by Brian Malkin
On April 29, the Second Circuit determined that Bayer's agreement to provide generic defendant Barr with money to settle and delay market entry of its generic version of Cipro® (ciprofloxacin) does not violate antitrust laws. Viewed as another set back to the Federal Trade Commission's ("FTC's") pleas for Congress to make such pay-for-delay settlements illegal, the Circuit invited plaintiff-appellants to petition for a rehearing en banc.
On April 28, Markus H. Meier, Assistant Director of the Health Care Division at FTC's Bureau of Competition, suggested in a presentation delivered at the American Conference Institute's Paragraph IV Disputes Conference in New York City that he hoped the Second Circuit was rethinking its precedent for Tamoxifen. In Joblove v. Barr Labs, Inc, (In re Tamoxifen Citrate Antitrust Litig., 466 F.3d 187, 208-12 (2d. Cir. 2005)), the Court found another pay-for-delay settlement did not violate antitrust laws. The Conference was co-chaired by FLH Partner Barry S. White and included a presentation by FLH Partner Brian J. Makin on Patent and IP Overview for Drugs and Biologics: Hatch-Waxman, Trade Dress, and More that focused on IP issues and biologics.
Under the settlement, Bayer agreed to: 1) pay Bar $49.1 million immediately, 2) make quarterly payments of between $12.5 and 17.125 million for the duration of the patent except for the last six months prior to the patent's expiration, and 3) provide Barr a guaranteed license to sell brand-name Cipro® at a reduced rate, i.e., authorized generic, for six months prior the patent's expiration. In return, Barr agreed to stipulate to the patent's validity and not to market a generic version of Cipro® until the patent expired.