According to Pharmalot blog, three pharmacy chains and a wholesaler have petitioned the Supreme Court to review legality of so called "pay-for-delay" arrangements between brand manufacturers and generic drug companies.
Pay-for-delay deals have been controversial for years. Various circuit courts around the US have issued conflicting rulings on the topic. The US Federal Trade Commission has been an outspoken opponent of these deals as "anti-competitive" for the consumer. The plaintiffs have asked the Supreme Court to review a deal between Bayer and Barr Pharmaceuticals (now owned by Teva) for the antibiotic ciprofloxacin.
Plaintiff's brief states that:
“The question of the proper standard for determining whether an exclusion payment is anti-compeitive has been percolating in the courts, and thoroughly debated in academica, for over a decade….This case presents the best opportunity for the court to resolve the circuit split, require compliance with the court’s patent and anti-trust precedents, and restore the Hatch-Waxman Act balance between extending pharmaceutical patent terms and preserving judicial review of those patents to ensure that the results monopolies are are warranted”
After more than a decade, it seems well past time for the High Court to set an appropriate National standard to judge these cases. Let's hope the court decides to hear the case.
Posted by Bruce Lehr December 20th 2010.