Breaking Down the Ozempic Patent Dispute
Prominent figures such as Oprah Winfrey, Whoopi Goldberg and Sharon Osbourne,[1] alongside millions of Americans, are using GPL-1 agonists, a category of medications designed to regulate blood sugar levels in individuals with type 2 diabetes,[2] to achieve rapid weight loss and gain better control over dietary habits. As reported by CNBC, in the fourth quarter of 2022, U.S. healthcare providers issued over 9 million prescriptions for Ozempic, Wegovy, and similar medications for diabetes and obesity[3]. Approximately 1 in 8 adults in the U.S. have utilized a GLP-1 drug at some point in their lives.[4] Presently, more than 15 million individuals, which accounts for about 6% of adults, are actively using a prescription for these medications.[5]
What is Ozempic?
In 2017, the Food and Drug Administration (FDA) approved Ozempic, generically known as semaglutide.[6]
Ozempic is a weekly injectable medication designed to assist in reducing blood sugar levels by stimulating the pancreas to produce increased amounts of insulin.[7] When used in conjunction with dietary and exercise regimens, it is formulated to enhance blood glucose management in adults diagnosed with type 2 diabetes, as well as to mitigate the risk of significant cardiovascular events, such as heart attack, stroke, or death.[8] It is important to note that Ozempic is not authorized for weight management purposes[9]; however, the drug has been globally marketed as the “magic fix” for weight loss[10].
The Purpose of Patent Law
Patents are instrumental in achieving a delicate equilibrium between the protection of inventors’ rights against competitors [11]. and the promotion of vigorous competition and innovation [12]. They confer exclusive rights to discoveries for a limited duration and guarantee a return on investment in these advancements [13].
Patent Dispute
On March 18, 2022, Novo Nordisk filed a patent infringement lawsuit in the United States District Court for the Northern District of West Virginia against Viatris subsidiary Mylan Pharmaceuticals, Inc. [14] This action was prompted by Mylan’s submission of an Abbreviated New Drug Application (ANDA) for a generic version of Ozempic, signaling its “intent to produce, sell, use,” [15] and engage in the commercial manufacture of an Ozempic generic that would infringe on nearly 20 of Novo Nordisk’s unexpired patents.
According to the FDA, “a generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics, and intended use.”[16] Generic drug applications are considered “abbreviated” because they generally do not need to include preclinical and clinical data to establish safety and effectiveness.[17] Instead, applicants must demonstrate that their product performs in the same manner as the innovator drug product.[18] Once approved, an applicant can manufacture and market the drug product as a safe, effective, and lower-cost alternative to the innovator drug.[19]
Here, Mylan’s generic drug uses protected technology related to the structure of the GLP-1 drug itself, the overall formulation of the medication and the injection device, among other characteristics.[20] Initially, Novo Nordisk sought the court’s intervention to halt Mylan from producing and marketing its generic version until the patents in question, including any extensions, had expired.[21] Mylan, in response, challenged the validity of Novo Nordisk’s patents.[22] Mylan petitioned to the Patent Trial Appeal Board (PTAB) to cancel three of Novo Nordisk’s patents.[23] While the board declined to review two of them, it agreed in October 2023 to consider Mylan’s challenge to the third patent (’462).[24]
Subsequently, Novo Nordisk pursued further legal action against Mylan, culminating in a lawsuit filed in July 2024.[25]
This lawsuit focused on the patents concerning the pharmaceutical composition and specific use of semaglutide in type 2 diabetes, upon which Mylan’s ANDA was alleged to infringe.[26] Additionally, Novo Nordisk asked the PTAB to sanction Mylan? for what it called harassing and duplicative litigation over the patent in review.[27] All proceedings and pending motions ultimately ended after both parties submitted a joint motion [28]
agreeing to settle the patent dispute and validity challenge concerning the former’s weight-loss drugs.[29]
Implications of the Dispute
In settling with Mylan, Novo Nordisk has strengthened its position as a leading pharmaceutical company in the diabetes sector with the success of Ozempic and Wegovy. Focusing strategically on obesity drugs has propelled the company to become one of Europe’s most valuable entities, with revenues reaching $33 billion in 2023.[30] Notably, most Ozempic users (constituting two-thirds of its sales last year) and nearly all Wegovy users are based in the U.S.[31] Novo Nordisk aims to combat serious chronic diseases, including obesity, which is linked to heart and kidney issues.[32]Considering that over 40 percent of adults in the U.S. are obese and the rising popularity of Ozempic (videos tagging the drug have garnered over one billion views on TikTok)[33], it seems that Novo Nordisk may have a monopoly in this market. Could this potentially hinder future innovations? That question remains unanswered.
Footnotes
