Tahir Amin, DipLP, co-founder and director of intellectual property of Initiative for Medicines, Access, and Knowledge, considers whether a recent law could help biosimilars.
According to a recent law, the Federal Trade Commission and Department of Justice will review possible pay-for-delay settlements. Will this help biosimilars?
So I believe the act that the president passed in relation to getting information about settlements in the biologics space is in, I believe, the Collins act, and I think it will allow the Federal Trade Commission, the FTC, to at least start getting those documents and those agreements and making sense of if there is anti-competitive behavior that is happening.
We believe that is an important step—long overdue considering the Biologics Price Competition and Innovation Act has been around since 2009. This has existed in the small-molecule space under Hatch-Waxman that the FTC is entitled to get all of these documents.
So I think it’s a positive step, so the question remains whether the FTC has the ability and the powers too really enforce some of the anti-trust options that it might have. Unfortunately, companies have become very good at redefining what is a pay-for-delay settlement, they offer different incentives to the biosimilars companies, and those are not really fitting in the normal standard pay-for-delay descriptions that the Supreme Court has warned against in 2013 I believe.