United States Patent 6,455,518: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 6,455,518, hereafter referred to as the '518 patent, is a significant intellectual property asset in the pharmaceutical sector. This patent pertains to specific formulations and uses of everolimus, a drug used in organ transplantation and other medical applications. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Inventors
The '518 patent was granted to Novartis Pharmaceuticals Corporation and Novartis AG, with the inventors contributing to the development of everolimus formulations. Everolimus is an immunosuppressive agent used to prevent organ rejection in transplant patients.
Scope of the Patent
Claims Overview
The '518 patent includes several claims that define the scope of protection for the inventors' work. These claims typically cover the composition of matter, methods of use, and specific formulations of everolimus.
- Composition of Matter Claims: These claims specify the chemical composition of the everolimus formulations, including the active ingredient and any excipients or additives.
- Method of Use Claims: These claims describe the specific medical uses of the everolimus formulations, such as prophylaxis of organ rejection in kidney and liver transplant patients.
- Formulation Claims: These claims detail the specific formulations of everolimus, including dosage strengths and delivery mechanisms[5].
Specific Claims
- Claim 7 of the '518 patent is particularly noteworthy as it has been the subject of litigation. This claim typically pertains to the use of everolimus in specific medical indications, such as kidney and liver transplantation[2][5].
Patent Landscape
Related Patents
The '518 patent is part of a larger family of patents related to everolimus. Other patents, such as U.S. Patent No. 6,239,124 ('124 patent) and U.S. Patent No. 8,410,131, also cover various aspects of everolimus formulations and uses. These patents collectively form a robust intellectual property portfolio for Novartis[2][5].
Litigation and Enforcement
The '518 patent has been involved in several high-profile litigation cases, particularly against generic drug manufacturers. For instance, Novartis Pharmaceuticals Corporation and Novartis AG have sued Par Pharmaceutical, Inc. for patent infringement related to the filing of an Abbreviated New Drug Application (ANDA) for generic everolimus tablets. These cases highlight the importance of the '518 patent in protecting Novartis's market position[5].
Validity and Obviousness Challenges
The '518 patent has faced challenges regarding its validity, particularly on grounds of obviousness and obviousness-type double patenting. However, in key litigation, the court has upheld the validity of certain claims, including Claim 7, against such challenges[2].
Impact on the Pharmaceutical Industry
The '518 patent significantly influences the pharmaceutical industry, particularly in the area of immunosuppressive therapies. It protects Novartis's proprietary formulations and methods of use, thereby preventing generic competition until the patent's expiration. This protection allows Novartis to maintain market exclusivity and recoup investment in research and development.
Patent Analytics and Claim Coverage
To manage and optimize the protection offered by the '518 patent, companies like Novartis use patent analytics tools. These tools help in tracking patents by claims and scope concepts, identifying gaps in coverage, and highlighting future design opportunities. Claim Coverage Matrices and interactive claim charts are essential in this process, enabling technical experts to review and analyze the patent landscape efficiently[3].
Expiry and Exclusivity
The '518 patent's term and associated exclusivities are critical for Novartis's business strategy. The patent's expiration date, along with any pediatric exclusivity, determines when generic competition can enter the market. For instance, the pediatric exclusivity associated with the '124 and '518 patents expired in January 2018, marking a significant milestone in the patent's lifecycle[2].
Conclusion
The United States Patent 6,455,518 is a pivotal asset for Novartis, protecting its everolimus formulations and methods of use. Understanding the scope, claims, and the broader patent landscape is crucial for navigating the complex world of pharmaceutical intellectual property. This patent's validity, litigation history, and impact on the industry underscore its importance in the field of immunosuppressive therapies.
Key Takeaways
- The '518 patent covers specific everolimus formulations and methods of use.
- Claim 7 is a key claim that has been the subject of litigation.
- The patent is part of a larger family of patents related to everolimus.
- Litigation has upheld the validity of certain claims against obviousness challenges.
- Patent analytics tools are essential for managing and optimizing patent protection.
- The patent's term and exclusivities are critical for business strategy.
Frequently Asked Questions (FAQs)
What is the main subject matter of the '518 patent?
The '518 patent pertains to specific formulations and methods of use of everolimus, an immunosuppressive agent.
What are the key claims of the '518 patent?
The key claims include composition of matter, methods of use, and specific formulations of everolimus, with Claim 7 being particularly significant.
Has the '518 patent been involved in any litigation?
Yes, the '518 patent has been involved in several litigation cases, particularly against generic drug manufacturers like Par Pharmaceutical, Inc.
How does the '518 patent impact the pharmaceutical industry?
The patent protects Novartis's proprietary formulations and methods of use, preventing generic competition and allowing Novartis to maintain market exclusivity.
What tools are used to manage and optimize the protection offered by the '518 patent?
Patent analytics tools, including Claim Coverage Matrices and interactive claim charts, are used to track patents, identify gaps in coverage, and highlight future design opportunities.
Cited Sources:
- United States Patent and Trademark Office. U.S. Patent No. 9,068,162 B2.
- Finnegan. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE.
- SLWIP. Patent Analytics.
- PubChem. Stable compositions of famotidine and ibuprofen.
- Insight.RPXCorp. Case 1:14-cv-01289-RGA Document 1 Filed 10/10/14 Page 1 of 10.
