Legal

UK Patent Court Delivers Setback to Biosimilar Bevacizumab Launch

June 26th 2019

By Kelly Davio

In this case, Pfizer hoped to launch its biosimilar bevacizumab in the UK market after the basic patent on the reference product, Genentech and Roche’s Avastin, expires in June 2020. However, the biosimilar maker has been hindered by what it has termed a patent thicket related to secondary patents.

When Can Biologic Patent Disputes Go Before the ITC?

June 25th 2019

By Allison Inserro

Under which situations might the International Trade Commission (ITC) be the right choice for biosimilar patent disputes instead of federal district court? A panel discussed these questions at the ACI 10th Summit on Biosimilars on Monday in New York City.

The Top 5 Biosimilars Articles for the Week of May 13

May 17th 2019

The Center for Biosimilars® recaps the top news for the week of May 13, 2019.

AbbVie and Boehringer Ingelheim Settle Over Biosimilar Adalimumab

May 14th 2019

By The Center for Biosimilars Staff

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

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

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

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

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

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

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.