Latest 3 Cases This Week: In re: Avandia Marketing, Sales and Products Liability Litigation (3d Cir.), Amgen Inc. v. Hospira, Inc. (Fed. Cir.), ...

Taking Stock: A Review of Justice Stevens’s Last Book and an Appreciation of His Extraordinary Service on the Supreme Court

RODGER CITRON

Rodger D. Citron, the Associate Dean for Research and Scholarship and a Professor of Law at Touro College, Jacob D. Fuchsberg Law Center, comments on the late Justice John Paul Stevens’s last book, The Making of a Justice: Reflections on My First 94 Years. Citron laments that, in his view, the memoir is too long yet does not say enough, but he lauds the justice for his outstanding service on the Supreme Court.

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In re: Avandia Marketing, Sales and Products Liability Litigation

Court: US Court of Appeals for the Third Circuit

Docket: 18-1010

Opinion Date: December 17, 2019

Judge: Restrepo

Areas of Law: Commercial Law, Consumer Law, Drugs & Biotech, Health Law, White Collar Crime

Health benefit plans sued GSK, the manufacturer of the prescription drug Avandia, under state consumer-protection laws and the Racketeer Influenced and Corrupt Organizations Act, 18 U.S.C. ch. 96 (RICO), based on GSK’s marketing of Avandia as having benefits to justify its price, which was higher than the price of other drugs used to treat type-2 diabetes. The district court granted GSK summary judgment, finding that the state-law consumer-protection claims were preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. ch. 9; the Plans had failed to identify a sufficient “enterprise” for purposes of RICO; and the Plans’ arguments related to GSK’s alleged attempts to market Avandia as providing cardiovascular “benefits” were “belated.” The Third Circuit reversed, applying the Supreme Court’s 2019 "Merck" decision. The state-law consumer-protection claims are not preempted by the FDCA. The Plans should have been given the opportunity to seek discovery before summary judgment on the RICO claims. Further, from the inception of this litigation, the Plans’ claims have centered on GSK’s marketing of Avandia as providing cardiovascular benefits as compared to other forms of treatment, so the district court’s refusal to consider the Plans’ “benefits” arguments was in error because those arguments were timely raised.

Amgen Inc. v. Hospira, Inc.

Court: US Court of Appeals for the Federal Circuit

Docket: 19-1067

Opinion Date: December 16, 2019

Judge: Kimberly Ann Moore

Areas of Law: Drugs & Biotech, Intellectual Property, Patents

Amgen’s patents relate to erythropoietin (EPO) isoforms and aspects of their production. EPO is a glycoprotein hormone that regulates red blood cell maturation and production. Recombinant human EPO is an important therapeutic protein for the treatment of anemia. Amgen manufactures and markets recombinant human EPO as Epogen. Hospira submitted its Biologics License Application (BLA) to the FDA, seeking approval for a biosimilar to Amgen’s Epogen product. Amgen sued Hospira for infringement under 35 U.S.C. 271(a) and 271(e)(2)(C). A jury found the asserted claims not invalid and infringed. Of the 21 accused drug substance batches, the jury found seven batches entitled to the Safe Harbor defense. The jury awarded Amgen $70 million in damages. The Federal Circuit affirmed, upholding the district court’s claim construction and finding substantial evidence of infringement. Section 271(e)(1) carves out a "Safe Harbor” exception to patent infringement liability when otherwise-infringing activities are solely for uses reasonably related to obtaining FDA approval. Substantial evidence supports the jury’s finding that the 14 batches at issue were not manufactured “solely for uses reasonably related to the development and submission of information” to the FDA.

Syngenta Crop Protection, LLC v. Willowood, LLC

Court: US Court of Appeals for the Federal Circuit

Docket: 18-1614

Opinion Date: December 18, 2019

Judge: Jimmie V. Reyna

Areas of Law: Copyright, Drugs & Biotech, Environmental Law, Intellectual Property, Patents

Syngenta sued Willowood, a Hong Kong company that sells fungicide to its Oregon-based affiliate, for infringement of patents directed to a fungicide compound and its manufacturing processes and infringement of copyrights for detailed product labels that provide directions for use, storage, and disposal, plus first-aid instructions and environmental, physical, and chemical hazard warnings. The district court dismissed the copyright claims as precluded by the Federal Insecticide Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. 135 and granted-in-part Syngenta’s summary judgment motion with respect to patent infringement. After a jury trial, the court entered a defense judgment on the patent claims. The Federal Circuit affirmed-in-part, reversed-in-part, and vacated in part. The district court did not provide an adequate analysis of the potential conflict between FIFRA and the Copyright Act. Because FIFRA does not, on its face, require a “me-too” registrant to copy the label of a registered product, FIFRA only conflicts with the Copyright Act to the extent that some particular element of Syngenta’s label is both protected under copyright doctrines and necessary for the expedited approval of Willowood’s generic pesticide. The court erred by imposing a single-entity requirement on the performance of a patented process under 35 U.S.C. 271(g); practicing a patented process abroad does not trigger liability under section 271(g) in the same manner that practicing a patented process domestically does under section 271(a).