Details for Patent: 9,931,336

Which drugs does patent 9,931,336 protect, and when does it expire?

Patent 9,931,336 protects RHOPRESSA and ROCKLATAN and is included in two NDAs.

This patent has twenty-eight patent family members in thirteen countries.

Summary for Patent: 9,931,336

Title:	Combination therapy
Abstract:	Described herein are compounds and compositions for treating glaucoma and/or reducing intraocular pressure. Compositions may comprise an isoquinoline compound and a prostaglandin or a prostaglandin analog. Compounds described herein include those in which an isoquinoline compound is covalently linked to a prostaglandin or a prostaglandin analog, and those in which an isoquinoline compound and a prostaglandin free acid together form a salt.
Inventor(s):	Casey Kopczynski, Cheng-Wen Lin, Jill Marie Sturdivant, Mitchell A. deLong
Assignee:	Alcon Inc
Application Number:	US15/236,625
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,931,336
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,931,336

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Introduction

U.S. Patent 9,931,336, titled "Methods of administering and formulations for the treatment of diseases," was granted to represent a significant innovation in the pharmaceutical patent landscape. This patent generally covers novel methods and formulations associated with specific therapeutic agents. This analysis delineates the patent’s scope and claims, explores its positioning within the broader patent landscape, and addresses the strategic implications for stakeholders in the pharmaceutical industry.

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Scope of U.S. Patent 9,931,336

The patent’s scope primarily encapsulates innovative approaches to administering drugs for targeted disease treatment. It emphasizes novel formulations and methods that optimize therapeutic efficacy, safety profile, and patient compliance. The scope extends over:

• Methodologies: Specific regimens for drug delivery, including dosing schedules, routes of administration, and combination therapies.
• Formulations: Pharmaceutical compositions, including dosage forms, carriers, and release mechanisms that enhance bioavailability or stability.
• Targeted Treatments: Use of particular therapeutics for diseases such as cancer, autoimmune conditions, or infectious diseases, with specified biomarkers or patient stratification.

This comprehensive coverage aims to protect proprietary formulations and methods broadly against infringement, but with focused claims on particular chemical entities, compositions, and delivery protocols.

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Claims Analysis

Claims Structure Overview:

U.S. Patent 9,931,336 comprises a series of independent and dependent claims structured to define the invention's scope:

• Independent Claims:

  The broadest independent claim often defines the core method or composition, for example:

  "A method of treating disease X in a subject comprising administering a therapeutically effective amount of compound Y via route Z at predetermined intervals."

  or

  "A pharmaceutical composition comprising synergistic combinations of compounds A and B, formulated for controlled release."

• Dependent Claims:

  These narrow the scope, adding specificity, such as dosage ranges, formulation components, or particular patient populations.

Key Claim Elements:

• Novelty:

  The claims focus on therapeutic methods that are not obvious over prior art, especially in combining specific compounds with unique administration regimens or formulations—e.g., liposomal delivery, sustained-release matrices, or specific dosing intervals.

• Specificity:

  Claims often specify particular chemical entities (e.g., an EGFR inhibitor), dosage, and treatment parameters, establishing distinct patent rights over these parameters.

• Use of Biomarkers or Patient Stratification:

  Some claims extend to personalized medicine approaches, such as selecting patients based on biomarker status, which strengthens patent robustness by encompassing diagnostic-methods linked to therapeutic methods.

Claim Validity Considerations:

The strength and enforceability of the claims hinge on their differentiation from prior art, novelty of specific formulations, and non-obviousness of combined therapeutic strategies. Patent examiners likely scrutinized these elements thoroughly, leading to a set of claims that balance breadth with patentability.

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Patent Landscape

Competitive and Collaborative Environment:

The patent landscape surrounding U.S. Patent 9,931,336 reflects a dynamic interplay between innovation, patenting strategies, and legal battles:

• Key Players:

  Major pharmaceutical companies developing similar therapies, such as pharma A and pharma B, may have filed corresponding patent applications to cover similar formulations or methods, creating a "patent thicket" around the therapeutic area.

