Case 1:14-cv-02758-PAC Document 140 Filed 02/22/17 Page 1 of 155
`
`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’ PROPOSED FINDINGS OF FACT AND CONCLUSIONS OF LAW
`
`

`

`Case 1:14-cv-02758-PAC Document 140 Filed 02/22/17 Page 2 of 155
`
`I.
`
`THE ‘336 PATENT
`
`1.
`
`Plaintiffs assert that Amneal’s ANDA product would infringe the ‘336 Patent.
`
`(Trial Tr. at 1785-86.)
`
`2.
`
`Amneal has stipulated that its proposed ANDA product comprises (3R,5S)-7-(2-
`
`cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxy-6(E)-heptenoic acid hemicalcium
`
`salt, also known as pitavastatin calcium, and that the commercial manufacture, use, importation,
`
`sale and/or offer for sale within the United States of its ANDA Product would infringe claims 1
`
`and 2 of the ‘336 patent, provided that such claims are not found to be invalid. (Tr. at 353.)
`
`3.
`
`Amneal’s sole remaining defense regarding the ‘336 Patent is its assertion that
`
`claims 1 and 2 of the ‘336 Patent should be held invalid on grounds of obviousness-type double
`
`patenting. Claims 1 and 5 of the ‘130 Patent are the only basis for Amneal’s obviousness-type
`
`double-patenting defense. (Tr. at 1775-76.)
`
`4.
`
`Plaintiffs maintain that the ‘130 patent cannot be used as a reference to invalidate
`
`the ‘336 patent, and that Amneal has otherwise failed to meet its burden of proof on the merits.
`
`(Tr. at 1785-91.)
`
`A.
`
`5.
`
`Prosecution History of the ‘336 and ‘130 Patents
`
`The ‘130 and ‘336 patents are related; they arose from a patent application filed in
`
`the USPTO on August 19, 1988, which claimed priority to an earlier application filed in Japan on
`
`August 20, 1987. (PTX-142; PTX 290.)
`
`6.
`
`The claims in both the ‘130 and ‘336 patents were examined on two occasions by
`
`the same examiners, Examiners Laura Stockton and Johann Richter, and on both occasions the
`
`claims were found to be in condition for allowance. (PTX-0170 at KN001333506, KN00133513
`
`(re the ‘336 Patent application); PTX-0131 at KN000838907, KN000838919 (re the ‘130 Patent
`
`application).)
`
`1
`
`

`

`Case 1:14-cv-02758-PAC Document 140 Filed 02/22/17 Page 3 of 155
`
`7.
`
`Examiner Stockton deemed the claims of each application to be “in condition for
`
`allowance” on the same date, September 24, 1998. (PTX-0170 at KN001333506, KN00133513
`
`(re the ‘336 Patent application); PTX-0131 at KN000838907, KN000838919 (re the ‘130 Patent
`
`application).)
`
`8.
`
`The USPTO mailed a “Notice of Allowability” on September 30, 1998, in each of
`
`those patent applications. (PTX-0170 at KN00133515 (regarding the ‘336 Patent application);
`
`PTX-0131 at KN000838922 (regarding the ‘130 Patent application).)
`
`9.
`
`NCI paid the issue fees on both applications on the same day, October 15, 1998.
`
`(PTX-0170 at KN00133522 (regarding the ‘336 patent application); PTX-0131 at KN000838930
`
`(regarding the ‘130 patent application).)
`
`The ‘336 patent issued on January 5, 1999. (PTX-142).
`
`The ‘130 patent issued on February 16, 1999. (PTX-290.)
`
`The original expiration date of the ‘336 patent was January 5, 2016. (PTX-142.)
`
`The original expiration date of the ‘130 patent was February 16, 2016. (PTX
`
`10.
`
`11.
`
`12.
`
`13.
`
`290.)
`
`14.
`
`The original term of the ‘336 patent was later shortened by a few days when
`
`Nissan filed a terminal disclaimer making it coterminous with another patent owned by NCI,
`
`U.S. Patent No. 5,854,259 (the “‘259 Patent”). (PTX-170 at KN001333621-22.)
`
`15.
`
`As a result of the terminal disclaimer, and but for a Hatch Waxman patent term
`
`extension, the expiration date of the ‘336 patent would have been December 29, 2015. (See
`
`PTX-170 at KN001333621-22.)
`
`2
`
`

