United States Patent 8,962,629: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,962,629, hereafter referred to as the '629 Patent, is a significant patent in the pharmaceutical industry, particularly related to the drug RINVOQ® (upadacitinib). This patent is part of a broader portfolio of patents held by AbbVie, protecting various aspects of upadacitinib and its uses. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The '629 Patent, titled "Tricyclic compounds," was granted to AbbVie and pertains to a class of tricyclic compounds, including upadacitinib, which is a Janus kinase (JAK) inhibitor. This compound is specifically indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate[2][4].
Scope of the Patent
The scope of the '629 Patent is defined by its claims, which are critical in determining the boundaries of the patent owner’s rights. The patent includes claims for the tricyclic compounds themselves, as well as their use in treating various conditions. Here are some key aspects of the scope:
Chemical Structure
The patent describes a specific class of tricyclic compounds, including their chemical structure and optional substitutions. These compounds are characterized by their cycloalkyl, pyrrolo, and heterocyclyl groups[1][5].
Therapeutic Uses
The patent claims cover the use of these compounds as JAK inhibitors, which are crucial in treating autoimmune diseases such as rheumatoid arthritis. The therapeutic scope is broad, encompassing various inflammatory conditions[2].
Pharmaceutical Formulations
The patent also includes claims related to pharmaceutical formulations containing these compounds, which are essential for their administration and efficacy[1].
Claims Analysis
The claims in the '629 Patent are designed to capture a broad yet specific scope of the invention. Here are some key points:
Genus Claims
The patent includes genus claims, which are claims that cover a class of compounds rather than specific embodiments. These claims are critical in the pharmaceutical industry as they allow for broader protection but must be supported by sufficient disclosure in the patent application to be valid[3].
Enablement and Written Description
The patent must comply with the enablement and written description requirements under 35 U.S.C. § 112(a). This means the specification must provide a written description of the invention in such full, clear, concise, and exact terms that any person skilled in the art can make and use the invention. The Federal Circuit has been stringent on these requirements, particularly for genus claims, ensuring that the scope of the claim is commensurate with the disclosure[3].
Patent Landscape
The '629 Patent is part of a complex patent landscape involving multiple patents related to upadacitinib and its uses.
Related Patents
AbbVie holds a portfolio of patents related to RINVOQ®, including several other patents listed in the litigation documents, such as RE47,221, 9,951,080, and others. These patents collectively provide comprehensive protection for the drug, covering various aspects from chemical structure to therapeutic uses and pharmaceutical formulations[2].
Patent Litigation
The '629 Patent has been involved in patent infringement litigation, with AbbVie alleging infringement by several generic drug manufacturers, including Hetero, Aurobindo, Sandoz, Intas, and Sun Pharmaceutical Industries. These companies have submitted Abbreviated New Drug Applications (ANDAs) to the FDA seeking approval to market generic versions of RINVOQ® before the expiration of the relevant patents[2].
Patent Term Restoration
The '629 Patent has also been subject to patent term restoration under the Drug Price Competition and Patent Term Restoration Act of 1984. This act allows for the extension of a patent term to compensate for the time spent in regulatory review by the FDA. For RINVOQ®, the regulatory review period has been a significant factor in determining the potential length of the patent extension[4].
Impact on the Pharmaceutical Industry
The '629 Patent and its associated patents have a significant impact on the pharmaceutical industry, particularly in the context of generic competition and innovation.
Generic Competition
The broad scope of the '629 Patent and related patents makes it challenging for generic manufacturers to design around these claims without infringing. This can delay the entry of generic versions into the market, allowing the patent holder to maintain market exclusivity for a longer period[2][3].
Innovation
The stringent requirements for genus claims and the need for detailed disclosure can make it difficult for innovators to claim the full scope of their invention. This can hinder innovation in the pharmaceutical and biotechnology industries, as companies may be unable to secure broad enough protection to justify the significant investment in research and development[3].
Key Takeaways
- Scope and Claims: The '629 Patent covers a specific class of tricyclic compounds, including their chemical structure, therapeutic uses, and pharmaceutical formulations.
- Genus Claims: The patent includes genus claims that must be supported by sufficient disclosure to be valid.
- Patent Landscape: The patent is part of a broader portfolio protecting upadacitinib and is involved in patent litigation and term restoration.
- Impact on Industry: The patent affects generic competition and innovation, highlighting the challenges in securing broad yet valid patent protection in the pharmaceutical industry.
FAQs
What is the main subject of United States Patent 8,962,629?
The main subject of the '629 Patent is a class of tricyclic compounds, specifically including upadacitinib, a JAK inhibitor used in treating rheumatoid arthritis.
What are genus claims in the context of the '629 Patent?
Genus claims are broad claims that cover a class of compounds rather than specific embodiments. These claims must be supported by sufficient disclosure in the patent application to be valid.
Why is the '629 Patent involved in litigation?
The '629 Patent is involved in litigation as AbbVie alleges that several generic drug manufacturers have infringed upon this and other related patents by submitting ANDAs to market generic versions of RINVOQ® before the expiration of the relevant patents.
What is patent term restoration, and how does it apply to the '629 Patent?
Patent term restoration is a provision that allows for the extension of a patent term to compensate for the time spent in regulatory review by the FDA. For the '629 Patent, this involves calculating the regulatory review period to determine the potential length of the patent extension.
How does the '629 Patent impact innovation in the pharmaceutical industry?
The '629 Patent and its associated stringent requirements for genus claims can make it challenging for innovators to secure broad enough protection to justify significant investment in research and development, potentially hindering innovation in the pharmaceutical and biotechnology industries.
Sources
- US8962629B2 - Tricyclic compounds - Google Patents
- in the united states district court
- Eviscerating Patent Scope - DigitalCommons@NYLS
- Federal Register/Vol. 87, No. 129/Thursday, July 7, 2022/Notices
- Tricyclic compounds - Patent US-8962629-B2 - PubChem
