WASHINGTON - President Bush's FDA rule meant to get generic drugs to market more quickly goes into effect Monday.
Most notably, the rule stops companies from "stacking" 30-month extensions on patents, and it clarifies the types of patents that can be submitted for listing in the Orange Book, the FDA book of patents.
The rule was first announced last fall, days in advance of the mid-term elections, prompting Democrats to criticize the president for courting senior citizens' votes. (See BioWorld Today, Nov. 7, 2002, and Oct. 22, 2002.)
The practice of stacking 30-month extensions to the point that an innovator games the system and delays seniors from accessing less expensive generic drugs is uncommon. Nevertheless, press accounts of such tactics have been fairly common.
Brian Coggio, an intellectual property partner with the law firm Orrick, Herrington & Sutcliffe in New York, told BioWorld Today there probably have been about 10 such cases. "Everybody looks at that change and says, Wow, that's a big change,' but it's really not because there have been so few cases where multiple stays came into play," he said. "It is a change, but it is not going to impact Hatch-Waxman across the board."
The Hatch-Waxman Act of 1984 created the generic drug industry.
Specifically, the final rule allows one 30-month extension per generic drug application. It also stops innovator companies from submitting certain new patent claims that are unlikely to represent substantial new innovation in order to extend their marketing protection.
Beginning Monday, the FDA will allow submission of patents on drug substance (active ingredient), drug product (formulation and composition) and the method of use (injectable, tablet, etc.).
"This is just making what you can and cannot list more clear," Coggio said. "The change isn't dramatic; it says you can't list packaging, metabolites, intermediates."
Meanwhile, on Capitol Hill, generic drug reform is being negotiated as part of the Medicare legislation. According to the FDA, the pending legislation complements the final rule. (The final rule must be in compliance with the law.)
The Medicare legislation contains language associated with both the 30-month stay and the Orange Book listings. Those two elements are not what's causing the controversy, Coggio said.
At issue is language that allows a generic manufacturer to argue that a patent was improperly listed. Current law prohibits that type of allegation.
Also under current law, an innovator must file a lawsuit within 45 days of a generic submitting its abbreviated new drug application (ANDA) in order to receive the 30-month injunction.
Under proposed law, even if an innovator does not file a suit, the generic can start a "declaratory judgment" saying its product doesn't infringe on an innovator's patent, i.e., the patent shouldn't be in the book.
"There is some question as to whether that provision is constitutional, because if the patentee decides not to sue, it is questionable whether there's a case or controversy, which is required before you can get access to a federal district court," Coggio said.
"So this change allowing the ANDA holder to challenge the listing of a patent and the change allowing the ANDA holder to institute a declaratory judgment if no suit is filed in 45 days are dramatic changes from the way Hatch-Waxman works today," he said.