Replies to post #207602 on Amarin Corp Plc (AMRN)

[Biobillionair]

8-9 Amarin:

AMARIN’S MOTION FOR PARTIAL SUMMARY JUDGMENT

ORAL ARGUMENT REQUESTED

Copy:

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Case 2:16-cv-02525-MMD-NJK
Document 234
Filed 08/09/19
Page 1 of 18
Nicholas J. Santoro (Nev. Bar No. 532) Jason D. Smith (Nev. Bar No. 9691) SANTORO WHITMIRE, LTD. 10100 W. Charleston Blvd., Suite 250 Las Vegas, Nevada 89135
Tel.: [phone]
Fax: [phone]
E-mail: [e-mail], [e-mail]
Christopher N. Sipes (admitted pro hac vice) Einar Stole (admitted pro hac vice)
Michael N. Kennedy (admitted pro hac vice) Megan P. Keane (admitted pro hac vice)
Eric R. Sonnenschein (admitted pro hac vice) Alaina M. Whitt (admitted pro hac vice)
Han Park (admitted pro hac vice)
Jordan L. Moran (admitted pro hac vice) COVINGTON & BURLING LLP
One CityCenter, 850 Tenth Street, NW Washington, DC 20001
Tel.: [phone]
Fax: [phone]
E-mail: [e-mail], [e-mail], [e-mail], [e-mail] [e-mail], [e-mail], [e-mail], [e-mail]
Attorneys for Plaintiffs Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited
UNITED STATES DISTRICT COURT DISTRICT OF NEVADA
AMARIN PHARMA, INC. et al., Plaintiffs,
v.
HIKMA PHARMACEUTICALS USA INC., et al.,
Defendants.
Case No.: 2:16-cv-02525-MMD-NJK (Consolidated with 2:16-cv-02562-MMD-NJK)
AMARIN’S MOTION FOR PARTIAL SUMMARY JUDGMENT
ORAL ARGUMENT REQUESTED

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Case 2:16-cv-02525-MMD-NJK Document 234 Filed 08/09/19 Page 2 of 18
TABLE OF CONTENTS
MEMORANDUM OF POINTS AND AUTHORITIES ................................................................ 1
I. INTRODUCTION AND FACTUAL BACKGROUND .................................................... 1
II. STATEMENT OF UNDISPUTED FACTS PURSUANT TO LR 56-1 ............................ 5
III. ARGUMENT...................................................................................................................... 8
A. Given the complexity of the science at issue in this case, Defendants must
support any invalidity defense with expert testimony. ........................................... 9
B. Amarin is entitled to summary judgment that all asserted claims are not anticipated under 35 U.S.C. § 102. ....................................................................... 11
C. Amarin is entitled to summary judgment that all asserted claims are not
invalid under 35 U.S.C. § 112............................................................................... 12
1. Defendants have disclosed no evidence that any asserted claim is
invalid for lack of written description....................................................... 13
2. Defendants have disclosed no evidence that any asserted claim is
invalid for lack of enablement. ................................................................. 14
3. Defendants have disclosed no evidence that any asserted claim is
invalid as indefinite................................................................................... 14
IV. CONCLUSION................................................................................................................. 15
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Case 2:16-cv-02525-MMD-NJK Document 234 Filed 08/09/19 Page 3 of 18
Plaintiffs Amarin Pharma Inc. and Amarin Pharmaceuticals Ireland Limited (collectively, “Amarin” or “Plaintiffs”), by and through its attorneys of record, hereby move for partial summary judgment rejecting all of Defendants’ affirmative defenses and counterclaims asserting invalidity, to the extent that said affirmative defenses and counterclaims allege that any asserted claim is anticipated under 35 U.S.C. § 102, or invalid under 35 U.S.C. § 112.1 This Motion is made and based upon the pleadings and papers on file herein, the below Memorandum of Points and Authorities, the Declaration of Michael N. Kennedy filed contemporaneously with this Motion, as well as any argument of counsel the Court may allow at any hearing on this Motion.
MEMORANDUM OF POINTS AND AUTHORITIES I. INTRODUCTION AND FACTUAL BACKGROUND
This Hatch-Waxman patent infringement litigation arises from Defendants’ desire to market generic copies of Amarin’s FDA-approved medication, Vascepa®2. Clinicians prescribe Vascepa to treat patients with severely elevated levels of triglycerides (“TGs”), a type of fat molecule found in blood. Severely elevated TGs, also known as “very-high” TGs, refers to TGs of at least 500 mg/dl (≥ 500 mg/dl). Patients with severe hypertriglyceridemia, as this condition is known, are at serious risk of developing pancreatitis, a potentially life-threatening inflammation of the pancreas. Vascepa, whose active ingredient is a highly purified omega-3 fatty acid called ethyl-eicosapentaenoic acid (“ethyl-EPA” or “EPA”), mitigates this risk by lowering the patient’s TG levels.
