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Astrazeneca v Apotex – Patent That Label!

I recently had a chance to re-read AstraZeneca LP v. Apotex, Inc., Appeal No. 2009-1381, 1424 (Fed. Cir. Nov. 1, 2010) and realized that it is a virtual case note on how to extend patent term by “patenting the label.” The primary patents on budesonide, an anti-asthma drug, had expired and AZ was trying to use two add-on patents (U.S. Pat. Nos. 6598603 and 6899099)claiming the drug administered in a  continuing once-a-day regimen for treating a respiratory disease and a kit containing the drug in a solvent and a label indicating the once-a-day regimen.

Apotex had filed a para. IV notification alleging invalidity and non-infringement but had been required by the FDA to copy AZ’s label which included a statement that the initial dosing, e.g., twice a day, should be titrated downward in some cases. AZ argued successfully that the Apotex labeling would induce infringement because titrating down from the recommended starting dose would necessarily lead to the claimed once-daily dosing regimen.

After interpreting the claims to exclude the drug encapsulated in liposomes (even though the specification of the patents taught this as an option, and no language in the claims excluded liposomal encapsulation—good lawyering Ms. Loring!), the Fed. Cir. agreed that the Apotex labeling would induce infringement. (There is a good discussion of the standards for inducing infringement in the opinion). However, the Fed. Cir. found that the kit claims were invalid, since the labeling packaged with the drug was not “functionally related” to the drug or to the kit: “Our decision In re Ngai foreclosed the argument that simply adding new instructions to a known product creates the functional relationship necessary to distinguish the product from the prior art.” Preliminary injunction affirmed.

Well, one valid “label claim” was all it took to keep a generic off the market, so read those labels when you are designing your client’s or company’s product life cycle management strategy. Conversely, if you are preparing a PIV opinion, watch out for attempts to patent (often obscure) portions of the label.

AstraZeneca v Apotex




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