A post on the wsj.com healthblog by Heather Won Tesoriero claims
"Late last night, a pair of congressmen introduced a bill aimed at creating a pathway for approval of generic biotech drugs.
Finally, you say. But, wait, there’s a catch, and it’s a big one. The legislation would also give brand-name biotech drugs an extra 14 1/2 years of patent protection. (Read a summary of the bill, or the complete text.) That almost defeats the purpose of establishing a route to market for generic biotech drugs, advocates for them say. "
Well I read the summary and the text and it sounds like someone is buying the generic trade group's spin on the patent protection. No one is getting 15 years of additional patent protection. Rather, it gives companies going forward 12 years of data exclusivity and 2.5 years of patent life that of course begins well before a biologic enters clinical trials. The wailing is part of a larger strategy by the generic trade group to argue for the right to challenge biologic patents early and get market exclusivity as generic firms receive if they do make a successful challenge. Wailing as in: "Waah! Innovators get solid patent protection so I can't start copying their products from day one...waah!!
I am sure the anti-capitalists who attack pharma and BIO will go wild...
http://blogs.wsj.com/health/2008/03/14/want-generic-biotech-you-might-wait-14-more-years/?mod=googlenews_wsj
"Late last night, a pair of congressmen introduced a bill aimed at creating a pathway for approval of generic biotech drugs.
Finally, you say. But, wait, there’s a catch, and it’s a big one. The legislation would also give brand-name biotech drugs an extra 14 1/2 years of patent protection. (Read a summary of the bill, or the complete text.) That almost defeats the purpose of establishing a route to market for generic biotech drugs, advocates for them say. "
Well I read the summary and the text and it sounds like someone is buying the generic trade group's spin on the patent protection. No one is getting 15 years of additional patent protection. Rather, it gives companies going forward 12 years of data exclusivity and 2.5 years of patent life that of course begins well before a biologic enters clinical trials. The wailing is part of a larger strategy by the generic trade group to argue for the right to challenge biologic patents early and get market exclusivity as generic firms receive if they do make a successful challenge. Wailing as in: "Waah! Innovators get solid patent protection so I can't start copying their products from day one...waah!!
I am sure the anti-capitalists who attack pharma and BIO will go wild...
http://blogs.wsj.com/health/2008/03/14/want-generic-biotech-you-might-wait-14-more-years/?mod=googlenews_wsj
