The Fourth Appellate District affirmed a judgment. The court held that a pharmaceutical company’s agreements with the would-be manufacturers of a generic equivalent of the company’s patented antibiotic to delay such production did not violate the Cartwright Act.
In 1991, generic drug manufacturers Barr Laboratories, Inc. filed an application for FDA approval of a generic version of the antibiotic “Cipro” under the federal Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act). The Hatch-Waxman Act streamlined the process of obtaining approval of generic versions of branded drugs by allowing a generic manufacturer to file an abbreviated new drug application (ANDA) under 21 U.S.C. §355(j). Regarding any patents that claimed the branded drug, pursuant to §355(j)(2)(A)(vii), the generic manufacturer was required to certify one of the following: “(I) that such patent information has not been filed, (II) that such patent has expired, (III) … the date on which such patent will expire, or (IV) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted.”
