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.
The S.D.N.Y. sided with Lupin and Bayer appealed to the Fed. Cir. The Pharmaceutical Research and Manufacturers of America has already filed an amicus brief supporting Bayer, arguing that the District Court judge disregarded basic claim interpretation and inducing infringement precedent in finding non-infringement. This would seem pretty straightforward but, remember, we are in the Alice In Wonderland world of Hatch-Waxman law and litigation. Simply filing an ANDA alleging non-infringement of an Orange Book Listed patent is an infringing act, and entitles the patent owner (e.g., the innovator) to sue and suspend the ability of the FDA to approve the ANDA for months.
Should a company be found liable for inducing infringement –and be barred from the market –when it will only market the drug for a non-infringing use? In AZ, discussed above and earlier, the proposed dosing information arguably was essential to proper use of the drug for its primary indication. This is not the case here – in fact, it is difficult to find the information on the additional patented bioactivities on the label. If the information about the secondary uses is so diffuse that it does not “instruct” the physician to prescribe it for those uses, does the label still induce infringement? Whichever way this case ultimately concludes, it should reinforce the value of combing proposed labels for patentable subject matter.