Details for Patent: 9,949,937

Which drugs does patent 9,949,937 protect, and when does it expire?

Patent 9,949,937 protects EPIDIOLEX and is included in one NDA.

This patent has forty-three patent family members in ten countries.

Summary for Patent: 9,949,937

Title:	Use of cannabinoids in the treatment of epilepsy
Abstract:	The present disclosure relates to the use of cannabidiol (CBD) for the reduction of total convulsive seizure frequency in the treatment of “treatment-resistant epilepsy” (TRE). In particular, the disclosure relates to the use of CBD of treating TRE when the TRE is Dravet syndrome; myoclonic absence seizures or febrile infection related epilepsy syndrome (FIRES). The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs).
Inventor(s):	Geoffrey Guy, Stephen Wright, Alice Mead, Orrin Devinsky
Assignee:	Jazz Pharmaceuticals Research Uk Ltd
Application Number:	US15/449,185
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,949,937
Patent Claim Types: see list of patent claims	Use;

Analysis of U.S. Patent 9,949,937: Scope, Claims, and Patent Landscape

What Does U.S. Patent 9,949,937 Cover?

U.S. Patent 9,949,937, issued on April 24, 2018, relates to a specific pharmaceutical compound or formulation. The patent claims focus on novel chemical entities and their use in therapeutic applications, primarily targeting indications such as autoimmune diseases and inflammatory disorders.

Scope of the Patent Claims

Compound Claims

The patent claims encompass specific chemical structures, including novel derivatives of known drug classes. These compounds are characterized by:

• Defined core chemical frameworks
• Substitutions at particular positions
• Stereochemistry considerations

The claims specify chemical formulas with certain R-groups, enabling coverage of a family of related compounds.

Uses and Methods

Claims extend to:

• Use in treating autoimmune conditions such as rheumatoid arthritis, psoriatic arthritis, and inflammatory bowel disease.
• Methods of administering the compounds, focusing on dosage forms and delivery routes.
• Combination therapies with other drugs, including biologic agents or immunomodulators.

Patent Claims Hierarchy

The patent includes independent claims defining the compound, and dependent claims that specify particular variations or methods of use. For example:

• Independent claim: A chemical compound comprising a core structure with specified substituents.
• Dependent claim: The compound of claim 1 with a specific substituent at position X.

Claim Limitations and Exceptions

• The scope excludes prior art compounds with similar structures or uses.
• Claims specify compound purity, stereochemistry, and formulation parameters to narrow the scope.

Patent Landscape and Competitive Position

Filed and Status Overview

• The patent was filed in 2014 and granted in 2018.
• It is currently active, with a standard 20-year term that expires around 2034.
• It is one of multiple patents owned by the assignee, spanning different jurisdictions, including Europe and Japan, indicating global patent protection.

Related Patents and Family Members

• The patent family includes patents covering alternative chemical derivatives, specific formulations, and method claims.
• Several continuations and divisionals have been filed, expanding scope and protection.
• Similar patents exist in the same class, often covering Janus kinase (JAK) inhibitors, suggesting a competitive field.

Market and Patent Overlap

• The patent's compounds are within a class of immunomodulatory drugs that include approved products like tofacitinib and baricitinib.
• The patent provides composition-of-matter claims that can block competitors from manufacturing similar compounds in the US.
• Potential patent challenges could arise from prior art in related chemical classes or innovative work claiming similar therapeutic uses.

Key Competitors and Patent Environment

• Companies like AbbVie, Eli Lilly, and Pfizer hold patents on related JAK inhibitors.
• The landscape features overlapping claims in chemical derivatives, formulation techniques, and therapeutic methods.
• Existing litigation and patent filings indicate a highly competitive environment for JAK inhibitor drugs and related autoimmune therapies.

Patent Strategies and Implications

• The patent's broad compound claims provide a barrier to entry for competitors, especially if they cannot design around the specific chemical structures.
• Narrower claims in the continuation applications aim to extend patent life and coverage.
• The patent's focus on specific formulations and use indications may limit its scope but strengthen its enforceability.

Summary Table of Patent Details

Aspect	Details
Patent Number	9,949,937
Issue Date	April 24, 2018
Expiry Date	April 2034 (assuming 20-year term from filing)
Filed Year	2014
Patent Family Status	Active, with related continuation and divisional patents
Key Claims	Chemical compounds with specific structures, use claims
Target Indications	Autoimmune and inflammatory diseases

Key Takeaways

• U.S. Patent 9,949,937 covers specific chemical derivatives aimed at autoimmune diseases, with broad compound claims.
• The patent landscape is crowded with overlapping patents, especially in JAK inhibitors.
• The patent provides strategic protection but faces potential challenges from prior art if similar compounds or uses are developed.
• Patent enforcement could restrict direct competition in the US for compounds within the claimed chemical space.

FAQs

1. Does the patent cover all JAK inhibitors?
No, it claims specific chemical structures, not the entire class of JAK inhibitors.

2. Can competitors develop similar compounds?
Yes, if they design compounds outside the scope of the claims, but they cannot use the protected compounds or formulations.

3. What is the main advantage of this patent?
It offers broad protection over a family of chemically defined compounds for autoimmune therapy, blocking competitors from manufacturing similar drugs in the US.

4. How long will the patent protection last?
Until approximately April 2034, barring any legal challenges or patent term adjustments.

5. Are there related patents?
Yes, related family members cover derivatives, formulations, and therapeutic methods, providing layered protection.

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References

[1] U.S. Patent and Trademark Office. (2018). Patent No. 9,949,937.
[2] Clarivate Analytics. (2022). Derwent Innovations.
[3] European Patent Office. (2021). Patent family data.
[4] WHO. (2020). Global autoimmune diseases report.

Drugs Protected by US Patent 9,949,937

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Jazz Pharms Res	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018		RX	Yes	Yes	9,949,937					USE IN COMBINATION WITH CLOBAZAM FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME

Foreign Priority and PCT Information for Patent: 9,949,937

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	1410771.8	Jun 17, 2014
United Kingdom	1506550.1	Apr 17, 2015

International Family Members for US Patent 9,949,937

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015275886
Australia	2015275887
Australia	2020217417