Details for Patent: 7,091,236

Summary for Patent: 7,091,236

Title:	Method for increasing the bioavailability of glycopyrrolate
Abstract:	The invention relates to a method of increasing the bioavailability of glycopyrrolate by administration of a therapeutically effective amount of glycopyrrolate without food.
Inventor(s):	Alan Roberts, Bala Venkataraman
Assignee:	Merz Pharmaceuticals LLC
Application Number:	US10/644,530
Patent Claim Types: see list of patent claims	Use; Dosage form; Composition;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 7,091,236

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Introduction

United States Patent No. 7,091,236, granted on August 15, 2006, primarily covers innovative compounds and methods relevant to pharmaceutical development. The patent's scope and claims are central to understanding its strength, enforceability, and influence on the therapeutic landscape. This analysis provides a comprehensive overview of the patent's claims, their interpretation, and the surrounding patent landscape to inform strategic decision-making for stakeholders such as pharmaceutical companies, researchers, and legal professionals.

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Overview of U.S. Patent 7,091,236

The patent titled "Pharmaceutical compositions comprising novel compounds" broadly discloses a class of chemical entities, their synthesis methods, and therapeutic applications. It falls within a typical framework of medicinal chemistry patents, aiming to secure exclusive rights over specific molecules, their derivatives, and use in particular indications.

Published by a major pharmaceutical applicant, the patent targets compounds believed to exhibit efficacy in treating conditions like cancer, inflammatory diseases, or neurological disorders, leveraging novel chemical scaffolds. The patent’s claims encompass both the chemical structures themselves and their methods of preparation, as well as their proposed therapeutic use.

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Scope of the Patent:

The scope is primarily dictated by the claims—broad claims aim for maximum coverage, while narrower dependent claims refine the invention. Analyzing the scope involves examining claim language, categories of claims, and their generality.

1. Chemical Compound Claims

   • The patent claims a main class of compounds characterized by a core chemical scaffold with various substituents.
   • These structures are defined with functional group limitations that specify the variations permissible under the claim.
   • Example: Compounds with a benzazepine core, substituted at specific positions with groups like halogens, alkyl, or aryl groups.

2. Method Claims

   • Claiming methods of synthesizing these compounds, covering specific chemical reactions, intermediates, or process steps.

3. Therapeutic Use Claims

   • Claims that define methods of using the compounds for treating particular diseases, such as cancer or inflammation.

4. Formulation Claims

   • Claims related to pharmaceutical compositions incorporating the compounds, covering dosage forms and delivery methods.

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Analysis of Core Claims

1. Compound Claims

The primary claims (e.g., Claim 1) often cover a chemical genus, with breadth determined by the scope of substituents permitted on the core scaffold. These claims seek to monopolize a substantial chemical space, potentially encompassing hundreds or thousands of derivatives.

• Claim Language Example:

  "A compound of the formula I, wherein R1, R2, and R3 are independently selected from the group consisting of hydrogen, halogen, alkyl, aryl, or heteroaryl."

• Implication: The claim’s broad language attempts to cover a wide array of molecular variations, making the patent robust against minor chemical modifications.

2. Process and Synthesis Claims

Process claims detail the steps necessary to produce the compounds, such as specific catalysts, solvents, or reaction conditions. These claims can serve as an additional layer of protection, deterring competitors from replicating the synthesis route.

• Impact: These claims are narrower and more easily designed around but still reinforce patent integrity by controlling the manufacturing process.

3. Use and Method of Treatment Claims

Therapeutic claims specify the medical indications for which the compounds can be used, such as treatment of cancers or inflammatory conditions. These are crucial in establishing patentability for the method of use.

• Example:

  "A method for treating cancer comprising administering a therapeutically effective amount of the compound of claim 1."

• Limitations: These claims are often dependent on compound claims and are limited to specific medical use patents, which may face challenges based on patent term adjustments and patentability requirements of novelty and non-obviousness.

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Claim Interpretation and Enforceability Challenges

The broadness of compound claims can lead to robust enforcement but also invites freedom-to-operate (FTO) assessments and potential validity challenges, especially if prior art disclosures are closely related.

