US drugmaker Genentech has sued Samsung Bioepis in Delaware, claiming the Korean company’s biosimilar version of breast cancer treatment Herceptin infringes 21 of its patents.

The 4 September complaint alleged Samsung had failed to comply with US rules requiring biosimilar manufacturers to exchange information on potential crossovers between their drugs and and brand-name patents and asked Judge Gregory Sleet to rule that Herceptin “copycat product” SB3 would violate the patents if it was imported, made or sold in the US.

The US Food and Drug Administration approved Herceptin – the first drug to use the antibody trastuzumab to target a particular strain of rapidly metastasising breast cancer known as HER2 – in 1998 and the US Patent and Trademark Office granted Genentech various patents covering the drug’s manufacture and use.

Judge Sleet is currently hearing a number of other patent disputes between Genentech and different biosimilar developers – including Pfizer, Teva and Amgen – over their prospective trastuzumab launches. In March last year, Genentech and Hoffmann La-Roche (the assignee of one of the Herceptin patents) agreed to a global settlement of a dispute with rival drugmaker Mylan, which granted the latter licences to launch its own trastuzumab product in all countries except Japan, Brazil and Mexico.

Samsung entered the fray in December 2017, when it announced that it had filed an abbreviated biologics licence application (aBLA) for SB3 with the FDA. Genentech says it wrote to Samsung to request a copy of its aBLA later that month but only received “redacted versions of four subsections of its aBLA, which represented a tiny fraction of its entire aBLA.”

Samsung answered Genentech’s requests for more information in early 2018 with further subsections of the aBLA, which still represented “only a small fraction” of its overall application according to the complaint.   

The company claims Samsung fell short of its obligations under the 2010 Biologics Price Competition and Innovation Act (BPCIA), which requires applicants to share a full copy of their aBLA and “such other information that describes the process or processes used to manufacture the biological product that is the subject of such application” with the reference product sponsor. Despite this, Genentech says it fulfilled its obligations by providing a list of the patents it believed SB3 would infringe and declaring that it wasn’t prepared to license any of them to Samsung.

In June, Samsung responded to the list with a letter claiming that none of the patents would be infringed by its product, which Genentech says contained “numerous deficiencies”, including failing to describe the product’s manufacturing process. In its own response in August, Genentech said it still believed SB3 would infringe “at least” 21 of its patents and proposed the current infringement action, which Samsung agreed to litigate on 3 September.

Genentech, which has retained Richards Layton & Finger as Delaware counsel, is seeking a declaratory judgment under the BPCIA that SB3 would infringe the 21 patents if it came to be manufactured, used, offered for sale, sold or imported in the US. It also asked for a permanent injunction against SB3’s launch until the patents had expired and warned that it would seek damages if the drug became available earlier.

In the United States District Court for the District of Delaware

Genentech et al v Samsung Bioepis

  • Judge Gregory Sleet

Counsel to Genentech

  • Richards Layton Finger

Frederick Cottrell and Jason Rawnsley in Wilmington

Counsel to Samsung

  • White & Case

William Lee, Lisa Pirozzolo, Emily Whelan, Kevin Prussia and Andrew Danford in Boston; Robert Gunther in New York; Robert Galvin in Palo Alto; and Daralyn Durie in San Francisco