Pharma Giants Tee Up Biologics Innovation Fight At Fed. Circ.

by April Breyer Menon | Aug 21, 2020

Venable Fizpatrick partner Ha Kung Wong spoke with Law360 for an article about Amgen v. Sanofi, a case currently pending at the Federal Circuit involving patents related to the biologic drugs Praluent and Repatha. At issue in this case is whether patents claiming a...

Venable’s BiologicsHQ Monthly Injection – July 2020

by April Breyer Menon | Aug 10, 2020

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Patent Cases to Watch in the Second Half of 2020

by April Breyer Menon | Jul 9, 2020

Venable partner Ha Kung Wong spoke with Law360 for an article about patent law Federal Circuit and Supreme Court cases to watch in 2020, including cases that will decide the fate of the Affordable Care Act and therefore the Biologics Price Competition and Innovation...

Venable’s BiologicsHQ Monthly Injection – June 2020

by April Breyer Menon | Jul 9, 2020

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Federal Circuit to Amend Rules for Appeals in Patent Cases

by April Breyer Menon | Jun 24, 2020

On July 1, 2020, the United States Court of Appeals for the Federal Circuit will adopt several amendments to its rules of practice, which govern procedural aspects of appeals from district court patent cases and appeals from Patent Trial and Appeal Board proceedings....

It’s a New Set of Rules for Insulin Products Under 351(k)

by April Breyer Menon | Jun 15, 2020

Based on an announcement last week, the longtime generics manufacturer Lannett would become among the first to file for insulin glargine product approval under the 351(k) Biologics License Application pathway. Venable’s Ha Kung Wong discusses previous and future...

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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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