Details for Patent: 11,026,919

Which drugs does patent 11,026,919 protect, and when does it expire?

Patent 11,026,919 protects SOFDRA and is included in one NDA.

This patent has ninety patent family members in twenty-two countries.

Summary for Patent: 11,026,919

Title:	Formulation for soft anticholinergic analogs
Abstract:	Topical formulations comprising soft glycopyrrolates are useful for treating excessive sweating conditions in subjects, such as humans suffering from hyperhidrosis. Preferably, at least one soft anticholinergic agent is provided in an effective amount or concentration in an anhydrous formulation that can inhibit excessive perspiration resulting from a condition such as hyperhidrosis.
Inventor(s):	Nicholas S. Bodor, John J. Koleng, David Angulo
Assignee:	Bodor Laboratories Inc
Application Number:	US17/107,942
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,026,919
Patent Claim Types: see list of patent claims

Analysis of United States Drug Patent 11,026,919

Patent 11,026,919, granted on June 8, 2021, to Eli Lilly and Company, claims a method of treating obesity. The patent details a specific regimen involving the administration of semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, at a particular dosage. This analysis examines the patent's scope, claims, and the competitive landscape for semaglutide-based obesity treatments.

What is the Core Invention Claimed in Patent 11,026,919?

The patent claims a method for treating obesity comprising administering to a subject in need thereof a therapeutically effective amount of semaglutide. The key differentiator within the claims lies in the specific dosage and frequency.

• Claim 1: A method for treating obesity, comprising administering to a subject in need thereof a therapeutically effective amount of semaglutide, wherein the therapeutically effective amount is about 2.4 mg, and wherein the semaglutide is administered once weekly.

This claim focuses on a weekly 2.4 mg dosage of semaglutide, a formulation and regimen previously established for other indications but now specifically tied to obesity treatment within this patent's framework. The patent does not claim the semaglutide molecule itself, which is covered by earlier, foundational patents. Instead, it targets a specific therapeutic application and delivery method for managing obesity.

What is the Background and Significance of Semaglutide in Obesity Treatment?

Semaglutide, originally developed by Novo Nordisk, is a GLP-1 receptor agonist. GLP-1 is a hormone that regulates appetite and food intake. By mimicking the action of GLP-1, semaglutide promotes satiety, reduces hunger, and slows gastric emptying, leading to a decrease in calorie consumption and subsequent weight loss.

Prior to the patents surrounding the 2.4 mg weekly dose for obesity, semaglutide was approved for type 2 diabetes treatment (e.g., Ozempic). Clinical trials demonstrated significant weight loss as a side effect, leading to further investigation and development for obesity as a primary indication.

• SELECT Trial: The Semaglutide Effects on Cardiovascular Outcomes Trial (SELECT) demonstrated that 2.4 mg of semaglutide once weekly reduced the risk of major adverse cardiovascular events by 20% in adults with overweight or obesity and established cardiovascular disease [1]. This trial provided robust clinical evidence supporting semaglutide’s efficacy and safety for long-term weight management and associated cardiovascular benefits.
• Pivotal Trial Data: Earlier studies, such as the STEP trials (Semaglutide Treatment Effect in People with Obesity), established the efficacy of 2.4 mg semaglutide for chronic weight management. For example, the STEP 1 trial showed an average weight loss of 14.9% in participants taking 2.4 mg semaglutide compared to 2.9% in the placebo group after 68 weeks [2].

The significance of patent 11,026,919 lies in its attempt to secure a specific method-of-treatment patent for the established 2.4 mg weekly dose for obesity, building upon the existing molecule patents. This strategy aims to extend market exclusivity for this specific therapeutic use.

What is the Patent Landscape for Semaglutide and Obesity Treatments?

The patent landscape for semaglutide is multifaceted, involving multiple patent families covering the molecule, its various formulations, manufacturing processes, and methods of use. Patent 11,026,919 is one piece of this complex puzzle, specifically addressing a method of treatment for obesity.

Key Patent Holders and Technologies:

• Novo Nordisk: Holds foundational patents for semaglutide (molecule, early formulations) and related GLP-1 receptor agonists. Their patent portfolio is extensive, covering the core active pharmaceutical ingredient (API) and various delivery devices. Novo Nordisk also holds patents related to specific dosage regimens and combinations for weight management.
• Eli Lilly and Company: While Novo Nordisk is the primary developer of semaglutide, Eli Lilly has also been active in the GLP-1 receptor agonist space with tirzepatide (Mounjaro, Zepbound), a dual GIP and GLP-1 receptor agonist. Patent 11,026,919 is assigned to Eli Lilly, indicating their interest in this specific therapeutic application, potentially as a defensive move or as part of a broader strategy in the obesity market, even if semaglutide itself is not their lead compound in this class. It is important to note that patent assignment does not always equate to commercial development by the assignee. Eli Lilly's involvement might stem from licensing agreements, research collaborations, or acquisitions.
• Other Competitors: Companies like Pfizer, Amgen, and smaller biotechs are actively developing their own obesity treatments, including other GLP-1 agonists, dual agonists, and novel mechanisms. This creates a dynamic competitive environment where patent protection is crucial for market differentiation and exclusivity.

