IP News

In The Arnold Partnership v. Dudas, 2004 WL 574480, CV-03-1339 (Fed. Cir. March 24, 2004), the Federal Circuit affirmed the district court's denial of a term extension for the drug marketed under the name Vicoprofen. Vicoprofen, an analgesic and anti-inflammatory drug, is a combination of hydrocodone bitrate and ibuprofen, both of which had been previously marketed either alone or in conjunction with other active ingredients.

The plaintiff received patent protection for the Vicoprofen and filed a New Drug Application (NDA) as required by the FDA. After receiving FDA approval, the plaintiff applied for a patent term extension under 35 U.S.C. '156 to restore the time spent for the approval of the NDA. The Federal Circuit affirmed the district court's denial because the drug did not meet the “first commercial marketing” requirement of 35 U.S.C '156(a)(5)(A). Plaintiff argued that the statute did not intend to determine the whether each ingredient was newly commercialized, but rather if the whole drug was new. The Federal Circuit disagreed. Pointing to the language of the statute, the court held that in order to be eligible for patent extension under 35 U.S.C. '156, at least one of the active ingredients in the drug must be new to the marketplace. The court noted that its reading of 35 U.S.C. '156 did not perfectly overlap the FDA's requirement of filing a NDA for a combination drug such as Vicoprofen, and suggested the lapse in protection was an issue best suited for Congress.