Understanding the Scope and Claims of United States Patent 10,987,364
Introduction
United States Patent 10,987,364, hereafter referred to as the '364 patent, is part of a broader patent landscape that involves complex legal and technical considerations. This patent is associated with Exeltis, a company that has been involved in several patent infringement disputes, particularly regarding their product SLYND®.
Background of the Patent
The '364 patent is one of the patents listed in the FDA’s Orange Book for SLYND®, a medication indicated for use by females of reproductive potential to prevent pregnancy[1].
Patent Claims and Scope
Claim Structure
Patent claims are the heart of any patent, defining the scope of the invention. The '364 patent, like other patents, includes a set of claims that outline what the invention covers. These claims can be independent or dependent, with independent claims standing alone and dependent claims referring back to other claims[3].
Claim Analysis
In the context of the '364 patent, the claims would be analyzed for their breadth, clarity, and validity. The patent scope can be measured using metrics such as independent claim length and independent claim count. Broader claims can be more contentious and may lead to longer examination processes and higher litigation costs[3].
Patent Landscape and Related Patents
Associated Patents
The '364 patent is part of a suite of patents held by Exeltis, including other patents such as U.S. Patent Nos. 9,603,860, 10,179,140, 10,603,281, 10,849,857, and others. These patents collectively protect various aspects of SLYND® and related formulations[1].
Litigation and Infringement
Exeltis has been involved in litigation with other companies, such as Lupin, alleging infringement of these patents. The litigation narrowed down to specific claims within these patents, including the '364 patent, focusing on issues of infringement, obviousness, written description, and indefiniteness[1].
Written Description Requirement
The written description requirement, as outlined in 35 U.S.C. § 112, is crucial for the validity of the '364 patent. This requirement mandates that the specification clearly allow persons of ordinary skill in the art to recognize that the inventor invented what is claimed. The test for sufficiency involves determining whether the disclosure reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date[1].
Obviousness and Invalidity Arguments
In patent litigation, arguments of obviousness and invalidity are common. For the '364 patent, the party challenging its validity would need to prove by clear and convincing evidence that the claims are obvious or lack a sufficient written description. The burden of proof lies with the challenging party, and the court must consider the perspectives of persons of ordinary skill in the art[1].
Examination and Prosecution Process
The process of obtaining a patent involves several stages, including filing a provisional patent application, followed by a non-provisional application. The U.S. Patent & Trademark Office (USPTO) examines the application, and if the claimed invention is patentable, the patent is granted after fees are paid. The '364 patent would have gone through this rigorous process, which can take several years and involves multiple rounds of arguments and amendments to the claims[5].
International Considerations
While the '364 patent is a U.S. patent, international patent applications can be filed through the Patent Cooperation Treaty (PCT) to seek protection in multiple countries. However, this process is costly and typically reserved for inventions with significant global commercial potential[5].
Commercial and Licensing Implications
The '364 patent, as part of Exeltis's intellectual property portfolio, has significant commercial implications. The patent protects the company's interests in SLYND® and related products, allowing them to maintain market exclusivity. Licensing agreements and commercial partnerships can also play a crucial role in the monetization of this patent[5].
Cost and Resource Considerations
Patenting and maintaining a patent like the '364 patent is a costly endeavor. The process involves substantial fees for filing, prosecution, and maintenance. These costs can range from $8,000 to $20,000 for a U.S. non-provisional patent application and significantly more for international patents[5].
Key Takeaways
- Patent Claims: The '364 patent's claims define its scope and are subject to analysis for breadth, clarity, and validity.
- Litigation: The patent has been involved in litigation over infringement and validity issues.
- Written Description: The patent must meet the written description requirement to be valid.
- Examination Process: The patent went through a rigorous examination process at the USPTO.
- International Considerations: International patent applications can be filed but are costly.
- Commercial Implications: The patent is crucial for Exeltis's market exclusivity and commercial strategies.
FAQs
Q: What is the '364 patent related to?
A: The '364 patent is related to SLYND®, a medication for preventing pregnancy, and is listed in the FDA’s Orange Book.
Q: What are the key issues in the litigation involving the '364 patent?
A: The key issues include infringement, obviousness, written description, and indefiniteness.
Q: How is the scope of a patent measured?
A: The scope can be measured using metrics such as independent claim length and independent claim count.
Q: What is the written description requirement in patent law?
A: The written description requirement mandates that the specification clearly allow persons of ordinary skill in the art to recognize that the inventor invented what is claimed.
Q: How long does the patent examination process typically take?
A: The patent examination process can take two to five years.
Sources
- United States District Court for the District of Delaware, "Exeltis USA, Inc. v. Lupin Pharmaceuticals, Inc."
- U.S. Patent and Trademark Office (USPTO), "USPTO | USAGov"
- SSRN, "Patent Claims and Patent Scope"
- USPTO, "Search for patents - USPTO"
- KU Office of Research, "Intellectual Property Protection"
