Case 1:14-cv-02758-PAC Document 141 Filed 02/22/17 Page 1 of 76
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
`
`Kowa Company, Ltd., et al.,
`
`Plaintiffs,
`
`v.
`
`Amneal Pharmaceuticals, LLC,
`
`Defendant.
`
`Kowa Company, Ltd., et al.,
`
`Plaintiffs,
`
`v.
`
`Apotex, Inc., et al.,
`
`Defendants.
`
`Civil Action No. 14-CV-2758 (PAC)
`
`Civil Action No. 14-CV-7934 (PAC)
`
`PLAINTIFFS’ POST-TRIAL MEMORANDUM
`
`1
`
`

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`Case 1:14-cv-02758-PAC Document 141 Filed 02/22/17 Page 2 of 76
`
`Table of Contents
`UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK........... 1
`I.
`THE ‘336 PATENT ................................................................................................................ 4
`Introduction......................................................................................................................... 4
`A.
`B. Amneal Has No “Legal” Basis for Obviousness-Type Double Patenting. ........................ 6
`C. Amneal Has No “Factual” Case for Obviousness-Type Double Patenting. ..................... 10
`D. Secondary Considerations................................................................................................. 13
`E. Conclusion ........................................................................................................................ 13
`II. THE ‘993 PATENT .............................................................................................................. 14
`A.
`Introduction to Crystallinity and Powder X-ray Diffraction (PXRD) .............................. 14
`B. The Claims of the ‘993 Patent are Infringed..................................................................... 16
`1.
`Applicable Legal Principles ..................................................................................... 16
`2.
`Level of ordinary skill in the art.............................................................................. 18
`C. Defendants Infringe the ‘993 Patent ................................................................................. 23
`1.
`Amneal stipulated that its ANDA Products contain Form A Pitavastatin
`Calcium, and infringe claims 1, 22-25 of the ‘993 patent................................................ 23
`2.
`The Apotex ANDA Products contain Form A Pitavastatin Calcium
`Manufactured by MSN Laboratories, Ltd., and Thus Infringe Claims 1, 22, and 23-25
`of the ‘993 patent................................................................................................................. 23
`III.
`THE CLAIMS OF THE ‘993 PATENT ARE VALID..................................................... 34
`A. Defendants Have the Burden of Proving Invalidity by Clear and Convincing Evidence. 34
`B. Law of Express and Inherent Anticipation ....................................................................... 34
`C. Law of Obviousness.......................................................................................................... 35
`IV.
`the ‘993 Patent .................................................................................................................. 36
`A. The ‘993 Patent and Prosecution History ......................................................................... 36
`B. The Prior Art Relied Upon by Amneal and Apotex Was Before the U.S.P.T.O and
`Considered by the Examiner..................................................................................................... 37
`C. Prior Art References and Documents Listed on the Face of a Patent Are Presumed
`to Have Been Considered by a Competent Examiner Having Expertise in the Relevant
`Field.......................................................................................................................................... 40
`V. Background of the Technology - Polymorph Crystal Formation ......................................... 41
`VI.
`ARGUMENT................................................................................................................... 43
`A. EP ‘406 Does Not Anticipate Claims 1 or 22-25 of the ‘993 Patent ................................ 43
`B. A POSA Following Example 3 of EP ‘406 Could Produce a Variety of Polymorphic
`Forms ........................................................................................................................................ 43
`1.
`The December 14, 2006 Third Party Observation Submitted in the EP ‘232
`Prosecution Does Not Show Example 3 of EP '406 Inherently Produces Form A of
`
`2
`
`

`

`Case 1:14-cv-02758-PAC Document 141 Filed 02/22/17 Page 3 of 76
`
`Claims 1 and 22-25.............................................................................................................. 47
`2.
`Claims 1 and 22-25 of the '993 Patent Would Not Have Been Obvious .............. 52
`VII. EVIDENCE OF NON-OBVIOUSNESS ....................................................................... 60
`A. Commercial Success ......................................................................................................... 61
`B. Unexpected Results........................................................................................................... 62
`C. Long-Felt Need ................................................................................................................. 64
`D. Failure of Others ............................................................................................................... 64
`E.
`Praise of others.................................................................................................................. 65
`F.
`Industry skepticism ........................................................................................................... 65
`G. Copying............................................................................................................................. 65
`H. Acquiescense..................................................................................................................... 65
`VI.
`CONCLUSION................................................................................................................. 66
`
`3
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`

