United States Patent 4,012,444: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,012,444, titled "5-[1-Hydroxy-2-(1-methyl-3-phenylpropyl)aminoethyl] salicylamide and physiologically acceptable acid addition salts thereof," is a patent that covers novel 1-phenyl-2-aminoethanol derivatives with biological activity. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, filed on June 29, 1970, and granted on March 15, 1977, is an improvement of an earlier invention described in U.S. application Ser. No. 669,263, now U.S. Pat. No. 3,644,353. It pertains to the field of pharmaceutical chemistry, specifically focusing on compounds with potential therapeutic applications[4].
Scope of the Patent
The patent covers a class of 1-phenyl-2-aminoethanol derivatives, which are characterized by their biological activity. These compounds are described by the general formula:
[ \text{R}_1 \text{R}_2 \text{R}_3 ]
where:
- (\text{R}_1) represents a hydrogen atom or a straight or branched chain alkyl radical containing from 1 to 6 carbon atoms.
- (\text{R}_2) represents a hydrogen atom or a benzyl group.
- (\text{R}_3) represents a hydrogen atom, or a straight or branched chain alkyl radical containing from 1 to 6 carbon atoms, which may be substituted by hydroxyl groups, amino groups, or heterocyclic rings[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention. Here are the key claims:
- Claim 1: This claim covers the 5-[1-Hydroxy-2-(1-methyl-3-phenylpropyl)aminoethyl] salicylamide compound and its physiologically acceptable acid addition salts.
- Subsequent Claims: These claims specify various aspects of the compounds, including their preparation processes, compositions containing these compounds, and the physiologically acceptable acid addition salts thereof[4].
Patent Term and Extensions
The original patent term for U.S. Patent 4,012,444 would have been 17 years from the date of grant, expiring on March 15, 1994. However, under certain circumstances, patents can be extended due to regulatory reviews. For instance, patents subject to FDA or Department of Agriculture reviews can be extended up to five years under 35 U.S.C. 156(e)(1)[1].
Regulatory Considerations
Given that the patent involves pharmaceutical compounds, it would have been subject to regulatory reviews by the FDA. If such reviews delayed the marketing approval of the product, the patent term could have been extended. However, the specific details of any extensions for this patent are not provided in the available sources.
Claim Construction and Patent Eligibility
In the context of patent law, claim construction is crucial for determining the scope of what is covered by a patent. The Federal Circuit has established guidelines for claim construction, emphasizing the importance of understanding the claims as a whole and in the context of the specification[2].
For patents like U.S. 4,012,444, which involve chemical compounds, the claims must be specific enough to define the invention clearly but broad enough to cover variations that are within the scope of the invention. The patent eligibility of such claims would be evaluated under 35 U.S.C. ยง 101, ensuring they are not directed to patent-ineligible subject matter such as natural phenomena or abstract ideas[5].
Patent Landscape
The patent landscape for pharmaceutical compounds, especially those with biological activity, is highly competitive and densely populated. Patents in this field often face challenges related to novelty, non-obviousness, and utility. The Patent Claims Research Dataset by the USPTO provides insights into the trends and measurements of patent scope, which can be useful for understanding the broader landscape[3].
Industry Impact
Patents like U.S. 4,012,444 play a significant role in the pharmaceutical industry by protecting innovative compounds and processes. This protection allows companies to invest in research and development, knowing that their inventions will be safeguarded for a period of time. The biological activity of the compounds described in this patent could have led to the development of new therapeutic agents, contributing to advancements in healthcare.
Expiry and Public Domain
The patent has expired, and the invention is now in the public domain. This means that the compounds and processes described in the patent can be freely used, manufactured, and sold without infringing on the original patent rights.
Key Takeaways
- Scope and Claims: The patent covers specific 1-phenyl-2-aminoethanol derivatives with biological activity and their preparation processes.
- Regulatory Considerations: Potential extensions due to FDA reviews could have affected the patent term.
- Patent Landscape: The patent is part of a competitive and densely populated field, with significant implications for the pharmaceutical industry.
- Public Domain: The patent has expired, making the invention freely available for use.
FAQs
Q: What is the main subject matter of U.S. Patent 4,012,444?
A: The patent covers novel 1-phenyl-2-aminoethanol derivatives with biological activity.
Q: How long was the original patent term for U.S. Patent 4,012,444?
A: The original patent term was 17 years from the date of grant, expiring on March 15, 1994.
Q: Can the patent term be extended under certain circumstances?
A: Yes, under 35 U.S.C. 156(e)(1), the patent term can be extended up to five years if the product was subject to regulatory reviews by the FDA or Department of Agriculture.
Q: What is the significance of claim construction in patent law?
A: Claim construction is crucial for determining the scope of what is covered by a patent, ensuring that the claims are specific yet broad enough to cover variations within the scope of the invention.
Q: Is the invention described in U.S. Patent 4,012,444 still protected?
A: No, the patent has expired, and the invention is now in the public domain.
Sources
- United States Patent and Trademark Office, "Extension Under 35 U.S.C. 156(e)(1) - OG Date: 29 July 2003."
- Thomson Reuters, "Patent Claim Construction in the Federal Circuit, 2024 ed."
- United States Patent and Trademark Office, "Patent Claims Research Dataset."
- Google Patents, "US4012444A - 5-[1-Hydroxy-2-(1-methyl-3-phenylpropyl)aminoethyl] salicylamide and physiologically acceptable acid addition salts thereof."
- United States Court of Appeals for the Federal Circuit, "AI VISUALIZE, INC. v. NUANCE COMMUNICATIONS, INC."
