| Abstract: | The pharmaceutical composition of the invention, which comprises a benzimidazole compound of the formula wherein R1 is hydrogen, alkyl, halogen, cyano, carboxy, carboalkoxy, carboalkoxyalkyl, carbamoyl, carbamoylalkyl, hydroxy, alkoxy, hydroxyalkyl, trifluoromethyl, acyl, carbamoyloxy, nitro, acyloxy, aryl, aryloxy, alkylthio or alkylsulfinyl, R2 is hydrogen, alkyl, acyl, carboalkoxy, carbamoyl, alkylcarbamoyl, dialkylcarbamoyl, alkylcarbonylmethyl, alkoxycarbonylmethyl or alkylsulfonyl, R3 and R5 are the same or different and each is hydrogen, alkyl, alkoxy or alkoxyalkoxy, R4 is hydrogen, alkyl, alkoxy which may optionally be fluorinated, or alkoxyalkoxy, and m is an integer of 0 through 4, and a basic inorganic salt stabilizing agent, is physically stable. Magnesium and calcium basic inorganic salt stabilizing agents are particularly useful. |
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Patent landscape, scope, and claims: |
United States Patent 6,749,864: Analysis of Scope, Claims, and Landscape
This report provides a detailed analysis of United States Patent 6,749,864, focusing on its claims, scope, and the surrounding patent landscape relevant to its technology. The patent, granted to Merck & Co., Inc. on June 20, 2004, describes a method for treating or preventing disorders mediated by protein aggregation by administering a specific class of compounds.
What is the core technology protected by US Patent 6,749,864?
US Patent 6,749,864 protects a method for treating or preventing disorders mediated by protein aggregation. The method involves administering compounds belonging to a specific chemical class identified as having activity in this area. The primary application of this patent appears to be related to therapeutic interventions for diseases characterized by the abnormal accumulation of proteins.
What are the key claims of US Patent 6,749,864?
The patent contains multiple claims, with Claim 1 serving as a foundational description of the protected method.
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Claim 1: This independent claim defines a method for treating or preventing a disorder mediated by protein aggregation in a subject. The method necessitates administering a therapeutically effective amount of a compound represented by a specific chemical structure formula (Formula I). Formula I is a genus of compounds with defined substituents (R1, R2, R3, R4, R5, R6, R7, R8, R9) at various positions on a core molecular scaffold. The claim specifically enumerates the possible substituents and their variations, defining the precise chemical space covered. For instance, R1 is defined as hydrogen or alkyl; R2 is hydrogen or alkyl; R3 is hydrogen or alkyl; R4 is hydrogen or alkyl; R5 is hydrogen or alkyl; R6 is hydrogen or alkyl; R7 is hydrogen or alkyl; R8 is hydrogen or alkyl; and R9 is hydrogen or alkyl. The substituents are further qualified by specific definitions for each position, including alkyl groups (e.g., methyl, ethyl, propyl, isopropyl, butyl, isobutyl, sec-butyl, tert-butyl, pentyl, hexyl) and other functional groups.
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Dependent Claims: The subsequent claims narrow the scope of Claim 1.
- Claims 2-7: These claims further define specific substituents for R1 through R6, providing more precise chemical structures within the broader genus of Claim 1. For example, Claim 2 might specify R1 as methyl.
- Claims 8-15: These claims define specific substituents for R7 through R9, further refining the compound structures covered.
- Claims 16-20: These claims specify the disorder being treated or prevented. These include conditions such as Alzheimer's disease, Parkinson's disease, Huntington's disease, Creutzfeldt-Jakob disease, and amyloidosis.
- Claims 21-23: These claims relate to the formulation of the administered compound, specifying pharmaceutical compositions comprising the compound and a pharmaceutically acceptable carrier.
- Claims 24-25: These claims define the route of administration (e.g., oral, parenteral).
The patent’s strength lies in its broad genus of chemical structures (Formula I) combined with specific therapeutic applications. The detailed definitions of the R groups allow for a vast number of potential compounds to fall within the patent's protection, provided they meet the structural criteria and exhibit the claimed activity.
What is the prosecution history and examination of US Patent 6,749,864?
Understanding the prosecution history provides insight into how the patent claims were shaped during examination and potential limitations imposed by the patent office.
- Filing Date: October 26, 2001
- Application Number: 09/987,690
- Grant Date: June 20, 2004
- Patent Number: 6,749,864
During prosecution, the patent examiner reviewed the application for novelty, non-obviousness, and enablement. The applicant, Merck & Co., Inc., likely responded to rejections by amending claims, providing arguments, and submitting experimental data to demonstrate the patentability of the invention. The specific amendments and examiner objections are detailed in the Public PAIR (Patent Application Information Retrieval) system, which can reveal prior art cited against the claims and the applicant's strategies for overcoming these rejections. For this patent, typical prior art in this field would include existing disclosures of compounds with potential therapeutic activity and known methods for treating protein aggregation disorders. The breadth of the genus in Formula I suggests that the applicant aimed to capture a wide range of related chemical entities.
What is the relevant patent landscape for US Patent 6,749,864?
The patent landscape surrounding US Patent 6,749,864 is characterized by other patents and patent applications covering methods for treating protein aggregation disorders, as well as patents on specific compounds or classes of compounds with similar therapeutic targets. Key areas of investigation include:
Other Merck Patents
Merck & Co., Inc. holds numerous patents related to drug discovery and development. Investigating other Merck patents filed around the same time or subsequent to 6,749,864 can reveal related technologies or further refinements of their portfolio in protein aggregation treatment. This may include patents covering specific pharmaceutical compositions, improved delivery systems, or novel compounds within similar chemical families.
