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.
Eye on Pharma: Canadian Aflibercept Settlement; Sandoz Acquires Cimerli; Payer Chooses Cyltezo
March 6th 2024Biocon Biologics settled with the maker of Eylea (aflibercept), announcing a launch date for its biosimilar competitor in Canada; Sandoz has officially acquired Cimerli, a ranibizumab biosimilar; AARP Medicare Rx from United Healthcare has added Cyltezo (adalimumab-adbm) and removed the originator (Humira) from its formulary.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Patient With MS Sues J&J Over ERISA Violation
February 14th 2024After a patient with multiple sclerosis (MS) was forced to pay exorbitant out-of-pocket costs for a brand name medication when she could’ve gotten a generic for way less, the patient filed a class action complaint against her employer, Johnson & Johnson (J&J), for violating the Employee Retirement Income Security Act of 1974 (ERISA).
Eye on Pharma: Fresh Biosimilar Lawsuits; FDA to Review Ustekinumab, Denosumab Biosimilars
January 11th 2024As Regeneron gears up for a legal battle with biosimilar competitors for its reference aflibercept, CareFirst files a lawsuit against Johnson & Johnson for restricting biosimilar ustekinumab competition; Celltrion and Accord BioPharma file with the FDA to approve their respective biosimilar candidates.
Eye on Pharma: Adalimumab Updates; New Eylea Biosimilar Lawsuit; Canada Gains Stelara Biosimilar
November 22nd 2023Several companies make moves to further their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).