United States Patent 7,659,285: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,659,285, hereafter referred to as the '285 patent, is a crucial intellectual property asset related to the drug pimavanserin tartrate, marketed as NUPLAZID. This patent is owned by ACADIA Pharmaceuticals Inc. and plays a significant role in the pharmaceutical industry, particularly in the treatment of Parkinson’s disease psychosis. Here, we delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Issue Date and Expiration
The '285 patent was issued on February 9, 2010, and is set to expire on August 24, 2026, which is 20 years from the priority date plus adjustments for patent term extension[4].
Inventors and Assignees
The patent was invented by David M. Weiner, Robert E. Davis, Mark R. Brann, and Carl-Magnus A. Andersson, and is assigned to ACADIA Pharmaceuticals Inc.[4].
Claims and Scope
Claim Structure
The '285 patent includes multiple claims that cover various aspects of pimavanserin tartrate, including its composition, methods of use, and methods of manufacture. The claims are structured to provide broad protection for the drug and its related processes.
Independent Claims
Independent claims are critical as they define the broadest scope of the invention. For the '285 patent, these claims typically involve the chemical structure of pimavanserin tartrate and its pharmaceutical uses. For instance, Claim 1 might describe the compound itself, while subsequent claims might detail specific methods of synthesis or therapeutic applications[4].
Dependent Claims
Dependent claims build upon the independent claims and provide additional specificity. These claims may include variations in the chemical structure, different formulations of the drug, or specific dosing regimens. They help to narrow down the scope and provide additional layers of protection against infringement[4].
Patent Scope Metrics
Independent Claim Length and Count
Research on patent scope metrics suggests that the length and count of independent claims can be indicative of the patent's breadth and complexity. For the '285 patent, analyzing the independent claim length and count can provide insights into how narrowly or broadly the patent protects the invention. Generally, shorter independent claims and fewer independent claims suggest a narrower scope, which can be beneficial in terms of clarity and enforceability[3].
Regulatory Review and Patent Term Extension
Regulatory Review Period
The '285 patent has undergone a significant regulatory review period. The period from the effective date of the investigational new drug (IND) application (November 9, 2003) to the initial submission of the new drug application (NDA) (September 1, 2015) is 4,314 days. This extensive review period is a critical factor in determining the patent term extension[5].
Patent Term Extension
Under 35 U.S.C. § 156, the '285 patent is eligible for a patent term extension due to the lengthy regulatory review process. The FDA has verified the regulatory review period for NUPLAZID, which includes 4,315 days during the testing phase and 242 days during the approval phase, totaling 4,557 days. This extension ensures that the patent holder retains exclusive rights for a longer period, compensating for the time spent in regulatory review[5].
Litigation and Infringement
Patent Infringement Disputes
The '285 patent has been involved in several patent infringement disputes. For example, ACADIA Pharmaceuticals Inc. has initiated litigation against generic drug manufacturers, such as Zydus and MSN Laboratories, alleging infringement of the '285 patent among others. These disputes often involve detailed claim-by-claim analyses to determine whether the generic products infringe the patented claims[1][2].
Court Decisions and Stipulations
In some cases, the courts have constructed the terms of the patents, and stipulations have been made regarding the validity and infringement of the claims. For instance, Zydus stipulated that their generic product did not infringe certain claims under specific constructions of the patent terms[1].
Patent Landscape
Related Patents
The '285 patent is part of a larger portfolio of patents related to pimavanserin tartrate. Other patents, such as the '740, '615, '480, and '891 patents, also cover various aspects of the drug and its uses. These patents collectively form a robust intellectual property barrier that protects ACADIA Pharmaceuticals Inc.'s exclusive rights to NUPLAZID[2].
Expiration Dates of Related Patents
The expiration dates of these related patents vary, with some expiring as early as January 15, 2024 (e.g., the '130, '393, '271, and '944 patents), and others expiring later, such as the '740 patent on April 29, 2030, and the '480 and '891 patents on August 27, 2038[2].
Industry Impact
Market Protection
The '285 patent and its related patents provide significant market protection for NUPLAZID, allowing ACADIA Pharmaceuticals Inc. to maintain exclusivity and prevent generic competition until the patents expire.
Innovation and Licensing
The robust patent protection around NUPLAZID incentivizes innovation by allowing the patent holder to recoup investment in research and development. However, it also increases licensing and litigation costs for potential competitors, which can be a barrier to entry for generic manufacturers[3].
Key Takeaways
- Patent Scope and Claims: The '285 patent includes broad and specific claims covering the composition, use, and manufacture of pimavanserin tartrate.
- Regulatory Review and Extension: The patent has undergone a lengthy regulatory review, leading to a patent term extension to compensate for the time spent in review.
- Litigation and Infringement: The patent has been involved in several infringement disputes, with detailed analyses and court constructions determining validity and infringement.
- Patent Landscape: The '285 patent is part of a larger portfolio protecting NUPLAZID, with various expiration dates for related patents.
- Industry Impact: The patent provides significant market protection, incentivizes innovation, but also increases costs for potential competitors.
FAQs
What is the main subject of the '285 patent?
The '285 patent primarily covers pimavanserin tartrate, a drug used to treat Parkinson’s disease psychosis, marketed as NUPLAZID.
When does the '285 patent expire?
The '285 patent is set to expire on August 24, 2026.
What is the regulatory review period for the '285 patent?
The regulatory review period for NUPLAZID, as verified by the FDA, is 4,557 days, including 4,315 days during the testing phase and 242 days during the approval phase.
Has the '285 patent been involved in litigation?
Yes, the '285 patent has been involved in several patent infringement disputes, particularly against generic drug manufacturers.
How does the '285 patent impact the pharmaceutical industry?
The '285 patent provides significant market protection for NUPLAZID, incentivizes innovation, but also increases licensing and litigation costs for potential competitors.
Sources
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... - Insight.rpxcorp.com
- Pimavanserin Capsules - Accessdata.fda.gov
- Patent Claims and Patent Scope - Hoover Institution
- D D D D D - Regulations.gov
- FDA U.S. FOOD & DRUG Re: NUPLAZID Patent Nos. - Regulations.gov
