United States Patent 6,770,623: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 6,770,623, titled "Stabilized Teriparatide Solutions," is a significant patent in the pharmaceutical industry, particularly in the treatment of osteoporosis. This patent, assigned to Eli Lilly and Company, protects a stabilized pharmaceutical composition of teriparatide, a recombinant form of parathyroid hormone used to treat bone fractures and osteoporosis.
Background of Teriparatide
Teriparatide, marketed under the brand name Forteo, was first approved in the United States in November 2002 and in Europe in April 2003. It is the first approved drug in a new category of osteoporosis treatments that work by stimulating new bone formation rather than just preventing bone loss[4].
Patent Overview
Inventors and Assignee
The patent was invented by Chin-Ming Chang and Henry A. Havel, both associated with Eli Lilly and Company in Indianapolis, Indiana. The patent was granted on August 3, 2004[1][2].
Patent Claims
The patent includes several claims that define the scope of the invention. Key claims include:
- A stabilized pharmaceutical composition in the form of a solution for parenteral administration of a parathyroid hormone.
- The solution contains teriparatide and has specific stabilizing agents to maintain the stability of the hormone.
- The composition is characterized by having less than 2% water by weight, which is crucial for maintaining the stability of the teriparatide[1][2].
Scope of the Patent
Stabilized Composition
The patent focuses on a stabilized solution of teriparatide, which is essential for its efficacy and shelf life. The composition must be formulated to prevent degradation of the hormone, ensuring that it remains effective when administered to patients. This includes the use of specific excipients and a controlled water content[1].
Parenteral Administration
The patent specifies that the composition is for parenteral administration, meaning it is designed to be administered via injection, bypassing the digestive system. This method ensures that the hormone is delivered directly into the bloodstream, enhancing its bioavailability and effectiveness[2].
Claims Analysis
Independent Claims
The patent includes several independent claims that define the core aspects of the invention. These claims are critical in determining the scope of protection and what would constitute infringement. For example, Claim 1 describes the stabilized pharmaceutical composition, while subsequent claims detail specific aspects such as the concentration of teriparatide and the presence of stabilizing agents[1].
Dependent Claims
Dependent claims build upon the independent claims, providing additional details and limitations. These claims help to narrow down the scope of the invention and provide a clearer understanding of what is protected. For instance, dependent claims might specify the types of stabilizing agents used or the pH range of the solution[1].
Patent Landscape
Related Patents
Eli Lilly and Company holds several related patents that complement the '623 patent. These include U.S. Patent Nos. 7,144,861, 7,550,434, 6,977,077, 7,163,684, and 7,351,414, all of which are related to various aspects of teriparatide formulations and methods of use. These patents collectively form a robust intellectual property portfolio protecting Forteo[5].
Litigation and Infringement
The '623 patent has been involved in significant litigation, particularly against generic manufacturers. For example, Eli Lilly and Company filed a complaint against Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries Ltd. for patent infringement related to their Abbreviated New Drug Application (ANDA) for a generic version of Forteo. The lawsuit alleged that Teva's generic product would infringe on several claims of the '623 patent, among others[5].
Impact on Innovation and Patent Quality
Patent Scope and Clarity
The debate over patent quality often centers around the breadth and clarity of patent claims. The '623 patent, with its detailed and specific claims, exemplifies a well-defined scope that helps in preventing overly broad interpretations. This clarity is crucial for maintaining incentives for innovation by reducing the risk of litigation and licensing disputes[3].
Economic and Legal Implications
The protection afforded by the '623 patent and related patents has significant economic and legal implications. It allows Eli Lilly and Company to maintain market exclusivity for Forteo, which is critical for recouping investment in research and development. However, it also means that generic competitors must wait until the patents expire before entering the market, which can impact patient access to affordable treatments[5].
Key Takeaways
- Stabilized Composition: The patent protects a stabilized solution of teriparatide, essential for its efficacy and shelf life.
- Parenteral Administration: The composition is designed for parenteral administration, ensuring direct delivery into the bloodstream.
- Claims Analysis: Independent and dependent claims define the core aspects and specific details of the invention.
- Related Patents: A robust portfolio of related patents protects various aspects of teriparatide formulations and methods of use.
- Litigation: The patent has been involved in significant litigation against generic manufacturers to protect market exclusivity.
FAQs
What is the main subject of United States Patent 6,770,623?
The main subject of United States Patent 6,770,623 is a stabilized pharmaceutical composition in the form of a solution for parenteral administration of teriparatide, a recombinant form of parathyroid hormone.
Who are the inventors of the patent?
The inventors of the patent are Chin-Ming Chang and Henry A. Havel, both associated with Eli Lilly and Company.
What is the significance of the water content in the patent?
The composition must have less than 2% water by weight to maintain the stability of the teriparatide.
How does the patent impact generic manufacturers?
The patent prevents generic manufacturers from marketing a generic version of Forteo until the patent expires, thereby protecting Eli Lilly and Company's market exclusivity.
What are some related patents to the '623 patent?
Related patents include U.S. Patent Nos. 7,144,861, 7,550,434, 6,977,077, 7,163,684, and 7,351,414, all of which are related to various aspects of teriparatide formulations and methods of use.
Sources
- United States Patent and Trademark Office. (2004). Stabilized Teriparatide Solutions. US Patent 6,770,623 B1.
- DrugPatentWatch. Claims for Patent: 6770623.
- Hoover Institution. (2016). Patent Claims and Patent Scope.
- DrugBank. Teriparatide: Uses, Interactions, Mechanism of Action.
- RPX Corporation. (2016). Case 1:16-cv-00167-UNA Document 1 Filed 03/17/16.
