Search Results: test Uncategorized

Federal Circuit Rules No Tribal Immunity in IPRs

This morning, the Federal Circuit issued its much anticipated decision in St. Regis Mohawk Tribe v. Mylan Pharmaceuticals.  A panel of the court, consisting of Judges Dyk, Moore, and Reyna, held that “tribunal sovereign immunity cannot be asserted in IPRs.”  Relying on the Supreme Court’s decisions in Oil States and SAS Institute,…

Read More

FDA Releases Biosimilar Action Plan (BAP) to Enhance Biosimilar Competition and Market Penetration

Today, the U.S. FDA released its Biosimilar Action Plan (BAP), which outlines the Administration’s proposed next steps to help reduce the costs of healthcare by expediting the development of robust biosimilar competition and market penetration, while encouraging innovation and maintaining incentives for investing in future products.  In remarks delivered at…

Read More

New BPCIA Complaint: Amgen Sues Pfizer over Proposed Filgrastim Biosimilar

Today, Amgen filed against Mylan concerning its Fulphila® (pegfilgrastim-jmdb) biosimilar of Neulasta®, and against Adello concerning its proposed filgrastim biosimilar. According to the complaint, the parties engaged in the patent dance, during which the parties negotiated and ultimately agreed that, of the seven patents that Amgen identified on its list…

Read More

BPCIA Litigation Roundup (Q2 2018)

Below is our second quarter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our previous quarterly updates (Q3 2016, Q4 2016, Q1 2017, Q2 2017, Q3 2017, Q4 2017, Q1 2018). Please also refer to our BPCIA Patent Litigation and Federal…

Read More