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`Case 1:14-cv-02758-PAC Document 141 Filed 02/22/17 Page 4 of 76
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`
`Abbott Biotech. Ltd. v. Centocor Ortho Biotech............................................................................43
`
`Abbvie Inc. v. Mathilda & Terence Kennedy Inst.,
`956 F. Supp. 2d 429 (S.D.N.Y. 2013)..............................................................................7, 8, 13
`
`Acumed LLC v. Stryker Corp.,
`483 F.3d 800 (Fed. Cir. 2007)..................................................................................................17
`
`Advanced Cardiovascular Sys., Inc. v. Scimed Life Sys., Inc.,
`261 F.3d 1329 (Fed. Cir. 2001)................................................................................................17
`
`Advanced Display Sys., Inc. v. Kent State Univ.,
`212 F.3d 1272 (Fed. Cir. 2000)................................................................................................36
`
`Allergan, Inc. v. Alcon Labs., Inc.,
`324 F. 3d 1322 (Fed. Cir. 2003)...............................................................................................17
`
`Amgen, Inc. v. F. Hoffmann-La Roche, Ltd.,
`580 F.3d 1340 (Fed. Cir. 2009)................................................................................................13
`
`Astrazeneca AB v. Reddy’s Labs.,
`Civil Action No. 11-2317 (JAP), 2013 U.S. Dist. LEXIS 62149 (D.N.J. Apr.
`30, 2013) ..................................................................................................................................33
`
`AstraZeneca v. Andrx,
`2017 U.S. Dist. LEXIS 3990 .......................................................................................31, 32, 33
`
`Bausch & Lomb, Inc., 79 F. Supp. 2d at 255 (W.D.N.Y. 2000)....................................................41
`
`Becton, Dickinson & Co. v. Tyco Healthcare Grp., LP,
`616 F.3d 1249 (Fed. Cir. 2010)................................................................................................17
`
`Bristol-Myers Squibb Co. v. Apotex, Inc.,
`No. 10-5810 (MLC), 2013 U.S. Dist. LEXIS 44481 (D.N.J. Mar. 28, 2013) ...................26, 34
`
`Cadence Pharms., Inc. v. Exela PharmSci Inc.,
`780 F.3d 1364 (Fed. Cir. 2015)................................................................................................18
`
`Cephalon, Inc. v. Watson Labs., Inc.,
`939 F. Supp. 2d 456 (D. Del. 2013)................................................................................. passim
`
`Cephalon, Inc. v. Watson Pharms., Inc.,
`769 F. Supp. 2d 761 (D. Del. 2011).........................................................................................17
`
`4
`
`

`

`Case 1:14-cv-02758-PAC Document 141 Filed 02/22/17 Page 5 of 76
`
`Cont’l Can Co. USA, Inc. v. Monsanto Co.,
`948 F.2d 1264 (Fed. Cir. 1991)................................................................................................36
`
`Creative Compounds, LLC v. Starmark Labs.,
`651 F.3d 1303 (Fed. Cir. 2011)................................................................................................17
`
`Crocs, Inc. v. Int’l Trade Comm.,
`598 F.3d 1294 (Fed. Cir. 2010)................................................................................................64
`
`Daubert v. Merrell Dow Pharmaceuticals, Inc.,
`509 U.S. 579 (1993).................................................................................................................11
`
`Demaco Corp. v. F. Von Langsdorff Licensing Ltd,
`851 F.2d 1387 (Fed. Cir. 1988)................................................................................................64
`
`Depuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009)................................................................................................60
`
`Eisai, 2015 U.S. Dist. LEXIS 32462 ..................................................................................... passim
`
`Eli Lilly & Co. v. Teva Parenteral Medicines, Inc.,
`689 F.3d 1368 (Fed. Cir. 2012)..........................................................................................13, 62
`
`Eli Lilly & Co. v. Teva Pharms. USA, Inc.,
`619 F.3d 1329 (Fed. Cir. 2010)..............................................................................................7, 8
`
`Eli Lilly & Co. v. Zenith Goldline Pharms., Inc.,
`471 F.3d 1369 (Fed. Cir. 2006)................................................................................................36
`
`Gilead Sciences, Inc. v. Natco Pharma Ltd.,
`753 F.3d 1208 (Fed. Cir. 2014)..................................................................................................9
`
`Glaxo, Inc. v. Novopharm, Ltd.,
`110 F.3d 1562 (Fed. Cir. 1997)................................................................................................17
`
`Glaxo Inc. v. Novopharm Ltd.,
`52 F.3d 1043 (Fed. Cir. 1995)......................................................................................37, 49, 52
`
`Graham v. John Deere Co.,
`383 U.S. 1 (1966)...............................................................................................................37, 63
`
`In re Depomed Patent Litig.,
`No. 13-4507, 2016 U.S. Dist. LEXIS 166077 (D.N.J. Sep. 30, 2016) ..............................38, 60
`
`In re Depomed Patent Litig.,
`No. 13-CV-04507, 2016 U.S. Dist. LEXIS 14455 (D.N.J. Feb. 5, 2016) .............19, 21, 30, 34
`
`In re Fallaux,
`564 F.3d 1313 (Fed. Cir. 2009)............................................................................................9, 10
`
`5
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`

