees’ asserted patents re-
`lated to cancer treatment drugs that oper-
`ated by blocking angiogenesis; compound
`was among its developer’s second-genera-
`tion compounds, and, although it repre-
`sented breakthrough in anti-angiogenesis
`cancer treatment when it was first dis-
`closed, as of subject patents’ priority
`dates, one skilled in art would have ac-
`knowledged its shortcomings and looked to
`more recent advances in field, which even
`in developer’s publications had taught
`away
`from
`compound.
` 35 U.S.C.A.
`§ 103(a).
`
`10. Patents O768
`Potential ‘‘lead compound’’ proposed
`by competitor would not have been select-
`ed as such for further development by one
`skilled in art, and instead appeared to have
`resulted largely from hindsight, precluding
`any finding of obviousness based on this
`compound with respect to patentees’ as-
`serted patents related to cancer treatment
`drugs that operated by blocking angiogen-
`esis; compound was among its developer’s
`first-generation compounds, and, although
`it demonstrated strong potency against
`vascular endothelial growth factor in vitro,
`there was no in vivo data available, and
`this compound, in fact, never made it be-
`yond developer’s laboratory. 35 U.S.C.A.
`§ 103(a).
`
`11. Patents O768
`Potential ‘‘lead compound’’ proposed
`by competitor, which compound was hypo-
`thetical compound listed as one of approxi-
`mately 1,200 possible combinations in prior
`patent application, would not have been
`selected as such for further development
`by one skilled in art, and instead appeared
`to have resulted largely from hindsight,
`precluding any
`finding of obviousness
`based on this compound with respect to
`patentees’ asserted patents related to can-
`cer treatment drugs that operated by
`blocking angiogenesis; compound was giv-
`en no name nor chemical structure in that
`application, had never actually been syn-
`thesized, and had no data demonstrating
`its properties, and application’s list of com-
`pound’s components offered no suggestion
`that it would yield promising results as
`lead. 35 U.S.C.A. § 103(a).
`
`12. Patents O799
`Even if competitor had identified ap-
`propriate lead compound in dimethyl suni-
`tinib, it failed to establish by clear and
`convincing evidence that modifying this
`compound to yield patented drug, sunitinib
`malate, would have been obvious to one
`skilled in art or that one skilled in art
`would have had reasonable expectation of
`success, precluding any finding of obvious-
`ness based on this compound with respect
`to patentees’ asserted patents related to
`cancer treatment drugs that operated by
`blocking angiogenesis; even though di-
`methyl sunitinib would have involved sin-
`gle modification to arrive at patented drug,
`several other structural changes would
`have been appealing next steps, rather
`than
`this modification.
` 35 U.S.C.A.
`§ 103(a).
`
`13. Patents O799
`Even if competitor had identified ap-
`propriate lead compounds in two com-
`pounds created by developer, it failed to
`
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`PFIZER INC. v. MYLAN PHARMACEUTICALS INC.
`Cite as 71 F.Supp.3d 458 (D.Del. 2014)
`
`461
`
`establish by clear and convincing evidence
`that modifying compounds to yield patent-
`ed drug, sunitinib malate, would have been
`obvious to one skilled in art or that one
`skilled in art would have had reasonable
`expectation of success, precluding any
`finding of obviousness based on this com-
`pound with respect to patentees’ asserted
`patents related to cancer treatment drugs
`that operated by blocking angiogenesis;
`modifying from developer’s second-genera-
`tion compound to first-generation com-
`pound, even if that proposed modification
`did not result in compound that was al-
`ready tested and essentially ignored by
`developer, would have been contrary to
`developer’s teachings, and other proposed
`modifications to that first-generation com-
`pound were unsupported by available data
`or were contrary to art. 35 U.S.C.A.
`§ 103(a).
