United States Patent 9,737,488: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,737,488, titled "Pharmaceutical composition for the treatment of cancer," is a significant patent in the pharmaceutical industry, particularly in the realm of cancer treatment. This patent, owned by Onyx Pharmaceuticals (now part of Bayer) and licensed to Bayer, covers specific pharmaceutical compositions containing sorafenib tosylate, a drug used in the treatment of various cancers.
Patent Overview
Issuance and Assignee
The patent was issued on August 22, 2017, and is assigned to Onyx Pharmaceuticals, with Bayer holding the exclusive license[1][4].
Patent Claims
The patent includes multiple claims that define the scope of the invention. Here are some key aspects:
Pharmaceutical Composition
- The patent claims cover an immediate release pharmaceutical composition comprising sorafenib tosylate in a portion of at least 40% by weight of the composition, along with at least one pharmaceutically acceptable excipient[1][4].
Formulation
- The composition is specifically described as an immediate release tablet, which is crucial for the effective delivery of the active ingredient, sorafenib tosylate[1][4].
Excipients
- The claims also specify the inclusion of various excipients, such as organic macromolecular compounds, sugars, or sugar alcohols, which are essential for the stability and efficacy of the formulation[4].
Treatment of Cancer
- The patent covers the use of this pharmaceutical composition for treating hyper-proliferative disorders, including various types of cancer such as solid tumors, lymphomas, sarcomas, and leukemias[4].
Scope of the Patent
Claim Language and Scope
The scope of the patent is defined by the language used in the claims. Here are some metrics and considerations:
Independent Claim Length and Count
- The patent's scope can be measured by the length and count of independent claims. Generally, narrower claims with fewer words and fewer independent claims indicate a more focused and potentially stronger patent[3].
Specificity of Claims
- The claims in this patent are specific, detailing the exact composition and formulation of the pharmaceutical product. This specificity helps in defining a clear boundary around the invention, reducing the likelihood of overly broad claims that could be challenged[3].
Patent Classes and Categories
The patent is classified under various categories in the International Patent Classification (IPC) system:
- A61K9/00—Medicinal preparations characterized by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds[4].
Patent Landscape
Litigation and Disputes
The patent has been involved in several legal disputes, particularly regarding generic versions of the drug:
Patent Infringement Suit
- A notable case involved Apotex, Inc., which submitted an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Nexavar (sorafenib tosylate). This led to a patent infringement suit by the patent holders, which was eventually dropped[1][5].
Compulsory Licenses
- In another instance, the Mumbai High Court upheld a compulsory license for Natco Pharma to manufacture a generic version of Nexavar in India, highlighting the global complexities in patent enforcement[2].
Exclusivity and Licensing
- Onyx Pharmaceuticals, the owner of the patent, has licensed it exclusively to Bayer. This licensing agreement ensures that Bayer has the sole rights to manufacture, market, and distribute the drug in the specified territories[1][5].
Impact on the Pharmaceutical Industry
Innovation and Competition
- The patent protects a specific formulation of sorafenib tosylate, which is crucial for the treatment of cancer. This protection can influence innovation by encouraging other companies to develop alternative formulations or new drugs, rather than generic versions of existing ones[3].
Generic Challenges
- The patent's claims and scope make it challenging for generic manufacturers to enter the market without infringing on the patent. This can delay the availability of cheaper generic alternatives, impacting patient access to affordable treatments[1][5].
Key Takeaways
- Specific Claims: The patent's claims are specific and detailed, covering an immediate release pharmaceutical composition with sorafenib tosylate.
- Litigation: The patent has been involved in significant litigation, including a dropped suit against Apotex and a compulsory license in India.
- Licensing: Onyx Pharmaceuticals has licensed the patent exclusively to Bayer.
- Impact on Industry: The patent influences innovation and competition in the pharmaceutical industry, particularly in cancer treatment.
FAQs
What is the main subject of United States Patent 9,737,488?
The main subject of this patent is a pharmaceutical composition for the treatment of cancer, specifically an immediate release tablet containing sorafenib tosylate.
Who owns and licenses this patent?
Onyx Pharmaceuticals owns the patent, and it is exclusively licensed to Bayer.
What are the key claims of this patent?
The key claims include the composition of sorafenib tosylate in a portion of at least 40% by weight, along with at least one pharmaceutically acceptable excipient, and the formulation as an immediate release tablet.
Has this patent been involved in any significant legal disputes?
Yes, it has been involved in a patent infringement suit against Apotex and a compulsory license dispute in India.
How does this patent impact the pharmaceutical industry?
It protects a specific formulation, influencing innovation and competition by encouraging the development of alternative treatments rather than generic versions of the protected drug.
Sources
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... - [PDF] IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ...
- Bayer, Onyx drop Nexavar patent suit | Life Sciences Intellectual ...
- Patent Claims and Patent Scope - Hoover Institution - [PDF] Patent Claims and Patent Scope
- US9737488B2 - Pharmaceutical composition for the treatment of cancer - Google Patents
- Bayer, Amgen Unit Drop IP Suit Over Cancer Drug Generic - Law360
