A provision on the "antibundling" of generic drug applications in the House Medicare prescription drug bill could be misused by the brand name industry to delay the market entry of generics, the Generic Pharmaceutical Association says.

"GPhA fears that this provision could be misinterpreted and be turned into a commercial tool for delaying generic market entry," the association said in a July 31 letter to Medicare conferees.

The antibundling provision is one area of difference in the Waxman/Hatch reform provisions of the House and Senate Medicare bills (HR 1, S 1) GPhA noted. The group is urging that the provision, which appears in HR 1 but not in S 1, be removed in conference.

For the purpose of filing generic applications, FDA allows "bundling" of different strengths and certain other variations of an innovator product into one ANDA. The agency does not allow bundling of different dosage forms. The policy conserves industry and FDA resources and can expedite reviews, GPhA said, adding that so far there have been "no known adverse issues" related to the policy.

If the HR 1 provision were intended merely to codify current policy, it would be "unnecessary at best," GPhA said. However, the provision "ultimately will be interpreted differently than FDA's current policy."

The provision "could be construed as disallowing the filing of a single ANDA under circumstances permitted today by FDA's guidance."

GPhA fears the statute could be interpreted as requiring a separate ANDA for each dose of a drug, thereby enabling brand name firms to obtain a 30-month stay of approval on each application.

Overall, GPhA prefers the Senate's Waxman/Hatch reform language to the House's, the letter states. In areas "where there are significant differences between the Senate and the House...we strongly urge the conferees to adopt the provisions contained in S 1," GPhA said.

The Senate bill includes a provision allowing generic firms to seek declaratory judgment on the validity of a patent if a brand drug manufacturer fails to sue within 45 days of a Paragraph IV certification notification. In contrast, HR 1's provision is unsatisfactory, GPhA says, because a generic company could seek a declaratory judgment action only if it provided the brand company access to confidential and proprietary information in its ANDA.

Supplying the information "may provide the brand industry with additional grounds to significantly delay generic competition," the letter says.

GPhA cites Dr. Reddy's recent case seeking declaratory judgment against Pfizer's Zoloft patents as an example of why the Senate language is needed. The judge ruled the generic firm did not prove "reasonable apprehension" of being sued by Pfizer (¹ 'The Pink Sheet' July 14, 2003, In Brief).

The Reddy's case demonstrates how brand firms can argue that declaratory judgment is premature and therefore should be dismissed for lack of subject matter jurisdiction, GPhA said. Sen. Charles Schumer (D-N.Y.) cited the case at a recent hearing as a reason to provide declaratory judgement.

The letter also responds to arguments by brand drug firms that the right to declaratory judgment on patents could be unconstitutional (see ² [A#00650320012] ).

"The provision in S 1 is a far cry from the kind of statutory provision that would require the federal courts to resolve a theoretical issue or an issue where there is no controversy and that therefore might be barred by Article III," the letter claims.

A company announces its patents by listing them in the "Orange Book," GPhA noted. "For strategic, commercial reasons, it may wish to delay litigation of that patent, but that business decision does not eliminate the apprehension created by the patent listing. Thus, the brand company's commercial decision should not be a barrier to a generic company's ability to obtain an early resolution of patent issues that clearly are the subject of a dispute between the generic and brand companies."

S 1 gives companies an incentive to list patents in the Orange Book by allowing courts to deny an award of damages for a brand firm if the disputed patent was not filed with FDA, a provision HR 1 lacks, GPhA says. GPhA also favors retaining the identical 180-day exclusivity provisions contained in both bills (³ [A#PS042234], p. 13).

Generic Rx Delays Could Result From House Medicare Provisions, GPhA Says

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