`
`14. Patents O799
`Even if competitor had identified ap-
`propriate
`lead compounds
`in dimethyl
`sunitinib or two compounds created by
`developer, it failed to establish by clear
`and convincing evidence that modifying
`this compound by creating malate salt
`form of sunitinib to yield patented drug,
`sunitinib malate, would have been obvious
`to one skilled in art or that one skilled in
`art would have had reasonable expectation
`of success, precluding any finding of obvi-
`ousness based on these compounds with
`respect to patentees’ asserted patents re-
`lated to cancer treatment drugs that oper-
`ated by blocking angiogenesis; competitor
`offered no explanation as to why one
`skilled in art would have found malate to
`be obvious choice if motivated to try suni-
`tinib salt, as there was nothing in prior
`art to suggest that malate was one of
`limited subset of salts to choose, or even
`that salt form of sunitinib would be bene-
`ficial, and malate did not appear on most
`current Food and Drug Administration
`
`(FDA) list of approved salt forms. 35
`U.S.C.A. § 103(a).
`15. Patents O708
`Patented compounds, including suni-
`tinib, possessed unexpected properties,
`thus weighing in favor of non-obviousness
`finding with respect to patents related to
`cancer treatment drugs that operated by
`blocking angiogenesis; activity of sunitinib,
`when compared with previous clinical can-
`didates, was much more potent against
`target receptor tyrosine kinases (RTKs) in
`vitro, even though it was synthesized with
`entirely different goals
`in mind, and
`claimed malate salt form of sunitinib
`solved several manufacturing problems
`that posed major barrier to bringing suni-
`tinib to market and had superior proper-
`ties when compared to other salts, though
`this form was not among initial screen of
`salts and was chosen ‘‘just for kicks.’’ 35
`U.S.C.A. § 103(a).
`16. Patents O704
`Patented compound, sunitinib malate,
`satisfied long-felt need in market for treat-
`ments for renal cell carcinoma and pan-
`creatic
`neuroendocrine
`tumors,
`thus
`weighing in favor of non-obviousness find-
`ing with respect to patents related to can-
`cer treatment drugs that operated by
`blocking angiogenesis;
`this need was
`caused largely by frequent failures of oth-
`ers to develop effective treatment for these
`cancers, despite efforts to address question
`of anti-angiogenesis, and evidence demon-
`strated that sunitinib malate provided
`greatly
`improved clinical outcomes for
`treating
`these cancers.
` 35 U.S.C.A.
`§ 103(a).
`17. Patents O768
`Patented compound, sunitinib malate,
`was commercial success, thus weighing in
`favor of non-obviousness finding with re-
`spect to patents related to cancer treat-
`ment drugs that operated by blocking an-
`giogenesis; drug remained dominant drug
`
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`462
`
`71 FEDERAL SUPPLEMENT, 3d SERIES
`
`for treating renal cell carcinoma, maintain-
`ing nearly 50% of market six years after
`its launch and with almost twice as much
`market share as its nearest competitor,
`drug was patentees’ largest revenue gen-
`erator among its oncology drugs, revenues
`had exceeded expenses each year drug had
`been on market, and, although drugs in
`industry, on average, tended to take 15 or
`16 years to break even and recoup invest-
`ment, drug was on pace to break even
`within 10 years. 35 U.S.C.A. § 103(a).
`18. Patents O705, 707
`Evidence of both initial skepticism
`and subsequent acceptance of patented
`compound, sunitinib malate, weighed in
`favor of non-obviousness finding with re-
`spect to patents related to cancer treat-
`ment drugs that operated by blocking an-
`giogenesis; several prior failed attempts
`at creating effective anti-angiogenesis
`drug created general sense of skepticism
`as to whether concept could work in prac-
`tice, and patentees’ drug constituted
`breakthrough in industry, widely praised
`by researchers and doctors. 35 U.S.C.A.
`§ 103(a).
`Patents O2091
`6,573,293, 7,125,905. Valid.
`
`Jack B. Blumenfeld, Maryellen Noreika,
`Morris, Nichols, Arsht & Tunnell, Wil-
`mington, DE, Stanley E. Fisher, Pro Hac
`Vice, Thomas H.L. Selby, Pro Hac Vice,
`for Plaintiffs.