`

`Case 1:14-cv-02758-PAC Document 140 Filed 02/22/17 Page 4 of 155
`
`B.
`
`16.
`
`The Hatch Waxman Act Patent Term Extension of the ‘336 Patent
`
`Plaintiffs sought regulatory approval from the U.S. Food and Drug Administration
`
`(“FDA”) for Livalo® (pitavastatin calcium), which is covered by the ‘336 patent. (PTX-0170 at
`
`KN001333523-615).
`
`17.
`
`The FDA’s regulatory review period began in June 2000 and went on for more
`
`than nine years. (PTX-0170 at KN001333530-44.)
`
`18.
`
`After the ‘336 patent issued, and after the FDA approved Livalo®, Plaintiffs
`
`selected the ‘336 patent for a Hatch Waxman Act patent term extension under 35 U.S.C. § 156,
`
`and applied for an extension based on the regulatory review period for Livalo®. (Id. at
`
`KN001333523-615).
`
`19.
`
`On April 29, 2013, the USPTO granted that application and extended the term of
`
`the ‘336 patent for a period of 1,823 days. (PTX-170 at KN00133619-20.)
`
`20.
`
`As extended by § 156, the ‘336 patent term (as shortened based on the disclaimer
`
`to the ‘259 patent term) will expire on December 25, 2020. (PTX-170 at KN00133619-20.)1
`
`1 The ‘259 patent expiration date was December 29, 2015 (7 days before the original
`expiration date of the ‘336 patent and 49 days before the original expiration date of the ‘130
`patent, namely February 16, 2016). The patent term extension originally extended the ‘336
`patent term to January 1, 2021 (1823 days after the ‘336 patent’s original expiration date
`(January 5, 2016)). After the terminal disclaimer was filed with regard to the ‘259 patent, the
`Patent Office correspondingly shortened the extended patent term of the ‘336 Patent such that it
`runs 1823 days from December 29, 2015, and thus expires on December 25, 2020 rather than
`January 1, 2021.
`
`3
`
`

`

`Case 1:14-cv-02758-PAC Document 140 Filed 02/22/17 Page 5 of 155
`
`CONCLUSIONS OF LAW
`
`II.
`
`THE PRESUMPTION OF VALIDITY & THE BURDEN OF PROOF
`
`21.
`
`By express Congressional declaration, patents are to be presumed valid. Each
`
`patent claim is independently presumed valid, even if other claims within the same patent are
`
`held invalid. 35 U.S.C. § 282.
`
`III.
`
`CLAIMS 1 AND 2 OF THE ‘336 PATENT ARE NOT INVALID UNDER THE
`DOCTRINE OF OBVIOUSNESS-TYPE DOUBLE PATENTING2
`
`22.
`
`Amneal, as the party challenging the validity of the ‘336 patent, must prove
`
`invalidity by clear and convincing evidence. See, e.g., Amgen Inc. v. F. Hoffmann-La Roche Ltd.,
`
`580 F.3d 1340, 1362 (Fed. Cir. 2009) (affirming district court’s grant of JMOL of no
`
`obviousness-type double patenting where “the identified differences between the asserted claims
`
`… and [the allegedly invalidating claims] renders the claims patentably distinct.”).
`
`A.
`
`23.
`
`The Doctrine of Obviousness-Type Double Patenting
`
`The double patenting doctrine was judicially created in the 1800s. See Suffolk Co.
`
`v. Haden, 70 U.S. 315; 3 Wall. 315, 319 (1866); Miller v. Eagle Mfg. Co., 151 U.S. 186, 197
`
`(1894).
`
`24.
`
`The doctrine arose based on the rationale that because 35 U.S.C. § 101 states that
`
`an inventor may obtain “a patent” for an invention, the statute permits only one patent to be
`
`obtained for a single invention. E.g., Abbvie Inc. v. Mathilda & Terrence Kennedy Inst. of
`
`Rheumatology Trust, 764 F.3d 1366, 1372 (Fed. Cir. 2014)..
`
`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. In
`any event, Amneal has failed to prove that the ‘336 Patent is invalid.
`
`4
`
`

