Promoting generic drug availability: Reforming the Hatch-Waxman Act to prevent unnecessary delays to consumers

St. John's Law Review, Spring 2001 by Giles, Laura

This agreement prevented any other generic manufacturers from marketing a generic version of Cardizem. Biovail, another generic manufacturer, filed an ANDA with the FDA but was prevented from obtaining preliminary FDA approval because Andries 180 day exclusivity period had not yet been triggered and therefore had not expired.99 Andrx's exclusivity period had not yet expired because under the agreement between Hoechst and Andrx, Andrx would not market the drug, so there would be no "commercial marketing trigger," and there was no patent litigation, so there would be no "court decision trigger."100 The agreement, had it continued, would have essentially prevented a generic version of Cardizem from being available at market.101

IV. POSSIBLE REFORMS TO THE HATCH-WAxmAN ACT

One of the most common complaints about the HatchWaxman Act involves the drafting of the Act.102 Those who have commented on the drafting have labeled it "vague," "complicated," and "unclear."103 This inelegant drafting has led to a number of problems applying the Act and effectuating its purpose.104 These problems need to be addressed to ensure that consumers have speedy access to generic drugs once the patent on the brand name has expired. Congress has realized that there are problems and loopholes in the statute that must be addressed, and the 106th Congress has proposed a bill to address some of these problems.105

A. 180-Day Exclusivity Period

The biggest problem in effectuating the purposes of the Hatch-Waxman Act has been the 180-day exclusivity period granted to the first generic manufacturer to file an ANDA.los The Act provides two "trigger" points for the beginning of the exclusivity period-a "commercial marketing" trigger and a "court decision" trigger.107 Applying the statute, the FDA believed that the period was triggered by the first substantially complete ANDA with a paragraph certification challenging the patent and had to successfully defend the patent suit brought by the innovator drug company.108 In Mova Pharm. Corp. v. Shalala,109 however, the United States Court of Appeals changed this interpretation.110

The court in Mova Pharm. Corp. found that the FDA's interpretation of the statute imposed a "successful defense requirement," which was not what Congress had intended in drafting the statute.111 Subsequent to Mova Pharm. Corp., the FDA issued a guidance document interpreting the statute to say that one need not be sued to obtain exclusivity.112 This provision of the Act should be amended113 to make it clear that an applicant who makes a paragraph IV certification need not successfully defend a patent infringement suit in order to trigger the exclusivity period.

The interpretation of the term "court" in the court decision trigger of the exclusivity period is yet another problem in the statute.114 Which court decision triggers the exclusivity period? The district court? The court of appeals? The Supreme Court? Two cases have addressed this issue and determined that the word "court" should be interpreted as the first court that finds the patent in question to be invalid, unenforceable, or not infringed. 115 The proposed bill has not adopted these versions116 and states that "court" means a court "from which no appeal can or has been taken."117