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15 June 2023AmericasMuireann Bolger

MSD wins patent extension feud over post-surgery drug

The three-year dispute revolved around proposed generic versions of a drug used to offset the effects of muscle relaxants | Pharma giant can retain patent until January 2026.

MSD, known as Merck in the US and Canada, has prevailed in a patent infringement lawsuit that concerned its best selling post-surgery treatment,  Bridion (sugammadex).

The pharma company released a  statement on June 13, confirming that the  US District Court for the District of New Jersey had ruled in favour of the claims of infringement.

MSD filed actions under the  Hatch-Waxman Act against 16 generic drug maker groups in 2020, relating to proposed generic versions of Bridion.

The drugmakers, including Teva Pharmaceuticals, argued that the US Patent and Trademark Office had incorrectly measured a patent extension term for the primary patent related to Bridion, US patent number RE44,733.

In handing down its decision, the court held that MSD and the office had correctly calculated the patent term extension period for the drug.

The ruling affirms and validates MSD’s US patent protection for Bridion until at least January 2026. A patent term extension is designed to restore some of the patent life lost during the regulatory review process for new drugs.

Sugammadex is used to reverse the effect of the muscle relaxants rocuronium and vecuronium, which are used during some operations to make the muscles relax and to help the patient to breathe.

Essentially, Sugammadex can speed the recovery from these muscle relaxants, and is usually administered at the end of the operation. It can be used in both adults and children

Commenting on the decision,  Jennifer Zachary, executive vice president and general counsel of MSD said: “[MSD’s] science and technology was used to develop and launch Bridion, and we’re pleased that the court recognised the validity of our full patent extension period granted by the patent office.

“Innovations like these contribute to a broader ecosystem that allows us to continue investing in research and development to bring important new therapies and vaccines forward to the patients who need them.”

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