Understanding the Scope and Claims of United States Patent 8,247,416
Introduction
United States Patent 8,247,416, titled "Phthalazinone derivative," is a significant patent in the field of pharmaceuticals, particularly in the context of DNA damage repair inhibitors. This patent, issued to various inventors including Martin Niall Morrison Barr, Smith Graeme Cameron, and others, is assigned to Kudos Pharmaceuticals Limited. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape it operates within.
Patent Overview
The patent US 8,247,416 was issued on August 21, 2012, and it pertains to phthalazinone derivatives, which are compounds used in the inhibition of poly(ADP-ribose) polymerase (PARP), an enzyme involved in DNA repair mechanisms[1][5].
Scope of the Patent
The scope of this patent is defined by its claims, which outline the specific compounds and their uses. Here are some key aspects:
Compounds
The patent describes a class of phthalazinone derivatives with specific chemical structures. These compounds are designed to inhibit PARP activity, which is crucial in the context of treating diseases caused by defects in DNA repair mechanisms, such as certain types of cancer[1].
Use in DNA Repair Inhibition
The patent highlights the use of these phthalazinone derivatives in the manufacture of medicaments for treating diseases caused by defects in genes that mediate homologous recombination. This is particularly relevant for cancers that have deficiencies in homologous recombination repair (HRR) pathways, such as BRCA1 and BRCA2 mutations[2].
Claims
The claims of the patent are critical as they define the boundaries of the patent owner’s rights. Here are some key points:
Independent Claims
The patent includes independent claims that describe the general structure of the phthalazinone derivatives and their use in inhibiting PARP activity. These claims are broad enough to cover a range of compounds but specific enough to ensure that the invention is clearly defined[1].
Dependent Claims
Dependent claims further specify the scope by detailing particular aspects of the compounds, such as specific substituents and their positions on the phthalazinone ring. These claims provide additional protection by covering various embodiments of the invention[1].
Patent Landscape
The patent landscape surrounding US 8,247,416 is complex and dynamic, influenced by several factors:
Related Patents
There are several related patents that cover similar or complementary aspects of PARP inhibitors and phthalazinone derivatives. For example, patents like US 8,143,241 and US 8,859,562 also relate to the use of PARP inhibitors in cancer treatment, with some overlapping but distinct claims[2].
Patent Expiration Dates
The patent US 8,247,416 has expired as of its scheduled expiration date. However, other related patents, such as those with expiration dates in 2029 and 2031, continue to shape the intellectual property landscape in this field[2].
Jurisprudence and Regulatory Environment
The scope and validity of genus claims, which are common in pharmaceutical patents, have been subject to scrutiny by the Federal Circuit. The rigid position on genus claims has made it challenging for innovators to obtain broad and meaningful patent protection without violating the enablement and written description requirements[3].
Impact on Pharmaceutical and Biotechnology Industries
The patent and its related claims have significant implications for the pharmaceutical and biotechnology industries:
Innovation and Competition
The patent's expiration allows for the potential entry of generic versions of the drug, which can increase competition and reduce costs. However, the complexity of genus claims and the need for detailed disclosure can hinder innovation by making it difficult for companies to protect their inventions without overly narrow claims[3].
Research and Development
The protection offered by this patent and others like it has driven research and development in the field of PARP inhibitors. The expiration of these patents can shift the focus towards new areas of research or the development of new compounds that fall outside the scope of existing patents[2].
Key Takeaways
- Compound Specificity: The patent US 8,247,416 specifically covers phthalazinone derivatives with defined chemical structures.
- Use in Cancer Treatment: These compounds are used to inhibit PARP activity, particularly in treating cancers with HRR deficiencies.
- Claims and Scope: The patent includes both independent and dependent claims that define the scope of protection.
- Patent Landscape: The patent is part of a broader landscape influenced by related patents and regulatory jurisprudence.
- Expiration and Impact: The patent's expiration affects the competitive landscape and innovation in the pharmaceutical industry.
FAQs
Q: What is the primary use of the phthalazinone derivatives described in US 8,247,416?
A: The primary use is in the inhibition of PARP activity, particularly for treating cancers with deficiencies in homologous recombination repair pathways.
Q: Who are the inventors and assignees of US 8,247,416?
A: The inventors include Martin Niall Morrison Barr, Smith Graeme Cameron, and others, with the patent assigned to Kudos Pharmaceuticals Limited.
Q: What is the significance of genus claims in pharmaceutical patents?
A: Genus claims are crucial as they allow for the protection of a class of compounds, but they must meet specific enablement and written description requirements to be valid.
Q: How does the expiration of US 8,247,416 affect the pharmaceutical industry?
A: The expiration can lead to the entry of generic versions, increasing competition and reducing costs, but it also shifts the focus towards new areas of research and development.
Q: What are some of the challenges faced by innovators in obtaining patent protection for pharmaceuticals?
A: Innovators face challenges in balancing broad claims with the need for detailed disclosure to meet enablement and written description requirements, as well as avoiding claims that are too narrow to be meaningful.
Sources
- US8247416B2 - Phthalazinone derivative - Google Patents
- Generic Lynparza Availability - Drugs.com
- Eviscerating Patent Scope - DigitalCommons@NYLS
- Patent 2946538 Summary - Canadian Patents Database
- Phthalazinone derivative - Patent US-8247416-B2 - PubChem
