As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more
Recently, the Federal Circuit issued its holding in a case dealing with asserting claims of an extended patent covering administration of dimethyl fumarate formulations to treat multiple sclerosis (MS). Dimethyl fumarate...more
A proposed bill offers a potential boon to patent owners. If passed, the “Facilitating Innovation to Fight Coronavirus Act” will add ten years to the patent term of eligible inventions. However, the bill will temporarily...more
On 6 July, China’s National People’s Congress (NPC) published additional amendments to its draft patent law, which was first released in January 2019. As we reported at that time here, the proposed Chinese Patent Law...more
In a recent decision, the issue before the Federal Circuit was the meaning of the term “product” in a patent term extension statute. Biogen Int'l GmbH v. Banner Life Scis. LLC, 956 F.3d 1351 (Fed. Cir. 2020). Section 156 of...more
Case Name: Biogen Int’l GmbH v. Banner Life Sciences LLC, No. 18-2054-LPS, 2020 U.S. Dist. LEXIS 3639 (D. Del. Jan. 7, 2020) (Stark, J.)....more
This year’s C5’s Pharma Patent Term Extensions Forum arrives at a critical time for the pharmaceutical industry. Overarching developments from the Teva U.K. decision (C-121/17) to the SPC Manufacturing Waiver and the most...more
On January 4, China’s National People’s Congress (NPC) released draft amendments to the Chinese Patent Law, proposing expanded and enhanced protections that may provide real benefits to companies that develop new drugs. ...more
Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing - While common among member countries of the Organisation for Economic Co-operation and Development...more
On September 21, 2017, the Comprehensive Economic and Trade Agreement (CETA) signed between the European Union (EU) and Canada provisionally entered into force in Canada. Among other things, this agreement seeks to harmonize...more
Seven years after Mylotarg® (gemtuzumab ozogamicin) was voluntarily withdrawn from the market, the U.S. Food and Drug Administration has re-approved Mylotarg® product....more
This is the final article in our five-part series on PTE. Obtaining a patent term extension (PTE) is extremely valuable to an innovator. By design, PTE extends the patent term to recoup time lost to the rigorous...more
This is the third article in our five-part series on PTE. Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is...more
Patent term extension is a valuable tool that drug manufacturers should consider, even when their products are not new entities. Recent decisions from the U.S. Patent and Trademark Office, coupled with various court...more