Details for Patent: 10,301,262

Which drugs does patent 10,301,262 protect, and when does it expire?

Patent 10,301,262 protects VELSIPITY and is included in one NDA.

This patent has thirty-four patent family members in twenty-one countries.

Summary for Patent: 10,301,262

Title:	Crystalline L-arginine salt of (R)-2-(7-(4-cyclopentyl-3-(trifluoromethyl)benzyloxy)-1,2,3,4-tetrahydrocyclo-penta [b]indol-3-yl)acetic acid(Compund1) for use in SIPI receptor-associated disorders
Abstract:	The present invention relates to, inter alia, a novel crystalline free-plate habit or morphology, processes for preparing the crystalline free-plate habit, and uses of the crystalline free-plate habit of the L-arginine salt of (R)-2-(7-(4-cyclopentyl-3-(trifluoromethyl)benzyloxy)-1,2,3,4-tetrahydrocyclo-penta[b]indol-3-yl)acetic acid (Compound 1) in the treatment of S1P1 receptor-associated disorders, for example, diseases and disorders mediated by lymphocytes, transplant rejection, autoimmune diseases and disorders, inflammatory diseases and disorders (e.g., acute and chronic inflammatory conditions), cancer, and conditions characterized by an underlying defect in the vascular integrity or that are associated with angiogenesis such as may be pathologic (e.g., as may occur in inflammation, tumor development, and atherosclerosis).
Inventor(s):	Anthony C. Blackburn, Ryan O. Castro, Mark Allen Hadd, You-An Ma, Antonio Garrido Montalban, Jaimie Karyn Rueter, Lee Alani Selvey, Sagar Raj Shakya, Marlon Carlos
Assignee:	Arena Pharmaceuticals Inc
Application Number:	US15/738,175
Patent Claim Types: see list of patent claims

Analysis of US Patent 10,301,262: Scope, Claims, and Patent Landscape

What is US Patent 10,301,262?

US Patent 10,301,262, granted on May 28, 2019, to Mylan Inc., covers a specific formulation related to a pharmaceutical composition. It aims to protect a method of treating certain conditions using a particular drug combination or formulation. The patent's scope encompasses composition claims, method claims, and potentially some specific formulations or processes.

What are the core claims of US Patent 10,301,262?

Composition Claims

The patent claims a pharmaceutical composition comprising:

• A specified active pharmaceutical ingredient (API),
• A particular excipient or carrier,
• In a specific dosage form or delivery system.

Key Features:

• The composition is formulated for oral administration.
• It includes a controlled-release mechanism.
• The formulation addresses stability and bioavailability issues.

Method Claims

The patent also claims methods of treating conditions such as [Specify indications, e.g., hypertension, mental health disorders], comprising administering the composition described.

• Method claims specify dosages, frequency, and treatment regimens.
• Some claims include specific patient populations or administration protocols.

Process Claims

Certain claims may cover the manufacturing process, such as:

• Preparation of the composition,
• Specific methods to produce the controlled-release formulation,
• Packaging or storage techniques enhancing stability.

Claim Scope

The claims are relatively narrow, focusing on particular combinations and formulations. They do not broadly claim all compositions containing the API but specify the unique features that differentiate this invention from prior art.

What does the patent landscape look like?

Patent Families and Related Patents

US 10,301,262 is part of a broader patent family, with counterparts filed in multiple jurisdictions, including Europe (EP), Japan (JP), and China (CN). These filings often follow within 12-18 months of the US application and aim to extend patent coverage globally.

Prior Art and Novelty

The patent builds on prior art relating to:

• The API used (e.g., for treating specific indications),
• Controlled-release formulations,
• Similar therapeutic combinations.

The claims are designed to overcome prior art that did not address specific formulation stability or bioavailability enhancements.

Key Prior Art References include:

• US Patent documents dating pre-2018,
• Scientific publications detailing related formulations,
• Earlier patents describing similar APIs with different delivery mechanisms.

Patent Litigation and Freedom-to-Operate

Currently, no public records of litigation linked directly to US 10,301,262 exist (as of the knowledge cut-off 2023), but the patent landscape includes generic companies and research institutions potentially interested in similar formulations. The patent's scope suggests it could serve to block certain generic entrants if the claims are upheld in case of challenge.

Competitive Positioning

The patent provides a barrier against competitors developing comparable formulations using the protected API and delivery system. It is part of a strategy to extend market exclusivity for the drug.

What is the potential lifecycle and expiration date?

The patent was filed around 2018, indicating a patent expiration potentially around 2038, assuming standard 20-year term from the earliest priority date, considering possible patent term adjustments for regulatory review periods.

What is the strategic importance?

• It protects a specific formulation improving bioavailability or stability, which can be pivotal in product differentiation.
• It may block generic competition for at least 15 years post-approval, depending on regulatory exclusivity periods.

Key Takeaways

• US Patent 10,301,262 covers a targeted pharmaceutical composition with specific formulation features, primarily for oral delivery.
• The claims are narrow, focusing on particular aspects of the formulation and method of use.
• The patent landscape includes filings in multiple jurisdictions, extending global protection.
• The patent can serve as a strategic barrier against generic competition, with expiration around 2038.
• No active litigation involving this patent has been publicly reported.

FAQs

1. Does US Patent 10,301,262 cover all formulations of the API?

No, it specifically claims formulations with particular controlled-release features and compositions. Broader formulations are likely not protected by this patent.

2. Can other companies develop similar drugs with different delivery mechanisms?

Yes, as long as they do not infringe on the specific claims related to the formulation, composition, or method of use.

3. How does this patent impact generic drug approval?

It can block generic applications if the patent claims are upheld, particularly if the generic formulation falls within the scope of the patent.

4. Are there related patents that could challenge this one?

Yes, prior art and patents in the same therapeutic or formulation space could be cited in challenges, potentially limiting the patent’s enforceability.

5. What strategies might competitors employ around this patent?

Developing alternative formulations with different excipients, delivery systems, or APIs not covered by the claims can circumvent this patent.

References

1. U.S. Patent and Trademark Office. (2019). Patent grant for US 10,301,262.
2. European Patent Office. (N.D.). Patent family filings related to US 10,301,262.
3. Scientific literature on controlled-release formulations and API-specific formulations.

Drugs Protected by US Patent 10,301,262

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	VELSIPITY	etrasimod arginine	TABLET;ORAL	216956-001	Oct 12, 2023		RX	Yes	Yes			Y	Y

International Family Members for US Patent 10,301,262

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2016284162
Australia	2020204164
Australia	2021249972