United States Patent 8,680,111: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,680,111, titled "Macrocyclic derivatives for the treatment of diseases," is a significant patent held by Pfizer Inc. This patent is crucial in the pharmaceutical industry, particularly in the development and treatment of various diseases using macrocyclic compounds.
Patent Overview
The patent was issued on March 25, 2014, and is set to expire on March 5, 2033[5,.
Inventors and Assignee
The patent was invented by a team of researchers including Simon Bailey, Benjamin Joseph Burke, Michael Raymond Collins, Jingrong Jean Cui, and several others, all affiliated with Pfizer Inc. in San Diego, CA[1][4].
Scope of the Patent
Macrocyclic Derivatives
The patent pertains to compounds of a specific formula, referred to as macrocyclic derivatives, and their pharmaceutically acceptable salts. These compounds are designed for the treatment of various diseases, including those related to abnormal cell growth such as cancer[1][4].
Chemical Structure
The macrocyclic derivatives are defined by a specific chemical structure, which is detailed in the patent. This structure includes various functional groups such as alkyl, hydrogen, cycloalkyl, and aryl groups, which are critical for the therapeutic efficacy of the compounds[1][4].
Claims of the Patent
The patent claims are central to understanding the scope of protection granted to Pfizer Inc.
Compound Claims
The patent includes claims for the specific macrocyclic compounds, their salts, and pharmaceutical compositions containing these compounds. These claims are broad enough to cover a range of compounds but specific enough to ensure that the inventions are clearly defined and distinguishable from prior art[1][4].
Method Claims
In addition to compound claims, the patent also includes method claims related to the use of these macrocyclic derivatives in treating diseases. These method claims are essential for protecting the therapeutic applications of the invented compounds[1][4].
Patent Landscape
Related Patents
The patent landscape surrounding US 8,680,111 includes several related patents, particularly those related to the drug Lorbrena (lorlatinib), which is also owned by Pfizer Inc. Lorbrena is protected by multiple patents, including US 10420749 and US 11299500, which cover different aspects such as crystalline forms of lorlatinib[2][5].
Exclusivity and Patent Protection
The patent provides exclusive rights to Pfizer Inc. to manufacture, use, and sell the macrocyclic derivatives until its expiration in 2033. This exclusivity is crucial for Pfizer to recoup its investment in research and development. Additionally, the patent is complemented by FDA-granted exclusivities, which can run concurrently with the patent term[5].
Challenges in Patent Protection
Genus Claims
The pharmaceutical and biotechnology industries face significant challenges in obtaining and maintaining broad patent protection, particularly with genus claims. The Federal Circuit's rigid application of Section 112(a) of the U.S. patent laws has made it difficult for innovators to claim the full scope of their inventions without violating the enablement and written description requirements[3].
Enablement and Written Description
The patent claims must satisfy the enablement and written description requirements, which can be challenging for genus claims. Innovators must balance between claiming broadly enough to protect their invention and narrowly enough to avoid invalidation due to lack of enablement or written description[3].
Impact on Pharmaceutical and Biotechnology Industries
Market and Investment
The pharmaceutical and biotechnology industries are heavily reliant on robust and predictable patent protection to support their commercialization strategies. Billions of dollars are invested in bringing novel therapeutics to market, and the market for these therapeutics, including biologics, is steadily expanding. The current jurisprudence on patent claims, however, has made it challenging for innovators to secure meaningful patent protection[3].
Competitive Landscape
The narrow scope of patent claims can allow competitors to design around the patented inventions, making minor changes to create similarly efficacious products. This can undermine the exclusivity and market position of the original innovator[3].
Key Takeaways
- Patent Scope: US 8,680,111 covers macrocyclic derivatives and their use in treating diseases, with specific claims for compounds and methods.
- Exclusivity: The patent provides Pfizer Inc. with exclusive rights until its expiration in 2033.
- Related Patents: The patent is part of a broader landscape including other patents related to Lorbrena.
- Challenges: The pharmaceutical industry faces challenges in obtaining broad patent protection due to strict application of Section 112(a).
- Market Impact: Robust patent protection is crucial for the commercialization of new therapeutics, but current jurisprudence makes it difficult to achieve.
FAQs
What is the main subject of United States Patent 8,680,111?
The main subject of this patent is macrocyclic derivatives and their use in treating various diseases.
Who are the inventors of this patent?
The inventors include Simon Bailey, Benjamin Joseph Burke, Michael Raymond Collins, Jingrong Jean Cui, and several others affiliated with Pfizer Inc.
When does the patent expire?
The patent is set to expire on March 5, 2033.
How does this patent relate to Lorbrena?
While US 8,680,111 is a distinct patent, it is part of the broader patent landscape that includes patents related to Lorbrena (lorlatinib), also owned by Pfizer Inc.
What challenges do pharmaceutical companies face in patent protection?
Pharmaceutical companies face challenges in obtaining broad patent protection due to the strict application of Section 112(a) of the U.S. patent laws, particularly with genus claims.
Cited Sources:
- US8680111B2 - Macrocyclic derivatives for the treatment of diseases - Google Patents
- Lorbrena patent expiration - Pharsight - GreyB
- Eviscerating Patent Scope - DigitalCommons@NYLS
- US8680111B2 - Macrocyclic derivatives for the treatment of diseases - Google Patents
- Generic Lorbrena Availability - Drugs.com
