More on In re Ciprofloxacin Hydrochloride Antitrust Litigation

Kevin McDonald and Larry Rosenberg of Jones Day writing at the Drug and Device Law blog provide their perspective on the above Federal Circuit case decided on October 15, 2008.  The following is excerpted from their guest post:

On October 15, 2008, the Federal Circuit joined the growing list of federal courts to hold that the use of cash payments to settle Hatch-Waxman patent litigation does not violate the antitrust laws as long as (1) the settlement excludes no more competition than would the patent itself and (2) the claim for patent infringement and/or validity is not a “sham,” that is, not “objectively baseless.” In In re Ciprofloxacin Hydrochloride Antitrust Litigation, No. 08-1097, 2008 WL 4570669 (Fed. Cir. Oct. 15, 2008), a unanimous panel of the United States Court of Appeals for the Federal Circuit affirmed the summary judgment granted to Bayer by the United States District Court for the Eastern District of New York, holding that Bayer’s settlement of patent litigation with a generic pharmaceutical manufacturer did not violate the antitrust laws.

To get around the patent listed for Cipro, Barr certified that Bayer’s patent was invalid. Bayer then filed a patent infringement suit against Barr, which by statute stayed the FDA approval of Barr’s generic drug for 30 months. The parties later settled the patent suit. Bayer made cash payments to Barr and granted it a license to enter the market with a generic version six months before the patent expired, while Barr dropped its challenge to the validity of Bayer’s patent.

In March 2005, Judge David Trager ruled that the settlement did not violate the antitrust laws because the settlement excluded no competition beyond the exclusionary scope of the patent. See In re Ciprofloxacin Hydrochloride Antitrust Litig., 363 F. Supp. 2d 514 (E.D.N.Y. 2005). As to reverse payments, Judge Trager pointed out that the Hatch-Waxman procedures create a scenario in which the generic challenger can potentially invalidate a valuable patent without even entering the market. The generic thus has everything to gain (free entry) and the patent holder everything to lose (the patent). As a result, the consideration required to settle such a case, whether in the form of cash, a license, or something else, necessarily flows from the patent holder to the generic challenger. The real question for antitrust purposes is whether the settlement keeps out any lawful (that is, non-infringing) competition. Because the antitrust laws do not protect competition that infringes a patent, the court concluded that the settlement of a patent claim brought in good faith (i.e., not a “sham”) that is no broader than the exclusionary scope of the patent itself cannot harm competition.

The FTC has taken the position that all of the court decisions ruling in favor of antitrust defendants on this issue are wrong, and has sought Congressional legislation to overturn them. The plaintiffs in In re Ciprofloxacin may ask the Supreme Court to review the case, although the Court has denied certiorari in all four of the federal appellate cases previously decided on this issue. In one of those cases, Schering-Plough Corp. v. FTC, 402 F.3d 1056 (11th Cir. 2005), the FTC filed its own cert. petition after losing in the 11th Circuit, whereupon the Solicitor General and the DOJ, when asked by the Supreme Court for their views, opposed the FTC’s petition.

Read the full post here.