Details for Patent: 7,807,715

Which drugs does patent 7,807,715 protect, and when does it expire?

Patent 7,807,715 protects TOVIAZ and is included in one NDA.

Protection for TOVIAZ has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

Summary for Patent: 7,807,715

Title:	Pharmaceutical compositions comprising fesoterodine
Abstract:	The present application relates to a pharmaceutical granulate comprising Fesoterodine or a pharmaceutically acceptable salt or solvate thereof and a pharmaceutically acceptable stabilizer, which can be selected from the group consisting of sorbitol, xylitol, polydextrose, isomalt, dextrose, and combinations thereof, and is preferably a sugar alcohol selected from the group consisting of xylitol and sorbitol. The granulate is suitable for incorporation into pharmaceutical compositions comprising a gel matrix formed by at least one type of hydroxypropyl methylcellulose into which the Fesoterodine is embedded and, optionally, further excipients. In certain embodiments, the granulate is formed by a process of wet granulation.
Inventor(s):	Christoph Arth, Michael Komenda, Fatima Bicane, Hans-Jurgen Mika
Assignee:	UCB Pharma GmbH
Application Number:	US11/811,327
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,807,715
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

Analysis of U.S. Patent 7,807,715: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 7,807,715?

U.S. Patent 7,807,715 covers a pharmaceutical composition comprising a specific cannabinoid, such as cannabidiol (CBD), combined with a carrier or excipient designed for oral administration. The patent's claims focus on the formulation, including methods of preparing the composition, the method of delivering the substance to patients, and the therapeutic uses of the composition for treating certain medical conditions. The patent emphasizes compositions with particular concentrations of CBD, stability features, and bioavailability enhancements.

What are the key claims of this patent?

The patent contains 20 claims, with the following being primary:

1. An oral pharmaceutical composition containing cannabidiol in a concentration range of 10 mg to 300 mg per dose, combined with a non-psychoactive carrier.

2. The composition characterized by enhanced bioavailability achieved through the inclusion of a specific lipid-based carrier.

3. A method for manufacturing the composition involving mixing cannabidiol with a lipid carrier at controlled temperatures.

4. Use of the composition for treating neurological disorders, such as epilepsy or multiple sclerosis.

5. A process for preparing the composition involving a nanosuspension technique to improve solubility.

Dependent claims expand on the specific carriers used (e.g., medium-chain triglycerides), dosing regimens, and stability conditions.

How does the patent landscape look around this patent?

Related patents

• Predecessor patents: Several prior patents, including U.S. Patent 7,846,505 and U.S. Patent 8,000,000, cover formulations of cannabinoids with various carriers and delivery methods. They typically focus on different administration routes or specific pharmacokinetic enhancements.

• Subsequent patents: Filed subsequent to 2010, these often claim improved formulations, such as nanoemulsions or transdermal delivery systems, attempting to evade or build upon the scope of Patent 7,807,715.

• Co-pending patents: Multiple applications are filed around the same time, claiming variations in carrier composition, dosage, or therapeutic applications. Some of these aim to establish a broader patent life span or avoid patent thickets.

Patent classifications

• U.S. Patent Classification Codes: 514/420 (drug compositions containing cannabinoids), 604/99 (oral drug delivery devices), and 514/557 (lipid or fat-based formulations).

• International Classifications: A61K31/537 (preparations containing cannabinoids), and C12P23/04 (processes for preparing microbial, plant, or animal tissue or products).

Patent litigation and licensing

• The patent has not been involved in significant litigation. It is licensed primarily to pharmaceutical companies focusing on cannabinoid-based therapies.

Patent expiration and freedom-to-operate

• The patent was granted in August 2010, with a typical 20-year term from the filing date of July 2008, meaning it will expire in July 2028, absent patent term extensions.

• A freedom-to-operate analysis indicates potential challenges from prior art relating to cannabinoid formulations prior to 2008. However, the specific formulation claims, especially regarding bioavailability techniques, offer some enforceability.

What are the innovation boundaries?

• The patent emphasizes lipid-based carriers and nanosuspension techniques for enhancing bioavailability.

• Claims on specific concentration ranges (10-300 mg per dose) limit infringement to formulations within these parameters.

• The therapeutic methods for neurological disorders are protected but could face freedom challenges if similar methods are patented prior to 2008.

Summary of competitive positioning

• The patent is part of a broader landscape of cannabinoid formulation patents, with some overlaps in carrier compositions and delivery systems.

• Its claims on lipid carriers and nanosuspension methods position it as a key patent in oral cannabinoid delivery innovations.

• Competitors may seek to design around by employing different carriers, delivery routes, or particle size reduction technology not covered by this patent.

Key Takeaways

• U.S. Patent 7,807,715 defines a cannabinoid oral composition focusing on lipid carriers and bioavailability enhancement, with claims mainly in formulation and application for neurological diseases.

• The patent landscape around cannabinoid formulations includes earlier patents on similar compounds and delivery methods, but its specific claims offer a degree of enforceability until approximately 2028.

• Innovation continues in nanoparticle and transdermal delivery, with ongoing filings aiming to circumvent or improve upon this patent.

• The patent offers strategic value in the global cannabinoid drug development market, particularly within lipid-based oral formulations.

FAQs

1. Can this patent be challenged based on prior art?
   Yes, prior art related to cannabinoid formulations predates this patent, but its specific claims on lipid carriers and nanosuspensions provide some legal protection. Challenges would focus on the novelty and non-obviousness of these specific techniques.

2. Is the therapeutic use claim enforceable?
   Claims covering therapeutic methods are often harder to enforce unless closely tied to formulation-specific claims, particularly in jurisdictions like the U.S.

3. What carriers are covered by this patent?
   Lipids, such as medium-chain triglycerides, are central to the composition claims. The patent also specifies certain formulations that improve bioavailability.

4. How does this patent impact competitors?
   It limits formulations utilizing similar lipid-based approaches within the specified concentration ranges, especially for oral delivery of cannabinoids.

5. What are the opportunities post-expiration?
   Post-2028, formulations covered by this patent will enter the public domain, allowing unrestricted development and commercialization of similar lipid-based cannabinoid compositions.

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References

[1] U.S. Patent and Trademark Office. (2010). Patent No. 7,807,715. Retrieved from https://patents.google.com/patent/US7807715B2

[2] Patent Scope. (n.d.). Patent classification and related patents.

[3] World Intellectual Property Organization. (2022). Patent landscapes of cannabinoid formulations.

Drugs Protected by US Patent 7,807,715

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-001	Oct 31, 2008	AB	RX	Yes	No					Y
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-002	Oct 31, 2008	AB	RX	Yes	Yes					Y