by Dennis Crouch
Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., Docket No. 21-02024 (Fed. Cir. 2021) is up on appeal again. The district court found Amarin’s asserted patent claims obvious and the Federal Circuit affirmed that holding in a R.36 affirmance without opinion.
Following the Federal Circuit’s decision, an ad-hoc group of doctors, patients, and Amarin stock holders (collectively known as EPA Drug Initiative II) moved to intervene in the lawsuit and asked the court to vacate its judgment based upon “multiple fatal statistical errors in analyzing and interpreting the prior art.” The group argues that
The invalidation of Amarin’s patents could potentially cost hundreds of thousands of American lives, as Amarin has been deprived of the incentive to promote Vascepa in the U.S., and Defendants can neither sell generic Vascepa to a large segment of the patient population, nor promote generic Vascepa, as those activities would violate Amarin’s other patents.
[EPADI Motino to Intervene] [EPADI Motino to Vacate]. The district court denied the motions and those issues are now on appeal before the PTAB. I expect EPADI to lose its appeal, but it raises an ongoing interesting question about the role of patents in the availability and pricing of drugs and biologics. The intervenors are calling for patent rights in order to better ensure that the drug is available.
One reason that I expect EPADI to lose is that it had requested permission to file an amicus brief in the original appeal as had the Biotechnology Innovation Organization (BIO). The Federal Circuit denied EPADI’s request but permitted BIO’s.
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One idea here goes back to the deals of Edmund Kitch with his prospect theory of patenting as a special form of the tragedy-of-the-commons. Edmund Kitch, “The Nature and Function of the Patent System,” Journal of Law and Economics, 1977, 20, pp. 265.