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Patent landscape, scope, and claims: |
Understanding the Scope and Claims of United States Patent 11,254,652
Introduction
United States Patent 11,254,652, titled "Crystalline forms of N-(4-(4-(cyclopropymethyl)piperazine-1-carbonyl)phenyl)quinoline-8-sulfonamide," is a significant patent in the pharmaceutical industry, particularly for Agios Pharmaceuticals, Inc. This patent is part of a broader landscape of intellectual property protection for drugs, and its analysis is crucial for understanding the complexities of pharmaceutical patenting.
Patent Overview
The patent, issued on February 22, 2022, covers crystalline and amorphous hemisulfate salt forms of a specific compound, along with pharmaceutical compositions, methods for their manufacture, and their uses in treating conditions associated with pyruvate kinase deficiency[4][5].
Claims and Scope
Claim Structure
The patent includes multiple claims, each detailing different aspects of the invention. Here are some key points about the claims:
- Composition Claims: These claims describe the crystalline and amorphous hemisulfate salt forms of the compound. For example, the patent specifies the chemical structure and the conditions under which these forms are stable[4].
- Method Claims: These claims outline the methods for manufacturing the pharmaceutical compositions and the uses thereof. This includes specific processes for preparing the crystalline forms and their application in treating pyruvate kinase deficiency[5].
- Use Claims: These claims define the therapeutic uses of the compound, focusing on its efficacy in treating conditions related to pyruvate kinase deficiency.
Scope of Protection
The scope of the patent is defined by the breadth and specificity of its claims. For instance:
- Chemical Specificity: The patent claims are highly specific to the crystalline forms of the compound, ensuring that any generic or competing product must avoid these exact forms to avoid infringement.
- Therapeutic Use: The use claims are directed towards treating specific medical conditions, which helps in maintaining exclusivity in the therapeutic application of the compound[4].
Patent Landscape and Regulatory Context
FDA and USPTO Regulations
The patent is part of the broader regulatory landscape governed by the FDA and USPTO. Here are some key points:
- Orange Book Listings: Patents like 11,254,652 are often listed in the FDA's Orange Book, which provides a list of approved drugs and their associated patents. This listing is crucial for generic drug manufacturers to understand what patents they need to avoid or challenge[1].
- Hatch-Waxman Act: The Hatch-Waxman Act plays a significant role in the patent landscape for pharmaceuticals. It allows brand-name drug companies to list their patents in the Orange Book and provides a 30-month stay on the approval of generic drug applications that challenge these patents[1].
Challenges in Pharmaceutical Patenting
The pharmaceutical industry faces unique challenges in patenting, particularly with regards to the scope and validity of patent claims.
- Enablement and Written Description: The Federal Circuit's recent jurisprudence on 35 U.S.C. § 112 has introduced significant uncertainty. The heightened test for enablement and written description has made it challenging for innovators to claim the full scope of their inventions without risking invalidation[3].
- Genus Claims: Genus claims, which cover a broad class of compounds, are particularly problematic. The Federal Circuit's rigid application of § 112(a) has made it difficult to obtain meaningful patent protection for pharmaceuticals and biologics[3].
Impact on Generic Competition
The patent landscape, including patents like 11,254,652, significantly impacts generic competition.
- Barriers to Entry: The extensive list of patents and the complexity of their claims create barriers for generic manufacturers. Each patent must be carefully analyzed to ensure that the generic product does not infringe on the brand-name drug's patents[1].
- Design-Around Strategies: Generic manufacturers often employ design-around strategies to avoid infringement. However, the broad and complex claims in patents like 11,254,652 make it challenging to design around without compromising the efficacy of the generic product[3].
Expiration Dates and Future Implications
The patent 11,254,652 is set to expire on November 21, 2038. Here are some implications:
- Generic Availability: Once the patent expires, generic versions of the drug can be developed and marketed, potentially reducing the cost and increasing the availability of the treatment[5].
- Innovation Incentives: The expiration of patents like 11,254,652 highlights the need for continuous innovation. Pharmaceutical companies must invest in new research and development to maintain their competitive edge and ensure future exclusivity[3].
Key Takeaways
- Specific Claims: The patent includes highly specific claims regarding the crystalline forms and therapeutic uses of the compound.
- Regulatory Context: The patent is part of the FDA's Orange Book and is subject to the Hatch-Waxman Act.
- Challenges in Patenting: The pharmaceutical industry faces challenges related to enablement, written description, and genus claims.
- Impact on Generic Competition: The patent creates barriers for generic manufacturers and necessitates careful design-around strategies.
- Future Implications: The expiration of the patent will open up opportunities for generic competition and underscore the need for continuous innovation.
FAQs
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What is the main subject of United States Patent 11,254,652?
- The patent covers crystalline and amorphous hemisulfate salt forms of a specific compound, along with their pharmaceutical compositions, manufacturing methods, and therapeutic uses.
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How does the patent impact generic competition?
- The patent creates barriers for generic manufacturers by requiring them to design around the specific claims to avoid infringement.
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What are the key regulatory frameworks governing this patent?
- The patent is governed by the FDA's Orange Book listings and the Hatch-Waxman Act.
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What challenges do pharmaceutical companies face in patenting similar inventions?
- Pharmaceutical companies face challenges related to enablement, written description, and genus claims under 35 U.S.C. § 112.
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When is the patent set to expire?
- The patent is set to expire on November 21, 2038.
Sources
- Listening Session on Joint USPTO-FDA Collaboration Initiatives - [PDF]
- Pyrukynd patent expiration - Pharsight
- Eviscerating Patent Scope, 21 UIC Rev. Intell. Prop. L. 121 (2022) - [PDF]
- US11254652B2 - Crystalline forms of N-(4-(4-(cyclopropymethyl)piperazine-1-carbonyl)phenyl)quinoline-8-sulfonamide - Google Patents
- Generic Pyrukynd Availability - Drugs.com
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