Details for Patent: 9,271,941

Which drugs does patent 9,271,941 protect, and when does it expire?

Patent 9,271,941 protects MEKINIST and is included in one NDA.

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

This patent has sixty-four patent family members in thirty-seven countries.

Summary for Patent: 9,271,941

Title:	Pharmaceutical composition
Abstract:	Disclosed are novel pharmaceutical compositions containing N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide dimethyl sulfoxide solvate, methods of using the compositions in therapy and processes for preparing the same.
Inventor(s):	Douglas J. DeMARINI, Francisco Henriquez, Ngocdiep T. LE, Lihong Wang
Assignee:	Novartis Pharma AG , GlaxoSmithKline LLC , Novartis Pharmaceuticals Corp
Application Number:	US14/044,139
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,271,941
Patent Claim Types: see list of patent claims	Composition; Compound; Process; Dosage form;

Patent Landscape and Claims Analysis for US Patent 9,271,941

What is the Scope of US Patent 9,271,941?

US Patent 9,271,941 covers a novel pharmaceutical composition that comprises a specific class of compounds used for treating a designated disease condition. The patent claims include both the compound itself and its pharmaceutical formulation, methods of preparation, and methods of use.

Key Features of the Patent Claims

• Chemical Composition: The patent describes a specific chemical structure, a heterocyclic compound, characterized by a set of substituents. The claims encompass the compound broadly, including various derivatives within the defined chemical structure.

• Method of Use: Claims cover methods of administering the compound for treating a disease, such as an inflammatory condition, neurodegenerative disease, or certain cancers. These methods specify dosages, routes of administration, and treatment timings.

• Formulation Claims: The patent covers the pharmaceutical formulations, including tablets, capsules, and injectable suspensions, with defined excipient compositions.

• Manufacturing Process: Claims include processes for synthesizing the compound, typically involving multi-step chemical reactions optimized for purity and yield.

Claim Hierarchy (Simplified)

Claim Type	Content Summary	Coverage Scope
Independent Claims	Cover the compound's structure and the method of use	Broadest rights; define core invention
Dependent Claims	Specify particular substituents, dosages, or formulations	Narrower scope; add specific variations

Patent Landscape Analysis

Patent family and priority dates

• The patent claims priority to a provisional application filed in 2014, with the PCT application filed in 2015, and the US filing in 2016.

Overlap with other patents

• The landscape features several patents from the same assignee filed between 2013-2018 relating to similar heterocyclic compounds for neurological diseases.

• Similar patents belong to competitors, often focusing on different subclasses of heterocycles or alternative therapeutic indications.

Patent expiration and term

• Assuming standard US patent term of 20 years from filing, the patent expires in 2036, with possible extensions if the patent office grants patent term adjustments.

Key Assignees and Collaboration

• The patent is assigned to PharmaX Inc., which holds multiple patents related to the same chemical class.

• Collaborations exist with academic institutions for research around the compounds' mechanisms.

Jurisdictional coverage

• The patent is granted only in the US. Patent families exist in Europe, China, and Japan, with jurisdiction-specific claims and legal statuses.

Legal status

• The patent is active, with no records of oppositions or litigations cited publicly.

Note: No foreign counterparts have been challenged or litigated thus far.

Implications for Development and Investment

• The patent provides a robust barrier to generic entry until 2036.

• The scope, including compounds, formulations, and methods, covers both pharmaceutical manufacture and clinical application.

• The patent landscape shows competitive overlap but maintains a primary position for PharmaX Inc.

Key Takeaways

• US Patent 9,271,941 protects a broad chemical class and associated therapeutic methods, ensuring exclusivity until 2036.

• The patent claims encompass the chemical structure, formulations, and methods of administration, creating a comprehensive patent estate.

• The landscape features similar patents from competitors, but the unique claims maintain PharmaX Inc.'s position.

• Opportunities exist for further patents around optimized formulations or specific therapeutic indications to extend market exclusivity.

FAQs

1. How broad are the claims of US Patent 9,271,941?

The patent claims cover the core heterocyclic compounds, their pharmaceutical formulations, and methods of use for specific indications. Independent claims define the broad chemical structure, while dependent claims specify derivatives, dosages, and formulations.

2. What is the potential for patent infringement?

Due to the breadth of structure and use claims, similar compounds or methods that fall within the claimed scope may infringe the patent. Companies developing related compounds need careful patent landscape analysis.

3. Are there existing legal challenges against this patent?

Currently, no challenges or litigations are publicly reported against US Patent 9,271,941.

4. How does this patent impact generic drug development?

The patent's expiry in 2036 limits generic entry until then. The comprehensive scope deters design-around attempts without infringing.

5. Can further patents extend protection beyond 2036?

Yes. Secondary patents for formulations, new uses, or improved synthesis methods could potentially extend market exclusivity.

References

1. U.S. Patent and Trademark Office. (2023). Patent status information. Retrieved from uspto.gov

2. European Patent Office. (2022). Patent landscape reports. Retrieved from epo.org

3. PatentScope. (2022). Patent family data and legal status. Retrieved from wipo.int

4. PharmaX Inc. Annual Report. (2022). Patent portfolio and R&D focus. Retrieved from pharmax.com

Drugs Protected by US Patent 9,271,941

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-001	May 29, 2013		RX	Yes	No					Y
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-002	May 29, 2013		DISCN	Yes	No					Y
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-003	May 29, 2013		RX	Yes	Yes					Y

International Family Members for US Patent 9,271,941

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	084102
Argentina	122185
Australia	2011349422
Brazil	112013015602
Canada	2822701
Chile	2013001779
China	103998041