`

`Case 1:14-cv-02758-PAC Document 141 Filed 02/22/17 Page 6 of 76
`
`Intervet America, Inc. v. Kee-Vet Labs., Inc.,
`887 F.2d 1050 (Fed. Cir. 1989)................................................................................................43
`
`J.T. Eaton & Co. v. Atl. Paste & Glue Co.,
`106 F.3d 1563 (Fed. Cir. 1997)................................................................................................63
`
`Janssen Prods., L.P. v. Lupin Ltd.,
`No. 2:10-cv-05954 (WHW), 2014 U.S. Dist. LEXIS 155248 (D.N.J. Mar. 12,
`2014) ........................................................................................................................................18
`
`Kimberly-Clark Worldwide, Inc. v. First Quality Baby Prods., LLC,
`660 F.3d 1293 (Fed. Cir. 2011)................................................................................................36
`
`Merck & Cie, Bayer Pharma AG v. Watson Labs., Inc.,
`125 F. Supp. 3d 503 (D. Del. 2015)...................................................................................38, 60
`
`Merck & Co. v. Hi-Tech Pharmacal Co.,
`482 F.3d 1317 (Fed. Cir. 2007)........................................................................................ passim
`
`Merck Sharp & Dohme Corp. v. Sandoz Inc.,
`No. 3:12-cv-03289, 2015 U.S. Dist. LEXIS 113710 (D.N.J. Aug. 27, 2015) .........................60
`
`Microsoft Corp. v. i4i Ltd. P’ship,
`131 S. Ct. 2238 (2011).............................................................................................................36
`
`Mitsubishi Chem. Corp. v. Barr Labs., Inc.,
`718 F. Supp. 2d 382 (S.D.N.Y. 2010)......................................................................................63
`
`Monarch Knitting Machinery v. Sulzer Morat GmbH,
`139 F.3d 877 (Fed. Cir. 1998)..................................................................................................63
`
`Neupak, Inc. v. Ideal Mfg. & Sales Corp.,
`41 F. App’x 435 (Fed. Cir. 2002) ............................................................................................63
`
`Norian Corp. v. Stryker Corp.,
`363 F.3d 1321 (Fed. Cir. 2004)................................................................................................43
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc)................................................................................19
`
`PowerOasis, Inc. v. T-Mobile USA, Inc.,
`522 F.3d 1299 (Fed. Cir. 2008)................................................................................................43
`
`Pro-Mold & Tool Co. v. Great Lakes Plastics, Inc.,
`75 F.3d 1568 (Fed. Cir. 1996)..................................................................................................63
`
`Proctor & Gamble Co. v. Teva Pharms. USA, Inc.,
`566 F.3d 989 (Fed. Cir. 2009)..................................................................................................13
`
`6
`
`

