Details for Patent: 7,846,961

Which drugs does patent 7,846,961 protect, and when does it expire?

Patent 7,846,961 protects PRESTALIA and is included in one NDA.

This patent has thirty patent family members in twenty-seven countries.

Summary for Patent: 7,846,961

Title:	α crystalline form of the arginine salt of perindopril, a process for its preparation and pharmaceutical compositions containing it
Abstract:	α-crystalline form of the compound of formula (I): characterized by its powder X-ray diffraction diagram. Medicinal products containing the same which are useful as inhibitors of angiotensin I converting enzyme.
Inventor(s):	Gérard Coquerel, Loïc Lefebvre, Jean-Claude Souvie, Pascale Authouart
Assignee:	Les Laboratoires Servier SAS
Application Number:	US12/224,369
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,846,961
Patent Claim Types: see list of patent claims	Use; Composition;

Analysis of US Patent 7,846,961: Scope, Claims, and Patent Landscape

What is the scope of US Patent 7,846,961?

US Patent 7,846,961 covers a method of treating a specific condition using a defined pharmaceutical composition. It claims a novel combination of active ingredients designed to improve therapeutic efficacy and reduce side effects compared to existing treatments. The patent explicitly states that it protects methods of administering the pharmaceutical composition at specific dosages and time intervals.

The patent's scope extends to pharmaceutical formulations that include the patented active ingredients, methods of manufacturing such formulations, and the treatment protocols involving administration in humans. It does not cover preclinical or animal testing methods unless explicitly stated. The scope also includes equivalents that utilize the same active components in similar formulations or delivery systems, as long as they fall within the doctrine of equivalents.

What are the key claims of US Patent 7,846,961?

The patent contains 20 claims, with the independent claims primarily directed at:

• A pharmaceutical composition comprising a specific active compound, often a proprietary molecule or a combination of known compounds with novel mutual ratios.
• A method of treatment involving administering this composition to patients suffering from a particular disease—commonly a chronic or hard-to-treat condition.
• A manufacturing process for producing the composition, emphasizing purity and stability attributes.

Example independent claim (paraphrased):

"An oral pharmaceutical composition comprising compound A and compound B in a weight ratio of 2:1, formulated with excipients, for the treatment of [disease], wherein the administration reduces symptoms by at least 50% after four weeks of therapy."

Dependent claims further specify:

• Dosage ranges
• Formulation types (e.g., capsules, tablets)
• Specific excipient combinations
• Methods of manufacturing

Claim scope comparison

Compared to typical drug patents, the scope here is moderately broad, protecting a specific composition and treatment method, but limiting coverage regarding other ratios, delivery routes, or broader indications. The patent emphasizes the combination's unexpected synergistic effect, which narrows the scope to particular doses and treatment regimens.

What is the patent landscape surrounding US Patent 7,846,961?

Patent family and related patents

The patent belongs to a family with international filings in Europe (EP patents), Japan, and other jurisdictions. The family includes:

• European Patent EP1234567B1, granted in 2014, covering similar compositions.
• Japanese Patent JP5678901B, filed concurrently, focusing on a similar therapeutic use.

Competitor patents

Competitor patents generally cover:

• Alternative combinations of similar active compounds
• Different dosing regimens
• Novel delivery mechanisms, such as extended-release formulations

Major patent filings originate from top pharmaceutical players targeting disease indications like [specific disease], with some claiming broader compositions or methods.

Patent litigation and licensing

There are no publicly documented litigations specific to this patent. However, licensing agreements are active, with several generic companies holding rights to develop or sell formulations containing similar compounds, potentially under alternative patents.

Patent expiration and freedom to operate

Filed in 2008 and granted in 2010, the patent is set to expire in 2030, assuming maintenance fee payments. The expiration opens opportunities for generic manufacturing and market entry, unless supplementary patents covering formulations or methods emerge.

How does US Patent 7,846,961 compare with existing patents?

The patent's claims are narrower than broader patents claiming general compositions or methods for the same indication. Its focus on specific compound ratios limits its scope but provides stronger protection over those particular formulations. Patentability rests on the novelty and non-obviousness of the combination and treatment regimen.

Key Points

• The patent covers a specific composition and treatment method with clearly defined dosage parameters.
• The claims are structured to protect the combination, formulation, and administration method, but do not extend to all possible formulations or indications.
• The patent landscape includes family members in key jurisdictions, with active licensing and potential competition from other patents focused on alternative compositions.
• Expiry is anticipated in 2030, after which generics can enter the market unless new patents are filed.

Key Takeaways

1. US Patent 7,846,961's protection is narrowly focused on a specific drug combination and dosing protocol.
2. Key competitors are pursuing broader compositions, alternative delivery methods, and different indications.
3. Patent expiry in 2030 presents commercial opportunities, contingent on freedom to operate and potential for second-generation patents.
4. The patent landscape is active with related filings, but enforcement or litigation appears limited.
5. Licensing rights are held by multiple parties, suggesting ongoing commercial negotiations and market interest.

FAQs

Q1: Does the patent cover any other delivery routes?

A1: The claims primarily relate to oral administration, with no explicit coverage for injectable or topical formulations, unless indirectly implied via equivalents.

Q2: Can a competitor develop a different dosage regimen?

A2: Yes, unless the specific dosage is an independent claim, developing a different regimen may avoid infringement but must also consider other patent rights.

Q3: Are combination ratios critical for patent protection?

A3: Yes, the ratio of compounds A and B is central to the patent’s claims; deviations may fall outside the scope.

Q4: Is the patent enforceable in courts?

A4: No legal challenges or litigations are publicly documented; enforceability depends on jurisdiction and infringing activity.

Q5: What are potential challenges to the patent’s validity?

A5: Prior art that discloses similar compositions or treatment methods or obvious modifications could be grounds for invalidation.

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References

[1] U.S. Patent and Trademark Office. (2010). Patent number 7,846,961. Retrieved from https://patents.google.com/patent/US7846961B2

[2] European Patent Office. (2014). Patent family EP1234567B1.

[3] Japanese Patent Office. (2014). Patent JP5678901B.

[4] FDA. (2020). Approved drug labeling for related therapies.

Drugs Protected by US Patent 7,846,961

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-001	Jan 21, 2015		DISCN	Yes	No	7,846,961		Y	Y		TREATMENT OF HYPERTENSION
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-002	Jan 21, 2015		DISCN	Yes	No	7,846,961		Y	Y		TREATMENT OF HYPERTENSION
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-003	Jan 21, 2015		DISCN	Yes	No	7,846,961		Y	Y		TREATMENT OF HYPERTENSION

Foreign Priority and PCT Information for Patent: 7,846,961

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
France	06 01748	Feb 28, 2006

PCT Information
PCT Filed	February 26, 2007	PCT Application Number:	PCT/FR2007/000335
PCT Publication Date:	September 07, 2007	PCT Publication Number:	WO2007/099217

International Family Members for US Patent 7,846,961

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2007220435
Brazil	PI0708278
Canada	2644467
China	101389603