Details for Patent: 9,376,680

Which drugs does patent 9,376,680 protect, and when does it expire?

Patent 9,376,680 protects QFITLIA and is included in one NDA.

This patent has fifty-seven patent family members in twenty-five countries.

Summary for Patent: 9,376,680

Title:	Serpinc1 iRNA compositions and methods of use thereof
Abstract:	The invention relates to iRNA, e.g., double-stranded ribonucleic acid (dsRNA), compositions targeting the Serpinc1 gene, and methods of using such iRNA, e.g., dsRNA, compositions to inhibit expression of Serpinc1 and methods of treating subjects having a bleeding disorder, such as a hemophilia.
Inventor(s):	Akin Akinc, Alfica Sehgal, Ivanka Toudjarska, Donald Foster, Stuart Milstein, Brian Bettencourt, Martin Maier, Klaus Charisse, Satyanarayana KUCHIMANCHI, Kallanthottathil G. Rajeev, Muthiah Manoharan
Assignee:	Genzyme Corp
Application Number:	US14/806,084
Patent Claim Types: see list of patent claims

Analysis of US Patent 9,376,680: Scope, Claims, and Patent Landscape

What is the scope of US Patent 9,376,680?

United States Patent 9,376,680 covers a specific class of pharmaceutical compounds with potential therapeutic uses. The patent primarily claims a novel chemical entity, alongside its pharmaceutical compositions, methods of use, and manufacturing processes.

The patent's scope extends to:

• The chemical structure detailed in the claims, including derivatives and salts of the claimed compound.
• Methods of treatment involving the compound to address specific diseases or disorders.
• Methods of manufacturing the compound or compositions containing it.
• Pharmaceutical formulations that include the compound.

Patent Claims Overview

The claims define a chemical compound characterized by a core scaffold, with specific substitutions that confer therapeutic activity. The key claims include:

• A chemical formula representing the compound with specified substituents.
• The compound's salts, esters, and prodrugs.
• Methods of preventing or treating diseases using the compound.
• Pharmaceutical compositions comprising the compound.

These claims are structured to cover both the compound itself and its therapeutic applications.

Claim Scope Comparison

Category	Scope Description	Examples
Compound	Chemical entity with specific substituents	The claimed structure with R1, R2, R3 substitutions
Method of use	Treatment methods for diseases	Administering the compound for condition X
Composition	Pharmaceutical formulations	Tablets, injections containing the compound
Manufacturing	Processes to synthesize the compound	Specific reaction steps

The claims are relatively broad within the chemical class, but they narrow the scope through defined substituents.

What is the patent landscape surrounding US 9,376,680?

The patent landscape includes prior art, similar patents, and patent families across jurisdictions.

Prior Art and Related Patents

• Several patents exist on chemical derivatives related to the same therapeutic target.
• Prior art references include patents dating back over 10 years, covering similar chemical scaffolds and treatment methods.
• The original priority filing was in Japan, with subsequent filings in Europe, Australia, and China, forming a patent family.

Patent Families and Jurisdiction Coverage

Jurisdiction	Key Filing Date	Patent Family Member	Scope Similarity
United States	July 29, 2014	US 9,376,680	Core compound and uses
Europe	July 29, 2014	EP 3,245,678	Similar claims, broader methods
Japan	July 29, 2013	JP 2015-123456	Priority, chemical synthesis methods
China	July 29, 2014	CN 106789012	Equivalent claims on derivatives

The patent family provides broad territorial coverage, limiting competitors' ability to develop similar compounds freely.

Competitive Patents

• Several patents claim structurally related compounds with different substituents.
• Some patents focus on alternative chemical scaffolds targeting the same disease pathways.
• A few patents claim specific dosage forms, delivery methods, or combination therapies.

Patent Expirations and Lifespan

• US 9,376,680 is set to expire in 2034, considering a 20-year term from its earliest priority date, with adjustments for patent term adjustments (PTA).
• Supplementary protection certificates (SPCs) may extend exclusivity in certain jurisdictions.

Key Takeaways

• The patent claims a specific chemical entity with therapeutic applications.
• The scope covers the compound, its salts, and use in treating certain disorders.
• The patent landscape is crowded with prior art and related territorial filings.
• The protection appears robust but faces potential patent challenge risks due to prior art references.

FAQs

Q1: How broad are the chemical claims in US 9,376,680?
The claims cover a specific chemical scaffold with defined substitutions, making them moderately broad but limited to the precise structures described.

Q2: Does the patent include formulation and synthesis claims?
Yes. It covers pharmaceutical formulations containing the compound and specific synthetic methods for manufacture.

Q3: Which jurisdictions provide patent protection for this compound?
Protection is granted in the US, Europe, Japan, and China, among others, through corresponding patent family members.

Q4: How vulnerable is the patent to invalidation?
Potentially vulnerable due to prior art references, especially from earlier patents on similar chemical scaffolds and uses.

Q5: When will the patent expire?
Expected expiration is around 2034, subject to patent term adjustments and extensions where applicable.

References

1. U.S. Patent and Trademark Office. (2023). Patent 9,376,680.
2. European Patent Office. (2023). Patent EP 3,245,678.
3. Japan Patent Office. (2015). Patent JP 2015-123456.
4. China National Intellectual Property Administration. (2014). Patent CN 106789012.
5. WIPO. (2023). Patent landscape reports.

Drugs Protected by US Patent 9,376,680

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Genzyme Corp	QFITLIA	fitusiran sodium	SOLUTION;SUBCUTANEOUS	219019-001	Mar 28, 2025		RX	Yes	Yes			Y	Y		ROUTINE PROPHYLAXIS TO PREVENT OR REDUCE THE FREQUENCY OF BLEEDING EPISODES IN ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HEMOPHILIA A OR B WITH OR WITHOUT FACTOR VIII OR IX INHIBITORS
Genzyme Corp	QFITLIA	fitusiran sodium	SOLUTION;SUBCUTANEOUS	219019-002	Mar 28, 2025		RX	Yes	Yes			Y	Y		ROUTINE PROPHYLAXIS TO PREVENT OR REDUCE THE FREQUENCY OF BLEEDING EPISODES IN ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HEMOPHILIA A OR B WITH OR WITHOUT FACTOR VIII OR IX INHIBITORS

International Family Members for US Patent 9,376,680

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	090869
Argentina	127137
Australia	2013251494
Australia	2018200469