Hot-Button Litigation Issues in the Biosimilar Sphere

Isaac Ashkenazi, partner at Paul Hastings LLP; Gregory Morris, PhD, partner and leader of life sciences litigation at Honigman Miller Schwartz and Cohn LLP; and John Molenda, PhD, partner and co-chair of Healthcare & Life Sciences practice at Steptoe & Johnson LLP, discussed current “hot button” litigation issues in the biosimilar sphere during the American Conference Institute’s Summit on Biosimilars, held June 25-27 in New York, New York.

Ashkenazi kicked off the session by providing a background of the Safe Harbor Act, which in the biosimilar space offers a company protection from potentially infringing on patents if the sole use for the production of a patented product is deemed “reasonably related” to the development and submission of information to the FDA for the manufacturing, use, or sale of drugs.

During his presentation, Ashkenazi discussed the recent court dealings in the Amgen v Hospira case. In the case, filed in September 2015, Amgen sued Hospira for excess lot production of a potential epoetin alfa (Epogen) biosimilar. The jury found that the Safe Harbor Act did not apply to 14 of the 21 batches the developer manufactured, awarding Amgen nearly $70 million in damages.

Ashkenazi closed his presentation asking that the audience consider a hypothetical not yet seen in a court of law, but a potential hot button issue: if a company is manufacturing a product utilizing the Biologics Licence Application approval pathway that does not infringe patents, but continues the development efforts to seek approval for an additional indication, does Safe Harbor apply?

During his presentation, Morris provided an in-depth look at the many settlements and potential launches surrounding potential adalimumab (Humira) biosimilars. There have been a few biosimilar patent battles over the launch of potential biosimilars. Specifically, in August 2016, AbbVie sued Amgen after briefly participating in the patent dance. In September 2017, the companies reached a settlement that Amgen’s Humira biosimilar will have a US launch date of January 2023, and a European launch of October 2018.

In addition, AbbVie’s suit against Samsung Bioepis over disputed patents resulted in a similar settlement. Bioepis’ biosimilar, not yet approved by the FDA, will not be allowed to enter the market in the European Union until October 2018, nor the US until June 2023. Recently, Patients for Affordable Drugs called on the Federal Trade Commission to examine whether this pay-for-delay deal violates anti-competitive and antitrust laws.

Though the biosimilar area is facing many different forms of litigation, presenters agreed that manufacturing processes and method of treatment patents are dominating the landscape at the moment. In addition, some other key takeaways are that many companies are not completing the patent dance, and IPRs have become an additional part of biosimilar litigations.

The panel left a key question for the audience to answer: Is it better for a biosimilar manufacturer to disclose more information upfront, or rather abstain from the patent dance entirely?