Legal

Celltrion Asks for Summary Judgment of Non-Infringement in Inflectra Case

April 12th 2018

By The Center for Biosimilars Staff

In ongoing litigation over Celltrion and Pfizer’s infliximab biosimilar, Inflectra, a Massachusetts district court has granted Celltrion’s motion for leave to file a motion for summary judgment of non-infringement.

Virginia Passes New Legislation Restricting PBM Practices

February 28th 2018

By Samantha DiGrande

Virginia’s House and Senate have both passed a new bill, HB1177, which prohibits PBMs from penalizing pharmacists for sharing drug pricing information with consumers.

Genentech Defends Patents on Bevacizumab, Rituximab in US, Japanese Courts

January 13th 2018

By The Center for Biosimilars Staff

Innovator drug developer Genentech, maker of the biologic therapies Avastin (bevacizumab) and Rituxan (rituximab), faces challenges from biosimilar developers in the United States and abroad. This week saw developments in cases concerning both molecules in US and Japanese courts of law.

Scott Lassman: Industry Takeaways from Allergan's Patent Transfer

January 11th 2018

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, responds to Allergan's recent transfer of patents to a soverign entity, and gives 2 takeaways for industry.

Saint Regis Mohawk Tribe Seeks Discovery Into PTAB in Ongoing Battle Over Restasis

January 4th 2018

By Kelly Davio

On January 2, counsel for the Saint Regis Mohawk Tribe filed a motion for discovery and requested an oral hearing concerning which judges will sit on the Patent Trial and Appeal Board (PTAB) panel that oversees its case.

The 4 Key Legal Developments in Biosimilars in 2017

December 27th 2017

By The Center for Biosimilars Staff

The Center for Biosimilars recounts 4 of the top legal developments in the biosimilars space during 2017.

James Stevenson, PharmD: Legal Battles, Payer Policies, Pharmacovigilance Pose Challenges for Biosimilars

December 22nd 2017

By Kelly Davio

Developments at the FDA and greater physician acceptance of biosimilars made 2017 a banner year for emerging therapies, according to James Stevenson, PharmD, FASHP, professor of clinical pharmacy at the University of Michigan College of Pharmacy.

Court Rules Sandoz Did Not Infringe on Amgen's Filgrastim, Pegfilgrastim Patent

December 21st 2017

By Kelly Davio

On December 19, Richard Seeborg, US district judge for the Northern District of California, granted a summary judgment of noninfringement in Amgen v Sandoz.

Federal Circuit Sides With Biosimilar Developer Sandoz in Landmark Decision

December 14th 2017

By Kelly Davio

The federal circuit ruled today in Amgen v Sandoz that state law cannot compel drug makers to participate in the so-called “patent dance” provided for in the Biologics Price Competition and Innovation Act because state law cannot preempt federal law.

Robert Cerwinski: Reference Product Sponsors and Biosimilar Development

November 29th 2017

Robert Cerwinski, JD, partner at Goodwin, discusses the challenges that reference product sponsors encounter when they also seek to develop biosimilars.