Detailed Analysis of the Scope and Claims of United States Patent 7,816,379
Introduction
United States Patent 7,816,379, issued on October 19, 2010, pertains to novel derivatives of oxazolidinone, a class of antibiotics. This patent is crucial for understanding the intellectual property landscape in the pharmaceutical industry, particularly in the development and marketing of antibacterial drugs.
Inventors and Assignees
The patent was invented by Jae Keol Rhee, Weon Bin Im, Chong Hwan Cho, Sung Hak Choi, and Tae Ho Lee. The patent is assigned to Dong-A Pharmaceutical Co., Ltd., with Trius Therapeutics, Inc. acting as the exclusive licensee[1][4].
Patent Claims
The patent includes a comprehensive set of claims that cover various aspects of the oxazolidinone derivatives.
Method of Manufacturing Claims
Claims 1-4, 6, 7, 9, 11-15, and 22 are method of manufacturing claims. These claims detail the processes for preparing the oxazolidinone derivatives, including specific chemical reactions and synthesis methods[1].
Product Claims
Claims 24, 25, 28, 29, 32-35, and 43 are product claims that describe the chemical structures and compositions of the oxazolidinone derivatives. These claims define the scope of the protected compounds[1].
Composition Claims
Claim 45 is a composition claim that specifies the formulations of the pharmaceutical compositions comprising the oxazolidinone derivatives[1].
Method of Use Claims
Claims 46-49 are method of use claims that outline the therapeutic applications of the oxazolidinone derivatives, particularly for the treatment of acute bacterial skin and skin structure infections[1].
Patent Scope
The scope of the patent is defined by the breadth and clarity of its claims.
Independent Claim Length and Count
Research suggests that the scope of a patent can be measured by the length and count of its independent claims. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Claim Clarity and Validity
The clarity and validity of the claims are critical for patent quality. The claims in U.S. Patent 7,816,379 are detailed and specific, reducing the likelihood of disputes over their interpretation[3].
Regulatory Approval and Marketing
The approved product, marketed under the tradename SIVEXTRO™, received permission for commercial marketing on June 20, 2014. This approval was granted after a thorough regulatory review process, including IND (Investigational New Drug) submissions and NDA (New Drug Application) approvals[1][5].
Patent Term Extension
Trius Therapeutics, Inc. applied for a patent term extension under 35 U.S.C. § 156, which allows for the extension of the patent term to compensate for the time spent in regulatory review. The extension sought was for at least 118 days, which would extend the patent expiration date from February 23, 2028, to at least June 20, 2028[1][5].
Significant Activities and Dates
The patent application and regulatory approval process involved several significant activities and dates, including the effective dates of IND submissions (December 27, 2007, and September 17, 2008) and the NDA approval date (June 20, 2014)[1].
Patent Landscape
The patent landscape for oxazolidinone derivatives is complex, with multiple patents covering different aspects of these compounds. U.S. Patent 7,816,379 is one of the key patents in this space, providing broad protection for the manufacturing, composition, and use of these antibacterial agents.
Competitive Environment
The pharmaceutical industry is highly competitive, and patents like U.S. Patent 7,816,379 play a crucial role in protecting intellectual property and maintaining market exclusivity. The specific claims and scope of this patent help in differentiating the product from others in the market[4].
Innovation and Litigation
Patents with clear and narrow claims, like U.S. Patent 7,816,379, are less likely to be involved in lengthy and complex litigation. This clarity promotes innovation by providing clear boundaries for what is protected and what is not[3].
Industry Expert Insights
Industry experts emphasize the importance of patent clarity and scope in promoting innovation. For example, a Federal Trade Commission (FTC) report highlighted that clear and specific patent claims can reduce licensing and litigation costs, thereby encouraging further innovation[3].
Illustrative Statistics
- The patent has 49 claims, with a mix of method of manufacturing, product, composition, and method of use claims.
- The regulatory review period for SIVEXTRO™ was approximately 6.5 years, from the effective date of the IND to the NDA approval[1].
Key Takeaways
- Comprehensive Claims: U.S. Patent 7,816,379 includes a wide range of claims covering manufacturing, composition, and therapeutic use.
- Regulatory Approval: The patent is associated with the regulatory approval of SIVEXTRO™, a significant antibacterial drug.
- Patent Term Extension: The patent term was extended to compensate for the time spent in regulatory review.
- Patent Clarity: The patent's clear and specific claims contribute to its validity and reduce the likelihood of litigation.
- Competitive Advantage: The patent provides a competitive edge in the pharmaceutical market by protecting the intellectual property related to oxazolidinone derivatives.
FAQs
What is the main subject of U.S. Patent 7,816,379?
The main subject of U.S. Patent 7,816,379 is novel derivatives of oxazolidinone and their use in pharmaceutical compositions.
Who are the inventors of U.S. Patent 7,816,379?
The inventors are Jae Keol Rhee, Weon Bin Im, Chong Hwan Cho, Sung Hak Choi, and Tae Ho Lee.
What is the tradename of the approved product under this patent?
The approved product is marketed under the tradename SIVEXTRO™.
Why was a patent term extension applied for?
A patent term extension was applied for to compensate for the time spent in regulatory review, extending the patent expiration date.
How does the clarity of patent claims impact innovation?
Clear and specific patent claims reduce licensing and litigation costs, thereby promoting innovation by providing clear boundaries for what is protected.
Cited Sources
- Regulations.gov: AUG 0 5 Z014 - Regulations.gov
- Regulations.gov: Untitled - Regulations.gov
- Hoover Institution: Patent Claims and Patent Scope - Hoover Institution
- Google Patents: US7816379B2 - Oxazolidinone derivatives - Google Patents
- Regulations.gov: (-~ li1 U.S. FOOD & DRUG - Regulations.gov
