Case 1:14-cv-02758-PAC Document 105 Filed 12/16/16 Page 1 of 14
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF NEW YORK
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`
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`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc., and
`Nissan Chemical Industries, Ltd.,
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`AMNEAL’S PROPOSED FINDINGS AND CONCLUSIONS OF LAW [REDACTED] RE:
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`AMNEAL’S NON-INFRINGEMENT OF THE ’993 PATENT
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`Civil Action No. 14-CV-2758 (PAC)
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`)))))))))))))
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`Plaintiffs,
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`v.
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`Amneal Pharmaceuticals, LLC
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`Defendant.
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`Case 1:14-cv-02758-PAC Document 105 Filed 12/16/16 Page 2 of 14
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`I. 
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`The ’993 Patent and Asserted Claims ..................................................................................1 
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`TABLE OF CONTENTS
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`The Asserted Claims ................................................................................................1 
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`The Specification .....................................................................................................4 
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`The API Used in the Manufacture of Amneal’s ANDA Product ........................................4 
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`Non-Infringement of Claims 1 and 22–25 of the ’993 Patent .............................................5 
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`Plaintiffs Have Failed to Prove That the API in Amneal’s ANDA Product
`Literally Meets Every Limitation of the Polymorph Form A as Claimed. ..............5 
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`Plaintiffs’ Have Failed to Prove Infringement of Any Asserted Claim
`Under the Doctrine of Equivalents. .........................................................................9 
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`II. 
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`III. 
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`ii
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`Case 1:14-cv-02758-PAC Document 105 Filed 12/16/16 Page 3 of 14
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`1.
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`Plaintiffs Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc., and Nissan
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`Chemical Industries, Ltd. (“Plaintiffs”) allege that Amneal Pharmaceuticals, LLC (“Amneal”)
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`infringes claims 1 and 22–25 of U.S. Patent No. 8,557,993 (“the ’993 patent”), by the filing of
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`Amneal’s Abbreviated New Drug Application (“ANDA”) No. 205961.
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`2.
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`As an initial matter, Plaintiffs cannot meet their burden to prove infringement
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`because they refused to produce their infringement expert Dr. James Kaduk for deposition by
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`Amneal before trial. The Federal Rules of course explicitly provide that “[a] party may depose
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`any person who has been identified as an expert whose opinions may be presented at trial.” Fed.
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`R. Civ. P. 26(b)(4)(A). The consequence of Plaintiffs’ refusal of Amneal’s deposition of Dr.
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`Kaduk must be that his opinions cannot be presented at trial. Thus, Plaintiffs fail to prove
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`infringement against Amneal without even reaching the merits of their claims.
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`3.
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`Even if Dr. Kaduk is permitted to testify against Amneal at trial, for the reasons set
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`forth below, Plaintiffs have failed to prove that Amneal’s ANDA product will infringe any asserted
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`claim, either literally or under the doctrine of equivalents. The opinions and evidence in Dr.
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`Kaduk’s expert reports (as to which Amneal was refused a deposition) are legally insufficient.
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`I.
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`The ’993 Patent and Asserted Claims
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`4.
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`The ’993 patent issued on October 15, 2013, from Application No. 13/664,498,
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`which was filed on October 31, 2012. (DTX-1307, the ’993 patent (MYLAN(Pitav) 009836–55).)
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`The earliest date to which the ’993 patent claims priority is February 12, 2003. (Id.)
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`5.
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`The Asserted Claims
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`Claims 1 and 22–25 of the ’993 patent are asserted against Amneal. These claims
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`are directed to specific polymorphs of pitavastatin hemicalcium limited by either a characteristic
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`1
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`Case 1:14-cv-02758-PAC Document 105 Filed 12/16/16 Page 4 of 14
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`set of X-ray powder diffraction peaks (i.e., corresponding 2θ values and relative intensities), or by
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`the depiction of one or more particular diffractograms.1
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`6.
