Understanding the Scope and Claims of United States Patent 10,300,065: A Detailed Analysis
Introduction to Patent 10,300,065
United States Patent 10,300,065, hereafter referred to as the '065 patent, is a significant patent related to the drug Brilinta (ticagrelor), which is used to prevent blood clots in patients with acute coronary syndrome or a history of myocardial infarction. This patent is crucial in the pharmaceutical landscape, particularly in the context of generic drug approvals and patent litigation.
Background of Brilinta and Its Patent Protection
Brilinta, developed by AstraZeneca, is protected by several patents listed in the FDA's Orange Book. The '065 patent is one of these, and it plays a vital role in extending the exclusivity period for Brilinta[4].
Patent Issue and Maintenance
The '065 patent was issued on May 28, 2019, and is subject to regular maintenance fees to keep it in force. Recent records show that the payment of the 4th-year maintenance fee was made on November 16, 2022[1].
Scope of the Patent
The '065 patent focuses on specific aspects of Brilinta, including dosage forms and modes of administration. This patent is part of a broader strategy to protect the intellectual property surrounding Brilinta, ensuring that AstraZeneca maintains market exclusivity for the drug.
Claim Language and Scope
The scope of a patent is often determined by the language and breadth of its claims. The '065 patent includes claims that are specific to the pediatric formulation of Brilinta, which has been granted a six-month extension for pediatric studies. This extension is a common strategy to prolong patent protection and is authorized under the FDA's pediatric exclusivity provisions[5].
Patent Claims and Their Significance
Patent claims are the heart of any patent, defining the scope of protection. For the '065 patent, the claims are tailored to cover the pediatric formulation, ensuring that any generic version targeting this demographic would infringe on these claims.
Independent Claim Length and Count
Research on patent scope suggests that the length and count of independent claims can influence the patent's validity and enforceability. Narrower claims, as seen in the '065 patent, are often associated with a higher probability of grant and a shorter examination process. This is because narrower claims tend to be more specific and less likely to be challenged for being overly broad[3].
Patent Litigation and Settlements
Patent litigation is a common occurrence in the pharmaceutical industry, especially when generic manufacturers file Abbreviated New Drug Applications (ANDAs) that challenge the validity or enforceability of existing patents. For Brilinta, litigation has been initiated against generic manufacturers, such as HEC Pharm Co., Ltd., within the statutory 45-day period following the ANDA filing. This litigation is aimed at protecting the '065 patent and other related patents from infringement[4].
Examples from Similar Cases
In similar cases, such as those involving Rexulti (brexpiprazole) and Ozempic (semaglutide), patent litigation has resulted in settlements that validate the patents-in-suit and prevent generic infringement. For instance, in the case of Otsuka Pharmaceutical Co., Ltd. v. MSN Labs. Pvt. Ltd., the patents were deemed valid and enforceable, and MSN was enjoined from infringing the patents[2].
Impact on Generic Drug Approvals
The '065 patent significantly impacts the timeline for generic versions of Brilinta. Generic manufacturers must either wait for the patent to expire or successfully challenge its validity in court. The six-month pediatric exclusivity extension granted to the '065 patent further delays the entry of generic competitors into the market[5].
Expiration Dates and Future Implications
The '065 patent is set to expire on January 27, 2036. This expiration date is crucial for both AstraZeneca and potential generic manufacturers. As the expiration approaches, generic companies will likely prepare to enter the market, and AstraZeneca may explore additional strategies to extend its market exclusivity or transition to other revenue streams[4].
Key Takeaways
- Patent Scope and Claims: The '065 patent is specific to the pediatric formulation of Brilinta, with claims that are narrow and focused.
- Patent Litigation: Litigation has been initiated to protect the '065 patent from generic infringement.
- Impact on Generic Drugs: The patent delays the entry of generic versions of Brilinta into the market.
- Expiration Date: The patent is set to expire on January 27, 2036.
- Strategic Implications: The patent's expiration will have significant implications for both AstraZeneca and generic manufacturers.
FAQs
What is the '065 patent related to?
The '065 patent is related to the drug Brilinta (ticagrelor), specifically its pediatric formulation.
When was the '065 patent issued?
The '065 patent was issued on May 28, 2019.
What is the significance of the six-month pediatric exclusivity extension?
The six-month pediatric exclusivity extension prolongs the patent protection period, delaying the entry of generic competitors into the market.
What is the current status of patent litigation related to the '065 patent?
Litigation has been initiated against generic manufacturers to protect the '065 patent from infringement.
When is the '065 patent set to expire?
The '065 patent is set to expire on January 27, 2036.
Sources
- Pharsight: Brilinta patent expiration.
- Robins Kaplan LLP: ANDA Litigation Settlements | Hatch-Waxman.
- SSRN: Patent Claims and Patent Scope.
- FDA: Ticagrelor Tablets - accessdata.fda.gov.
- DrugPatentWatch: Details for Patent: 10300065.
