Judge Rules Mylan Did Not Infringe Novo Nordisk Patent In Wegovy Generic Case

The Novo Nordisk A/S (NYSE:NVO) attempt to block Mylan Pharmaceuticals from launching a generic version of its weight-loss drug Wegovy hit a major obstacle as the court ruled in Mylan's favor on key infringement claims related to U.S. Patent No. 9,764,003.

Read more about the NVO stock price here.

A federal district court in Delaware favored Mylan — now part of Viatris Inc. (NASDAQ:VTRS).

Novo filed the lawsuit under the Hatch-Waxman Act, alleging Mylan's Abbreviated New Drug Application (ANDA) for a generic semaglutide product infringes five patents tied to its popular weight loss drug Wegovy (semaglutide).

Also Read: Does Higher Dose Of Wegovy Result In More Weight Loss? Novo Nordisk Seeks European Approval

The suit claims Mylan's generic would violate patent protections listed in the FDA's Orange Book, thus constituting an act of infringement.

However, Mylan contended that as a drug manufacturer — not a prescriber — it cannot directly infringe method-of-treatment claims.

Novo conceded it wasn't alleging direct infringement by Mylan itself, but rather that Mylan's product would indirectly infringe when used by physicians and patients.

As such, the court granted Mylan's motion for a judgment of no direct infringement as unopposed.

The court also granted judgment of no contributory infringement, noting that Novo had proposed stipulating to this outcome. Contributory infringement involves selling a component especially made for use in a patented method, and the judge agreed that Mylan did not meet this standard.

The main point of contention centered on induced infringement, which occurs when a party actively encourages patent infringement.

Here, the court focused on Mylan's proposed product label.

Since Mylan's semaglutide label does not instruct that the drug be administered without other therapeutic agents, and in fact anticipates coadministration in certain scenarios, the court ruled there was no inducement of infringement.

Novo argued that the label implicitly directs weight loss without additional agents by referencing only diet and exercise for some patients. However, the court found this insufficient. It concluded that hypothetical prescribing practices or Mylan's expectations don't prove intent to induce infringement.

Because Mylan's proposed product does not meet all the limitations of claim one — and all other claims depend on it—the court granted a full judgment of no induced infringement of the #003 patent.

Concurrently, on Friday, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending an update of the Alhemo (concizumab) label to include the treatment of severe haemophilia A and moderate or severe haemophilia B without inhibitors.

The positive CHMP opinion is based on the phase 3 explorer8 trial results, which met its primary endpoint. The results demonstrated that Alhemo prophylaxis compared with no prophylaxis treatment led to an 86% reduction and 79% reduction in treated spontaneous and traumatic bleeds for patients living with haemophilia A without inhibitors and haemophilia B without inhibitors, respectively.

NVO Price Action: NVO stock is up 0.62% at $71.17 at publication on Friday.

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