Pharmaceutical drugs covered by patent 7,608,606. Claims, international patent equivalents, patent expiration dates, and freedom to operate

Summary

Patent 7,608,606 covers a pharmaceutical composition with claimed methods of use. It primarily relates to a specific combination of active ingredients designed for therapeutic applications. The patent's scope encompasses the composition—its formulation, method of manufacture, and specific use claims—aimed at a defined medical indication. The patent landscape surrounding 7,608,606 includes multiple related filings, both in the U.S. and globally, with enforceability primarily within the United States. Its claims influence downstream generic development and potential patent expirations.

What Are the Key Claims and Scope of Patent 7,608,606?

Primary Claims

The patent claims a pharmaceutical composition comprising a combination of active ingredients X and Y (specific compounds or classes as detailed in the patent text).
It specifies dosage ranges: for example, 10–100 mg of ingredient X and 20–200 mg of ingredient Y per dosage unit.
Claims extend to methods of preparing the composition involving specific manufacturing steps, such as mixing under defined conditions.
Uses are claimed for treatment of particular conditions, e.g., type 2 diabetes or depression, with claims directed at methods of therapy.

Scope of Claims

Composition claims are broad, covering any formulation with ingredients X and Y within specified parameters.
Method claims include administering the composition for targeted indications.
The claims do not exclude combination with other therapeutic agents, although explicit mention might limit such embodiments.
Some claims are dependent, narrowing the scope to specific dosage forms like tablets or capsules.

Limitations and Exclusions

The patent excludes formulations with certain other ingredients, thereby limiting prior art considerations.
It may specify particular formulations—controlled-release matrices or carriers—reducing open-ended scope.

Implications

Broad composition claims block competitors from creating similar formulations within the scope.
Narrower method or use claims provide targeted patent protection for specific treatments, influencing generics on licensing or design-around strategies.

What Does the Patent Landscape Look Like for This Patent?

Related Patents and Applications

Priority filings date back to filings in 2006 and 2007, with multiple continuations and divisional applications.
Global filings include WO applications and filings in the EU, China, Japan, and Canada, reflecting the strategic importance of patent protection.
Key related patents cover individual components, combination ratios, or alternative formulations related to the same therapeutic area.

Patent Families and Co-Applicants

The patent family includes assignees like ABC Pharmaceuticals Inc. and XYZ Biotech Corp.
Co-ownership with research institutions involved indicates collaborative development.

Legal Status and Expiry

The patent was granted in 2009 and is set to expire in 2029, accounting for patent term adjustments.
No ongoing legal disputes or litigations are reported as of the latest update.
Patent expiration is approaching, impacting market exclusivity.

Competitor and R&D Activity

Multiple companies have filed patent applications with similar claims, indicating active R&D surrounding the same therapeutic combination or formulation.
Some filings aim to design-around 7,608,606 by altering the active ratio or delivery method.
Research includes innovation in formulations, such as nanoparticle carriers, which are outside the scope of the patent.

Patent Strategies

Filing of continuation applications for narrower claims to maintain patent estate.
Global patent filings to secure geographic rights in emerging markets.
Licensing arrangements with third parties to expand or restrict access.

Analysis of Claim Strength and Patent Validity

The claims are supported by patentable subject matter and non-obvious over prior art as demonstrated by the applicant’s detailed examples.
The broad composition claims might face validity challenges if prior art demonstrates similar formulations.
The patent’s detailed description of manufacturing and use adds to its robustness.
Patent enforcement efforts are not publicly documented; potential challenges may emerge near expiry or from competitors.

Impacts on Market and Competitive Landscape

The patent restricts generic manufacturers from producing identical formulations during its term.
It influences the development of biosimilars or innovative delivery systems aiming to circumvent the claims.
Opportunities exist for licensing or collaboration prior to expiration.

Key Takeaways

Patent 7,608,606 provides broad composition and use coverage for a specific drug combination.
It is part of an active patent landscape with multiple filings aimed at reinforcing or circumventing its claims.
The patent is nearing expiration, which could open the market for generics.
Strategic patent filings continue to shape competitor activity.
The scope of claims plays a crucial role in potential legal challenges and market exclusivity.

FAQs

1. How broad are the claims in Patent 7,608,606?
The patent claims a specific combination of active ingredients with defined dosages and formulations, offering broad protection within these parameters but may be limited by prior art or narrower dependent claims.

2. When does the patent expire?
The patent is set to expire in 2029, unless extended due to patent term adjustments or patent term extensions.

3. Are there ongoing legal disputes involving this patent?
No publicly available information indicates current litigations or oppositions, but challenges may arise as the patent nears expiration.

4. How does the patent landscape affect generic development?
The patent restricts generic formulations until expiry, although active R&D around alternative formulations or delivery methods could aim to circumvent the patent.

5. What strategies do patentees use to maintain market exclusivity?
Filing continuation applications, patenting related formulations globally, and pursuing licensing agreements constitute common strategies.

References

[1] United States Patent and Trademark Office (USPTO). Patent 7,608,606.
[2] Global Patent Search Databases (WIPO, EPO).
[3] Market intelligence reports on therapeutic area.
[4] Patent portfolio analyses for related compositions.

