April Breyer Menon, Author at Venable's BiologicsHQ

180-Day Advance Notice Of First Commercial Marketing Is Mandatory For All Biosimilar Applicants

by April Breyer Menon | Jul 7, 2016

On July 5, 2016, the Federal Circuit issued a decision interpreting the 180-day-notice-of-first-commercial-marketing provision of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). Amgen Inc. v. Apotex Inc. (Amgen II), No. 2016-1308 (Fed. Cir. July...

Courts Invalidating Life Sciences Discoveries at Alarming Rate Under Mayo/Alice

by April Breyer Menon | Jun 5, 2016

In the 1980s, Dr. Malcolm Simons discovered that certain DNA sequences in coding regions (exons) of genes are correlated with non-coding regions (introns), i.e. they are “linked” together within an individual’s genome. These non-coding regions, often colloquially...

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...

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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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