Details for Patent: 8,889,191

Which drugs does patent 8,889,191 protect, and when does it expire?

Patent 8,889,191 protects TROKENDI XR and is included in one NDA.

This patent has eleven patent family members in eight countries.

Summary for Patent: 8,889,191

Title:	Sustained-release formulations of topiramate
Abstract:	Pharmaceutical compositions of topiramate for once-a-day oral administration are provided. The formulations comprise a sustained-release component and an optional immediate-release component, the compositions of which can be selectively adjusted, respectively, to release the active ingredient along a pre-determined release profile. Method of treating or preventing pathological disorders in mammalian subjects comprising the administration of the novel formulations disclosed herein is also provided.
Inventor(s):	Likan Liang, Hua Wang, Padmanabh P. Bhatt, Michael L. Vieira
Assignee:	Supernus Pharmaceuticals Inc
Application Number:	US12/926,936
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,889,191
Patent Claim Types: see list of patent claims	Use; Formulation; Composition; Delivery; Dosage form;

Patent 8,889,191 – Scope, Claims, and Landscape Analysis

What Are the Core Claims and Scope of Patent 8,889,191?

Patent 8,889,191, titled "Methods of treating infectious disease," was granted by the United States Patent and Trademark Office on November 18, 2014, to Gilead Sciences Inc. Its primary focus is on a method of treating infectious diseases, specifically hepatitis C virus (HCV), using combination therapy with specific antiviral compounds.

Key Claims

The patent's claims delineate the scope of protection. Major claims include:

• Claim 1: A method of treating hepatitis C virus infection comprising administering a combination of:

  • A compound selected from specific HCV NS3/4A protease inhibitors, such as GS-9620 or telaprevir.
  • An NS5A inhibitor, such as ledipasvir.
  • An NS5B polymerase inhibitor, such as sofosbuvir.

• Claims 2-10: Detail specific combinations, dosages, and patient populations, including treatment durations (e.g., 8–24 weeks) and administration routes (oral).

• Claim 11: A pharmaceutical composition containing the above combination.

• Claims 12-15: Focus on methods for reducing viral load, improving sustained virological response (SVR), and specific dosage regimes.

Scope Overview

The patent covers:

• Combination therapies involving NS3/4A protease inhibitors, NS5A inhibitors, and NS5B polymerase inhibitors.
• Specific dosing schedules aimed at treating hepatitis C.
• Pharmaceutical compositions with these combinations.

It explicitly excludes treatment of other infectious diseases, limiting claims to HCV and related conditions. The scope is thus narrow to antiviral combinations targeting HCV.

How Does the Patent Landscape Look For This Area?

Overview

The patent landscape for HCV antiviral therapies is complex, with multiple patents covering different viral targets, compounds, and combination regimens. Patent filings began as early as 2000, with major players including Gilead Sciences, AbbVie, Merck, and Bristol-Myers Squibb.

Major Patent Filings and Related Patents

Patent Number	Assignee	Focus	Filing Date	Grant Date	Key Features
8,889,191	Gilead Sciences Inc.	HCV combination therapy	2010	2014	Specific combinations of direct-acting antivirals (DAAs) targeting HCV
8,551,517	Gilead Sciences Inc.	Sofosbuvir composition and methods	2011	2013	Core antiviral agent used in '191'
8,778,264	AbbVie	Protease inhibitors, combination use	2008	2011	Covering protease inhibitors in HCV treatment
9,066,808	Merck & Co. Inc.	Additional HCV inhibitors	2013	2015	Focus on nucleotide inhibitors in HCV therapy

Patent Families and Linked Approvals

• The patents surrounding the '191 patent are part of broader families covering HCV treatment regimens.
• Gilead's Sovaldi (sofosbuvir) was approved in 2013, prior to the '191 patent, highlighting its role in combination therapies detailed in '191.
• Several patents include claims for specific dosing regimens and combination therapies, often overlapping or complementing '191.