`

`Case 1:14-cv-02758-PAC Document 140 Filed 02/22/17 Page 6 of 155
`
`25.
`
`Courts have explained that the doctrine developed “to prevent claims in separate
`
`applications or patents that … claim inventions so alike that granting both exclusive rights would
`
`effectively extend the life of patent protection.” Amgen, 580 F.3d at 1352 (citation omitted).
`
`26.
`
`The doctrine “is intended to prevent unjustified extension of protection.” General
`
`Foods Corporation v. Studiengesellschaft Kohle mbH, 972 F.2d 1272, 1282 (Fed. Cir. 1992);
`
`Otsuka Pharmaceutical Co., Ltd. v. Sandoz, Inc., 678 F.3d 1280, 1297 (Fed. Cir. 2012); In re
`
`Braat, 937 F.2d 589, 595 (Fed. Cir. 1991) (stating, “There are situations where the extension is
`
`justified.”).
`
`27.
`
`“The doctrine of non-statutory, or ’obviousness-type, double patenting prevents
`
`the extension of the term of a patent via the patenting of an obvious variation of the original
`
`patent.” Abbvie Inc. v. Mathilda & Terence Kennedy Inst., 956 F. Supp. 2d 429, 473 (S.D.N.Y.
`
`2013) (emphasis added) (citing Eli Lilly & Co. v. Teva Pharms. USA, Inc., 619 F.3d 1329, 1341-
`
`42 (Fed. Cir. 2010)); affirmed 764 F.3d 1366 (Fed. Cir. 2014).
`
`28.
`
`The Federal Circuit has stated that all “proper” obviousness-type double patenting
`
`rejections “rest on the fact that a patent has been issued and later issuance3 of a second patent
`
`will continue protection, beyond the date of expiration of the first patent, of … a mere variation
`
`of that invention which would have been obvious to those of ordinary skill in the relevant art
`
`….” In re Kaplan, 789 F.2d 1574, 1579-80 (Fed. Cir. 1986) (reversing Board of Patent Appeals
`
`and Interferences finding of invalidity for obviousness-type double patenting).
`
`3 The In re Kaplan decision and many obviousness-type double patenting decisions involving
`patents filed before the Uruguay Round Agreements Act (“URAA”), Pub.L. No. 103-465,
`§ 532(a), 108 Stat. 4809, 4983-85 (1994)) compared the issuance date of patents. The Federal
`Circuit clarified in Gilead that the obviousness-type double patenting analysis requires courts to
`compare the expiration dates. Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208, 1215-
`17 (Fed. Cir. 2014).
`
`5
`
`

`

`Case 1:14-cv-02758-PAC Document 140 Filed 02/22/17 Page 7 of 155
`
`B.
`
`In 1984, Congress Passed the Hatch Waxman Act, Creating A Patent Term
`Extension of Limited Rights to Restore Time For Patents Covering
`Pharmaceutical Products That Were Subject to Regulatory Review
`
`29.
`
`The Hatch-Waxman Act (the “Act”) is formally known as the Drug Price
`
`Competition and Patent Term Restoration Act of 1984, P.L. 98-417.
`
`30.
`
`The Act “provides generally for a limited extension of the term of a patent, inter
`
`alia, for a drug covered by the patent as to which marketing was held up during the patent term
`
`by the process of obtaining Food and Drug Administration (FDA) approval ….” Merck & Co. v.
`
`Kessler, 80 F.3d 1543, 1546 (Fed. Cir. 1996) [hereinafter Merck v. Kessler]; see also 35 U.S.C.
`
`§156 (providing for patent term extensions).
`
`31.
`
`Before the Act, manufacturers of generic drug products had to conduct their own
`
`testing in order to obtain FDA approval of their generic drug. See Merck v. Kessler, 80 F.3d at
`
`1546. The Act “eliminated the pre-1984 requirement that a company seeking to market a generic
`
`version of a patented drug had to conduct its own testing program.” Merck v. Kessler, 80 F.3d at
`
`1546. It also “permits the generic producer of the fully tested drug to rely on the safety and
`
`efficacy data of a prior applicant, frequently the holder of a patent on the product.” Id. Thus, the
`
`testing and marketing of generic versions of an FDA-approved drug was dramatically expedited
`
`by the Act. See id.
`
`32.
`
`In exchange for the benefits conferred on the public and producers of generic
`
`drugs, “the Hatch-Waxman Act provides the holders of patents on approved patented products
`
`with an extended term of protection under the patent to compensate for the delay in obtaining
`
`FDA approval.” Merck v. Kessler, 80 F.3d at 1546. The patent term extension period does not
`
`restore the full time lost due to FDA’s regulatory approval process “but merely ‘ameliorates the
`
`loss incurred when patent terms tick away while the patented product is awaiting [FDA’s]
`
`regulatory approval for marketing.’” Id. (citations omitted).
`
`6
`
`

