United States Patent 7,585,860: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,585,860, titled "Substituted Oxazolidinones and Their Use in the Field of Blood Coagulation," is a significant patent in the pharmaceutical industry, particularly in the area of blood coagulation and thromboembolic disorders. This patent, assigned to Bayer Schering Pharma Aktiengesellschaft, is part of a broader patent landscape that influences the development, manufacture, and market entry of related drugs.
Patent Overview
Patent Number and Issue Date
The patent number is 7,585,860 B2, and it was issued on September 8, 2009[5].
Inventors and Assignee
The inventors listed on the patent include Alexander Straub, Thomas Lampe, Jens Pohlmann, Susanne Rohrig, Elisabeth Perzborn, Karl-Heinz Schlemmer, and Joseph Pernerstorfer, all affiliated with Bayer Schering Pharma Aktiengesellschaft in Germany[5].
Claim Scope
The patent claims relate to substituted oxazolidinones and their use in the field of blood coagulation. Specifically, it covers compounds that are suitable for the prophylaxis and/or treatment of thromboembolic disorders. The claims are detailed and specify the chemical structures and methods of use for these compounds[5].
Claim Analysis
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims are crucial as they set the boundaries of what is considered novel and non-obvious over the prior art. Independent claims typically provide the broadest definition of the invention and are often the focus of patent litigation and validity challenges[3].
Dependent Claims
Dependent claims further narrow down the scope of the invention by adding additional limitations to the independent claims. These claims help to provide a clearer picture of the specific embodiments of the invention and can be used to defend against challenges of obviousness or invalidity[3].
Patent Landscape and Related Patents
Associated Patents
The patent 7,585,860 B2 is part of a family of patents related to the compound rivaroxaban, which is used in the treatment of thromboembolic disorders. Other related patents include U.S. Patent No. 7,157,456 and U.S. Patent No. 7,592,339. These patents collectively cover various aspects of rivaroxaban, including its composition, formulation, and methods of use[1][5].
Orange Book Listings
The patents associated with rivaroxaban, including the 7,585,860 B2 patent, are listed in the FDA's Orange Book. The Orange Book compiles patent information for approved drug products, including drug substance patents, drug product patents, and method of use patents. This listing is crucial for generic drug manufacturers as it informs them of the patents that must be addressed before they can seek approval for a generic version of the drug[2][4].
Exclusivity and Market Impact
Market Exclusivity
The issuance and listing of these patents in the Orange Book provide market exclusivity to the innovator company, in this case, Bayer. This exclusivity period can range from several years to over a decade, depending on the patent expiration dates and any additional exclusivities granted under the Federal Food, Drug and Cosmetic Act (FD&C Act)[2][4].
Generic Competition
Generic drug manufacturers must navigate these patents by either challenging their validity or waiting for their expiration. For example, Sigmapharm Laboratories, LLC, and Mylan Pharmaceuticals Inc. submitted Abbreviated New Drug Applications (ANDAs) with Paragraph IV certifications, asserting that the patents, including the 7,585,860 B2 patent, were invalid or would not be infringed by their proposed generic products[1].
Litigation and Validity Challenges
Obviousness Challenges
The validity of the 7,585,860 B2 patent, along with other related patents, has been challenged in court. Defendants in patent infringement cases often argue that the claimed inventions are obvious over the prior art. However, in the case of Bayer Intellectual Property GMBH v. Aurobindo Pharma Ltd., the court found that the secondary considerations of non-obviousness, such as commercial success and long-felt but unsolved need, weighed in favor of non-obviousness[1].
Secondary Considerations
Secondary considerations, as outlined in Graham v. John Deere Co., play a significant role in determining the non-obviousness of a patent. These include factors such as commercial success, long-felt but unsolved need, failure of others, and unexpected results. In the context of chemical compounds, these considerations are particularly important due to the unpredictable nature of the art[1].
Patent Scope and Quality
Metrics for Patent Scope
The scope of a patent, including the 7,585,860 B2 patent, can be measured using metrics such as independent claim length and independent claim count. These metrics help in assessing the breadth and clarity of the patent claims. Narrower claims are often associated with a higher probability of grant and a shorter examination process[3].
Patent Examination Process
The examination process at the USPTO tends to narrow the scope of patent claims, ensuring that the claims are clear and not overly broad. This process is crucial in maintaining patent quality and preventing the issuance of patents with questionable validity[3].
Conclusion
The United States Patent 7,585,860 B2 is a critical component of the patent landscape surrounding rivaroxaban and thromboembolic disorder treatments. Understanding its claims, associated patents, and the broader patent landscape is essential for both innovator companies and generic manufacturers. The patent's validity and scope have been subject to legal challenges, highlighting the importance of secondary considerations and the metrics used to measure patent scope.
Key Takeaways
- Patent Claims and Scope: The patent covers substituted oxazolidinones and their use in blood coagulation, with detailed claims specifying chemical structures and methods of use.
- Related Patents: Part of a family of patents related to rivaroxaban, including U.S. Patent No. 7,157,456 and U.S. Patent No. 7,592,339.
- Orange Book Listings: Listed in the FDA's Orange Book, which informs generic manufacturers of relevant patents.
- Market Exclusivity: Provides market exclusivity to the innovator company, impacting generic competition.
- Litigation and Validity: Challenged in court with arguments of obviousness, but found valid based on secondary considerations.
- Patent Scope and Quality: Measured using metrics like independent claim length and count, ensuring clarity and validity.
FAQs
What is the main subject of United States Patent 7,585,860 B2?
The main subject of the patent is substituted oxazolidinones and their use in the field of blood coagulation, particularly for the prophylaxis and/or treatment of thromboembolic disorders.
Who are the inventors and assignee of the patent?
The inventors include Alexander Straub, Thomas Lampe, Jens Pohlmann, Susanne Rohrig, Elisabeth Perzborn, Karl-Heinz Schlemmer, and Joseph Pernerstorfer. The assignee is Bayer Schering Pharma Aktiengesellschaft.
How does the patent impact generic drug manufacturers?
Generic drug manufacturers must address the patents listed in the Orange Book, including the 7,585,860 B2 patent, by either challenging their validity or waiting for their expiration before seeking approval for a generic version.
What are the key metrics for measuring patent scope?
Key metrics include independent claim length and independent claim count, which help in assessing the breadth and clarity of the patent claims.
What are secondary considerations in determining non-obviousness?
Secondary considerations include commercial success, long-felt but unsolved need, failure of others, and unexpected results, which are particularly important in the context of chemical compounds.
How does the patent examination process affect patent claims?
The examination process at the USPTO tends to narrow the scope of patent claims, ensuring that the claims are clear and not overly broad, which helps in maintaining patent quality.
