April Breyer Menon, Author at Venable's BiologicsHQ

Seven Years of Orange Book Patent IPRs: Where Are We Now?

by April Breyer Menon | Nov 22, 2019

Heralded as a less expensive, faster way to challenge patents, inter partes review (IPR) before the US Patent Trial and Appeal Board (PTAB) has proven remarkably popular. IPR was first available on September 12 2012, and within days, the first petitions challenging...

Venable’s BiologicsHQ Monthly Injection – October 2019

by April Breyer Menon | Nov 11, 2019

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Will Authorized Biologics Disrupt The Market For Biosimilars?

by April Breyer Menon | Nov 5, 2019

In an article for Biosimilar Development, Ha Kung Wong and Erica Norey discuss the potential impact of authorized biologics on the developing biosimilars market. The article draws upon experience with authorized generics in the small molecule drug market and...

Federal Circuit Panel Determines That Appointment of Administrative Patent Judges Violates Appointments Clause of Constitution

by April Breyer Menon | Nov 4, 2019

On October 31, 2019, a Federal Circuit panel (Judges Moore, Reyna, and Chen), in Arthrex, Inc. v. Smith & Nephew, Inc., No. 2018-2140, held that the appointment of administrative patent judges (APJs) by the Secretary of Commerce under Title 35 violates the...

U.S. Patent System Crimps Drug Innovation for Toughest Diseases

by April Breyer Menon | Oct 16, 2019

In an article for Bloomberg Law, Venable partner Ha Kung Wong discusses how the U.S. patent system and inter partes review (IPR) proceedings affect pharmaceutical innovation. The article can be viewed here.

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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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