United States Patent 9,012,440: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,012,440, titled "Co-crystals of tramadol and co-crystal formers selected from NSAIDs/coxibs, processes for preparation of the same and their uses as medicaments or in pharmaceutical formulations," is a significant patent in the pharmaceutical industry. This patent, filed by various applicants over the years through a series of continuations, pertains to the development and use of co-crystals involving tramadol and other nonsteroidal anti-inflammatory drugs (NSAIDs) or coxibs.
Background and History
The patent 9,012,440 is part of a long series of patent applications and continuations. It originated from an application filed on October 29, 2013, as part of a continuation of earlier applications dating back to 2010[4].
Scope of the Patent
Co-Crystals and Their Preparation
The patent primarily focuses on the creation and use of co-crystals formed between tramadol and various NSAIDs or coxibs. Co-crystals are solid materials composed of two or more different molecules that are crystallized together. In this case, the co-crystals involve tramadol, a pain reliever, and NSAIDs/coxibs like celecoxib, which are anti-inflammatory agents[4].
Pharmaceutical Uses
The co-crystals are intended for use in pharmaceutical formulations, particularly for the treatment of pain. The combination of tramadol and NSAIDs/coxibs aims to enhance the therapeutic efficacy and reduce the side effects associated with individual components when used separately[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- The patent claims the co-crystals themselves, including specific ratios and forms of the tramadol and NSAID/coxib combinations.
- It also claims the processes for preparing these co-crystals, which involve various methods such as grinding, solvent evaporation, and other crystallization techniques[4].
Dependent Claims
- These claims further specify the characteristics of the co-crystals, such as their physical properties, stability, and bioavailability.
- They also cover the pharmaceutical formulations that incorporate these co-crystals, including tablets, capsules, and other dosage forms[4].
Patent Landscape
Related Patents and Applications
The patent 9,012,440 is part of a larger family of patents that include other related inventions. For example, patents like 8,598,152, 10,238,668, 10,548,909, and others are continuations or related applications that cover various aspects of the co-crystal technology and its applications[2][4].
Regulatory Approvals
The approval of the drug product SEGLENTIS® (celecoxib and tramadol hydrochloride) by the FDA on October 15, 2021, is closely related to this patent. However, the patent term extension application for U.S. Patent 8,598,152, which is part of the same family, was determined to be ineligible under 35 U.S.C. § 156[2].
Patent Scope Metrics
Independent Claim Length and Count
Research suggests that the scope of a patent can be measured using metrics such as independent claim length and independent claim count. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Impact on Pharmaceutical Industry
Innovation and Competition
The development of co-crystals like those described in this patent can significantly impact the pharmaceutical industry by offering new therapeutic options and potentially reducing the side effects of existing medications. However, the broad scope of such patents can also lead to increased licensing and litigation costs, affecting innovation incentives[3].
Market Exclusivity
The absence of a generic version of SEGLENTIS® in the U.S. market, despite the patent landscape, highlights the exclusive marketing rights granted by the FDA and the protective nature of drug patents and exclusivity periods[5].
Challenges and Considerations
Patent Term Extensions
The eligibility for patent term extensions under 35 U.S.C. § 156 is a critical aspect. The determination that the '152 patent is not eligible for such an extension underscores the complexities and strict criteria involved in these applications[2].
Regulatory Compliance
Compliance with FDA regulations and the approval process is crucial. The approval of SEGLENTIS® and the related patent landscape illustrate the intricate relationship between regulatory approvals and patent protections[2].
Key Takeaways
- Co-Crystal Technology: The patent focuses on the creation and use of co-crystals involving tramadol and NSAIDs/coxibs for pain treatment.
- Pharmaceutical Uses: The co-crystals are designed to enhance therapeutic efficacy and reduce side effects.
- Patent Claims: The patent includes claims for the co-crystals, their preparation processes, and pharmaceutical formulations.
- Related Patents: Part of a larger family of patents covering various aspects of co-crystal technology.
- Regulatory Approvals: Closely related to the FDA approval of SEGLENTIS® but subject to strict patent term extension criteria.
- Impact on Industry: Offers new therapeutic options but can also increase licensing and litigation costs.
FAQs
What is the primary focus of United States Patent 9,012,440?
The primary focus is on the creation and use of co-crystals involving tramadol and NSAIDs/coxibs for pain treatment.
What are the key claims of the patent?
The key claims include the co-crystals themselves, the processes for preparing them, and the pharmaceutical formulations that incorporate these co-crystals.
Is SEGLENTIS® a generic version of the drug covered by this patent?
No, there is currently no therapeutically equivalent generic version of SEGLENTIS® available in the United States[5].
Why was the patent term extension application for U.S. Patent 8,598,152 determined to be ineligible?
The application was determined to be ineligible because the permission for the commercial marketing or use of the product was not the first permitted commercial marketing or use under the relevant provisions of law[2].
How does the scope of this patent impact the pharmaceutical industry?
The patent can offer new therapeutic options but may also increase licensing and litigation costs, affecting innovation incentives[3].
Cited Sources
- United States Patent and Trademark Office, "United States Patent 11,478,488 B2," Google Patents.
- Regulations.gov, "Patent Term Extension - Regulations.gov," FDA.
- SSRN, "Patent Claims and Patent Scope," SSRN.
- Google Patents, "United States Patent 10,548,909 B2," Google Patents.
- Drugs.com, "Generic Seglentis Availability - Drugs.com," Drugs.com.
