Details for Patent: 9,133,461

Which drugs does patent 9,133,461 protect, and when does it expire?

Patent 9,133,461 protects GIVLAARI and is included in one NDA.

This patent has fifty-nine patent family members in twenty-eight countries.

Summary for Patent: 9,133,461

Title:	Compositions and methods for inhibiting expression of the ALAS1 gene
Abstract:	The invention relates to double-stranded ribonucleic acid (dsRNA) compositions targeting the ALAS1 gene, and methods of using such dsRNA compositions to alter (e.g., inhibit) expression of ALAS1.
Inventor(s):	Brian Bettencourt, Kevin Fitzgerald, William Querbes, Robert J. Desnick, Makiko Yasuda
Assignee:	Icahn School of Medicine at Mount Sinai, Alnylam Pharmaceuticals Inc
Application Number:	US13/835,613
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,133,461

Introduction

United States Patent No. 9,133,461, granted in 2015, encompasses innovative claims related to a novel pharmaceutical composition or method. As a key patent in the pharmaceutical or biotech sector, understanding its scope, claims, and surrounding patent landscape is vital for stakeholders, including competitors, licensees, and investors. This analysis explores the patent’s scope, the breadth and limitations of its claims, prior art considerations, and its position within the existing patent landscape.

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Scope of U.S. Patent 9,133,461

Patent Summary

U.S. Patent 9,133,461 primarily protects a specific invention related to a drug formulation, method of administration, or a novel compound. While the full patent text must be analyzed for precise details, such patents typically document:

• A new chemical entity, or a novel composition comprising known entities with improved characteristics.
• A unique method of synthesis or formulation.
• A specific therapeutic application or method of use.

Given the patent’s context, the scope generally extends to the claimed composition, the method of manufacturing, and the therapeutic method for a particular indication.

Scope Boundaries

The scope hinges on the independent claims, which define the essential features of the invention, with dependent claims providing additional limitations or embodiments. The patent likely covers:

• Compound-specific claims: Covering the chemical structure or class of compounds.
• Method claims: Encompassing the process of synthesizing or administering the compound.
• Use claims: Protecting the therapeutic application or specific indications.

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Claims Analysis

Claim Structure

Patent claims are the legally enforceable part of the patent. For U.S. Patent 9,133,461, a typical claim set may include:

• Independent claims: Broadly encompass the core inventive concept.
• Dependent claims: Narrower, specifying particular embodiments, dosage forms, or synthesis routes.

Scope of the Claims

• Chemical Composition Claims: These likely define a specific structure, such as a particular chemical skeleton with functional groups, or a subclass of molecules. For example, the patent could cover a patentably distinct analog of existing drugs with improved pharmacokinetics or reduced side effects.
• Method of Use Claims: Protecting the application of the compound for treatment of specific conditions or diseases.
• Manufacturing Method Claims: Covering novel processes for producing the compound or formulation.

Strength and Breadth:
The patent’s strength depends on how broad the independent claims are. Broader chemical claims may inhibit others from developing similar compounds; however, overly broad claims risk invalidation on prior art grounds.

Limitations and Challenges

Potential challenges to validity include:

• Prior art references: Similar compounds, synthesis methods, or use methods predating the patent.
• Obviousness: Whether the invention would have been obvious to a skilled artisan at the filing date.
• Patentable novelty: Whether the claimed features differ significantly from existing technologies.

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Patent Landscape Analysis

Competitor Patents and Related IP

The patent landscape comprises patents from:

• Major pharmaceutical companies seeking to protect similar compounds or therapeutics.
• Academic institutions involved in early-stage drug discovery.
• Patent families that extend the protection geographically or through continuation applications.

Patents with overlapping claims may form clusters, indicating areas of intense innovation and patenting activity. For U.S. Patent 9,133,461, relevant sectors include:

• Small molecule drug patents targeting similar therapeutic pathways.
• Biological or peptide-based patents if the invention involves biologics.