`Joshua A. Mack, Pro Hac Vice, Kath-
`erine Hasper, Pro Hac Vice, Katherine
`Van Gunst, Pro Hac Vice, Kirin K. Gill,
`Pro Hac Vice, Robert A. Delafield, II, Pro
`
`1. Prior to trial, the parties submitted an ex-
`hibit of uncontested facts in conjunction with
`their Pretrial Order. (D.I.138, Ex. 1.) The
`court takes most of its findings of fact from
`the parties’ uncontested facts. The court has
`
`Hac Vice, Tung–On Kong, Pro Hac Vice,
`for Defendant.
`
`MEMORANDUM
`GREGORY M. SLEET, UNITED
`STATES DISTRICT JUDGE
`I. INTRODUCTION
`In this patent infringement action, plain-
`tiffs Pfizer Inc., Pharmacia & Upjohn
`Company, Pharmacia & Upjohn Company
`LLC, Sugen, Inc., C.P. Pharmaceuticals
`International C.V., Pfizer Pharmaceuticals
`LLC, and PF Prism C.V. (collectively,
`‘‘Pfizer’’) allege that pharmaceutical prod-
`ucts proposed by defendant Mylan Phar-
`maceuticals Inc. (‘‘Mylan’’) infringe the as-
`serted
`claims of
`the patents-in-suit.
`(D.I.1.) The court held a four-day bench
`trial
`in this matter on November 26
`through November 29, 2012. (D.I.148–
`151.) Presently before the court are the
`parties’ post-trial proposed findings of fact
`and conclusions of law concerning the va-
`lidity of the patents-in-suit, specifically
`whether the asserted claims are invalid as
`obvious under 35 U.S.C. § 103. (D.I.152,
`153.)
`Pursuant to Federal Rule of Civil Proce-
`dure 52(a), and after having considered the
`entire record in this case and the applica-
`ble law, the court concludes that: (1) all
`asserted claims of the patents-in-suit are
`not invalid due to obviousness; and (2)
`Pfizer’s Rule 52(c) motion is granted, and
`Mylan’s Rule 52(c) motion
`is denied.
`These findings of fact and conclusions of
`law are set forth in further detail below.
`
`II. FINDINGS OF FACT 1
`A. The Parties
`1. Plaintiff Pfizer Inc. is a corporation
`organized and existing under the
`
`also reordered and renumbered some para-
`graphs, corrected some formatting errors,
`and made minor edits for the purpose of
`concision and clarity that it does not believe
`
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`PFIZER INC. v. MYLAN PHARMACEUTICALS INC.
`Cite as 71 F.Supp.3d 458 (D.Del. 2014)
`
`463
`
`laws of Delaware and has a place of
`business at 235 East 42nd Street,
`New York, New York 10017.
`2. Plaintiff Pharmacia & Upjohn Com-
`pany was a Delaware corporation
`that was converted into a Delaware
`limited
`liability
`company
`and
`changed its name to Pharmacia &
`Upjohn Company LLC on August
`14, 2004.
` Pharmacia & Upjohn
`Company LLC has offices located at
`7000 Portage Road, Kalamazoo,
`Michigan 49001.
`3. Plaintiff Sugen, Inc. (‘‘Sugen’’) is a
`corporation organized under
`the
`laws of Delaware and has a place of
`business at 235 East 42nd Street,
`New York, New York 10017.
`4. Plaintiff C.P. Pharmaceuticals Inter-
`national C.V. (‘‘CPPI CV’’) is a limit-
`ed partnership (commanditaire ven-
`nootschap ) organized under
`the
`laws of the Netherlands, having its
`registered seat in Rotterdam, the
`Netherlands, and registered at the
`trade register held by the Chamber
`of Commerce in Rotterdam, under
`number 24280998. CPPI CV is a
`wholly owned subsidiary of Pfizer
`Inc. and has a place of business at
`235 East 42nd Street, New York,
`New York 10017.
`(‘‘PF
`5. Plaintiff PF PRISM C.V.
`PRISM CV’’) is a limited partner-
`ship (commanditaire vennootschap )
`organized under the laws of the
`Netherlands, and registered at the
`trade register held by the Chamber
`of Commerce
`in Rotterdam, the
`Netherlands,
`under
`number
`51840456.
