Legal

AbbVie and Boehringer Ingelheim Settle Over Biosimilar Adalimumab

May 14th 2019

By The Center for Biosimilars Staff

Article

AbbVie announced today that it has settled its patent litigation with Boehringer Ingelheim over adalimumab.

Federal Circuit Affirms Judgment That Sandoz Did Not Infringe on Amgen's Patents

May 9th 2019

By Kelly Davio

Article

Yesterday, the federal circuit affirmed a district court’s decision in a patent dispute between Amgen and Sandoz.

Congress Votes on Amending Orange and Purple Books in Effort to Encourage Generics and Biosimilars

May 8th 2019

By Kelly Davio

Article

The House of Representatives has passed a pair of bills that make changes to the FDA’s Orange Book and Purple Book, which provide information on generic drugs and biosimilars, respectively.

Amgen Settles With One Biosimilar Developer, Sues Another

May 6th 2019

By Kelly Davio

Article

Last week, biosimilar developer Coherus BioSciences announced that it has reached a settlement with innovator drug maker Amgen over a trade secret case that was pending in the Superior Court of California. Separately, Amgen filed a new complaint against biosimilar developer Samsung Bioepis.

In Ongoing Adalimumab Litigation With Coherus, Amgen Denies Patent Infringement

April 29th 2019

By Kelly Davio

Article

Amgen has now answered Coherus BioSciences’ complaint and denies that it has infringed on Coherus’ patents. Amgen also said that the patents are invalid for failure to comply with requirements of the law.

PBMs Under Pressure From New Legislation and Fresh Lawsuits

April 24th 2019

By Kelly Davio

Article

Earlier this month, pharmacy benefit managers (PBMs) were called before the Senate Finance Committee to answer questions about how their businesses impact drug prices for Americans. While the executives deflected criticism and pointed to issues like legal challenges to biosimilars as playing a key role in keeping drug prices high, lawmakers and officials are taking steps to rein in PBMs.

Judge Grants BI's Motion to Compel AbbVie to Produce Documents in Ongoing Humira Litigation

April 18th 2019

By Kelly Davio

Article

This month, US magistrate judge Richard A. Lloret granted Boehringer Ingelheim (BI)’s motion to compel AbbVie to produce prelitigation disclosures and settlements concerning its brand-name adalimumab, Humira.

Genentech Sues Pfizer Over Proposed Bevacizumab Biosimilar, PF-06439535

April 9th 2019

By Kelly Davio

Article

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

Article

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

Article

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