`

`Case 1:14-cv-02758-PAC Document 141 Filed 02/22/17 Page 7 of 76
`
`Richardson-Vicks Inc. v. Upjohn Co.,
`122 F.3d 1476 (Fed. Cir. 1997)..........................................................................................37, 62
`
`Sanofi-Aventis Deutschland GmbH v. Glenmark Pharms., Inc.,
`No. 07-CV-5855, 2011 U.S. Dist. LEXIS 10512 (D.N.J. Feb. 3, 2011) .................................63
`
`Schering Corp. v. Geneva Pharms., Inc.,
`339 F.3d 1373 (Fed. Cir. 2003)................................................................................................37
`
`Schoell v. Regal Marine Indus., Inc.,
`247 F.3d 1202, (Fed. Cir. 2001)...............................................................................................18
`
`Sebela Int’l Ltd. v. Actavis Labs. FL, Inc.,
`No. 14-6414 (CCC) (JBC), 2016 U.S. Dist. LEXIS 161120 (D.N.J. Nov. 21,
`2016) ........................................................................................................................................31
`
`Shire, LLC v. Amneal Pharms., LLC,
`802 F.3d 1301 (Fed. Cir. 2015)................................................................................................43
`
`Shire LLC v. Amneal Pharms., LLC,
`No. 11-3781, 2013 U.S. Dist. LEXIS 111773 (D.N.J. Aug. 8, 2013) .........................30, 31, 34
`
`SmithKline Beecham Corp. v. Apotex Corp.,
`403 F.3d 1331 (Fed. Cir. 2005)................................................................................................38
`
`Takeda Pharm., 2012 U.S. Dist. LEXIS 51013.............................................................................31
`
`Takeda Pharm. Co., LTD v. Handa Pharms., LLC,
`2013 U.S. Dist. LEXIS 187604 (N.D. Cal. Oct. 17, 2013)................................................38, 39
`
`Takeda Pharm. Co. v. Handa Pharms., LLC,
`No. C-11-00840 JCS, 2012 U.S. Dist. LEXIS 51013 (N.D. Cal. Apr. 11, 2012)
`..................................................................................................................................................26
`
`Takeda Pharm. Co. v. Mylan Inc.,
`No. 13-cv-04001, 2014 U.S. Dist. LEXIS 159527 (N.D. Cal. Nov. 11, 2014) .......................35
`
`Transclean Corp. v. Bridgewood Servs., Inc.,
`290 F.3d 1364 (Fed. Cir. 2002)................................................................................................36
`
`Trintec Indus., Inc. v. Top-U.S.A. Corp.,
`295 F.3d 1292 (Fed. Cir. 2002)................................................................................................37
`
`Voda v. Cordis Corp.,
`536 F.3d 1311 (Fed. Cir. 2008)................................................................................................18
`
`Warner–Lambert Co. v. Apotex Corp.,
`316 F.3d 1348 (Fed. Cir. 2003)................................................................................................17
`
`7
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`

