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Federal Circuit affirms Safe Harbor ruling and $70 million award in Amgen Inc. v. Hospira, Inc.

On December 16, 2019, the Court of Appeals for the Federal Circuit issued an opinion that fully upheld the District of Delaware’s denial of Hospira, Inc.’s motion for judgment as a matter of law (JMOL), or alternative motion for new trial, in Amgen Inc. v. Hospira, Inc., Nos. 2019-1067, 2019-1102.  The ruling maintained the jury’s verdict that: (1) Hospira infringed one of Amgen Inc.’s two asserted patents, (2) fourteen batches of drug substance for Hospira’s biosimilar was not covered by the Safe Harbor provision of 35 U.S.C. § 271(e)(10), and (3) Amgen was entitled to $70 million in damages.

In 2014, Hospira submitted a Biologics License Application (BLA) to the FDA, seeking approval for a biosimilar to Amgen’s Epogen product, a recombinant human erythropoietin (EPO).  EPO is a glycoprotein that regulates red blood cell maturation and production. Amgen sued Hospira for infringement of two patents related to forms of EPO and aspects of their production, U.S. Patent No. 5,856,298 (the ’298 patent) and U.S. Patent No. 5,756,349 (the ’349 patent).  After a trial in 2017, the jury found the asserted claims of the ’298 patent not invalid and infringed, the asserted claims of the ’349 patent not invalid and not infringed, and further concluded that fourteen batches out of twenty-one manufactured by Hospira were not entitled to the Safe Harbor defense.  The jury awarded Amgen $70 million in damages.  Both Hospira and Amgen moved post-trial to vacate the jury’s verdict.  Both motions were denied by the district court.

Hospira and Amgen each appealed the district court’s denial of their respective post-trial motions.  Hospira argued, inter alia, that the district court’s jury instructions on the Safe Harbor defense were improper, and that no reasonable jury could have found that only some, but not all, of its twenty-one drug batches were protected by the Safe Harbor given that all of the batches were used to generate information that was submitted to the FDA.  The Safe Harbor provision, 35 U.S.C. § 271(e)(1), provides a defense for otherwise infringing activities by stating that it is not an act of infringement to make a patented invention which is primarily manufactured “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.”  The jury instructions, in relevant part, stated:

 If Hospira has proved that the manufacture of a particular batch was reasonably related to developing and submitting information to the FDA in order to obtain FDA approval, Hospira’s additional underlying purposes for the manufacture and use of that batch do not remove that batch from the Safe Harbor defense. (Emphasis added.).

Hospira argued that the jury instructions improperly focused on reasons why each batch of EPO was manufactured, and not how they were used or whether those uses were reasonably related to the development and submission of information to the FDA.  Hospira further argued that all twenty-one of the EPO batches it manufactured between 2013 and 2015 were used for various types of testing, including biosimilarity, revisions to release specifications, stability testing, and continued process verification.  Hospira contended that because that each type of testing was conducted as part of its BLA submission or its response to the FDA’s Complete Response Letter, all twenty-one batches should have been protected under the Safe Harbor provision.

The Federal Circuit disagreed, reasoning that because the patented inventions are methods of manufacture, the relevant inquiry was not how Hospira used each batch, but whether each act of manufacturing was solely for a use reasonably related to submitting information to the FDA.  The court further emphasized that each accused activity must be evaluated separately.  The Federal Circuit also found that substantial evidence supported the jury’s conclusion that the fourteen batches at issue were not manufactured “solely for uses reasonably related to the development and submission of information” to the FDA.  The jury had limited the protected batches to two that were used for qualifying Hospira’s manufacturing process and equipment, and five that were used for a mandatory pre-approval inspection by the FDA.  Both documentary evidence and expert testimony demonstrated that the manufacturing of the remaining batches was not required for FDA pre-approval, and was instead intended to serve as the commercial inventory of a future launch.  The court focused on the differences between manufacturing required by the FDA for an approval, and drug batches made for commercial use (e.g., continued process verification) or post-approval commitments (e.g., stability testing), where only the former are protected by the Safe Harbor provision.  The court further rejected Hospira’s argument that simply submitting information about a drug substance lot to the FDA brings the manufacture of that lot within the protections of the Safe Harbor, noting that “routine record retention requirements associated with testing and other aspects of the commercial production process” are not protected by the Safe Harbor.  Momenta Pharms., Inc. v. Teva Pharms. USA, Inc., 809 F.3d 610, 620-21 (Fed. Cir. 2015).

