Mylan fails to void MSD diabetes treatment patent at PTAB

MSD, known as Merck in the US and Canada, has prevailed against a bid by Mylan Pharmaceuticals and other generic drug makers to invalidate a diabetes treatment patent.

The US Patent and Trademark Board delivered its decision in favour of the pharmaceutical company on Friday, May 7.

MSD sued 14 companies, including Mylan, for alleged infringement of US patent number 7,326,708, which was issued in July 2008 and covers the blockbuster diabetes treatment Janumet XR.

In October 2019, Mylan Pharmaceuticals countered by filing a petition to institute an inter partes review of the patent’s claims which was later granted in May 2020. Dr. Reddy’s Laboratories and Sun Pharmaceuticals Industries joined Mylan in the challenge.

The generics drug makers argued that the patent claims were invalid on the grounds of anticipation and obviousness.

They held that an earlier-filed international patent application, also owned by MSD, expressly or inherently discloses a form of salt claimed in the ’708 patent.

MSD contended the patent was not obvious because the claimed subject matter was highly unpredictable and the generics drug makers had failed to show a reason why it would have been made by an ordinarily skilled person with a reasonable expectation of success.

The PTAB found in favour of MSD, stating that the petitioners had failed to show by a “preponderance of the evidence” that the disputed claims are unpatentable, and had not met their “burden and proved unpatentability of the challenged claims”.

Janumet together with its sister drug Januvia generates huge profits for MSD. In the third quarter of 2020 alone, Januvia and Janumet accounted for $1.3 billion in profits for the pharmaceutical company. The ‘708 patent is due to expire in 2022.

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