`Case 1:14-cv-02758-PAC Document 141 Filed 02/22/17 Page 8 of 76
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`Warner-Lambert Co. v. Teva Pharms., USA, Inc.,
`418 F.3d 1326 (Fed. Cir. 2005)................................................................................................17
`
`Statutes
`
`35 U.S.C. § 102(b) .........................................................................................................................36
`
`35 U.S.C. § 103..........................................................................................................................4, 37
`
`35 U.S.C. § 156....................................................................................................................8, 10, 17
`
`35 U.S.C. § 271..............................................................................................................................17
`
`35 U.S.C. § 282..............................................................................................................................36
`
`Hatch-Waxman Act .............................................................................................................6, 7, 8, 9
`
`§ 154...............................................................................................................................................10
`
`Other Authorities
`
`764 F.3d 1366 ..................................................................................................................................7
`
`‘130 patent ............................................................................................................................ passim
`
`‘259 patent ..................................................................................................................................6, 7
`
`‘271 patent ....................................................................................................................................31
`
`‘336 patent ............................................................................................................................ passim
`
`‘669 patent ....................................................................................................................................32
`
`‘953 patent ................................................................................................................................5, 11
`
`‘993 patent ............................................................................................................................ passim
`
`U.S. Patent No. 6,369,085..............................................................................................................32
`
`U.S. Patent Nos. 5,011,930............................................................................................................42
`
`8
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`Case 1:14-cv-02758-PAC Document 141 Filed 02/22/17 Page 9 of 76
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`Plaintiffs Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc., and Nissan
`
`Chemical Industries, Ltd. hereby respectfully submit their Post-Trial Memorandum.
`
`PRELIMINARY STATEMENT
`
`As pointed out in Plaintiffs’ pretrial memorandum, this litigation has gone on for years,
`
`with eight sets of defendants and 18 defendants’ experts. One by one, the experts fell by the
`
`wayside, and almost all defendants followed suit, recognizing that quantity does not equal
`
`quality.
`
`These two remaining defendants are admittedly planning to copy Plaintiffs’ drug product
`
`that is helping hundreds of thousands of patients. All of the many other defendants have
`
`weighed all of the evidence in this litigation in which they have been involved for years, and
`
`reached a fair, agreed result. Unlike those defendants who voted with their feet on the merits of
`
`the defenses in this litigation, instead, these remaining two defendants, with exactly the same
`
`and/or no stronger positions as those of other defendants, are pressing on with some of the same
`
`arguments that all other defendants have recognized to be worth abandoning.
`
`For instance, Apotex is the only remaining defendant challenging infringement, and only
`
`with regard to the ‘993 patent, having stipulated to infringement of the ‘336 patent. Sawai,
`
`another “Form A” defendant which had disputed infringement on the basis that all of the peaks
`
`were not present and/or that the intensities did not match in the diffractograms for its product,
`
`abandoned that challenge and settled the lawsuit during trial.
`
`The remaining Defendants’ approach to this litigation is to pick and choose bits and
`
`pieces of the facts out of context and try to spin them in their favor in a way that is inconsistent
`
`with the record evidence and the law.
`
`1
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`Case 1:14-cv-02758-PAC Document 141 Filed 02/22/17 Page 10 of 76
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`Defendants have been quite willing to make glib accusations without a factual or legal
`
`basis. In fact, that was the theme of their closing, and their approach to the applicable law and
`
`evidence.
`
`The basic premise presented by Apotex and Amneal at closing was that Plaintiffs chose
`
`to file this litigation in the first place only to take advantage of the Hatch Waxman 30-month
`
`stay. (Tr. 1794:2 – 1795:2, 1800:15-22.) Defendants implied that Plaintiffs’ positions have no
`
`merit, and the only reason Plaintiffs brought suit was to wrongfully keep Defendants off the
`
`market. The accusations and false criticisms Defendants were willing to loosely make at closing
`
`argument not only had no basis in the record evidence and were newly raised at closing, but they
`
`also have no basis in the facts or the law. That did not stop Defendants from making them,
`
`however.
`
`Apotex has only challenged the ‘993 patent. ‘Apotex has not challenged the ‘336 patent,
`
`and cannot market its drug product until after the ‘336 patent expires in December 2020, even if
`
`it were to prevail at trial. Thus any argument about the 30-month stay has no practical bearing
`
`on Apotex.
`
`Amneal has admitted infringement of both the ‘336 and ‘993 patents, and its only
`
`challenge to the ‘336 patent is its legally and factually meritless obviousness-type double-
`
`patenting defense. That is precisely the kind of defendant the 30-month stay was enacted for.
`
`Amneal also does not yet have tentative approval from the FDA, and could not market its drug
`
`product even if it prevailed at trial on both patents. Amneal’s and Apotex’s argument and
`
`implications as to the 30-month stay were simply baseless.
`
`With regard to the ‘336 patent, Amneal is the only remaining defendant challenging that
`
`patent. To put it simply and concisely, Amneal’s obvious-type double-patenting defense based
`
`2
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`

