
By Jonathan Hatch & David Kleban, JD Supra
With the Democratic primary process in full swing, we thought it fitting to take a look at where the candidates stand with respect to antitrust issues. As it turns out, this is a fairly active election cycle for antitrust, with most Democratic candidates invoking antitrust laws (and proposed laws) in connection with their visions for the future. The increased focus on antitrust has not been lost on other observers.
Perhaps the candidate most explicitly focused on the nuts and bolts of antitrust-related legislation is Amy Klobuchar, who is responsible for introducing the Monopolization Deterrence Act (which would amend Section 2 of the Sherman Act to allow the DOJ and FTC to sue for civil penalties), the Consolidation Prevention and Competition Promotion Act (which would revise merger requirements under the Clayton Act by, among other things, shifting the burden of proof to merging companies to show that consolidation will not harm competition), the Merger Enforcement Improvement Act (which would amend antitrust enforcement requirements regarding mergers by, among other things, requiring the FTC to study overlapping ownership or control by investors in certain markets), and the Preserve Access to Affordable Generics and Biosimilars Act—all in 2019.
The last of these bills would amend the FTC Act to prohibit pay-for-delay deals in which a brand manufacturer provides a generic or biosimilar manufacturer with “anything of value, including an exclusive license,” unless the thing provided “is compensation solely for other goods or services” the generic or biosimilar manufacturer has promised to provide,” or if the procompetitive benefits of the agreement outweigh any anticompetitive effects. (Certain other safe harbors apply, including deals that allow for entry of a product prior to expiration of the patent and a payment for reasonable litigation expenses “not to exceed” $7.5 million.) Pay-for-delay litigation is a subject we talk about on this blog with some regularity and a particular concern for Senator Klobuchar, who gave the subject air-time during one of the Democratic debates.
Pay-for-delay is a subject on which several of the other candidates seem to agree. Senators Warren, Sanders, and Klobuchar (together with Senators Booker and Gillibrand, who have left the presidential race) were co-sponsors on the 2017 Improving Access to Affordable Prescription Drugs Act, which, among numerous other provisions, included a prohibition on pay-for-delay deals largely similar to that found in the Preserve Access to Affordable Generics and Biosimilars Act mentioned above. Meanwhile, Pete Buttigieg has released a plan that would “end” such deals as part of a broader effort to reduce drug prices.
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