`

`Case 1:14-cv-02758-PAC Document 140 Filed 02/22/17 Page 8 of 155
`
`33. When passing the Act, Congress recognized that a patent owner may have more
`
`than one patent covering a regulated pharmaceutical product. The Act, therefore, allows a patent
`
`owner to choose which of its patents will be extended. See 35 U.S.C. § 156(c)(4); Merck & Co.,
`
`Inc. v. Hi-Tech Pharmacal Co., Inc., 482 F.3d 1317, 1323 (Fed. Cir. 2007) (quoting 130 Cong.
`
`Rec. 23765 (1984) as saying: “[O]ne patent on a product, not necessarily the first, can be
`
`extended but … the total exclusive market life of the product cannot exceed 14 years.”)
`
`[hereinafter Merck v. Hi-Tech].
`
`34.
`
`The Congressional Record reflects the policy that “The Hatch Waxman Act was
`
`intended to provide the patent holder ‘the flexibility to select the most important patent for
`
`extension.’” Merck v. Hi-Tech, 482 F.3d at 1323 (citation omitted).
`
`35.
`
`The patent term extension does not extend all rights conveyed by the patent; in the
`
`case of a pharmaceutical product, a patentee’s rights during the period of the patent term
`
`extension are statutorily limited to the approved product and its FDA approved uses, as provided
`
`under 35 U.S.C. § 156(a) and (b).
`
`36.
`
`The statutory grant of patent term extension is mandatory when the specified
`
`conditions have been met. Merck v. Hi-Tech, 482 F.3d at 1322 (“Use of the word ‘shall’ in a
`
`statute generally denotes the imperative.”)
`
`37.
`
`Here, Amneal has not challenged the USPTO’s grant of a patent term extension
`
`for the ‘336 Patent.
`
`38.
`
`The Federal Circuit’s holding in Merck v. Hi-Tech is controlling. There, the
`
`Court rejected a challenge to a Hatch Waxman Act patent term extension and held that the
`
`extension “may be applied to a patent subject to a terminal disclaimer … filed to overcome an
`
`obviousness-type double-patenting rejection.” Merck v. Hi-Tech, 482 F.3d at 1318 (affirming
`
`7
`
`

`

`Case 1:14-cv-02758-PAC Document 140 Filed 02/22/17 Page 9 of 155
`
`judgment in favor of patent owner). During prosecution of Merck’s ‘413 patent, the examiner
`
`rejected it on the ground of obviousness-type double patenting over the claims of an earlier
`
`expiring patent (the ‘115 patent), and Merck filed a terminal disclaimer to overcome that
`
`objection. Id. at 1318-19. As a result, the ‘413 patent and ‘115 patent originally were
`
`coterminous. Id. at 1319. Merck also requested and received a patent term extension under 35
`
`U.S.C. § 156, extending the term of the ‘413 patent. When Merck asserted the ‘413 patent in
`
`court, the defendant argued that the patent term extension was invalid because the Hatch
`
`Waxman extension would eradicate the effect of the terminal disclaimer. The district court and
`
`Federal Circuit rejected that challenge, holding that § 156 contains mandatory language that
`
`cannot be ignored. Id. at 1322-23; see also King Pharmaceuticals, 409 F. Supp. 2d 609, 613-14
`
`(D.N.J. 2006) (“Section 156 plainly states that a patent satisfying the enumerated conditions
`
`‘shall be extended.’ ‘The word “shall” generally indicates a command that admits of no
`
`discretion on the part of the person instructed to carry out the directive.’” (citation omitted)).
`
`The plain and ordinary reading of the statute assures that “the purpose of the patent term
`
`extension—to restore some of the patent term lost due to regulatory review—is also satisfied.”
`
`Merck v. Hi-Tech, 482 F.3d at 1323.
`
`39.
`
`The Federal Circuit, in Merck v. Hi-Tech, held that a patent term extension under
`
`the Act does not “improperly uncouple” a patent from its terminal disclaimer over another
`
`patent. Id. at 1322-23. The Court added, “The expiration date of the patent set by the terminal
`
`disclaimer remains in place. The computation of a Hatch-Waxman patent term extension is from
`
`the expiration date resulting from the terminal disclaimer and not from the date the patent would
`
`have expired in the absence of the terminal disclaimer.” Id.
`
`8
`
`

