Understanding the Scope and Claims of United States Patent 8,829,195
Introduction
United States Patent 8,829,195, issued on September 9, 2014, is a significant patent in the pharmaceutical industry, particularly for the inhibition of ABL1, ABL2, and BCR-ABL1 kinases. This patent is owned by Novartis AG and involves a team of inventors including Stephanie Kay Dodd, Pascal Furet, Robert Martin Grotzfeld, and others.
Patent Overview
The patent titled "Compounds and compositions for inhibiting the activity of ABL1, ABL2 and BCR-ABL1" describes a series of compounds and their compositions designed to inhibit specific kinase activities. These kinases are crucial in the context of certain cancers, such as chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL)[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention. Here are some key aspects:
Specific Compounds
Claims 1, 2, 3, 5, 8, 9, and 10 specifically read on the approved product, which involves compounds with detailed structural descriptions. For example, Claim 1 describes a compound with a specific pyrazolylpyridine structure, including substitutions and modifications that are critical for its kinase inhibitory activity[1][4].
Structural Descriptions
The claims provide detailed chemical and generic names, as well as physical structures or characteristics of the compounds. This level of specificity is essential for defining the boundaries of the patent and ensuring that the claims are not overly broad or vague[1].
Kinase Inhibition
The compounds claimed in the patent are characterized by their ability to inhibit ABL1, ABL2, and BCR-ABL1 kinases with high potency, as evidenced by IC50 values ranging from 0.1 nM to 12 nM in radiometric filter binding assays[4].
Patent Term and Exclusivity
Patent Term
The patent was issued on September 9, 2014, and under normal circumstances, it would expire 20 years from the date of filing. However, the patent term can be extended due to regulatory review. In this case, the expiration date is May 13, 2033, with no patent term adjustment (PTA)[1].
Exclusivity
In addition to patent protection, the FDA can grant exclusivity periods that run simultaneously with the patent. These periods can vary from 180 days to seven years, depending on the circumstances of the exclusivity grant. This exclusivity provides additional market protection for the drug beyond the patent term[2].
Patent Landscape and Industry Impact
Genus Claims
The patent landscape in the pharmaceutical industry is complex, especially regarding genus claims. Genus claims are broad claims that cover a class of compounds rather than specific embodiments. However, recent jurisprudence has made it challenging to obtain valuable patent protection for such claims. The Federal Circuit's rigid stance on genus claims requires that the specification must include a written description that enables any person skilled in the art to make and use the claimed compounds. This has created a dilemma for innovators, who must balance between claiming broadly enough to protect their invention and narrowly enough to avoid invalidation[3].
Regulatory and Litigation Challenges
The process of obtaining and maintaining patent protection in the pharmaceutical industry is fraught with regulatory and litigation challenges. Patents like U.S. Patent 8,829,195 must navigate through strict examination processes and potential litigation. The scope of the claims must be carefully drafted to ensure they are commensurate with what is taught in the patent application, avoiding both overly broad and overly narrow claims[3].
Economic and Competitive Implications
Market Protection
The patent and exclusivity periods provide Novartis AG with significant market protection, allowing the company to recoup its investment in research and development. This protection is crucial in the highly competitive pharmaceutical market, where generic and biosimilar competitors are eager to enter once patents expire[2].
Innovation Incentives
The patent system is designed to incentivize innovation by providing exclusive rights to inventors. For Novartis AG, the protection afforded by U.S. Patent 8,829,195 encourages continued research and development in kinase inhibitors, which are vital for treating various cancers[3].
Conclusion
U.S. Patent 8,829,195 is a critical patent in the pharmaceutical industry, particularly for the treatment of cancers involving ABL1, ABL2, and BCR-ABL1 kinases. The patent's claims are detailed and specific, ensuring robust protection for the invented compounds. However, the broader patent landscape, especially regarding genus claims, presents ongoing challenges for innovators in this field.
Key Takeaways
- Specific Claims: The patent includes detailed claims about the chemical structure and kinase inhibitory activity of the compounds.
- Patent Term and Exclusivity: The patent expires on May 13, 2033, with potential extensions due to regulatory review and additional exclusivity periods.
- Genus Claims: The patent landscape is challenging for genus claims, requiring a balance between broad and narrow claims to ensure validity.
- Regulatory and Litigation Challenges: The patent must navigate strict examination and potential litigation to maintain its validity.
- Economic and Competitive Implications: The patent provides significant market protection, incentivizing innovation in kinase inhibitors.
FAQs
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What is the primary focus of U.S. Patent 8,829,195?
- The primary focus is on compounds and compositions for inhibiting the activity of ABL1, ABL2, and BCR-ABL1 kinases.
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Who are the inventors of U.S. Patent 8,829,195?
- The inventors include Stephanie Kay Dodd, Pascal Furet, Robert Martin Grotzfeld, Wolfgang Jahnke, Darryl Brynley Jones, Paul William Manley, Andreas Marzinzik, Xavier Francois Andre Pelle, Bahaa Salem, and Joseph Schoepfer.
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What is the significance of genus claims in pharmaceutical patents?
- Genus claims are broad claims that cover a class of compounds, but recent jurisprudence has made it challenging to obtain valuable patent protection for such claims due to strict requirements for written descriptions and enablement.
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How does the patent term extension work for U.S. Patent 8,829,195?
- The patent term can be extended due to regulatory review, and the current expiration date is May 13, 2033, with no patent term adjustment (PTA).
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What is the impact of FDA exclusivity on the patent?
- FDA exclusivity provides additional market protection beyond the patent term, ranging from 180 days to seven years, depending on the circumstances.
Sources
- US Patent No. 8829195 - Regulations.gov
- Generic Scemblix Availability - Drugs.com
- Eviscerating Patent Scope - DigitalCommons@NYLS
- US8829195B2 - Google Patents
- Federal Register/Vol. 88, No. 247 - Govinfo.gov
