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Biosimilar Suits: Another Court To Rule On Declaratory Judgement Timing

 
• By Brenda Sandburg

Infringement suits have become routine, but Amgen’s, Celltrion’s and Teva’s suits against Genentech’s patents illustrate new trend by biosimilar sponsors to seek declaratory judgements of noninfringement. 

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For the second time, a biosimilar sponsor is seeking a declaratory judgment that it is not infringing Genentech Inc. patents. This time around, Celltrion Inc. and partner Teva Pharmaceuticals USA Inc. are trying to obtain a ruling they do not infringe patents covering Genentech's Herceptin (trastuzumab) and Rituxan (rituximab).

Celltrion and Teva filed a pair of complaints against Genentech on Jan. 11 in the US District Court for the Northern District of California requesting a declaratory judgment of non-infringement, invalidity and unenforceability relating to 38 Herceptin patents and 37 Rituxan patents

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EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

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• By Dave Wallace

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Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 
• By Derrick Gingery

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

Biosimilars Industry Celebrates EMA’s Plan to Reduce Clinical Trials

 
• By Dave Wallace

The European Medicines Agency’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam.

More from Biosimilars & Generics

Beyond Tariffs: The Silver Lining Of The US Pharma Security Investigation

 
• By Jessica Merrill

An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Pink Sheet's sister publication Scrip about the latest developments.

US FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 
• By Urtė Fultinavičiūtė

The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 
• By Derrick Gingery

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.