Amarin spent many years and hundreds of millions of dollars to demonstrate to FDA’s satisfaction that Vascepa delivered important therapeutic benefits with an improved safety and tolerability profile relative to prior art treatments. Defendants seek to piggyback on Amarin’s work, attempting to sell generic equivalents of Vascepa by arguing that the patents covering
1 See Def. Hikma’s Answer to Compl. 20–34 (Jan. 9, 2017) (ECF No. 27); Def. Dr. Reddy’s Answer to Compl. 23–56 (Jan. 13, 2017) (ECF No. 33) (asserting affirmative defenses and counterclaims based on 35 U.S.C. §§ 101, 102, 103 and 112).
2 The ® symbol will generally be omitted herein. 1

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Case 2:16-cv-02525-MMD-NJK Document 234 Filed 08/09/19 Page 4 of 18
Vascepa’s approved methods of treatment are invalid as obvious, notwithstanding that Vascepa’s clinical trial results disproved the conventional wisdom.
As of March 2008, the date of invention for the patents at issue in this case, other TG- lowering medications existed. These medications, however, presented patients with significant safety and tolerability concerns. For example, a drug called Lovaza, like Vascepa an omega-3 fatty acid product, was FDA-approved for lowering TGs in patients with severe hypertriglyceridemia but was known to substantially increase those patients’ bad cholesterol— known as LDL-C.3 Vascepa was the first, and remains the only, product approved for the treatment of severe hypertriglyceridemia that has been shown to reduce triglycerides in such patients without raising LDL-C, as Defendants’ own retained expert, Dr. Jay Heinecke, conceded. See Declaration of Michael N. Kennedy in Support of Amarin’s Motion for Partial Summary Judgment (“Kennedy Decl.”), Exhibit 1, Heinecke Deposition Tr. 143:9–144:10.
Amarin spent years conducting clinical trials to confirm that Vascepa represented a substantial improvement upon prior therapies. For example, in the “MARINE” clinical trial, Amarin showed that Vascepa safely lowers TG levels in patients with severe hypertriglyceridemia without increasing LDL-C, and is better tolerated than prior medications. The results of the MARINE trial are part of the FDA-approved prescribing information for Vascepa, and Defendants are relying on the MARINE data to obtain approval of their own generic copies of Vascepa.
Following the success of the MARINE trial, Amarin spent the intervening years, and over $300 million, to conduct another clinical trial, called “REDUCE-IT,” to investigate whether Vascepa can reduce a patient’s risk of suffering a major adverse cardiovascular event, such as
3 Other approved medications for lowering TGs in patients with severe hypertriglyceridemia included fibrates and niacin. Undesirable side effects and safety concerns associated with these drugs often affected user compliance thereby reducing treatment efficacy. In addition to the increase in LDL-C levels observed in patients with very high TGs, fibrates were associated with rhabdomyolysis if combined with a statin. Niacin was known to cause intense flushing, which made it difficult and unappealing to use for many patients.
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Case 2:16-cv-02525-MMD-NJK Document 234 Filed 08/09/19 Page 5 of 18
cardiovascular death, nonfatal heart attack, and non-fatal stroke, among others. Several earlier cardiovascular outcomes trials, involving other TG-lowering drugs, had failed to show substantial risk reduction. But REDUCE-IT’s topline results, announced in September 2018, far exceeded expectations. Specifically, REDUCE-IT established that treatment with Vascepa brought about an approximately 25% relative reduction in risk of major adverse cardiovascular events on top of the risk reduction accomplished by statin therapy.
REDUCE-IT has been recognized as “a stunning clinical trial result that upends years of skepticism about the long-term heart benefit of products containing omega-3 fatty acids.”4 The results were met with “surprise, speculation, and hope,”5 with doctors praising the unexpected REDUCE-IT results.6 One physician commented, “I went into this study not convinced that Vascepa would make a difference, but these results will definitely change my practice and the way I treat patients.”7 Vascepa is the only agent approved for treatment of severe hypertriglyceridemia that has been shown to provide cardiovascular benefit to patients on statins. Exhibit 1 at 147:7–13.
4 Kennedy Decl., Exhibit 2, Adam Feuerstein, Amarin Fish oil capsule shows dramatic benefit for cardiovascular patients, potentially upending market, STAT+ (Sept. 24, 2018), https://www.statnews.com/2018/09/24/amarin-fish-oil-capsule-shows-dramatic-benefit-for- cardiovascular-patients, at 1.
