United States Patent 8,518,987: A Detailed Analysis
Introduction
The United States Patent 8,518,987, hereafter referred to as the '987 Patent, is a significant intellectual property asset in the pharmaceutical industry, particularly related to the drug darunavir, which is used in the treatment of HIV. This patent is part of a broader portfolio held by Janssen Sciences Ireland UC, a subsidiary of Johnson & Johnson. Here, we will delve into the scope, claims, and the patent landscape surrounding this patent.
Background
Darunavir, the active ingredient protected by the '987 Patent, is a protease inhibitor used in combination with other medications to treat HIV-1 infection. The patent is one of several that Janssen holds for darunavir and its formulations, including Prezista and Prezcobix[2].
Scope of the Patent
The '987 Patent pertains to specific formulations and methods of manufacturing darunavir, particularly focusing on the crystalline forms and solvates of the compound. Here are some key aspects of the patent's scope:
Crystalline Forms and Solvates
The patent describes and claims various crystalline forms of darunavir, including solvates, which are crucial for the stability and bioavailability of the drug. The specification details the methods for preparing these crystalline forms, which are essential for pharmaceutical applications[5].
Manufacturing Methods
The '987 Patent also covers improved methods for synthesizing darunavir, including the use of specific solvents and conditions that enhance the yield and purity of the compound. These methods are designed to overcome the drawbacks of earlier synthesis techniques[1].
Claims of the Patent
The claims of the '987 Patent are critical in defining the scope of protection. Here are some key claims:
Claim 1
Claim 1 typically defines the broadest scope of the invention, often describing the crystalline form of darunavir or its solvates. For example, Claim 1 might specify a particular crystalline form of darunavir that contains stoichiometric or non-stoichiometric amounts of a solvent[1].
Dependent Claims
Dependent claims further narrow down the scope by adding additional limitations. These might include specific methods of preparation, particular solvents used, or other characteristics of the crystalline forms.
Patent Landscape
The patent landscape surrounding the '987 Patent is complex and highly competitive, given the significance of darunavir in HIV treatment.
Competitors and Generics
Generic drug manufacturers, such as Lupin Ltd. and Teva, have been involved in litigation with Janssen over the infringement of patents related to darunavir. These cases highlight the ongoing battles in the pharmaceutical industry to protect intellectual property rights and to bring generic versions of critical drugs to market[1].
Expiration Dates
The '987 Patent is scheduled to expire on August 16, 2024, which marks a significant milestone in the patent lifecycle. After this date, generic versions of darunavir could potentially enter the market, subject to regulatory approvals and any remaining patent protections[2].
Regulatory Framework
The FDA's Orange Book and the Purple Book play crucial roles in managing the patent landscape for pharmaceuticals. These resources list patents associated with approved drugs and provide critical information for generic and biosimilar applicants. Janssen, as the reference product sponsor, must submit and update patent information in these databases[2].
Litigation and Legal Proceedings
The '987 Patent has been at the center of several legal disputes, particularly involving generic drug manufacturers.
Janssen Prods., L.P. v. Lupin Ltd.
In this case, Janssen sued Lupin for alleged infringement of the '987 Patent, among others. The court's decisions on motions for summary judgment highlighted the complexity of patent litigation and the burden on defendants to prove non-infringement or invalidity of the patents[1].
Market Impact
The '987 Patent has significant implications for the market, particularly in terms of pricing and accessibility of darunavir.
Pricing and Accessibility
Patent protection allows Janssen to maintain market exclusivity, which can influence the pricing of the drug. Once the patent expires, the entry of generic versions is expected to increase competition and potentially reduce prices, making the drug more accessible to patients[4].
Key Players and Collaborations
The AI-driven drug discovery landscape, while not directly related to the '987 Patent, indicates a broader trend of innovation and collaboration in the pharmaceutical industry.
Global Focus
The United States, China, and Europe are leading regions in AI-driven drug discovery, with both established players and emerging entities contributing to the field. This global focus suggests a competitive and evolving landscape where intellectual property plays a crucial role[3].
Conclusion
The United States Patent 8,518,987 is a critical component of Janssen's intellectual property portfolio related to darunavir. Understanding its scope, claims, and the surrounding patent landscape is essential for navigating the complex world of pharmaceutical patents.
Key Takeaways
- Scope and Claims: The '987 Patent covers specific crystalline forms and solvates of darunavir, along with methods for their synthesis.
- Patent Landscape: The patent is part of a competitive landscape with ongoing litigation and regulatory oversight.
- Expiration Dates: The patent is set to expire on August 16, 2024, which could lead to the entry of generic versions.
- Market Impact: Patent protection influences pricing and accessibility, with potential changes post-expiration.
- Global Focus: The broader pharmaceutical industry is marked by global innovation and competition.
FAQs
Q: What is the main subject of the '987 Patent?
A: The '987 Patent pertains to specific crystalline forms and solvates of darunavir, along with methods for their synthesis.
Q: Who is the patent holder of the '987 Patent?
A: The patent holder is Janssen Sciences Ireland UC, a subsidiary of Johnson & Johnson.
Q: What is the significance of the '987 Patent in the pharmaceutical industry?
A: The patent protects Janssen's exclusive rights to manufacture and market darunavir, a critical drug for HIV treatment.
Q: When is the '987 Patent set to expire?
A: The patent is scheduled to expire on August 16, 2024.
Q: How does the expiration of the '987 Patent affect the market?
A: The expiration could lead to the entry of generic versions of darunavir, potentially reducing prices and increasing accessibility.
Sources
- Janssen Prods., L.P. v. Lupin Ltd. - Casetext
- Information About our Pharmaceutical Patent Portfolio - Janssen
- AI Driven Drug Discovery Patent Landscape Report 2024 - ResearchAndMarkets.com
- BIOMEDICAL RESEARCH NIH Should Publicly Report More Information about the Licensing of Its Intellectual Property - GAO
- Case 2:17-cv-06872 Document 1 Filed 09/07/17 - PharmaCompass
