Bayer Schering Pharma et al. v. Lupin et al., Nos. 2011-1143, -1228 (Fed. Cir.)
In a 2-1 opinion this past Monday, the Federal Circuit affirmed a district court decision dismissing Bayer's patent infringement claims against Watson, Sandoz and Lupin because their ANDAs did not seek approval for the patented use. At issue, according to the majority opinion, was whether the FDA approved certain uses of YASMIN (drospirenone/ethinyl estradiol) that were not mentioned in the "Indications and Usage" section of the drug label.
Bayer's U.S. Patent No. 5,569,652 is a method-of-use patent listed in the Orange Book for YASMIN, a product approved "for the prevention of pregnancy in women who alect to use an oral contraceptive" (according to the Indications and Usage section of the YASMIN label). The '652 patent claims a method of simultaneously achieving a contraceptive effect, an anti-androgenic effect (which can be useful for treating acne), and an anti-mineralocorticoid effect (which can be useful for reducing excess water retention). After Watson, Sandoz and Lupin submitted ANDAs with paragraph IV certifications to the '652 patent, Bayer filed suit against the ANDA applicants under 35 U.S.C. § 271(e)(2), alleging that their generic versions of YASMIN would induce infringement of the '652 patent.
In the district court, Watson and Sandoz moved for judgment of noninfringement on the pleadings under Fed. R. Civ. P. 12(c), arguing that their ANDAs related to the use of of generic YASMIN only for oral contraception and not for the combination of uses claimed in the '652 patent. The district court granted their motions, holding that "because the FDA had not given approval for the use of the drug that was claimed in the '652 patent, Bayer could not state a claim for patent infringement."
On appeal, Bayer argued that the FDA did approve the use of the drug for all three effects because in the Clinical Pharmacology section of the drug label, which is identical to the proposed label in each ANDA, there was information regarding the use of the drug for all three effects. While the Federal Circuit acknowledged that the description of the effects in the label demonstrated that the FDA was aware that YASMIN could cause those effects, the court did not agree that the presence of the information anywhere in the label was sufficient evidence to show that the FDA approved YASMIN to achieve the combination of the three effects claimed in the '652 patent.
According to the Federal Circuit, "The FDA labeling regulation, 21 C.F.R. § 201.57, makes clear that the FDA has not approved the use of Yasmin to produce the pharmacological effects that are listed in the Clinical Pharmacology section of the label." The court stated that approved uses are listed in the Indications and Usage section of the label and indications or uses "must not be implied or suggested in other sections of the labeling if not included in [the Indications and Usage] section." Moreover:
The reference in the Clinical Pharmacology section of the label to the anti-mineralocorticoid and anti-androgenic activity of drospirenone is certainly not a direct indication of an appropriate use for Yasmin, and even if it could be considered an "implied or suggested" indication of an appropriate use, the regulation expressly states that such implied or suggested uses do not constitute approved uses.
The Federal Circuit further remarked that the FDA regulation requires that "the label provide a summary of essential scientific information needed for the safe and effective use of the drug" and the Yasmin label does not provide this type of summary regarding the anti-androgenic and anti-mineralocorticoid effects. The court found this to be further evidence that the FDA did not approve YASMIN to treat those effects.
The court continued:
the fact that certain of the effects of a drug are described in the Clinical Pharmacology section of the label does not mean that the FDA has approved the use of the drug to produce those effects; it only ensures that physicians are aware of the full range of the drug's pharmacological effects (especially those that might be considered adverse effects) when prescribing the drug for a purpose set forth in the Indications and Usage section and under the conditions described in other parts of the label.
The court concluded that the FDA did not approve the YASMIN for its anti-androgenic and anti-mineralocorticoid effects because the FDA did not find YASMIN to be safe and effective to cause those effects and the recognition of such safety and efficacy is absent from the YASMIN label. The court held that since the FDA did not approve YASMIN for the method of use claimed in the '652 patent and the defendants' ANDAs sought to market the generic form solely for contraceptive use, the defendants could not induce infringement of the '652 patent.
In dissent, Judge Newman found the majority's ruling to be in error because "the portion of the FDA label in which a product's properties are described is irrelevant to whether the patent is infringed. . . ." Instead, in her view, "[t]he infringement inquiry is whether the generic counterpart, when used in accordance with its proposed ANDA authorization, would infringe the patent."
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