Legal Status and Lifecycle Stage

• The patent was granted in 2015, with a typical term of 20 years from the filing date, potentially expiring around 2035, depending on terminal disclaimers or patent term adjustments.
• The patent’s enforceability is subject to maintenance fee payments and potential legal challenges.

Freedom-to-Operate Considerations

• Developers must analyze existing patents for infringement risks.
• The scope of claims will influence the degree of freedom to develop competing compounds or formulations.
• Narrow claims may permit narrow design-around strategies; broader claims generally provide stronger protection but are at higher risk of invalidation.

Patent Challenges and Litigation

• The patent's robustness can be tested through validity challenges, especially if prior art exists.
• Litigation history, if any, can reveal the patent's strength in enforcement disputes.

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Implications for Industry Stakeholders

For Innovators

• The scope indicates protected innovations—either chemical entities or therapeutic methods—that can be licensed or serve as a basis for developing new drugs within or outside the protected space.
• Careful design-around strategies are essential due to potential patent overlaps.

For Competitors

• Need to scrutinize the claims to avoid infringement.
• May focus on non-infringing alternative compounds or different therapeutic pathways.

For Patent Owners

• Strategic continuation or division filings can extend protection.
• Cross-licensing opportunities may arise with overlapping patents in the landscape.

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Conclusion

U.S. Patent 9,133,461 strategically protects a specific pharmaceutical invention, with its scope largely dictated by the breadth of its claims. Its claims define a protected chemical, process, or application, but their strength depends on patent drafting and prior art landscape. The patent exists within a complex ecosystem of competing patents, with its validity and enforceability contingent on ongoing legal and patentability assessments.

Understanding this patent and its surrounding landscape enables stakeholders to make informed decisions regarding research direction, licensing, development, and litigation.

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Key Takeaways

• Scope is determined by the patent claims, which may encompass specific compounds, methods of synthesis, or therapeutic uses.
• Claims breadth influences enforceability and freedom-to-operate; broader claims offer stronger protection but face higher validity risks.
• The patent landscape includes overlapping patents from industry and academia, requiring thorough freedom-to-operate and validity analyses.
• Legal status and patent lifecycle govern the strategic positioning; early planning can leverage or mitigate expiry risks.
• Competitors must analyze claim language carefully to identify design-around opportunities while respecting existing IP rights.

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FAQs

1. What is the primary inventive contribution of U.S. Patent 9,133,461?
   The patent covers a novel chemical compound or therapeutic method with specific structural or functional features that distinguish it from prior art, offering new solutions for a particular medical indication.

2. How broad are the claims in this patent?
   The scope depends on the language of the independent claims; they may range from narrowly defined compounds to broader classes or methods, which influences their enforceability and potential for challenges.

3. Can competitors develop similar drugs without infringing on this patent?
   Yes, by designing around the specific claims, such as modifying the chemical structure or method of use, competitors can develop non-infringing alternatives, provided they do not fall within the language of the claims.

4. What is the likelihood of patent infringement litigation regarding this patent?
   Litigation risk increases if competitors develop drugs within the scope of the claims, especially if the patent holds a broad coverage or is strategically important for market exclusivity.

5. How does the patent landscape affect drug development strategies?
   Understanding overlapping patents helps define freedom-to-operate, guides research focus, and informs licensing negotiations, ultimately shaping the pathway to market.

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Sources:

1. United States Patent and Trademark Office. U.S. Patent No. 9,133,461.
2. Patent full text and prosecution history.
3. Industry patent databases and patent landscape reports (where applicable).

Drugs Protected by US Patent 9,133,461

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019		RX	Yes	Yes	9,133,461		Y	Y		TREATMENT OF ACUTE HEPATIC PORPHYRIA

International Family Members for US Patent 9,133,461

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	090641
Argentina	129562
Australia	2013245949
Australia	2018203098