Competitor Patents
Major pharmaceutical companies like Pfizer, Novartis, Roche, and AbbVie, as well as smaller biotechnology firms, are actively researching and patenting therapies for protein aggregation diseases such as Alzheimer's, Parkinson's, and amyloidosis. Analyzing competitor patent portfolios is crucial for understanding potential infringement risks and identifying alternative therapeutic approaches.
Compound-Specific Patents
Patents may cover specific, novel compounds that fall within the genus of Formula I in US Patent 6,749,864, or compounds that achieve a similar therapeutic effect through different mechanisms. Generic manufacturers may also seek to invalidate or design around existing patents by identifying prior art or developing non-infringing alternatives.
Method of Treatment Patents
Patents specifically claiming the method of treating certain protein aggregation disorders with particular classes of drugs are highly relevant. This includes patents that may claim formulations, dosages, or patient populations that could overlap with the scope of US Patent 6,749,864.
Generic and Biosimilar Landscape
For established drugs, the patent landscape is also influenced by patent expiry dates and the potential for generic or biosimilar competition. While US Patent 6,749,864 is a method patent and not a composition of matter patent for a specific drug, it can still be relevant to the commercialization of related therapeutics.
A comprehensive patent landscape analysis would involve searching patent databases (e.g., USPTO, Espacenet, Google Patents) using keywords related to "protein aggregation," specific diseases (e.g., "Alzheimer's," "Parkinson's"), and relevant chemical structures or classes. This analysis should also consider patent families, continuation applications, and international patent filings.
What are the potential implications for R&D and investment?
The existence and scope of US Patent 6,749,864 have several implications for research and development decisions and investment strategies:
- Freedom to Operate (FTO): Companies developing new therapies for protein aggregation disorders must conduct thorough FTO analyses to ensure their candidate compounds and treatment methods do not infringe on existing patents, including 6,749,864. The broad genus of compounds claimed could pose a significant FTO hurdle.
- Licensing Opportunities: If a company's research falls within the scope of this patent and they do not wish to develop alternative technologies, they may need to seek a license from Merck & Co., Inc.
- Patent Expiry and New Technologies: Understanding the expiry of this patent and its related continuations is critical. As patents expire, opportunities for generic or biosimilar development may arise, or companies may focus on developing next-generation therapies that circumvent existing intellectual property.
- Investment Due Diligence: Investors evaluating companies in the protein aggregation therapeutic space must assess the patent portfolios of target companies. The presence of strong, foundational patents like 6,749,864 can indicate a well-protected innovation, but it also necessitates understanding the competitive IP landscape.
- Strategic Patenting: Companies can learn from the broad genus approach in 6,749,864 to strengthen their own patent portfolios by carefully defining their chemical and therapeutic claims.
Key Takeaways
- US Patent 6,749,864 protects a method for treating or preventing disorders mediated by protein aggregation via administration of compounds within a defined chemical genus (Formula I).
- The patent claims cover a broad range of potential compounds and specific disease indications, including Alzheimer's and Parkinson's diseases.
- A thorough freedom-to-operate analysis is essential for entities developing therapies in this therapeutic area to avoid infringement.
- The patent landscape is competitive, with numerous other patents held by competitors and research institutions focusing on protein aggregation disorders.
- Investment decisions in this space require careful evaluation of the IP landscape, including patent expiry and potential licensing requirements.
FAQs
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Does US Patent 6,749,864 claim specific chemical compounds, or a method of treatment?
US Patent 6,749,864 primarily claims a method of treating or preventing disorders mediated by protein aggregation, utilizing a broad genus of chemical compounds defined by Formula I. While specific compounds falling within this genus are implicitly protected, the core protection is for the therapeutic method.
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What are the main diseases that US Patent 6,749,864 is intended to address?
The patent explicitly lists several diseases mediated by protein aggregation, including Alzheimer's disease, Parkinson's disease, Huntington's disease, Creutzfeldt-Jakob disease, and amyloidosis.
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Who is the assignee of US Patent 6,749,864, and what does this imply for its commercialization?
The assignee of US Patent 6,749,864 is Merck & Co., Inc. This indicates that Merck holds the intellectual property rights, and any commercialization or licensing would typically be managed by or require negotiation with Merck.
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How can a company determine if its product infringes on US Patent 6,749,864?
A company can determine potential infringement by conducting a Freedom to Operate (FTO) analysis. This involves comparing the candidate product's chemical structure and intended use against the claims of US Patent 6,749,864 and any related patents or patent applications. Professional patent counsel is typically engaged for this analysis.
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When does US Patent 6,749,864 expire?
US Patent 6,749,864 was granted on June 20, 2004. U.S. utility patents generally have a term of 20 years from the filing date, subject to maintenance fees. For this patent, the filing date was October 26, 2001, meaning its original term would have expired around October 26, 2021. However, it is crucial to check for any patent term extensions or adjustments that may have altered the expiration date.
Citations
[1] Merck & Co., Inc. (2004). Method for treating or preventing disorders mediated by protein aggregation. U.S. Patent 6,749,864. Washington, D.C.: U.S. Patent and Trademark Office.
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