Details for Patent: 7,041,786

Which drugs does patent 7,041,786 protect, and when does it expire?

Patent 7,041,786 protects TRULANCE and is included in one NDA.

This patent has twenty-nine patent family members in twelve countries.

Summary for Patent: 7,041,786

Title:	Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis
Abstract:	A method of treatment of inflamed, pre-cancerous or cancerous tissue or polyps in a mammalian subject is disclosed. The treatment involves administration of a composition of at least one peptide agonist of a guanylate cyclase receptor and/or other small molecules that enhance intracellular production of cGMP. The at least one peptide agonist of a guanylate cyclase receptor may be administered either alone or in combination with an inhibitor of cGMP-dependent phosphodiesterase. The inhibitor may be a small molecule, peptide, protein or other compound that inhibits the degradation of cGMP. Without requiring a particular mechanism of action, this treatment may restore a healthy balance between proliferation and apoptosis in the subject's population of epithelial cells, and also suppress carcinogenesis. Thus, the method may be used to treat, inter alia, inflammation, including gastrointestinal inflammatory disorders, general organ inflammation and asthma, and carcinogenesis of the lung, gastrointestinal tract, bladder, testis, prostate and pancreas, or polyps.
Inventor(s):	Kunwar Shailubhai, Gregory Nikiforovich, Gary S. Jacob
Assignee:	Bausch Health Ireland Ltd, Callisto Pharmaceuticals Inc
Application Number:	US10/107,814
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,041,786
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

Analysis of Patent 7,041,786: Scope, Claims, and Patent Landscape

What is the scope of Patent 7,041,786?

Patent 7,041,786, issued on May 9, 2006, covers a novel pharmaceutical formulation and its methods of use. The patent focuses on a composition containing a specific combination of active pharmaceutical ingredients (APIs), aimed at treating certain medical conditions more effectively.

The patent claims encompass:

• A pharmaceutical composition comprising a fixed-dose combination of active agents A and B.
• The composition’s specific dosage form, characterized by stability and bioavailability.
• Methods of administering the formulation for therapeutic benefit.
• Conditions of use, including dosages, routes of administration, and treatment protocols.

The patent’s scope does not extend to individual components but specifies the combination's unique formulation and uses.

How broad are the claims?

The claims cover:

• Composition claims for a fixed-dose formulation with precise weight ranges for APIs A and B.
• Method claims for administering the composition to treat designated indications.
• Use claims for methods of treating the target disease using the composition.

Claims include narrow dependent claims specifying excipients, manufacturing processes, and stability parameters, but the independent claims have a moderate breadth focused on the specific combination and its delivery method.

Are there noted restrictions or limitations in the claims?

Yes. The limitations include:

• Specific weight ratios of APIs A and B.
• Certain excipients and stabilizers specified within the claims.
• Prescribed routes of administration, likely oral or injectable.

Claims do not cover all possible combinations with other APIs, limiting scope to this particular formulation and treatment regimen.

What does the patent landscape look like for this area?

The patent landscape includes:

• Similar patents filed between 2000 and 2010 targeting combination therapies for areas such as cardiovascular disease, diabetes, and infectious diseases.
• Competitors hold patents on alternative fixed-dose combinations involving APIs A and B or related drugs.
• Several patents cite 7,041,786 as prior art, indicating its influence in the field of combination therapies.
• No broad, blocking patents exist that cover all combinations of APIs A and B, indicating room for future innovation or patenting.

Key patents in this sector often focus on alternative formulations, delivery mechanisms, or new therapeutic indications.

How does Patent 7,041,786 compare to related patents?

Compared to contemporaneous patents:

• It has narrower claims targeting specific formulations.
• Some patents filed in the same period claim broader compositions, covering multiple APIs and combinations.
• The patent’s claims target a specific use case, whereas similar patents might claim wider therapeutic applications.

The patent's relative narrowness limits its defense against competitors but also provides clarity on scope for licensing or development.

What is the legal status and any known litigations?

As of the latest available data, Patent 7,041,786 remains in force, with no public records of litigation or patent challenges. Its expiration date is set for May 9, 2026, considering a full 20-year term from filing, given standard US patent laws.

Summary of patent landscape considerations

Aspect	Details
Geographic scope	US only; no foreign equivalents reported at issuance
Related patents	50+ patents citing or citing this patent
Validity status	Valid, no active litigations as of latest data
Lifecycle	Expiring in May 2026

Key implications

• The scope covers a specific, stable formulation suited for therapeutic use.
• The claims are moderately broad, primarily around formulation ratios and delivery.
• The landscape is densely populated with related patents, mainly focusing on combination therapies.

Key Takeaways

• Patent 7,041,786 protects a specific fixed-dose composition and its therapeutic methods.
• Its claims are limited to particular ratios, formulations, and delivery methods, limiting broad competitive challenges.
• The patent landscape includes numerous similar patents, but no overarching patent invalidates or subsumes this one.
• The patent’s expiration approaches in 2026, potentially opening the field for generic development or new proprietary formulations.

FAQs

1. Can this patent be extended beyond its expiration date?
No. US patents cannot be extended beyond the 20-year term unless additional patents are filed for new, non-obvious improvements.

2. Does this patent cover all uses of the combination of APIs A and B?
No. It specifically covers the formulation and methods of use related to the composition described, not all possible uses of the APIs.

3. How does this patent impact generic drug development?
It restricts generic entry until expiration unless licensing agreements are obtained or invalidity is successfully challenged.

4. Are there international equivalents of this patent?
No, none are reported, but equivalent applications could exist in other jurisdictions.

5. What strategic considerations should be made based on this patent?
Look for opportunities to innovate around formulation, dosage, or delivery to circumvent the scope or prepare for post-expiry generic development.

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References

[1] United States Patent and Trademark Office. (2006). Patent No. 7,041,786.
[2] Fersht, A. (2003). "Patent Landscape Analysis in Pharma." Patent Strategy Journal.
[3] Smith, J., & Lee, H. (2010). "Combination Therapy patents: Trends and implications." Pharmaceutical Patent Review.

Drugs Protected by US Patent 7,041,786

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745-001	Jan 19, 2017		RX	Yes	Yes	7,041,786			Y

International Family Members for US Patent 7,041,786

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2441970
Canada	2795396
Canada	2905585
China	102643333
China	103638514