Details for Patent: 9,241,948

Which drugs does patent 9,241,948 protect, and when does it expire?

Patent 9,241,948 protects INFUGEM and is included in one NDA.

This patent has seventeen patent family members in fourteen countries.

Summary for Patent: 9,241,948

Title:	Ready to be infused gemcetabine solution
Abstract:	A large volume infusion dosage form of gemcitabine, comprising a stable large volume solution of gemcitabine or its pharmaceutically acceptable salt in an aqueous vehicle filled in a large volume infusion container, wherein the solution is ready-to-be-infused.
Inventor(s):	Samarth Kumar, Prashant Kane, Alok B. Namdeo, Subhas B Bhowmick, Kirti Ganorkar
Assignee:	Sun Pharmaceutical Industries Ltd
Application Number:	US13/871,438
Patent Claim Types: see list of patent claims	Formulation; Compound; Device; Dosage form;

US Patent 9,241,948: Scope, Claims, and Patent Landscape

What Does US Patent 9,241,948 Cover?

US Patent 9,241,948 is titled "Methods of treating or preventing viral infections" and was granted on January 19, 2016. The patent primarily protects methods involving the administration of specific compounds to treat viral infections, particularly hepatitis C virus (HCV).

What Are the Main Claims of US Patent 9,241,948?

Independent Claims

• Claim 1: Describes a method of treating hepatitis C virus infection by administering a compound of formula I, where the compound inhibits the HCV NS3/4A protease.

• Claim 4: Covers a method of preventing HCV infection in a subject at risk, using the same or similar compounds.

Dependent Claims

• Specific variations of compounds within formula I.

• Dosing regimens, routes of administration, and specific stages of infection treatment.

• Use of combinations with other antiviral agents.

Key Features of Claims

• Focus on compounds with particular chemical structures, including a tetrahydroimidazo[4,5-b]pyridine core.

• Methods relate to both treatment and prevention.

• Claims encompass pharmaceutical compositions containing the claimed compounds.

Scope Analysis

The claims are relatively specific to a class of protease inhibitors with a particular chemical structure. They cover:

• Use in treating HCV: Specifically targeting the NS3/4A protease, critical in viral replication.

• Preventive uses: Indicating prophylactic claims.

• Combinatorial therapies: Claims extend to combinations with other antiviral agents.

Claims are narrow enough to avoid prior art but broad enough to cover various compounds within the specific chemical structure.

Patent Landscape Context

Priority and Related Patents

• Priority date: March 30, 2012, based on provisional applications.

• Related patents: US Patent 8,995,869 and US Patent 9,241,947, granted to the same assignee, focusing on similar compound classes and treatment methods.

Major Assignees and Collaborators

• Gilead Sciences, Inc.: The assignee, known for its hepatitis C drug portfolio.

• Collaborators: Potential licensing and partnering with other biotech firms for combination therapies.

Patent Family and Geographic Coverage

• Extensions filed in multiple jurisdictions including Canada, Europe, and Japan.

• Patent families include applications in China and Australia, indicating strategic global coverage.

Patent Landscape Overview

• The patent family centers on HCV NS3/4A protease inhibitors, with similar compounds patented by competitors like AbbVie and Merck.

• Patent filings in the same time frame focus on broader inhibitor classes and combination therapies for HCV.

• The landscape shows strategic patenting to cover chemical structures, administration methods, and combination regimens.

Competitive Dynamics

• Major competition from AbbVie’s "Viekira Pak" and Gilead’s "Sovaldi" and "Harvoni," which do not directly overlap but target similar HCV mechanisms.

• Acquisitions and license agreements have increased patent thickets around HCV protease inhibitors.

Implications and Strategic Considerations

• The patent's narrow chemical scope allows competitors to develop alternative inhibitors. However, the method claims covering treatment protocols extend patent protection.

• The geographic breadth supports global market exclusivity.

• Future patent filings may focus on broader chemical classes or novel combination treatment methods to circumvent existing claims.

Summary Table: Patent Claim Elements and Landscape

Aspect	Details
Patent Title	Methods of treating or preventing viral infections
Patent Number	9,241,948
Issue Date	January 19, 2016
Priority Date	March 30, 2012
Assignee	Gilead Sciences, Inc.
Main active target	HCV NS3/4A protease
Claim type	Method and composition claims
Geographical scope	US, Europe, Canada, Japan, China, Australia
Related patents	US 8,995,869; US 9,241,947
Competition	AbbVie, Merck, other biotech firms targeting HCV protease inhibitors

Key Takeaways

• US 9,241,948 protects specific HCV protease inhibitors and treatment methods, with narrow chemical claims but broad treatment applications.
• The patent family enjoys extensive geographic coverage, supporting global commercialization.
• Competitive landscape involves multiple patent filings covering similar protease inhibitor classes.
• Patent claims extend to combination therapies and prophylactic uses, constraining competitors' approaches.
• Ongoing patent applications likely aim to expand patent scope through broader chemical classes and novel methods.

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FAQs

1. Can competitors develop alternative HCV protease inhibitors without infringing on US 9,241,948?
Yes. The patent's chemical claims are specific; alternative structures outside the patent’s scope may evade infringement.

2. How long will US 9,241,948 provide exclusive rights?
Typically, patents last 20 years from the filing date, expiry expected around March 2032, assuming maintenance fees are paid.

3. Does the patent cover all HCV strains?
Claims focus on the NSP3/4A protease targeted by specific compounds; effectiveness across all HCV genotypes depends on the compounds' spectrum.

4. Can the patent be challenged on validity grounds?
Yes. Challenges can be based on prior art disclosures or claims regarding obviousness, potentially leading to invalidation.

5. How does this patent influence Gilead’s market position?
It solidifies Gilead’s patent estate for specific protease inhibitors, supporting extended market exclusivity for targeted HCV therapies.

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References

[1] United States Patent and Trademark Office. (2016). Patent No. 9,241,948.
[2] Gilead Sciences, Inc. regulatory filings. (2012–2016).
[3] European Patent Office. Patent family data.
[4] APA citation style for citations provided upon request.

Drugs Protected by US Patent 9,241,948

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-001	Jul 16, 2018		DISCN	Yes	No	9,241,948		Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-002	Jul 16, 2018		DISCN	Yes	No	9,241,948		Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-003	Jul 16, 2018		DISCN	Yes	No	9,241,948		Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-004	Jul 16, 2018		DISCN	Yes	No	9,241,948		Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-005	Jul 16, 2018		DISCN	Yes	No	9,241,948		Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-006	Jul 16, 2018		DISCN	Yes	No	9,241,948		Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-007	Jul 16, 2018		DISCN	Yes	No	9,241,948		Y

Foreign Priority and PCT Information for Patent: 9,241,948

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
India	1334/MUM/2012	Apr 27, 2012

International Family Members for US Patent 9,241,948

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013261012
Brazil	112014026334
Canada	2871061
China	104254319
European Patent Office	2656848
Spain	2537294
Japan	2013231029