Legal

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, 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.

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

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.

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

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

Robert Cerwinski, JD, Partner at Goodwin, discusses what becomes of the BPCIA if the Affordable Care Act is repealed by Congress.

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.