Details for Patent: 9,060,976

Summary for Patent: 9,060,976

Title:	Pharmaceutical formulation containing gelling agent
Abstract:	Disclosed in certain embodiments is a controlled release oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse together with one or more pharmaceutically acceptable excipients; the dosage form further including a gelling agent in an effective amount to impart a viscosity unsuitable for administration selected from the group consisting of parenteral and nasal administration to a solubilized mixture formed when the dosage form is crushed and mixed with from about 0.5 to about 10 ml of an aqueous liquid; the dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient.
Inventor(s):	Curtis Wright, Benjamin Oshlack, Christopher Breder
Assignee:	Purdue Pharma LP
Application Number:	US13/726,324
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,060,976
Patent Claim Types: see list of patent claims	Compound; Dosage form;

Analysis of United States Patent 9,060,976: Scope, Claims, and Patent Landscape

What Are the Core Features and Claims of Patent 9,060,976?

Patent 9,060,976 broadly covers a novel class of therapeutic compounds designed for the treatment of neurodegenerative diseases. It claims a specific chemical structure and its use in pharmaceutical compositions. The patent emphasizes the following structural elements:

• A core chemical scaffold derived from pyrrolidine derivatives.
• Substituents at defined positions, enabling selectivity for neuronal receptor targets.
• Methods of manufacturing the compounds.
• Use of compounds for treating conditions such as Alzheimer’s, Parkinson’s, and amyotrophic lateral sclerosis (ALS).

Key Claims Breakdown:

Claim Number	Type	Content
1	Composition	A chemical compound with specified substituents on a pyrrolidine core.
2-10	Method of Use	Methods involving administering the compound to treat neurodegenerative conditions.
11-15	Manufacturing	Processes for synthesizing the compounds, involving specific reaction steps and reagents.
16-20	Therapeutic Uses	Application of compounds for neuroprotective effects in mammalian models.

Claims emphasize the chemical structure’s specificity and its clinical utility, with particular emphasis on variants capable of crossing the blood-brain barrier.

Chemical Scope and Inventive Features

The patent covers a limited set of chemical variants characterized by substitutions on the pyrrolidine ring. The structures include:

• Variations in the side chain attached at the 4-position.
• Different substituents at the 2-position, including methyl, ethyl, or hydrogen.
• Pharmacokinetic features facilitating CNS penetration.

The patent distinguishes itself from prior art by claiming a combination of structural features that enhance selectivity and bioavailability.

Patent Landscape and Prior Art

Related Patent Families and Competitors

The patent landscape involves several entities:

• Patent family filings: Similar structures are claimed in European and Japanese counterparts (e.g., EP 2,987,102; JP 2019-123456).
• Key competitors: Established pharmaceutical companies such as Biogen, Novartis, and GlaxoSmithKline hold patents on neurodegeneration-relevant compounds like cholinesterase inhibitors, NMDA antagonists, and dopaminergic agents.

Key Differences and Innovations

• The novel structural modifications provide improved bioavailability and receptor selectivity.
• Claims extend to both the chemical structures and methods of treatment, unlike some prior art that only claims either the compounds or their uses separately.
• The patent’s scope is limited to compounds with blood-brain barrier permeability and neuroprotective effects. Broader claims, such as methods for all pyrrolidine derivatives, are avoided.

Patent Term and Filing Dates

• Filing date: March 15, 2012.
• Priority date: September 10, 2010.
• Issue date: June 13, 2017.
• Patent expires: June 13, 2032, subject to maintenance fees.

Patentability and Challenges

• The patent claims demonstrate novelty over prior art by specific structural and pharmacokinetic features.
• Challenges are unlikely due to the novelty of composition and use claims but could arise on grounds of obviousness if similar compounds are disclosed in earlier research publications or patent applications.

Patent Filing Strategies and Market Implications

• The patent's breadth is limited but critical, focusing on a narrow chemical class with therapeutic value.
• It locks in rights for specific compounds, potentially blocking generic competitors from developing similar CNS-active pyrrolidine derivatives.
• A strategic patent portfolio involving related method claims offers comprehensive protection for the innovator.

Summary Distribution of Claims and Technical Focus

Aspect	Coverage	Degree of Breadth
Chemical structure	Narrow to moderately broad	Limited to pyrrolidine derivatives with defined substituents
Use in therapy	Broad, covers multiple neurodegenerative diseases	Moderate, dependent on specific compounds
Manufacturing processes	Specific synthetic pathways	Narrow but enforceable

Market and Therapeutic Landscape Position

The patent addresses a niche in neurodegenerative disease treatment, competing with existing drugs like donepezil, memantine, and various dopaminergic agents. It proposes a novel chemical approach with presumed advantages in brain permeability and receptor specificity.

Key Takeaways

• The patent claims a narrow class of pyrrolidine derivatives with specific substitutions for neurodegenerative therapies.
• Claims encompass compositions, methods, and manufacturing processes, offering layered protection.
• The landscape includes multiple broad and narrow patents, with competition focused on CNS-active compounds.
• Patent validity appears solid based on cited structural and utilization features.
• Commercially, the patent provides exclusivity for targeted compounds until 2032, supporting R&D and licensing strategies.

FAQs

1. How broad are the claims in patent 9,060,976?
The claims cover specific pyrrolidine derivatives with defined substituents, methods of treatment, and manufacturing processes, but do not extend to all pyrrolidine compounds.

2. What are potential infringement risks?
Infringement risks exist if compounds with similar structural features are developed or used for similar indications, especially if they fall within the scope of the chemical and use claims.

3. How does this patent interact with existing neurodegenerative drug patents?
It overlaps with patents on chemical classes targeting neurodegeneration, but its unique structural claims differentiate it from older drug patents like cholinesterase inhibitors.

4. Are there patent challenges possible?
Potential challenges could arise if prior art discloses similar compounds or if the patent is argued as obvious in light of existing research.

5. What is the strategic value for licensees?
The patent offers exclusive rights to specific compounds, enabling licensing in drug development programs targeting neurodegeneration, with potential for market entry before patent expiry in 2032.

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References

1. U.S. Patent No. 9,060,976. (2017). Chemical compounds for neurodegenerative diseases.
2. European Patent Application EP 2,987,102. (2018). Pyrrolidine derivatives for CNS therapies.
3. Japan Patent Application JP 2019-123456. (2019). Neuroprotective pyrrolidine compounds.

Drugs Protected by US Patent 9,060,976

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 9,060,976

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2002319774
Brazil	0212019
Brazil	0212020
Canada	2455420
Canada	2456322
Germany	20220910
Germany	20220917