United States Patent 6,765,117: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,765,117, titled "Process for stereoselective synthesis of prostacyclin derivatives," is a significant patent in the field of pharmaceutical chemistry. This patent, owned by United Therapeutics Corporation, plays a crucial role in the production of specific prostacyclin derivatives, particularly relevant in the synthesis of treprostinil sodium, a medication used for treating pulmonary arterial hypertension.
Background
The patent was issued on July 20, 2004, and was set to expire on October 24, 2017. It is a result of a divisional application from earlier filings, tracing back to October 24, 1997[1][4].
Inventors and Assignees
The named inventors on the ’117 patent are Robert M. Moriarty, Raju Penmasta, Liang Guo, Mungala S. Rao, and James P. Staszewski. The patent is assigned to United Therapeutics Corporation[1].
Claims
The patent asserts several claims, with the primary focus on claims 1-4. Here is a brief overview of the key claims:
- Claim 1: Describes the stereoselective production of a specific isomeric compound.
- Claim 2: Specifies the stereoselectively produced isomeric compound with particular substituents.
- Claims 3-4: Further detail the synthesis process and the resulting compounds[1].
Patent Scope
The scope of the patent is defined by its claims, which are narrowly focused on the stereoselective synthesis of prostacyclin derivatives. This specificity is crucial as it distinguishes the invention from prior art methods, which were less efficient and less stereoselective. The patent scope is measured by metrics such as independent claim length and independent claim count, which can indicate the breadth and clarity of the patent claims[3].
Process for Stereoselective Synthesis
The patented process is an improvement over prior art methods, requiring fewer steps and being more stereoselective. This process is particularly important for the synthesis of 9-deoxy-PGF1-type compounds, which are used in medications like treprostinil sodium[4].
Patent Landscape
The patent landscape surrounding the ’117 patent involves several key aspects:
- Litigation: United Therapeutics Corporation has been involved in patent infringement litigation, notably against Sandoz, Inc., where the court found that Sandoz’s proposed generic product would infringe claims of the ’117 patent[1].
- Expiration: The patent expired on October 24, 2017, which has significant implications for generic manufacturers and the market availability of treprostinil sodium.
- Regulatory Environment: The patent is subject to the Hatch-Waxman Act, which governs the approval of generic drugs and the listing of patents in the Orange Book[1].
Impact on Pharmaceutical Industry
The ’117 patent has a substantial impact on the pharmaceutical industry, particularly in the production of treprostinil sodium. The expiration of this patent has allowed generic manufacturers to enter the market, potentially reducing costs and increasing accessibility of the medication.
Legal and Regulatory Considerations
The patent's validity and infringement were subject to legal scrutiny. The court's findings that Sandoz’s proposed ANDA product would infringe the ’117 patent highlight the importance of patent protection in the pharmaceutical industry. The Hatch-Waxman Act plays a crucial role in balancing innovation with generic competition[1].
Innovation and Competition
The patent's expiration has opened up the market for generic competition, which can drive innovation and reduce costs. However, it also underscores the need for continuous innovation to maintain market leadership, as seen in the pharmaceutical industry's ongoing research and development efforts.
Conclusion
United States Patent 6,765,117 is a critical patent in the field of pharmaceutical chemistry, particularly for the synthesis of prostacyclin derivatives. Its scope, claims, and the surrounding patent landscape are intricately linked to the production and market availability of important medications like treprostinil sodium.
Key Takeaways
- The patent is focused on the stereoselective synthesis of prostacyclin derivatives.
- It was issued on July 20, 2004, and expired on October 24, 2017.
- The patent is owned by United Therapeutics Corporation.
- Claims 1-4 are central to the patent's scope.
- The patent has been subject to litigation, notably against Sandoz, Inc.
- The expiration of the patent has allowed generic manufacturers to enter the market.
Frequently Asked Questions (FAQs)
Q: What is the main subject of United States Patent 6,765,117?
A: The main subject is the process for stereoselective synthesis of prostacyclin derivatives.
Q: Who are the inventors listed on the patent?
A: The inventors are Robert M. Moriarty, Raju Penmasta, Liang Guo, Mungala S. Rao, and James P. Staszewski.
Q: What is the significance of the patent's expiration?
A: The expiration allows generic manufacturers to produce the medication, potentially reducing costs and increasing accessibility.
Q: What legal framework governs this patent?
A: The patent is subject to the Hatch-Waxman Act, which regulates the approval of generic drugs and the listing of patents in the Orange Book.
Q: How does the patent impact the pharmaceutical industry?
A: It affects the production and market availability of treprostinil sodium, a medication for pulmonary arterial hypertension, and influences generic competition and innovation.
Cited Sources
- Final UTC v. Sandoz Trial Op - GovInfo
- U.S. Patent and Trademark Office (USPTO) - USAGov
- Patent Claims and Patent Scope - SSRN
- Process for stereoselective synthesis of prostacyclin derivatives - Google Patents
- AI VISUALIZE, INC. v. NUANCE COMMUNICATIONS, INC. - CAFC