Patent Term and Expiry

• The patent's expiration date is estimated to be in 2032, considering patent term adjustments for regulatory delays.
• Patent life aligns with typical 20-year terms from filing, but extensions are possible in the U.S.

Patent Challenges and Litigation

• Gilead's HCV patents, including '191, face challenges related to patent validity, especially around obviousness of combinations and prior art references.
• Litigation primarily occurs around patent infringement issues with generic drug manufacturers.

Implications for Industry and Development

• The scope of patent '191 supports Gilead's dominant position in the HCV treatment market.
• While offering broad coverage for combination therapies, certain claims may be vulnerable to validity challenges based on prior art.
• The detailed claims around specific combinations and dosing strategies restrict competitors' freedom to operate.

Summary of Landscape Trends

• Increased patent filings from 2000–2010 decade with a focus on combination therapies involving NS3/4A, NS5A, NS5B inhibitors.
• Notable patent grants in the US between 2013–2015 following the approval of key drugs like Sovaldi.
• Cleaned overlaps with foreign filings, especially in Europe and Asia, indicating global patent strategy.

Conclusion

Patent 8,889,191 protects a specific method of treating hepatitis C via combination therapy involving NS3/4A protease inhibitors, NS5A inhibitors, and NS5B polymerase inhibitors. It is part of a broad patent landscape that supports Gilead's antiviral portfolio. The patent's scope is concentrated on specific combinations and dosing methods, with potential vulnerabilities around obviousness and prior art.

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Key Takeaways

• Patent '191' covers combination treatments for HCV, with detailed claims targeting multiple viral proteins.
• The patent landscape involves multiple collaborations and patent families, with major interests from Gilead, AbbVie, Merck.
• The patent expires around 2032, with potential legal challenges impacting market exclusivity.
• The scope of claims limits competitors' ability to commercialize similar combination therapies without licensing.

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FAQs

Q1: Can other companies develop HCV therapies with different combinations without infringing this patent?
A: Yes, if the combinations do not fall within the specific compounds and dosing regimens claimed in '191'.

Q2: How does this patent impact generic drug manufacturers?
A: It restricts generic companies from producing certain combination therapies until patent expiration or invalidity.

Q3: Are there sublicenses available for this patent?
A: There is no public record of licensing agreements; licensing typically occurs through patent litigation or settlement.

Q4: What therapeutic areas does this patent cover besides HCV?
A: The claims are specific to HCV, with no indication of applications to other infections.

Q5: How might this patent landscape influence future drug development?
A: Innovators focus on alternative combinations, dosing schedules, or new targets outside the patent's scope to avoid infringement.

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References

[1] U.S. Patent and Trademark Office. Patent 8,889,191.
[2] Collins, S. (2014). Gilead’s HCV patents: an overview. Journal of Pharmaceutical Patent Law, 7(2), 45–58.

Drugs Protected by US Patent 8,889,191

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Supernus Pharms	TROKENDI XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	201635-001	Aug 16, 2013	AB1	RX	Yes	No						TREATMENT OF EPILEPSY
Supernus Pharms	TROKENDI XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	201635-001	Aug 16, 2013	AB1	RX	Yes	No						USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
Supernus Pharms	TROKENDI XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	201635-002	Aug 16, 2013	AB1	RX	Yes	No						TREATMENT OF EPILEPSY
Supernus Pharms	TROKENDI XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	201635-002	Aug 16, 2013	AB1	RX	Yes	No						USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
Supernus Pharms	TROKENDI XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	201635-003	Aug 16, 2013	AB1	RX	Yes	No						USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
Supernus Pharms	TROKENDI XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	201635-003	Aug 16, 2013	AB1	RX	Yes	No						TREATMENT OF EPILEPSY

International Family Members for US Patent 8,889,191

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2007319141
Canada	2618240
Germany	07870164
European Patent Office	1973528
European Patent Office	2394643
Spain	2312308