United States Patent 4,590,213: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 4,590,213, hereafter referred to as the '213 patent, is part of a complex patent landscape involving pharmaceutical compounds, particularly those related to fluoxetine hydrochloride, the active ingredient in Eli Lilly's antidepressant drug Prozac. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Inventors
The '213 patent was one of several patents stemming from the original application Serial No. 432,379 filed by Bryan B. Molloy and Klaus K. Schmiegel, inventors at Eli Lilly and Company. This progeny of patents includes multiple divisional applications, continuation applications, and issued patents related to fluoxetine hydrochloride[4].
Scope of the Invention
The '213 patent specifically concerns the treatment of humans suffering from anxiety. It covers methods for administering a pharmaceutical compound within a class of compounds that includes fluoxetine hydrochloride to treat anxiety disorders. This scope is narrower than some of the other related patents, such as the '895 patent, which deals with the treatment of depression, and the '356 patent, which pertains to the treatment of animals suffering from hypertension[4].
Claims Analysis
The claims of the '213 patent are crucial in defining the protected invention. Here, the patent claims a method for treating anxiety by administering a specific dosage of fluoxetine hydrochloride. These claims must be analyzed in the context of the overall patent landscape to understand their coverage and potential overlaps with other patents.
Claim Coverage Matrix
To understand the coverage of the '213 patent, a Claim Coverage Matrix can be useful. This matrix categorizes patents by claims and scope concepts, helping to identify which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist. For the '213 patent, this would involve categorizing the claims under scope concepts related to anxiety treatment and comparing them with other patents in the same family[3].
Claim Charts
Using Claim Charts generated by tools like ClaimScape®, technical experts can review the patent coverage to determine if the scope concepts of the '213 patent are applicable to target products or methods. These charts help in identifying whether there are gaps in the current coverage and highlight future design opportunities. For instance, if the '213 patent's claims do not cover a specific method of anxiety treatment that is valuable, this would be highlighted as a gap in coverage[3].
Patent Landscape
The '213 patent is part of a dense patent landscape involving multiple patents related to fluoxetine hydrochloride. Here are some key aspects of this landscape:
Related Patents
- U.S. Patent No. 4,018,895 ('895 patent): Covers the treatment of humans suffering from depression.
- U.S. Patent No. 4,194,009 ('009 patent): Claims a class of pharmaceutical compounds, including fluoxetine hydrochloride, for administration in psychotropically effective amounts.
- U.S. Patent No. 4,329,356 ('356 patent): Concerns the treatment of animals suffering from hypertension.
- U.S. Patent No. 4,626,549 ('549 patent): Covers a method for blocking the uptake of serotonin by brain neurons through administering a dosage of fluoxetine hydrochloride[4].
Double Patenting Issues
The '213 patent, along with other patents in this family, has faced issues related to double patenting. The doctrine of obviousness-type double patenting prevents inventors from obtaining multiple patents for essentially the same invention. In the case of In re Hubbell, the Federal Circuit held that an earlier-filed patent application with a common inventor could lead to a rejection under the doctrine of obviousness-type double patenting, even if there was no common ownership or qualifying joint research agreement[1].
Litigation and Validity
The '213 patent, although part of a complex litigation involving Eli Lilly and Barr Laboratories, was not directly at the center of the main disputes. However, the broader patent family was involved in significant litigation. For example, Barr Laboratories challenged the validity of other related patents, such as the '081 and '549 patents, on grounds of failure to disclose the best mode and obviousness-type double patenting[4][5].
Best Mode Requirement
While the '213 patent itself was not challenged on the best mode requirement, this requirement is crucial for all patents. The best mode requirement mandates that the patent applicant disclose the best mode known to them for carrying out the invention. In the related case involving the '081 and '549 patents, the court held that the failure to disclose a preferred method for synthesizing a compound did not contravene the best mode requirement because it was not part of the claimed invention[4].
Conclusion
The United States Patent 4,590,213 is a significant part of the patent landscape surrounding fluoxetine hydrochloride. Understanding its scope, claims, and the broader patent landscape is essential for managing intellectual property and navigating potential legal challenges.
Key Takeaways
- Scope and Claims: The '213 patent covers methods for treating anxiety using fluoxetine hydrochloride.
- Patent Landscape: It is part of a complex family of patents related to fluoxetine hydrochloride.
- Double Patenting: The doctrine of obviousness-type double patenting is a critical consideration in this patent family.
- Litigation: The patent family has been involved in significant litigation, particularly regarding validity and infringement.
- Best Mode Requirement: The patent complies with the best mode requirement as it discloses the necessary methods for the claimed invention.
FAQs
What is the main subject matter of the '213 patent?
The '213 patent primarily deals with methods for treating anxiety by administering fluoxetine hydrochloride.
How does the '213 patent fit into the broader patent landscape?
It is part of a family of patents related to fluoxetine hydrochloride, including patents for treating depression, anxiety, and hypertension in animals.
What is the doctrine of obviousness-type double patenting?
This doctrine prevents inventors from obtaining multiple patents for essentially the same invention, ensuring that each invention is patentably distinct from others.
Was the '213 patent involved in any significant litigation?
While not directly at the center, the broader patent family was involved in litigation between Eli Lilly and Barr Laboratories, particularly regarding the '081 and '549 patents.
What is the best mode requirement in patent law?
The best mode requirement mandates that the patent applicant disclose the best mode known to them for carrying out the invention, which must be part of the claimed invention.
Sources
- Pierce, N. Scott. "INVENTORSHIP, DOUBLE PATENTING, AND THE AMERICA INVENTS ACT." Berkeley Technology Law Journal, vol. 30, no. 2, 2015.
- Tsuruta et al. V. Nardella. Casetext, 2023.
- Schwegman, Lundberg & Woessner. "Patent Analytics." Schwegman, Lundberg & Woessner, 2023.
- Eli Lilly and Company v. Barr Laboratories. Justia, 2023.
- Lilly and Co. v. Barr Laboratories. VLEX, 2023.