`
`alters the meaning of the paragraphs from the
`Pretrial Order. Otherwise, any differences
`between this section and the parties’ state-
`ment of uncontested facts are unintentional.
`The court’s findings of fact with respect to
`matters that were the subject of dispute be-
`
`6. Plaintiff Pfizer Pharmaceuticals
`LLC is a limited liability company
`organized under the laws of Dela-
`ware and has a place of business at
`Km 1.9, Road 689, Vega Baja, Puer-
`to Rico 00693. Pfizer Pharmaceuti-
`cals LLC is a wholly-owned subsid-
`iary of PF PRISM CV.
`7. The plaintiffs will collectively be re-
`ferred to as ‘‘Pfizer.’’
`8. Defendant Mylan Pharmaceuticals
`Inc. (‘‘Mylan’’) is a corporation orga-
`nized and existing under the laws of
`West Virginia, and has a place of
`business located at 781 Chestnut
`Ridge Road, Morgantown, WV
`26505.
`9. The court has subject matter juris-
`diction, as well as personal jurisdic-
`tion over all parties.
`
`B. Background
`1. The idea of treating cancer by block-
`ing angiogenesis, i.e., the formation
`of blood vessels, was first suggested
`in 1971. The concept, however, was
`still unproven in October 2000, and
`the FDA had not approved any drug
`for this purpose.
`2. Of the many possible approaches to
`reduce angiogenesis, one branch of
`Sugen’s research focused on using
`small molecules to inhibit receptor
`tyrosine kinases (‘‘RTKs’’) on the
`cell surface. Various RTKs bind to
`external growth factors that pro-
`mote
`angiogenesis
`and
`tumor
`growth, such as VEGF (vascular en-
`dothelial growth factor), PDGF (pla-
`
`tween the parties are included in Part III this
`opinion (‘‘Discussion and Conclusions of
`Law’’), preceded by the phrase ‘‘the court
`finds’’ or ‘‘the court concludes.’’
`
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`464
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`71 FEDERAL SUPPLEMENT, 3d SERIES
`
`telet derived growth factor), and
`FGF (fibroblast growth factor).
`3. Sugen’s first compound to reach
`clinical studies was SU5416. It was
`the first small molecule shown to be
`effective in treating tumors by inhib-
`iting angiogenesis. SU5416 was not
`orally bioavailable, meaning it could
`not be administered to a patient
`orally, and patients required fre-
`quent injections. SU5416 went all
`
`the way through FDA Phase III
`clinical trial but was never approved
`for market.
`
`4. Sugen synthesized SU11248—what
`came to known as sunitinib—as part
`of a research project aimed at at-
`tacking tumors directly, rather than
`through angiogenesis inhibition.
`
`5. Sunitinib has the following chemical
`structure:
`
`C. The Patents–in–Suit
`1. U.S. Patent Number 6,573,293 (‘‘the
`8293 patent’’)—‘‘Pyrrole Substituted
`2–Indolinone Protein Kinase Inhibi-
`tors’’—issued on June 3, 2003, to
`Sugen and Pharmacia & Upjohn
`Company, as assignees. Sugen is
`the current owner of the 8293 patent.
`2. U.S. Application Number 09/783,264
`(‘‘the 8264 application’’), which issued
`as the 8293 patent, was filed on Feb-
`ruary 15, 2001 with the United
`States Patent and Trademark Office
`(‘‘the PTO’’).
`3. The expiration date of the 8293 pat-
`ent is February 15, 2021.
`4. The 8293 patent lists ten inventors on
`its face: Peng Cho Tang, Todd A.
`Miller, Xiaoyuan Li, Li Sun, Chung
`Chen Wei, Shahrzad Shirazian,
`
`Congxin Liang, Tomas Vojkovsky,
`Asaad S. Nematalla, and Michael
`Hawley.
`
`5. The 8293 patent claims priority back
`to provisional applications filed on
`February 15, 2000, July 6, 2000, and
`October 27, 2000, as Provisional Ap-
`plication Numbers
`60/182,710,
`60/216,422, and 60/243,532, respec-
`tively.
