United States Patent 7,763,635: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,763,635, hereafter referred to as the '635 patent, is one of several patents associated with the drug product Sanctura XR® (trospium chloride extended-release capsules). This patent, along with others, was central to a significant legal battle involving Allergan, Inc. and generic drug manufacturers. Here, we delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The '635 patent is part of a series of patents (including U.S. Pat. Nos. 7,410,978, 7,759,359, 7,781,448, and 7,781,449) that cover methods of treatment and dosages related to Sanctura XR®, a medication used for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency[2][5].
Scope of the Patent
The '635 patent, like its companion patents, focuses on specific formulations and methods of administration for trospium chloride. The scope includes claims related to the extended-release formulation of the drug, which is designed to improve patient compliance and reduce side effects. This scope is critical as it defines the boundaries of what is considered novel and non-obvious in the context of this particular drug formulation[2].
Claims of the Patent
The claims of the '635 patent are detailed and specific, outlining the composition and method of use for the extended-release trospium chloride capsules. These claims include:
- The formulation of the extended-release capsules.
- The dosage regimen for treating overactive bladder.
- The specific characteristics of the drug release mechanism.
These claims are essential for understanding what aspects of the drug and its use are protected under the patent[2].
Patent Landscape
The patent landscape surrounding the '635 patent is complex and involves multiple stakeholders. Here are some key points:
International Patent Offices
While the '635 patent is a U.S. patent, similar patents may exist in other countries. Searching international patent databases, such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO), can reveal whether similar patents have been filed or granted in other jurisdictions[1].
Related Patents and Patent Families
The '635 patent is part of a patent family that includes other related patents (e.g., U.S. Pat. Nos. 7,410,978, 7,759,359, 7,781,448, and 7,781,449). Understanding the relationships between these patents is crucial for comprehending the overall patent strategy and the scope of protection[2].
Global Dossier
Using tools like the Global Dossier, users can access the file histories of related applications from participating IP Offices, including the IP5 Offices. This can provide insights into the prosecution history and any office actions related to the '635 patent and its family members[1].
Common Citation Document (CCD)
The CCD application consolidates prior art citations from multiple offices, allowing for a comprehensive view of the prior art landscape relevant to the '635 patent. This is particularly useful for assessing the validity and potential infringement of the patent claims[1].
Legal Challenges and Outcomes
The '635 patent, along with its companion patents, was challenged by generic drug manufacturers Watson Laboratories, Inc., Sandoz, and Paddock in a significant legal case. Here are the key points:
Allergan, Inc. v. Watson Laboratories, Inc.
In this case, the defendants (Watson, Sandoz, and Paddock) alleged that the asserted claims of the '635 patent, among others, were invalid due to anticipation and obviousness. The court ultimately ruled in favor of the defendants, finding the asserted claims of the '635 patent to be invalid[2][5].
Impact on the Patent
The invalidation of the '635 patent claims had significant implications for Allergan, Inc. and the generic drug manufacturers. It paved the way for the approval of generic versions of Sanctura XR®, potentially reducing the market share and revenue of the branded product[5].
Conducting a Preliminary Patent Search
To understand the full context of the '635 patent, conducting a thorough patent search is essential. Here are some steps and resources:
Patent Public Search
Using the Patent Public Search tool provided by the USPTO, one can search for prior art and related patents. This tool offers enhanced access to prior art and is a powerful resource for patent searching[1].
Patent and Trademark Resource Centers (PTRCs)
Local PTRCs can provide additional resources and training in patent search techniques, which can be invaluable for a comprehensive search[1].
Public Search Facility
The USPTO Public Search Facility in Alexandria, VA, offers access to patent and trademark information in various formats, including online, microfilm, and print. Trained staff are available to assist with searches[1].
Data and Statistics
For a deeper analysis, datasets like the Patent Claims Research Dataset provided by the USPTO can be useful. This dataset contains detailed information on claims from U.S. patents granted between 1976 and 2014 and U.S. patent applications published between 2001 and 2014. It includes claim-level statistics and document-level statistics, which can help in understanding the scope and trends of patent claims[3].
Key Takeaways
- Scope and Claims: The '635 patent covers specific formulations and methods of administration for trospium chloride extended-release capsules.
- Patent Landscape: The patent is part of a larger family and has been subject to international and domestic patent searches.
- Legal Challenges: The patent was invalidated in a court ruling, allowing for the approval of generic versions of Sanctura XR®.
- Search Resources: Tools like Patent Public Search, Global Dossier, and PTRCs are essential for conducting thorough patent searches.
FAQs
Q: What is the main subject of the '635 patent?
A: The '635 patent covers the extended-release formulation and method of use for trospium chloride capsules used in treating overactive bladder.
Q: Which companies were involved in the legal challenge to the '635 patent?
A: The legal challenge involved Allergan, Inc. and generic drug manufacturers Watson Laboratories, Inc., Sandoz, and Paddock.
Q: What was the outcome of the legal case involving the '635 patent?
A: The court ruled that the asserted claims of the '635 patent were invalid, allowing for the approval of generic versions of Sanctura XR®.
Q: How can one conduct a thorough search related to the '635 patent?
A: Using resources like the Patent Public Search tool, Global Dossier, and local PTRCs can help in conducting a comprehensive search.
Q: What datasets can be used to analyze patent claims like those in the '635 patent?
A: The Patent Claims Research Dataset provided by the USPTO is a valuable resource for analyzing patent claims and understanding trends in patent scope.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Robins Kaplan - Allergan, Inc. v. Watson Laboratories, Inc.: https://www.robinskaplan.com/newsroom/insights/allergan-inc-v-watson-laboratories-inc
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Stifel - Supernus Pharmaceuticals, Inc.: https://www.stifel.com/prospectusfiles/pd_1495.pdf
- Biospace - Watson Pharmaceuticals, Inc. Confirms Favorable District Court Ruling in Generic Sanctura XR® Patent Suit: https://www.biospace.com/watson-pharmaceuticals-inc-confirms-favorable-district-court-ruling-in-generic-sanctura-xr-patent-suit/
