Glenmark infringed Bayer’s Finacea patent, says Federal Circuit

The US Court of Appeals for the Federal Circuit ruled that Glenmark Pharmaceuticals infringed a Bayer Healthcare patent for the rosacea treatment Finacea.

The court entered a final judgment in favour of Bayer and directed the Food and Drug Administration (FDA) not to approve Glenmark’s Abbreviated New Drug Application (ANDA) until after November 18, 2018, which is when Bayer’s patent expires.

Glenmark submitted an ANDA to the FDA seeking to market a generic version of Finacea Gel. In the submission, Glenmark asserted that the 6,534,070 patent is invalid and not infringed.

The US District Court for the District of Delaware previously ruled in favour of Bayer, prompting Glenmark to appeal.

However, yesterday, May 16 the court ruled that Glenmark had infringed Bayer’s patent under the doctrine of equivalents.

Unlike Finacea, Glenmark’s generic version used a different inactive ingredient called isopropyl myristate, instead of triglycerides and lecithin. The difference in the ingredient was the main point of debate in the dispute.

The Federal Circuit ruled that even though the two products contained different inactive ingredients, Glenmark’s version infringed the patent under the doctrine of equivalents. It was further explained that the reason for the ruling is that Glenmark’s generic version “performs substantially the same function in substantially the same way with substantially the same result”.

The ruling was also based on the understanding that the isopropyl myristate in Glenmark’s generic product provides the same function as triglyceride and lecithin in Bayer’s product—that is enhancing penetration of the active ingredient, azelaic acid.

Glenmark argued that Bayer failed to prove that triglycerides and lecithin enhance penetration of the active ingredient, as Bayer’s patent did not mention the function of those chemicals.

But the Federal Circuit wrote: “Because we see no reversible error in the district court’s decision that Glenmark’s generic product infringed the asserted claims and that the asserted claims are not invalid, the district court’s judgment is affirmed.”