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`Asserted claims 1 and 22–25 are reproduced below:
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`Claim 1:
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`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
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`A) polymorph A exhibits a characteristic X-ray powder 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);
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`B) polymorph B exhibits a characteristic X-ray powder diffraction pattern
`with characteristic peaks expressed in 2θ at 4.6 (w), 5.3 (vs), 6.2 (s), 7.7 (s),
`9.2 (m), 9.6 (m), 10.3 (w), 11.3 (m), 11.7 (w), 12.6 (vw), 13.0 (w), 13.9 (m),
`14.7 (vw), 14.9 (w), 15.6 (w), 16.3 (m), 17.0 (vw), 17.4 (vw), 18.0 (w), 18.7
`(m), 19.3 (m), 20.0 (s), 20.5 (w), 20.8 (m), 21.2 (w, shoulder), 21.5 (m), 22.4
`(m), 23.2 (s), 23.8 (m), 24.4 (vw), 25.2 (w, broad), 26.0 (w), 26.4 (vw), 27.0
`(w), 27.9 (vw), 28.9 (w);
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`C) polymorph C exhibits a characteristic X-ray powder diffraction pattern
`with characteristic peaks expressed in 2θ at 4.1 (m), 5.6 (s), 7.8 (m), 8.3 (m),
`10.3 (m), 11.6 (w), 17.5 (w), 17.9 (w),18.7 (m), 19.5 (s), 20.6 (m), 21.5 (vw),
`21.9 (m), 23.1 (m), 24.0 (w), 24.8 (w);
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`D) polymorph D exhibits a characteristic X-ray powder diffraction pattern
`with characteristic peaks expressed in 2θ at 5.0 (m), 6.5 (m), 6.8 (s), 8.7 (m),
`10.0 (m), 10.2 (m), 10.8 (m), 13.1 (w), 13.5 (m), 14.3 (s), 15.3 (vw), 16.1 (m),
`16.8 (w), 18.2 (w), 18.5 (m), 19.0 (w), 19.9 (m), 20.5 (m), 21.0 (vs), 21.7 (s),
`22.3 (w), 23.4 (m), 24.0 (m), 25.6 (w), 26.2 (m);
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`E) polymorph E exhibits a characteristic X-ray powder diffraction pattern with
`characteristic peaks expressed in 2θ at 4.4 (vw), 5.0 (s), 6.6 (s), 6.8 (s), 8.9 (s),
`10.0 (m), 10.3 (s), 10.8 (m), 13.3 (s), 13.6 (m), 14.0 (s), 15.2 (vw), 15.9 (w),
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`1 As of the parties’ pre-trial filing exchanges, Plaintiffs’ only alleged basis for infringement of
`any ’993 patent claim against Amneal was as to the claimed crystalline polymorph “A.”
`Plaintiffs thus dropped any allegation that the API in Amneal’s ANDA product alternatively
`meet the claimed polymorph “E” limitations, or that Amneal infringes any of the previously-
`asserted claims (32 and 33) directed only to form E.
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`2
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`Case 1:14-cv-02758-PAC Document 105 Filed 12/16/16 Page 5 of 14
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`16.4 (w), 16.9 (vw), 17.8 (vw), 18.3 (m), 18.9 (w), 20.2 (vs), 20.4 (m), 20.7
`(m), 20.9 (m), 21.1 (vs), 21.6 (m), 21.7 (m), 22.3 (m), 23.5 (m), 23.8 (m), 24.1
`(w), 24.7 (vw), 25.4 (vw), 26.6 (m), 30.2 (w), 34.0 (vw); and
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`F) polymorph F exhibits a characteristic X-ray powder diffraction pattern with
`characteristic peaks expressed in 2θ at 5.1 (m), 5.6 (w), 7.0 (s), 8.8 (m), 9.6
`(s), 10.2 (w), 10.9 (m), 11.3 (w), 11.9 (m), 12.5 (m), 13.0 (s), 13.7 (m), 14.4
`(s), 14.7 (m), 15.3 (vw), 15.5 (w), 16.8 (m), 17.6 (w), 18.3 (m), 19.3 (m), 19.7
`(m), 20.6 (m), 21.2 (vs), 21.8 (s), 22.8 (s), 23.1 (w), 23.8 (w, shoulder), 24.1
`(s), 24.8 (s), 25.7 (m), 26.2 (vw), 26.6 (m), 26.9 (w), 28.4 (w), 29.5 (w), 29.8
`(vw), 30.9 (m);
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`wherein, for each of said polymorphs, (vs) stands for very strong intensity; (s)
`stands for strong intensity; (m) stands for medium intensity; (w) stands for
`weak intensity; (vw) stands for very weak intensity.
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`Claim 22:
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`A pharmaceutical composition comprising an effective amount of the
`crystalline polymorph or amorphous form according to claim 1, and a
`pharmaceutically acceptable carrier.