5 Kennedy Decl., Exhibit 3, Kastelein et al., FISHing for the Miracle of Eicosapentaenoic Acid, 380 N. Engl. J. Med. 89, 89 (2019) at 1 (“After a parade of failed cardiovascular outcome trials of fish oils, REDUCE-IT has shown a substantial benefit with respect to major adverse cardiovascular events.”).
6 Kennedy Decl., Exhibit 4, O’Connor, Fish Oil Drug May Prevent Heart Attack and Strokes in High-Risk Patients, The New York Times (Sept. 25, 2018), https://www.nytimes.com/2018/09/25/well/fish-oil-heart-attack-stroke-triglyceridesomega- 3s.html, at 1 (“‘I’m very surprised by the magnitude of the results, which quite frankly are large ... My expectations were very low. A lot of people are legitimately surprised by this.’”) (quoting Dr. Michael J. Blaha, the director of clinical research at the Ciccarone Center for the Prevention of Heart Disease at Johns Hopkins Medical School, who was not involved in the study).
7 Exhibit 2 at 3 (quoting Dr. Norman Lepor, a cardiologist at Cedars-Sinai Medical Center in Los Angeles and a Vascepa study investigator).
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Case 2:16-cv-02525-MMD-NJK Document 234 Filed 08/09/19 Page 6 of 18
Amarin obtained several patents claiming methods of treating patients with very high
triglycerides to achieve (or avoid) certain lipid effects in accordance with the important results
from the MARINE trial. Use of Vascepa according to its product labeling embodies these
asserted claims. Claim 1 of the ’728 patent can be considered representative for present
purposes:
1. A method of reducing triglycerides in a subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl who does not receive concurrent lipid altering therapy comprising: administering orally to the subject about 4 g per day of a pharmaceutical composition comprising at least about 96%, by weight of all fatty acids present, ethyl eicosapentaenoate, and substantially no docosahexaenoic acid or its esters for a period of 12 weeks to effect a reduction in triglycerides without substantially increasing LDL-C compared to a second subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl who has not received the pharmaceutical composition and a concurrent lipid altering therapy.
Kennedy Decl., Exhibit 5, U.S. Patent No. 8,293,728 (issued Oct. 23, 2012) (“the ’728 Patent”) at 21. Other asserted claims cover different aspects of the treatment methods discovered by Amarin’s scientists, such as reducing triglycerides by certain percentages, avoiding any LDL-C rise, and reducing a patient’s levels of a protein called apolipoprotein B. Amarin is currently asserting infringement of 15 claims from six patents.
The parties have recently completed expert discovery, including three rounds of expert reports. In the opening round, Defendants served a single expert report advancing a single invalidity defense—that all asserted patent claims are obvious under 35 U.S.C. § 103.8 But Defendants have not disclosed expert testimony, or other evidence, that might support a judgment of invalidity of any asserted claim on any ground other than obviousness. For example, as Defendants’ counsel recently confirmed, Defendants’ experts have not opined that
8 Dr. Heinecke also opined that a single claim—dependent Claim 18 of U.S. Patent No. 8,318,715 (“the ’715 patent”)—is indefinite because the term “second subject” is not sufficiently defined in independent claim 17 of the ’715 patent. See Kennedy Decl., Exhibit 6, March 11, 2019 Opening Expert Report of Jay W. Heinecke, M.D. at 148, ¶¶ 408–09. But Amarin later corrected claim 18 of the ’715 patent to address this issue, and in any event that claim is no longer being asserted in this case.
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Case 2:16-cv-02525-MMD-NJK Document 234 Filed 08/09/19 Page 7 of 18
the claims are anticipated under 35 U.S.C. § 102. Exhibit 1 at 95:17–20. Nor have Defendants adduced evidence that the asserted claims are invalid under any aspect of 35 U.S.C. § 112 (such as lack of enablement, lack of written description, or indefiniteness). To the contrary, Defendants’ invalidity expert conceded at deposition that he had treated the claims as not indefinite in forming his opinions, Exhibit 1 at 99:11–24, and was not offering an opinion concerning the defense of lack of written description.
It is Defendants’ burden, by clear and convincing evidence, to establish invalidity of the asserted claims. That being the case, Defendants were required to disclose any and all asserted grounds of invalidity in their opening round expert reports. And where, as here, the technology at issue is complex, the Federal Circuit and other courts have consistently held that expert testimony explaining in clear and convincing fashion how each claim is invalid is required for an accused infringer to maintain an invalidity defense. The Federal Circuit has warned:
It is not our task, nor is in the task of the district court, to attempt to interpret confusing or general testimony to determine whether a case of invalidity has been made out, particularly at the summary judgment stage. Indeed, to accept confusing or generalized testimony as evidence of invalidity is improper. The risk is great that the confusion or generality is the result, not of an inarticulate witness or complex subject matter, but of a witness who is unable to provide the essential testimony.
