Articles: 1-10 of 127

Federal Circuit Upholds Jury Award, Weighs in on Willfulness Standard, in Adynovate® Dispute

USA - March 30 2021 According to the Federal Circuit, $173 million was the right damages award for almost three years of patent infringement resulting from Baxalta’s…

Sandoz Petitions the Supreme Court for Review of Enbrel® Patent License

USA - March 8 2021 The fight over proposed Enbrel® (etanercept) biosimilar Erelzi® continues. Sandoz Inc., Sandoz International GmbH and Sandoz GmbH (“Sandoz”) recently…

Federal Circuit Axes Amgen Antibody Patents, Finding Lack of Enablement

USA - February 18 2021 The Federal Circuit considered its 35 U.S.C. § 112 enablement case law and found that “the enablement inquiry for claims that include functional…

FDA Approves Breyanzi®—A New Biologic for Treating Large B-Cell Lymphoma

USA - February 9 2021 On February 5, 2021, the FDA approved Juno Therapeutics, Inc.’s Breyanzi® (lisocabtagene maraleucel) for “treatment of adult patients with relapsed…

2021 Biosimilar Approval and Litigation Update

USA - February 1 2021 The last two years saw the launch of several biosimilars. Looking ahead to 2021, several others may be on the horizon. In 2019-2020, the FDA approved…

Rehearing Denied in Federal Circuit Hatch-Waxman Venue Case

USA - January 28 2021 The Federal Circuit has spoken. In a per curiam opinion, it denied Valeant’s petition for rehearing by the panel and rehearing en banc. A case…

Opposition to Rehearing Filed in Major Federal Circuit Case Narrowing Hatch-Waxman Venue

USA - January 11 2021 Last week, Mylan filed a brief in opposition to Valeant’s petition for rehearing en banc in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No…

WTO to Discuss Member Proposal to Waive IP Rights for COVID-19 Technologies

Global - January 6 2021 On October 2, 2020, India and South Africa urged the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS)…

Rehearing Requested in Major Federal Circuit Case Narrowing Venue in Hatch-Waxman Cases

USA - December 14 2020 Earlier this month, Valeant Pharmaceuticals North America LLC (“Valeant”) filed a petition for rehearing en banc in Valeant Pharms. N. Am. LLC v…

FDA’s Draft Guidance for Industry Seeks to Answer Questions on Biosimilar Interchangeability

USA - November 30 2020 FDA has published new draft guidance for industry titled "Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and…