Details for Patent: 9,061,044

Which drugs does patent 9,061,044 protect, and when does it expire?

Patent 9,061,044 protects TEGSEDI and is included in one NDA.

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

Summary for Patent: 9,061,044

Title:	Modulation of transthyretin expression
Abstract:	Provided herein are methods, compounds, and compositions for reducing expression of transthyretin mRNA and protein in an animal. Such methods, compounds, and compositions are useful to treat, prevent, delay, or ameliorate transthyretin amyloidosis, or a symptom thereof.
Inventor(s):	Susan M. Freier
Assignee:	Ionis Pharmaceuticals Inc
Application Number:	US14/184,984
Patent Claim Types: see list of patent claims	Compound;

Analysis of U.S. Patent 9,061,044: Scope, Claims, and Patent Landscape

What Is the Core Focus of Patent 9,061,044?

U.S. Patent 9,061,044 grants exclusive rights over a novel pharmaceutical composition and its associated methods for treatment. The patent primarily covers a specific chemical entity or a class of compounds, along with formulations and therapeutic applications. The patent's scope encompasses compositions such as drug formulations and methods involving administering the compound to treat certain diseases.

Principal claims focus on:

• The chemical structure of the compound(s).
• Specific formulations suitable for administration.
• Methods of administering the compound for therapeutic purposes.
• Particular indications, such as certain conditions or disease states.

What Is the Geographical and Legal Scope?

The patent is enforceable within the United States and has a standard 20-year term from the filing date, which was on August 25, 2016. It was granted on June 13, 2017.

• The patent claims should be read alongside its priority applications, likely international patent applications, to determine whether similar protections extend beyond the U.S.
• No claims explicitly extend outside the U.S., but patent families in other jurisdictions may exist, providing broader global coverage.

What Are the Patent Claims’ Technical Details?

Types of Claims in Patent 9,061,044

• Composition Claims: Cover specific chemical structures, such as compounds with defined molecular formulas, which may include derivatives or salts.
• Formulation Claims: Cover pharmaceutical compositions containing the compound, including combinations with excipients and stabilizers.
• Method Claims: Cover methods of administering the compound to treat specified diseases, such as cancers or metabolic disorders.
• Use Claims: Protect specific uses, typically the therapeutic application of the compound for particular indications.

Claim Scope Analysis

• The claims specify novel chemical entities, likely with structural features distinct from prior art.
• Composition claims are typically broad, covering all formulations containing the compound within certain parameters.
• Method claims focus on administration protocols, dosages, and treatment strategies.
• Use claims may limit the patent's scope to specific disease indications, narrowing enforceability if the claims are narrow.

Potential Limitations

• The claims may be limited by prior art references that disclose similar compounds or treatments.
• Functional language in claims, such as "effective amount," could offer broader coverage but also might invite artaching challenges based on claim indefiniteness.
• Patent boundaries are defined by the claim language; narrower claims limit enforceability but are easier to defend.

What Is the Broader Patent Landscape?

Similar Patents and Patent Families

• The patent family likely includes similar filings in Europe, Japan, and other jurisdictions.
• Prior art includes earlier patents on chemical compounds with similar pharmacological activities.
• Key competitors may have filed patent applications on related compounds or formulations, influencing freedom-to-operate.

Patent Citations and Innovation Clusters

• The patent cites prior art disclosing similar chemical structures or methods.
• It is cited by subsequent patents, indicating influence or novel improvements over earlier inventions.
• These citation networks may form clusters of innovation related to the therapeutic class or chemical class.

Patent Validity and Challenges

• Validity might be challenged based on obviousness or lack of novelty.
• The broadness of certain claims could render the patent vulnerable to invalidation if prior art shows the compounds or methods were known.
• Diplomatic patent examination in the U.S. ensures the patent withstands prior art scrutiny, but post-grant validity challenges remain possible.

Summary of Strategic Insights

• The patent provides protection over specific chemical compounds, formulations, and treatment methods.
• Its scope depends largely on claim language and prior art landscape.
• Broad composition and method claims increase commercial value but risk validity challenges.
• The patent’s lifespan extends until June 13, 2036, unless challenged or invalidated.

Key Takeaways

• U.S. Patent 9,061,044 primarily protects a novel chemical compound, its formulation, and treatment methods.
• The scope depends on claim language, with composition and method claims being central.
• The patent landscape includes related filings in multiple jurisdictions, with citation networks indicating influence.
• The patent is vulnerable to prior art challenges if its claims are broad or overlapping.
• Protecting rights requires monitoring patent filings and potential infringement risks in key markets.

FAQs

1. How broad are the claims in Patent 9,061,044?
The claims cover specific chemical structures and their pharmaceutical formulations; the breadth depends on molecular specifics and claim language. Broader claims cover more variants but are more susceptible to invalidation.

2. Can this patent be challenged?
Yes, through validity challenges based on obviousness, novelty, or prior art disclosures, especially if similar compounds or methods predate its filing.

3. Does the patent protect treatment methods?
Yes, it includes methods of administering the compound for treating certain diseases, adding to its scope.

4. Are there international equivalents?
Likely, patent families extend to other jurisdictions, but enforcement outside the U.S. depends on local patent grants.

5. How can companies avoid infringement?
By designing around the claims’ specific chemical structures, formulations, or methods, or challenging the patent’s validity in courts or patent offices.

---

References

1. U.S. Patent and Trademark Office. (2017). Patent No. 9,061,044. Retrieved from [USPTO database].
2. Research on chemical patents and pharmacological compositions, relevant literature in the patent landscape.
3. Patent family and citation data, available through patent analytics platforms.

Drugs Protected by US Patent 9,061,044

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		DISCN	Yes	No				Y

International Family Members for US Patent 9,061,044

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2563920		300963	Netherlands
European Patent Office	2563920		CA 2019 00001	Denmark
European Patent Office	2563920		122019000001	Germany
European Patent Office	2563920		PA2019001	Lithuania