November 11th 2024
Part 1 of this 3-part series for Global Biosimilars Week focuses on legal barriers to biosimilar access in the US, including the patent system, and discusses ongoing legislative efforts to address these challenges.
With the Future of the ACA in Question, Are US Biosimilars at Risk?
December 19th 2018While many stakeholders are concerned most immediately about how a recent ruling on the Affordable Care Act (ACA) could affect US patients’ healthcare options and coverage for pre-existing conditions, the biosimilars industry is also concerned about the future of one key feature of the ACA that keenly impacts the biosimilars landscape: the Biologics Price Competition and Innovation Act.
Republican Lawmakers Introduce Bill to Limit IPRs by Generic and Biosimilar Developers
December 18th 2018Last week, Republicans in the House of Representatives and in the Senate introduced legislation that would restrict generic and biosimilar developers from challenging patents on reference drugs using the inter partes review (IPR) process.
Court Denies J&J's Motion to Dismiss in Walgreen and Kroger Antitrust Suit
December 17th 2018Johnson and Johnson (J&J) recently filed a motion to dismiss in the antitrust claim brought against the company by Walgreen and Kroger in regard to sales of J&J’s reference infliximab product, Remicade. In early December, the District Court for the Eastern District of Pennsylvania denied the motion.
Genentech's Civil Suit Against JHL Alleges Proof of Criminal Theft of Trade Secrets
December 8th 2018The complaint includes a screenshot of Xanthe Lam’s Genentech-issued computer, which shows a folder titled “JHL” that contained subfolders, 4 of which were named for Genentech medicines for which JHL was in the process of developing a biosimilar.
Experts Discuss BPCIA Litigation Confusion, Differences Between IPRs and PGRs
November 15th 2018Experts from Venable, Alkermes, and Novartis provide updates to the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and explain the differences between inter partes review (IPR) and post grant review (PGR) litigation.
Amgen Files Cross-Appeal in Ongoing Battle Over Epoetin Alfa
November 5th 2018Amgen filed a cross appeal in this long-running case on October 15, 2018. The appeal challenges, among other things, the district court’s previous judgement that Hospira had not infringed on another patent named in the original suit, US Patent Number 5,756,349, which covers the production of erythropoietin.
Sandoz Settles With AbbVie Over Humira Biosimilar, Hyrimoz
October 12th 2018On Thursday, biosimilar developer Sandoz announced that it had reached a global settlement of its patent disputes with AbbVie, maker of the reference Humira. The settlements will allow Sandoz to enter some European markets with its biosimilar adalimumab, Hyrimoz, as early as October 16, 2018.
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.