Understanding the Scope and Claims of United States Patent 11,110,081
Introduction
United States Patent 11,110,081, titled "Tacrolimus for Improved Treatment of Transplant Patients," is a significant patent in the field of pharmaceuticals, particularly in the treatment of transplant patients. This patent, assigned to Veloxis Pharmaceuticals A/S, introduces an extended release oral dosage form of tacrolimus, a crucial immunosuppressive drug. Here, we delve into the details of the patent's scope, claims, and the broader patent landscape.
Background of Tacrolimus
Tacrolimus is a potent immunosuppressive agent widely used to prevent the rejection of transplanted organs. The traditional formulations of tacrolimus require multiple daily doses, which can be cumbersome for patients and may lead to non-adherence. The innovation in this patent addresses this issue by providing a once-daily extended release formulation[4].
Patent Scope
The scope of a patent is defined by its claims, which must be clear, concise, and fully supported by the description provided in the patent application[5].
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims define the invention broadly and stand alone, while dependent claims further limit the scope of the independent claims. For instance, Claim 1 of the patent describes the extended release oral dosage form comprising tacrolimus or a pharmaceutically active analogue thereof, designed for once-daily administration. Dependent claims, such as Claim 2, specify additional characteristics, like the dosage form being a tablet or capsule[4].
Claim Analysis
Claim Length and Count
Research on patent scope often uses metrics such as independent claim length and independent claim count to measure the breadth of a patent. Narrower claims, as seen in this patent, are associated with a higher probability of grant and a shorter examination process compared to broader claims[3].
Specific Claims
- Claim 1: Defines the extended release oral dosage form of tacrolimus.
- Claim 2: Specifies the dosage form as a tablet or capsule.
- Claim 3: Describes the release profile of the tacrolimus.
- Claim 4: Outlines the pharmaceutical composition including tacrolimus and other excipients.
These claims collectively define the unique aspects of the invention, ensuring that the protection sought is clear and specific[4].
Patent Landscape
Prior Art and References
The patent cites several prior art documents, including U.S. patents and international publications, which indicate the existing state of the art in immunosuppressive treatments and drug delivery systems. For example, references like U.S. Patent 6,168,806 B1 and WO 2006/083130 A1 are mentioned, highlighting the evolution of tacrolimus formulations[1].
Competitors and Related Patents
The patent landscape in the field of immunosuppressive drugs is highly competitive. Other pharmaceutical companies have developed various formulations of tacrolimus and other immunosuppressants. For instance, patents like U.S. Patent 8,664,239 B2, also related to tacrolimus formulations, demonstrate the ongoing innovation in this area[1].
Economic and Innovation Impact
Patent Quality and Scope
The debate over patent quality often revolves around the breadth and clarity of patent claims. This patent, with its well-defined and narrow claims, aligns with the trend of ensuring that patents are of high quality, thereby promoting innovation rather than litigation. The metrics of independent claim length and count validate that this patent has a focused scope, which is beneficial for both the patent holder and the broader innovation ecosystem[3].
Market Impact
The introduction of a once-daily extended release formulation of tacrolimus can significantly improve patient compliance and quality of life. This innovation can also influence market dynamics by offering a more convenient treatment option, potentially increasing market share for Veloxis Pharmaceuticals A/S.
Legal and Regulatory Aspects
PCT Rules and USPTO Guidelines
The patent adheres to the rules and guidelines set by the Patent Cooperation Treaty (PCT) and the United States Patent and Trademark Office (USPTO). The claims are clear, concise, and fully supported by the description, as required by PCT Article 6 and USPTO regulations[5].
Amendments and Examination Process
The patent has undergone several amendments during its application process, which is common in the patent examination phase. The changes made during this process have likely narrowed the scope of the claims, ensuring that the patent is granted with a clear and valid scope[3].
Key Takeaways
- Innovative Formulation: The patent introduces a once-daily extended release formulation of tacrolimus, enhancing patient compliance.
- Clear and Concise Claims: The claims are well-defined, narrow, and fully supported by the description.
- Market Impact: The new formulation can improve patient quality of life and influence market dynamics.
- Adherence to Regulations: The patent complies with PCT and USPTO guidelines.
- Economic Impact: The focused scope of the patent promotes innovation and reduces the likelihood of litigation.
FAQs
Q: What is the main innovation in United States Patent 11,110,081?
A: The main innovation is the development of an extended release oral dosage form of tacrolimus for once-daily administration.
Q: How do the claims in this patent contribute to its scope?
A: The claims define the invention clearly and concisely, with independent claims outlining the broad aspects and dependent claims providing additional specifics.
Q: What are the implications of narrow claims in patent scope?
A: Narrow claims are associated with a higher probability of grant and a shorter examination process, promoting innovation and reducing litigation.
Q: How does this patent align with PCT and USPTO regulations?
A: The patent adheres to PCT Article 6 and USPTO guidelines, ensuring that the claims are clear, concise, and fully supported by the description.
Q: What is the potential market impact of this new formulation of tacrolimus?
A: The once-daily extended release formulation can improve patient compliance and quality of life, potentially increasing market share for Veloxis Pharmaceuticals A/S.
Sources
- United States Patent and Trademark Office, "US11110081B2 - Tacrolimus for improved treatment of transplant patients," Google Patents.
- USPTO, "Patent Claims Research Dataset," USPTO Economic Research.
- Marco, Alan C., Sarnoff, Joshua D., and deGrazia, Charles, "Patent Claims and Patent Scope," SSRN.
- Google Patents, "US11110081B2 - Tacrolimus for improved treatment of transplant patients."
- USPTO, "1824-The Claims," Manual of Patent Examining Procedure (MPEP).