Schumer v. Lab. Computer Sys., Inc., 308 F.3d 1304, 1316 (Fed. Cir. 2002).
Accordingly, to clarify which issues will be addressed at trial, and to prevent any possible sandbagging from Defendants, the Court should grant Amarin partial summary judgment that (a) no asserted claim is anticipated under 35 U.S.C. § 102; and (b) no asserted claim is invalid under
35 U.S.C. § 112.
II. STATEMENT OF UNDISPUTED FACTS PURSUANT TO LR 56-1
1. This is a Hatch-Waxman patent case arising from Defendants’ desire to market generic copies of Amarin’s successful FDA-approved medication, Vascepa. See Pl.’s Compl. at 2 (Oct. 31, 2016) (ECF No. 1); Pl.’s Mot. to Consolidate at 3–4 (Dec. 22, 2016) (ECF No. 25).
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Case 2:16-cv-02525-MMD-NJK Document 234 Filed 08/09/19 Page 8 of 18
2. Vascepa is a pharmaceutical comprised of a highly purified omega-3 fatty acid called ethyl-eicosapentaenoic acid (“ethyl-EPA” or “EPA”). See, e.g., Decl. of Ronald H. Wharton, M.D., in Supp. of Defs.’ Claim Construction at 8–9 (Dec. 12, 2017) (ECF No. 102-1).
3. Vascepa is indicated “as an adjunct to diet to reduce triglyceride (“TG”) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.” Kennedy Decl., Exhibit 7, Vascepa Prescribing Information (2017) at 2.
4. Patients with severe hypertriglyceridemia are at risk of developing pancreatitis, a potentially life-threatening inflammation of the pancreas. See, e.g., Decl. of Ronald H. Wharton, M.D., in Supp. of Defs.’ Claim Construction at 7 (Dec. 12, 2017) (ECF No. 102-1).
5. Amarin originally asserted infringement of 14 patents. See Pl.’s Compl. at 2 (Oct. 31, 2016) (ECF No. 1).
6. In accordance with the Court’s June 21, 2019 Order (ECF No. 229), Amarin has elected the following 15 asserted claims: Claims 1, 13, and 16 of the ’728 Patent, Claim 14 of the ’715 Patent, Claims 1, 7, and 8 of U.S. Patent No. 8,357,677 (“the ’677 Patent”), Claims 1, 7, and 8 of U.S. Patent No. 8,367,652 (“the ’652 Patent”), Claims 4, 7, and 17 of U.S. Patent No. 8,431,560 (“the ’560 Patent”), and Claims 1 and 5 of U.S. Patent No. 8,518,929 (“the ’929 Patent”).9 See Kennedy Decl., Exhibit 8, Letter from Alaina Whitt, Counsel for Amarin, to Defs.’ Counsel (July 19, 2019) at 1–2.
7. The parties served their first round of expert reports on March 11, 2019. In the opening round of expert discovery, Defendants submitted a single report, from Dr. Jay Heinecke. He opined that each asserted claim was invalid for obviousness. See, e.g., Exhibit 6 at 16, ¶¶ 19– 20. However, Dr. Heinecke did not opine that any of the asserted claims was invalid for any other reason. See Exhibit 6.10
9 See Exhibit 5; Pl.’s Opening Markman Br. at Ex. 5, 6, 7, 12, 14 (Nov. 1, 2017) (ECF Nos. 89-7, 89-8, 89-9, 89-14, 89-16).
10 Although only a small portion of Dr. Heinecke’s Opening Expert Report is cited in this Motion, the complete report is attached to provide the full scope of his invalidity arguments.
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Case 2:16-cv-02525-MMD-NJK Document 234 Filed 08/09/19 Page 9 of 18
8. The parties served their second round of expert reports on May 10, 2019. See Defs’ Mot. to Modify Disc. Plan and Scheduling Order at 6 (Dec. 19, 2018) (ECF No. 165).
9. The parties served their third round of expert reports on June 10, 2019. See id.
10. The parties completed depositions of the experts who have submitted reports on
July 17, 2019. See Joint Stipulation for Extension of Time for Expert Disc. Deadline and Claim Reduction Deadline at 3 (June 19, 2019) (ECF No. 228).
11. Dr. Heinecke acknowledged during his July 17, 2019 deposition that he did not form any opinions to the effect that any asserted claim is anticipated (i.e., that it is lacking novelty). See Exhibit 1 at 93:2–95:21.
12. At Dr. Heinecke’s July 17, 2019 deposition, Hikma’s counsel represented that the “scope of [Dr. Heinecke’s] opinions” is “not about anticipation.” Exhibit 1 at 95:13–21.
