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Home > IPLJ > Vol. Volume X > No. 2 (2011)

 

Abstract

The Hatch-Waxman Act of 1984 regulates approval by the Food and Drug Administration (“FDA”) of generic counterparts to patented drugs. In a series of recent cases, large pharmaceutical companies have been accused of exploiting Hatch-Waxman in violation of the antitrust laws. In essence, the allegations are concerned with the large pharmaceutical companies that have paid manufacturers not to market inexpensive generic versions of patented drugs, thereby restraining trade and maintaining a monopoly. In the case of Biovail v. Hoechst Aktiengesellschaf, Inc., the generic drug manufacturer, Biovail, sued Hoechst Aktiengesellschaf (“Hoechst”), a pharmaceutical company, for antitrust violations resulting from Biovail’s effort to gain approval from the FDA to market a generic version of Cardizem, a heart drug patented by Hoechst. The claims are that Hoechst unfairly manipulated the Hatch-Waxman Act to prevent Biovail from obtaining FDA approval for a generic counterpart to Cardizem. Even though the defendant Hoechst, may have intended to exclude the plaintiff, Biovail, as competitors, Hoechst will be substantially immune from antitrust liability under the Noerr-Pennington doctrine (“Noerr Immunity”), because Hoechst was acting within its constitutionally protected rights. The Noerr Immunity enjoyed by Hoechst is necessary to insure that the free- competition goals of the antitrust laws do not destroy Hoechst’s right to petition the government, as guaranteed by the First Amendment. Part I of this Comment discusses both the legal framework of the Hatch-Waxman Act as well as Biovail’s claims. Part II analyzes Biovail’s claims with respect to potential violations by Hoechst under section 1 and section 2 of the Sherman Antitrust Act (the “Sherman Act”). Part III analyzes Hoechst’s immunity under the Noerr Immunity doctrine. This Comment concludes that the Noerr Immunity doctrine protects Hoechst, even if they intended to manipulate the Hatch-Waxman Act.

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