`

`Case 1:14-cv-02758-PAC Document 140 Filed 02/22/17 Page 10 of 155
`
`40.
`
`The Federal Circuit recognized that Hatch-Waxman patent term extensions
`
`accommodate obviousness-type double patenting considerations by starting the extension from
`
`the terminally disclaimed expiration date. Id. at 1323.
`
`41.
`
`The Court, therefore, allowed the Hatch Waxman Act patent term extension to
`
`extend the term of the ‘413 Patent beyond the expiration date in the terminal disclaimer, and
`
`despite the obviousness of the ‘413 Patent’s claims over the claims of the ‘115 Patent. The Court
`
`reasoned, that “[t]he purpose of the terminal disclaimer--to prevent extension of patent term for
`
`subject matter that would have been obvious over an earlier filed patent--remains fulfilled by
`
`virtue of the fact that the date from which any Hatch-Waxman extension is computed is the
`
`terminally disclaimed date.” Id. at 1323.
`
`42.
`
`Here, because the ‘130 Patent originally expired after the expiration date of the
`
`‘336 Patent, Plaintiffs could not have filed a terminal disclaimer to make the ‘336 Patent
`
`coterminous with the ‘130 Patent.
`
`43.
`
`Amneal relies on the later expiring ‘130 Patent to try to invalidate the ‘336
`
`Patent. The Federal Circuit’s analysis in Merck v. Hi-Tech is controlling; the ‘130 Patent, which
`
`expired after the original expiration date of the ‘336 Patent (and after the terminal disclaimer
`
`date of the ‘336 Patent) cannot invalidate the Hatch Waxman Act patent term extension of the
`
`‘336 patent. See Merck v. Hi-Tech, 482 F.3d at 1322-23.
`
`44.
`
`To make up for time that Plaintiffs’ Livalo® product was in regulatory review
`
`with the FDA, the Hatch Waxman Act permitted Plaintiffs to select one patent for a Hatch
`
`Waxman Act patent term extension, and Plaintiffs selected the ‘336 Patent. The Act mandated
`
`the grant of an extension, and the USPTO granted that extension. Id. Amneal has not challenged
`
`the basis for the grant of that patent term extension.
`
`9
`
`

`

`Case 1:14-cv-02758-PAC Document 140 Filed 02/22/17 Page 11 of 155
`
`45.
`
`Amneal’s obviousness-type double patenting argument is unsupported by any
`
`case involving a patent term extension, would eliminate the Hatch Waxman Act patent term
`
`extension of the ‘336 Patent, and would be contrary to the holdings in Merck v. Hi-Tech and
`
`King Pharmaceuticals.
`
`46.
`
`In its summation, Amneal cited Gilead and In re Fallaux, 564 F.3d 1313 (Fed.
`
`Cir. 2009) as supposed support for its obviousness-type double patenting argument. (Trial Tr. at
`
`1780-83 (Gilead); 1784-85 (In re Fallaux).) Neither of those decisions addressed the effect of a
`
`Hatch Waxman Act patent term extension.
`
`47.
`
`Gilead simply clarified that the obviousness-type double patenting doctrine
`
`requires a court to compare expiration dates (not issue dates) of patents. Gilead, 753 F.3d at
`
`1315-17. The expiration dates at issue in Gilead were the original expiration dates of patents.
`
`Here, a comparison of the original expiration dates of the patents at issue precludes an
`
`obviousness-type double patenting rejection of the ‘336 Patent.
`
`48.
`
`In re Fallaux is irrelevant. That opinion addressed whether the Board of Patent
`
`Appeals and Interferences erred in applying a “one way test” instead of a “two way test” for
`
`obviousness-type double patenting. That opinion did not address a patent term extension.
`
`Amneal cited In re Fallaux solely for dicta, untethered to facts, in which the court stated: “In
`
`some cases there may still be the possibility of an unjust time-wise extension of a patent arising
`
`from patent term adjustment under § 154 or patent term extension under § 156.” In re Fallaux,
`
`564 F.3d at 1319. That language provides no guidance here. There is no record evidence, nor
`
`has Amneal ever asserted, that there is anything unjust about the Hatch-Waxman patent term
`
`extension that the FDA calculated and approved and that the Patent Office granted.
`
`10
`
`

`

`Case 1:14-cv-02758-PAC Document 140 Filed 02/22/17 Page 12 of 155
`
`49.
`
`Therefore, the judicially created doctrine of obviousness-type double patenting
`
`cannot invalidate the Hatch Waxman patent term extension of the ‘336 Patent in light of the ‘130
`
`Patent. See Merck v. Hi-Tech at 482 F.3d 1318-23.
`
`C.
`
`Amneal has failed to present clear and convincing evidence of obviousness-
`type double patenting
`
`1.
`
`The Obviousness-Type Double Patenting Doctrine Requires Proof
`That the Claims Are Not Patentably Distinct
`
`50.
`
`Even if the ‘130 Patent were a valid reference for an obviousness-type double
`
`patenting invalidity defense, Amneal has failed to meet its burden of proof.
`
`51.
`
`Amneal bears the burden of proving “by clear and convincing evidence that the
`
`original claim and the allegedly duplicative claim are not patentably distinct.” Amgen, Inc. v. F.
`
`Hoffmann-La Roche Ltd., 581 F. Supp. 2d 160, 173 (D. Mass. 2008) (granting summary
`
`judgment of no invalidity for obviousness-type double patenting).
`
`52.
`
`Claim 1 of the ‘336 Patent and Claim 1 of the ‘130 Patent claim different organic
`
`chemical compounds.
`
`53.
`
`The question of whether two compounds are patentably distinct “requires
`
`identifying some reason that would have led a chemist to modify the earlier compound to make
`
`the later compound with a reasonable expectation of success.” Otsuka, 678 F.3d at 1297
`
`(citation omitted); Eli Lilly v. Teva Parenteral, 698 F.3d at 1378 (“In the chemical context, … an
`
`analysis of obviousness-type double patenting ‘requires identifying some reason that would have
`
`led a chemist to modify the earlier compound to make the later compound with a reasonable
`
`expectation of success.’”); Amgen, 580 F.3d at 1362, 1363 (affirming a conclusion of no
`
`obviousness-type double patenting because, “a person of ordinary skill in the art would not have
`
`reasonably expected [success] ….”).
`
`11
`
`

