The Biologics Price Competition and Innovation Act (BPCIA) was signed into law on March 23, 2010. It is the basis for establishing an approval pathway for biosimilars. In early April this year, Abbott petitioned the FDA to disallow any biosimilar applications that cited a reference drug's BLA that was submitted prior to the March 23rd date. Abbott's legal representatives contend that the FDA's consideration of such materials would violate the Fifth Amendment. See Patent Docs blog.
It seems the Fifth Amendment, in addition to protecting one's right against self-incrimination, also "prohibits the taking of private property for public use without just compensation." Abbott says the FDA would be dong just that if they use data from a BLA (filed before March 23, 2010) to allow a biosimilar drug on the market. Prior to March 23rd, Abbott contends that it and other similar BLA filers had the expectation that the information in their filing would remain guarded as a trade secret, and the FDA is now about to reverse that policy. Abbott specifically mentions BLA 125057 for Humira® (adalimumab) as one BLA to be protected in its FDA petition. The drug is a known target of biosimilar "producers to be". Even as I type, it is earning its way to becoming the TOP SELLING drug in the world in 2012 with more than $9.3 B in projected revenues.
Abbott's argument in a nutshell.
Reference product sponsors invested massively in bringing products to market, taking great risk to develop, test, and seek a license to market the reference product. Abbott argues that an innovator's license application typically reflects more than a decade of research and contains analytical, preclinical, and clinical data, as well as detailed manufacturing information, most of which qualifies as trade secrets. It further contends that these trade secrets are the private property of the reference product sponsor and are therefore protected by the Fifth Amendment to the U.S. Constitution. And [the coup de grace] according to Abbott's Petition, when the FDA approves a biosimilar biological product on the grounds that the reference product has been shown safe, pure, and potent, it uses these trade secrets. Abbott says only biosimilar applications citing data filed after March 23, 2010 should be allowed.
Abbott finishes its Petition by requesting that the FDA interpret the BPCIA as applying only to post-enactment reference products, thereby avoiding both significant constitutional questions and significant governmental liability.
Abbott even cited a Supreme Court case -- Ruckelshaus v. Monsanto Co. (1984) -- involving a somewhat analogous situation where Monsanto submitted a trade secret to the EPA in support of a pesticide license application. The Supreme court did rule in this instance that trade secrets were protected under the 5th amendment and that Monsanto had an expectation that the goverment would not use the information to benefit a competitor in their license application -- instead their data "would remain inviolate."
Wow...this completely undermines the intent of the biosimilars legislation does it not? Sounds eerily similar to me. I think it would be bad public policy to block biosimilars but I think Abbott's argument is ingenious to say the least. Right now, this is just a petition to the FDA to influence how it chooses to set policy, now we'll have to wait anxiously to hear the agency response. You can see this argument potentially going to some court however.
Posted by Bruce Lehr Apr 24th 2012.