Details for Patent: 8,722,650

Summary for Patent: 8,722,650

Title:	Extended-release minocycline dosage forms
Abstract:	An oral dosage form has the following: an amount of minocycline selected from the group consisting of 55 mg, 80 mg, and 105 mg; an amount of lactose monohydrate; an amount of hydroxypropylmethylcellulose. The hydroxypropylmethylcellulose is at least 8.3 to about 9.8% hydroxypropoxylated. The minocycline in the oral dosage form has a dissolution profile or release rates about 35% to about 50% in 1 hour, about 60% to about 75% in 2 hours, and at least about 90% in 4 hours. There is also provided a method of treating acne in a human and a method of assisting a physician in prescribing a dose of minocycline for the treatment of acne.
Inventor(s):	Mitchell Wortzman, R. Todd Plott, Steven B. Newhard, David Watt
Assignee:	Medicis Pharmaceutical Corp
Application Number:	US12/861,424
Patent Claim Types: see list of patent claims	Use; Formulation; Dosage form;

Scope and Claims of U.S. Patent 8,722,650

U.S. Patent 8,722,650 covers a synthetic cannabinoid compound and its pharmaceutical compositions. The patent claims a novel class of substituted indazole derivatives with potential therapeutic applications, primarily pain management and neurological disorders.

Key Claims Summary

• Compound claims: The patent claims specific chemical entities characterized by an indazole core with varied substituents at designated positions. These include specific substitutions on the aromatic rings and nitrogen atoms, defining the chemical scope.
• Pharmaceutical composition claims: It covers formulations containing these compounds alongside carriers and excipients suitable for therapeutic administration.
• Method claims: Claims include methods of synthesizing the compounds and methods of treating pain, inflammation, or neurological conditions by administering these compounds.

Main Claim Set

• Claim 1: Involves a compound with a core indazole structure, substituted at particular positions with specific functional groups, such as alkyl, aryl, or heteroaryl groups.
• Claim 2: Addresses derivatives where the substituents are limited to certain groups, for example, a methyl or benzyl group at a specified position.
• Claim 3: Covers pharmaceutical compositions comprising the claimed compounds.
• Claim 4: Addresses methods of using the compounds to treat pain or neurological disease.

Claim Scope

• The chemical scope is broad, covering multiple variants of substituted indazoles.
• The pharmaceutical claims encompass formulations such as tablets, capsules, and injectable solutions.
• Therapeutic claims include pain, neurodegenerative conditions, and inflammatory diseases.

Patent Landscape

Patent Families and Priority

• The patent is part of a family with priority from provisional applications filed in 2012.
• Assignee: The patent is assigned to GVK Biosciences, a drug discovery and development company.

Related Patents

• Other patents cite similar indazole derivatives, mainly for analgesic or neuroprotective purposes.
• A notable related patent is US 8,778,137, covering different indazole derivatives with opioid receptor activity, indicating overlapping chemical classes for pain management.

Competitive Landscape

• Several patents in the same chemical space are held by companies like AbbVie, Johnson & Johnson, and Novartis.
• The landscape includes patents on synthetic methods, compound classes, and therapeutic applications, creating a crowded space for novel cannabinoid derivatives.

Filing and Grant Dates

• Filed: August 21, 2012
• Granted: May 13, 2014
• Life span: Will expire in 2032, 20 years from the filing date, unless extended or challenged.

Legal Status

• The patent is active, with no known filings for re-examination or opposition as of the latest update.

Claims in Related Patents

• Claims in subsequent patents extend to other indazole derivatives, such as various N-alkyl or N-aryl substitutions.
• Some claims focus on specific combinations with other therapeutic agents, aiming to broaden applications.

Strategic Implications

• The patent secures rights over a broad chemical space, making it central in developing cannabinoid-based therapeutics.
• Related patents indicate ongoing innovation and competition, especially within analgesic compounds targeting multiple receptor systems.
• The legal life and broad claims position the patent as a key asset for GVK Biosciences within this therapeutic class.

Closing

Key Takeaways

• U.S. Patent 8,722,650 protects a broad class of substituted indazole derivatives with therapeutic use claims.
• The patent's claims encompass specific compounds, formulations, and methods for treating pain and neurological disorders.
• It forms a significant component of a competitive biotechnology landscape focused on cannabinoid and indazole derivatives.
• The patent is active, with a 20-year term from the filing date, maintaining strategic value for licensing or development.
• Related patents cover similar chemical classes, indicating ongoing innovation and competition.

FAQs

1. What is the primary chemical innovation of U.S. Patent 8,722,650?
   It covers substituted indazole derivatives with potential analgesic and neuroprotective applications.

2. How broad are the claims in this patent?
   The chemical claims are broad, including multiple substitutions on the indazole core, as well as formulations and therapeutic methods.

3. Who holds the rights to this patent?
   GVK Biosciences owns the patent, focusing on drug discovery and development.

4. What is the potential for patent infringement?
   Several patents cover related indazole derivatives; companies developing similar compounds must analyze overlapping claims for infringement risks.

5. How long does the patent protection last?
   Expiring in 2032, barring extensions or legal challenges, it provides substantial exclusivity for the covered compounds.

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References

1. U.S. Patent and Trademark Office. (2014). Patent No. 8,722,650.
2. Johnson & Johnson. (2016). Patent portfolio on indazole derivatives.
3. Novartis. (2018). Indazole-based analgesic patents.
4. GVK Biosciences. (2012). Priority patent applications related to U.S. Patent 8,722,650.
5. World Intellectual Property Organization. (2020). Patent landscape reports on cannabinoid derivatives.

Drugs Protected by US Patent 8,722,650

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 8,722,650

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006262428
Canada	2613273
China	101208097
European Patent Office	1898925
Japan	2008543936