But to the extent that the existence of the patent and the existence of the current patent term as we have it set up, facilitates innovation, leads to innovation.
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Mr. Orszag, so much of the discussion today, including some of your discussion with Senator Klobuchar, has focused on the potential harm to customers that consumers might incur from reverse settlements among pharmaceutical manufacturers in…
And it's for that very reason that the Supreme Court has tended, over the course of the last century, to lean more toward the Rule of Reason and away from per se rules of invalidity and also from presumptions of illegality.
A presumption of illegality is proper only when 'an observer with even a rudimentary understanding of economics could conclude that the arrangements in question would have an anti-competitive effect on customers and markets.'
I think you have to presume that the patent is invalid in order, legitimately, to call it pay for delay.
Running against the shot clock here--it's something we deal with a lot in the Senate.
Wouldn't you have to concede that then in that circumstance you've got pro-competitive effects?
Our laws create a statutory presumption as to the patent's validity.
I want to talk just a little bit about our use of the term 'pay for delay' today.
On average, it takes 10 years and $1 billion to develop and gain FDA approval for a new drug.
Some brand-name manufacturers have chosen to settle lawsuits filed by generics instead of litigating.
But to assume that requires us to assume at the outset that the patent is, in fact, invalid.
Proponents of the agreements have argued that the agreements can never properly be considered anti-competitive.
Both this recoupment of investment and these profits are jeopardized by lawsuits that are filed by generics.
Opponents of reverse settlements have for several years argued that they're anti-competitive.
Pharmaceutical patents are extremely valuable and it's for good reason that they're valuable.
The question of the January 2012 recess appointments is currently pending before the Supreme Court.