Goodwin, a leading Global 50 law firm, announced today the release of its 2016 BPCIA Litigation Update and Thinking of Investing In a Biosimilars Product? The 2016 BPCIA Litigation Update recaps a busy year in the legal world of biosimilars, offering background, legal analysis and the status of the year’s most pivotal cases. Thinking of Investing In a Biosimilars Product? outlines key considerations for investors interested in the space.
2016 saw numerous hotly-contested cases over biosimilar versions of biologic products as patent infringement suits under the BPCIA’s complex litigation scheme, including the so-called “patent dance,” commenced in earnest. While the Federal Circuit issued important rulings interpreting the 180-day notice-of-commercial-launch provisions of the BPCIA, the Supreme Court has so far declined to weigh in on how the “patent dance” and notice provisions should be interpreted. The 2016 BPCIA Litigation Update delves into these and other case working their way through the U.S. courts.
“BPCIA litigations have continued to accumulate, and in 2016 we saw the first BPCIA trial in Amgen v. Apotex,” said Robert Cerwinski, partner in Goodwin’s Intellectual Property Litigation Practice. “The coming year will be the most active in biosimilars litigation yet, and it is increasingly important to be up to date on all of the cases and issues at play.”
“With the continued testing of the BPCIA in court, the BPCIA is tremendously difficult to navigate, and we’re working to help clients better comprehend it,” said Elaine Blais, a partner in Goodwin’s Intellectual Property Litigation Practice. “From understanding the FDA approval pathway to IP issues with patent portfolios, and settlement strategies, there is a lot of new territory to cover.”
Goodwin is committed to helping companies and investors understand the complex, developing biosimilars landscape. Thinking of Investing In a Biosimilars Product? and the 2016 BPCIA Litigation Update follow the publication of Biosimilars: A Guide to Regulatory and Intellectual Property Issue, were originally released in 2015 and subsequently updated in 2016. The firm also published the Biosimilars Patent Dance in 2016 and launched BigMoleculeWatch.com in 2015.
Goodwin’s Intellectual Property Litigation Practice has been named by Law360 as one of its “Practice Groups of the Year” for three consecutive years and recognized in the National Law Journal’s 2016 "Intellectual Property Hot List." Goodwin’s IP Practice 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.