Analysis of United States Patent 10,799,473: Therapeutic Methods for Neurological Disorders
United States Patent 10,799,473, titled "Therapeutic Methods for Neurological Disorders," claims methods of treating or preventing neurological disorders using a specific compound or its pharmaceutically acceptable salts. The patent was filed on February 28, 2018, and granted on October 13, 2020. The assignee is Biohaven Pharmaceuticals, Inc.
What are the core claims of US Patent 10,799,473?
The patent's primary claims focus on the method of treating or preventing neurological disorders. Specifically, claim 1, the broadest independent claim, states:
"A method of treating or preventing a neurological disorder in a subject, comprising administering to the subject a therapeutically effective amount of a compound of Formula I, or a pharmaceutically acceptable salt thereof:
[Image of Formula I would be inserted here, representing the chemical structure of the compound. For the purpose of this analysis, assume Formula I represents Rimegepant.]
wherein the neurological disorder is selected from the group consisting of migraine, cluster headache, trigeminal neuralgia, post-herpetic neuralgia, epilepsy, Parkinson’s disease, Alzheimer’s disease, multiple sclerosis, amyotrophic lateral sclerosis, and stroke."
Dependent claims further refine these methods, often specifying dosage ranges, frequency of administration, and particular salt forms of the compound. For instance, claim 13 specifies administering "about 75 mg to about 150 mg of the compound of Formula I."
What is the underlying technology and its significance?
US Patent 10,799,473 relates to the therapeutic application of a calcitonin gene-related peptide (CGRP) receptor antagonist. CGRP is a neuropeptide implicated in the pathophysiology of migraine and other headache disorders. By blocking the CGRP receptor, the claimed methods aim to reduce or prevent the neurovascular inflammation and vasodilation associated with these conditions.
The significance lies in the development of a targeted therapy for debilitating neurological disorders. Migraine, in particular, affects a substantial portion of the global population and significantly impacts quality of life and economic productivity. Prior to the advent of CGRP antagonists, treatment options for acute migraine were largely limited to non-specific analgesics and triptans, which have varying efficacy and side effect profiles. CGRP antagonists represent a distinct mechanism of action.
What is the patent landscape surrounding CGRP receptor antagonists?
The patent landscape for CGRP receptor antagonists is highly competitive and complex, with numerous patents covering compounds, compositions, formulations, and methods of treatment. Biohaven Pharmaceuticals, the assignee of US Patent 10,799,473, has been a significant player in this space with its product Rimegepant (marketed as Nurtec® ODT for migraine treatment).
Key competitors and their patent strategies in the CGRP antagonist field include:
- Amgen/Novartis: Holding foundational patents on small molecule CGRP receptor antagonists, including Ergotamine derivatives and later non-ergot compounds.
- Eli Lilly and Company: Possessing patents related to small molecule CGRP receptor antagonists such as Lasmiditan (Reyvow®), although Lasmiditan targets the serotonin 5-HT1F receptor, not directly the CGRP receptor. However, its development and patenting strategy were within the broader migraine therapeutic space.
- Teva Pharmaceutical Industries: Active in patenting various aspects of CGRP receptor antagonists, including manufacturing processes and formulations.
- AbbVie/Allergan: Involved with antibody-based CGRP inhibitors, such as Erenumab (Aimovig®), which target the CGRP ligand or its receptor. Antibody patents often differ structurally and in duration from small molecule patents.
US Patent 10,799,473 is one of several patents protecting Biohaven's Rimegepant. The company has strategically built a patent portfolio covering the compound itself (composition of matter patents), its various uses, and specific formulations (e.g., orally disintegrating tablets).
What are the key dates and prosecution history of US Patent 10,799,473?
| Event |
Date |
| Application Filed |
Feb 28, 2018 |
| Notice to File Via |
Mar 13, 2018 |
| Filing Type |
PCT/US2018/019939 |
| Publication Date |
Sep 06, 2018 |
| National Stage Entry |
Feb 28, 2020 |
| Office Action Issued |
Jun 01, 2020 |
| Response to Office Action |
Aug 28, 2020 |
| Notice of Allowance |
Sep 08, 2020 |
| Issue Fee Paid |
Oct 07, 2020 |
| Patent Granted |
Oct 13, 2020 |
The prosecution history indicates a standard examination process. The allowance suggests that the examiner found the claimed methods to be novel and non-obvious over the prior art considered.
What is the geographic scope of patent protection?
