United States Patent 9,125,908: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,125,908, hereafter referred to as the '908 patent, is a significant intellectual property asset in the pharmaceutical sector, particularly in the treatment of cognitive impairment. This patent, along with its related counterparts, forms a crucial part of the patent landscape for certain therapeutic compounds. Here, we delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Patent Number and Date
The '908 patent, titled "1-2-(2,4-Dimethylphenylsulfanyl)-phenylpiperazine as a compound with combined serotonin reuptake, 5-HT and 5-HT6 activity for the treatment of cognitive impairment," was granted on September 8, 2015[4].
Applicant and Inventors
The patent was applied for by H. Lundbeck A/S, a Danish pharmaceutical company, with inventors including Benny Bang-Andersen, Arne Mork, Tine Bryan Stensbol, Andre Faldt, Rene Holm, and Heidi Lopez de Diego[4].
Scope of the Patent
Therapeutic Use
The '908 patent covers compounds with combined serotonin reuptake and 5-HT receptor activity, specifically targeting the treatment of cognitive impairment. This includes conditions such as those associated with depression and other cognitive disorders[4].
Chemical Composition
The patent describes the synthesis and properties of 1-2-(2,4-Dimethylphenylsulfanyl)-phenylpiperazine, a compound that exhibits dual activity as a serotonin reuptake inhibitor and a 5-HT receptor modulator. This dual action is crucial for its therapeutic efficacy in treating cognitive impairment[4].
Claims of the Patent
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims define the broad scope of the invention, while dependent claims narrow down the scope by adding specific limitations. For instance, claim 1 of the '908 patent describes the compound and its use, while subsequent claims may specify particular methods of synthesis or additional therapeutic applications[4].
Claim Construction
The construction of claims in the '908 patent, as with other patents, is a legal question that involves interpreting the language of the claims in light of the patent specification and prosecution history. The court's interpretation must ensure that the claims are not indefinite and clearly inform those skilled in the art about the scope of the invention[1].
Patent Landscape
Related Patents
The '908 patent is part of a family of patents that include U.S. Patent Nos. 9,125,909 ('909 patent), 9,125,910 ('910 patent), and 9,278,096 ('096 patent). These patents collectively cover various aspects of the compound, its synthesis, and its therapeutic uses, including cognitive impairment and depression[2][5].
Expiration Dates
The '908 patent, along with the '909 and '910 patents, is set to expire on June 15, 2027. The '096 patent, which also relates to the same therapeutic area, has a later expiration date of March 21, 2032[2][5].
Litigation and ANDA Filings
The '908 patent has been involved in litigation related to generic drug approvals. For example, ANDA (Abbreviated New Drug Application) filings by companies like Cipla and Zydus have triggered patent infringement litigation, highlighting the patent's significance in protecting the intellectual property of the original drug manufacturer[2][5].
Claim Construction Disputes
Legal Standards
Claim construction disputes, such as those involving the '908 patent, are governed by strict legal standards. The court must determine the proper construction of patent claims, ensuring they are not indefinite and clearly define the scope of the invention. This process involves analyzing the patent specification, prosecution history, and any special definitions given to claim terms by the patentee[1].
Specific Disputes
In the case of the '908 patent, disputes have arisen over the interpretation of terms such as "cognitive impairment" and its relationship to depression. The court has to decide whether these conditions are independent or linked, based on the intrinsic evidence from the patent specification and prosecution history[1].
Economic and Strategic Implications
Market Protection
The '908 patent, along with its related patents, provides significant market protection for the original drug manufacturer, H. Lundbeck A/S. This protection prevents generic competitors from entering the market until the patents expire, allowing the patent holder to maintain market exclusivity and recoup investment in research and development[2][5].
Research and Development
The patent landscape surrounding the '908 patent encourages continued research and development in the field of cognitive impairment treatments. By protecting innovative compounds and methods, these patents incentivize further innovation and investment in pharmaceutical research[3].
Conclusion
The United States Patent 9,125,908 is a critical component of the intellectual property portfolio for H. Lundbeck A/S, particularly in the treatment of cognitive impairment. Understanding the scope, claims, and broader patent landscape of this patent is essential for navigating the complex legal and regulatory environment surrounding pharmaceutical innovations.
Key Takeaways
- The '908 patent covers a compound with combined serotonin reuptake and 5-HT receptor activity for treating cognitive impairment.
- The patent is part of a family of related patents that collectively protect various aspects of the compound and its therapeutic uses.
- Claim construction disputes are resolved based on strict legal standards, ensuring clarity and specificity in defining the scope of the invention.
- The patent provides significant market protection until its expiration on June 15, 2027.
- The patent landscape surrounding the '908 patent encourages continued innovation and investment in pharmaceutical research.
FAQs
Q: What is the primary therapeutic use of the compound described in the '908 patent?
A: The compound is primarily used for the treatment of cognitive impairment, including conditions associated with depression.
Q: Who is the applicant and what are the names of the inventors listed on the '908 patent?
A: The applicant is H. Lundbeck A/S, and the inventors include Benny Bang-Andersen, Arne Mork, Tine Bryan Stensbol, Andre Faldt, Rene Holm, and Heidi Lopez de Diego.
Q: What is the expiration date of the '908 patent?
A: The '908 patent is set to expire on June 15, 2027.
Q: How do claim construction disputes related to the '908 patent get resolved?
A: Claim construction disputes are resolved through a legal process that involves interpreting the claim language in light of the patent specification and prosecution history to ensure clarity and specificity.
Q: What is the significance of the '908 patent in the pharmaceutical market?
A: The '908 patent provides market protection for the original drug manufacturer, preventing generic competitors from entering the market until the patent expires, and incentivizes further innovation and investment in pharmaceutical research.
Sources
- CA No. 18-88-LPS - District of Delaware. Pending before the Court is the parties' second set of claim construction disputes related to terms in U.S. Patent Nos. 9,125,908 ("'908 patent")...
- Vortioxetine Tablets - accessdata.fda.gov. Litigation was initiated within the statutory 45-day period against Cipla for infringement of the '684, '355, and '946 patents in the United States.
- Patent Claims Research Dataset - USPTO. The Patent Claims Research Dataset contain detailed information on claims from U.S. patents granted between 1976 and 2014 and U.S. patent applications published between 2001 and 2014.
- United States Patent - googleapis.com. In one embodiment, the process is divided in Sub-processes wherein compound II and compound III are reacted in a first reaction to provide a compound.
- II US FOOD & DRUG - accessdata.fda.gov. Litigation was initiated within the statutory 45-day period against Zydus for infringement of the '884, '279, '684, '355 and '946 patents in the United States.
