by April Breyer Menon | Mar 17, 2023 | Focus, News
Introduction It has been 13 years since the Biologics Price Competition and Innovation Act (BPCIA) was enacted and biosimilars had a pathway to enter the U.S. market. While there have been challenges over this time, the U.S. biosimilar market has come a long way and...
by April Breyer Menon | Mar 15, 2023 | News, Newsletters
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by April Breyer Menon | Feb 28, 2023 | Focus, News, Spotlight On
Download PDF *Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they are challenged under §...
by April Breyer Menon | Feb 28, 2023 | News, Spotlight On
Download PDF *Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple litigations/IPRs are...
by April Breyer Menon | Feb 28, 2023 | News, Spotlight On
Download PDF *Trastuzumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple litigations/IPRs...
by April Breyer Menon | Feb 28, 2023 | News, Spotlight On
Download PDF Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference...