April Breyer Menon, Author at Venable's BiologicsHQ

Beyond Biosimilarity: Draft Guidance for Demonstrating Biologic Interchangeability

by April Breyer Menon | Mar 17, 2017

The primary focus of the FDA, industry, and counsel preparing for the advent of follow-on biologics in the United States has been the legal and regulatory framework governing the approval of such products as biosimilars under the Biologics Price Competition and...

Supreme Court Rejects Federal Circuit’s Basis for Finding Infringement Liability for U.S. Exporters Under § 271(f)(1): Life Technologies Corp. et al. v. Promega Corp.

by April Breyer Menon | Feb 22, 2017

The Supreme Court reversed the Federal Circuit’s interpretation of an infringement liability statute in litigation over whether shipping a single component of a patented multi-component invention to be assembled overseas qualifies as an infringing act under 35 U.S.C....

Federal Circuit Pushes Back on Procedural Issues

by April Breyer Menon | Feb 1, 2017

The Federal Circuit is not afraid to call to task the Patent Trial and Appeal Board when it comes to potential procedural breaches. Justin Oliver and Kathryn Easterling review relevant cases. Download PDF

Federal Circuit Dismisses Appeal By IPR Petitioner For Lack Of Article III Standing Due To Insufficient Evidence Of Injury To Petitioner Arising From Challenged Patent

by April Breyer Menon | Jan 9, 2017

The Court of Appeals for the Federal Circuit today held that, in order to appeal a final decision from an inter partes review (IPR) proceeding, an IPR petitioner must prove Article III standing, including an injury in fact—and moreover must do so by a burden of proof...

The Supreme Court Hears Oral Argument On Infringement Liability For U.S. Exporters Under § 271(f)(1): Life Technologies Corp., et al. v. Promega Corp.

by April Breyer Menon | Dec 7, 2016

On December 6, 2016, the Supreme Court heard oral argument on the interpretation and application of 35 U.S.C. § 271(f)(1) in Life Technologies Corp., et al. v. Promega Corp. At issue is whether the export from the United States of a single component of a patented...

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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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