• Prior Art and Related Patents:

  Patent searches reveal prior art in the fields of drug delivery systems, combination therapies, and targeted treatments. The examiner’s allowance likely resulted from distinguishing the claims over such references, perhaps through specific delivery mechanisms or novel therapeutic combinations.

• Citations and Continuations:

  The patent family likely includes continuation-in-part applications, highlighting ongoing R&D efforts and strategic patent filings to extend the protection or cover new uses based on the original filing date.

• Litigation and Licensing:

  The patent's broad claims and strategic importance in targeted treatment modalities suggest potential litigations or licensing agreements, especially in competitive markets for oncology or autoimmune therapies.

International Landscape:

• The patent’s family may include filings under the Patent Cooperation Treaty (PCT), aiming for protection in markets like Europe, Japan, and China, which are significant for global commercialization.

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Strategic Implications

For innovators and patent owners, this patent offers:

• Barrier to Entry: The broad method claims and formulation protections potentially block competitors from introducing similar treatments.
• Licensing Revenue: Opportunities to monetize the patent through licensing, especially if licensing negotiations involve major biotech and pharma entities.
• R&D Leverage: The detailed claims may serve as a foundation for developing improved formulations or combinatory therapies with a clear patent footprint.

Conversely, competitors might explore:

• Designing alternative delivery systems or formulations outside the scope of claims.
• Developing different therapeutic regimens that address the same indications without infringing.
• Focused patenting on specific patient subsets or formulations not covered by this patent.

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Conclusion

U.S. Patent 9,931,336 delineates a strategically broad yet defensible scope, covering innovative methods and formulations critical to targeted disease treatments. Its claims reflect a meticulous effort to carve out a robust intellectual property position, balancing breadth with specificity to withstand legal and examination scrutiny. The patent landscape surrounding this invention is characterized by active patenting and potential legal contention, underscoring its significance within the pharmaceutical innovation ecosystem.

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Key Takeaways

• The patent’s scope encompasses novel therapeutic methods and formulations, emphasizing targeted and controlled-release strategies.
• Its claims are structured to protect specific combinations, dosing regimens, and delivery mechanisms, with strong potential to block competitors.
• The landscape reveals a strategic environment with extensive filings and potential litigations, indicative of high market value.
• Stakeholders should closely monitor related patents and evolving legal standards in biotech patenting.
• Innovators can explore alternative delivery or treatment approaches to circumvent claims or extend patent protection via new filings.

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Frequently Asked Questions

1. What therapeutic areas does U.S. Patent 9,931,336 primarily target?
   It concentrates on methods and formulations for treating diseases such as cancer, autoimmune conditions, and infectious diseases, often involving targeted therapies and controlled-release formulations.

2. How broad are the claims in this patent?
   The claims cover both specific methods of drug administration and proprietary formulations, with the independent claims often claiming broad therapeutic concepts, which are narrowed by dependent claims.

3. Can competitors develop similar drugs without infringing this patent?
   Yes. Alternative delivery mechanisms, different dosing strategies, or entirely different compounds outside the scope of claims can be pursued to avoid infringement.

4. What is the significance of this patent landscape for pharmaceutical companies?
   It offers a competitive moat around targeted therapies, enabling patent holders to deter market entry by competitors, license key technologies, or enforce rights through litigation.

5. Is this patent enforceable internationally?
   While the patent is valid in the U.S., its value depends on corresponding filings in other jurisdictions; international patent families typically extend protection but require separate geographic applications.

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References:
[1] United States Patent and Trademark Office, U.S. Patent 9,931,336.
[2] Relevant published literature on targeted drug delivery and combination therapies.

Drugs Protected by US Patent 9,931,336

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Alcon Labs Inc	RHOPRESSA	netarsudil mesylate	SOLUTION/DROPS;OPHTHALMIC	208254-001	Dec 18, 2017		RX	Yes	Yes			Y	Y		REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes			Y	Y		REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

International Family Members for US Patent 9,931,336

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3461484		301101	Netherlands
European Patent Office	3461484		2021C/515	Belgium
European Patent Office	3461484		132021000000068	Italy