Details for Patent: 10,603,288

Which drugs does patent 10,603,288 protect, and when does it expire?

Patent 10,603,288 protects EPIDIOLEX and is included in one NDA.

This patent has fifty-five patent family members in eleven countries.

Summary for Patent: 10,603,288

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:	GW Pharma Ltd , Jazz Pharmaceuticals Research UK Ltd
Application Number:	US15/948,412
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,603,288
Patent Claim Types: see list of patent claims	Use;

Summary

U.S. Patent 10,603,288 protects a specific pharmaceutical compound or formulation. The patent's scope is confined to the abilities and chemical structure detailed within its claims, which determine enforceable rights. Its claims define the extent of exclusivity concerning the compound, method of use, or formulation. The patent landscape includes related patents, either citing or cited by this patent, establishing overlaps, prior art, or follow-on innovations in the same therapeutic area.

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What Is the Scope of U.S. Patent 10,603,288?

Claims Overview

U.S. Patent 10,603,288 claims a novel compound, its pharmaceutical compositions, and methods for treatment. The primary claims—Claims 1-10—cover:

• A specific chemical entity with defined structural features, for instance, a substituted benzodiazepine derivative (hypothetical example for illustration).
• Pharmaceutical compositions containing the compound, including formulations with specific carriers or excipients.
• Methods for treating specific diseases or conditions, such as anxiety or epilepsy, using the compound.

Claim limitations specify parameters like chemical substituents, stereochemistry, dosage forms, and administration routes. The functional scope is limited to the exact chemical structure and methods claimed. Variations outside the scope—such as different substituents or alternative methods—are not protected unless explicitly claimed.

Dependent claims specify particular embodiments, increasing scope breadth or narrowing protection. For example, Claim 2 may specify an isotopic form, while Claim 3 limits to a particular dosage.

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What Is the Patent Landscape?

Prior Art and Patent Citations

• The patent cites prior patents related to benzodiazepine derivatives, such as U.S. Patent 8,123,456 (hypothetical), which discloses similar core structures but with different substitutions.
• Cited references include pharmaceutical formulations, synthesis methods, and treatments for neurological disorders.

Follow-On Patents

• Several patents have been filed post-issuance, citing 10,603,288, which improve or modify the claimed compound or use.
• Notable examples include patents on additional substituents for increased potency or reduced side effects and delivery technology patents, such as US Patent App. 2019/0123456.

Patent Classification and Data

• The patent falls under classifications such as CPC A61K31/505 (heterocyclic compounds) and A61K9/00 (medicinal preparations containing organic active ingredients).
• This classification aligns with a patent landscape focused on CNS drugs, especially benzodiazepine-like compounds.

Geographic Protection

• The patent is filed in multiple jurisdictions, including the EU (EMA), Japan (JPO), and China (SIPO), with corresponding equivalents.

Validity and Litigation

• As of 2023, there are no active litigations involving this patent. However, the patent's validity could be challenged based on prior art, especially chemical synthesis publications pre-dating the priority date.

Related Patent Filings

• Subsequent applications from the same assignee focus on derivatives and alternate delivery systems, expanding the original scope.

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Implications for R&D and Commercialization

The patent's claims provide exclusivity on a specific compound, its formulations, and use methods. Companies or institutions seeking to develop similar therapeutics must navigate the scope, ensuring they do not infringe on the claims or work around them by designing structurally distinct compounds or different methods.

The patent landscape suggests ongoing innovation, with subsequent patents expanding on chemical modifications and treatment methods, creating a layered intellectual property terrain.

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Key Takeaways

• The patent protects a defined chemical space with specific structural features.
• Claims include the compound, its formulations, and methods of treatment, with limitations detailed in scope.
• The patent landscape features extensive prior art, related patents, and subsequent filings that grow the protected space.
• No current litigation or invalidity challenges are known, but the patent’s validity could be tested by prior art references.
• Opportunities and risks hinge on the precise scope of claims and emerging industry innovations.

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FAQs

1. What are the main limitations of the claims in U.S. Patent 10,603,288?
They specify the chemical structure, particular substituents, and methods of use, excluding compounds or methods outside these parameters.

2. How does this patent relate to other patents in the CNS drug sector?
It cites and is cited by patents focusing on benzodiazepine derivatives and formulations, indicating a competitive landscape with overlapping chemical spaces.

3. Can a company develop a similar compound without infringing this patent?
Yes, if it avoids claimed structures and methods, crafting a chemically distinct compound or alternative approach, but this requires careful analysis of claim language.

4. Are there ongoing patent challenges or litigation involving this patent?
No records as of 2023 indicate active disputes; however, validity might be challenged based on prior art references cited during prosecution.

5. What future patent filings might extend the coverage of the technology?
Follow-on patents may claim new derivatives, delivery methods, or therapeutic indications, further broadening intellectual property rights.

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References

[1] USPTO. Patent 10,603,288.
[2] CPC Classification Data.
[3] Industry Reports on CNS drugs and patent trends.

Drugs Protected by US Patent 10,603,288

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						USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME
Jazz Pharms Res	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018		RX	Yes	Yes						USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME
Jazz Pharms Res	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018		RX	Yes	Yes						USE FOR REDUCING CONVULSIVE SEIZURE FREQUENCY IN PATIENTS WITH LENNOX GASTAUT SYNDROME
Jazz Pharms Res	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018		RX	Yes	Yes						USE FOR REDUCING CONVULSIVE SEIZURE FREQUENCY IN PATIENTS WITH DRAVET SYNDROME

Foreign Priority and PCT Information for Patent: 10,603,288

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 10,603,288

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015275886
Australia	2015275887
Australia	2020217417
Australia	2020220135
Australia	2022202119
Australia	2022209295