United States Patent 9,562,017: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,562,017, titled "Hydrogen sulfate salt," is a significant patent in the pharmaceutical sector, particularly related to the compound selumetinib, which is used in the treatment of various medical conditions. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Inventors and Assignees
The patent was issued to a group of inventors including John DeMattei, Tsung-Hsun Chuang, Gorkhn Sharma-Singh, Paul Alfred Dickinson, Mohammed Pervez, Richard Anthony Storey, Christopher John Squire, James Gair Ford, and Ronald John Roberts. The assignee of this patent is Array Biopharma Inc., now part of Pfizer Inc.[4].
Patent Issuance and Expiration
The patent was issued on February 7, 2017. It is set to expire on December 12, 2026, which is a critical date for understanding the timeline of exclusivity and potential generic competition[1][4].
Scope of the Invention
The patent relates to Compound 1, specifically its hydrogen sulfate salt and solvates, including crystalline and amorphous forms. It also covers processes for the preparation of these forms. Compound 1 is identified as selumetinib, a MEK inhibitor used in the treatment of neurofibromatosis type 1 (NF1) and other conditions[1][4].
Claims
The patent includes multiple claims that define the scope of the invention. Here are some key claims:
- Claim 1: This claim covers the hydrogen sulfate salt of Compound 1, including its crystalline and amorphous forms.
- Claim 2: This claim pertains to solvates of the hydrogen sulfate salt of Compound 1.
- Claim 3: This claim includes processes for preparing the hydrogen sulfate salt and its solvates.
- Claim 4: This claim covers pharmaceutical compositions comprising the hydrogen sulfate salt of Compound 1 and a pharmaceutically acceptable carrier[4].
Patent Landscape
Related Patents
Several patents are related to the same compound and its applications:
- Patent 7,425,637: This patent, which expires on March 13, 2025, also relates to MEK inhibitors and is part of the broader portfolio covering selumetinib[1].
- Patent 8,178,693: Issued on May 15, 2012, this patent covers N3 alkylated benzimidazole derivatives as MEK inhibitors and expires on March 13, 2025[1].
- Patent 9,156,795: This patent, issued on October 13, 2015, also covers the hydrogen sulfate salt and solvates of Compound 1 and expires on December 12, 2026[1].
Exclusivities
In addition to patent protection, the FDA has granted exclusivities related to selumetinib:
- New Chemical Entity Exclusivity: Expires on April 10, 2025.
- Pediatric Exclusivity: Expires on April 10, 2027, for the treatment of pediatric patients with NF1 who have symptomatic, inoperable plexiform neurofibromas[1].
Impact on the Pharmaceutical Industry
The patent and its related exclusivities have significant implications for the pharmaceutical industry:
- Market Exclusivity: The combination of patent protection and FDA-granted exclusivities ensures that Array Biopharma Inc. (now Pfizer Inc.) maintains market exclusivity for selumetinib until the expiration dates.
- Generic Competition: After the patent and exclusivity periods expire, generic versions of selumetinib can enter the market, potentially reducing costs and increasing accessibility for patients[1].
Legal and Regulatory Considerations
The patent landscape is influenced by legal and regulatory frameworks:
- Patent Eligibility: The broader debate on patent eligibility, particularly for pharmaceutical and biotechnology inventions, affects how patents like US 9,562,017 are interpreted and enforced. The Alice-Mayo framework and other judicial precedents play a crucial role in determining the validity and scope of such patents[3].
- Litigation: Patent disputes, such as those involving infringement claims, can impact the validity and enforceability of patents. However, US 9,562,017 has not been involved in any high-profile litigation to date[2].
Conclusion
United States Patent 9,562,017 is a critical patent in the pharmaceutical sector, covering the hydrogen sulfate salt of selumetinib and its various forms. The patent's scope, claims, and the surrounding patent landscape highlight its importance in maintaining market exclusivity for the treatment of specific medical conditions. As the patent approaches its expiration date, the industry can expect changes in the competitive landscape.
Key Takeaways
- Patent Scope: Covers the hydrogen sulfate salt and solvates of selumetinib.
- Expiration Date: December 12, 2026.
- Related Patents: Several related patents cover MEK inhibitors and expire around the same time.
- Exclusivities: FDA-granted exclusivities extend market exclusivity until April 10, 2027.
- Impact on Industry: Ensures market exclusivity until expiration, after which generic competition can emerge.
Frequently Asked Questions (FAQs)
What is the primary compound covered by US Patent 9,562,017?
The primary compound is selumetinib, a MEK inhibitor.
What are the key claims of US Patent 9,562,017?
The key claims include the hydrogen sulfate salt and solvates of Compound 1, processes for their preparation, and pharmaceutical compositions.
When does the patent expire?
The patent expires on December 12, 2026.
What exclusivities have been granted by the FDA for selumetinib?
The FDA has granted New Chemical Entity Exclusivity until April 10, 2025, and Pediatric Exclusivity until April 10, 2027.
How does the patent landscape affect generic competition?
The combination of patent protection and FDA exclusivities delays the entry of generic versions until the exclusivity periods expire.
Cited Sources
- Generic Koselugo Availability - Drugs.com
- in the united states district court for the district of delaware med-el ...
- US Inventor's brief - In the Supreme Court of the United States
- US9562017B2 - Hydrogen sulfate salt - Google Patents