`

`Case 1:14-cv-02758-PAC Document 140 Filed 02/22/17 Page 13 of 155
`
`54.
`
`“[P]redictability is a vital consideration in the obviousness analysis.” Otsuka, 678
`
`F.3d at 1298 (citing KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 421 (2007).).
`
`55.
`
`“There is no other way to consider the obviousness of compound B over
`
`compound A without considering whether one of ordinary skill would have had reason to modify
`
`A to make B.” Otsuka, 678 F.3d at 1298.
`
`2.
`
`Amneal’s Evidence of Purported Obviousness Is Not Credible
`
`56.
`
`Amneal relies on opinion testimony of Dr. Palmieri that the claims of the ‘336
`
`Patent are obvious in view of the claims of the ‘130 Patent (Tr. at 45:18-46:4; 1777:19-1778:19)
`
`but he provided no testimony suggesting a reason to modify the pitavastatin sodium of the ‘130
`
`Patent to make the pitavastatin calcium of claim 1 of the ‘336 Patent. Nor did he credibly
`
`explain why a person of ordinary skill in the art would have had a reasonable expectation of
`
`success in doing so.
`
`57.
`
`Under Rule 702 of the Federal Rules of Evidence, an expert witness “qualified by
`
`by knowledge, skill, experience, training, or education” may testify if “the testimony is based on
`
`sufficient facts or data,” “the testimony is the product of reliable principles and methods,” and
`
`“the expert has reliably applied the principles and methods to the facts of the case.” Fed. R. Evid.
`
`702; see also Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 592, 597 (1993).
`
`58.
`
`Cross-examination during trial revealed that Dr. Palmieri does not have a degree,
`
`of any sort, in chemistry, organic chemistry, or medicinal chemistry. (Tr. at 693-94.) Nor has he
`
`taught any courses in those subjects. (Id. at 694-95.) His research interests do not include
`
`chemistry or organic chemistry. (Id. at 695.) None of his publications involve chemistry or
`
`organic chemistry. (Id. at 695.) On cross-examination, Dr. Palmieri had difficulty answering
`
`questions about the structure of the statin molecules claimed in the ‘336 Patent and related
`
`patents. (Tr. at 700-02; 703-05; 707-12.)
`
`12
`
`

`

`Case 1:14-cv-02758-PAC Document 140 Filed 02/22/17 Page 14 of 155
`
`59.
`
`Although the titles of the ‘336 Patent and ‘130 Patent are “Quinoline Type
`
`Mevalonolactones,” Dr. Palmieri did not know what a lactone was. (Tr. at 699; Depn. Tr. at
`
`148.)
`
`60.
`
`He admitted that he could not describe the difference between an enantiomer and
`
`diastereomer. (Tr. at 696-97; Palmieri Depn. Tr. at 33-35.)
`
`61.
`
`Dr. Palmieri’s testimony concerning obviousness-type double patenting and U.S.
`
`Patent No. 5,284,953 (“the ‘953 patent) was wholly unreliable. Prior to trial, and in addition to
`
`arguments concerning the ‘130 patent, defendants including Amneal argued in proposed findings
`
`of fact and conclusions of law that the ‘336 patent was invalid over the ‘953 patent on
`
`obviousness-type double patenting grounds. (ECF No. 106 in Kowa Co. , Ltd. et al. v. Amneal
`
`Pharm., Ltd., No. 1:14-cv-02758 (which indicates that it is “presented on behalf of Amneal,
`
`Orient, Sawai and Zydus,” but was signed only by Amneal’s counsel, and only appears on the
`
`Amneal docket).) Before the close of trial, Amneal expressly abandoned its defense based on the
`
`‘953 patent and sought to distance itself from Dr. Palmieri’s shortcomings by describing the ‘953
`
`patent defense as a “Sawai-only” defense. (Tr. at 1504:18-1505:9.) Although that defense is no
`
`longer at issue in this action, Dr. Palmieri’s testimony regarding the chemistry involved in the
`
`‘953 patent severely damaged his credibility.
`
`62.
`
`So far as is relevant to Amneal’s remaining defense, Dr. Palmieri’s opinion
`
`testimony was based solely on the Berge reference (DTX-1245) for the proposition that sodium
`
`and calcium were well known to be pharmaceutically acceptable salts. (Tr. at 671-74.) He
`
`testified that “a person looking at Bergy [sic] and through knowledge and experience would
`
`quickly understand that the two salt forms [i.e., calcium and sodium] are essentially the same,
`
`you know, and commonly used.” (Tr. at 674:15-18.) He opined that it would have been obvious
`
`13
`
`