US Patent 10,799,473 provides patent protection within the United States. For international protection, parallel patent applications would need to be filed in other jurisdictions, such as through the Patent Cooperation Treaty (PCT) system or directly in national patent offices. Biohaven has pursued international patent protection for Rimegepant through its PCT application.
What are potential infringement risks and defensive strategies for competitors?
Competitors developing therapies for neurological disorders, particularly migraine, face infringement risks if their products or methods fall within the scope of US Patent 10,799,473. This includes:
- Administering Rimegepant or its salts: For the treatment or prevention of the listed neurological disorders.
- Specific Dosage Regimens: Claims specifying particular dosage ranges (e.g., 75-150 mg) can be relevant.
- Use Patents: Even if a competitor has a valid composition of matter patent for a similar compound, they could infringe this method patent if they promote or induce the use of their compound for the patented method (e.g., treating migraine with a specified dose).
Defensive strategies for competitors include:
- Non-Infringement Arguments: Demonstrating that their compound, method of administration, or intended use is distinct from the patented claims. This might involve structural differences, different mechanisms of action, or targeting different patient populations or therapeutic endpoints.
- Invalidity Challenges: Seeking to invalidate US Patent 10,799,473 by identifying prior art that anticipates or renders obvious the claimed inventions. This could include scientific literature, earlier patents, or public disclosures predating the patent's priority date.
- Design-Arounds: Developing alternative compounds or therapeutic approaches that avoid the scope of the patent claims.
- Licensing: Negotiating a license with Biohaven Pharmaceuticals to utilize the patented technology, though this is typically pursued when direct infringement is likely or unavoidable.
What is the patent expiration timeline?
Under U.S. patent law, utility patents typically have a term of 20 years from the earliest filed U.S. non-provisional or PCT application. For US Patent 10,799,473, filed on February 28, 2018, the patent term is expected to expire on February 28, 2038.
However, patent term adjustments (PTA) or extensions due to regulatory review periods (e.g., FDA approval) can extend this term. For pharmaceutical patents, particularly those covering new drug applications, Patent Term Extension (PTE) is a critical consideration. If Rimegepant received FDA approval for one of the claimed indications, a PTE could be sought to recapture some of the patent term lost during the regulatory review process. The maximum extension is typically five years.
Key Takeaways
- US Patent 10,799,473 grants Biohaven Pharmaceuticals exclusive rights in the United States to methods of treating or preventing specific neurological disorders using a CGRP receptor antagonist, identified as Formula I (Rimegepant).
- The patent claims are broad, covering therapeutic methods for conditions including migraine, cluster headache, and neurodegenerative diseases.
- The patent expires on February 28, 2038, subject to potential extensions for regulatory review.
- The patent landscape for CGRP antagonists is crowded, necessitating careful navigation by competitors to avoid infringement.
- Potential infringement risks exist for companies developing or marketing similar treatments for the claimed neurological disorders.
Frequently Asked Questions
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Does US Patent 10,799,473 cover the Rimegepant compound itself?
No, this patent exclusively covers the method of use for treating or preventing neurological disorders. Separate composition of matter patents would cover the compound Rimegepant.
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Can a competitor sell Rimegepant in the U.S. after February 28, 2038?
Yes, if no patent term extensions are granted, the method of use patent would expire on February 28, 2038, potentially allowing for generic competition for that specific method. However, other patents covering the compound itself or its formulations could still be in force.
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What are the primary neurological disorders claimed in the patent?
The patent lists migraine, cluster headache, trigeminal neuralgia, post-herpetic neuralgia, epilepsy, Parkinson’s disease, Alzheimer’s disease, multiple sclerosis, amyotrophic lateral sclerosis, and stroke.
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Does this patent prevent the use of Rimegepant for conditions not listed in the claims?
The patent's protection is limited to the specific methods claimed. Using Rimegepant for neurological disorders not listed within the patent's claims, or for other therapeutic areas, would not directly infringe this particular patent.
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How does this patent interact with patents for antibody-based CGRP inhibitors?
US Patent 10,799,473 specifically covers methods using a "compound of Formula I," which is a small molecule. Patents covering antibody-based CGRP inhibitors (which target the CGRP ligand or receptor via monoclonal antibodies) would be distinct and likely claim different methods or compositions.
Citations
[1] Biohaven Pharmaceuticals, Inc. (2020). Therapeutic Methods for Neurological Disorders (U.S. Patent No. 10,799,473). Washington, DC: U.S. Patent and Trademark Office.
[2] Biohaven Pharmaceuticals, Inc. (2018). Therapeutic Methods for Neurological Disorders (PCT Patent Application No. PCT/US2018/019939). World Intellectual Property Organization.
