After years of back-and-forth with several generics makers, Sanofi came out on top in its latest Jevtana litigation, successfully blocking generic competition to the prostate cancer drug from Novartis’ Sandoz.
The drug was approved in 2010 to treat metastatic castration-resistant prostate cancer (mCRPC) and has since remained one of Sanofi’s top oncology products.
The patent case concerned Jevtana’s patent ‘777, which covers methods of increasing survival and expires in 2030. Sandoz argued that it didn’t infringe the patent because its generic's label didn't specifically intend to extend survival but instead stated its use “for the treatment of” mCRPC.
U.S. District Judge Richard G. Andrews sided with Sanofi on that argument, finding that Sandoz’s label does promote use of the product for increasing survival.
“I find that Plaintiffs have proven by a preponderance of the evidence that Defendant's label will induce infringement of the asserted claims of the '777 patent,” Andrews said in a trial opinion (PDF).
Next, Sandoz tried an obviousness argument, claiming that the patent in question is invalid as the treatment for increasing survival would be an “obvious modification” to the prior studies of the compound.
That effort also didn’t pass muster with the judge, who determined that the company’s arguments in that aspect weren’t clear or convincing and that administering the drug to increase survival in mCRPC patients wouldn’t have been obvious.
Now, Sanofi is vindicated by the District Court’s opinion that the ‘777 patent would be infringed upon with Sandoz’s product and is not invalid.
Sanofi has been vigorously defending its Jevtana patents for years now. In 2019, it prevailed in an appeal, overturning a prior ruling that invalidated several Sanofi claims on its ‘592 patent. That earlier judgment also blocked generics from Fresenius Kabi, Accord Healthcare, Apotex and others and was upheld on appeal by the generics makers.
Sandoz was the last standing Jevtana generic suit, Sanofi noted in its first-quarter earnings release (PDF).
The aging drug is still Sanofi’s top oncology money maker, bringing in 391 million euros ($425 million) in 2022. But the company is looking to freshen up its cancer portfolio, or more specifically go “back to the magic,” CEO Paul Hudson said during Sanofi’s fourth-quarter earnings call. It currently has 23 oncology projects in its pipeline, 11 of which are currently in phase 1 development.