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`Claim 23:
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`A crystalline polymorph A, B, C, D, E, F, or the amorphous form, of (3 R,5
`S)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3 -yl]-3,5-dihydroxy-6(E)-
`heptenoic acid hemicalcium salt of claim 1, wherein polymorph A has an X-
`ray powder diffraction pattern substantially as depicted in FIG. 1, polymorph
`B has an X-ray powder diffraction pattern substantially as depicted in FIG. 2,
`polymorph C has an X-ray powder diffraction pattern substantially as depicted
`in FIGS. 3A and 3B, polymorph D has an X-ray powder diffraction pattern
`substantially as depicted in FIG. 4, polymorph E has an X-ray powder
`diffraction pattern substantially as depicted in FIG. 5, polymorph F has an X-
`ray powder diffraction pattern substantially as depicted in FIG. 6, and the
`amorphous form has an X-ray powder diffraction pattern substantially as
`depicted in FIGS. 7A and 7B.
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`Claim 24:
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`A crystalline polymorph A of (3R,5S)-7[2-cyclopropyl-4-(4-fluorophenyl)
`quinolin-3-yl]-3,5-dihydroxy-6(E)-heptenoic acid hemicalcium salt, which
`exhibits a characteristic X-ray powder 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), and 34.0 (w), wherein (vs) stands for very
`strong intensity, (s) stands for strong intensity, (m) stands for medium
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`3
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`Case 1:14-cv-02758-PAC Document 105 Filed 12/16/16 Page 6 of 14
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`intensity, (w) stands for weak intensity, and (vw) stands for very weak
`intensity.
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`Claim 25:
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`A crystalline polymorph A of (3R,5S)-7[2-cyclopropyl-4-(4-fluorophenyl)
`quinolin-3-yl]-3,5-dihydroxy-6(E)-heptenoic acid hemicalcium salt, having an
`X-ray powder diffraction pattern substantially as depicted in FIG. 1.
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`(DTX-1307 at 10:50–11:37; 13:7–41.)
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`7.
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`The Specification
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`The specification of the ’993 patent explains that “[i]t is known that pharmaceutical
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`substances can exhibit polymorphism,” which it defines as “the ability of any substance to have
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`two or more different crystal structures.” (DTX-1307 at 1:67–2:3.) The ’993 patent also
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`recognizes that “[d]ifferent polymorphs, pseudopolymorphs or the amorphous form differ in their
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`physical properties such as melting point, solubility etc.” (Id. at 2:6–8.)
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`8.
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`Further, the ’993 patent depicts one or more “characteristic X-ray powder
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`diffraction patterns” for each of the crystalline forms A–F and the amorphous form that are
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`explicitly incorporated into the claims as shown above. (DTX-1307 at 10:34–47, FIGS. 1–7B,
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`10:50–11:37, 13:7–41.) For instance, the ’993 patent describes that Figure 1 “is a characteristic
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`X-ray powder diffraction pattern for Form A,” and Figures 3A and 3B “are two characteristic X-
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`ray powder diffraction patterns for Form C.” (DTX-1307 at 10:34–35, 38–39, FIG. 1, FIGS. 3A–
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`3B.) As to potential experimental error in the powder X-ray diffractograms of the alleged
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`invention, the ’993 patent discloses only that “2θ angles are recorded with an experimental error
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`of ±0.1–0.2°.” (Id. at 5:61–67.)
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`II.
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`The API Used in the Manufacture of Amneal’s ANDA Product
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`4
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`Case 1:14-cv-02758-PAC Document 105 Filed 12/16/16 Page 7 of 14
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`10.
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` None of Plaintiffs’ experts performed any testing of their own—XRPD or
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`otherwise—on Amneal’s ANDA product or the API in the ANDA product to prove infringement,
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`either literally or under the doctrine of equivalents.
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`III. Non-Infringement of Claims 1 and 22–25 of the ’993 Patent
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`Plaintiffs Have Failed to Prove That the API in Amneal’s ANDA Product
`Literally Meets Every Limitation of the Polymorph Form A as Claimed.
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`12.
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`“To prove infringement, the patentee must show that the accused device meets each
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`claim limitation, either literally or under the doctrine of equivalents.” Dynacore Holdings Corp.
