Semaglutide Patent Battle: Mylan Prevails Against Novo

A federal court recently ruled in favor of Mylan Pharmaceuticals Inc. in a patent infringement case brought by Novo Nordisk, Inc. and Novo Nordisk A/S, concerning the drug semaglutide, marketed by Novo as WEGOVY®. The lawsuit, filed under the Hatch-Waxman Act, revolved around Mylan's Abbreviated New Drug Application (ANDA) for a generic version of WEGOVY®.

Technical Details of the Semaglutide Patent and Mylan's Arguments

Novo Nordisk accused Mylan of infringing five patents related to WEGOVY®, a prescription injection containing semaglutide, a GLP-1 receptor agonist. One key patent in dispute was U.S. Patent No. 9,764,003 (the #003 patent).

Mylan sought a judgment on the pleadings, arguing it did not infringe the #003 patent. The #003 patent includes method-of-treatment claims, specifically claim 1, which describes: "A method for reducing body weight, comprising administering semaglutide once weekly in an amount of at least 0.7 mg and up to 1.6 mg to a subject in need thereof, wherein said semaglutide is administered without another therapeutic agent". The court had previously construed "administered without another therapeutic agent" to mean "administered without another therapeutic agent as part of the method for reducing body weight, or for treating the conditions of diabetes or hypertension".

Mylan's arguments for non-infringement focused on three main points:

• No Direct Infringement: Mylan, as a pharmaceutical company, does not directly treat or administer drugs to patients, and therefore argued it could not directly infringe the method-of-treatment claims under 35 U.S.C. § 271(a). Novo Nordisk clarified that it did not allege Mylan directly infringed the patent, but rather that the "use" of Mylan's ANDA product by "physicians, prescribers, and/or patients" would directly infringe, which would then be a predicate for Mylan's indirect infringement.
• No Contributory Infringement: Mylan argued that Novo could not state a claim for contributory infringement of the #003 patent under 35 U.S.C. § 271(c). Novo Nordisk proposed a stipulation of no contributory infringement for the #003 patent, which Mylan accepted.
• No Induced Infringement: Mylan contended that its proposed generic drug label did not instruct users to perform the patented method, particularly the limitation of being "administered without another therapeutic agent". Mylan's label explicitly states that its semaglutide product "should not be used in combination with other semaglutide-containing products or any other GLP-1 receptor agonist". However, the label does not prohibit the coadministration of other therapeutic agents for weight loss, diabetes, or hypertension. The label even anticipates such coadministration by mentioning potential impacts on other oral medications, increased risk of hypotension with antihypertensive therapy, and increased risk of hypoglycemia with insulin secretagogues or insulin. Furthermore, the label advises reducing, rather than eliminating, the dose of concomitantly administered insulin secretagogue or insulin.

Novo Nordisk attempted to argue that warnings against coadministration for certain risks implied an intent to induce use without other therapeutic agents. However, the court found that the explicit warnings against specific coadministrations, coupled with the absence of such directives for other therapeutic agents, indicated Mylan's intent to allow coadministration of those other agents. Novo also argued that the label's instruction to use semaglutide "with diet and exercise alone" implied no other therapeutic agent, but the court noted the label simply stated it was an "adjunct to a reduced calorie diet and increased physical activity" and did not imply these were the only coadministered therapies.

What Mylan (Defendant) Won

The court granted Mylan's motion for judgment on the pleadings. Specifically, Mylan won on all three points:

• No Direct Infringement: The court granted Mylan's motion for judgment of no direct infringement by Mylan, as Novo Nordisk did not oppose this      specific point.
• No Contributory Infringement: The court entered a stipulated judgment of no contributory infringement of the #003 patent by Mylan.
• No Induced Infringement: The court found that Mylan's proposed label does not encourage, promote, or recommend that physicians and patients not      coadminister Mylan's semaglutide product with another therapeutic agent (other than semaglutide-containing products or GLP-1 receptor agonists) for reducing body weight or treating diabetes or hypertension. Therefore, Mylan does not induce infringement of the "administered without another therapeutic agent" limitation of claim 1 of the #003 patent. Because all other claims of the #003 patent depend on claim 1, and the accused product must meet all limitations of an asserted claim to infringe, the court concluded that Mylan's ANDA product does not infringe claim 1.

History Behind This Conflict

The conflict stems from the Hatch-Waxman Act, which aims to balance innovation by brand-name drug manufacturers with timely access to generic drugs. Under this act, when a generic drugmaker applies to market a drug with the same active ingredient as a branded drug, the FDA cannot approve the generic application if it would infringe the brand-name manufacturer's patent. Brand-name manufacturers list their patents in the FDA's "Orange Book". If a non-expired patent listed in the Orange Book claims the drug, the FDA can withhold approval of the generic company's application for 30 months. The filing of an ANDA for a generic drug covered by an Orange Book-listed patent is defined as an act of infringement, creating a legal basis for courts to resolve disputes concerning infringement and validity of such patents.

Novo Nordisk, as the manufacturer of the brand-name drug WEGOVY®, initiated this lawsuit against Mylan Pharmaceuticals Inc. after Mylan sought FDA approval for its generic version. The case, Civil Action No. 23-101-CFC, was filed in the United States District Court for the District of Delaware. This type of litigation is common in the pharmaceutical industry, as brand-name companies seek to protect their patented products from generic competition. The court's decision on July 22, 2025, represents a significant development in this ongoing patent dispute.