13. Dr. Heinecke acknowledged during his July 17, 2019 deposition that he has not formed any opinions that any asserted claim is invalid for lacking adequate written description under 35 U.S.C. § 112. See Exhibit 1 at 97:7–13.
14. Dr. Heinecke acknowledged during his July 17, 2019 deposition that he has not offered any opinions that any asserted claim is invalid for being indefinite under 35 U.S.C. § 112. See Exhibit 1 at 96:18–97:1.
15. Dr. Heinecke stated, based on guidance from counsel, that he understood that the asserted patents’ claim terms concerning LDL-C are not indefinite. See Exhibit 6 at 19–20, ¶ 32; Exhibit 1 at 99:3–24.
16. Amarin has proposed the following definition of a person of ordinary skill in the art:
[A] person of ordinary skill in the art in this case would be (1) a clinician with an M.D., or D.O. and at least 2 to 3 years of experience in the diagnosis, evaluation, and treatment of lipid blood disorders, including severe hypertriglyceridemia (i.e., TG levels of at least 500 mg/dl) or (2) alternatively, a clinician, such as a nurse practitioner or physician’s assistant, with 3 to 5 years of experience in the diagnosis, evaluation, and treatment of lipid blood disorders, including severe hypertriglyceridemia.
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Case 2:16-cv-02525-MMD-NJK Document 234 Filed 08/09/19 Page 10 of 18
Kennedy Decl., Exhibit 9, May 10, 2019 Rebuttal Expert Report of Jay W. Heinecke, M.D. at 3, ¶ 21.
17. Defendants have proposed the following definition of a person of ordinary skill in
the art:
[T]he person of ordinary skill in the art to whom the patents-in-suit are directed would, in March 2008, have had at least a medical degree or an advanced degree in the field of lipid biochemistry. The person of ordinary skill in the art would also have had several years of experience in the development and/or clinical use of fatty acids to treat blood lipid disorders, including fish oil based fatty acids, i.e., EPA and DHA, and their dosage forms. The person of ordinary skill in the art would also have had access to a team including one or more of a medical doctor, an analytical chemist familiar with lipids and fish oils, a lipid biochemist, a pharmaceutical chemist or a person working in a comparable field with an advanced degree (such as a Ph.D. or M.D.). Any one of these persons could and would consult with any of the others. The person of ordinary skill in the art could have a lower level of formal education if such person has a higher degree of experience. The person of ordinary skill in the art would easily have understood the prior art references referred to herein, and would have the capability to draw inferences from that information.
Exhibit 6 at 21–22, ¶ 37.
18. Dr. Heinecke’s proffered opinion is that “a POSA would have had a high level of
skill relevant to the asserted patents.” Exhibit 1 at 276:13–25.
III. ARGUMENT
A moving party is entitled to summary judgment under Fed. R. Civ. P. 56(c) when there is no genuine issue of material fact and the evidence establishes the moving party’s entitlement to judgment as a matter of law. Celotex Corp. v. Catrett, 477 U.S. 317, 322–23 (1986). Moreover, the Court “must view the evidence presented [by Defendants] through the prism of the substantive evidentiary burden” they bear to prove invalidity—i.e., by the clear and convincing standard. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 254 (1986); see also Creative Compounds, LLC v. Starmark Labs., 651 F.3d 1303, 1309–10 (Fed. Cir. 2011); Sonner v. Schwabe N. Am., Inc., 911 F.3d 989, 992 (9th Cir. 2018); AAT Bioquest, Inc. v. Texas Fluorescence Labs., Inc., 2015 WL 1738402, at *3 (N.D. Cal. Apr. 13, 2015).
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A court considering a summary judgment motion views all facts, and draws all inferences, in the light most favorable to the nonmoving party. See, e.g., F.T.C. v. Stefanchik, 559 F.3d 924, 927 (9th Cir. 2009).11 Once the moving party satisfies Rule 56 by demonstrating the absence of any genuine issue of material fact, the burden shifts to the party resisting summary judgment to “set forth specific facts showing that there is a genuine issue for trial.” Anderson, 477 U.S. at 256. The nonmoving party “must produce specific evidence, through affidavits or admissible discovery material, to show that” there is a sufficient evidentiary basis on which a reasonable fact finder could find in her favor. Bhan v. NME Hosps., Inc., 929 F.2d 1404, 1409 (9th Cir. 1991).
Because it is the Defendants’ burden to show that the asserted claims are invalid, Amarin is not required to present any factual evidence in this motion. See, e.g., Creative Compounds, 651 F.3d at 1312–13 (affirming summary judgment that claims were not invalid for prior invention since non-movant accused infringer put forward only attorney argument); see also Biotec Biologische Naturverpackungen GmbH & Co. v. Biocorp, Inc., 249 F.3d 1341, 1353–54 (Fed. Cir. 2001) (affirming grant of summary judgment that patents were not invalid in the “absence of explanation by the [non-movant’s] expert as to why [the references he identified] rendered the Biotec patents invalid”).