This opinion showcases the complex nature of the Safe Harbor provision as applied to biologic medicines.  As the district courts and the Federal Circuit begin to hear more such cases of substance, the meaning of the provision will continue to be shaped and clarified.

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Thomas Wintner IP Attorney Mintz Levin Boston
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Tom is an intellectual property and commercial litigator who is equally at home handling cases in trial and appellate courts. Tom counsels clients in a variety of industries, including life sciences, health care, higher education, and real estate. He has extensive experience with patent litigation, trade secrets, and other intellectual property matters, especially those involving pharmaceutical and biologic drugs and diagnostics. Tom also has extensive experience with class action litigation in both federal and state court.

Tom's intellectual property work draws on his prior...

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Peter J. Cuomo, Mintz Levin, Patent Litigation Lawyer, Expert Discovery Attorney,Patent Litigation IPRs & Other Post-Grant Proceedings Federal Circuit Appeals Hatch-Waxman ,ANDA Litigation Federal District Court
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Peter’s practice involves intellectual property enforcement and defense, and client counseling on issues related to IP rights. Peter's primary focus is in patent litigation where he has experience in every phase from pre-suit investigations through appeal, including, initial evaluation and case initiation, fact and expert discovery, pre-and post-trial motion practice, and trials and appeals. In addition to suits centered on the assertion and defense of infringement claims, Peter has experience with the successful resolution of multiple inventorship disputes and related misappropriation claims.

Peter has represented clients across a wide range of technologies such as biotechnology inventions, automotive parts, medical and mechanical devices, consumer products. He has also worked on numerous high-stakes Hatch-Waxman litigations for major pharmaceutical companies through trial and appeals. In addition to patent litigation, Peter has experience in disputes involving breach of contracts, unfair competition, trademarks and trade secret misappropriation claims.

Peter is a registered patent attorney licensed to practice and argue before the United States Patent and Trademark Office. In addition to representing clients in US District Courts and the US Court of Appeals for the Federal Circuit, he has experience in multiple post-grant proceedings before the Patent Trial and Appeal Board and its predecessor. He also provides patent and product analyses, and evaluations of prior art related to infringement and invalidity opinions.

Prior to joining the firm, he practiced in the intellectual property litigation practice in the Boston office of another international law firm. Peter also previously worked in and supervised an academic laboratory focused on researching infectious diseases. He is a co-author on multiple scientific papers and spent time in Zambia investigating the co-infection of measles and HIV. During law school, Peter was an editor on the Boston University Journal of Science and Technology Law and worked as a research assistant in intellectual property and the Health Law Department.

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Nana Liu Associate Mintz Life Sciences, Pharmaceuticals,Patent Litigation, International Trade Commission, Hatch-Waxman,  ANDA Litigation,
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Nana focuses her practice on intellectual property litigation, including matters at the International Trade Commission (ITC) and Hatch-Waxman pharmaceutical cases. She also assists with litigation in federal district courts and appellate litigation at the US Court of Appeals for the Federal Circuit. She primarily represents companies in the life sciences industry.

Prior to joining Mintz Levin, Nana served as a judicial law clerk to the now-retired Hon. Andrew R. Grainger of the Massachusetts Appeals Court.

While earning her law degree, Nana was a law clerk at a Massachusetts-...

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