http://blog.pharmtech.com/2009/06/26/the-seven-year-itch-in-biologics-patent-exclusivity/ The blog of Pharmaceutical Technology magazine Fri, 12 Mar 2010 00:24:37 -0500 http://wordpress.org/?v=2.8.4 hourly 1 http://blog.pharmtech.com/2009/06/26/the-seven-year-itch-in-biologics-patent-exclusivity/comment-page-1/#comment-17184 Raymond Huml Tue, 14 Jul 2009 14:13:09 +0000 http://blog.pharmtech.com/?p=1470#comment-17184 You’ve got the biopharmaceutical industry pushing for 12 to 14 years of exclusivity, and free market advocates pushing for zero. Clearly neither spectrum will persevere in the struggle for exclusivity, and the White House offers a compromise to bridge the gap. The solution, though expected, will probably leave both sides unhappy campers. Even with a regulatory path going forward, you leave open the bigger question – how to address policy to ensure fair pricing? I’m not sure the patients – or the payers – will be completely happy with a 20-25% reduction in follow-on biologics costs compared to the savings they’ve come to expect from small molecule generics (e.g., 80-90%), but at least we are moving in the right direction. You’ve got the biopharmaceutical industry pushing for 12 to 14 years of exclusivity, and free market advocates pushing for zero. Clearly neither spectrum will persevere in the struggle for exclusivity, and the White House offers a compromise to bridge the gap. The solution, though expected, will probably leave both sides unhappy campers. Even with a regulatory path going forward, you leave open the bigger question – how to address policy to ensure fair pricing? I’m not sure the patients – or the payers – will be completely happy with a 20-25% reduction in follow-on biologics costs compared to the savings they’ve come to expect from small molecule generics (e.g., 80-90%), but at least we are moving in the right direction.

]]> http://blog.pharmtech.com/2009/06/26/the-seven-year-itch-in-biologics-patent-exclusivity/comment-page-1/#comment-15827 Lindsay S Wed, 01 Jul 2009 12:53:19 +0000 http://blog.pharmtech.com/?p=1470#comment-15827 Drug development costs are soaring – requiring on average nearly $1 billion and 17 years to bring a compound to market. So it’s not surprising that drug companies need and want exclusivity after spending millions of dollars in development. Legislators and regulators will need to strike a balance between rewarding innovation and addressing anticompetitive concerns. It will be interesting to see what happens…and you raise an interesting point about leveraging other models in healthcare reform to achieve a similar outcome. Drug development costs are soaring – requiring on average nearly $1 billion and 17 years to bring a compound to market. So it’s not surprising that drug companies need and want exclusivity after spending millions of dollars in development. Legislators and regulators will need to strike a balance between rewarding innovation and addressing anticompetitive concerns. It will be interesting to see what happens…and you raise an interesting point about leveraging other models in healthcare reform to achieve a similar outcome.

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