5 Key Legal Developments for US Biosimilars in 2019

December 31, 2019
Allison Inserro

Cases involving adalimumab featured in 2 of the 5 top legal stories in 2019 that dealt with various legal matters, including charges of patent thicketing.

Cases involving adalimumab featured in 2 of the 5 top legal stories in 2019 that dealt with various legal matters, including charges of patent thicketing.

5. Court of Appeals for the Federal Circuit Declines to Halt Sales of Biosimilar Bevacizumab

In a one-page order filed in August 2019, a panel of judges for the US Court of Appeals for the Federal Circuit denied Genentech’s motion for an injunction that would have blocked Amgen from selling its biosimilar bevacizumab, Mvasi, pending the outcome of an appeal. The case stems from a dispute over the notice of commercial marketing for the biosimilar.

4. Class Action Lawsuit Filed Against AbbVie and Biosimilar Developers Alleges Collusion

In March 2019, a class action lawsuit was 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.

3. In Agreement With Genentech, JHL Must Destroy Its Biosimilar Cell Lines and Banks

In the fall of 2019, Genentech reached a memorandum of understanding with JHL Biotech in its civil lawsuit related to the theft of Genentech’s trade secrets. The plan requires JHL to stop developing its biosimilars referencing Genentech’s products: rituximab (Rituxan), dornase alfa (Pulmozyme), trastuzumab (Herceptin), and bevacizumab (Avastin). Several of the proposed biosimilars had already entered phase 3 development.

2. FTC Seeking Information About J&J's Strategy for Brand-Name Infliximab, Remicade

Johnson & Johnson (J&J) said in July 2019 that the Federal Trade Commission (FTC) had issued civil subpoenas as part of an antitrust investigation into the contracting practices for the autoimmune drug Remicade, the originator infliximab sold by its Janssen unit. In 2017, Pfizer sued J&J, alleging that J&J’s contracts with payers for Remicade were anticompetitive and aimed to block sales of Pfizer’s infliximab biosimilar, Inflectra, which was approved in 2016. J&J is fighting the Pfizer lawsuit, but in August 2018, the district court for the Eastern District of Pennsylvania denied J&J’s motion to dismiss the case.

1. AbbVie and Boehringer Ingelheim Settle Over Biosimilar Adalimumab

In May 2019, AbbVie announced that it has settled its patent litigation with Boehringer Ingelheim (BI) over adalimumab. Under the terms of the settlement, BI’s biosimilar, Cyltezo, will not enter the US market until July 1, 2023. BI will pay royalties to AbbVie for licensing of its patents covering the reference drug, Humira, and BI acknowledged the enforceability of AbbVie’s patents.

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