Amarin Seeks En Banc Review in Skinny Label Inducement
In a closely watched case, **Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc.**, the Federal Circuit is being asked to reconsider its approach to "skinny label" jurisprudence, a legal doctrine that has significant implications for the pharmaceutical industry. Hikma's recent petition for rehearing en banc highlights the complexities and potential pitfalls associated with induced infringement claims when generic drugs enter the market with FDA-approved labels that exclude patented uses.
#### Background of the Case
The dispute centers around Amarin's drug Vascepa (icosapent ethyl), initially approved by the FDA in 2012 to treat severe hypertriglyceridemia. In 2019, Amarin obtained a second FDA-approved indication for Vascepa to reduce cardiovascular risk in certain patients—a use covered by Amarin's method-of-use patents. Hikma sought to introduce a generic version of Vascepa but did so under a "skinny label" that specifically carved out the patented cardiovascular indication, pursuant to 21 U.S.C. § 355(j)(2)(A)(viii).
However, despite Hikma's attempt to avoid infringement by excluding the patented use from its label, Amarin sued Hikma for induced infringement. The lawsuit alleged that Hikma's public statements, including press releases referring to its product as the "generic version of Vascepa" and noting Vascepa's total sales figures, indirectly encouraged use of the generic drug for the patented cardiovascular indication.
The district court initially dismissed Amarin's claims, concluding that neither Hikma's skinny label nor its public statements constituted active inducement of infringement. However, on appeal, a Federal Circuit panel reversed this decision, finding that Amarin had plausibly alleged inducement based on the totality of Hikma's actions, including its press releases and website content.
#### Issues at Stake in the Rehearing Petition
Hikma's petition for rehearing en banc raises two critical questions for the Federal Circuit to address:
1. **Implied Active Inducement:** Can a patentee claim that a defendant "actively induces infringement" under 35 U.S.C. § 271(b) without the defendant making any explicit statement that mentions or encourages the patented use?
2. **"Generic Version" Safe Harbor:** Does a generic drugmaker induce infringement by referring to its product as a "generic version" of a branded drug, approved for a patented method, and quoting sales figures for the branded product—without directly mentioning the patented method?
Hikma argues that the Federal Circuit's decision conflicts with established precedent on inducement under 35 U.S.C. § 271(b), which requires "affirmative steps to bring about the desired result" of infringement, as outlined in **Global-Tech Appliances, Inc. v. SEB S.A.** The petition emphasizes that the panel's decision seems to rely on an inference of encouragement rather than on clear, affirmative acts, potentially setting a dangerous precedent that could blur the lines between permissible actions and induced infringement.
#### The Skinny Label Doctrine: Balancing Innovation and Generic Competition
The skinny label doctrine is a key mechanism that allows generic manufacturers to enter the market by omitting patented uses from their product labels, thereby avoiding direct infringement. This approach promotes competition and reduces healthcare costs by enabling the production of less expensive generic drugs while respecting the patent holder's rights to exclusive use of specific indications.
However, the Amarin v. Hikma case highlights the challenges in applying this doctrine, particularly when generic manufacturers communicate about their products in ways that might suggest broader use beyond the labeled indications. Hikma's petition argues that allowing induced infringement claims based on vague or indirect references could undermine the effectiveness of the skinny label pathway, deterring generic manufacturers from using this approach due to the fear of litigation.
#### Implications for the Pharmaceutical Industry
The outcome of this case could have far-reaching implications for the pharmaceutical industry, particularly for how generic manufacturers approach the marketing and labeling of their products. If the Federal Circuit upholds its panel's decision, it may lead to increased litigation over induced infringement, even when generic manufacturers take steps to carve out patented uses from their labels. This could, in turn, discourage the use of skinny labels, potentially delaying the entry of cost-saving generics into the market.
#### Request for Government Input
Amarin's petition suggests that the Federal Circuit should seek the views of the Solicitor General before deciding on the rehearing. The government has previously expressed concerns that the potential for inducement liability in skinny label cases could deter the use of the section viii pathway, which is intended to facilitate the entry of generic drugs into the market. The Solicitor General's input could provide important context and guidance on balancing patent rights with the public interest in promoting access to affordable generic medications.
#### Conclusion
The Amarin v. Hikma case underscores the delicate balance between protecting patent rights and fostering competition in the pharmaceutical industry. As the Federal Circuit considers whether to rehear the case en banc, the stakes are high for both brand-name and generic drug manufacturers. The decision could redefine the contours of induced infringement and shape the future of generic drug labeling practices.
At Destiny Aigbe, we are closely monitoring this case and its potential impact on the pharmaceutical industry. Our team of experienced intellectual property attorneys is here to provide guidance on navigating the complexities of patent law, including strategies for minimizing litigation risks in the context of generic drug approvals. If you have any questions or need assistance with your patent strategy, please contact us.
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This blog post provides an overview of the key issues in the Amarin v. Hikma case and its implications for the pharmaceutical industry. For more detailed analysis or personalized legal advice, please feel free to reach out to our team. Stay tuned for future updates on this and other important developments in intellectual property law.