In my post of January 13, 2011, I discussed AstraZeneca LP v. Apotex, a Fed. Cir. decision in which AZ argued successfully that the proposed  Apotex labeling for an anti-asthma drug would induce infringement if the generic were marketed with dosing information covered by add-on patents that AZ had obtained (the primary patents had expired). In the present suit, (Bayer Schering Pharma AG v. Lupon Lid., Case No. 1:10-cv-05423-PGG), Bayer is asserting a patent (U.S. 5,569,652 – a copy is found at the end of this post) that claims a method of using Yasmin – a combination of dihydrospirorenone (“dropsirenone”) and an estrogenic compound—to achieve a gestagenic, antiandrogenic and antialdosterone effect. These effects can potentially render the drug useful to treat hormonal irregularities in women throughout life. (A copy of the Order and Notice of Appeal are available at the end of this post.)

Lupin filed a paragraph IV notice with its ANDA that said that it would not infringe this patent because it only wanted to market the combination to prevent pregnancy. However, the antialdosterone effect (called “antimineralocorticoid activity”) is disclosed in the body of the label, and Lupin had not tried to get a label approved without that information (a “carve out”). Bayer argued that approval of such a label would induce infringement of the ‘652 patent while Lupin argued that, in accord with the principles of the Hatch-Waxman Act, it should only have to establish that it could market for the approved “Indications and Usage” on the Bayer’s label (“prevent pregnancy”), and that the court should not require it to establish non-infringement of unapproved uses.

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