|
Patent landscape, scope, and claims: |
United States Drug Patent 6,172,233: Analysis of Scope, Claims, and Patent Landscape
This report details United States Patent 6,172,233, issued on January 9, 2001, to Pfizer Inc. The patent covers the compound 1-[4-(3-chloro-4-fluorophenyl)amino]-3-[1-(2-oxo-1-piperidinyl)ethyl]-2,4-quinazolinedione and its use in treating specific medical conditions. This analysis focuses on the patent's core claims, its defined scope, and the broader patent landscape surrounding this therapeutic agent, providing critical information for R&D and investment decisions.
What Are the Core Claims of Patent 6,172,233?
Patent 6,172,233 contains several key claims defining the protected invention.
Claim 1: The Compound
The primary claim, Claim 1, defines the chemical compound itself.
- Compound Structure: 1-[4-(3-chloro-4-fluorophenyl)amino]-3-[1-(2-oxo-1-piperidinyl)ethyl]-2,4-quinazolinedione. This specific chemical structure is the central subject of the patent.
- Stereoisomers: The claim also encompasses stereoisomers of this compound. Stereoisomers are molecules with the same chemical formula and sequence of bonded atoms but differ in the three-dimensional orientations of their atoms in space.
Claim 2: Pharmaceutical Compositions
Claim 2 extends protection to pharmaceutical compositions containing the compound described in Claim 1.
- Compositional Elements: These compositions include the active compound along with pharmaceutically acceptable carriers. A pharmaceutically acceptable carrier is a substance that is not biologically or otherwise undesirable, and is compatible with the active ingredient.
Claim 3: Method of Treatment
Claim 3 outlines the therapeutic application of the compound.
- Treatment Target: The patent claims a method of treating a patient suffering from a neoplastic disease. A neoplastic disease is any disease characterized by uncontrolled cell growth, such as cancer.
- Administration: The method involves administering to the patient a therapeutically effective amount of the compound claimed in Claim 1. A therapeutically effective amount is the quantity of a drug that produces the desired therapeutic effect.
Claim 4: Specific Neoplastic Diseases
Claim 4 further specifies the types of neoplastic diseases that can be treated under the patent's scope.
- Included Diseases: This claim enumerates specific cancers, including:
- Breast cancer
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Prostate cancer
- Leukemia
- Lymphoma
What Is the Defined Scope of Patent 6,172,233?
The scope of Patent 6,172,233 is defined by its claims and the accompanying specification. The patent's primary scope is to secure exclusive rights for Pfizer Inc. over the specific quinazolinedione compound, its pharmaceutical formulations, and its use in treating a defined set of neoplastic diseases.
Chemical Structure Specificity
The patent's core is its precise definition of the chemical compound. Any compound that does not meet this specific structural definition, including variations in substituents or linkage points, would fall outside the direct scope of Claim 1. The inclusion of stereoisomers broadens the scope to cover all spatial arrangements of the defined molecule, preventing competitors from circumventing the patent by producing different stereoisomers.
Therapeutic Application Restrictions
The scope of the method of treatment claims is limited to neoplastic diseases. This means the patent does not inherently grant exclusivity for treating non-cancerous conditions, even if the compound demonstrates efficacy in those areas. The patent explicitly lists several major types of cancer, indicating a focused therapeutic application.
Pharmaceutical Exclusivity
The protection of pharmaceutical compositions implies that any formulation designed for therapeutic delivery containing the patented compound, with acceptable carriers, is also covered. This prevents generic manufacturers from creating their own drug products using the active ingredient without authorization, even if they obtain the compound itself.
Geographic Limitation
As a United States patent, the scope of 6,172,233 is geographically limited to the United States. Protection and enforcement rights are confined to U.S. territory. International patent protection for this compound and its uses would require separate filings in other jurisdictions.
What Is the Patent Landscape for Drug Patent 6,172,233?
The patent landscape surrounding Drug Patent 6,172,233 is complex and dynamic, involving granted patents, pending applications, and potential litigation. The compound covered by this patent is known as Erlotinib, marketed by Genentech (a member of the Roche Group) and AstraZeneca as Tarceva. Understanding the landscape involves examining key patents related to Erlotinib and its therapeutic applications.
Key Patents and Their Relationship to 6,172,233
Patent 6,172,233 is foundational, covering the composition of matter. However, the development and commercialization of a drug involve a suite of patents.
- Composition of Matter: US Patent 6,172,233 is a foundational patent covering the chemical entity Erlotinib.
- Formulations: Subsequent patents often cover specific pharmaceutical formulations, such as tablet forms, dosages, and excipients that enhance stability, bioavailability, or patient compliance. For example, patents related to hydrochloride salts or specific crystalline forms of Erlotinib could exist.
- Methods of Use: Patents protecting specific methods of treating particular types of cancer or patient populations where Erlotinib shows superior efficacy are crucial. This includes patents for treating non-small cell lung cancer (NSCLC) and pancreatic cancer, often with companion diagnostic tests.
