United States Patent RE46276: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent RE46276, titled "Triazolo(4,5-D)pyrimidine compounds," is a reissue patent that protects the drug BRILINTA (ticagrelor), a medication used to prevent blood clots. This patent is crucial for AstraZeneca UK Limited, the assignee, as it extends the exclusivity period for the drug. Here, we delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Inventors and Assignee
The patent was invented by David Hardem, Anthony Ingall, Brian Springthorpe, Paul Willis, and Simon Guile, and is assigned to AstraZeneca UK Limited[1][4].
Patent Application and Issue
The original patent application was filed on December 2, 1999, as part of the PCT (Patent Cooperation Treaty) with the application number PCT/SE99/02256. The U.S. Patent and Trademark Office (USPTO) issued the original patent (U.S. Patent No. 6,525,060) on February 25, 2003, which was later reissued as U.S. Patent RE46276[1][4].
Scope of the Patent
Chemical Compounds
The patent covers triazolo(4,5-d)pyrimidine compounds, their use as medicaments, compositions containing them, and processes for their preparation. The compounds are defined by a specific chemical formula, with various substituents (R, X, R¹, R², R³) as detailed in the patent specification[1][4].
Therapeutic Use
These compounds are particularly significant in the field of cardiovascular medicine, as they are used in the formulation of ticagrelor, a potent antiplatelet agent. Ticagrelor is prescribed to reduce the risk of heart attack and stroke in patients with acute coronary syndrome or a history of myocardial infarction[1].
Claims of the Patent
Types of Claims
The patent includes various types of claims, such as use claims, composition claims, compound claims, process claims, and dosage form claims. These claims are designed to protect the specific chemical compounds, their therapeutic applications, and the methods of their preparation and administration[1][4].
Infringement and Enforcement
AstraZeneca has actively enforced this patent against generic manufacturers. For instance, in the case of AstraZeneca UK Limited vs. various generic drug manufacturers, the court has upheld the validity and enforceability of the '276 patent, preventing the marketing and sale of generic ticagrelor tablets prior to the patent's expiration[2].
Patent Landscape
Global Protection
The patent has a broad global footprint, with eighty-five patent family members in thirty-four countries. This extensive protection ensures that AstraZeneca maintains exclusivity for ticagrelor across multiple jurisdictions[1].
Supplementary Protection Certificates (SPCs)
In addition to the basic patent protection, the patent has been supplemented with SPCs in several European countries, further extending the exclusivity period for ticagrelor in these regions[1].
Litigation and Patent Disputes
The patent has been involved in several litigation cases, particularly against generic drug manufacturers seeking to market their own versions of ticagrelor. These cases highlight the importance of this patent in protecting AstraZeneca's intellectual property and market share[2][5].
Impact on Generic Manufacturers
ANDA Filings and Approval
Generic manufacturers must navigate the complex landscape of patent exclusivities when filing Abbreviated New Drug Applications (ANDAs) for ticagrelor. Any attempt to market a generic version before the patent's expiration can result in infringement claims and potential injunctions[2][5].
Settlements and Agreements
In some cases, generic manufacturers have entered into settlements with AstraZeneca, agreeing not to market their products until the patent's expiration. These agreements underscore the patent's strength and the significant barriers to entry for generic competitors[5].
Metrics for Measuring Patent Scope
Claim Length and Count
Research on patent scope suggests that narrower claims, as measured by claim length and count, are associated with a higher probability of grant and a shorter examination process. This is relevant for RE46276, as the claims have been refined through the reissue process to ensure clarity and enforceability[3].
Examination Process
The examination process for RE46276 would have involved narrowing the scope of the claims to ensure they are specific, clear, and valid. This process is crucial in maintaining the patent's integrity and preventing overly broad claims that could lead to litigation and validity challenges[3].
Key Takeaways
- Patent Protection: RE46276 provides extensive protection for ticagrelor, covering its chemical composition, therapeutic use, and manufacturing processes.
- Global Reach: The patent has a significant global footprint, with protection in thirty-four countries and supplementary protection certificates in several European countries.
- Litigation: AstraZeneca has actively enforced this patent against generic manufacturers, highlighting its importance in maintaining market exclusivity.
- Impact on Generics: Generic manufacturers face substantial barriers to entry due to the patent's exclusivity period and the potential for infringement claims.
- Patent Scope: The patent's claims have been refined to ensure clarity and enforceability, reflecting best practices in patent drafting and examination.
FAQs
What is the primary compound protected by U.S. Patent RE46276?
The primary compound protected is ticagrelor, a triazolo(4,5-d)pyrimidine compound used as an antiplatelet agent.
Who is the assignee of U.S. Patent RE46276?
The assignee is AstraZeneca UK Limited.
What is the therapeutic use of the compounds covered by RE46276?
The compounds are used to reduce the risk of heart attack and stroke in patients with acute coronary syndrome or a history of myocardial infarction.
How has AstraZeneca enforced this patent against generic manufacturers?
AstraZeneca has filed lawsuits to prevent the marketing and sale of generic ticagrelor tablets prior to the patent's expiration, citing infringement under U.S. patent laws.
What are Supplementary Protection Certificates (SPCs), and how do they relate to RE46276?
SPCs are extensions of the patent protection period granted in certain European countries. For RE46276, SPCs have been obtained in several European countries to further extend the exclusivity period for ticagrelor.
Sources
- DrugPatentWatch, Summary for Patent: RE46276 - Triazolo(4,5-D)pyrimidine compounds.
- Insight.RPXcorp, Case 1:17-cv-01639-RGA Document 1 Filed 11/13/17.
- Hoover Institution, Patent Claims and Patent Scope.
- Google Patents, USRE46276E1 - Triazolo(4,5-D)pyrimidine compounds.
- Robins Kaplan LLP, ANDA Litigation Settlements.