A. Given the complexity of the science at issue in this case, Defendants must support any invalidity defense with expert testimony.
As a general rule, expert testimony is required to support an invalidity defense. See, e.g., Centricut, LLC v. Esab Grp., Inc., 390 F.3d 1361, 1369–70 (Fed. Cir. 2004) (“Where the field or art is complex, we have repeatedly approved the use of expert testimony to establish infringement. We have also noted that ‘typically’ expert testimony will be necessary in cases
11 Although Federal Circuit precedent governs this patent case, the Federal Circuit applies the relevant regional circuit’s law as to procedural issues and other matters not unique to patent law. See Panduit Corp. v. All States Plastics Mfg. Co., 744 F.2d 1564, 1574–75 (Fed. Cir. 1984).
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involving complex technology.”) (internal citations omitted). Specifically, courts have consistently held that “an expert opinion from one skilled in the art is generally required to [establish] patent invalidity in cases involving complex technology and non-intuitive engineering principles.” Diodem, LLC v. Lumenis, Inc., 2005 WL 6220667, at *7 (C.D. Cal. Jan. 10, 2005) (citing Schumer, 308 F.3d at 1315 (“Typically, testimony concerning [invalidity] must be testimony from one skilled in the art.”)).
This case fits comfortably within that general rule, as the technology related to these method of treatment claims implicates scientific fields such as lipidology and analytical chemistry. See, e.g., INVISTA N. Am. S.a.r.l. v. M&G USA Corp., 951 F. Supp. 2d 626, 651–52 (D. Del. 2013) (granting partial summary judgment of no invalidity because nonmovant “has no expert testimony regarding” the combination at issue and “the field of polymer chemistry is a complex area of technology, and where patent claims involve complex issues of technology, expert testimony is required to aid the fact finder”).12 Indeed, both sides have put forward definitions of a “person of ordinary skill in the art” that clearly recognizes the complexity of this field, both requiring the hypothetical POSA to possess advanced medical and/or scientific training, as well as several years of experience treating blood lipid disorders. SOF ¶¶ 16–17. Defendants’ expert, Dr. Heinecke, made a point of saying that practitioners in this field have a high level of skill. See Exhibit 1 at 276:20–25. Thus, Defendants cannot credibly argue that an invalidity defense in this case involves technology that is “simple and easily understood” where the patent specification is within “the grasp of an ordinary layperson.” Proveris Sci. Corp. v. Innovasystems, Inc., 536 F.3d 1256, 1267 (Fed. Cir. 2008).
12 See also Allergan, Inc. v. Barr Labs., Inc., 501 F. App’x 965, 972 (Fed. Cir. 2013) (where the patent involved a drug for treating glaucoma, finding that “this is not a case where ‘the technology is simple,’ or where the references are ‘easily understandable without the need for expert explanatory testimony’”) (internal citations omitted); AAT Bioquest, 2015 WL 1738402, at *5 (granting partial summary judgment of no invalidity for written description for patents involving calcium ion indicators because the accused infringer “presented only attorney argument” on the issue).
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B. Amarin is entitled to summary judgment that all asserted claims are not anticipated under 35 U.S.C. § 102.
Defendants have the burden to prove an anticipation defense. See, e.g., OSRAM Sylvania, Inc. v. Am. Induction Techs., Inc., 701 F.3d 698, 704–05 (Fed. Cir. 2012). As the Federal Circuit has repeatedly reaffirmed:
A finding of anticipation requires clear and convincing evidence that each and every element is found within a single prior art reference, arranged as claimed. Testimony concerning anticipation must typically explain in detail how each claim element is disclosed in the prior art reference. The testimony is insufficient if it is merely conclusory.
ATEN Int’l Co., Ltd. v. Uniclass Techn. Co., Ltd., No. 2018-1606, slip op. at 7, 2019 WL 3558562, at *3 (Fed. Cir. Aug 6, 2019) (internal quotations omitted); see also Creative Compounds, 651 F.3d at 1313; Koito Mfg. Co. v. Turn-Key-Tech, LLC, 381 F.3d 1142, 1152 (Fed. Cir. 2004).
