Understanding the Scope and Claims of United States Patent 9,017,731
Introduction
The United States Patent 9,017,731, hereafter referred to as the '731 patent, is a significant intellectual property asset in the pharmaceutical sector. This patent, like others, is composed of several key sections that define its scope, claims, and the protection it affords its holders.
Patent Overview
Publication and Legal Status
The '731 patent, titled "Dosage forms that provide prolonged therapy," was granted on April 28, 2015. It is currently active, indicating that it remains a valid and enforceable patent[4].
Claims Section
Importance of Claims
The claims section is the most critical part of any patent, as it defines the scope of the invention and outlines what the patentee has the right to exclude others from making, using, or selling. For the '731 patent, the claims are structured to particularly point out and distinctly claim the subject matter of the invention[5].
Structure of Claims
Each claim in the '731 patent consists of a preamble and a body, connected by a transition word or phrase. Here is an example of how a claim might be structured:
- Preamble: An introductory statement naming the invention.
- Body: Defines the elements or steps of the invention.
- Transition: Words or phrases like "comprising," "consisting of," or "wherein" that link the preamble to the body.
For instance, Claim 1 of the '731 patent might read:
"A pharmaceutical composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles, wherein the composition provides prolonged release of the amphetamines."
Claim Scope and Breadth
The scope of the claims in the '731 patent is crucial for understanding what is protected and what is not. 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 narrowing during the examination process[3].
Patent Scope and Metrics
Independent Claim Length and Count
Research has shown that metrics such as independent claim length and independent claim count can be used to measure patent scope. For the '731 patent, these metrics would indicate the breadth and complexity of the claims. Narrower claims, as measured by shorter lengths and fewer counts, tend to have higher grant probabilities and shorter examination durations[3].
Technology and Invention
Dosage Forms for Prolonged Therapy
The '731 patent pertains to dosage forms designed to provide prolonged therapy, specifically involving amphetamine-based pharmaceutical compositions. The invention includes various pluralities of resin particles that release the active ingredient over an extended period, ensuring sustained therapeutic effects[4].
Litigation and Enforcement
Patent Infringement Cases
The '731 patent has been involved in litigation, particularly in cases where generic drug manufacturers have sought to challenge its validity or avoid infringement. For example, Granules' submission of an Abbreviated New Drug Application (ANDA) to the FDA, which alleged that the claims of the '731 patent were invalid or would not be infringed by their generic products, led to legal action by the patent holders[2].
Legal Implications
In such cases, the patent holders argue that the generic products would infringe on one or more claims of the '731 patent, and they seek injunctive relief to prevent irreparable harm. The legal battles highlight the importance of the patent in protecting the intellectual property rights of the inventors and the commercial value of the patented invention[2].
Continuations and Family Allowance Rates
Complexity in Patent Examination
The '731 patent, like other patents, may be part of a larger family of applications that include continuations, continuations-in-part, and divisional applications. These continuation procedures can complicate the calculation of patent allowance rates but are crucial for understanding the full scope of protection afforded by the patent[1].
Technology Fields and Classification
Broad Technology Fields
The '731 patent falls under the broad technology field of "Drugs and Medical" according to the National Bureau of Economics Research (NBER) classification scheme. This classification helps in aggregating and analyzing patents within specific technological domains[1].
Key Takeaways
- Claims Structure: The '731 patent's claims are structured with a preamble and body, defining the scope of the invention.
- Patent Scope Metrics: Independent claim length and count are important metrics for measuring patent scope and predicting grant probabilities.
- Litigation: The patent has been involved in litigation related to generic drug applications and infringement allegations.
- Technology: The patent pertains to dosage forms for prolonged therapy, specifically involving amphetamine-based compositions.
- Continuations: The patent may be part of a larger family of applications, including continuations and divisional applications.
FAQs
Q: What is the main subject matter of the '731 patent?
A: The '731 patent pertains to dosage forms that provide prolonged therapy, specifically involving amphetamine-based pharmaceutical compositions.
Q: How are the claims in the '731 patent structured?
A: Each claim consists of a preamble and a body, connected by a transition word or phrase, defining the elements or steps of the invention.
Q: What metrics can be used to measure the scope of the '731 patent?
A: Independent claim length and independent claim count are used to measure patent scope and predict grant probabilities.
Q: Has the '731 patent been involved in any litigation?
A: Yes, the patent has been involved in litigation related to generic drug applications and infringement allegations.
Q: Under which broad technology field does the '731 patent fall?
A: The '731 patent falls under the "Drugs and Medical" technology field according to the NBER classification scheme.
Sources
- Carley, M., & Hegde, D. (n.d.). What Is the Probability of Receiving a US Patent?. USPTO.
- United States District Court for the District of Delaware. (2024). Case 1:24-cv-01356-UNA Document 1 Filed 12/11/24 PageID #: 4.
- SSRN. (2016). Patent Claims and Patent Scope. SSRN.
- Google Patents. (n.d.). US9017731B2 - Dosage forms that provide prolonged therapy.
- The Lens. (2020). How To Read a Patent. The Lens.