`
`6. Pfizer is asserting infringement of
`claims 5 and 21 of the 8293 patent
`against Mylan. For purposes of this
`action, the priority date for asserted
`claims 5 and 21 is October 27, 2000.
`
`7. U.S. Patent Number 7,125,905 (‘‘the
`8905 patent’’)—‘‘Pyrrole Substituted
`2–Indolinone Protein Kinase Inhibi-
`tors’’—issued on October 24, 2006.
`
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`PFIZER INC. v. MYLAN PHARMACEUTICALS INC.
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`
`465
`
`Sugen is the current owner of the
`8905 patent.
`
`8. U.S. Application Number 11/028,477
`(‘‘the 8477 application’’), which issued
`as the 8905 patent, was filed on Janu-
`ary 4, 2005 with the PTO. The 8477
`application is a continuation of Ap-
`plication Number 10/412,690, filed
`with the PTO on April 14, 2003, now
`abandoned, which is a division of the
`8264 application.
`
`9. The expiration date of the 8905 pat-
`ent is February 15, 2021.
`
`10. The 8905 patent lists ten inventors
`on its face: Peng Cho Tang, Todd
`A. Miller, Xiaoyuan Li, Li Sun,
`Chung Chen Wei, Shahrzad Shira-
`zian, Congxin Liang, Tomas Vo-
`jkovsky, Asaad S. Nematalla, and
`Michael Hawley.
`
`11. The 8905 patent also claims priority
`back
`to provisional applications
`filed on February 15, 2000, July 6,
`2000, and October 27, 2000, as Pro-
`visional
`Application Numbers
`60/182,710, 60/216,422, and 60/243,-
`532, respectively.
`
`12. Pfizer is asserting infringement of
`claims 1 and 2 of the 8905 patent
`against Mylan. For purposes of
`this action, the priority date for
`asserted claims 1 and 2 is October
`27, 2000.
`
`1. The Asserted Claims
`
`8293 Patent, Claim 5
`a.
`1. Claim 5 of the 8293 Patent reads:
`The compound or salt of claim 1,
`wherein the compound is selected
`from the group consisting of:
`
`or an L-malate salt thereof.
`8293 Patent, Claim 21
`b.
`2. Claim 21 of the 8293 Patent reads: A
`pharmaceutical composition, com-
`prising a compound or salt of claim 5
`and, a pharmaceutically acceptable
`carrier or excipient.
`
`c.
`
`8905 Patent, Claim 1
`
`3. Claim 1 of the 8905 Patent reads: A
`compound that is the L-malate salt
`of 5–(5–fluoro–2–oxo–1,2–dihydroin-
`dol–3–ylidenemethyl)–2,4–dimethyl–
`1H–pyrrole–3–carboxylic acid
`(2–
`diethylaminoethyl)amide.
`
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`71 FEDERAL SUPPLEMENT, 3d SERIES
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`8905 Patent, Claim 2
`d.
`4. Claim 2 of the 8905 Patent reads: A
`pharmaceutical composition compris-
`ing the compound of claim 1 and a
`pharmaceutically acceptable carrier
`or excipient.
`
`D. Sutentb and Mylan’s ANDA
`1. The 8293 and 8905 patents cover,
`inter alia, the compound sunitinib
`malate. Pfizer sells pharmaceutical
`capsules containing sunitinib malate
`under the trade name Sutentb,
`pursuant to a New Drug Applica-
`tion that has been approved by the
`United States Food and Drug Ad-
`ministration (‘‘FDA’’). Sutentb is
`indicated for the treatment of ‘‘ad-
`vanced renal cell carcinoma,’’ ‘‘gas-
`trointestinal stromal tumor after
`disease progression on or intoler-
`ance to
`imatinib mesylate,’’ and
`‘‘progressive,
`well-differentiated
`pancreatic neuroendocrine tumors
`in patients with unresectable locally
`advanced or metastatic disease.’’
`The FDA has approved Sutentb in
`12.5 mg, 25 mg, 37.5 mg, and 50 mg
`dosage strengths.
