Press Release
January 11, 2016

Goodwin Procter Releases 2016 Guidebook On Biosimilars Regulatory, IP Issues

Goodwin Procter announced today the release of the 2016 edition of Biosimilars: A Guide to Regulatory and Intellectual Property Issues. The guide provides clarity to the complex, developing regulatory and legal framework around biosimilars, and the 2016 update offers analysis on the first waves of patent litigation related to biosimilars – including the pivotal Amgen v. Sandoz case – and important market developments around the globe.

The guide, originally released in January 2015, examines regulatory approval pathways and intellectual property issues for biologic drug products. Biosimilars, and other follow-on biologic drug products such as “biobetters,” represent a rapidly expanding segment of the global pharmaceutical market. The unique properties of biologics, in particular their differences from traditional small molecule drug products, present challenges to current legal and regulatory schemes in the U.S. and abroad.

“2015 saw significant legal activity regarding biosimilars,” said Elaine Blais, partner in Goodwin Procter’s Intellectual Property Litigation Practice and a lead author of the publication. “Now that the first biosimilars application has been approved by FDA, and the initial patent lawsuits related to biosimilars have played out in the courts, the coming year will see a wave of subsequent litigation – and it is important to be up to date.”

Amgen v. Sandoz opened up the possibilities of additional paths to approval, outside of the patent dance,” said Goodwin partner and lead author of the guide, Robert Cerwinski. “This may lead to a wave of new applications. Yet the Biologics Price Competition and Innovation Act (BPCIA) is still being tested in court, so it’s imperative that companies and their attorneys navigate these waters carefully.”

The 2016 edition highlights a number of noteworthy observations, including: 

  • Updated global market developments for biosimilars
  • Biosimilar activity at the FDA, including the approval of the first biosimilar application submitted under the 262(k) pathway
  • Details on regulations regarding biosimilars outside the U.S., including the impact of the Trans-Pacific Partnership (TPP)
  • Recent legal developments concerning the BPCIA
  • Other legal developments that could potentially impact biosimilars, including recent case law on induced infringement and pharmaceutical patents and recent case law affecting the statutory safe harbor

In-house attorneys and executives can view the table of contents of Biosimilars: A Guide to Regulatory and Intellectual Property Issues and request a gratis copy of the guide online.

Biosimilars: A Guide to Regulatory and Intellectual Property Issues is part of a series of guidebooks published by Goodwin Procter’s Intellectual Property Litigation Practice.

Goodwin’s Intellectual Property Litigation Practice, named by Law360 as one of its “Practice Groups of the Year” for two consecutive years, has worked with clients to secure preliminary injunctions, declaratory and summary judgments, favorable results in Markman proceedings, advantageous settlements, victories at trial and appellate relief. Goodwin attorneys routinely work with clients to take cases from pre-suit investigations through discovery and trials. Widely recognized as a leader in life sciences patent matters, Goodwin Procter has been named for three consecutive years as “Biotechnology Law Firm of the Year” by U.S. News Best Lawyers.