FDA Patent Listing Procedures May Need Revision, Hatch And Waxman Say

FDA should apply more judgment in analyzing patents submitted for listing in the "Orange Book" when generic competition is imminent, Sens. Kennedy (D-Mass.) and Hatch (R-Utah) and Rep. Waxman (D-Calif.) said in a letter to HHS Secretary Thompson.

FDA must exhibit "vigilance in making certain that there is no gamesmanship to undermine competitive interests by allowing late-issued patents to be listed," the letter says. "If the agency determines that the relationship between these new patent claims and the existing product are not well-founded and cannot meet a good faith test, there should be appropriate consequences with respect to the Orange Book."

"We recognize that some new patents may be valid and may somehow be integral to the already marketed product and therefore can be listed despite their late issuance," the letter adds.

"We understand that FDA is generally reluctant to engage in detailed patent validity inquiries," the letter notes. "But nothing in the agency's governing statute, nor in its regulations, precludes it from carefully reviewing an application for an Orange Book listing."

FDA has taken the position that its role in listing patents is strictly ministerial, and that it is for courts to judge the applicability of a patent to a particular product. "We are hopeful you will direct the agency to exercise its discretion as appropriate and reject a mechanical reading of the law," the letter states.

The upcoming expiration of the basic compound patent for AstraZeneca's Prilosec (omeprazole) appears to have provided the immediate impetus for the letter.

Kennedy, Hatch and Waxman note that the omeprazole compound patent will expire in October, following a six-month pediatric exclusivity extension. If another patent is listed, it "could have the practical effect of extending patent protection on Prilosec, the world's best selling drug, for two-and-a-half additional years."

AstraZeneca received several new production patents for omeprazole in 2001, and also took a non-exclusive license to three patents issued to aaiPharma related to the isomeric structure of the product. The company opted not to list any of the patents in the "Orange Book" (¹ (Also see "Omeprazole Isomer Data Based On AaiPharma Patents Submitted To FDA" - Pink Sheet, 3 Sep, 2001.)).

AstraZeneca may, however, be seeking a change in Prilosec labeling, according to aaiPharma. The 6-methoxy isomer, which was not previously described in labeling, is in fact the predominant form in the product, aaiPharma said.

The implications of its finding may drive aaiPharma to file a citizen petition separate from AstraZeneca's actions, aaiPharma said.

FDA should give "careful scrutiny to any request it receives that may have the effect of extending that medication's patent," the letter from Kennedy, Hatch and Waxman advises.

An amendment to the House FDA appropriations bill by Reps. Brown (D-Ohio) and Emerson (R-Mo.) to allocate $1 mil. for FDA review of Orange Book submissions passed by voice vote in July.

The provision could be introduced during Senate debate on the bill, but Hatch is opposed to using appropriations bills as vehicles for patent legislation.

Legislation sponsored by Sens. McCain (R-Ariz.) and Schumer (D-N.Y.) has a broader scope: S 812 would eliminate the 30-month stay of approval triggered by patent challenges. Brown and Emerson are the House co-sponsors.

Hatch is unlikely to support legislation that would alter one of the compromises from the original Waxman/Hatch bill. A more active role by FDA in the listing process could resolve the issue without legislation.

Another bill addressing generic issues appears to be moving forward. Sen. Leahy (D-Vt.) is close to an agreement with Hatch regarding Leahy's S 754, which would require that deals between brand and generic companies be reported to the Federal Trade Commission and the Department of Justice.

Leahy, who took Hatch's seat as chair of the Judiciary Committee after Democrats assumed control of the Senate, is working on the specifics of the bill's provisions but has reached a conceptual agreement with Hatch on its basic outline.