How Pharma Should Prep for the Six-Bill Avalanche From Congress

The US pharmaceutical industry may soon face major regulatory changes as six bipartisan bills designed to rein in tactics that keep drug prices high and delay generic competition close in. The Senate Judiciary Committee unanimously voted to advance all six of the bills at the beginning of this month, in an attempt to target long-criticised practices by branded drugmakers. Led by committee chairman and Iowa Senator Chuck Grassley, the bills aim to end pay-for-delay deals, curb alleged abusive patent tactics like product hopping and patent thickets, and improve coordination between agencies like the US Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA). They also target “sham” citizen petitions that delay generics and ensure the Federal Trade Commission (FTC) completes its review of pharmacy benefit management’s impact on competition.

Cole Schotz member Kumar Vinnakota notes that the bill looks to streamline the biosimilar “patent dance” that originator and biosimilar companies face in BPCIA litigations. If enacted, the APPA would cap the number of reference product sponsor patents a brand-name drugmaker can use in BPCIA litigation at 20. The exceptions in the proposed APPA bill may decrease the cost of BPCIA litigations, explains Vinnakota.

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