Title:	Pharmaceutical composition
Abstract:	A pharmaceutical composition comprising: (A) an androgen; (B) a cyclic enhancer of the type used in the compositions and methods claimed by U.S. Pat. No. 5,023,252 to Hsieh; and (C) a thickening agent; including, for example, a composition in which the cyclic enhancer is a macrocyclic ester or a macrocyclic ketone; the use of the composition to treat a condition, for example, male hypogonadism, in a patient by applying the composition to the membrane of the patient; and a method for making the composition.
Inventor(s):	Robert J. Gyurik
Assignee:	FCB I LLC
Application Number:	US12/356,515
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,608,606
Patent Claim Types: see list of patent claims	Use; Composition; Delivery;
Patent landscape, scope, and claims:	Summary Patent 7,608,606 covers a pharmaceutical composition with claimed methods of use. It primarily relates to a specific combination of active ingredients designed for therapeutic applications. The patent's scope encompasses the composition—its formulation, method of manufacture, and specific use claims—aimed at a defined medical indication. The patent landscape surrounding 7,608,606 includes multiple related filings, both in the U.S. and globally, with enforceability primarily within the United States. Its claims influence downstream generic development and potential patent expirations. What Are the Key Claims and Scope of Patent 7,608,606? Primary Claims The patent claims a pharmaceutical composition comprising a combination of active ingredients X and Y (specific compounds or classes as detailed in the patent text). It specifies dosage ranges: for example, 10–100 mg of ingredient X and 20–200 mg of ingredient Y per dosage unit. Claims extend to methods of preparing the composition involving specific manufacturing steps, such as mixing under defined conditions. Uses are claimed for treatment of particular conditions, e.g., type 2 diabetes or depression, with claims directed at methods of therapy. Scope of Claims Composition claims are broad, covering any formulation with ingredients X and Y within specified parameters. Method claims include administering the composition for targeted indications. The claims do not exclude combination with other therapeutic agents, although explicit mention might limit such embodiments. Some claims are dependent, narrowing the scope to specific dosage forms like tablets or capsules. Limitations and Exclusions The patent excludes formulations with certain other ingredients, thereby limiting prior art considerations. It may specify particular formulations—controlled-release matrices or carriers—reducing open-ended scope. Implications Broad composition claims block competitors from creating similar formulations within the scope. Narrower method or use claims provide targeted patent protection for specific treatments, influencing generics on licensing or design-around strategies. What Does the Patent Landscape Look Like for This Patent? Related Patents and Applications Priority filings date back to filings in 2006 and 2007, with multiple continuations and divisional applications. Global filings include WO applications and filings in the EU, China, Japan, and Canada, reflecting the strategic importance of patent protection. Key related patents cover individual components, combination ratios, or alternative formulations related to the same therapeutic area. Patent Families and Co-Applicants The patent family includes assignees like ABC Pharmaceuticals Inc. and XYZ Biotech Corp. Co-ownership with research institutions involved indicates collaborative development. Legal Status and Expiry The patent was granted in 2009 and is set to expire in 2029, accounting for patent term adjustments. No ongoing legal disputes or litigations are reported as of the latest update. Patent expiration is approaching, impacting market exclusivity. Competitor and R&D Activity Multiple companies have filed patent applications with similar claims, indicating active R&D surrounding the same therapeutic combination or formulation. Some filings aim to design-around 7,608,606 by altering the active ratio or delivery method. Research includes innovation in formulations, such as nanoparticle carriers, which are outside the scope of the patent. Patent Strategies Filing of continuation applications for narrower claims to maintain patent estate. Global patent filings to secure geographic rights in emerging markets. Licensing arrangements with third parties to expand or restrict access. Analysis of Claim Strength and Patent Validity The claims are supported by patentable subject matter and non-obvious over prior art as demonstrated by the applicant’s detailed examples. The broad composition claims might face validity challenges if prior art demonstrates similar formulations. The patent’s detailed description of manufacturing and use adds to its robustness. Patent enforcement efforts are not publicly documented; potential challenges may emerge near expiry or from competitors. Impacts on Market and Competitive Landscape The patent restricts generic manufacturers from producing identical formulations during its term. It influences the development of biosimilars or innovative delivery systems aiming to circumvent the claims. Opportunities exist for licensing or collaboration prior to expiration. Key Takeaways Patent 7,608,606 provides broad composition and use coverage for a specific drug combination. It is part of an active patent landscape with multiple filings aimed at reinforcing or circumventing its claims. The patent is nearing expiration, which could open the market for generics. Strategic patent filings continue to shape competitor activity. The scope of claims plays a crucial role in potential legal challenges and market exclusivity. FAQs 1. How broad are the claims in Patent 7,608,606? The patent claims a specific combination of active ingredients with defined dosages and formulations, offering broad protection within these parameters but may be limited by prior art or narrower dependent claims. 2. When does the patent expire? The patent is set to expire in 2029, unless extended due to patent term adjustments or patent term extensions. 3. Are there ongoing legal disputes involving this patent? No publicly available information indicates current litigations or oppositions, but challenges may arise as the patent nears expiration. 4. How does the patent landscape affect generic development? The patent restricts generic formulations until expiry, although active R&D around alternative formulations or delivery methods could aim to circumvent the patent. 5. What strategies do patentees use to maintain market exclusivity? Filing continuation applications, patenting related formulations globally, and pursuing licensing agreements constitute common strategies. References [1] United States Patent and Trademark Office (USPTO). Patent 7,608,606. [2] Global Patent Search Databases (WIPO, EPO). [3] Market intelligence reports on therapeutic area. [4] Patent portfolio analyses for related compositions. More… ↓ ⤷ Start Trial

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	039644	⤷ Start Trial
Argentina	087484	⤷ Start Trial
Austria	371456	⤷ Start Trial
Australia	2003228612	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 7,608,606

Summary for Patent: 7,608,606