шеринг или байер

The drug at issue in the present case was Yasmin, an oral contraceptive.  Bayer's predecessor company received FDA approval in 2001, where the FDA "concluded that adequate information has been presented to demonstrate that the drug product is safe and effective for use as recommended in the agreed upon enclosed labeling text."  The drug Yasmin or its use for contraception alone was not covered by a Bayer patent.  Instead, Bayer had listed three patents in the Orange Book, one of which was U.S. Patent No. ("the '652 patent").  All of the claims in this patent recite that the claimed method achieves three effects simultaneously:  a contraceptive effect, an anti-androgenic effect (effective in treating conditions such as hirsutism or acne), and an anti-aldosterone effect (which can be used to reduce excess

As background, when a pharmaceutical company files a New Drug Application (NDA) with the FDA seeking approval to market a new drug, it is required to identify every patent that claims the drug or use of the drug that could reasonably be asserted in an infringement action.  For method-of-use claims, the FDA regulations provide that the patents must claim "indications or other conditions of use that are described in the pending or approved application" (21 C.F.R. ВW 314.53(b)).  These patents are then listed in the Orange Book.  Anyone wanting to market a generic version of the drug before the expiration of any method-of-use patents must either state that it is not seeking approval of the claimed method, i.e., that it created a carve-out, (a section viii statement), or they must certify that the claim is either invalid or not infringed (a Paragraph IV certification).  The filing of an ANDA with a Paragraph IV certification is a statutory act of infringement, which can give rise to a "Hatch-Waxman" litigation.

In a second case involving the Hatch-Waxman regulatory scheme decided by the Federal Circuit on Monday, the Court held in Bayer Schering Pharma AG v. Lupin, Ltd. that for an ANDA filing to infringe a method-of-use claim, the proposed label must indicate that the FDA has determined that the drug is safe and effective for the claimed method.  Judge Newman dissented, however, because the District Court had made this determination on the pleadings but failed to conduct a standard infringement analysis.  Instead, Judge Newman believed the question should have been whether the sale or use of the generic equivalent, in accordance with the representations in the ANDA, would infringe the claims of the patents, which should have at least proceeded past the pleading stage.

Bayer Schering Pharma AG v. Lupin, Ltd. (Fed. Cir. 2012)

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Patent Docs: Bayer Schering Pharma AG v. Lupin, Ltd. (Fed. Cir. 2012)