`2. Mylan has submitted to the FDA
`Abbreviated New Drug Application
`(‘‘ANDA’’) No. 201–275, seeking ap-
`proval to sell generic versions of
`drug products containing sunitinib
`malate in 12.5 mg, 25 mg, 37.5, and
`50 mg dosage strengths (‘‘Mylan’s
`ANDA Products’’). ANDA No. 201–
`275 contains certifications pursuant
`to 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
`with respect to the 8293 and 8905
`patents asserting that the 8293 and
`8905 patents are invalid, unenforcea-
`ble, and/or will not be infringed by
`the manufacture, use, offer for sale,
`or sale of Mylan’s ANDA products.
`
`3. Mylan has since stipulated that the
`manufacture, use, sale, offer for sale,
`or importation of Mylan’s ANDA
`Products, as well as the active ingre-
`dient contained therein,
`infringes
`claims 5 and 21 of the 8293 Patent,
`and claims 1 and 2 of the 8905 Pat-
`ent.2
`
`III. DISCUSSION AND CONCLU-
`SIONS OF LAW
`The court has subject matter jurisdic-
`tion over this matter pursuant to 28 U.S.C.
`§§ 1331, 1338, and 2201. Venue is proper
`in this court under 28 U.S.C. §§ 1391 and
`1400(b).
` The only
`issue remaining
`is
`whether the asserted claims of the pat-
`ents-in-suit are invalid due to obviousness.
`After having considered the entire record
`in this case, the substantial evidence in the
`record, the parties’ post-trial submissions,
`and the applicable law, the court concludes
`that: (1) none of asserted claims of the
`patents-in-suit are invalid due to obvious-
`ness; and (2) Pfizer’s Rule 52(c) motion is
`granted, and Mylan’s Rule 52(c) motion is
`denied. The court’s reasoning follows.
`
`A. Obviousness
`The defendants challenge the validity of
`each of the asserted claims, arguing that
`they are obvious in light of the prior art.
`The court finds, for the reasons that fol-
`low, that the defendants have failed to
`establish by clear and convincing evidence
`that the patents-in-suit are obvious.
`1. The Legal Standard
`[1] 35 U.S.C. § 103(a) provides that a
`patent may not be obtained ‘‘if the differ-
`ences 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 to a person having ordi-
`nary skill in the art.’’ 35 U.S.C. § 103(a).
`
`2.
`
`(D.I.106, 107.)
`
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`PFIZER INC. v. MYLAN PHARMACEUTICALS INC.
`Cite as 71 F.Supp.3d 458 (D.Del. 2014)
`
`467
`
`Obviousness is a question of law that is
`predicated on several factual inquires. See
`Richardson–Vicks v. Upjohn Co., 122 F.3d
`1476, 1479 (Fed.Cir.1997).
` Specifically,
`the trier of fact is directed to assess four
`considerations: (1) the scope and content
`of the prior art; (2) the level of ordinary
`skill in the art; (3) the differences between
`the claimed subject matter and the prior
`art; and (4) secondary considerations of
`non-obviousness, such as commercial suc-
`cess, long felt but unsolved need, failure of
`others, acquiescence of others in the indus-
`try that the patent is valid, and unexpected
`results. See Graham v. John Deere Co.,
`383 U.S. 1, 17–18, 86 S.Ct. 684, 15 L.Ed.2d
`545 (1966).
`
`[2, 3]
`‘‘A patent shall be presumed val-
`id.’’ 35 U.S.C. § 282. A party seeking to
`challenge the validity of a patent based on
`obviousness must demonstrate by ‘‘clear
`and convincing evidence’’ 3 that the inven-
`tion described in the patent would have
`been obvious to a person of ordinary skill
`in the art at the time the invention was
`made. Importantly, in determining what
`would have been obvious to one of ordi-
`nary skill in the art, the use of hindsight is
`not permitted. See KSR Intern. Co. v.
`Teleflex, Inc., 550 U.S. 398, 421, 127 S.Ct.
`1727, 167 L.Ed.2d 705 (2007) (cautioning
`the trier of fact against ‘‘the distortion
`caused by hindsight bias’’ and ‘‘arguments
`reliant upon ex post reasoning’’ in deter-
`mining obviousness). In KSR, the Supreme
`Court rejected the rigid application of the
`principle that there should be an explicit
`‘‘teaching, suggestion, or motivation’’ in
`the prior art, the nature of the problem, or
`the knowledge of a person having ordinary
`skill in the art, in order to find obvious-
`
`3.
