United States Patent 9,611,267: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,611,267, issued on April 4, 2017, is a significant patent in the field of pharmaceuticals, particularly focusing on substituted tricyclic compounds as inhibitors of Fibroblast Growth Factor Receptors (FGFR). This patent, assigned to Incyte Corporation, has far-reaching implications for the treatment of FGFR-associated diseases, including various types of cancer.
Inventors and Assignees
The patent was invented by Liangxing Wu, Colin Zhang, Chunhong He, Liang Lu, and Wenqing Yao, and is assigned to Incyte Corporation and Incyte Holdings Corporation, both based in Wilmington, Delaware[2][4].
Patent Scope and Claims
Substituted Tricyclic Compounds
The patent describes a class of substituted tricyclic compounds and their pharmaceutical compositions that act as inhibitors of one or more FGFR enzymes. These compounds are designed to be effective in treating diseases associated with FGFR, such as cancer[2][4].
FGFR Inhibition
FGFRs are a family of receptor tyrosine kinases that play crucial roles in cell proliferation, differentiation, and survival. The inhibition of FGFRs is a promising therapeutic strategy for treating cancers that result from FGFR mutations or overexpression. The patented compounds are engineered to selectively target and inhibit these receptors, thereby inhibiting tumor growth and progression[2].
Chemical Structure and Synthesis
The patent details the chemical structure of the substituted tricyclic compounds, including various substituents and their positions on the tricyclic core. It also outlines methods for synthesizing these compounds, which is crucial for their production and use in pharmaceutical formulations[1][4].
Pharmaceutical Compositions
The patent includes descriptions of pharmaceutical compositions that contain the substituted tricyclic compounds. These compositions can be formulated in various ways, such as tablets, capsules, or injectable solutions, to facilitate administration and efficacy in treating FGFR-associated diseases[2][4].
Therapeutic Applications
The primary therapeutic application of these compounds is in the treatment of cancers that are driven by FGFR mutations or overexpression. This includes a range of solid tumors and hematological malignancies. The patent also suggests potential applications in other diseases where FGFR signaling is implicated, such as skeletal disorders and metabolic diseases[2].
Patent Expiration Dates
The patent is set to expire on January 30, 2035. This expiration date is significant as it marks the end of the exclusive rights granted to the patent holders, after which generic versions of the drug could potentially be developed and marketed[2].
Related Patents and Exclusivity
In addition to Patent 9,611,267, Incyte Corporation holds several other patents related to FGFR inhibitors, including Patents 10,131,667, 11,466,004, and 11,628,162. These patents have different expiration dates, with the latest expiring on August 30, 2040. The presence of multiple patents and their varying expiration dates helps to extend the period of exclusivity for the drug, protecting it from generic competition for a longer period[2].
Patent Landscape and Challenges
Genus Claims and Enablement
The patent landscape for pharmaceutical and biotechnology inventions has become increasingly complex, particularly with regards to genus claims. Genus claims aim to capture a broad class of compounds rather than specific embodiments. However, recent jurisprudence from the Federal Circuit has made it more challenging to obtain meaningful patent protection for such claims. The court's heightened test for enablement and the broader application of the written description doctrine have introduced significant uncertainty and complexity in drafting patent claims that are both broad enough to be meaningful yet narrow enough to avoid invalidation[3].
Designing Around Narrow Claims
One of the challenges in drafting patent claims is the risk that competitors can design around narrow claims by making minor modifications. This can result in similarly efficacious products that do not infringe on the original patent. Conversely, drafting claims too broadly can lead to them being invalidated for lack of enablement or insufficient written description[3].
Impact on Pharmaceutical and Biotechnology Industries
The current patent landscape, as influenced by the Federal Circuit's jurisprudence, has particularly affected the pharmaceutical and biotechnology industries. Innovators in these fields face the dilemma of either claiming too broadly and risking invalidation or claiming too narrowly and allowing competitors to easily design around their patents. This has made it difficult to achieve meaningful patent protection, which is crucial for the development and commercialization of new drugs and biologics[3].
Key Takeaways
- Patent Scope: The patent covers substituted tricyclic compounds as FGFR inhibitors, with detailed descriptions of their chemical structure and synthesis.
- Therapeutic Applications: The compounds are primarily used in treating FGFR-associated cancers and other diseases.
- Patent Expiration: The patent expires on January 30, 2035.
- Related Patents: Multiple related patents extend the exclusivity period for the drug.
- Challenges: The patent landscape is complex due to issues with genus claims, enablement, and written description requirements.
FAQs
Q: What is the primary therapeutic application of the compounds described in Patent 9,611,267?
A: The primary therapeutic application is in the treatment of cancers driven by FGFR mutations or overexpression.
Q: Who are the inventors of Patent 9,611,267?
A: The inventors are Liangxing Wu, Colin Zhang, Chunhong He, Liang Lu, and Wenqing Yao.
Q: What is the expiration date of Patent 9,611,267?
A: The patent expires on January 30, 2035.
Q: What are the challenges in drafting patent claims for pharmaceutical and biotechnology inventions?
A: The challenges include balancing the breadth of claims to avoid invalidation while preventing competitors from designing around narrow claims.
Q: How does the current patent landscape affect the pharmaceutical and biotechnology industries?
A: The current landscape makes it difficult to achieve meaningful patent protection due to stringent requirements for enablement and written description, affecting the development and commercialization of new drugs and biologics.
Cited Sources:
- United States Patent and Trademark Office. (2017). United States Patent 9,611,267 B2. Retrieved from https://patentimages.storage.googleapis.com/b0/b5/40/ea874d2bd3f0c1/US9611267.pdf
- Drugs.com. (2024). Generic Pemazyre Availability. Retrieved from https://www.drugs.com/availability/generic-pemazyre.html
- Falati, S. (2022). Eviscerating Patent Scope. Retrieved from https://digitalcommons.nyls.edu/cgi/viewcontent.cgi?article=2521&context=fac_articles_chapters
- United States Patent and Trademark Office. (2020). United States Patent 11,053,246. Retrieved from https://patentimages.storage.googleapis.com/49/f0/3a/bbf565d278584c/US11053246.pdf
