Statistics Archive — Page 10 of 10 — Venable's BiologicsHQ

PGR and District Court Outcomes by § 112 Challenge Type

by April Breyer Menon | Feb 28, 2022

Since § 112 invalidity challenges are available in PGRs we compared PGR § 112 challenge outcomes for indefiniteness, written description and enablement to those challenges in district court (DC) litigations. For this analysis we reviewed district court...

Institution Outcomes: Biologic and Orange Book Drug IPRs

by April Breyer Menon | Sep 30, 2023

Biologic Drug IPR Petitions include IPR petitions relating to CDER-listed biologic products and drugs for which follow-on products are approved under the 505(b)(2) pathway, such as insulin. IPR petitions relating to manufacturing patents that may be relevant...

FWD Outcomes: Biologic and Orange Book Drug IPRs

by April Breyer Menon | Sep 30, 2023

Timeline: Inter Partes Review (IPR)

by April Breyer Menon | Jan 6, 2023

BiologicsHQ and materials published on BiologicsHQ are published for informational purposes only. Neither the information nor any opinion expressed on BiologicsHQ constitute legal advice, create an attorney-client relationship, or constitute a solicitation for...

Timeline: Post Grant Review (PGR)

by April Breyer Menon | Jan 6, 2023

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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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