In The Arnold Partnership v. Jon Dudas et al., No. 03-1339 (Fed. Cir. March 24, 2004), the federal circuit affirmed a district court decision denying the Arnold Partnership (“Arnold”) a patent term extension under §156 of its ‘252 patent, relating to drug compositions used for treating pain.
Vicoprofen® is commercialized under the ‘252 patent, and contains both hydrocodone bitartrate and ibuprofen as active ingredients. Although both ingredients had been marketed previously on an individual basis, they had never been sold together in a single product. FDA required a new NDA before approving Vicoprofen® for marketing, which was filed and eventually approved. Because of FDA approval delay, Arnold applied for patent term extension under §156, which was denied because Vicoprofen® did not comply with the first commercial marketing requirement of 156(a)(5)(A). Both the PTO and the district court reasoned that the prior commercialization of each active ingredient individually precluded the eligibility of the combination for regulatory review.
Reviewing without deference the district court’s interpretation of §156, the federal circuit first considered the relevant language of §156, providing for patent term extension if the “regulatory review period [for the drug product] is the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred.” 35 U.S.C. § 156 (2004). ‘Drug product’ under the act is defined as “the active ingredient of—a new drug . . . including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient.” Id. (emphasis added). In affirming the district court, the court reasoned that the plain meaning of the statute required the consideration of a drug product patent’s eligibility for extension on a component-by-component (or an ingredient-by-ingredient) basis.
The court rejected arguments that its reading of §156 did not perfectly overlay with FDA’s practices and regulations, which require a new NDA for combination drugs, or that an alternative interpretation of §156 suggested that the combination as a whole was the approved product rather than the individual components.
To view the full decision visit http://www.aplf.org/mailer/Issue199.doc
To discuss this topic further, please feel free to contact the author Michael R. Dzwonczyk, (firstname.lastname@example.org), at Sughrue Mion, PLLC in Washington DC., USA.
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