Details for Patent: 7,816,396

Summary for Patent: 7,816,396

Title:	Method for increasing the bioavailability of glycopyrrolate
Abstract:	The invention relates to a method of treating sialorrhea in a human patient, which comprises orally administering glycopyrrolate in a liquid solution to the human patient under fasted conditions.
Inventor(s):	Roberts; Alan (Woodstock, GA), Venkataraman; Balaji (Alpharetta, GA)
Assignee:	Shionogi Pharma, Inc. (Atlanta, GA)
Application Number:	12/648,068
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,816,396
Patent Claim Types: see list of patent claims	Use; Formulation;

United States Patent 7,816,396: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 7,816,396, titled "Method for increasing the bioavailability of glycopyrrolate," is a significant patent in the pharmaceutical industry, particularly in the treatment of sialorrhea. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background

Glycopyrrolate is a medication used to treat sialorrhea, or excessive salivation. The patent in question focuses on a method to enhance the bioavailability of glycopyrrolate when administered orally in a liquid solution[4].

Scope of the Patent

The patent describes a method for treating sialorrhea by orally administering glycopyrrolate in a liquid solution. This method aims to increase the bioavailability of the drug, making it more effective in reducing excessive salivation.

Key Aspects of the Scope

• Administration Method: The patent specifies the oral administration of glycopyrrolate in a liquid solution, which is designed to improve the drug's absorption and efficacy.
• Bioavailability Enhancement: The method outlined in the patent is intended to increase the bioavailability of glycopyrrolate, ensuring that more of the drug is available in the bloodstream to treat sialorrhea effectively.
• Clinical Application: The primary clinical application is the treatment of sialorrhea, a condition often associated with neurological disorders such as Parkinson's disease, cerebral palsy, and others.

Claims of the Patent

The claims of the patent are crucial as they define the scope of protection granted to the inventor.

Independent Claims

• The patent includes claims that describe the specific method of administering glycopyrrolate in a liquid solution to increase its bioavailability.
• These claims are detailed and specify the formulation, dosage, and administration protocol to ensure the desired therapeutic effect[4].

Dependent Claims

• Dependent claims further elaborate on the independent claims by adding additional limitations or specifications.
• These claims may include variations in the formulation, such as different concentrations of glycopyrrolate or the use of specific excipients to enhance bioavailability.

Patent Landscape

Understanding the patent landscape is essential for navigating the intellectual property rights surrounding glycopyrrolate and its use in treating sialorrhea.

Related Patents

• Other patents related to glycopyrrolate, such as U.S. Patent 7,638,552, also deal with formulations and methods of administration but may have different claims and scopes[1].
• These patents collectively form a complex landscape where multiple stakeholders may have overlapping or competing interests.

Litigation and Settlements

• The patent has been involved in litigation, as evidenced by the tentative approval of a generic version of glycopyrrolate oral solution, which was delayed due to patent issues. Suven Life Sciences Limited and Taro Pharmaceutical Industries Ltd were involved in a lawsuit initiated by Merz Pharmaceuticals, LLC and Merz North America, Inc. regarding the infringement of the '552 and '396 patents[1].
• Such litigation highlights the importance of patent protection and the potential for disputes in the pharmaceutical industry.

Exclusivity and Patent Protection

The patent's exclusivity period is a critical factor in its landscape.

Patent Expiration

• The patent expired on August 20, 2023, which means that generic versions of the drug can now be marketed without infringing on the original patent[1].

Impact of Expiration

• The expiration of the patent opens the market to generic competitors, potentially reducing the cost of the medication and increasing accessibility for patients.
• However, it also means that the original patent holder no longer has exclusive rights to the method described in the patent.

Regulatory Aspects

Regulatory compliance is essential for any pharmaceutical product, including those protected by patents.

FDA Approval

• The FDA plays a crucial role in approving generic versions of drugs, including those that may infringe on existing patents. The agency requires detailed information and may request additional amendments before granting final approval[1].

ANDA Filings

• Abbreviated New Drug Applications (ANDAs) are filed for generic drugs, and these filings often involve paragraph IV certifications, which assert that the generic version does not infringe on existing patents or that the patents are invalid or unenforceable[1].

Patent Analytics and Claim Coverage

To fully understand the patent landscape, companies often use patent analytics tools.

Claim Coverage Matrix

• Tools like the Claim Coverage Matrix help in categorizing patents by claims and scope concepts, making it easier to identify gaps or opportunities in patent coverage[3].

Claim Charts

• Interactive claim charts generated by software like ClaimScape® facilitate the review of patent coverage with technical experts, helping to determine if there are gaps in current coverage and highlighting future design opportunities[3].

Industry Impact

The patent's impact extends beyond the legal and regulatory realms to affect the broader pharmaceutical industry.

Competitive Landscape

• The expiration of the patent and the entry of generic competitors can significantly alter the competitive landscape, potentially leading to price reductions and increased market competition.

Innovation

• The method described in the patent has driven innovation in the treatment of sialorrhea, encouraging further research and development in oral drug formulations.

Key Takeaways

• Method of Administration: The patent describes a specific method for orally administering glycopyrrolate to increase its bioavailability.
• Patent Expiration: The patent expired on August 20, 2023, allowing for the entry of generic versions.
• Litigation: The patent was involved in litigation related to generic drug approvals.
• Regulatory Compliance: FDA approval and ANDA filings are critical for generic versions of the drug.
• Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts are essential for navigating the patent landscape.

FAQs

What is the primary purpose of U.S. Patent 7,816,396?

The primary purpose of U.S. Patent 7,816,396 is to describe a method for increasing the bioavailability of glycopyrrolate when administered orally in a liquid solution to treat sialorrhea.

Why is the patent's expiration date significant?

The patent's expiration date is significant because it marks the end of the exclusive rights held by the patent holder, allowing generic versions of the drug to enter the market.

What role does the FDA play in the approval of generic versions of glycopyrrolate?

The FDA plays a crucial role in approving generic versions of glycopyrrolate through the ANDA process, ensuring that the generic versions meet the necessary standards for safety and efficacy.

How does patent analytics help in understanding the patent landscape?

Patent analytics tools help in categorizing patents by claims and scope concepts, identifying gaps or opportunities in patent coverage, and facilitating the review of patent coverage with technical experts.

What is the impact of the patent's expiration on the pharmaceutical industry?

The expiration of the patent can lead to increased competition from generic versions, potentially reducing prices and increasing accessibility of the medication for patients.

Cited Sources

1. FDA Letter: "Glycopyrrolate Oral Solution - accessdata.fda.gov"
2. IP Watchdog: "Patent Filings Roundup: Landmark Brings 250th Complaint"
3. SLWIP: "Patent Analytics | Intellectual Property Law"
4. Google Patents: "Method for increasing the bioavailability of glycopyrrolate"
5. Robins Kaplan: "ANDA Litigation Settlements Fall 2021 | Hatch-Waxman"

Drugs Protected by US Patent 7,816,396

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