United States Patent 5,089,509: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,089,509, titled "Disubstituted Acetylenes Bearing Heteroaromatic and Heterobicyclic Groups Having Retinoid Like Activity," is a significant patent in the pharmaceutical industry, particularly for the drug product TAZORAC@ (tazarotene). This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Patent Details
- Patent Number: 5,089,509
- Grant Date: February 18, 1992
- Original Expiration Date: February 18, 2009
- Product Trade Name: TAZORAC@ (tazarotene)
- Owner of Record: Allergan, Inc.[1].
Scope of the Patent
The patent covers disubstituted acetylenes that exhibit retinoid-like activity, which are used in the treatment of various skin conditions such as acne, psoriasis, and photoaging. The scope includes the chemical compounds, their synthesis, and their therapeutic applications.
Claims Analysis
Claim Structure
The patent includes multiple claims that define the scope of the invention. These claims are structured to cover the specific chemical compounds, their methods of preparation, and their use in therapeutic applications. The claims are designed to be broad enough to encompass various derivatives and applications while being specific enough to distinguish the invention from prior art[1].
Independent and Dependent Claims
Independent claims define the core aspects of the invention, such as the chemical structure of the disubstituted acetylenes and their therapeutic uses. Dependent claims further specify these core aspects, often detailing specific substituents, methods of synthesis, or particular therapeutic applications[3].
Patent Term Extension
Regulatory Review Period
The patent term was extended under 35 U.S.C. § 156 due to the regulatory review period required by the Food and Drug Administration (FDA). The FDA approved TAZORAC@ on June 13, 1997, and the regulatory review period was calculated from February 8, 1990, to June 13, 1997[1][4].
Extension Calculation
The extension period was calculated based on the testing and approval phases of the regulatory review. The total regulatory review period was 1,335 days, but due to the 14-year limit from the approval date, the extension was limited to 845 days, extending the patent expiration to June 13, 2011[1].
Double Patenting Considerations
Statutory Double Patenting
The prohibition against double patenting ensures that an applicant cannot obtain two patents for the same invention or for obvious variations of an invention already patented. This is crucial in preventing the unjustified extension of exclusive rights[2].
Non-Statutory Obviousness-Type Double Patenting
This type of double patenting involves rejecting a patent application if the claimed invention is an obvious variation of an invention for which the applicant already has a patent. This ensures that the public can freely use the claimed invention and its obvious modifications after the patent expires[2].
Patent Landscape
Competitive Environment
The patent landscape for retinoid-like compounds is competitive, with multiple players in the pharmaceutical industry developing similar compounds. The extension of the patent term for U.S. Patent 5,089,509 provided Allergan, Inc. with additional time to exclusively market TAZORAC@, thereby maintaining a competitive edge[1].
Innovation and Public Benefit
The patent system is designed to promote innovation by providing exclusive rights in exchange for public disclosure. The expiration of the patent allows the public to use the invention freely, which can lead to further innovation and public benefit[2].
Impact on Innovation
Patent Scope and Quality
The scope of a patent, such as U.S. Patent 5,089,509, can influence innovation. Broader patents can sometimes lead to increased litigation and licensing costs, potentially diminishing innovation incentives. However, narrower claims, as seen in this patent, can facilitate a smoother examination process and higher grant probabilities[3].
Forward Citations and Patent Maintenance
The number of forward citations and patent maintenance payments can indicate the impact of a patent on subsequent innovation. Patents with narrower claims at publication tend to have more forward citations and shorter examination processes, suggesting a positive impact on innovation[3].
Regulatory and Legal Framework
35 U.S.C. § 156
This section of the U.S. Code allows for the extension of a patent term due to regulatory review periods. The extension is calculated based on the time spent in regulatory review, ensuring that the patentee does not lose patent term due to lengthy regulatory processes[4].
35 U.S.C. § 121
This section deals with the prohibition against using a patent issued on a restricted application as a reference against a divisional application or the original application. This ensures that divisional applications are not unfairly rejected due to earlier patents issued from the same family[2].
Key Takeaways
- Patent Scope: U.S. Patent 5,089,509 covers disubstituted acetylenes with retinoid-like activity, including their synthesis and therapeutic applications.
- Claims: The patent includes both independent and dependent claims to define the invention broadly yet specifically.
- Patent Term Extension: The patent term was extended by 845 days due to FDA regulatory review, expiring on June 13, 2011.
- Double Patenting: The patent complies with double patenting rules to prevent unjustified extension of exclusive rights.
- Impact on Innovation: Narrower claims can facilitate innovation by reducing litigation and licensing costs.
FAQs
What is the main subject matter of U.S. Patent 5,089,509?
The main subject matter is disubstituted acetylenes bearing heteroaromatic and heterobicyclic groups with retinoid-like activity, specifically the drug product TAZORAC@ (tazarotene).
Why was the patent term extended for U.S. Patent 5,089,509?
The patent term was extended due to the regulatory review period required by the FDA, which delayed the market approval of TAZORAC@.
What is the significance of 35 U.S.C. § 156 in patent term extension?
This section allows for the extension of a patent term to compensate for the time spent in regulatory review, ensuring the patentee does not lose patent term due to lengthy regulatory processes.
How does double patenting prohibition affect U.S. Patent 5,089,509?
The prohibition ensures that the applicant cannot obtain another patent for the same invention or an obvious variation, preventing the unjustified extension of exclusive rights.
What is the impact of narrower claims on innovation, as seen in U.S. Patent 5,089,509?
Narrower claims can lead to a higher probability of grant, shorter examination processes, and reduced litigation and licensing costs, thereby facilitating innovation.
