United States Patent RE47739: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent RE47739, titled "2-(pyridin-2-ylamino)-pyrido[2,3-D]pyrimidin-7-ones," is a reissued patent that has significant implications in the field of pharmaceuticals, particularly in the treatment of cell proliferative disorders. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Inventors and Assignees
The patent was invented by a team of researchers including Mark Barvian, Richard John Booth, John Quinn III, Joseph Thomas Repine, Derek J. Sheehan, Peter Lawrence Toogood, Scott Norman Vanderwel, and Hairong Zhou. The assignee of this patent is Warner-Lambert Company LLC, which is now a part of Pfizer Inc.[2][4].
Scope of the Invention
The patent covers a class of substituted 2-amino pyridines that are potent inhibitors of cyclin-dependent kinase 4 (cdk4). These compounds are particularly useful in treating cell proliferative diseases such as cancer and restenosis, as well as inflammation. Cyclin-dependent kinases play a crucial role in regulating cell division and proliferation, making inhibitors of these kinases valuable therapeutic agents[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention. Key claims include:
- The chemical structure of the substituted 2-amino pyridines, specifically the 2-(pyridin-2-ylamino)-pyrido[2,3-D]pyrimidin-7-ones.
- The method of using these compounds as inhibitors of cdk4.
- The therapeutic applications of these compounds in treating cell proliferative disorders and inflammation[4].
Patent Expiration and Extensions
The original patent was set to expire earlier, but a patent term extension (PTE) was granted under the Drug Price Competition and Patent Term Restoration Act of 1984. This extension prolonged the patent term by more than four years, until March 5, 2027[5].
Pharmacological Significance
The compounds described in this patent are significant because they target cdk4, an enzyme critical in the cell cycle. By inhibiting cdk4, these compounds can halt or slow down the proliferation of cancer cells, making them valuable in cancer therapy. This mechanism is similar to that of other cdk inhibitors, such as palbociclib (Ibrance), which is also used in cancer treatment[4].
Market Impact
The extension of the patent term for RE47739 has significant market implications. It allows Pfizer to maintain exclusivity over the use of these compounds for a longer period, potentially delaying the entry of generic versions into the market. This can impact the pricing and availability of these critical therapeutic agents[5].
Competitive Landscape
In the context of cancer treatment, the competitive landscape includes other cdk inhibitors like palbociclib (Ibrance), which is also developed by Pfizer. The approval of generic versions of such drugs can significantly alter the market dynamics, but the extended patent term for RE47739 ensures that Pfizer retains a competitive edge for a longer period[2].
Regulatory Framework
The patent term extension was granted under the provisions of the Drug Price Competition and Patent Term Restoration Act of 1984. This act allows for the restoration of patent term lost due to regulatory delays, ensuring that pharmaceutical companies have sufficient time to recoup their investment in research and development[5].
Technological Advancements
The development of these compounds represents a technological advancement in the field of oncology. The precise targeting of cdk4 by these inhibitors highlights the progress in understanding cellular mechanisms and the ability to design specific therapeutic agents to intervene in these processes[4].
Economic Implications
The extended patent term can have economic implications, both for Pfizer and for the healthcare system. It can influence the cost of treatment, as generic alternatives may not be available until the patent expires. This can also impact the research and development investments by other companies, as they may need to wait longer to develop similar or competing products[5].
Legal Considerations
The interpretation of patent claims and the scope of the patent are critical legal considerations. Changes in interpretation methodologies can affect the patent scope, as discussed in the context of the "claim scope paradigm." This concept is important for evaluating the impact of different interpretation methodologies on the substantive function of patent claims[3].
Conclusion and Future Outlook
United States Patent RE47739 is a pivotal patent in the field of oncology, providing potent inhibitors of cdk4 that are crucial in treating cell proliferative diseases. The extended patent term ensures Pfizer's continued exclusivity, but it also underscores the need for ongoing research and development in this area to address the evolving needs of cancer treatment.
Key Takeaways
- The patent covers substituted 2-amino pyridines that inhibit cdk4.
- These compounds are used in treating cell proliferative diseases and inflammation.
- The patent term has been extended until March 5, 2027.
- The invention has significant pharmacological and market implications.
- The regulatory framework supports patent term extensions for pharmaceuticals.
- The patent landscape is influenced by technological advancements and economic considerations.
FAQs
What is the main therapeutic application of the compounds described in US Patent RE47739?
The main therapeutic application is the treatment of cell proliferative diseases such as cancer and restenosis, as well as inflammation.
Who are the inventors and assignees of US Patent RE47739?
The inventors include Mark Barvian, Richard John Booth, John Quinn III, and others, with Warner-Lambert Company LLC (now part of Pfizer Inc.) as the assignee.
What is the significance of the patent term extension for US Patent RE47739?
The patent term extension allows Pfizer to maintain exclusivity over the use of these compounds until March 5, 2027, potentially delaying the entry of generic versions.
How do the compounds described in this patent work?
The compounds work by inhibiting cyclin-dependent kinase 4 (cdk4), an enzyme critical in the cell cycle, thereby halting or slowing down the proliferation of cancer cells.
What is the competitive landscape for cdk inhibitors like those described in US Patent RE47739?
The competitive landscape includes other cdk inhibitors like palbociclib (Ibrance), also developed by Pfizer, with generic versions potentially entering the market once the patent expires.
Cited Sources:
- United States Reissued Patent RE47739 - Google Patents
- Generic Ibrance Availability - Drugs.com
- Patent Claim Interpretation Methodologies and Their Claim Scope - SSRN
- USRE47739E1 - 2-(pyridin-2-ylamino)-pyrido[2,3-D]pyrimidin-7-ones - Google Patents
- Pfizer Confirms U.S. Patent Term Extension for IBRANCE® (palbociclib) Until March 2027 - Pfizer News