The Curious Case of Yasmin ® : When Does a generic‘s Label Induce Doctors to Practice a Patented Method of use?

Abstract

*Arnall Golden Gregory LLP, 171 17th Street NW, Atlanta, GA 30305, USA Tel.: +1 404 873 8512 E-mail: clark.sullivan@agg.com In a decision with interesting implications for the pharmaceutical industry, the Federal Circuit on April 16, 2012, rejected efforts by Bayer Schering Pharma AG to enforce a method of treatment patent against Lupin, Ltd and several other generic challengers, because the object of the treatment claimed in the patent was only described in the ‘Pharmacology’ section of the generic label, as opposed to the ‘Indications and Usage’ section [1]. The patent at issue – the so-called ‘652 patent’ – relates to Yasmin, an oral contraceptive approved by the US FDA for the prevention of pregnancy [101]. In the ‘652 patent’, Bayer claimed a method of using its oral contraceptive 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 antimineralcorticoid effect, which can be effective in reducing excess water retention in the body). Claim 1 is representative and it recites: “a method of simultaneously achieving, during premenopause or menopause a gestagenic effect, antiandrogenic affect and an antialdosterone effect in a female patient in need thereof comprising administering an amount of dihydrospirorenone to said female patient, wherein said amount of dihydrospirorenone is effective to simultaneously achieve a gestagenic effect, antiandrogenic effect and antialdosterone effect in said patient.” The fact that this patent was a method of treatment patent was crucial to the eventual decision because, unlike new molecule patents or pharmaceutical composition patents, a generic drug company never actually performs a method of treatment and, thus, never directly infringes the method. Rather, they are approved solely on the basis of bioequivalence testing, which is typically performed in healthy subjects. Therefore, the question for purposes of patent infringement is whether the generic company has taken some action to induce doctors and patients to perform the patented method in violation of 35 U.S.C. §271(b) (which states that “Whoever actively induces infringement of a patent shall be liable as an infringer” ) [2]. To demonstrate inducement liability under section 271(b), the patentee must establish that the alleged infringer had “knowledge that the induced acts constitute patent infringement” [3]. In addition, “Inducement requires evidence of culpable conduct, directed to encouraging another’s infringement, not merely that the inducer had knowledge of the direct infringer’s activities” [4]. In other words, the generic manufacturer must know that it is inducing acts that constitute patent infringement and it must take some affirmative act towards encouraging infringement. Since generic