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Life Sciences › Patent Dance

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

American Conference Institute (ACI) on

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

Fish & Richardson

Biosimilars 2020 Year in Review

Fish & Richardson on

Introduction - The biosimilar pathway was designed to increase competition for biologics and reduce healthcare costs. Yet 2020 saw a slowdown in biosimilar activity with the lowest number of annual biosimilar approvals since...more

Fish & Richardson

How Biosimilars Are Approved and Litigated: Patent Dance Timeline

Fish & Richardson on

A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an FDA-approved reference biological product. Biosimilar applicants have a number of choices to make on the path...more

Morrison & Foerster LLP

FDA Approves 25th Biosimilar

Morrison & Foerster LLP on

On November 15, 2019, FDA approved Pfizer’s adalimumab product, a biosimilar to AbbVie’s Humira, marking the 25th approval of a biosimilar under the Biologics Price Competition and Innovation Act (BPCIA). A biosimilar is a...more

Morgan Lewis

Amgen Moves to Dismiss Genentech’s Misrepresentation Claim

Morgan Lewis on

Amgen paints a different picture as to the bad actor during the parties’ negotiations pursuant to the Biologics Price Competition and Innovation Act. Shortly after Amgen received US Food and Drug Administration (FDA)...more

Ladas & Parry LLP

Skipping The Patent Dance: U.S. Supreme Court In Amgen V Sandoz Makes It More Difficult For Patent Owners To Delay Marketing Of...

Ladas & Parry LLP on

On June 12, 2017, in a unanimous decision authored by Justice Thomas in Amgen Inc. v. Sandoz Inc., the United States Supreme Court considered the complex statutory scheme that attempts to expedite resolution of patent...more

Robinson+Cole Health Law Diagnosis

Supreme Court Decision Allows Faster Marketing of Biosimilars

Robinson+Cole Health Law Diagnosis on

On Monday, June 12, 2017, the United States Supreme Court in a unanimous decision held that manufacturers making biosimilars of biologic drugs did not have to wait until after gaining federal approval of the biosimilar to...more

Foley & Lardner LLP

Industry Perspectives On The Biosimilar Patent Dance

Foley & Lardner LLP on

The Supreme Court could issue its decision in the Amgen v. Sandoz biosimilar patent dance case any day now. Last week I participated in a panel discussion with industry stakeholders considering how the decision might–or might...more

Knobbe Martens

Supreme Court Grants Certiorari in Amgen v. Sandoz

Knobbe Martens on

On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more

Fenwick & West Life Sciences Group

Federal Circuit: A Biosimilar Applicant Must Provide Notice of Intent to Market a Biosimilar Product, No Exceptions

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On July 5, 2016, in Amgen v. Apotex (No. 2016-1308), the Federal Circuit again held that a biosimilar applicant must provide its biologic competitor with 180 days’ notice of intent to commercially market a biosimilar product....more

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