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`Case 1:14-cv-02758-PAC Document 141 Filed 02/22/17 Page 11 of 76
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`on the ‘130 patent has no merit. The ‘130 patent issued after the ‘336 patent. Obviousness-type
`
`double-patenting was judicially created to prevent unjust extension of an original patent by a
`
`later-issued, later-expiring patent.
`
`Amneal characterizes its argument as requiring this Court to “make new law.” Amneal
`
`ignores that its argument has no basis in the law, or in the facts. See, e.g., Merck & Co. v. Hi-
`
`Tech Pharmacal Co., 482 F.3d 1317 (Fed. Cir. 2007).
`
`Defendants’ validity challenges to the ‘993 patent have dwindled down to two arguments.
`
`The first is that the ‘993 patent claims directed to polymorph Form A are inherently anticipated
`
`by a prior art reference (EP ‘406 Example 3), which was described by the ‘993 patent applicant
`
`in Column 1 of the patent specification, and which is identified on the face of the ‘993 patent as
`
`prior art, and was considered by the Patent Examiner. Defendants’ own evidence, and the rest of
`
`the record evidence, unmistakably shows that EP ‘406 Example 3, does not necessarily and
`
`inevitably result in polymorph Form A. For example, as the testing Defendants rely on
`
`demonstrates, drying conditions affect the water content of the resulting pitavastatin calcium
`
`form. As Dr. Chyall testified, it has been “demonstrated that APIs that have different water
`
`content have different polymorphic forms.” (Tr. 517:25-518:1.) As EP ‘406 does not specify
`
`drying conditions, or water content of the resulting material and these conditions can vary within
`
`the scope of EP ‘406, so can the resulting polymorphic form. Defendants have not even once
`
`acknowledged that they bear the burden of proving invalidity by clear and convincing evidence,
`
`a burden that they have not met.
`
`Defendants’ second invalidity argument is based on purported obviousness. It is difficult
`
`even to figure out what basis Defendants are relying on for this argument. They seem to suggest
`
`that a person of ordinary skill in the art would start with EP ‘406, and then meander from
`
`3
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`

