Understanding the Scope and Claims of United States Patent 9,592,208
Introduction
United States Patent 9,592,208, titled "Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol," is a patent that covers specific pharmaceutical compositions. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
The patent in question pertains to formulations that include a S1P receptor modulator, specifically 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol. This compound is used in various therapeutic applications, particularly in the treatment of multiple sclerosis and other autoimmune diseases.
Claims Analysis
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically outline the essential components and characteristics of the pharmaceutical formulations.
- Claim 1: This claim defines the pharmaceutical composition comprising the S1P receptor modulator, along with other excipients such as cyclodextrin and mannitol. It specifies the weight ratios and the form of the composition (e.g., oral tablets, capsules)[4].
Dependent Claims
Dependent claims further narrow down the scope by adding additional limitations or specifications to the independent claims.
- Claim 2: This claim may specify particular methods of preparation or additional ingredients that can be included in the formulation[4].
Scope of Protection
The scope of protection for this patent is determined by the breadth of its claims. Here are some key points:
Genus Claims
Genus claims, which cover a class of compounds or formulations, are common in pharmaceutical patents. However, recent jurisprudence, particularly from the Federal Circuit, has made it challenging to obtain broad genus claims due to heightened enablement and written description requirements[3].
- Enablement Requirement: The patent must provide sufficient disclosure to enable any person skilled in the art to make and use the invention. For genus claims, this often means that the specification must include detailed descriptions and examples of various species within the genus[3].
Written Description Requirement
The written description requirement ensures that the patent application describes the invention in "such full, clear, concise, and exact terms as to enable any person skilled in the art" to understand what the inventor has invented. This can be particularly challenging for broad genus claims, as the inventor must demonstrate possession of the entire scope of the claimed genus[3].
Patent Landscape
Regulatory Approval and Patent Term Extension
Pharmaceutical patents, including US 9,592,208, can be subject to patent term extensions (PTE) under the Hatch-Waxman Act. This act allows for the extension of a patent term to compensate for delays in the regulatory approval process. However, the patent must meet specific criteria, such as being the first permitted commercial marketing or use of the drug product, and the application for PTE must be filed before the patent expires[1].
Orange Book Listings
Patents related to pharmaceutical products are often listed in the FDA's Orange Book. This listing can impact the approval of generic versions of the drug. For instance, if a brand-name manufacturer lists a patent in the Orange Book, the FDA will not approve a generic company’s application until the patent expires or is delisted. Recent amendments to the Orange Book Transparency Act aim to prevent branded manufacturers from listing patents that do not directly claim the drug or its method of use, thereby blocking generic competition[2].
Litigation and Enforcement
Patents like US 9,592,208 can be subject to various legal proceedings, including patent infringement lawsuits and challenges through the Patent Trial and Appeal Board (PTAB).
- Maintenance Fees and Litigation: The patent has undergone several maintenance fee payments and has been involved in litigation, indicating its importance and the ongoing efforts to protect its validity and enforce its claims[5].
Industry Impact
The pharmaceutical industry is highly dependent on robust patent protection to incentivize innovation and investment in drug development. However, the current patent landscape, with its stringent requirements for enablement and written description, poses significant challenges.
- Innovation and Competition: The ability to secure broad patent claims is crucial for innovators to protect their inventions and prevent competitors from designing around narrow claims. The rigid application of § 112(a) by the Federal Circuit has made it difficult for pharmaceutical companies to achieve meaningful patent protection[3].
Key Takeaways
- Claims Scope: The patent claims must be carefully drafted to balance breadth and specificity, ensuring compliance with enablement and written description requirements.
- Regulatory Approval: Patents can be extended under the Hatch-Waxman Act, but strict criteria must be met.
- Orange Book Listings: Accurate listing of patents in the Orange Book is crucial to prevent unnecessary delays in generic approvals.
- Litigation: Patents are frequently involved in legal proceedings, highlighting the need for robust enforcement strategies.
- Industry Challenges: The pharmaceutical industry faces significant challenges in securing broad patent claims due to recent jurisprudence.
Frequently Asked Questions
Q: What is the main compound covered by US 9,592,208?
A: The main compound is 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol, a S1P receptor modulator.
Q: How does the Hatch-Waxman Act impact pharmaceutical patents?
A: The Hatch-Waxman Act allows for patent term extensions to compensate for delays in regulatory approval processes.
Q: What is the significance of Orange Book listings for pharmaceutical patents?
A: Orange Book listings can delay the approval of generic drugs if the listed patents claim the drug or its method of use.
Q: Why are genus claims challenging in pharmaceutical patents?
A: Genus claims are challenging due to the stringent enablement and written description requirements imposed by recent Federal Circuit jurisprudence.
Q: How do maintenance fees impact the validity of a patent?
A: Maintenance fees are necessary to keep a patent in force; failure to pay these fees can result in the patent lapsing.
Cited Sources
- Alacrita, "Pharmaceutical Patent Term Extension: An Overview"
- CAFC, "Teva Branded Pharmaceutical Products R&D, Inc."
- DigitalCommons@NYLS, "Eviscerating Patent Scope"
- Google Patents, "US9592208B2 - Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol"
- Pharsight, "Gilenya patent expiration"
