A dispute over an innovative faecal transplant medicine is the first involving an entirely new class of therapeutic microbiome drugs to reach a jury.
Swiss biopharmaceutical company Ferring Pharmaceuticals has been hit with a USD 25 million damages bill after a US jury found it had infringed the patents for a pioneering faecal transplant therapy belonging to competitor Finch Therapeutics and the University of Minnesota.
The jury, whose verdict was handed down by the District Court for the District of Delaware on 9 August, found that Ferring had wilfully infringed on three patents that Finch owned and licensed from the University. The patents relate to a first-of-its-kind faecal microbiome therapy indicated for the prevention of the Clostridioides difficile infection (CDI), a potentially life-threatening ailment that causes an infection of the colon, often sparked by the use of antibiotic medicines. Ferring, who has been ordered to pay the damages based on USD 14 million worth of sales, must also pay Finch for future royalties.
The spat centres on Ferring’s Rebyota drug, which in 2022 was the first faecal transplant medicine for recurrent CDI to be approved by the US Food and Drug Administration (FDA).
According to a 2011 study by the US Centers for Disease Control and Prevention, CDI infects around 500,000 people in the US per year and is linked to around 30,000 annual deaths.
While Ferring maintained that its Rebyota therapy and the technology underlining it did not directly or indirectly infringe on the patents in question, the jury concluded that Finch and the university, whose professors Alex Khoruts and Mike Sadowsky are believed to be the inventors of the primary patents, had ownership of the patents that produced this new class of therapeutics.
The jury trial follows several years of legal wranglings between the parties which started with Ferring filing a pre-emptive action against Massachusetts-headquartered Finch in 2021, seeking a declaratory judgment that the patents in suit were either invalid or not infringed.
In the filing, Ferring asserted that there was an “actual, justiciable, and continuing controversy” existing between the two companies over the validity of the patents.
Explaining its anticipatory action, Ferring said in the filing that Finch’s stated intentions to “aggressively enforce their patent portfolio”, gave rise to the reasonable belief that the defendants would claim that making, using and selling Rebyota in the US would infringe certain patents. The Swiss company also contended that Rebyota was not manufactured in a way that would violate the patents at issue.
Finch’s win comes after its announcement last year that it was ceasing its CDI research, which resulted in a 95% cut to its workforce. Finch said its decision was based on several factors, including the “harmful impact of ongoing unauthorised use of the company’s intellectual property”.
In a statement, Ferring said it was disappointed with the jury verdict and was “considering next steps”.
In a filing lodged with the US Securities and Exchange Commission yesterday (12 August), Finch stated it expects Ferring to file post-trial motions and pursue an appeal of the judgment.
Ferring was represented by partners Daralyn Durie, Matthew Chivvis and Whitney O’Byrne of Morrison & Foerster, while a team at Kirkland & Ellis led by partners Michael De Vries, Adam Alper, Sharre Lotfollahi, Patricia Carson and Leslie Schmidt acted for Finch.
In other recent patent battles, fleet management technology company Omnitracs was awarded USD 19.4 million in July after its rival Platform Science was found to have infringed on one its patents. Omnitracs is also gearing up to face Motive Technologies, which it alleges also developed competing products with the assistance of former Omnitracs employees, in a trial scheduled for February 2025.
Also in July, the Court of Appeal in London made a landmark ruling in an eagerly anticipated judgment concerning the licensing of standard-essential patents (SEPs) and the fair, reasonable and non-discriminatory (FRAND) rates implementers should pay for past sales.