United States Patent 10,912,781: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,912,781, hereafter referred to as the '781 patent, is a critical component in the patent landscape surrounding the drug eslicarbazepine acetate, marketed under the brand name APTIOM®. This patent is central to ongoing litigation and regulatory discussions, particularly in the context of generic drug approvals.
Background of Eslicarbazepine Acetate
Eslicarbazepine acetate is an antiepileptic drug used to treat partial-onset seizures. It is administered orally once a day in tablet form. The drug is protected by a series of patents, each covering different aspects of its formulation, method of use, and administration.
The '781 Patent: Formulation Claim
The '781 patent specifically pertains to a formulation claim for a tablet containing eslicarbazepine acetate as the active pharmaceutical ingredient (API)[4][5].
Claim 17: Formulation Details
Claim 17 of the '781 patent is the focal point of the formulation claim. This claim describes the specific composition and characteristics of the tablet formulation, including the API, excipients, and other components necessary for the stable and effective delivery of eslicarbazepine acetate.
Patent Infringement Litigation
The '781 patent has been at the center of patent infringement litigation involving Bial-Portela and Sunovion (the plaintiffs) and various generic drug manufacturers, including Alkem Laboratories and Dr. Reddy’s Laboratories.
Alkem Laboratories Case
In the case against Alkem Laboratories, Bial-Portela and Sunovion asserted that Alkem's submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of APTIOM® constituted infringement under 35 U.S.C. § 271(e)(2)(A). Alkem denied infringement of claim 17 of the '781 patent and also challenged the validity of this claim[4].
Dr. Reddy’s Laboratories Case
Similarly, in the litigation against Dr. Reddy’s Laboratories, the plaintiffs alleged that Dr. Reddy’s ANDA filing for a generic version of APTIOM® infringed upon the '781 patent, among others. Dr. Reddy’s had filed a Paragraph IV certification with the FDA, asserting that the patents, including the '781 patent, were invalid, unenforceable, or would not be infringed by their generic product[5].
Patent Scope and Claims
The scope of the '781 patent is defined by its claims, particularly claim 17. This claim outlines the specific formulation of the eslicarbazepine acetate tablet, which is crucial for maintaining the drug's efficacy and stability.
Claim Language and Scope
The claim language in the '781 patent is precise and detailed, ensuring that any generic formulation must adhere strictly to the specified composition to avoid infringement. The scope of the patent is narrowed to the specific formulation, which helps in distinguishing it from other potential formulations that might not infringe on this patent[3].
Regulatory Framework
The regulatory framework governing the '781 patent is established by the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA). These amendments require brand manufacturers to list their patents in the FDA's Orange Book, which includes patent numbers, expiration dates, and use codes for method-of-use patents[4].
Expiration Date and Patent Landscape
The '781 patent is set to expire on October 23, 2028. This expiration date is significant as it marks the period after which generic manufacturers can freely market their versions of eslicarbazepine acetate without infringing on this particular patent. The patent landscape surrounding eslicarbazepine acetate includes multiple patents with varying expiration dates, which complicates the timeline for generic entry into the market[1][5].
Impact on Generic Drug Approval
The '781 patent, along with other related patents, affects the approval timeline for generic versions of APTIOM®. Generic manufacturers must navigate these patents by either challenging their validity or waiting for their expiration. The FDA's approval process for ANDAs is influenced by these patent disputes, as seen in the delays and amendments required for final approval[1].
Litigation Outcomes and Implications
The outcomes of the litigation involving the '781 patent have significant implications for both the brand and generic drug manufacturers. A finding of infringement can block generic entry, while a finding of invalidity or non-infringement can clear the path for generic competition. The Delaware court's decision in the Alkem case, which found some patents valid and infringed, highlights the complexities and challenges in these legal battles[2].
Conclusion
The United States Patent 10,912,781 is a pivotal patent in the intellectual property landscape surrounding eslicarbazepine acetate. Its formulation claim is central to ongoing patent infringement litigation and regulatory discussions. Understanding the scope, claims, and expiration date of this patent is crucial for both brand and generic drug manufacturers as they navigate the complex landscape of pharmaceutical patents.
Key Takeaways
- The '781 patent pertains to a specific formulation of eslicarbazepine acetate tablets.
- Claim 17 of the '781 patent is the focal point of the formulation claim.
- The patent is set to expire on October 23, 2028.
- Ongoing litigation involves challenges to the patent's validity and infringement claims.
- The Hatch-Waxman Amendments govern the regulatory framework for this patent.
- The patent's expiration date and litigation outcomes significantly impact the timeline for generic drug approvals.
Frequently Asked Questions (FAQs)
1. What is the '781 patent related to?
The '781 patent is related to a specific formulation of eslicarbazepine acetate tablets, used to treat partial-onset seizures.
2. What is the significance of claim 17 in the '781 patent?
Claim 17 of the '781 patent describes the specific composition and characteristics of the eslicarbazepine acetate tablet formulation, which is crucial for maintaining the drug's efficacy and stability.
3. When is the '781 patent set to expire?
The '781 patent is set to expire on October 23, 2028.
4. How does the '781 patent affect generic drug approvals?
The '781 patent, along with other related patents, affects the approval timeline for generic versions of APTIOM®. Generic manufacturers must navigate these patents by either challenging their validity or waiting for their expiration.
5. What are the implications of the litigation outcomes involving the '781 patent?
The outcomes of the litigation involving the '781 patent have significant implications for both brand and generic drug manufacturers. A finding of infringement can block generic entry, while a finding of invalidity or non-infringement can clear the path for generic competition.
Cited Sources:
- FDA Letter: Eslicarbazepine Acetate Tablets - accessdata.fda.gov
- Pharma IP Circle: Eslicarbazepine – USA - Pharma IP Circle
- Hoover Institution: Patent Claims and Patent Scope - hoover.org
- Casetext: Bial-Portela & CA. v. Alkem Labs. - casetext.com
- RPX Corporation: PORTELA & CA S.A., BIAL - HOLDING, S.A., and SUNOV - insight.rpxcorp.com
