In a decision with interesting implications for the pharmaceutical industry, the Federal Circuit on April 16, 2012 rejected efforts by Bayer Schering Pharma AG (“Bayer”) to enforce a method of treatment patent against Lupin, Ltd. and several other generic challengers, because the treatment claimed in Bayer’s patent was only described in the “Pharmacology” section of the generic challenger’s label, as opposed to the approved “Indications” section. See Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 1316 (Fed. Cir. 2012).
The drug at issue – Yasmin® – is an oral contraceptive approved by FDA for the prevention of pregnancy. The drug is protected by a patent – the ‘652 patent – that claims the use of the drug to achieve three simultaneous effects: a contraceptive (or gestagenic) effect, an anti-androgenic effect (which reduces the activity of male hormones and can be effective in treating conditions such as hirsutism or acne), and an anti-aldosterone effect (also known as an anti-mineralcorticoid effect, which can be effective in reducing excess water retention in the body).
The problem for Bayer was that FDA did not approve the drug based on its anti-androgenic effects or its anti-aldosterone effects. However, FDA did allow Bayer to list certain anti-androgenic and anti-aldosterone effects it had observed during animal testing in the “Pharmacology” section of its label. Because the generic challenger had copied Bayer’s pharmacology section into its own label, Bayer argued that the generic’s label encouraged doctors to use the drug for all three effects at once, and that the generic challenger would induce doctors to infringe its patent if allowed on the market. Bayer even presented the testimony of an obstetrician-gynecologist with experience in the clinical use of contraceptives, who testified that prescribing Yasmin® as an oral contraceptive with the intent to produce an anti-mineralocorticoid pharmacological effect and an anti-androgenic pharmacological effect “is clearly stated and on-label.”
The Federal Circuit rejected this evidence of inducement, and affirmed that references to preclinical studies and potential side-effects in the pharmacology section of a generic’s label will not induce doctors to prescribe the drug for those particular effects. The Court disregarded Bayer’s obstetrician testimony as “contrary to the contents of the FDA-approved label for Yasmin.”
Central to the Federal Circuit’s holding was its review of FDA’s regulations, and the fact that Bayer had not secured FDA approval to market its drug for two of the uses required by the claims. According to the Court, even though the label:
[S]tates that Yasmin exhibits anti-mineralocorticoid activity and has the potential for antiandrogenic activity based on animal studies, neither that passage nor anything else on the label provides any safety or efficacy information associated with the possible use of Yasmin in treating patients who are in need of those effects. Thus, while the label mentions potential antimineralocorticoid and anti-androgenic activity, it does not do so in any way that recommends or suggests to physicians that the drug is safe and effective for administration to patients for the purposes of inducing these effects.
In effect, the Court held that a generic’s label would not encourage doctors to use a drug for uses mentioned in the Pharmacology section of the label, because there was no real evidence (i.e., two well controlled clinical trials) that the drug would be effective.
The Court’s decision is causing quite a stir in the patent community, as attorneys try and resolve its holding with other inducement cases, such as the Federal Circuit’s decision in the budesonide litigation, where the Court held that the generic challenger induced infringement of a dosing patent, based on a titration regimen described in the label that “would lead inevitably to infringement.” At the end of the day, the case may turn on the simple fact that Bayer was attempting to circumvent the requirement to present clinical trials to support its marketed indications, and that if it had, the generic challengers could have carved those indications from their label and avoided infringement of the patent.