United States Patent 8,486,941: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,486,941, titled "Phenyl amino pyrimidine compounds and uses thereof," is a significant patent in the pharmaceutical industry, particularly in the area of protein kinase inhibitors. This patent, assigned to GlaxoSmithKline LLC, involves compounds that inhibit JAK kinases, which are crucial in the treatment of various diseases. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, filed as US12/530,610, was granted on July 2, 2013. It pertains to phenyl amino pyrimidine compounds that act as inhibitors of protein kinases, including JAK kinases. These compounds are of interest due to their potential therapeutic applications in treating conditions such as inflammatory diseases, autoimmune diseases, and certain types of cancer[4].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific inventions and their uses that are protected under the patent. Here are some key aspects:
Claims
The patent includes multiple claims that cover various aspects of the invention:
- Compound Claims: These claims describe the specific chemical structures of the phenyl amino pyrimidine compounds. For example, Claim 1 describes a compound with a particular molecular structure that inhibits JAK kinases[4].
- Method Claims: These claims cover the methods of using these compounds to inhibit JAK kinases and treat related diseases.
- Use Claims: These claims specify the therapeutic uses of the compounds, such as treating inflammatory diseases and autoimmune diseases.
Enablement and Written Description
The patent must satisfy the enablement and written description requirements under 35 U.S.C. ยง 112. This means the patent specification must provide enough detail so that a person skilled in the art can make and use the invention. Recent jurisprudence from the Federal Circuit has heightened the standards for enablement and written description, particularly for genus claims, which can make it challenging to obtain broad patent protection in the pharmaceutical and biotechnology industries[3].
Patent Landscape and Industry Impact
Regulatory Review and Patent Term Extension
The approval of the drug product associated with this patent, OJJAARA, has led to applications for patent term extension. The FDA determined a regulatory review period of 5,127 days, which forms the basis for calculating the potential patent extension. The USPTO applies statutory limitations to determine the actual extension period, and in this case, the applicant seeks an extension of 828 days or 5 years[1].
Challenges in Pharmaceutical and Biotechnology Industries
The current patent landscape, particularly the Federal Circuit's stance on genus claims, poses significant challenges for innovators in the pharmaceutical and biotechnology sectors. The rigid application of enablement and written description requirements makes it difficult to secure broad patent protection. Innovators are caught between claiming too broadly, which may not be supported by the patent specification, and claiming too narrowly, which allows competitors to design around the claims easily[3].
Industry Expert Insights
Industry experts highlight the complexity and uncertainty introduced by recent jurisprudence. For example, Shahrokh Falati notes that the Federal Circuit's current position on genus claims has made it exceedingly difficult to obtain valuable patent protection for drugs and biologics, causing havoc in these industries[3].
Statutory Framework
Drug Price Competition and Patent Term Restoration Act
The patent term extension for this invention is governed by the Drug Price Competition and Patent Term Restoration Act of 1984. This act allows for the extension of a patent term for up to 5 years if the patented item was subject to regulatory review by the FDA before it was marketed. The regulatory review period, which includes both the testing and approval phases, is crucial in determining the extent of the patent extension[1].
Petitions and Redetermination
The FDA and USPTO provide mechanisms for petitions and redetermination regarding the dates and terms of the patent extension. Interested parties can submit petitions to challenge the published dates or to determine whether the applicant acted with due diligence during the regulatory review period. These petitions must comply with specific requirements and formats as outlined in the relevant regulations[1].
Key Takeaways
- Specific Claims: The patent includes detailed claims about the chemical structures and therapeutic uses of phenyl amino pyrimidine compounds.
- Regulatory Review: The FDA's determination of the regulatory review period is critical for calculating the patent term extension.
- Industry Challenges: Recent jurisprudence on genus claims poses significant challenges for obtaining broad patent protection in the pharmaceutical and biotechnology industries.
- Statutory Framework: The patent term extension is governed by the Drug Price Competition and Patent Term Restoration Act of 1984.
- Petitions and Redetermination: Mechanisms are available for challenging the published dates and terms of the patent extension.
FAQs
What is the main subject of United States Patent 8,486,941?
The main subject of United States Patent 8,486,941 is phenyl amino pyrimidine compounds that act as inhibitors of protein kinases, including JAK kinases.
How does the FDA determine the regulatory review period for patent term extension?
The FDA determines the regulatory review period by calculating the time from the submission of the New Drug Application (NDA) to the approval of the drug product, which includes both the testing and approval phases[1].
What are the challenges posed by recent jurisprudence on genus claims in the pharmaceutical industry?
Recent jurisprudence has made it difficult to obtain broad patent protection due to heightened standards for enablement and written description, forcing innovators to balance between claiming too broadly or too narrowly[3].
Can the public challenge the published dates for patent term extension?
Yes, the public can submit petitions to challenge the published dates or to determine whether the applicant acted with due diligence during the regulatory review period, following specific requirements and formats[1].
What is the significance of the Drug Price Competition and Patent Term Restoration Act of 1984 in this context?
This act allows for the extension of a patent term for up to 5 years if the patented item was subject to regulatory review by the FDA before it was marketed, which is relevant for calculating the patent term extension for the invention covered by US Patent 8,486,941[1].
Sources
- Federal Register/Vol. 89, No. 185/Tuesday, September 24, 2024
- Untitled - Regulations.gov
- Eviscerating Patent Scope - DigitalCommons@NYLS
- US8486941B2 - Phenyl amino pyrimidine compounds and uses thereof - Google Patents
