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Federal Circuit Affirms ITC’s Non-Institution Decision, Offering Guidance for Future FDCA-Related Section 337 Claims

In its long-awaited decision in Amarin Pharma. v. ITC, the Federal Circuit provided guidance on the U.S. International Trade Commission’s discretion to decline to institute an investigation under section 337 of the Tariff Act (19 U.S.C. § 1337) and the interplay between section 337 claims and the Food, Drug, and Cosmetics Act (FDCA) – an increasingly common issue at the ITC. The opinion also addressed the Federal Circuit’s appellate jurisdiction to review the ITC’s non-institution decisions. Companies that litigate at the ITC, particularly those that manufacture, distribute, or import FDA-regulated products, should be aware of the implications of this decision.

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Proposed Legislation Would Authorize FDA To Approve Follow-on Biologics


Time to Read: 1 minutes Practices: Life Sciences

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The "Access to Life-Saving Medicine Act," introduced in late September, would authorize the Food and Drug Administration to approve follow-on biologics that closely resemble previously approved biological products. In its current version, the bill provides manufacturers of follow-on biologics with virtually everything they could ask for. The bill gives FDA substantial discretion to approve follow-on biologics and, in sharp contrast to the current legislative scheme governing drugs, the bill would not afford innovator companies any period of marketing exclusivity whatsoever for their biologic products. As a result, the manufacturers of previously approved biological products would be well-served to follow the forthcoming legislative debate on this issue very closely. For more on the bill and its various provisions, please click "Download PDF" to read Ropes & Gray's client alert.

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