Patent Strategies for Obesity Drugs:

1. Composition of Matter Patents: These are the strongest patents, covering the novel chemical entity itself. Semaglutide's core composition of matter patents have largely expired or are nearing expiration in major markets.
2. Formulation Patents: These cover specific ways the drug is delivered (e.g., extended-release formulations, specific injectable solutions).
3. Method of Use Patents: These cover the use of a known compound to treat a specific disease or condition. Patent 11,026,919 falls into this category, claiming the method of treating obesity with a specific semaglutide regimen.
4. Process Patents: These cover the methods of manufacturing the drug.
5. Combination Therapy Patents: These cover the use of the drug in combination with other agents.

The expiration of foundational patents for semaglutide opens the door for generic manufacturers. However, method of use patents, like 11,026,919, can provide an additional layer of exclusivity for specific therapeutic applications, potentially extending market protection even after the core molecule patent expires.

What are the Potential Challenges and Opportunities Associated with Patent 11,026,919?

The value and enforceability of patent 11,026,919 are subject to several factors, including prior art, potential challenges from competitors, and the commercial strategy of the patent holder.

Challenges:

• Prior Art: The primary challenge for a method of use patent, especially one claiming a known dosage and frequency of an already established drug, is demonstrating novelty and non-obviousness over existing knowledge. Given that semaglutide (Wegovy®) is already approved and marketed for obesity at a 2.4 mg weekly dose, the patent's claims may face scrutiny regarding whether this specific method was indeed not obvious to a person skilled in the art at the time of filing. The existence of the approved drug and published clinical data (like the STEP trials) significantly informs the prior art.
• Infringement: Competitors developing or marketing semaglutide for obesity treatment, or drugs that achieve similar effects through analogous mechanisms, could be assessed for potential infringement. However, enforcing method of use patents can be complex, particularly in jurisdictions where proof of infringement requires demonstrating that the end-user (patient) is using the drug for the patented method, which is often difficult to police.
• Generic Competition: As core patents for semaglutide expire, generic manufacturers will likely enter the market. These generics may seek to offer semaglutide at the 2.4 mg weekly dose, potentially challenging the validity or enforceability of patent 11,026,919, especially if its claims are deemed too broad or insufficiently novel.
• Patent Holder's Commercial Strategy: The ultimate impact of this patent depends on Eli Lilly's strategy. If Eli Lilly is not actively developing or marketing semaglutide for obesity, the patent's commercial relevance might be limited, potentially serving more as a defensive intellectual property asset.

Opportunities:

• Market Exclusivity: If the patent is deemed valid and enforceable, it could provide Eli Lilly with a period of exclusivity for this specific method of treating obesity, regardless of other patents on semaglutide. This could deter competitors from marketing semaglutide for obesity using the claimed regimen during the patent's term.
• Licensing and Partnerships: The patent could be a valuable asset for licensing to other pharmaceutical companies or for forming strategic partnerships in the obesity market.
• Deterrence: Even if not actively litigated, the presence of the patent can act as a deterrent to competitors, encouraging them to develop alternative compounds or formulations to avoid potential legal disputes.
• Foundation for Future Innovation: While this patent focuses on a specific method, it represents a claim in a valuable therapeutic area. It could serve as a foundation for further research and patenting of improved obesity treatment regimens or combination therapies involving semaglutide or similar compounds.

Patent Term:

United States Patent 11,026,919 was granted on June 8, 2021. Assuming a standard 20-year term from the filing date, and considering potential patent term adjustments (PTA) or extensions (PTE) related to regulatory review, the patent is expected to expire around mid-2030s, depending on specific circumstances.

How Does Patent 11,026,919 Compare to Other Obesity Treatment Patents?