Here, not only does Dr. Heinecke’s expert report contain no opinion that any asserted claim is anticipated, but Defendants’ counsel stipulated on the record at Dr. Heinecke’s deposition that the scope of his opinions are “not about anticipation.” Exhibit 1 at 93:2–95:21. And Defendants served no other expert report opining that any claim is anticipated. Because Defendants have failed to adduce any evidence to support a defense of anticipation, let alone clear and convincing evidence, judgment of no anticipation should be granted. See, e.g., Vectura Ltd. v. GlaxoSmithKline LLC, No. cv 16-638-RGA, 2019 WL 1244942, at *2–4 (D. Del. 2019) (granting patentee summary judgment of no anticipation for patents involving pharmaceutical compositions for inhalation because the accused infringer’s technical expert’s report on anticipation failed to address most limitations of the claims).
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C. Amarin is entitled to summary judgment that all asserted claims are not invalid under 35 U.S.C. § 112.
Accused infringers, such as Defendants, have several potential defenses available under 35 U.S.C. § 112.13 For example, a claim can be invalid for lack of written description, which requires an accused infringer to show that the inventor did not actually invent the invention claimed. See, e.g., ARIAD Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). A claim can be invalid for lack of enablement, which requires the accused infringer to show that the inventor has not provided sufficient information in the patent for others to make and use the claimed invention. See, e.g., ALZA Corp. v. Andrx Pharms., LLC, 603 F.3d 935, 940 (Fed. Cir. 2010). Or, a claim can be invalid as indefinite, which requires the accused infringer to show that a person of ordinary skill in the art cannot understand with reasonable certainty the scope of the invention. See, e.g., Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901 (2014). Defendants have the burden to show invalidity under section 112 by clear and convincing evidence. See, e.g., Intirtool, Ltd. v. Texar Corp., 369 F.3d 1289, 1294 (Fed. Cir 2004). Here, Defendants have disclosed no evidence that could support a section 112 defense.14
13 “The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out the invention.” 35 U.S.C. § 112 (pre-America Invents Act (AIA)). Pre-AIA law applies to patent applications, such as the ones at issue here, filed before September 16, 2012.
14 See. e.g, Lucent Tech. Inc. v. Gateway, Inc., 2007 WL 1449804, at *3 (S.D. Cal. May 15, 2007) (granting partial summary judgment of no invalidity for lack of written description, when nonmovant failed to present any expert evidence); see also McKesson Automation, Inc. v. Swisslog Holding AG, 2009 WL 3648555, at *28 (D. Del. Oct. 30, 2009), adopted in relevant part, 712 F. Supp. 2d 283 (D. Del. 2010) (recommending that the district court grant partial summary judgment of no invalidity where nonmovant failed to present any expert testimony that the patent was invalid for lack of written description); Gen. Elec. Co. v. SonoSite, Inc., 641 F. Supp. 2d 793, 819–20 (W.D. Wis. 2009) (granting summary judgment of no invalidity when non-movant offered wholly conclusory testimony that patent claim did not meet written description requirement).
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1. Defendants have disclosed no evidence that any asserted claim is invalid for lack of written description.
Dr. Heinecke’s opening expert report disclosed opinions only concerning obviousness. During his deposition, he confirmed that he had formed no opinions concerning whether any asserted claim was invalid for lacking written description. See Exhibit 1 at 97:7–13. Accordingly, Defendants have no basis to put forward a written description defense at trial. Nonetheless, Defendants might try to rely on four scattered and duplicative paragraphs in Dr. Heinecke’s reply report as purportedly supporting a written description defense.15 Any such argument should be rejected. First, as a procedural matter, Defendants cannot rely on invalidity testimony proffered for the first time on reply to meet their affirmative duty to adduce clear and convincing evidence to support an invalidity defense. Because “[e]xperts must limit their reply reports to the scope of the issues raised in the rebuttal reports,” Sloan Valve Co. v. Zurn Indus., Inc., 2013 WL 3147349, at *1 (N.D. Ill. June 19, 2013), such a report is not “the proper place for presenting new arguments.” R & O Construction Co. v. Rox Pro Int'l Grp., Ltd., No. 2:09-cv- 01749, 2011 WL 2923703, at *3 (D. Nev. July 18, 2011); see also Tuuamalemalo v. Las Vegas Metro. Police Dep’t, No. 2:16-cv-00619, 2017 WL 1550235, at *1 (D. Nev. Apr. 28, 2017) (“[A]n expert’s rebuttal testimony may not introduce new, alternative or previously unconsidered theories.”). In fact, in the course of obtaining a substantial extension of the deadline for opening expert reports, Defendants acknowledged that their “invalidity arguments must be addressed in [] opening expert reports” (ECF No. 173 at 4). Defendants cannot now be heard to argue that they are entitled to support invalidity arguments with expert opinions disclosed for the first time in the third round of reports.
