United States Patent 4,026,894: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,026,894, issued to Abbott Laboratories, is a significant patent in the pharmaceutical industry, particularly for the treatment of hypertension and other ailments. This patent revolves around the compound terazosin hydrochloride. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent application for terazosin hydrochloride was filed on October 14, 1975, as Ser. No. 621,980. The resulting patent, U.S. Pat. No. 4,026,894, was issued on May 31, 1977. This patent is crucial for understanding the development and protection of pharmaceutical inventions[1].
Scope of the Patent
The patent covers the compound terazosin hydrochloride, which is used in the treatment of hypertension and other related conditions. The scope of the patent includes the chemical composition and the process for its preparation. The patent's claims are specific to the compound itself and its use in medical treatments, highlighting the innovative aspect of this pharmaceutical invention[1].
Claims of the Patent
The claims of U.S. Pat. No. 4,026,894 are centered around the chemical structure and the therapeutic applications of terazosin hydrochloride. These claims are designed to protect the unique aspects of the compound and its method of use, ensuring that Abbott Laboratories maintains exclusivity over this specific pharmaceutical product. The claims are detailed and specific, aiming to prevent infringement by generic manufacturers until the patent's expiration[1].
Divisional Patents
An interesting aspect of this patent is the filing of a divisional patent application, Ser. No. 760,895, which was filed on January 21, 1977. This divisional application led to the issuance of U.S. Pat. No. 4,112,097. The divisional patent shares the same specification as the original application but was used to extend the patent term under different regulatory changes, such as those introduced by the Uruguay Round Agreements Act (URAA)[1].
Regulatory Impact and FDA Listings
The patent information for terazosin hydrochloride was submitted to the FDA and listed in the Orange Book, a publication that details approved drug products with therapeutic equivalence evaluations. This listing is crucial because it affects the approval of generic versions of the drug. Under U.S. law, the FDA cannot approve new drug applications that infringe on listed patents for a period of 30 months or until the patent dispute is resolved[1].
Patent Expiration and Litigation
A significant legal battle ensued regarding the expiration date of the divisional patent, U.S. Pat. No. 4,112,097. Abbott Laboratories argued that the patent term should be extended due to changes in patent law, but the court ultimately ruled that the patent expired on October 14, 1995. This decision was based on the unambiguous terms of the URAA and the specific filing dates of the patent applications[1].
Patent Landscape and Industry Implications
The patent landscape for pharmaceuticals is complex and heavily regulated. Patents like U.S. Pat. No. 4,026,894 play a critical role in protecting innovation and ensuring that companies can recoup their investment in research and development. However, the expiration of such patents opens the door for generic competition, which can significantly impact the market dynamics and pricing of the drug.
Impact on Generic Manufacturers
Generic manufacturers, such as Novopharm and Geneva Pharmaceuticals, often wait for the expiration of patents to enter the market with their own versions of the drug. The litigation surrounding U.S. Pat. No. 4,112,097 highlights the importance of accurate patent term calculations and the potential for legal disputes when generic manufacturers seek to enter the market[1].
Regulatory Changes and Patent Eligibility
The broader patent landscape is influenced by regulatory changes and judicial interpretations. For instance, the URAA and subsequent legal rulings have shaped how patent terms are calculated and how patents are listed with regulatory bodies like the FDA. These changes can have far-reaching implications for pharmaceutical companies and their intellectual property strategies[1].
Conclusion on Patent Scope and Claims
U.S. Pat. No. 4,026,894 is a pivotal patent in the pharmaceutical industry, particularly for the treatment of hypertension. The scope and claims of this patent are specific to the compound terazosin hydrochloride and its therapeutic applications. The patent's history, including the divisional patent and the legal battles over its expiration, underscores the complexity and importance of patent law in protecting pharmaceutical innovations.
Key Takeaways
- Patent Scope: The patent covers the compound terazosin hydrochloride and its use in treating hypertension.
- Claims: Specific to the chemical structure and therapeutic applications of the compound.
- Divisional Patents: The divisional patent, U.S. Pat. No. 4,112,097, was filed to extend the patent term under regulatory changes.
- Regulatory Impact: Listed in the FDA's Orange Book, affecting the approval of generic versions.
- Patent Expiration: The divisional patent expired on October 14, 1995, following a legal dispute.
- Industry Implications: The patent's expiration opened the market to generic competition.
FAQs
Q: What is the compound covered by U.S. Pat. No. 4,026,894?
A: The compound covered is terazosin hydrochloride, used in treating hypertension.
Q: Why was a divisional patent filed for this invention?
A: The divisional patent was filed to extend the patent term under regulatory changes introduced by the URAA.
Q: What is the significance of the FDA's Orange Book listing for this patent?
A: The listing in the Orange Book affects the approval of generic versions of the drug, as the FDA cannot approve new drug applications that infringe on listed patents.
Q: What was the outcome of the litigation regarding the expiration date of U.S. Pat. No. 4,112,097?
A: The court ruled that the patent expired on October 14, 1995.
Q: How does the expiration of this patent impact the pharmaceutical market?
A: The expiration opens the market to generic competition, potentially affecting the pricing and market dynamics of the drug.
Sources
- Abbott Laboratories v. Novopharm Ltd., 104 F.3d 1305 - Casetext.
- The Importance of Prong Two of Step 2A for AI Inventions - Baker Botts.
- Patent Claims and Patent Scope - SSRN.
- Process and intermediate for the preparation of terazosin - EPO.
- Patent Eligibility of Diagnostic Method Claims Following Proposed PERA Act of 2023 - Bloomberg Law.
