Claim Construction Error and Factual Dispute Precludes Summary Judgment

The U.S. Court of Appeals for the Federal Circuit held that infringement may exist if evidence establishes that a "menstrual shift" occurs after a woman begins taking the accused contraceptive product, such that the use of the accused product after an initial period of time results in a dosing that follows the patented method and product. Bio-Technology General Corp. v. Duramed Pharmaceuticals, Inc., No. 02-1195 (Fed. Cir. April 1, 2003).

This case involves an oral contraceptive regimen marketed as a licensed product with the brand name Mircette. Mircette is sold in a 28-pill blister pack. A woman using Mircette is instructed to sequentially take the 28 pills. The first 21 pills comprise a combination of progestin and estrogen, followed by two placebos with the final five pills containing estrogen alone.

Duramed filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval for a generic version of Mircette system. Bio-Technology General (BTG) filed suit.

The district court entered summary judgment that Duramed did not infringe U.S. Patent RE 35,724 by filing the ANDA. The district court determined that there was no literal infringement since a single package of the Duramed product reversed the delivery sequence prescribed by claim 1 (estrogen before progestin). The district court reasoned that a woman would have to take at least two packages of the accused contraceptive in order to complete the claimed regimen and that because "the elements of the accused products are placed in a reversed order to achieve a different result than that obtained in the patented system," there was no infringement under the doctrine of equivalents. BTG appealed.

The Federal Circuit reversed, finding that the district court erred in its narrow claim construction and that summary judgment should not have been entered due to the existence of material factual disputes. Specifically, the Federal Circuit found sufficient evidence had been offered by BTG at the summary judgment stage to support their contention that woman who used the accused product practiced the claimed method as a result of menstrual shift.

The Federal Circuit held that the district court construed the claims too narrowly by limiting them to a particular arrangement of estrogen and progestin pills in a single one-month package. Instead, the Federal Circuit found that a proper claim construction would include estrogen pills taken at the beginning of a woman’s menstrual cycle, followed by progestin pills for the remainder of the menstrual cycle.