United States Patent 4,087,544: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,087,544, issued on May 2, 1978, is a significant patent in the pharmaceutical industry, particularly in the context of gabapentin and related cyclic amino acid compounds. This patent, held by Warner-Lambert (now part of Pfizer), plays a crucial role in the treatment of various neurological disorders.
Background of the Patent
The patent titled "Cyclic Amino Acid Compounds and Methods of Using the Same" discloses and claims methods for using specific cyclic amino acid compounds, including gabapentin, for therapeutic purposes. This patent is closely related to another expired patent, U.S. Patent 4,024,175, which disclosed the cyclic amino acid compounds themselves[1][4].
Scope of the Patent
The scope of U.S. Patent 4,087,544 is focused on the methods of using the cyclic amino acid compounds for treating certain medical conditions. Here are the key aspects:
Therapeutic Uses
The patent claims methods for treating various neurological and other disorders, including epilepsy, anxiety, and other conditions. Specifically, it covers the use of gabapentin and its derivatives for these therapeutic applications[1][4].
Compounds Covered
The patent includes claims for the use of 1-aminomethyl-1-cyclohexane acetic acid (gabapentin) and other related cyclic amino acid compounds. These compounds are used in their free form or as salts and esters[4].
Method of Treatment
The patent describes the administration of these compounds in unit dosage forms to mammals, particularly humans, in need of such treatment. The methods include oral and other routes of administration[4].
Claims of the Patent
The claims of U.S. Patent 4,087,544 are critical in defining the scope of protection. Here are some key points:
Independent Claims
The patent includes independent claims that define the invention broadly. For example, Claim 1 specifies the use of certain cyclic amino acid compounds for treating neurodegenerative diseases and other conditions[4].
Dependent Claims
Dependent claims further narrow down the scope by specifying particular aspects of the invention, such as specific dosages, administration routes, and patient populations.
Patent Landscape
Understanding the patent landscape surrounding U.S. Patent 4,087,544 is essential for grasping its significance and impact.
Related Patents
- U.S. Patent 4,024,175: This patent, also held by Warner-Lambert, discloses the cyclic amino acid compounds themselves, including gabapentin in its water-free form. This patent has expired, placing the compounds in the public domain[1].
- U.S. Patent 5,084,479: This patent, also related to gabapentin, covers novel methods for treating neurodegenerative diseases using the same cyclic amino acid compounds. It was the subject of significant litigation, including the case of Warner-Lambert Co. v. Apotex Corp[1][4].
Litigation and Legal Implications
The patent was involved in several legal disputes, particularly regarding generic drug manufacturers. For instance, in Warner-Lambert Co. v. Apotex Corp., Apotex filed a paragraph IV certification claiming that the patents, including the `544 Patent, were invalid or would not be infringed by their generic version of gabapentin. The Federal Circuit ultimately affirmed the summary judgment in Apotex's favor, indicating that the generic manufacturer did not infringe the patent[1][4].
Expiration and Public Domain
U.S. Patent 4,087,544 has expired, which means that the methods of using gabapentin and other cyclic amino acid compounds as described in the patent are now in the public domain. This allows other companies to manufacture and market generic versions of these drugs without infringing on the original patent[1].
Impact on the Pharmaceutical Industry
The expiration of U.S. Patent 4,087,544 has had a significant impact on the pharmaceutical industry:
Generic Competition
With the patent in the public domain, generic drug manufacturers can produce and market gabapentin without the need for a license from the original patent holder. This has led to increased competition and lower prices for the drug[1].
Innovation
The expiration of this patent has also spurred innovation in the field of neurological treatments. Other companies can now build upon the research and methods disclosed in the patent to develop new treatments and improvements.
Regulatory Aspects
The patent is closely tied to regulatory aspects, particularly under the Hatch-Waxman Act:
FDA Approval and Patent Listing
The Hatch-Waxman Act requires NDA applicants to list any patents that claim the drug or its method of use with the FDA. These patents are listed in the "Orange Book," which is crucial for generic drug manufacturers filing ANDAs (Abbreviated New Drug Applications)[1][2].
Patent Term Extension
Under 35 U.S.C. ยง 156, patents can be extended to compensate for the time spent in FDA approval. However, since U.S. Patent 4,087,544 has expired, this provision is no longer applicable[5].
Conclusion
U.S. Patent 4,087,544 played a pivotal role in the development and commercialization of gabapentin, a drug used to treat various neurological conditions. The patent's scope and claims defined the methods of using these compounds, and its expiration has opened the door for generic competition and further innovation in the pharmaceutical industry.
Key Takeaways
- Scope and Claims: The patent covers methods for using cyclic amino acid compounds, including gabapentin, for therapeutic purposes.
- Related Patents: It is closely related to other patents, such as U.S. Patent 4,024,175 and U.S. Patent 5,084,479.
- Litigation: The patent was involved in significant litigation, particularly with generic drug manufacturers.
- Expiration: The patent has expired, placing its methods in the public domain.
- Impact: The expiration has led to increased generic competition and innovation in neurological treatments.
FAQs
What is the main subject of U.S. Patent 4,087,544?
The main subject of U.S. Patent 4,087,544 is the methods of using cyclic amino acid compounds, including gabapentin, for treating various neurological and other disorders.
Why is this patent significant in the pharmaceutical industry?
This patent is significant because it covers the therapeutic uses of gabapentin, a widely used drug for neurological conditions, and its expiration has allowed for generic competition.
What other patents are related to U.S. Patent 4,087,544?
Related patents include U.S. Patent 4,024,175, which discloses the cyclic amino acid compounds themselves, and U.S. Patent 5,084,479, which covers novel methods for treating neurodegenerative diseases.
What was the outcome of the litigation involving this patent?
The litigation, particularly in Warner-Lambert Co. v. Apotex Corp., resulted in a summary judgment in favor of the generic drug manufacturer, indicating no infringement of the patent.
What is the current status of U.S. Patent 4,087,544?
U.S. Patent 4,087,544 has expired, placing its methods in the public domain.
Sources
- Warner-Lambert Company v. Apotex Corp., Case No. - Casetext
- 316 F.3d 1348 - Public Resource
- Patent Claims Research Dataset - USPTO
- Warner-Lambert Co. v. Apotex Corp. - Case Law - VLEX 894771792
- Untitled - USPTO
