April Breyer Menon, Author at Venable's BiologicsHQ

PREVAIL Act Reforms at the PTAB

by April Breyer Menon | Aug 14, 2023

The Act’s Objectives USPTO data indicate that as many as 80% of instituted Patent Trial and Appeal Board (PTAB) proceedings that reach a final written decision (FWD) result in the invalidation of at least one challenged patent claim, with 65% of those proceedings...

What Do the Humira Biosimilar / Interchangeable Launches Mean for the Adalimumab Market?

by April Breyer Menon | Aug 7, 2023

At the beginning of July, seven additional Humira® (adalimumab) biosimilars, including one interchangeable, joined Amjevita™ (adalimumab-atto) in the US marketplace. Abrilada™ (adalimumab-afzb) is the only FDA-approved adalimumab biosimilar that has not...

PTAB Eliminates POP Review and Expands Director Review to Institution Decisions

by April Breyer Menon | Jul 31, 2023

As of July 24, 2023, the United States Patent and Trademark Office (USPTO) revised the interim Director Review process and replaced the Precedential Opinion Panel (POP) with the Appeals Review Panel process, which will review decisions in ex parte, re-examination, and...

Venable’s BiologicsHQ Monthly Injection – June 2023

by April Breyer Menon | Jul 15, 2023

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Senators Tillis and Coons Reintroduce Patent Eligibility Reform Legislation

by April Breyer Menon | Jun 30, 2023

On June 22, 2023, Senators Thom Tillis (R-N.C.) and Chris Coons (D-Del.) announced the reintroduction of legislation to reform the patent eligibility requirements under 35 U.S.C. § 101. The “Patent Eligibility and Restoration Act of 2023,” similar to the...

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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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