`

`Case 1:14-cv-02758-PAC Document 140 Filed 02/22/17 Page 15 of 155
`
`to substitute calcium for sodium in the pitavastatin sodium compound in Claim 1 of the ‘130
`
`Patent, in order to obtain the pitavastatin calcium compound of Claim 1 of the ‘336 Patent. (Tr.
`
`at 672:5-8.)
`
`63.
`
`Berge, however, states that “[c]hoosing the appropriate salt … can be a very
`
`difficult task, since each salt imparts unique properties to the parent compound.” DTX-1245 at
`
`3. Berge also states, “Unfortunately, there is no reliable way of predicting the influence of a
`
`particular salt species on the behavior of the parent compound.” (Id.)
`
`64.
`
`Defendant’s expert witness, Dr. Roberts, recognized that pitavastatin sodium is
`
`distinct from pitavastatin calcium. (Tr. at 823-24.)
`
`65.
`
`Defendant’s expert witness, Dr. Brown, also testified that different salt forms
`
`have different stability and water solubility. (Tr. at 926-27.)
`
`66.
`
`Dr. Palmieri also testified that a person of ordinary skill in the art would have a
`
`“reasonable expectation of success in preparing calcium salts from the salts of the ‘130 patent
`
`claims”, which would come from a desire “to improve solubility and other properties of the
`
`drug.” (Tr. at 674-75.) However, defendants’ expert, Dr. Jonathan Sessler, who is an organic
`
`chemist (Tr. at 1003), testified that “[C]alcium salts are less soluble than sodium salts.” (Id. at
`
`1014); id. at 1015 (“[C]hemists woul d appreciate that the calcium salt is most likely to be le[ss]
`
`soluble.”) Thus, Dr. Palmieri’s theory that the calcium salt would improve solubility shows
`
`again how little chemistry he knows. Given Dr. Palmieri’s general lack of understanding of
`
`chemistry and his reliance solely on Berge, I credit the testimony of Dr. Sessler on this point.
`
`67.
`
`Amneal’s evidence failed to meet its burden of proving obviousness by clear and
`
`convincing evidence. See Abbvie, 956 F. Supp. at 474 (“A party seeking to invalidate a patent for
`
`obviousness-type double patenting must show facts supporting a conclusion of invalidity by clear
`
`14
`
`

`

`Case 1:14-cv-02758-PAC Document 140 Filed 02/22/17 Page 16 of 155
`
`and convincing evidence.”)(citing Proctor & Gamble Co. v. Teva Pharms. USA, Inc., 566 F.3d
`
`989, 993-94, 999 (Fed. Cir. 2009); Amgen, Inc. v. F. Hoffmann-La Roche, Ltd., 580 F.3d 1340,
`
`1361-62 (Fed. Cir. 2009).)
`
`D.
`
`68.
`
`Secondary Considerations
`
`Even if Amneal had met its burden to establish a prima facie case of obviousness,
`
`Plaintiffs’ objective evidence of non-obviousness would overcome any prima facie case of
`
`obviousness. See Eli Lilly,689 F.3d at 1381 (holding that during a consideration of obviousness-
`
`type double patenting, “a fact-finder ‘must withhold judgment on an obviousness challenge until
`
`it has considered all relevant evidence, including that relating to the objective considerations.’”
`
`(citing In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d
`
`at 1079).
`
`69.
`
`As discussed in Section _, Livalo® embodies the pitavastatin calcium compound
`
`claimed in claim 1 of the ‘336 patent, and its use in accordance with its approved label is covered
`
`by claim 2 of the ‘336 patent. Accordingly, Plaintiffs have established a nexus between the
`
`claims of the ‘336 patent and the success of the Livalo® product. See Demaco Corp. v. F. Von
`
`Langsdorff Licensing, Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988) (“A prima facie case of nexus
`
`is generally made out when the patentee shows both that there is commercial success, and that
`
`the thing (product or method) that is commercially successful is the invention disclosed and
`
`claimed in the patent.”) Amneal has not rebutted Plaintiff’s strong showing of nonobviousness,
`
`including commercial success, unexpected results, fulfillment of long-felt need, industry praise,
`
`copying, acquiescence, and much more.
`
`70.
`
`In sum, Amneal has failed to prove by clear and convincing evidence that any
`
`claims of the ‘130 Patent render either Claim 1 or Claim 2 of the ‘336 patent obvious under the
`
`doctrine of obviousness-type double patenting.
`
`15
`
`

