Understanding the Scope and Claims of United States Patent 9,212,204
Introduction
United States Patent 9,212,204, titled "Treatment of Rett syndrome using glycyl-L-2-methylprolyl-L-glutamic acid," is a significant patent in the pharmaceutical sector, particularly for the treatment of Rett syndrome and other neurological disorders. Here, we will delve into the details of this patent, including its scope, claims, and the broader patent landscape.
Patent Overview
The patent, issued on December 15, 2015, is assigned to Neuren Pharmaceuticals Limited and is now associated with Acadia Pharmaceuticals Inc. It covers the use of glycyl-L-2-methylprolyl-L-glutamic acid (G-2-MePE) for treating Rett syndrome, a genetic disorder that affects brain development, leading to severe mental and physical disability[2][4].
Patent Claims
The patent includes several claims that define the scope of protection:
Composition Claims
The patent claims compositions that include G-2-MePE, which is the active ingredient used in the treatment. These claims are specific to the chemical formulation and its use in therapeutic applications[4].
Method Claims
The patent also includes method claims that describe the administration of G-2-MePE for treating Rett syndrome and other Autism Spectrum Disorders (ASD). These methods detail the effective amounts and modes of administration of the compound[4].
Use Claims
Use claims are another critical aspect, specifying the therapeutic uses of G-2-MePE, including its application in increasing the effective amounts of certain enzymes in the central nervous system (CNS) such as choline acetyltransferase (ChAT), glutamic acid decarboxylase (GAD), and nitric oxide synthase (NOS)[4].
Patent Scope
The scope of the patent is defined by its claims, which are narrowly focused on the specific use of G-2-MePE in treating neurological disorders.
Claim Language and Scope
The claims are written to ensure clarity and specificity, avoiding overly broad language that could lead to disputes over patent scope. The use of specific chemical formulations and therapeutic methods helps to define the boundaries of the patent protection[3].
Exclusivity
The patent holder enjoys exclusivity in the market for the specified use of G-2-MePE until the patent expires. This exclusivity is granted by the FDA and can run concurrently with the patent term. For this patent, the exclusivity periods include New Chemical Entity Exclusivity until March 10, 2028, and Orphan Drug Exclusivity until March 10, 2030[2].
Patent Expiration and Legal Activities
The patent is set to expire on January 27, 2032. However, the expiration date can be influenced by various legal activities such as patent term extensions, amendments to claims, or abandonment of the patent.
Recent Legal Activities
Recent activities include the filing of a Patent Term Extension Application under 35 USC 156 and letters to the regulating agency regarding the regulatory review period. These activities indicate ongoing efforts to potentially extend the patent term or adjust its claims[1].
Broader Patent Landscape
Understanding the broader patent landscape is crucial for strategizing market entry and competition.
Family Patents
The patent is part of a family of patents that protect various aspects of the drug, including crystalline forms and compositions of trofinetide (another name for G-2-MePE). These patents have different expiration dates, with some extending up to 2042[1][2].
International Protection
While the focus here is on U.S. patents, it is important to note that Daybue (the drug associated with this patent) is protected by patents in multiple countries. This global protection adds another layer of complexity to market entry strategies[1].
Impact on Generic Launch
The expiration of this patent and associated exclusivities will be critical for the launch of generic versions of the drug.
Generic Entry Points
Generic manufacturers will need to wait until the patent and exclusivity periods expire before they can launch their products. The last exclusivity period ends in 2030, but the patent itself does not expire until 2032. This timeline provides a clear roadmap for generic entry into the market[2].
Key Takeaways
- Patent Claims: The patent includes composition, method, and use claims specific to G-2-MePE for treating Rett syndrome and ASD.
- Patent Scope: The scope is narrowly defined to avoid disputes and ensure clarity.
- Exclusivity: The patent holder enjoys exclusivity until 2030, with the patent expiring in 2032.
- Legal Activities: Ongoing legal activities could affect the patent term and claims.
- Broader Landscape: The patent is part of a larger family of patents with global protection.
- Generic Launch: Generic versions can enter the market after the patent and exclusivity periods expire.
FAQs
Q: What is the main subject of United States Patent 9,212,204?
A: The main subject is the treatment of Rett syndrome using glycyl-L-2-methylprolyl-L-glutamic acid (G-2-MePE).
Q: Who is the assignee of this patent?
A: The patent is assigned to Neuren Pharmaceuticals Limited, now associated with Acadia Pharmaceuticals Inc.
Q: What are the key claims of this patent?
A: The patent includes claims for compositions, methods, and uses of G-2-MePE in treating neurological disorders.
Q: When does the patent expire?
A: The patent is set to expire on January 27, 2032.
Q: Are there any exclusivity periods associated with this patent?
A: Yes, there are exclusivity periods, including New Chemical Entity Exclusivity until March 10, 2028, and Orphan Drug Exclusivity until March 10, 2030.
Sources
- Pharsight: Daybue patent expiration.
- Drugs.com: Generic Daybue Availability.
- Hoover Institution: Patent Claims and Patent Scope.
- Google Patents: US9212204B2 - Treatment of Rett syndrome using glycyl-L-2-methylprolyl-L-glutamic acid.
- Regulations.gov: Untitled - Regulations.gov.
