Legal

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.

Robert Cerwinski: Healthcare Reform and the BPCIA

August 21st 2017

Robert Cerwinski, JD, Partner at Goodwin, discusses what becomes of the BPCIA if the Affordable Care Act is repealed by Congress.

Legal Battles Over the Biosimilars Patent Dance Continue in Amgen v Hospira

June 1st 2017

By Kelly Davio

The ongoing district court litigation of Amgen v Hospira—a case regarding Hospira’s proposed biosimilar to epoetin alfa (Epogen), a biological agent used to treat anemia—progressed on May 26, 2017, when counsel for Amgen filed a motion for a preliminary injunction.

Yet Another Pegfilgrastim Biosimilar Candidate Announces Positive Clinical Study Data

May 17th 2017

By Jackie Syrop