April Breyer Menon, Author at Venable's BiologicsHQ

PTAB Sees Fewer Drug Patent Fights as Generics’ Strategy Shifts

by April Breyer Menon | Feb 8, 2021

Venable Fizpatrick partner Ha Kung Wong spoke with Bloomberg Law for an article discussing the possible reasons for the recent decline in inter partes review (IPR) challenges to patents listed in the FDA’s Orange Book. The article by Bloomberg Law can be viewed...

Venable’s BiologicsHQ Monthly Injection – January 2021

by April Breyer Menon | Feb 8, 2021

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Purple Book to Include Patent and Additional Information on Biologic Drugs

by April Breyer Menon | Feb 1, 2021

As part of the “Consolidated Appropriations Act, 2021,” a COVID-19 relief and spending bill, 42 U.S.C. § 262(k) was amended to include new provisions for the FDA’s Database of Licensed Biological Products (“Purple Book”). According to the new legislation, within 180...

Venable’s BiologicsHQ Monthly Injection – December 2020

by April Breyer Menon | Jan 12, 2021

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Patent Cases To Watch In 2021

by April Breyer Menon | Jan 3, 2021

Venable Fizpatrick partner Ha Kung Wong spoke with Law360 for an article analyzing the patent cases to watch in 2021, including U.S. v. Arthrex, which involves the constitutionality of how administrative patent law judges who preside over inter partes review (IPR) and...

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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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