Antitrust Issues Surrounding Biosimilars, Originator Products Not Going Away Anytime Soon

There have been changes to the biosimilar “ecosystem” that will keep federal dockets busy with litigation for the foreseeable future, according to a panel discussing trends in antitrust issues at the ACI 10th Summit on Biosimilars.

An increased number of biosimilar applications have been filed that target extremely successful reference products, noted Vernon M. Winters, JD, of Sidley Austin LLP. It is speculated by industry observers that there are 10 applications pending at the FDA, he said.

As of the end of May, there have been 32 cases filed under the Biologics Price Competition and Innovation Act (BPCIA), although many concerned BPCIA disclosure and patent dance obligations, or what he called “procedural skirmishes,” he said. While outright “pay-for-delay” settlements are on the decline, he said, citing a report from the Federal Trade Commission, outright patent litigation is clearly part of the biosimilar environment.

Winters also discussed the 2016 Supreme Court divided ruling in FTC v Actavis that a brand-name drug maker’s payment to a generic competitor to settle patent litigation can violate antitrust laws.

Under that ruling, a dozen or so lawsuits have been filed against AbbVie over its blockbuster brand-name adalimumab, Humira, for alleged use of a patent thicket to maintain a monopoly. The lawsuits include those from various unions, who allege that they have paid artificially high prices.

In addition, Nicholas Groombridge, JD, of Paul, Weiss, Wharton & Garrison LLP, discussed the issues surrounding the Pfizer Inc v Johnson & Johnson antitrust suit over Johnson & Johnson’s originator infliximab (Remicade). The suit, filed in September 2017, alleges that Johnson & Johnson engaged in exclusionary contracts, bundled rebates, and multiproduct bundling practices related to its originator infliximab that have effectively denied patients access to biosimilar therapies (including Pfizer’s Inflectra) and have undermined price competition in the biologics marketplace.

Discovery in the case is ongoing, he said, with more than 170 nonparty subpoenas and ongoing disputes over the scope and timing of discovery.