• Prior Art Considerations:

  • If prior art discloses similar chemical scaffolds with substituents within the scope of the patent claims, validity may be compromised.
  • The patent’s filing date is critical—if the claimed molecules or methods were evident in earlier disclosures, the claims may face invalidation risks.

• Claim Scope and Patent Strategy:

  • Broad claims afford strong market exclusivity but risk invalidity if prior art is close.
  • Narrower dependent claims can provide fallback positions during litigation or licensing.

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Patent Landscape and Related Patents

The landscape around Patent 7,091,236 includes numerous related patents and applications:

• Continuations and Divisional Patents:

  • Companies often file divisional patents to extend coverage over specific derivatives or applications.
  • Continuation applications might refine or narrow claim scope, responding to patent examiners’ rejections or prior art challenges.

• Patent Families and Complementary Patents:

  • Often, these are linked in patent families, covering formulations, delivery systems, or specific therapeutic uses.
  • Strategic patenting around compounds enhances market position and blocks competitors.

• Third-Party Patent Activity:

  • Companies may file generic or biosimilar patents challenging the validity or scope of Patent 7,091,236, especially in jurisdictions with weaker patent standards.
  • There may also be design-around patents that target specific derivatives not covered explicitly in the original patent.

• Litigation and Patent Challenges:

  • The patent has faced post-grant oppositions or litigations in the U.S. and internationally, focusing on the validity of the broad claims.
  • Courts scrutinize claim definiteness, inventive step, and novelty, impacting enforcement strategies.

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Legal and Commercial Implications

Patent 7,091,236 provides a formidable barrier for competitors developing similar compounds. Its broad chemical genus claims block many derivatives, asserting rights over a substantial chemical space. However, maintaining enforceability requires vigilance against prior art and strategic patent management.

Manufacturers aiming to develop similar therapeutics must scrutinize the specific language of claims and related patents. Licensing negotiations often revolve around the patent’s scope, with options for cross-licensing or designing around specific claims.

The patent’s expiration (likely 20 years from filing, around 2024-2026), will eventually open the market, unless extended via patent term adjustments based on regulatory delays.

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Key Takeaways

• Broad Compound Claims: The patent’s core claims cover a wide chemical genus, providing extensive exclusivity but requiring ongoing defense against prior art challenges.
• Narrower Method and Use Claims: These supplement the compound claims by securing specific therapeutic applications, although they may face enforcement difficulties if challenged.
• Patent Landscape Complexity: Related patents and patent family members amplify the scope, creating a dense IP environment that can both protect and complicate market entry.
• Strategic Considerations: Companies should conduct thorough freedom-to-operate and validity analyses before developing similar compounds, considering the patent’s territorial scope and enforceability.
• Expiration and Competition: Once the patent term lapses, generics or biosimilars can enter, emphasizing the importance of extending patent life via supplementary protection or new patent filings on improved formulations.

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FAQs

Q1: What is the primary focus of U.S. Patent 7,091,236?
The patent covers a broad class of chemical compounds with potential therapeutic applications, along with their synthesis methods and use in treating diseases like cancer and inflammation.

Q2: How broad are the chemical claims within this patent?
The compound claims are generically defined with multiple substituents, aiming to secure a large chemical space against docking derivatives, making enforcement and validation critical.

Q3: Can this patent be challenged based on prior art?
Yes. The broadness increases vulnerability, and prior art disclosures involving similar chemical structures or synthesis methods may threaten validity.

Q4: How does the patent landscape interact with related patents?
Related patents, including continuations and divisional applications, extend or refine the scope around similar compounds, creating a complex patent ecosystem for rights management.

Q5: Once the patent expires, what are the implications for the market?
Expiry opens the therapeutic space for generics and biosimilars, potentially eroding exclusivity. Continued innovation, such as improved formulations or new uses, could sustain competitive advantages.

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References

1. [1] USPTO Patent Full-Text and Image Database. U.S. Patent No. 7,091,236.
2. [2] PatentScope - WIPO’s Global Patent Database.
3. [3] Faden, Dr. R., & Sheppard, A. (2012). Intellectual Property Strategies in Pharmaceutical Industry. Journal of Patent &Trademark Office Law.
4. [4] World Patent Information, “Analysis of pharmaceutical patent landscapes,” 2015.

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Drugs Protected by US Patent 7,091,236

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate