Biosimilar bill could be "stake in the heart"
The imminent threat of generic competition ensured a big turnout at the "Super Session", in which panelists discussed why the outcome of current debates about patent reform and biosimilars are "immensely important" to biotech.
Robert Armitage, senior vice president and general counsel at Eli Lilly, said that data protection "needs to be at least 14 years" to ensure that innovator companies have adequate time to recoup the investment needed to get a drug to market.
To support this arguement Armitage cited a study by Henry Grabowski, an economics professor at Dukes University, North Carolina, US, which said 12.8 to 16.2 years protection is needed to break even. This is significantly more than would be afforded to innovator companies under the bill proposed by Henry Waxman, which Armitage believes generics companies would be "delighted" to see pass into law.
However, this delight may be shortlived because the five years data protection afforded to companies under Waxman's bill would make biotech innovation unsustainable and in turn harm the biosimilar sector, according the discussions in the session.
"The perversity of patent protection"
Armitage went on to discuss what he described as "the perversity of patent protection", which punishes medications for chronic diseases, novel therapies and those that focus on prevention rather than treatment. This is because "the more challenging the R&D effort the shorter the patent life", with complex clinical trials in new areas taking longer to perfom.
In addition, Armitage said that "some breakthough biologics lack any effective patent protections", including billion dollar products, which makes implementing sufficient data protection vital.