`‘‘Clear and convincing evidence is evidence
`that places in the fact finder ‘an abiding con-
`viction that the truth of [the] factual conten-
`tions are ‘highly probable.’ ’’ Alza Corp. v.
`Andrx Pharms., LLC, 607 F.Supp.2d 614, 631
`(D.Del.2009) (quoting Colorado v. New Mexi-
`
`ness. See KSR, 550 U.S. at 415, 127 S.Ct.
` The KSR Court acknowledged,
`1727.
`however, the importance of identifying ‘‘ ‘a
`reason that would have prompted a person
`of ordinary skill in the relevant field to
`combine the elements
`in the way the
`claimed new invention does’ in an obvious-
`ness determination.’’ Takeda Chem. In-
`dus. v. Alphapharm Pty. Ltd., 492 F.3d
`1350, 1356–57
`(Fed.Cir.2007)
`(quoting
`KSR, 550 U.S. at 418, 127 S.Ct. 1727).
`[4, 5]
`‘‘Obviousness does not require
`absolute predictability of success,’’ but
`rather, requires ‘‘a reasonable expectation
`of success.’’ See Medichem, S.A. v. Rola-
`bo, S.L., 437 F.3d 1157, 1165 (Fed.Cir.
`2006) (quoting In re O’Farrell, 853 F.2d
`894, 903–04 (Fed.Cir.1988)). To this end,
`obviousness ‘‘cannot be avoided simply by
`a showing of some degree of unpredictabil-
`ity in the art so long as there was a
`reasonable probability of success.’’ Pfizer,
`Inc. v. Apotex, Inc., 480 F.3d 1348, 1364
`(Fed.Cir.2007). Moreover, while the Fed-
`eral Circuit has noted that pharmaceuti-
`cals can be an ‘‘unpredictable art’’ to the
`extent that results may be unexpected, it
`also recognizes that, per KSR, evidence of
`a ‘‘finite number of identified, predictable
`solutions’’ or alternatives ‘‘might support
`an inference of obviousness.’’ See Eisai
`Co. Ltd. v. Dr. Reddy’s Labs. Ltd., 533
`F.3d 1353, 1359 (Fed.Cir.2008).
`
`2. The Level of Ordinary
`Skill in the Art
`A person of ordinary skill in the art with
`respect to the patents-in-suit would have:
`(1) the skills of a Ph.D.-educated medicinal
`chemist, with knowledge and experience
`regarding kinase targets and chemical
`scaffolds as they relate to anti-angiogenes-
`is drugs; 4 or (2) the skills of a Ph.D. or
`
`co, 467 U.S. 310, 316, 104 S.Ct. 2433, 81
`L.Ed.2d 247 (1984)).
`
`4. Pfizer’s identification of a person of ordi-
`nary skill in the art is derived from Drs.
`Lydon and Denny. (D.I. 153 at 3 (citing Tr.
`
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`M.D. with experience in the fields of ki-
`nase
`inhibitor compounds and cancer
`treatment, with one to five years of post-
`doctoral experience in drug development.5
`The court concludes that the parties’ defi-
`nitions of a person of ordinary skill in the
`art do not differ in a meaningful way.
`3. The Scope and Content of the Prior
`Art and Differences Between the
`Claimed Subject Matter and the
`Prior Art
`Although there are four asserted claims
`in the patents-in-suit, the controlling ques-
`tion for each of the claims is whether
`synthesizing sunitinib malate would have
`been obvious to one skilled in the art as of
`the priority date. Mylan argues that the
`asserted claims are obvious for two rea-
`sons: (1) a nearly identical analog of suni-
`tinib was disclosed in Patent Application
`WO 99/61422 (‘‘the 8422 application’’); and
`(2) the lead compounds available as of the
`priority date would have motivated one
`skilled in the art to derive the claimed
`sunitinib malate.
` The court addresses
`each of these arguments in turn.
`a. The 8422 Applica