Year in Review: Top Five Legal Developments of 2019 Impacting Biosimilars

As we close out another calendar year, we look back at the top legal developments of 2019 that could influence the market for biologics and biosimilars. These five major court decisions will likely impact the legal strategy in the biosimilars space in 2020 and moving forward.

1.  On December 16, 2019, the Federal Circuit affirmed a Delaware jury’s finding that 14 batches of Hospira’s biosimilar to EPOGEN (epoetin alfa) infringed Amgen’s manufacturing patent. In doing so, the Federal Circuit upheld $70 million in damages and a jury instruction regarding the limits of the Safe Harbor in the manufacture of biosimilar products prior to FDA licensure.

2.  On August 9, 2019, Judge Cecchi of the District of New Jersey upheld the validity of two patents that Immunex asserted against Sandoz based on the development and licensure of a proposed biosimilar to ENBREL (etanercept). The decision, which addressed obviousness, lack of enablement, lack of written description, and obviousness-type double-patenting, was the first substantive ruling on the invalidity of patents in the BPCIA context following a bench trial and is now on appeal.

3.  In Helsinn Healthcare v. Teva Pharmaceuticals USA, the Supreme Court affirmed that the America Invents Act did not change the law regarding the on-sale bar. The Supreme Court held that the sale of an invention to a third party, even one who is contractually obligated to keep the invention confidential, places the invention “on sale” within the meaning of 35 U.S.C. § 102(a).

4.  In a development that could impact the use of post-grant proceedings, the Federal Circuit held in Anthrex Inc. v. Smith & Nephew Inc. that the current statutory structure for appointing Administrative Patent Judges who sit on the PTAB violates the Appointments Clause of the U.S. Constitution.  Petitions for rehearing are pending.

5.  Finally, in a pair of decisions issued shortly after each other, the District Court of Delaware denied Genentech’s motions for preliminary injunctions to prevent the commercial launch of biosimilars of trastuzumab and bevacizumab. These decisions, which were followed soon after by denials of stays pending appeal, paved the way for U.S. market launches of biosimilars of both molecules. The district court decisions are on appeal.