"Orange Book" Patent Abuses Could Be Addressed By FDA Limitations - Atty.

FDA should issue regulations limiting "Orange Book" patent listings by brand name pharmaceutical companies to those patents that claim the listed drug or approved method of use, attorney David Weeda suggested at the Warburg Dillon Read Specialty Pharmaceutical Conference in New York City May 26. Weeda, a partner at the D.C. firm Olsson, Frank and Weeda, is a former FDA associate chief counsel.

"The abuse of the ["Orange Book"] system...can be dealt with directly" by FDA, Weeda said. The agency "should, consistent with the statute, limit the listing of patents to only those patents which claim the listed drug or the method of using the approved drug."

Weeda, whose clients include the National Association of Pharmaceutical Manufacturers, urged the generic industry to confront FDA about "Orange Book" abuses.

"While FDA has stated that it has no expertise in patent law, it certainly has the technical expertise to determine whether a patent covers a form of the active ingredient which is contained in the listed drug and the expertise to assess whether packaging and related patents claim the drug or a method of use," Weeda said. "I would urge the industry to address this issue directly with FDA."

"If FDA refuses to respond," the attorney suggested, "Congress should be engaged to direct the agency to remedy the situation."

Congress may need to be called in to settle the ongoing dispute over 180-day exclusivity for "first-to-file" generic products, Weeda continued. The original generic exclusivity provision in the 1984 Waxman/Hatch amendment was crafted hastily, and subsequent court decisions have served only to confuse the issue, he suggested.

"If there is one area in Waxman/Hatch that needs legislative attention, it's the generic drug exclusivity provision," Weeda declared.

"The industry needs to come to grips with what changes should be made to the current statute. Without agreement, it very well may be more expeditious to repeal the provision." Repeal would at least make the situation "a lot more certain than [it is] right now," Weeda said.

The former FDA counsel said he believes FDA's next attempt to write a rule on generic exclusivity is likely to address the commercial arrangements between first-to-file companies and innovator firms. If a company enters an agreement that restricts the commercial availability of an exclusivity holder's product, then FDA will consider "first commercial marketing" to have occurred, thereby starting the clock on the 180-day protected period, Weeda said.

However, Weeda was doubtful there would be any effective action from FDA on the generic exclusivity rule for some time. First, it is unlikely the proposed rule will be issued this summer, he said.

When the rule is issued eventually, it is almost certain to be challenged by further court actions, "and we will all have to live with further uncertainty until there is a court determination," Weeda noted.

Weeda warned the generic drug industry to watch pending patent extension bills for prescription drugs because they could open up the floodgates for "anticompetitive" legislation.

Reps. Ed Bryant (R-Tenn.) and Jim McDermott's (D-Wash.) Patent Fairness Act would extend exclusivity for "pipeline" drugs that were in development when Waxman/Hatch was passed and subsequently experienced delays during the review process. Schering-Plough's antihistamine Claritin is the drug most visibly affected by the bill.

"While this bill applies only to those pipeline drugs that experienced five years in FDA's review queue, if you lower that five years - and this is just starting out in the legislative process, so you never know what's going to happen - if I'm Lilly, I might come in and say, 'lower that to four years,' because if you lower that to four years, Prozac falls under it," Weeda pointed out. He also noted that some firms might seek to get rid of the years-in-the-queue limitation completely.

A lobbying group associated with Mylan called the Campaign for Fair Pharmaceutical Competition announced a program May 26 aimed at the Democratic sponsors of the patent legislation. Called "Buy Jim Back," the campaign seeks to raise $7,762 from Seattle voters in one dollar increments to match the size of a Schering donation to McDermott.