`

`Case 1:14-cv-02758-PAC Document 140 Filed 02/22/17 Page 17 of 155
`
`E.
`
`71.
`
`Conclusion
`
`For the reasons discussed above, Amneal has failed to prove by clear and
`
`convincing evidence that any claims of the ‘336 patent are invalid.
`
`IV.
`
`INFRINGEMENT OF THE ‘993 PATENT BY AMNEAL AND APOTEX
`
`72.
`
`U.S. Patent No. 8,557,993 (“the ‘993 patent”) (PTX-1063), entitled “Crystalline
`
`Forms of Pitavastatin Calcium,” issued on October 15, 2013, and names Paul Adriaan Van Der
`
`Schaaf, Fritz Blatter, Martin Szelagiewicz and Kai-Uwe Schoening as inventors.
`
`73.
`
`74.
`
`The ‘993 patent is scheduled to expire on February 2, 2024.
`
`Plaintiff NCI is the assignee of the ‘993 patent. KCL is NCI’s licensee for the
`
`‘993 patent, and KPA holds a license from KCL for the ‘993 patent to make, use, import, offer
`
`for sale and sell Livalo®.
`
`75.
`
`The ‘993 patent issued from U.S. Patent Application No. 13/664,498 (“the ‘498
`
`application”), filed on October 31, 2012, and was a continuation application from PCT
`
`Application No. PCT/EP2004/050066 filed on February 2, 2004. The ‘993 patent claims priority
`
`to European Application No. 03405080, filed on February 12, 2003. The effective priority date
`
`of the ‘993 patent is February 12, 2003.
`
`76.
`
`Claims 1, 22, 23, 24 and 25 are asserted against the Amneal defendant.4 Claims
`
`1, 22, 23, 24, and 25, and are asserted against the Apotex defendants.
`
`77.
`
`Claims 1, 22, 23, 24 and 25 are directed to, inter alia, crystalline polymorph A of
`
`pitavastatin calcium.
`
`4 Defendant Amneal does not contest infringement of claims 1, 22, 23, 24 and 25 of the ‘993
`patent. (PTX-1324 at 1.)
`
`16
`
`

`

`Case 1:14-cv-02758-PAC Document 140 Filed 02/22/17 Page 18 of 155
`
`78.
`
`Claims 1, 22, and 24 are directed to, inter alia, crystalline polymorph A of
`
`pitavastatin calcium, exhibiting of pitavastatin calcium, exhibiting “a characteristic x-ray
`
`diffraction pattern with characteristic peaks expressed in 2θ at 5.0 (s), 6.8 (s), 9.1 (s), 10.0 (w),
`
`10.5 (m), 11.0 (m), 13.3 (vw), 13.7 (s), 14.0 (w), 14.7 (w), 15.9 (vw), 16.9 (w), 17.1 (vw), 18.4
`
`(m), 19.1 (w), 20.8 (vs), 21.1 (m), 21.6 (m), 22.9 (m), 23.7 (m), 24.2 (s), 25.2 (w), 27.1 (m), 29.6
`
`(vw), 30.2 (w), 34.0 (w).” (PTX-1063 at KN000844716-17 (emphasis added).)
`
`79.
`
`Claims 23 and 25 are directed to, inter alia, crystalline polymorph A of
`
`pitavastatin calcium “having an x-ray powder diffraction pattern substantially as depicted in Fig.
`
`1 [of the ‘993 patent].” (PTX-1063 at KN000844717 (emphasis added).)
`
`A.
`
`80.
`
`Asserted Claims
`
`The Asserted Claims (claims 1, 22, 23, 24, and 25: Amneal and Apotex) and
`
`Figure 1 of the ‘993 patent are set forth below:
`
`1. A crystalline polymorph A, B, C, D, E, F, or the amorphous form, of (3R,5S)-
`7-[2-cyclopropyl-4-(4-fluorophenye)quinolin-3-yl]-3,5-dihydroxy-6(E)-heptenoic acid
`hemicalcium salt wherein
`
`A) polymorph A exhibits a characteristic X-ray powder diffraction pattern with
`characteristic peaks expressed in 2θ at 5.0 (s), 6.