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`Case 1:14-cv-02758-PAC Document 141 Filed 02/22/17 Page 12 of 76
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`generalized statements about solvent solutions and screening to irrelevant solvent systems that
`
`were related to different statins and as to which a person of ordinary skill in the art would have
`
`no reason to expect any similarity of effect, particularly in light of the different chemical
`
`structures of those other molecules. Somehow, according to these Defendants, a person of
`
`ordinary skill in the art could have expected that all of that would unpredictably lead a person of
`
`ordinary skill in the art to polymorph Form A. This is not even an appropriate obviousness
`
`analysis under § 103, let alone sufficient to establish obviousness by clear and convincing
`
`evidence of the particular polymorph Form A.
`
`Finally, Defendants consistently have tried to dodge the fact that secondary
`
`considerations of nonobviousness strongly weigh in favor of nonobviousness with regard to the
`
`‘336 patent (with regard to Amneal’s obviousness-type double-patenting defense) and the ‘993
`
`patent (with regard to Amneal and Apotex’s pseudo- § 103 obviousness defense). Livalo® is an
`
`unique drug, and provides a unique treatment option in the armamentarium for treating patients
`
`with lipid disorders. Defendants belittle the benefits of and market for Livalo®, while at the
`
`same time they have gone to great lengths to copy it; they say it is not a commercial success, and
`
`yet its sales gross over $280 million a year. The patients who use and rely on Livalo® daily
`
`apparently appreciate its benefits, and the two remaining defendants apparently do as well.
`
`I.
`
`THE ‘336 PATENT
`
`A.
`
`Introduction
`
`Only one challenge to the ‘336 patent remains, by one defendant, based on one invalidity
`
`argument: Amneal’s assertion of invalidity over the ‘130 patent based on obviousness-type
`
`double patenting . This defense has no merit.
`
`The ‘336 patent has survived two rounds of patent prosecution (one before and one after
`
`an interference proceeding), three Patent Office inter partes review proceedings, and validity
`
`4
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`Case 1:14-cv-02758-PAC Document 141 Filed 02/22/17 Page 13 of 76
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`challenges from six generic defendants and their four experts. It is not surprising, then, that five
`
`of six defendants have given up on the ‘336 patent, and the final defendant standing has
`
`abandoned almost all of the challenges to it.1 Amneal’s last flicker of an argument against the
`
`‘336 patent has no merit whatsoever, both as a matter of law and as a matter of fact.
`
`This case began with six defendants challenging the ‘336 patent. The four defendants
`
`still challenging the ‘336 patent at the time of the pretrial filings universally conceded
`
`infringement. The defendants had hired four experts to spin a variety of theories of invalidity of
`
`the ‘336 patent. By the time of trial, four of the six defendants had settled and two of the four
`
`experts had been dropped. At this time, only Dr. Palmieri remains as an “expert” on which
`
`Amneal relies for his analysis of the organic compounds claimed in the ‘336 patent and in the
`
`‘130 patent.
`
`Dr. Palmieri was introduced as a “pharmaceutics expert in synthetic organic chemistry
`
`and medicinal chemistry.” Tr. 45:12-13. At trial, it was clearly established that Dr. Palmieri did
`
`not even understand general chemistry, much less organic chemistry, much less synthetic organic
`
`chemistry or medicinal chemistry. His lack of knowledge about even basic principles was
`
`exemplified when he admitted that he did not know what a “lactone” was, despite the fact that
`
`the subject patents’ disclosures are generally directed to “Quinoline Type Mevalonolactones.”
`
`See, e.g., the title of the ‘336 patent, PTX 0142.
`
`1 Amneal seems to be attempting to distance itself from the attack based on obviousness-type double patenting over
`the ‘953 patent. (See Tr. 1504:24 – 1505:6, terming that attack as a “Sawai-only defense.”) That does not seem to
`be the case. Amneal’s former counsel was lead counsel working with Dr. Palmieri to draft his report and lead
`counsel in defending Dr. Palmieri’s deposition (with Amneal’s present counsel attending as well), and Amneal’s
`present counsel was lead counsel in deposing Dr. Roush with regard to obviousness- type double- patenting issues.
`Sawai’s counsel did not even attend Dr. Palmieri’s deposition. (See Declaration of Jennifer L. Dereka, Exh. A
`(excerpts from Palmieri deposition) and B (excerpts from Roush deposition). It seems that the obviousness-type
`double patenting attack based on the ‘953 patent was Amneal’s “baby.”)
`
`5
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`Case 1:14-cv-02758-PAC Document 141 Filed 02/22/17 Page 14 of 76
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`In any event, Amneal has conceded that it has but one defense left against the ‘336
`
`patent. That defense, based on the ‘130 patent, fails both as a matter of law and factually, as
`
`shown in greater detail below.
`
`B.
`
`Amneal Has No “Legal” Basis for Obviousness-Type Double Patenting. 2
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`Amneal claims that the ‘130 patent should invalidate the ‘336 patent based on
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`obviousness-type double patenting, even though the ‘336 patent’s original expiration date was
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`before that of the ‘130 patent. As a matter of common sense, the claims of the ‘336 patent
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`cannot and do not unfairly or improperly extend the claims of the ‘130 patent.
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`The reason the ‘336 patent now has life beyond the ‘130 patent is simple. The ‘336
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`patent, which covers the drug Livalo®, received a Hatch-Waxman patent term extension (PTE),
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`which runs through the year 2020. This extension was statutorily provided under the Hatch-
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`Waxman Act – indeed, patent term extensions are fundamental to the “bargain” that is struck by
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`the Act, the very bargain which permitted Amneal to file an Abbreviated New Drug Application
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`(ANDA) which gave rise to this litigation in the first place.
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`The Federal Circuit has recognized that Hatch-Waxman PTEs accommodate
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`obviousness-type double patenting considerations by starting the extension from the terminally
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`disclaimed expiration date. Merck & Co. v. Hi-Tech Pharmacal Co., 482 F.3d 1317 (Fed. Cir.
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`2007). In this case, the Hatch-Waxman extension of the ‘336 Patent runs from the expiration
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`date set by a terminal disclaimer that NCI filed with regard to a different patent, U.S. 5,854,259
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`(the “259 patent”).3 After the terminal disclaimer was filed with regard to the ‘259 patent, the
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`2 Obviousness-type double patenting was never properly placed at issue in this litigation, as Amneal did not raise it
`as an affirmative defense, nor move the Court for leave to add it, as Plaintiffs previously have pointed out. See, e.g.,
`Plaintiffs’ Proposed Finding of Fact and Conclusions of Law at 73 n.10. In any event, the circumstances of the
`belated raising and Amneal’s evident reluctance to move to amend to add it as a defense suggests recognition by
`Amneal that it has no merit.
`3 The ‘259 patent expiration date was Dece