Federal Circuit: Specific Jurisdiction Over Generic Pharmaceutical Defendant Proper in District of Delaware Based On Defendants’ Plans To Market Its Generic Drugs In Delaware

by April Breyer Menon | May 17, 2016

In companion cases Acorda Therapeutics Inc. v. Mylan Pharm, Inc. (No. 2015-1456) and AstraZeneca AB v. Mylan Pharm. Inc. (No. 2015-1460), the Federal Circuit held that the District of Delaware may exercise specific jurisdiction over generic pharmaceutical company...

The U.S. Patent and Trademark Office Releases an Update to the 2014 Interim Guidance on Patent Subject Matter Eligibility

by April Breyer Menon | May 6, 2016

On May 6, 2016, Michelle K. Lee, the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office (USPTO), announced a second update (May 2016 Update) to the Interim Guidance on Patent Subject Matter Eligibility...

Coordinating Biosimilar Litigation and Proceedings

by April Breyer Menon | Dec 12, 2015

Biologics and biosimilars together represent a rapidly growing component of the pharmaceutical marketplace, and the unique legal issues that accompany them demand careful strategic planning to successfully navigate proceedings in the myriad venues where disputes will...

The Amgen v. Sandoz BPCIA Decision Stands: the Federal Circuit Denies an En Banc Rehearing

by April Breyer Menon | Oct 22, 2015

On October 16, 2015, the Federal Circuit declined to rehear en banc its July decision interpreting key provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). Download PDF

Amgen v. Sandoz: Divided Federal Circuit Attempts to Unravel the BPCIA

by April Breyer Menon | Sep 1, 2015

In its recent Amgen Inc. v. Sandoz Inc. decision, the Federal Circuit decided two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). First, the Court held that the BPCIA does not require a biosimilar applicant...

Statistics Show IPRs Favor Patent Challenges

by April Breyer Menon | Aug 25, 2015

Discussion of the various patent reform proposals to Inter Parties Review (IPR) practice that are currently before Congress, with an eye to IPR statistics, and equivalent statistics from post-grant Opposition proceedings before the European Patent Office (EPO)....

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Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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