Understanding the Scope and Claims of United States Patent 10,376,517
Introduction
The United States Patent 10,376,517, titled "Methods of synthesizing thyroid hormone analogs and polymorphs thereof," is a significant patent in the pharmaceutical industry, particularly in the field of thyroid hormone treatments. This patent, issued on August 13, 2019, is held by inventors Rebecca Taub, Charles H. Reynolds, Lianhe Shu, Ping Wang, and Duk Soon Choi.
Patent Overview
This patent describes innovative methods for synthesizing pyridazinone compounds, which are used as thyroid hormone analogs and their prodrugs. Here’s a breakdown of the key aspects:
Inventors and Assignees
The patent is credited to a team of inventors from various scientific backgrounds, indicating a collaborative effort in developing these synthesis methods. The assignee of the patent is typically the entity that owns the rights to the invention, often a pharmaceutical company or research institution.
Patent Claims
The patent claims are crucial as they define the scope of the invention and the rights granted to the patent holder. For US Patent 10,376,517, the claims include:
- Methods of Synthesis: The patent details preferred methods for the large-scale preparation of pyridazinone compounds with high purity. These methods are designed to improve yield and efficiency compared to previous synthesis techniques[5].
- Thyroid Hormone Analogs: The patent covers the synthesis of thyroid hormone analogs, which are compounds that mimic the natural thyroid hormones but may have different properties or effects.
- Polymorphs and Prodrugs: The invention also includes methods for preparing polymorphic forms of these compounds and their prodrugs, which are compounds that, after administration, are metabolized into the active drug[5].
Scope of the Patent
The scope of the patent is determined by the breadth and specificity of its claims.
Genus Claims
In the pharmaceutical and biotechnology industries, genus claims are common. These claims cover a broad class of compounds rather than specific embodiments. However, the Federal Circuit has taken a rigid stance on genus claims, making it challenging to obtain valuable patent protection for drugs and biologics. The claims in US Patent 10,376,517 must be specific enough to meet the written description requirement under 35 U.S.C. § 112(a), ensuring that any person skilled in the art can make and use the invention[3].
Breadth of Protection
The broader the scope of the patent claims, the more meaningful the patent protection. However, if the claims are too broad and not commensurate with what is taught in the application, they may be invalidated. The patent claims in US Patent 10,376,517 are carefully crafted to capture the specific methods and compounds while avoiding overly broad claims that could be easily designed around[3].
Patent Expiration and Generic Launch
The patent expiration dates are critical for understanding when generic versions of the drug can be launched.
Patent Expiration Dates
US Patent 10,376,517, along with related patents (US9266861, US11564926, US11986481), is set to expire on September 17, 2033. This date can be affected by legal activities such as patent term extensions, amendments, or abandonment. For instance, patent term extension applications have been filed for some of these patents, which could potentially extend their life[2][5].
Generic Launch Date
The estimated generic launch date for Rezdiffra, the drug protected by these patents, is September 17, 2033, assuming no changes in the patent landscape. Tracking ongoing legal activities on these patents is essential to predict any potential changes in the generic launch date[2].
Non-Obviousness Doctrine
The non-obviousness doctrine is a crucial aspect of patent law, ensuring that patents are granted only for technologically significant advances.
Statutory Requirements
For a patent to be valid, the differences between the claimed invention and the prior art must be such that the claimed invention as a whole would not have been obvious to a person having ordinary skill in the art. This doctrine is central to the patent system's goal of stimulating useful innovation[1].
Application to US Patent 10,376,517
The methods and compounds described in US Patent 10,376,517 must meet the non-obviousness requirement. The patent claims two key elements: improved synthesis methods and the preparation of specific thyroid hormone analogs and their polymorphs. These advancements must be significant enough to be considered non-obvious over the existing prior art[1].
Patent Infringement and Damages
Understanding patent infringement and the potential damages is vital for protecting the rights of the patent holder.
Direct Infringement
Direct infringement occurs when someone makes, uses, offers for sale, sells, or imports the patented invention without authorization. The Patent Act (35 U.S.C. § 271(a)) clearly states that if a patent is found to be valid and infringed, its owner is entitled to infringement damages[1].
Damages Determination
Patent damages can be determined in two primary measures: lost profits and reasonable royalties. Reasonable royalties are the dominant damages determination, with over 80% of all patent damage awards being reasonable royalties. Courts apply a fifteen-factor analysis set out in Georgia-Pacific Corp. v. United States Plywood Corp to determine reasonable royalty rates[1].
Conclusion
US Patent 10,376,517 represents a significant advancement in the synthesis of thyroid hormone analogs and their polymorphs. The patent's scope, claims, and expiration dates are critical for understanding its impact on the pharmaceutical industry.
Key Takeaways
- Patent Claims: The patent covers specific methods for synthesizing pyridazinone compounds as thyroid hormone analogs and their prodrugs.
- Scope of Protection: The claims must be broad enough to provide meaningful protection but specific enough to meet the written description requirement.
- Patent Expiration: The patent is set to expire on September 17, 2033, which will open the door for generic versions of the drug.
- Non-Obviousness: The invention must meet the non-obviousness doctrine to be considered a technologically significant advance.
- Infringement and Damages: The patent holder is entitled to damages if the patent is found to be valid and infringed, with reasonable royalties being the dominant measure.
FAQs
Q: What is the main subject of US Patent 10,376,517?
A: The main subject is the methods of synthesizing thyroid hormone analogs and their polymorphs.
Q: Who are the inventors of US Patent 10,376,517?
A: The inventors include Rebecca Taub, Charles H. Reynolds, Lianhe Shu, Ping Wang, and Duk Soon Choi.
Q: When is the patent set to expire?
A: The patent is set to expire on September 17, 2033.
Q: What is the significance of the non-obviousness doctrine in this patent?
A: The non-obviousness doctrine ensures that the invention is a technologically significant advance over the prior art.
Q: How are patent damages typically determined for infringed patents?
A: Patent damages are typically determined through lost profits or reasonable royalties, with reasonable royalties being the more common measure.
Sources
- INVENTIONS AND PATENTS FOR TREATING THYROID DISEASE - McKinney Law Review[1]
- Rezdiffra patent expiration - Pharsight[2]
- Eviscerating Patent Scope - DigitalCommons@NYLS[3]
- US10376517B2 - Methods of synthesizing thyroid hormone analogs and polymorphs thereof - Google Patents[4]
- Generic Rezdiffra Availability - Drugs.com[5]
