Understanding the Scope and Claims of United States Patent 7,431,944
Introduction
United States Patent 7,431,944, titled "Delivery of Multiple Doses of Medications," was granted on October 7, 2008, to inventors Atul M. Mehta, Andrew L. Zeitlin, and Maghsoud M. Dariani, and assigned to Celgene Corporation. This patent is significant in the field of pharmaceuticals, particularly in the development of dosage forms for oral administration of medications like methylphenidate.
Background and Context
The patent is a continuation-in-part of several earlier applications, including those filed on May 15, 1996, January 5, 1996, and December 4, 1995. This indicates a long-standing research and development effort in creating innovative dosage forms[1].
Patent Scope
The scope of the patent revolves around the design and delivery of oral medication dosage forms, specifically those that provide an immediate dose followed by one or more additional doses at predetermined times. This is particularly relevant for medications like methylphenidate, which is used to treat conditions such as Attention Deficit Hyperactivity Disorder (ADHD).
Key Aspects of the Patent Scope
- Immediate and Delayed Release: The dosage forms are engineered to release a substantial immediate dose of the medication upon ingestion, followed by additional doses at specified intervals. This ensures a sustained therapeutic effect without the need for multiple administrations[1].
- Controlled Release Profile: The patent describes various formulations and delivery systems that allow for a controlled release profile, which is crucial for maintaining therapeutic levels of the medication over an extended period.
- Oral Administration: The focus is on oral dosage forms, which are more patient-friendly and easier to administer compared to other routes of administration.
Patent Claims
The patent includes multiple claims that define the scope of the invention. Here are some key claims:
Independent Claims
- Claim 1 describes a dosage form for oral administration of a methylphenidate drug, which provides an immediate dose upon ingestion followed by one or more additional doses at predetermined times[1].
- Claim 2 specifies the composition of the dosage form, including the active ingredient and various excipients that facilitate the controlled release profile.
Dependent Claims
- These claims further detail the specific components, such as the type of release-controlling agents, the formulation of the immediate and delayed-release layers, and the manufacturing process.
Classification and Field of Search
The patent is classified under various sections of the U.S. Patent Classification system, including 424/497, 424/458, 424/474, and others. This classification helps in identifying the patent's relevance to specific areas within the pharmaceutical and drug delivery fields[1].
Related Patents and Prior Art
The patent references several prior patents and applications, including those related to drug delivery systems and formulations. For example, patents like US 5,837,284 and US 5,733,756 are mentioned as part of the continuation-in-part process, indicating a build-up of knowledge and innovation in this area[1].
Industry Impact
The invention described in this patent has significant implications for the pharmaceutical industry, particularly in the treatment of ADHD and other conditions requiring sustained medication release.
Clinical Significance
- The controlled release profile ensures that patients receive a consistent therapeutic dose over an extended period, improving compliance and efficacy.
- The immediate and delayed release mechanism helps in managing symptoms more effectively, reducing the need for frequent dosing.
Market and Commercial Impact
- The patent protects Celgene Corporation's intellectual property, allowing them to market and sell these innovative dosage forms exclusively.
- The presence of such patents can influence market dynamics, as generic versions of these medications may not be available until the patent expires.
Litigation and Patent Landscape
The patent landscape for methylphenidate and similar medications is complex, with multiple patents and patent applications in play.
Patent Litigation
- Patents like US 7,431,944 can be involved in litigation, especially when generic manufacturers seek to enter the market. For instance, reexamination certificates and patent lawsuits can affect the patent's validity and scope[5].
Generic and API Market
- The generic API market for methylphenidate hydrochloride is active, with multiple applicants, NDAs, and clinical trials. However, the presence of patents like US 7,431,944 can delay the entry of generic versions[4].
Metrics for Patent Scope
Research on patent scope often uses metrics such as independent claim length and independent claim count to assess the breadth and clarity of patents. Narrower claims, as seen in the examination process, are associated with a higher probability of grant and a shorter examination process[3].
Conclusion
United States Patent 7,431,944 represents a significant advancement in drug delivery technology, particularly for medications requiring sustained release profiles. The patent's scope, claims, and impact on the pharmaceutical industry highlight its importance in both clinical and commercial contexts.
Key Takeaways
- Innovative Dosage Forms: The patent describes novel dosage forms that provide immediate and delayed release of medications like methylphenidate.
- Controlled Release Profile: The invention ensures a sustained therapeutic effect through a controlled release mechanism.
- Industry Impact: The patent has significant implications for patient compliance, efficacy, and market dynamics.
- Litigation and Patent Landscape: The patent is part of a complex landscape involving multiple patents, applications, and potential litigation.
FAQs
Q: What is the primary focus of United States Patent 7,431,944?
A: The primary focus is on the delivery of multiple doses of medications, specifically methylphenidate, through oral dosage forms with immediate and delayed release profiles.
Q: Who are the inventors of this patent?
A: The inventors are Atul M. Mehta, Andrew L. Zeitlin, and Maghsoud M. Dariani.
Q: What is the significance of the controlled release profile in this patent?
A: The controlled release profile ensures that patients receive a consistent therapeutic dose over an extended period, improving compliance and efficacy.
Q: How does this patent impact the pharmaceutical industry?
A: It protects Celgene Corporation's intellectual property, influences market dynamics, and affects the entry of generic versions of the medication.
Q: What metrics are used to assess the scope of patents like US 7,431,944?
A: Metrics such as independent claim length and independent claim count are used to assess the breadth and clarity of patents.
Sources
- United States Patent and Trademark Office. US 7431,944 B2: Delivery of Multiple Doses of Medications. October 7, 2008.
- Legal Calculators. In re Kokatnur, 32 C.C.P.A. 743 (1944).
- SSRN. Patent Claims and Patent Scope. September 29, 2016.
- Drug Patent Watch. DEXMETHYLPHENIDATE HYDROCHLORIDE - Generic Drug Details.
- Insight.RPXcorp.com. Case 3:08-cv-06247-FLW-TJB Document 1 Filed 12/05/08 Page 1 of ...
