Teva wants new rules for first generic entrants in EU

Home/Policies & Legislation | Posted 06/07/2009 post-comment0 Post your comment

In Europe first EU generic entrants should be given a period of market exclusivity, Teva Europe President and CEO, Dr Gerard Van Odijk, claimed at the World Generic Medicines Congress Europe 2009 held in London, UK, in February. He said that once a product’s patent expired “everyone jumps on the bandwagon. What we need is an alternative way to continue the appetite to take risks in Europe.”

According to Dr Van Odijk rule changes are needed to encourage the pharmaceutical industry to continue taking risks and rebalance power that has shifted from generics to Big Pharma. This should involve granting market exclusivity in Europe for a first generic entrant as a reward for having taken the risks and running up substantial costs. It would mirror the exclusivity benefits for first-to-file generics in the US.

Subsequent generics enjoy the free ride on the investment of the first mover, he said. “Revenues during the exclusive period would allow generic companies to recoup their investments, e.g. by funding additional drug developments and pursuing new patent challenges.”

Dr Van Odijk said that way Big Pharma would be forced to improve innovation. “The playing field in Europe between innovators and generics is not fair. It is apparent to us that Big Pharma focuses efforts too much on defending patents towards the end of their life to the exclusion of pursuing innovative medicines.” While he stressed that Teva was in favour of “good patent protection on innovation,” he added that “when the party is over, it’s over.”

Dr Van Odijk stressed there should never be any place for vexatious litigation. The attractions of Big Pharma delaying generics are that they can generate extra profits, which generally exceed litigation costs. “Yet the majority of cases are lost by innovators”, Dr Van Odijk claimed.

Dr Van Odijk suggested originator companies should be compelled under a new European Patent Court to give an upfront financial guarantee, a so-called “bond”, to fund fast payouts of damages claims to deter “delay tactics”. That would rebalance power in this litigation setting and would really force innovators to rethink strategy. A new European Patent Court would rule on patent disputes and give first instant decisions within 12 to 18 months and decisions on appeal within nine to 12 months.

Source: APM Health Europe

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