Legal

Genentech Sues Pfizer Over Proposed Bevacizumab Biosimilar, PF-06439535

April 9th 2019

By Kelly Davio

Genentech, together with City of Hope, has filed a new complaint for patent infringement against Pfizer over PF-06439535, Pfizer’s proposed bevacizumab biosimilar referencing Genentech’s Avastin.

Class Action Lawsuit Filed Against AbbVie and Biosimilar Developers Alleges Collusion

March 19th 2019

By Kelly Davio

A class action lawsuit has been filed by United Food and Commercial Workers Local 1500 (UFCW Local 1500) against AbbVie for alleged use of a patent thicket to maintain a monopoly for its brand-name adalimumab, Humira. The complaint also alleges that AbbVie and a number of its biosimilar competitors colluded to divide the market for adalimumab between Europe and the United States.

Judge Grants Preliminary Injunction in Biosimilar Trade Secret Case

March 11th 2019

By Kelly Davio

This month, US District Judge William Alsup granted biologic developer Genentech some relief in its civil case against biosimilar developer JHL.

Ahead of an FDA Decision on Its Pegfilgrastim Biosimilar, Sandoz Sues Amgen

February 26th 2019

By The Center for Biosimilars Staff

This month, biosimilar developer Sandoz filed suit against Amgen, asking the United States district court for the Northern District of California for a declaratory judgment of patent noninfringement and invalidity.

"Not So Different:" The Supreme Court and US Biosimilars

February 23rd 2019

Those who follow the biosimilars space closely are aware that, in the context of the US market, legal concerns regarding biosimilars can be just as regulatory ones in informing how drug makers do business. One recent case that impacts on upon the biosimilars market was recently heard before the before the United States Supreme Court, and the outcome of the case will potentially impact drug makers seek patent protection for various aspects of their products.

Judge Dismisses RICO Claims, But 3 Insulin Makers Must Still Face Drug Pricing Lawsuit

February 19th 2019

By Kelly Davio

A United States District Judge in New Jersey has allowed a proposed class-action lawsuit against 3 major insulin makers to proceed.

In a Win for Boehringer Ingelheim, AbbVie Must Turn Over Humira Documents

February 12th 2019

By The Center for Biosimilars Staff

In a long-running patent dispute with biosimilar developer Boehringer Ingelheim, AbbVie, maker of the brand-name adalimumab, Humira, has been ordered to produce documents related to its efforts to obtain patents that could shield its blockbuster drug from biosimilar competition.

Court Rules That Momenta's Abatacept Appeal Is Moot

February 8th 2019

By The Center for Biosimilars Staff

This week, the United States Court of Appeals for the Federal Circuit found that Momenta lacked standing to appeal a decision upholding a patent covering abatacept (Orencia) and said that Momenta’s appeal was rendered moot by the drug makers’ choice to stop developing its biosimilar.

Coherus Settles With AbbVie, Sues Amgen, Over Biosimilar Adalimumab

January 28th 2019

By Kelly Davio

Coherus BioSciences announced on Friday that it has become the latest biosimilar developer to settle with AbbVie, maker of the brand-name adalimumab, Humira, over a proposed biosimilar. In an intellectual property twist, Coherus also announced that it has sued a rival biosimilar developer, Amgen.

Government Shutdown Could Take a Substantial Toll on Biosimilars, Experts Say

January 16th 2019

By Kelly Davio

When the shutdown ends, said Scott Lassman, JD, partner at Goodwin, “It’s not going to be like flipping a switch…this is going to have longer-term consequences.”