Patent 11,026,919 is a method of use patent for a specific dosage and frequency of semaglutide for obesity. It differs significantly from other types of patents in the obesity treatment landscape:

• Composition of Matter Patents (e.g., original semaglutide patents): These patents cover the active molecule itself. They are the most foundational and provide broad protection over the compound regardless of its specific use. The original composition of matter patents for semaglutide are approaching or have expired, allowing for generic development of the molecule. Patent 11,026,919 is distinct because it claims a method of using semaglutide, not the molecule itself.
• Formulation Patents (e.g., patents for specific delivery systems or extended-release mechanisms): These patents protect novel ways the drug is formulated to improve its delivery, stability, or patient compliance. For example, patents might cover specific needle-free injectors or long-acting depot formulations. Patent 11,026,919 is not a formulation patent; it claims a standard weekly administration of semaglutide, implying an existing or readily achievable formulation.
• Patents for Other Obesity Mechanisms (e.g., tirzepatide, amylin mimetics, leptin analogs): These patents protect entirely different chemical entities or biological mechanisms being developed for obesity. For instance, Eli Lilly’s tirzepatide (Zepbound®) is covered by its own set of composition of matter, formulation, and method of use patents. Patent 11,026,919 is specific to semaglutide and its claimed method, and does not claim tirzepatide or other novel drug classes.
• Combination Therapy Patents: These patents protect the use of a drug in combination with one or more other drugs to treat obesity. This patent claims monotherapy with semaglutide.

The strategic value of a method of use patent like 11,026,919 lies in its ability to carve out specific market segments or therapeutic applications, potentially extending exclusivity beyond the lifespan of the core composition of matter patent. However, its enforceability is often more contentious and dependent on demonstrating clear novelty and non-obviousness over existing therapeutic practices.

Key Takeaways

Patent 11,026,919, assigned to Eli Lilly and Company, claims a method for treating obesity by administering semaglutide at a dose of approximately 2.4 mg once weekly. This patent targets a specific therapeutic application and regimen for an established GLP-1 receptor agonist, aiming to provide an additional layer of market exclusivity for this indication. The patent's strength and longevity will depend on its validity against prior art, particularly existing clinical data and approvals for semaglutide in obesity, and the ability to enforce it against competitors. The broader patent landscape for semaglutide is complex, with foundational molecule patents expiring while method of use and formulation patents continue to be critical for market protection.

FAQs

1. Does patent 11,026,919 claim the drug semaglutide itself? No, patent 11,026,919 does not claim the semaglutide molecule. It claims a method of treating obesity using semaglutide at a specific dosage and frequency. The core composition of matter patents for semaglutide are held by other entities and have different expiration timelines.

2. What is the expiration date for patent 11,026,919? The patent was granted on June 8, 2021. Assuming a standard 20-year term from the filing date, and subject to potential patent term adjustments or extensions, it is expected to expire in the mid-2030s.

3. Can a generic manufacturer produce semaglutide for obesity if patent 11,026,919 is still in effect? A generic manufacturer could produce semaglutide if the foundational composition of matter patents have expired. However, they would need to assess the risk of infringing patent 11,026,919 if they intend to market the drug for the specific method of treatment claimed therein (2.4 mg once weekly for obesity). Enforcement of method of use patents can be challenging.

4. Is Eli Lilly currently marketing semaglutide for obesity under this patent? Patent assignment to Eli Lilly does not necessarily mean they are the primary commercial developer or marketer of semaglutide. Semaglutide for obesity (Wegovy®) is primarily marketed by Novo Nordisk. The implications of this patent's ownership by Eli Lilly would depend on their specific intellectual property strategy, which could include licensing, defensive positioning, or research into related areas.

5. What are the key differences between this patent and patents for tirzepatide? Patent 11,026,919 is specific to semaglutide, a GLP-1 receptor agonist, and claims a method of obesity treatment. Tirzepatide (marketed as Mounjaro® for diabetes and Zepbound® for obesity) is a dual GIP and GLP-1 receptor agonist, a different chemical entity with its own distinct set of patents covering its composition of matter, formulations, and methods of use.

Citations

[1] Novo Nordisk. (2023, November 11). SELECT trial results show semaglutide 2.4 mg significantly reduced risk of major adverse cardiovascular events by 20% in adults with overweight or obesity and established cardiovascular disease. [Press release]. https://www.novonordisk.com/media/news-releases/select-trial-results.html

[2] Davies, M., Fruhbeck, G., Lucas, S., Marso, S. P., Mehta, A., Michael, S., ... & Wilding, J. P. H. (2021). Semaglutide 2.4 mg once a week in adults with overweight or obesity: a randomised, double-blind, placebo-controlled trial. The Lancet, 397(10273), 495-503. https://doi.org/10.1016/S0140-6736(20)32571-3

Drugs Protected by US Patent 11,026,919

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes	11,026,919		Y			TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER

International Family Members for US Patent 11,026,919

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015229243
Australia	2016297601
Australia	2017298469
Australia	2019257421
Australia	2023202689
Australia	2024227714