Search Results for: "amgen v apotex"

New BPCIA Complaint: Amgen Sues Apotex, Again, over Proposed Pegfilgrastim and Filgrastim Biosimilars

Amgen filed a complaint against Apotex today in the Middle District of Florida, alleging infringement of U.S. Patent No. 9,856,287 based on Apotex’s aBLAs for filgrastim and pegfilgrastim biosimilars. The ’287 patent issued on January 2, 2018 and is directed to methods of protein refolding in non-mammalian expression systems.  According to…

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BPCIA Litigations

The table below chronologically lists the U.S. patent litigations filed under the BPCIA regarding aBLAs for biosimilar products.  For additional details, please consult the links below and our quarterly BPCIA litigation roundup. # Litigation Accused Biosimilar [status] Reference Product [suit#] Complaint Filed Status/Outcome District Court Appeal 1 Amgen v. Sandoz,…

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Federal Circuit Issues Mandate in Amgen v. Apotex

As we previously reported, last month a Federal Circuit panel affirmed the district court’s judgment that Apotex’s pegfilgrastim and filgrastim biosimilar candidates do not infringe Amgen’s protein refolding method patent. Amgen’s time for filing a petition for panel rehearing or rehearing en banc of last month’s panel decision expired on…

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BPCIA Litigation Roundup (Fall 2017)

Below is our fall update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates (Summer 2016, Fall 2016, Midwinter 2017, Spring 2017, Summer 2017).

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Federal Circuit Provides Guidance on Statements in Patent Dance Letters and Sunovion in Amgen v Apotex

As we previously reported, yesterday the Federal Circuit affirmed the Southern District of Florida’s finding of non-infringement in Amgen v. Apotex. In that case, Amgen asserted the ’138 patent against Apotex based on Apotex’s aBLAs for biosimilar versions of Amgen’s Grastofil™ (filgrastim) and Lapelga™ (pegfilgrastim) products.  Claim 1, the only independent claim,…

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Federal Circuit Oral Arguments in NYC Today

This week, six Federal Circuit panels will hear oral argument on at various venues in New York City.  Two of today’s oral arguments are in biosimilar cases that we have been closely following on this blog. First, at 10:00 AM, a panel will hear oral argument at the U.S. Court…

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BPCIA Litigation Roundup (Spring 2017)

Below is our spring update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates (Summer 2016, Fall 2016, Midwinter 2017).

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