Understanding the Scope and Claims of United States Patent 11,053,214
Introduction
United States Patent 11,053,214, titled "Compositions and methods related to pyridinoylpiperidine 5-HT1F agonists," is a significant patent in the pharmaceutical industry, particularly for the treatment and prevention of migraine headaches. This patent, assigned to CoLucid Pharmaceuticals, Inc., a wholly owned subsidiary of Eli Lilly & Company, is crucial for understanding the patent landscape and the protection it offers.
Patent Overview
- Inventors: Brigida Allieri, Paul Fagan, Emma Sharp, and Raymond D. Skwierczynski.
- Issuance Date: July 6, 2021.
- Assignee: CoLucid Pharmaceuticals, Inc.[2][5].
Claims and Scope
The patent covers new pseudo-polymorphs of the hemisuccinate salt of 2,4,6-trifluoro-N-[6-(1-methyl-piperidine-4-carbonyl)-pyridin-2-yl]-benzamide. These pseudo-polymorphs are designed for use in pharmaceutical compositions, specifically for the treatment and prevention of migraine headaches.
Key Claims
- The patent includes claims related to the specific chemical compounds, their methods of preparation, and their use in pharmaceutical formulations.
- The claims are detailed and specific, ensuring that any competitor must meet every condition of the claim to avoid infringement. For instance, the patent specifies the exact chemical structure and the therapeutic application, making it harder for competitors to design around the patent without infringing on it[3].
Patent Landscape
The patent landscape surrounding U.S. Patent 11,053,214 is complex and involves several key aspects:
Related Patents
- Patent 12,071,423: This patent, also related to pyridinoylpiperidine 5-HT1F agonists, has a later expiration date (July 6, 2040) and may provide additional protection for similar or related inventions[5].
- Patent 7,423,050: Although the details of this patent are not provided in the sources, it is part of the broader patent portfolio related to the same therapeutic area.
Exclusivity and Generic Competition
As of the current date, there is no therapeutically equivalent generic version of Reyvow (lasmiditan), the drug protected by this patent, available in the United States. This exclusivity is maintained through the patent protection, which prevents generic manufacturers from entering the market until the patent expires on December 5, 2037[5].
Patent Infringement and Litigation
The patent is currently involved in a patent infringement dispute. Qilu Pharmaceutical Co., Ltd. and Qilu Pharma Inc. have submitted an Abbreviated New Drug Application (ANDA) to the FDA, seeking approval to manufacture and sell a generic version of Reyvow before the expiration of the patent. Eli Lilly & Company and CoLucid Pharmaceuticals, Inc. have filed a complaint alleging patent infringement under the Patent Laws of the United States[2].
Obviousness and Patent Validity
The validity of pharmaceutical patents, including U.S. Patent 11,053,214, can be challenged based on obviousness. The Federal Circuit's "lead compound" test has been criticized for creating an extra-statutory standard that makes it harder to invalidate compound patents as obvious. This test requires showing that a chemist of ordinary skill in the art would have specifically selected the claimed compound over others, which can unnecessarily block generic entry and maintain monopoly prices[1].
Patent Scope Measurement
The scope of a patent can be measured in various ways, including the number of words in its first claim. Generally, longer claims imply more conditions that must be met for a patent to be violated, making the patent narrower. This approach is widely acknowledged by practitioners and has been validated against the judgment of patent attorneys[3].
Terminal Disclaimers and Patent Term
The patent system allows for terminal disclaimers to overcome obviousness-type double patenting rejections. However, these disclaimers do not extend the patent term beyond the original patent's expiration date. In the case of U.S. Patent 11,053,214, the patent term will expire on December 5, 2037, unless any patent term adjustments or extensions are applied[4].
Industry Impact
The protection offered by U.S. Patent 11,053,214 is crucial for Eli Lilly & Company and CoLucid Pharmaceuticals, Inc. as it prevents generic competition and maintains market exclusivity for Reyvow. This exclusivity allows the companies to recoup their investment in research and development and incentivizes further innovation in the pharmaceutical sector.
Key Takeaways
- Patent Coverage: U.S. Patent 11,053,214 covers specific pseudo-polymorphs of a chemical compound used in treating migraine headaches.
- Exclusivity: The patent maintains exclusivity for Reyvow until its expiration in 2037.
- Litigation: The patent is involved in a patent infringement dispute with Qilu Pharmaceutical Co., Ltd.
- Obviousness: The patent's validity could be challenged based on obviousness, but current standards may favor maintaining the patent.
- Scope Measurement: The patent's scope is narrow due to specific claims.
FAQs
What is the main subject matter of U.S. Patent 11,053,214?
U.S. Patent 11,053,214 covers new pseudo-polymorphs of the hemisuccinate salt of 2,4,6-trifluoro-N-[6-(1-methyl-piperidine-4-carbonyl)-pyridin-2-yl]-benzamide, used in pharmaceutical compositions for treating and preventing migraine headaches.
Who are the inventors of U.S. Patent 11,053,214?
The inventors are Brigida Allieri, Paul Fagan, Emma Sharp, and Raymond D. Skwierczynski.
What is the current status of generic competition for Reyvow?
As of the current date, there is no therapeutically equivalent generic version of Reyvow available in the United States.
What is the significance of the "lead compound" test in patent validity?
The "lead compound" test is an extra-statutory standard that makes it harder to invalidate compound patents as obvious, potentially blocking generic entry and maintaining monopoly prices.
When does the patent protection for U.S. Patent 11,053,214 expire?
The patent protection for U.S. Patent 11,053,214 expires on December 5, 2037.
Sources
- Amicus Brief on Behalf of Association for Accessible Medicine. Supreme Court of the United States, 2018.
- Case 2:24-cv-05847-EP Document 1 Filed 05/03/24. Insight.RPXCorp, 2024.
- The Ways We've been Measuring Patent Scope are Wrong. Boston University School of Law, 2017.
- Comments of the Pharmaceutical Research and Manufacturers of America. PhRMA, 2024.
- Generic Reyvow Availability. Drugs.com, 2024.
