Legal

Sandoz Settles With AbbVie Over Humira Biosimilar, Hyrimoz

October 12th 2018

By Kelly Davio

On 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.

Ha Kung Wong: Changes to IPRs and PGRs for Biologics

October 4th 2018

Ha Kung Wong, JD, partner at Fitzpatrick, Cella, Harper and Scinto, addresses recent changes to inter partes review (IPR) and post-grant review (PGR) proceedings with respect to biologic drugs.

Ha Kung Wong: The Biosimilar Manufacturer's Approach to the Patent Dance

September 25th 2018

Ha Kung Wong, JD, partner at Fitzpatrick, Cella, Harper and Scinto, discusses how manufacturers now approach the "patent dance" in light of Sandoz v Amgen.

Judge Denies Hospira's Motions in Epoetin Alfa Biosimilar Case

August 28th 2018

By The Center for Biosimilars Staff

Hospira 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.

Celltrion Did Not Infringe Janssen's Remicade Patent, Court Finds in Summary Judgment

August 2nd 2018

By The Center for Biosimilars Staff

This week, the district court of Massachusetts granted Celltrion’s motion for a summary judgment of non-infringement of the last patent in question in the long-running Janssen v Celltrion case.

Sovereign Immunity Does Not Extend to IPRs, Says Court in Long-Running Restasis Battle

July 23rd 2018

By The Center for Biosimilars Staff

On 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.

Sheila Frame: The BPCIA's Impact on Industry

June 12th 2018

Sheila Frame, vice president and head of biopharmaceuticals, North America, at Sandoz, explains how the Biologics Price Competition and Innovation Act (BPCIA) has impacted the industry.

Tahir Amin: Lessons Learned from Allergan's Patent Transfer

May 29th 2018

Tahir Amin, DipLP, co-founder and director of intellectual property of Initiative for Medicines, Access, and Knowledge, discusses lessons learned from Allergan's transfer of patents to a sovereign tribe.

Imron Aly, JD: Hatch-Waxman and BPCIA Litigation

May 16th 2018

Imron Aly, JD, partner at Schiff Hardin, LLP, explains how lessons learned from Hatch-Waxman proceedings can be applied to Biologics Price Competition and Innovation Act (BPCIA) litigation.

USPTO Proposes Amendments to Rules for Inter Partes Review

May 9th 2018

By Kelly Davio

The 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.