United States Patent RE41783: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent RE41783, titled "Pyrrolo[2,3-D]pyrimidine compounds," is a reissue patent assigned to GlaxoSmithKline Intellectual Property Development Ltd. This patent is significant in the pharmaceutical industry, particularly in the development of inhibitors for protein kinases. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Priority Date
The patent RE41783 has a priority date of July 13, 1996, indicating that the original application was filed over two decades ago. This long history highlights the ongoing relevance and importance of the compounds described in the patent[5].
Chemical Structure and Compounds
The patent describes pyrrolo[2,3-D]pyrimidine compounds, which are characterized by specific chemical structures. These compounds are defined by various substituents (R1, R2, and R3) that can vary, leading to a range of conformational isomers, enantiomers, and diastereomers. The invention also includes tautomers and pharmaceutical compositions containing these compounds or their prodrugs[1].
Claims and Scope
Inhibitors of Protein Kinases
The primary claim of the patent is the use of these pyrrolo[2,3-D]pyrimidine compounds as inhibitors of protein kinases, specifically Janus Kinase 3 (JAK3). Protein kinases are enzymes that play crucial roles in cellular signaling pathways, and inhibiting them can be therapeutic for various diseases[1].
Pharmaceutical Applications
The patent encompasses pharmaceutical compositions and methods for treating or preventing a wide range of disorders, including organ transplant rejection, lupus, multiple sclerosis, rheumatoid arthritis, psoriasis, Type I diabetes, cancer, asthma, atopic dermatitis, autoimmune thyroid disorders, ulcerative colitis, Crohn's disease, Alzheimer's disease, and leukemia. These applications underscore the broad therapeutic potential of the compounds[1].
Stereochemistry and Tautomers
The patent includes all optical isomers and stereoisomers of the compounds, as well as their mixtures and tautomers. This comprehensive approach ensures that all possible forms of the compounds are covered, maximizing their therapeutic utility[1].
Patent Landscape
Validity and Enforceability
Patents like RE41783 are subject to litigation and challenges regarding their validity and enforceability. Similar patents in the pharmaceutical sector have been upheld in court, such as in cases involving Otsuka Pharmaceutical Co., Ltd. and Allergan, Inc., where the patents were found valid and enforceable against generic manufacturers[2].
Settlements and Litigation
The patent landscape is also shaped by settlement agreements and litigation outcomes. For instance, settlements in ANDA (Abbreviated New Drug Application) litigation often result in generic manufacturers being enjoined from infringing the patents until their expiration, unless a license is granted. This ensures that the patent holder maintains exclusivity over the market for the patented compounds[2].
Patent Scope and Examination Process
Research on patent scope indicates that the examination process tends to narrow the scope of patent claims. This is evident from studies showing that narrower claims at publication are associated with a higher probability of grant and a shorter examination process. The scope of RE41783, therefore, would have been carefully defined and refined during the examination process to ensure its validity and enforceability[3].
Impact on Innovation and Research
Promoting Scientific Progress
The patent system is designed to promote scientific progress by providing incentives for innovation. By granting protection to early-stage inventions like the pyrrolo[2,3-D]pyrimidine compounds, the patent system encourages further research and development in these areas. This is particularly important in unpredictable fields where basic research may not immediately yield practical applications[4].
Utility and Patentability
The utility requirement for patentability is a critical aspect of patent law. For research inputs like the compounds described in RE41783, the utility must be demonstrated, even if the practical application is not immediately clear. This ensures that the patent system supports the development of valuable research inputs that can lead to significant therapeutic advancements[4].
Key Takeaways
- Broad Therapeutic Applications: The pyrrolo[2,3-D]pyrimidine compounds covered by RE41783 have a wide range of therapeutic applications, including autoimmune diseases, cancer, and other significant health conditions.
- Inhibition of Protein Kinases: The primary therapeutic mechanism involves the inhibition of protein kinases, particularly JAK3, which is crucial for treating various diseases.
- Comprehensive Coverage: The patent includes all optical isomers, stereoisomers, tautomers, and pharmaceutical compositions, ensuring maximum therapeutic utility.
- Patent Validity and Enforceability: The patent has been subject to the rigorous examination process and is likely to be upheld in litigation, ensuring exclusivity for the patent holder.
- Impact on Innovation: The patent promotes scientific progress by providing incentives for further research and development in the field of protein kinase inhibitors.
FAQs
What are the primary therapeutic targets of the compounds described in RE41783?
The primary therapeutic targets are protein kinases, specifically Janus Kinase 3 (JAK3), which are involved in various cellular signaling pathways.
What diseases can be treated using the compounds described in RE41783?
The compounds can be used to treat or prevent a range of diseases, including organ transplant rejection, lupus, multiple sclerosis, rheumatoid arthritis, psoriasis, Type I diabetes, cancer, asthma, atopic dermatitis, autoimmune thyroid disorders, ulcerative colitis, Crohn's disease, Alzheimer's disease, and leukemia.
How does the patent landscape affect the exclusivity of RE41783?
The patent landscape, including litigation and settlement agreements, ensures that the patent holder maintains exclusivity over the market for the patented compounds until the patent expires, unless a license is granted.
What is the significance of including all optical isomers and stereoisomers in the patent?
Including all optical isomers and stereoisomers maximizes the therapeutic utility of the compounds by covering all possible forms, which can have different biological activities.
How does the patent system support the development of early-stage inventions like those described in RE41783?
The patent system provides incentives for innovation by granting protection to early-stage inventions, encouraging further research and development even in unpredictable fields.
Sources
- USRE41783E1 - Pyrrolo[2,3-D]pyrimidine compounds - Google Patents
- ANDA Litigation Settlements | Hatch-Waxman - Robins Kaplan
- Patent Claims and Patent Scope - Hoover Institution
- The Research Patent - Scholarship@Vanderbilt Law
- US-RE41783-E1 - Unified Patents Portal
