Understanding the Scope and Claims of United States Patent 9,278,961
Introduction to Patent 9,278,961
United States Patent 9,278,961, titled "Pyridyl inhibitors of hedgehog signalling," is a crucial patent in the field of oncology, particularly for the treatment of malignancies. This patent is owned by Genentech Inc. and is set to expire on December 15, 2028.
Inventors and Issuance
The patent was issued on March 8, 2016, to a team of inventors including Gunzner Janet L., Sutherlin Daniel, Stanley Mark S., Bao Liang, Castanedo Georgette M., Lalonde Rebecca L., Wang Shumei, Reynolds Mark E., Savage Scott J., Malesky Kimberly, Dina Michael S., and Koehler Michael F. T.[2][4].
Claims and Scope
General Formula and Inhibitors
The patent describes novel inhibitors of hedgehog signaling, which are therapeutic agents for treating malignancies. These inhibitors have a specific general formula, denoted as Formula I, which defines the chemical structure of the compounds. The claims are centered around these pyridyl inhibitors and their use in modulating hedgehog signaling pathways, which are critical in various types of cancer[2][4].
Hedgehog Signaling Pathway
The hedgehog signaling pathway is a key regulatory pathway in cell development and growth. In cancer, this pathway can be aberrantly activated, leading to uncontrolled cell proliferation. The inhibitors described in this patent target this pathway, providing a therapeutic approach to treating cancers where hedgehog signaling is dysregulated[2].
Specific Compounds and Uses
The patent includes detailed descriptions of specific compounds that fit the general formula and their methods of preparation. It also outlines the therapeutic uses of these compounds, including their application in treating various types of malignancies. The claims are broad enough to cover a range of compounds but specific enough to ensure the novelty and non-obviousness of the inventions[2].
Patent Expiration and Generic Availability
Expiration Date
The patent is set to expire on December 15, 2028. This expiration date is critical for generic drug manufacturers, as it marks the time when they can begin developing and marketing generic versions of the drug without infringing on the original patent[2][4].
Exclusivities and Generic Launch
In addition to the patent expiration, the FDA has granted several exclusivities to Erivedge, the drug protected by this patent. These exclusivities can delay the launch of generic or bioequivalent versions of the drug, even after the patent has expired. Therefore, generic manufacturers must consider both the patent expiration and any remaining exclusivities when planning their product launch[4].
Impact on the Pharmaceutical Industry
Innovation and Competition
The expiration of this patent will open up the market for generic versions of the drug, increasing competition and potentially reducing costs for patients. This can drive innovation as other companies may invest in research and development to create new or improved therapies targeting the hedgehog signaling pathway[1].
Market Opportunities
Generic drug manufacturers can prepare for the patent expiration by developing their own versions of the drug. This involves understanding the active ingredient, the route of administration, and other critical details outlined in the patent. For example, the active ingredient in this case is a pyridyl inhibitor of hedgehog signaling, and the route of administration is oral (capsule or tablet)[2].
Metrics for Measuring Patent Scope
Independent Claim Length and Count
Research on patent scope suggests that metrics such as independent claim length and independent claim count can be useful in evaluating the breadth and clarity of patent claims. Narrower claims are often associated with a higher probability of grant and a shorter examination process, which can be relevant when analyzing the scope of patents like 9,278,961[3].
Conclusion
United States Patent 9,278,961 is a significant patent in the field of cancer treatment, protecting novel inhibitors of hedgehog signaling. Understanding its claims, scope, and expiration date is crucial for both the original patent holder and potential generic drug manufacturers. As the patent approaches its expiration, it will be important to monitor any remaining exclusivities and prepare for the potential entry of generic competitors into the market.
Key Takeaways
- Patent Expiration: December 15, 2028
- Active Ingredient: Pyridyl inhibitors of hedgehog signaling
- Route of Administration: Oral (capsule or tablet)
- Therapeutic Use: Treating malignancies where hedgehog signaling is dysregulated
- Exclusivities: FDA-granted exclusivities may delay generic launch
- Impact on Industry: Increased competition and potential for reduced costs; drives innovation in related therapies
FAQs
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What is the main therapeutic use of the drug protected by Patent 9,278,961?
- The main therapeutic use is treating malignancies where hedgehog signaling is dysregulated.
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Who is the owner of Patent 9,278,961?
- The patent is owned by Genentech Inc.
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What is the expiration date of Patent 9,278,961?
- The patent is set to expire on December 15, 2028.
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What are the FDA-granted exclusivities related to this patent?
- The FDA has granted several exclusivities to Erivedge, which can delay the launch of generic or bioequivalent versions of the drug.
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How does the expiration of this patent impact the pharmaceutical industry?
- The expiration opens up the market for generic versions, increasing competition and potentially reducing costs for patients, and drives innovation in related therapies.
Sources
- GreyB - Cancer Drug Patents Expiring 2024-2028
- Drugs.com - Generic Erivedge Availability
- SSRN - Patent Claims and Patent Scope
- Pharsight - GreyB - Erivedge patent expiration
