Detailed Analysis of the Scope and Claims of United States Patent 9,149,532
Introduction
United States Patent 9,149,532, assigned to Daiichi Sankyo Company, Limited, is a significant patent in the pharmaceutical industry, particularly in the field of anticoagulant medications. This patent protects a specific pharmaceutical composition, and understanding its scope and claims is crucial for both the patent holder and potential competitors.
Patent Overview
Publication and Assignment
The patent, titled "Pharmaceutical composition," was issued on October 6, 2015, and is assigned to Daiichi Sankyo Company, Limited. The inventors listed include Kojima Masazumi, Kuno Yoshio, Nakagami Hiroaki, Sagasaki Shinji, Ishidoh Koichi, and Sekiguchi Gaku[5].
Scope of the Patent
Pharmaceutical Composition
The patent relates to a pharmaceutical composition that is useful as an anticoagulant. The composition is designed to improve the dissolution property of the active ingredient, which is critical for its efficacy and bioavailability. The composition includes:
- Active Ingredient: N 1-(5-chloropyridin-2-yl)-N 2-((1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-[(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino-cyclohexyl)ethanediamide, or a pharmacologically acceptable salt or hydrate thereof.
- Additives: One or more species selected from the group consisting of a sugar alcohol and a water-swelling additive[4].
Therapeutic Uses
The active ingredient in this composition is known for its utility in various therapeutic applications, including:
- Blood Coagulation Factor X Inhibitor: Preventing and/or treating thrombosis or embolism.
- Thrombotic Diseases: Treating conditions such as cerebral infarction, cerebral embolism, heart infarction, angina pectoris, pulmonary embolism, Buerger's disease, deep vein thrombosis, and others[4].
Claims of the Patent
Key Claims
The patent claims are focused on the specific composition and its improved dissolution properties. The main claims include:
- Composition Claims: The patent claims the pharmaceutical composition comprising the specified active ingredient and additives.
- Dissolution Property Claims: The composition is claimed to exhibit satisfactory dissolution properties in a wide pH range, which is crucial for its therapeutic efficacy[4].
Scope of Protection
The scope of protection provided by this patent is broad enough to cover various aspects of the pharmaceutical composition but narrow enough to be specific and enforceable. The claims are designed to capture the essence of the invention while preventing easy circumvention by competitors.
Patent Landscape
Exclusivity and Patent Term
The patent is protected until March 28, 2028, which is approximately 20 years from the filing date. This exclusivity period ensures that Daiichi Sankyo has sole marketing rights for the protected composition during this time[5].
Related Patents
The patent is part of a family of patents related to the drug Savaysa, which includes other patents such as US7365205. These patents collectively protect various aspects of the drug, including the active ingredient, dosage forms, and manufacturing processes[2].
Challenges and Oppositions
Since January 8, 2019, the patents related to Savaysa have been open to challenges. However, none of the patents have expired yet, and the generic launch date is estimated to be March 28, 2028, based on the current patent landscape[2].
Impact on the Pharmaceutical Industry
Genus Claims and Enablement
The patent landscape in the pharmaceutical industry is complex, especially regarding genus claims. The Federal Circuit's current position on genus claims makes it challenging for innovators to obtain broad patent protection without violating the enablement and written description requirements. This patent navigates these challenges by providing a detailed description of the composition and its dissolution properties, ensuring that the claims are both broad and specific enough to be enforceable[3].
Competitive Strategy
Understanding the scope and claims of this patent is crucial for competitors who may be considering entering the market with generic versions of Savaysa. The patent's protection until 2028 and the specific claims related to the composition and dissolution properties make it essential for competitors to identify markets with weaker patent protection or to develop alternative formulations that do not infringe on the existing patent claims[2].
Key Takeaways
- Patent Protection: The patent protects a specific pharmaceutical composition with improved dissolution properties until March 28, 2028.
- Therapeutic Uses: The composition is useful as an anticoagulant and treats various thrombotic diseases.
- Claims: The patent claims are focused on the composition and its dissolution properties.
- Patent Landscape: The patent is part of a family of patents related to Savaysa, and understanding the broader patent landscape is crucial for market strategy.
- Industry Impact: The patent highlights the complexities of genus claims and enablement in the pharmaceutical industry.
FAQs
What is the main active ingredient protected by US Patent 9,149,532?
The main active ingredient is N 1-(5-chloropyridin-2-yl)-N 2-((1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-[(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino-cyclohexyl)ethanediamide, or a pharmacologically acceptable salt or hydrate thereof[4].
What is the therapeutic use of the composition protected by this patent?
The composition is used as an anticoagulant and is particularly useful in preventing and/or treating thrombosis or embolism, as well as various thrombotic diseases[4].
When does the patent protection for US Patent 9,149,532 expire?
The patent protection expires on March 28, 2028[5].
Are there other patents related to this composition?
Yes, this patent is part of a family of patents related to the drug Savaysa, including US7365205 and others[2].
How does this patent impact the development of generic versions of Savaysa?
The patent's specific claims and protection period until 2028 make it essential for competitors to either wait for the patent to expire or develop alternative formulations that do not infringe on the existing patent claims[2].
Sources
- US9707296B2 - Pharmaceutical composition - Google Patents
- Savaysa patent expiration - Pharsight - GreyB
- Eviscerating Patent Scope - DigitalCommons@NYLS
- US9149532B2 - Pharmaceutical composition - Google Patents
- Generic Savaysa Availability - Drugs.com
