United States Patent 5,502,077: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,502,077, titled "Fatty acid composition," is a significant patent in the field of pharmaceuticals and nutrition, particularly concerning omega-3 fatty acids. This patent, granted to Pronova BioPharma Norge AS, has been a cornerstone in the protection of Lovaza®, a prescription drug used to reduce triglyceride levels in adult patients. Here, we delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Invention
The patent, filed on June 23, 1992, and granted on March 26, 1996, describes a specific composition of fatty acids, particularly long-chain, polyunsaturated omega-3 fatty acids. The invention focuses on a composition that includes at least 90% by weight of these fatty acids, with EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) constituting at least 85% by weight of the total fatty acids. The ratio of EPA to DHA is specified to be between 1:1 and 2:1, with a preferred ratio of about 3:2[4].
Claims
The patent includes several claims that define the scope of the invention:
- Claim 1: A fatty acid composition comprising at least 90% by weight of long-chain, polyunsaturated omega-3 fatty acids, where EPA and DHA constitute at least 85% by weight of the total fatty acids.
- Claim 2: The composition of claim 1, where the ratio of EPA to DHA is between 1:1 and 2:1.
- Claim 3: The composition of claim 1, where the ratio of EPA to DHA is about 3:2.
- Subsequent Claims: These include various aspects of the composition, such as the method of production, the use of ethyl esters, and the application of the composition in medical treatments[4].
Patent Scope and Protection
The scope of the patent is defined by its claims, which are designed to protect the specific composition and its method of production. The patent ensures that any product with a similar composition and production method would infringe on these claims. This protection was crucial in the litigation against generic manufacturers, such as Teva Pharmaceuticals and Par Pharmaceutical, who sought to market generic versions of Lovaza®. The court's ruling in favor of Pronova BioPharma Norge AS validated the patent's claims and maintained the patent protection until at least April 2017[2].
Patent Landscape
Related Patents
The patent 5,502,077 is part of a family of patents related to fatty acid compositions and their medical applications. Other patents in this family include U.S. Patent No. 5,656,667 and U.S. Patent No. 5,698,594, which also pertain to similar compositions and their uses in treating cardiovascular diseases[4].
Global Dossier and International Protection
The Global Dossier service provided by the USPTO allows users to view the patent family for a specific application, including related applications filed at participating IP Offices. This service is crucial for understanding the global protection landscape of a patent like 5,502,077, which may have corresponding patents in other jurisdictions[1].
Litigation and Enforcement
The enforcement of this patent has been significant, with Pronova BioPharma Norge AS successfully defending it against several generic manufacturers. The litigation highlights the importance of patent protection in the pharmaceutical industry, where the development and marketing of generic drugs can significantly impact the original patent holder's market share and revenue[2].
Economic and Market Impact
The protection afforded by this patent has substantial economic implications. Lovaza®, the product based on this patent, generated over $900 million in U.S. sales in 2011 alone. The patent's validity ensured that Pronova BioPharma Norge AS and its partner, GlaxoSmithKline, maintained market exclusivity for this product until the patent's expiration[2].
Research and Data Analysis
The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents, including those related to this family of patents. This dataset can be used to analyze the scope and trends of patent claims, offering insights into the patent landscape and the strategies employed by patent holders[3].
Conclusion
United States Patent 5,502,077 is a pivotal patent in the field of omega-3 fatty acid compositions, providing significant protection for Lovaza® and its manufacturers. The patent's claims, scope, and the broader patent landscape underscore the importance of intellectual property in the pharmaceutical industry.
Key Takeaways
- Specific Composition: The patent protects a specific composition of omega-3 fatty acids with a defined ratio of EPA to DHA.
- Litigation and Enforcement: Successful defense against generic manufacturers has maintained market exclusivity.
- Economic Impact: Significant revenue generation due to patent protection.
- Global Protection: Part of a global patent family with corresponding patents in other jurisdictions.
- Research and Analysis: The USPTO's datasets provide valuable insights into patent claims and trends.
FAQs
Q1: What is the main subject of United States Patent 5,502,077?
A1: The main subject is a specific composition of long-chain, polyunsaturated omega-3 fatty acids.
Q2: What is the ratio of EPA to DHA in the patented composition?
A2: The ratio is specified to be between 1:1 and 2:1, with a preferred ratio of about 3:2.
Q3: How has the patent been enforced?
A3: The patent has been successfully defended in litigation against generic manufacturers to maintain market exclusivity.
Q4: What is the economic impact of this patent?
A4: The patent has generated significant revenue, with Lovaza® sales exceeding $900 million in 2011.
Q5: Are there related patents in this family?
A5: Yes, there are related patents, including U.S. Patent No. 5,656,667 and U.S. Patent No. 5,698,594.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Finnegan - Pronova Prevails in U.S. Lovaza® Patent Litigation: https://www.finnegan.com/en/firm/news/pronova-prevails-in-u-s-lovaza-patent-litigation.html
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US5502077A: https://patents.google.com/patent/US5502077A/da
