Case Name: Amarin Pharma, Inc. v. Hikma Pharms USA Inc., No. 16-cv-02525, 2020 WL 1517568 (D. Nev. March 30, 2020) (Du, J.)
Drug Product and Patent(s)-in-Suit: Vascepa® (icosapent ethyl); U.S. Patents Nos. 8,293,728 (“the ’728 patent”), 8,318,715 (“the ’715 patent”), 8,357,677 (“the ’677 patent”), 8,367,652 (“the ’652 patent”), 8,431,560 (“the ’560 patent”) and 8,518,929 (“the ’929 patent”)
Nature of the Case and Issue(s) Presented: The patents-in-suit disclosed methods of lowering the levels of certain fats in the bloodstream by using drugs made from purified omega-3 fatty acids of fish oils. More particularly, they claimed methods of treating severe hypertriglyceridemia (“HTG”) by administering 4 grams per day of purified EPA. Plaintiff sued Defendant alleging patent infringement under the Hatch-Waxman Act. After a bench trial in January 2020, the court found that Hikma infringed the asserted claims under Amarin’s inducement theory, but that the asserted patent claims were all invalid as obvious.
Why Hikma Prevailed: In defense of Amarin’s infringement claim, Hikma argued that its proposed label would not infringe a claim limitation requiring that the ANDA products be administered for at least 12 weeks. The court disagreed, noting that the evidence indicated that physicians generally prescribed Vascepa for between four to twelve months at a time and that severe HTG had a genetic component that required long-term treatment. Further, the “Clinical Studies” section of Hikma’s label described a clinical study where patients were administered icosapent ethyl for 12 weeks. Next, Hikma argued that it did not induce infringement of a claim limitation that required a reduction in triglyceride (“TG”) levels, no increase in LDL-C levels, or a reduction in Apo B levels (the “Other Health Benefits Claims”). But the court concluded that the “Clinical Studies” section of Hikma’s proposed label stated that “the average patient ... received the benefits described in the Other Health Benefits Claims.” Finally, Hikma argued that its proposed labeling did not suggest, as claimed, that physicians could administer the ANDA product without a concurrent lipid altering therapy. But the court noted that the “Indications and Usage” section did not contain any instruction that Hikma’s ANDA products must be administered with a lipid-altering drug. Further, the “Clinical Studies” section noted that only 25% of the participants were on a concomitant lipid-altering therapy, indicating that Hikma intended its ANDA products to be used by patients who did not received concurrent lipid-altering therapy.
The court next addressed the issue of obviousness. The parties agreed that the only difference between the claimed method and the prior-art Lovaza PDR entry was that the former claimed purified EPA, whereas the latter contained a mixture of EPA and DHA. Further, it was known that Lovaza caused an increase in LDL-C, which a physician would have been motivated to reduce when treating patients with severe HTG. In addition, the Mori prior-art reference found that the increase of LDL-C was attributable to DHA and not EPA. The court next found that Amarin’s secondary indicia of non-obviousness did not rebut the prima facie showing of obviousness. In particular, Amarin’s reliance on the REDUCE-IT clinical trial was unpersuasive because it lacked a sufficient nexus to the asserted claims. All the patients in that study were using a statin, but the patents-in-suit claimed treatment absent a statin. The REDUCE-IT clinical study also did not attribute the reduction in triglycerides to the claimed used of EPA. Thirdly, the positive impact of the REDUCE-IT clinical study was not attributed to the claimed reduction in LDL-C. And finally, the REDUCE-IT clinical study was not commensurate with the scope of the claims because the results were limited, unlike the claims, to patients with multiple cardiovascular risk factors and with TG levels below 500.
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