Understanding the Scope and Claims of United States Patent 8,907,099
Introduction
United States Patent 8,907,099, titled "Nitrocatechol derivatives as COMT inhibitors," is a significant patent in the pharmaceutical industry, particularly in the treatment of central and peripheral nervous system disorders. Here, we will delve into the details of this patent, including its scope, claims, and the broader patent landscape.
Inventors and Assignee
The patent was invented by David Alexander Learmonth, Laszlo Erno Kiss, Pedro Nuno Leal Palma, Humberto Dos Santos Ferreira, and Patricio Manuel Vieira Araujo Soares da Silva. It is assigned to Bial-Portela & Ca, S.A., a pharmaceutical company based in Portugal[2][5].
Patent Issuance and Expiration
The patent was issued on December 9, 2014, and is set to expire on May 12, 2027. This expiration date is crucial as it marks the end of the exclusive rights granted to the patent holder[2][5].
Patent Scope and Claims
The patent describes new compounds of the nitrocatechol derivative class, which have potential therapeutic applications as catechol-O-methyltransferase (COMT) inhibitors. COMT inhibitors are used in the treatment of Parkinson's disease and other neurological disorders by preventing the breakdown of dopamine, thereby increasing its availability in the brain.
- Chemical Formulation: The patent details the synthesis and characterization of these nitrocatechol derivatives, highlighting their structural features and chemical properties[1][2].
- Therapeutic Applications: The compounds are described as having valuable pharmaceutical properties, particularly in treating central and peripheral nervous system disorders. This includes their potential use in managing Parkinson's disease and other conditions where dopamine levels are critical[1][4].
Claims
The patent includes several claims that define the scope of the invention:
- Independent Claims: These claims outline the specific chemical structures of the nitrocatechol derivatives and their use as COMT inhibitors. The claims are detailed and specific, ensuring that the patent holder has exclusive rights over these particular compounds and their therapeutic applications[1].
- Dependent Claims: These claims further specify the methods of synthesis, dosage forms, and other aspects related to the use of these compounds. They provide additional protection by covering various aspects of the invention beyond the core chemical structures[1].
Patent Landscape
The patent landscape surrounding US 8,907,099 is complex and involves multiple related patents and exclusivities:
- Related Patents: There are several other patents related to COMT inhibitors and nitrocatechol derivatives, some of which are also held by Bial-Portela & Ca, S.A. These patents cover different aspects of the drug, including other chemical formulations, methods of administration, and additional therapeutic uses[2][5].
- Exclusivities: In addition to the patent protection, the drug may also be protected by FDA-granted exclusivities, which can run concurrently with or independently of patent protection. These exclusivities can extend the period during which the drug remains protected from generic competition[2].
Impact on Generic Competition
The expiration of the patent on May 12, 2027, will mark the beginning of the end of the exclusive rights held by Bial-Portela & Ca, S.A. over these specific nitrocatechol derivatives. However, the presence of other related patents and exclusivities may delay the entry of generic versions of the drug into the market. For example, other patents related to the drug Ongentys, which is protected by similar COMT inhibitor patents, are estimated to expire as late as May 27, 2035[5].
Challenges and Litigation
Patents like US 8,907,099 are often subject to challenges and litigation. As the patent approaches its expiration date, it becomes more vulnerable to challenges from generic manufacturers seeking to enter the market. The patent has been open to challenges since April 24, 2024, which could potentially affect its validity and the exclusivity period[5].
Metrics for Patent Scope
The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. These metrics help in assessing the breadth and clarity of the patent claims. Narrower claims are generally associated with a higher probability of grant and a shorter examination process, while broader claims may face more scrutiny and potential challenges[3].
Conclusion
United States Patent 8,907,099 is a critical patent in the field of neurological disorder treatments, particularly for Parkinson's disease. Its scope and claims are well-defined, covering specific nitrocatechol derivatives and their use as COMT inhibitors. The patent landscape is complex, with multiple related patents and exclusivities that protect the drug from generic competition. As the patent approaches its expiration date, it will be important to monitor any challenges and the subsequent impact on the pharmaceutical market.
Key Takeaways
- Patent Details: US 8,907,099 covers nitrocatechol derivatives as COMT inhibitors.
- Expiration Date: The patent expires on May 12, 2027.
- Therapeutic Use: The compounds are used in treating central and peripheral nervous system disorders.
- Related Patents: Multiple patents protect different aspects of the drug.
- Exclusivities: FDA-granted exclusivities can extend protection beyond patent expiration.
- Challenges: The patent is open to challenges, which could affect its validity.
FAQs
Q: What is the main subject of United States Patent 8,907,099?
A: The patent covers nitrocatechol derivatives as catechol-O-methyltransferase (COMT) inhibitors.
Q: Who are the inventors of this patent?
A: The inventors are David Alexander Learmonth, Laszlo Erno Kiss, Pedro Nuno Leal Palma, Humberto Dos Santos Ferreira, and Patricio Manuel Vieira Araujo Soares da Silva.
Q: When does the patent expire?
A: The patent expires on May 12, 2027.
Q: What are the therapeutic applications of the compounds described in the patent?
A: The compounds are used in treating central and peripheral nervous system disorders, particularly Parkinson's disease.
Q: Are there other patents related to this drug?
A: Yes, there are several other patents and exclusivities that protect different aspects of the drug.
Cited Sources
- United States Patent and Trademark Office, "Nitrocatechol derivatives as COMT inhibitors," US 8,907,099 B2, December 9, 2014.
- Drugs.com, "Generic Ongentys Availability," November 6, 2024.
- SSRN, "Patent Claims and Patent Scope," September 29, 2016.
- United States Patent and Trademark Office, "Clinical improvements in patients afflicted with Parkinson's," US 10,583,130 B2, July 31, 2018.
- Pharsight - GreyB, "Ongentys patent expiration," November 2024.