Second, the testimony in Dr. Heinecke’s reply report does not in any event suffice to preserve a defense of lack of written description. That testimony amounts to nothing more than
15 Specifically, paragraphs 71, 183, 189, and 204. See Kennedy Decl., Exhibit 10, June 7, 2019 Reply Expert Report of Jay W. Heinecke, M.D. ¶¶ 71, 183, 189, 204.
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the conclusory assertion that if the patent claims are not obvious, then a skilled artisan “would not have believed that the inventors of the asserted patents had achieved that result based on the specification either.” Exhibit 10 at 6, ¶ 71; see also id. ¶¶ 183, 189, 204. But testimony that a skilled artisan would have been skeptical of the results claimed is evidence of validity, see, e.g., WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1335 (Fed. Cir. 2016), and it does not suffice to make out a defense of lack of written description. Such a defense requires instead that Defendants prove with clear and convincing evidence that the specification does not “reasonably convey[] to those skilled in the art that the inventor had possession of the claimed matter as of the filing date.” ARIAD Pharm. Inc., 598 F.3d at 1351. The level of detail required to satisfy the written description requirement “varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.” Id. Dr. Heinecke never considers these legal requisites for a section 112 written description defense (indeed, Dr. Heinecke could not even recall being instructed on such a defense, see Exhibit 1 at 97:2–6), let alone apply the legal requirements to the patent disclosure in this case. Accordingly, summary judgment in favor of Amarin is warranted. See, e.g., Gen. Elec. Co., 641 F. Supp. 2d at 818–19 (granting summary judgment where challenger did not adduce evidence showing the patent failed to describe the claimed invention).
2. Defendants have disclosed no evidence that any asserted claim is invalid for lack of enablement.
Dr. Heinecke’s three expert reports contain no opinions that the asserted patent claims are invalid for lack of enablement. As Defendants disclosed no expert testimony concerning enablement, they cannot support such a defense at trial.
3. Defendants have disclosed no evidence that any asserted claim is invalid as indefinite.
Dr. Heinecke’s opening expert report contains no opinions that any of the asserted claims is invalid for indefiniteness. To the contrary, Dr. Heinecke stated, based on guidance from
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counsel, that he understood that the asserted patents’ claim terms concerning LDL-C are not indefinite. See Exhibit 6 at 19–20, ¶ 32; Exhibit 1 at 99:3–24. Indeed, Dr. Heinecke acknowledged he has no opinions on indefiniteness. See Exhibit 1 at 96:18–97:1. The Court has already considered Defendants’ indefiniteness argument concerning certain claims during claim construction. See Defs.’ Responsive Claim Construction Br. at 32–40 (Dec. 13, 2017) (ECF No. 102). The Court indicated that Defendants could raise the matter again in a dispositive motion. See Claim Construction Order at 9–10 (Aug. 10, 2018) (ECF No. 135) (“Defendants conflate claim construction and an indefiniteness analysis in light of claim construction. . . . the indefiniteness analysis is more appropriately addressed at the summary judgment stage.”). But, as Defendants put forward no expert testimony concerning indefiniteness, they cannot support such a defense at trial.
** *
Given Defendants’ failure to disclose any expert testimony that might possibly support
such a defense, the Court should grant Amarin partial summary judgment that the asserted claims are not invalid under 35 U.S.C. § 112.
IV. CONCLUSION
For the foregoing reasons, Amarin respectfully requests that the Court grant partial summary judgment on Defendants’ affirmative defenses and counterclaims to the extent that they allege (a) anticipation under 35 U.S.C. § 102, or (b) invalidity under any aspect of 35 U.S.C. §
112. DATED:
August 9, 2019
Respectfully submitted,
/s/ Jason D. Smith
Nicholas J. Santoro (Nev. Bar No. 532) Jason D. Smith (Nev. Bar No. 9691) SANTORO WHITMIRE, LTD.
10100 W. Charleston Blvd., Suite 250 Las Vegas, NV 89135
Tel: [phone] / Fax: [phone] E-mail: [e-mail], [e-mail]
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Case 2:16-cv-02525-MMD-NJK
Document 234 Filed 08/09/19 Page 18 of 18
16
Christopher N. Sipes (admitted pro hac vice) Einar Stole (admitted pro hac vice)
Michael N. Kennedy (admitted pro hac vice) Megan P. Keane (admitted pro hac vice)
Eric R. Sonnenschein (admitted pro hac vice) Alaina M. Whitt (admitted pro hac vice)
Han Park (admitted pro hac vice)
Jordan L. Moran (admitted pro hac vice) COVINGTON & BURLING LLP
One CityCenter, 850 Tenth Street, NW Washington, DC 20001
Tel: [phone] / Fax: [phone] E-mail: [e-mail], [e-mail], [e-mail], [e-mail], [e-mail], [e-mail], [e-mail], [e-mail]
Attorneys for Plaintiffs Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited