If you had any doubt that Abbott, now Abbvie, was quite serious about legally protecting its trade secrets. Think again. AbbVie is suing the EMA to prevent possible sharing of its trial data in support of Humira. Competitors, specifically UCB and InterMune, are seeking the data through a Freedom of Information filing.
The previous blog post similarly discusses Abbvie's Citizen Petition to the FDA over the same issue. In that letter, AbbVie highlights that it believes that an FDA revelation of its Humira data would represent a breach under the Takings Clause of the Fifth Amendment. If AbbVie is suing EMA above, it most certainly would pursue similar action if the FDA were to move toward sharing of its trade secrets with potential biosimilar filers.
This is shaping up to be quite an interesting set of legal challenges. I don't know if there is a good negotiated legal solution to be had here or not. Presumably it would be very expensive as AbbVie is trying to protect its $9 B per year franchise in Humira. That's a healthy compensatory amount at minimum for FTO permision. See Fierce Biotech for more.
Posted by Bruce Lehr Mar 11th 2013.