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`v. U.S. Philips Corp., 363 F.3d 1263, 1273 (Fed. Cir. 2004). Plaintiffs’ evidence of infringement
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`of the ’993 patent against Amneal is legally insufficient in this case. Plaintiffs’ have not shown
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`that the API in Amneal’s ANDA product meets the peak positions and relative intensity limitation
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`recited in asserted claims 1 and 24, or substantially as depicted in the X-ray powder diffraction
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`pattern (Figure 1) of asserted claims 23 and 25, for the crystalline polymorph A as specifically
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`claimed. Because Plaintiffs have not proved infringement of claim 1, there can also be no
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`2
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`5
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`Case 1:14-cv-02758-PAC Document 105 Filed 12/16/16 Page 8 of 14
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`infringement of claim 22, which depends from claim 1. Wahpeton Canvas Co. v. Frontier, Inc.,
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`870 F.2d 1546, 1552 n.9 (Fed. Cir. 1989).
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`3 Although one of Plaintiffs’ other experts, Dr. Stephen R. Byrn, also generally agreed with Dr.
`Kaduk’s opinions for purposes of his infringement opinions on dependent claim 22, Dr. Byrn
`offered no independent XRPD analysis outside of or in addition to what Dr. Kaduk offered, and
`thus, Dr. Byrn’s testimony cannot remedy the deficiencies of Plaintiffs’ infringement case
`against Amneal.
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`6
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`Case 1:14-cv-02758-PAC Document 105 Filed 12/16/16 Page 9 of 14
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`16.
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`Dr. Kaduk’s say-so assertions are particularly insufficient because Dr. Kaduk
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`admitted that he could have, but chose not to, generate and report a peak list from his software to
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`corroborate his assertions on infringement as to each peak. But Dr. Kaduk never printed or
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`otherwise produced any such peak list data
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`t—are in fact present and sufficient to satisfy
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`the corresponding claim limitations. As such, his expert opinions fall short.
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`17.
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`Second, Dr. Kaduk’s infringement opinions as to the relative intensities for peaks
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`recited in claims 1 and 24, and depicted in claims 23 and 25, are insufficient because they can only
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`generate infringement by contradicting the language of the claims. The claims include relative
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`intensity limitations—either through explicit designations (“vs, s, m, w, or vw”) or through
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`incorporation of the peaks and corresponding relative intensities in Figure 1 into the claims. (DTX-
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`7
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`Case 1:14-cv-02758-PAC Document 105 Filed 12/16/16 Page 10 of 14
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`1307 at 10:50–11:37; 13:7–41.) Thus, it appears undisputed that the claims require not only peaks
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`identified at specific positions, but also with corresponding relative intensities. Yet Dr. Kaduk
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`simply dismissed any differences in relative intensity—
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`But perhaps more to the point, Dr. Kaduk cannot contradict the relative intensity limitations of the
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`claims because of some unspecified “experimental error.” Under the law of infringement, experts
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`are not free to “contradict” the plain language of the claims in opining “that a critical claim
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`limitation is found in the accused device.” Dynacore Holdings Corp. v. U.S. Philips Corp., 363
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`F.3d 1263, 1278 (Fed. Cir. 2004). Dr. Kaduk’s relative intensity analysis thus further fails to show
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`infringement.
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`18.
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`Had it been impossible or even unfeasible for Plaintiffs or their experts to produce
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`their own diffractograms of the API used in Amneal’s ANDA product, perhaps Dr. Kaduk’s say-
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`so about peak positions
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` to produce different relative
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`intensities would have been understandable, if not acceptable. But here everyone agrees that
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`XRPD testing is routine in the art, so Dr. Kaduk or one of Plaintiffs’ other experts could have
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`tested the API used in Amneal’s ANDA product. Or perhaps more appropriately they could have
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`tested samples of Amneal’s ANDA product itself, which is the product for which infringement
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`must be judged. See Biotech Biologische Naturverpackungen GmbH & Co. v. Biocorp, Inc., 249
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`F.3d 1341, 1350 (Fed. Cir. 2001) (“Infringement of product claims by an imported product requires
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`that the product be viewed in the form in which it is present within the United States.”).
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`8
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`Case 1:14-cv-02758-PAC Document 105 Filed 12/16/16 Page 11 of 14
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`Plaintiffs’ Have Failed to Prove Infringement of Any Asserted Claim Under
`the Doctrine of Equivalents.
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`19.
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`Like Dr. Kaduk’s literal infringement opinions, his opinions offered for Plaintiffs’
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`doctrine of equivalents argument are insufficient as a matter of law. “Each element contained in
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`a patent claim is deemed material to defining the scope of the patented invention, and thus the
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`doctrine of equivalents must be applied to individual elements of the claim, not to the invention as
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`a whole.” Warner-Jenkinson Co. v. Hilton David Chem., 520 U.S. 17, 29 (1997). Here Dr. Kaduk
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`merely offered his conclusory opinion that the variations in the peak lists and diffractograms of
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`the API in Amneal’s ANDA product compared to the claims are insubstantial and do not indicate
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`any difference in the properties of the polymorph. But these opinions, even if credited, do not
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`identify, much less satisfy objective equivalency as to any specific missing or varying peak
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`element. This is not a proper showing of infringement under the doctrine of equivalents. Id. at 40
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`(“The determination of equivalence should be applied as an objective inquiry on an element-by-
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`element basis.”).
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`20.
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`Nor was Dr. Kaduk’s doctrine of equivalents testimony sufficiently particularized,
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`as required by Federal Circuit precedent. See Tex. Instruments Inc. v. Cypress Semiconductor
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`Corp., 90 F.3d 1558, 1567 (Fed. Cir. 1996) (“Generalized testimony as to the overall similarity
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`between the claims and the accused infringer’s product or process will not suffice.”). Dr. Kaduk
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`did not identify any particularized “function,” “way,” or “result,” that he deems to be substantially
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`the same between the claims and the accused API, and instead offered only a general assertion that
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`the X-ray diffraction patterns show substantially the same structure. This is insufficient under the
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`doctrine of equivalents, not to mention that Dr. Kaduk presented no additional scientific evidence
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`9
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`Case 1:14-cv-02758-PAC Document 105 Filed 12/16/16 Page 12 of 14
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`to back his generalized opinions about insubstantial differences from the asserted claims. Again,
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`Plaintiffs’ doctrine of equivalents proof comes down to Dr. Kaduk’s mere say-so.
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`21.
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`Dr. Kaduk’s opinions and Plaintiffs’ doctrine of equivalents arguments also ignore
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`the inherently narrow claims at issue here, and thus the correspondingly narrow scope of available
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`equivalents. See Moore U.S.A., Inc. v. Standard Register Co., 229 F.3d 1091, 1106 (Fed. Cir.
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`2000) (“[A]ll claim limitations are not entitled to an equal scope of equivalents. Whether the result
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`of the All Limitations Rule, prosecution history estoppel, or the inherent narrowness of the claim
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`language, many limitations warrant little, if any, range of equivalents.”) (internal citations
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`omitted). Here the patentee explicitly chose to limit the claims to the polymorph form A having
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`particular peaks and associated relative intensities (claims 1 and 24) or having a diffractogram
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`substantially as depicted and incorporated in Figure 1 (claims 23 and 25). The available scope
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`under doctrine of equivalents scope is thus similarly narrow. Sage Prods., Inc. v. Devon Indus.,
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`Inc., 126 F.3d 1424, 1424 (Fed. Cir. 1997) (“[F]or a patentee who has claimed an invention
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`narrowly, there may not be infringement under the doctrine of equivalents in many cases, even
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`though the patentee might have been able to claim more broadly.”). Accordingly, Dr. Kaduk’s
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`generalized opinions about overall similarity are inappropriate given the patentee’s narrow
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`claiming here.
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`22.
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`As such, Plaintiffs have not proved that Amneal’s proposed ANDA product will
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`infringe any asserted claim of the ’993 patent, either literally or under the doctrine of equivalents.
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`Case 1:14-cv-02758-PAC Document 105 Filed 12/16/16 Page 13 of 14
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`Dated: December 16, 2016
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`Respectfully submitted,
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`/s/ Steven A. Maddox
`Steven A. Maddox (Pro Hac Vice)
`Jeremy J. Edwards (Pro Hac Vice)
`Kaveh Saba (Pro Hac Vice)
`Maddox Edwards PLLC
`1900 K Street N.W., Suite 725
`Washington, D.C. 20006
`(202) 830-0707
`smaddox@meiplaw.com
`jedwards@meiplaw.com
`ksaba@meiplaw.com
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`Case 1:14-cv-02758-PAC Document 105 Filed 12/16/16 Page 14 of 14
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`CERTIFICATE OF SERVICE
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`
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`I, Steven A. Maddox, hereby certify that on December 16, 2016, a true and correct copy of
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`the foregoing was filed pursuant to the Electronic Case Filing (ECF) system with service to be
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`completed by Notification of Electronic Filing (NEF) on counsel of record for all parties from the
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`Court.
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`/s/ Steven A. Maddox
`Steven A. Maddox
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`12
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