November 22nd 2023
Several companies make moves to further their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).
Judge Denies Hospira's Motions in Epoetin Alfa Biosimilar Case
August 28th 2018Hospira had asked the court for a judgment that producing batches of a biosimilar product is an activity protected by safe harbor provisions, that Hospira did not infringe on the ’298 patent (which Hospira claims is invalid), and that damages owed to Amgen not exceed $1.5 million per batch of the drug (if those batches were later sold). Alternatively, it sought a new trial in the case.
Sovereign Immunity Does Not Extend to IPRs, Says Court in Long-Running Restasis Battle
July 23rd 2018On July 20, the United States Court of Appeals for the Federal Circuit ruled in the case of the St Regis Mohawk Tribe v Mylan Pharmaceuticals that sovereign immunity does not extend to inter partes review (IPR) proceedings.
USPTO Proposes Amendments to Rules for Inter Partes Review
May 9th 2018The United States Patent and Trademark Office (USPTO), in a proposed rule published today on the Federal Register, seeks to amend the rules for inter partes review proceedings, and similar proceedings, before the Patent Trial and Appeal Board.
Celltrion Asks for Summary Judgment of Non-Infringement in Inflectra Case
April 12th 2018In 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.
Genentech Defends Patents on Bevacizumab, Rituximab in US, Japanese Courts
January 13th 2018Innovator 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.
Saint Regis Mohawk Tribe Seeks Discovery Into PTAB in Ongoing Battle Over Restasis
January 4th 2018On 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.
Federal Circuit Sides With Biosimilar Developer Sandoz in Landmark Decision
December 14th 2017The 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.
Legal Battles Over the Biosimilars Patent Dance Continue in Amgen v Hospira
June 1st 2017The 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.