United States Patent 9,593,100: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,593,100, assigned to Novartis AG, is a significant patent in the field of pharmaceuticals, particularly focusing on compounds and compositions as protein kinase inhibitors. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background
The patent in question, US 9,593,100, is titled "Compounds and Compositions as Protein Kinase Inhibitors" and was granted on March 14, 2017. It is part of a series of patents related to encorafenib, a drug used in the treatment of certain cancers.
Scope of the Patent
Overview of the Invention
The patent describes a class of compounds that act as inhibitors of protein kinases, enzymes that play crucial roles in various cellular processes, including cell signaling pathways. These compounds are particularly useful in the treatment of diseases associated with abnormal protein kinase activity, such as cancer[5].
Chemical Structure
The patent specifies the chemical structure of these compounds, including their derivatives and salts. The compounds are defined by a specific molecular formula and are synthesized through detailed chemical processes outlined in the patent[5].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover the specific compounds, their pharmaceutical compositions, and methods of using these compounds for treating diseases. For example, Claim 1 describes a specific compound of a particular molecular structure, while Claim 10 describes a pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier[5].
Dependent Claims
Dependent claims further narrow down the scope by specifying particular aspects of the independent claims. These include claims related to specific dosages, methods of administration, and therapeutic uses. For instance, Claim 11 depends on Claim 10 and specifies a method of treating a cancer patient using the pharmaceutical composition[5].
Patent Landscape
Related Patents
The patent landscape surrounding US 9,593,100 includes several related patents, particularly those related to encorafenib. For example, patents such as US 9,314,464 and US 8,501,758 (now RE49,556) also cover aspects of encorafenib and its use in treating cancer. These patents are part of a broader strategy to protect the intellectual property related to this drug[1].
Regulatory Review Periods
The patent term extension applications for these related patents highlight the complex regulatory landscape. The FDA's approval process, including Investigational New Drug (IND) filings and New Drug Applications (NDAs), plays a critical role in determining the patent term extensions. However, the law limits the extension to a single patent per regulatory review period for the same product, as clarified by the Federal Circuit in cases like Novartis AG v. Ezra Ventures LLC[1].
Legal and Regulatory Considerations
Patent Term Extensions
The applicant sought multiple patent term extensions based on different regulatory review periods for the same approved product, encorafenib. However, this approach is not supported by the law, which allows only one patent term extension per regulatory review period for any given product. This is in line with 35 U.S.C. § 156 and 37 C.F.R. § 1.785(b)[1].
Judicial Precedents
The Federal Circuit has consistently held that Congress did not intend to compensate for the loss of term for all patents affected by a regulatory review period. Instead, the patent holder must choose which qualifying patent to extend. This is evident from the Novartis AG v. Ezra Ventures LLC case, which sets a precedent for such scenarios[1].
International Patent Landscape
Global Dossier
The Global Dossier service provided by the USPTO allows users to access file histories of related applications from participating IP Offices. This service is crucial for understanding the global patent family and the status of related applications, including those filed in other jurisdictions[4].
Common Citation Document (CCD)
The CCD application consolidates prior art cited by all participating offices for the family members of a patent application. This tool helps in visualizing the search results for the same invention produced by several offices, facilitating a more integrated global patent system[4].
Economic and Strategic Implications
Patent Scope and Claims
The scope and claims of US 9,593,100 are critical for Novartis AG's strategic positioning in the pharmaceutical market. The patent's coverage of specific compounds and their therapeutic uses provides a competitive edge, allowing the company to protect its investment in research and development[3].
Market Impact
The approval and patent protection of encorafenib have significant market implications. The drug's efficacy in treating certain cancers makes it a valuable asset, and the patent landscape ensures that Novartis AG can maintain market exclusivity for a defined period. This exclusivity is crucial for recouping investment and driving further innovation[5].
Challenges and Opportunities
Patent Litigation
The complex patent landscape around encorafenib and related compounds can lead to patent litigation. Companies must navigate the legal framework carefully to avoid infringement and ensure their patents are not challenged by competitors[1].
Licensing and Collaboration
The patent landscape also presents opportunities for licensing and collaboration. Novartis AG can leverage its patent portfolio to form strategic partnerships, expanding the reach of its drugs and fostering further research and development[5].
Key Takeaways
- Patent Scope: US 9,593,100 covers specific compounds and compositions as protein kinase inhibitors, with detailed chemical structures and therapeutic uses.
- Claims: The patent includes independent and dependent claims that define the scope of the invention, including specific compounds, pharmaceutical compositions, and methods of use.
- Regulatory Landscape: The patent is part of a broader regulatory landscape that includes multiple related patents and regulatory review periods, with legal limitations on patent term extensions.
- International Landscape: The patent is part of a global patent family, with tools like the Global Dossier and CCD facilitating international patent management.
- Economic Implications: The patent provides Novartis AG with a competitive edge and market exclusivity, which are crucial for economic success and further innovation.
FAQs
Q: What is the main subject of United States Patent 9,593,100?
A: The main subject of US 9,593,100 is compounds and compositions that act as protein kinase inhibitors, particularly useful in treating diseases like cancer.
Q: How many patent term extensions can be granted for the same product under FDA approval?
A: Only one patent term extension can be granted for the same product under FDA approval, as per 35 U.S.C. § 156 and 37 C.F.R. § 1.785(b).
Q: What is the significance of the Global Dossier in patent management?
A: The Global Dossier provides access to file histories of related applications from participating IP Offices, facilitating a more integrated global patent system.
Q: How does the patent landscape impact Novartis AG's market position?
A: The patent landscape ensures Novartis AG's market exclusivity for encorafenib, allowing the company to protect its investment and drive further innovation.
Q: What are the potential challenges in managing the patent portfolio related to US 9,593,100?
A: Potential challenges include patent litigation and the need to navigate complex regulatory and legal frameworks to avoid infringement and ensure patent validity.
Sources
- Lisa M. Hemmendinger, Ph.D. In Re: Patent Term Extension Banner - FDA Letter attached as Appendix C to each of the PTE applications.
- WO-2005068452-A1 - Unified Patents Portal.
- Patent Claims Research Dataset - USPTO Economic Working Paper 2016-04.
- Search for patents - USPTO - Public Search Facility and Global Dossier.
- US-20130053419-A1 - Unified Patents Portal.
