Providing shared exclusivity to generic applicants ensures faster access to market for generics, FDA said in explaining its shift from a "patent by patent" approach to 180-day exclusivity.

"Past experience has shown that first generics who are the sole applicants eligible for exclusivity often find it in their interest not to begin the exclusivity period," the agency said.

The Federal Trade Commission is investigating several patent litigation settlements where the generic companies have agreed not to enter the market in return for payments from brand firms.

Shared exclusivity "would reward the first applicant to file a paragraph IV certification with respect to each patent," FDA said.

FDA maintains its new approach benefits both the ANDA applicants and consumers. Sharing is advantageous to ANDA applicants because the collective effort among applicants in challenging the multiple patents reduces the "barriers to approval."

Each first applicant can realize "some part of the benefit from removing the multiple patents as barriers to approval, when any one of those patents could have delayed approval of ANDAs."

Consumers benefit because there is a greater chance of a generic making it to the market when multiple companies get exclusivity, FDA said. "With multiple ANDAs approved, it is more likely that the exclusivity period will be triggered and at least one of the drugs will reach the market during the exclusivity period."

The agency concedes that the approach may "deprive" applicants the chance to be the sole generic competitor.

However, "exclusivity is already structured in a way that eligibility for exclusivity does not guarantee 180-days as the sole marketed drug," the agency said.

For example, FDA says, a "court decision could trigger exclusivity before the ANDA is approved," or "uncertainty over the patent could result in no marketing until an affirmance in the federal circuit of a district court win."

FDA also considered a second approach to the multiple patent issue: to grant exclusivity to "the very first ANDA applicant to file a patent challenge to any patent listed for the innovator drug." However, the approach would be "less consistent" with the statutory language, "because this approach would be based upon a challenge to only one listed patent."

FDA previously awarded separate and multiple exclusivity periods based on which applicant "filed the first paragraph IV certification for each listed patent." The policy was adopted during the review of generic cisplatin (¹ Also see "Generic Exclusivity Does Not Apply After Challenged Patent Expires - FDA" - Pink Sheet, 16 August, 1999., p. 11)

FDA granted shared exclusivity to Andrx and GenPharm for the 10 mg and 20 mg strengths of omeprazole (² Also see "Andrx Generic Prilosec Clears FDA; Approval Could Expedite Patent Litigation" - Pink Sheet, 19 November, 2001., p. 21). Andrx' 10 mg, 20 mg and 40 mg strengths were approved Nov. 16. Andrx plans to market its generic omeprazole following a decision in the ongoing Prilosec patent trial in Manhattan federal court. GenPharm's omeprazole ANDA is not yet tentatively approved.

If the agency had granted GenPharm and Andrx separate exclusivity periods based on its "patent-based multiple exclusivity" approach, it would have created an impasse, FDA said.

Under the previous policy, "Andrx could not be given final approval until GenPharm's exclusivity for certain patents had run; but GenPharm could not be given final approval until Andrx's exclusivity for other patents had run," FDA said. Hence, the generics would not be approved and the "commercial marketing trigger would not be available."

"The only trigger to begin the running of each exclusivity would be a court decision on each of the relevant patents," FDA said. "Whether either applicant would be the sole marketer for any period of time would depend entirely on the order and timing of the court decisions."

The shared exclusivity is triggered when either company begins marketing the product or after a court decision "on any one of the patents that qualified any applicant for exclusivity."

FDA is addressing the exclusivity dispute between Dr. Reddy's and Andrx over the 40 mg omeprazole capsule "separately" (³ Also see "Dr. Reddy’s Omeprazole Case: Is Pediatric Exclusivity Extension Of Patent?" - Pink Sheet, 3 December, 2001., p. 12).

“Shared” Generic Exclusivity In Multi-Patent Cases Speeds Launch – FDA

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