Here's an update from the Patent Doc blog. It details the Washington Legal Foundation (WLF) comments on Abbott's Citizen Petition to FDA regarding its policy on approval of biosimilars. Regular readers of this blog will have seen previously that Abbott asked the FDA to not share any of its BLA filing information on Humira or any other manufacturers filing on their drugs that were submitted to the agency prior to March 23, 2010 when looking to approve a biosimilar. The March date being when BPCIA was enacted into law.
Abbott's argument is that to share the information with a competitor would constitute the government taking its valuable trade secrets, which Abbott had every right to expect would be held confidential when filed, without just compensation to Abbott. This would constitute an infringment by the goverment of Abbott's rights under the Takings Clause in the Fifth Amendment.
In short, WLF agrees with Abbott. WLF says while the government has the right to enact biosimilar legislation in part to help reduce the costs of biological drugs which in turn might decrease the profits of innovators ...it doesn't have the right to do so by taking private property (e.g. taking information from a BLA filed before the biosimilar law existed). On balance, WLF argues that such appropriation of private proprty is more harmful than any benefits one might see in having biosimilars on te market from such an action. Some companies should not bear a disproportionate burden of costs to benefit the public which should be borne by the public as a whole.
So far other groups have weighed in against Abbott as well. These include the Generic Pharmaceutical Association (GPhA), Therapeutic Proteins International LLC (biosimilar's manufacturer), and Zuckerman Spaeder LLP (litigation firm).
We haven't heard the last of this. I expect to see this in the Supreme Court someday.
Posted by Bruce Lehr Mar 8th 2013.