United States Patent 8,946,262: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,946,262, titled "Methods of preventing and treating gastrointestinal dysfunction," is a crucial patent in the pharmaceutical industry, particularly related to the drug Entereg (alvimopan). This patent is held by Merck Sharp & Dohme Corp. and has significant implications for both the original drug manufacturer and generic drug producers.
Patent Overview
Patent Number and Issue Date
The patent number is US 8,946,262, and it was issued on February 3, 2015[2].
Drug and Indication
This patent pertains to the drug Entereg (alvimopan), which is used to prevent and treat gastrointestinal dysfunction, specifically postoperative ileus (POI) following surgeries[2].
Claims and Scope
Method Claims
The patent includes method claims that describe specific ways of preventing and treating gastrointestinal dysfunction using alvimopan. These claims are broad and cover various aspects of the drug's use, including dosing regimens and patient populations. For example, the patent claims methods for administering alvimopan to patients undergoing surgery to prevent POI, highlighting the drug's efficacy in this context[2].
Scope Concepts
The scope of the patent is defined by the claims, which are categorized by overarching scope concepts. These concepts help in understanding the protection provided by the patent and identifying any gaps or opportunities in the patent landscape. In this case, the scope concepts include the prevention and treatment of gastrointestinal dysfunction, the use of alvimopan in surgical patients, and specific dosing methods[3].
Patent Landscape
Orange Book Listings
The patent is listed in the FDA's Orange Book, which is a critical database of approved drug products with therapeutic equivalence evaluations. The listing of this patent in the Orange Book means that any generic version of Entereg must address this patent before receiving FDA approval. Generic manufacturers must either prove non-infringement or invalidity of the patent or wait for its expiration[4].
Exclusivity and Litigation
The patent has been involved in litigation, as seen in the case of Merck Sharp & Dohme Corp. v. Teva Pharms. USA, Inc. This litigation highlights the importance of this patent in protecting Merck's exclusive rights to Entereg. The settlement terms often include injunctions against generic manufacturers until the patent's expiration, ensuring Merck's market exclusivity for the drug[1].
Patent Expiration
The patent is set to expire in February 2030, which marks a significant milestone for generic manufacturers. After this date, generic versions of Entereg can enter the market without infringing on Merck's patent rights[2].
Impact on Generic Manufacturers
ANDA Filings
Generic manufacturers seeking to produce a generic version of Entereg must file an Abbreviated New Drug Application (ANDA) with the FDA. As part of this process, they must certify their position regarding the listed patents, either by asserting non-infringement, invalidity, or waiting for the patent's expiration. The presence of this patent in the Orange Book creates a barrier to entry for generics until the patent expires or is successfully challenged[4].
Litigation and Settlements
Generic manufacturers may face litigation if they challenge the patent's validity or infringement. Settlements in such cases often result in the generic manufacturer being enjoined from making and selling their ANDA product until the patent expires. For example, in the case of Merck Sharp & Dohme Corp. v. Teva Pharms. USA, Inc., the settlement terms included an injunction against Teva until the expiration of the patent-in-suit[1].
Patent Analytics and Claim Coverage
Claim Coverage Matrix
To understand the full scope of protection provided by this patent, a Claim Coverage Matrix can be used. This tool categorizes patents and claims by scope concepts, helping to identify which claims actively protect the intellectual property and where gaps or opportunities exist. For Merck, this matrix would highlight the comprehensive coverage of methods for preventing and treating gastrointestinal dysfunction using alvimopan[3].
Claim Charts
Interactive claim charts generated by tools like ClaimScape® can help technical experts review the patent coverage. These charts facilitate the identification of areas where claim coverage is strong or weak, aiding in strategic decisions about patent maintenance, new design options, and potential challenges to the patent[3].
Regulatory and Legal Considerations
REMS Patents
While the patent in question is not a REMS (Risk Evaluation and Mitigation Strategies) patent, it is worth noting that REMS patents can pose significant challenges to generic entry. REMS patents, if listed in the Orange Book, can delay generic approval due to induced infringement claims. Proposals to delist REMS patents and stricter scrutiny of their validity are ongoing legal and regulatory discussions[4].
eBay Test and Injunctions
In cases of infringement, the Supreme Court's four-factor test from eBay Inc. v. MercExchange, L.L.C. is applied to determine whether an injunction should be awarded. This test considers irreparable harm, the adequacy of damages, the balance of hardships, and the public interest. For patents like US 8,946,262, this test could influence the outcome of litigation, potentially favoring monetary damages over injunctions[4].
Key Takeaways
- Patent Scope and Claims: The patent covers methods for preventing and treating gastrointestinal dysfunction using alvimopan, with broad claims that protect Merck's exclusive rights.
- Orange Book Listings: The patent is listed in the FDA's Orange Book, creating a barrier to generic entry.
- Litigation and Settlements: Generic manufacturers face litigation and often settle with injunctions until the patent expires.
- Patent Expiration: The patent is set to expire in February 2030, marking a significant date for generic entry.
- Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts help in understanding and managing the patent landscape.
FAQs
What is the primary use of the drug covered by US Patent 8,946,262?
The primary use of the drug covered by US Patent 8,946,262 is to prevent and treat gastrointestinal dysfunction, specifically postoperative ileus (POI) following surgeries.
When is the patent set to expire?
The patent is set to expire in February 2030.
How does the Orange Book listing affect generic manufacturers?
The Orange Book listing of the patent requires generic manufacturers to address the patent through certification of non-infringement, invalidity, or waiting for the patent's expiration before receiving FDA approval.
What tools can be used to analyze the patent landscape for this patent?
Tools such as Claim Coverage Matrix and Claim Charts can be used to analyze the patent landscape, helping to identify gaps and opportunities in the claim coverage.
What are the implications of the eBay test for patent infringement cases involving this patent?
The eBay test could influence the outcome of litigation, potentially favoring monetary damages over injunctions based on factors such as irreparable harm, the adequacy of damages, the balance of hardships, and the public interest.
Sources
- Robins Kaplan LLP Law Firm: ANDA Litigation Settlements.
- Pharsight: Entereg patent expiration.
- Schwegman Lundberg & Woessner, P.A.: Patent Analytics.
- Boston University Law Review: Five Solutions to the REMS Patent Problem.
