Biosimilar Legal Decisions to Keep an Eye out for in 2019

Here are our picks of some legal developments to keep an eye out for in the new year:

Etanercept biosimilar trial decision – This past September, in the Immunex v. Sandoz BPCIA patent litigation concerning Sandoz’s Erelzi (etanercept-szzs), an FDA-approved but yet-unmarketed biosimilar of Enbrel®, the New Jersey district court held a 10-day bench trial concerning the validity of claims of two asserted patents. In December, the parties completed post-trial briefing regarding whether Sandoz had proven that the asserted claims of the patents-in-suit are invalid on grounds of obviousness-type double patenting, lack of written description, non-enablement, and obviousness. The parties are now awaiting a decision from the court.
Filgrastim and pegfilgrastim biosimilars appeals – This past year, Amgen appealed to the Federal Circuit after receiving adverse decisions from district courts in two BPCIA patent litigiations concerning biosimilars of its Neupogen® (filgrastim) and Neulasta® (pegfilgrastim) products. First, in Amgen v. Sandoz, Amgen appealed from the Northern District of California to challenge the district court’s grant of summary judgment of non-infringement in favor of Sandoz regarding its biosimilar Zarxio® (filgrastim-sndz) and its proposed pegfilgrastim biosimilar. Second, in Amgen v. Coherus, Amgen appealed after the district court in the District of Delaware dismissed Amgen’s patent infringement complaint against Coherus concerning its Udenyca (pegfilgrastim-cbqv) biosimilar, which Coherus has stated it is planning to commercially launch in the United States tomorrow, January 3, 2019. Both appeals have been fully briefed and are awaiting oral argument dates.
Epoetin alfa biosimilar appeal – This past October, in the Amgen v. Hospira BPCIA patent litigation concerning Hospira’s Retacrit® (epoetin alfa-epbx), a biosimilar of Epogen®/Procrit®, Hospira filed an appeal to the Federal Circuit after the Delaware district court entered final judgment of patent infringement against Hospira and awarded Amgen $70 million in damages and approximately $10 million in pre-judgment interest, plus post-judgment interest in an amount to be determined at a later date. The damages award followed a September 2017 jury verdict that Hospira infringed a now-expired Amgen process patent by manufacturing fourteen batches of drug substance in 2013-2015 outside of the protection of the safe harbor of 35 U.S.C. § 271(e)(1), which allows use of patented processes if reasonably related to the development and submission of information to the FDA. Amgen also filed a cross-appeal concerning aspects of the district court’s decision, such as its finding that Hospira did not infringe a second asserted process patent. The parties have already begun appellate briefing, and could potentially obtain a decision from the Federal Circuit before the end of 2019.
Monoclonal antibody IPR appeals to address the constitutionality of subjecting pre-AIA patents to IPR – In the coming year, the Federal Circuit is expected to consider several appeals of the PTAB’s final written decisions in inter partes reviews of patents relating to monoclonal antibodies. First, AbbVie has appealed five final written decisions finding the challenged claims of three of its method of use patents concerning adalimumab to be unpatentable. These appeals have been consolidated. Second, Genentech has appealed final written decisions regarding two patents that Hospira successfully challenged before the PTAB. One patent concerns a method of use with bevacizumab (the active ingredient in Avastin®), and the other patent concerns a protein purification process using protein A chromatography. In all of these appeals, in addition to challenging the PTAB’s decisions on the merits, AbbVie and Genentech have argued that it is unconstitutional under the Fifth Amendment to the U.S. Constitution to subject patents that issued prior to the enactment of the America Invents Act in 2011 to inter partes review. The United States has intervened in all of these appeals to address the constitutionality issue. All of the appeals were fully briefed in 2018, though the Federal Circuit reopened briefing in the AbbVie appeal in light of the United States’ intervention in that appeal and ordered briefing completed during January 2019. Oral arguments have not yet been scheduled.
Abatacept IPR appeal to address standing to appeal unfavorable IPR decisions – In February 2017, Momenta filed an appeal to the Federal Circuit to challenge an unfavorable final written decision in an inter partes review in which Momenta had challenged Bristol-Myers Squibb’s (BMS) patent concerning abatacept, the active ingredient in Orencia®. In response, BMS argued that the appeal should be dismissed for lack of Article III standing because Momenta was not marketing a product within the purview of the patent claims and was years away from filing any regulatory application seeking approval to do so. Although the Federal Circuit heard oral argument in the appeal more than a year ago, it has not yet issued a decision. Since then, the parties have submitted numerous letters to the Federal Circuit concerning the standing issue, including, most recently, to address Momenta’s public statement that it “has initiated discussions with its collaboration partner, Mylan, to exit its participation in the development of . . . M834, a proposed biosimilar of ORENCIA®”—a development that Momenta contends does not moot its appeal.