Understanding the Scope and Claims of United States Patent 11,267,799
Introduction
United States Patent 11,267,799, titled "Solid forms of an HIV capsid inhibitor," is a significant patent in the pharmaceutical industry, particularly in the field of HIV treatment. This patent, assigned to Gilead Sciences, Inc., covers crucial aspects of HIV capsid inhibitors, which are vital in the treatment of HIV infections.
Patent Overview
Inventor and Assignee
The patent was invented by Bing Shi and is assigned to Gilead Sciences, Inc., a leading pharmaceutical company known for its innovative treatments in the field of infectious diseases[2][4].
Patent Issue Date and Expiration
The patent was issued on March 8, 2022, and is set to expire on June 4, 2041[2][4].
Scope of the Patent
Subject Matter
The patent focuses on solid forms of an HIV capsid inhibitor, including pharmaceutically acceptable salts and cocrystals of the inhibitor. These solid forms are critical for the stability, efficacy, and bioavailability of the drug[4].
Claims
The patent includes several claims that define the scope of protection. Here are some key aspects:
- Solid Forms: The patent claims various solid forms of the HIV capsid inhibitor, such as crystalline forms, amorphous forms, and cocrystals. These forms are designed to enhance the drug's stability and pharmacokinetic properties[4].
- Pharmaceutically Acceptable Salts: The patent covers a range of pharmaceutically acceptable salts of the inhibitor, which are important for improving the drug's solubility and bioavailability[4].
- Cocrystals: Cocrystals of the inhibitor with various co-formers are also claimed. Cocrystals can improve the physical and chemical properties of the drug, such as its melting point, solubility, and stability[4].
Patent Claims and Their Significance
Genus Claims vs. Species Claims
The patent claims are a mix of genus and species claims. Genus claims cover a broad class of compounds, while species claims are more specific. However, the current jurisprudence in the U.S. patent system, particularly the Federal Circuit's stance on genus claims, requires that the specification must enable any person skilled in the art to make and use the claimed genus without undue experimentation. This can be challenging, especially when the genus includes thousands of potential species[3].
Enablement Requirement
The patent must meet the enablement requirement under 35 U.S.C. § 112(a), which means the specification must be written in "such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same." For genus claims, this often involves identifying and testing numerous species within the genus, which can be practically and economically burdensome[3].
Patent Landscape
Related Patents
The patent is part of a larger portfolio of patents related to HIV capsid inhibitors held by Gilead Sciences. Other relevant patents include those covering therapeutic compounds of similar formulas and their pharmaceutical compositions, such as Patents 10,071,985 and 10,654,827. These patents also expire on August 17, 2037, and are crucial for the overall intellectual property protection of Gilead's HIV treatment portfolio[2].
Global Protection
Patent 11,267,799 has twenty-six patent family members in thirteen countries, indicating a broad global protection strategy for the drug. This extensive coverage helps in preventing generic versions and ensuring market exclusivity for Gilead Sciences in various jurisdictions[5].
Impact on the Pharmaceutical Industry
Market Exclusivity
The patent grants Gilead Sciences exclusive rights to market the drug, preventing generic versions from entering the market until the patent expires. This exclusivity period is crucial for the company to recoup its investment in research and development[2].
Competitive Advantage
The broad scope of the patent claims and the extensive global protection provide a significant competitive advantage to Gilead Sciences. Competitors are barred from developing similar drugs that fall within the claimed scope, allowing Gilead to dominate the market for HIV capsid inhibitors[5].
Challenges and Limitations
Despite the strong patent protection, the pharmaceutical industry faces challenges related to genus claims and the enablement requirement. The rigid stance of the Federal Circuit on these issues can make it difficult for innovators to claim the full scope of their inventions without violating the enablement and written description requirements[3].
Conclusion
United States Patent 11,267,799 is a pivotal patent in the field of HIV treatment, offering comprehensive protection for solid forms of an HIV capsid inhibitor. The patent's scope, including claims on solid forms, pharmaceutically acceptable salts, and cocrystals, ensures that Gilead Sciences maintains a strong market position. However, the patent landscape is complex, with challenges related to genus claims and enablement requirements that innovators must navigate.
Key Takeaways
- Patent Scope: Covers solid forms, pharmaceutically acceptable salts, and cocrystals of an HIV capsid inhibitor.
- Exclusivity: Grants Gilead Sciences exclusive marketing rights until June 4, 2041.
- Global Protection: Extensive global coverage with twenty-six patent family members in thirteen countries.
- Challenges: Faces challenges related to genus claims and the enablement requirement under U.S. patent law.
- Competitive Advantage: Provides a significant competitive advantage by preventing competitors from developing similar drugs.
FAQs
Q1: What is the main subject matter of United States Patent 11,267,799?
The main subject matter is the solid forms of an HIV capsid inhibitor, including pharmaceutically acceptable salts and cocrystals.
Q2: Who is the inventor and assignee of the patent?
The inventor is Bing Shi, and the assignee is Gilead Sciences, Inc.
Q3: When does the patent expire?
The patent expires on June 4, 2041.
Q4: What are the challenges related to genus claims in this patent?
The challenges include meeting the enablement requirement under 35 U.S.C. § 112(a), which requires identifying and testing numerous species within the genus, and the Federal Circuit's rigid stance on genus claims.
Q5: How does this patent impact Gilead Sciences' market position?
The patent provides Gilead Sciences with exclusive marketing rights, preventing generic versions and ensuring a competitive advantage in the market for HIV capsid inhibitors.
Sources
- United States Patent and Trademark Office - US11267799B2 - Solid forms of an HIV capsid inhibitor[1].
- Drugs.com - Generic Sunlenca Availability[2].
- DigitalCommons@NYLS - Eviscerating Patent Scope[3].
- Google Patents - US11267799B2 - Solid forms of an HIV capsid inhibitor[4].
- DrugPatentWatch - Pharmaceutical drugs covered by patent 11,267,799[5].