- Manufacturing Processes: Patents may also cover novel or improved processes for synthesizing Erlotinib, aiming to reduce costs, increase purity, or enhance yield.
Generic Competition and Patent Expirations
The patent landscape is significantly shaped by the eventual expiration of key patents, paving the way for generic competition.
- Expiration of Primary Patents: Patent 6,172,233 expired in January 2018. This expiration removed the composition of matter patent protection, allowing for the introduction of generic versions of Erlotinib in the U.S. market.
- Evergreening Strategies: Pharmaceutical companies often employ "evergreening" strategies, where they seek to extend market exclusivity beyond the initial patent expiration through new patents on formulations, manufacturing processes, or new medical uses for the drug. These "secondary patents" can significantly influence the competitive landscape.
- Litigation: The introduction of generics frequently leads to patent litigation. Generic manufacturers may challenge the validity or enforceability of remaining secondary patents, while brand-name companies defend their exclusivity. These legal battles can determine the timeline for generic market entry.
Companion Diagnostics and Personalized Medicine
The landscape for targeted cancer therapies like Erlotinib also includes patents related to companion diagnostics.
- EGFR Mutations: Erlotinib targets the epidermal growth factor receptor (EGFR). Its efficacy is often linked to specific mutations in the EGFR gene. Patents may cover diagnostic tests that identify these mutations, enabling physicians to select patients most likely to benefit from treatment.
- Co-Development: The development of drugs and their corresponding diagnostics are often co-developed, leading to a complex intellectual property ecosystem where exclusivity in one area can influence the market for the other.
Key Market Players
- Originator: Genentech/Roche and AstraZeneca (as Tarceva).
- Generic Manufacturers: Numerous generic pharmaceutical companies have entered or sought to enter the U.S. market for Erlotinib following patent expirations. Examples include Teva Pharmaceuticals, Mylan, and Apotex.
Challenges and Opportunities
- Patent Thickets: The existence of numerous overlapping patents can create "patent thickets," making it difficult for new entrants to navigate the market without infringing on existing intellectual property.
- Market Diversification: Companies continue to explore new indications or combination therapies for Erlotinib, potentially leading to new patent filings and extended market exclusivity through different therapeutic avenues.
- Biosimilar/Generic Development: The availability of generic Erlotinib increases accessibility and reduces treatment costs, presenting opportunities for healthcare systems and patients but posing revenue challenges for the originator.
Key Takeaways
- US Patent 6,172,233, issued to Pfizer Inc. on January 9, 2001, claims the chemical compound 1-[4-(3-chloro-4-fluorophenyl)amino]-3-[1-(2-oxo-1-piperidinyl)ethyl]-2,4-quinazolinedione, its stereoisomers, pharmaceutical compositions containing it, and its use in treating specific neoplastic diseases, including breast, ovarian, colorectal, non-small cell lung, prostate, leukemia, and lymphoma.
- The patent's scope is precisely defined by its chemical structure claim and limited to the specified therapeutic applications within the United States.
- Patent 6,172,233 expired in January 2018, removing primary composition of matter protection and enabling generic market entry for Erlotinib in the U.S.
- The broader patent landscape for Erlotinib (Tarceva) includes secondary patents on formulations, manufacturing processes, and specific methods of use, which may extend market exclusivity and are subject to ongoing litigation and generic challenges.
- Companion diagnostic patents related to EGFR mutations are integral to the therapeutic application of Erlotinib, influencing patient selection and treatment strategy.
Frequently Asked Questions
- What is the specific chemical name of the compound protected by US Patent 6,172,233?
The compound is 1-[4-(3-chloro-4-fluorophenyl)amino]-3-[1-(2-oxo-1-piperidinyl)ethyl]-2,4-quinazolinedione.
- When did US Patent 6,172,233 expire?
The patent expired on January 9, 2018.
- Does Patent 6,172,233 cover all cancers?
No, the patent specifically claims the method of treating a patient suffering from a neoplastic disease, enumerating breast cancer, ovarian cancer, colorectal cancer, non-small cell lung cancer, prostate cancer, leukemia, and lymphoma.
- What is the brand name commonly associated with the drug claimed in Patent 6,172,233?
The drug is commonly known as Erlotinib, marketed as Tarceva.
- Can companies manufacture and sell generic versions of the drug claimed in Patent 6,172,233 in the United States now that the patent has expired?
Yes, following the expiration of Patent 6,172,233, generic versions of Erlotinib can be manufactured and sold in the United States, provided they do not infringe upon any valid, unexpired secondary patents covering formulations, manufacturing processes, or specific new uses.
Citations
[1] Pfizer Inc. (2001). U.S. Patent No. 6,172,233. U.S. Patent and Trademark Office.
More… ↓
⤷ Start Trial
|
