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31 October 2019
On 21 October 2019 California's governor, Gavin Newsom, signed a bill designed to enhance antitrust scrutiny of patent settlements between branded and generic pharmaceutical companies. The bill was passed by the California legislature in September 2019.
The bill's principal change is that it creates a presumption that patent settlements where a generic pharmaceutical company receives "anything of value" from the branded pharmaceutical company have anti-competitive effects and violate the Cartwright Act, California's state antitrust law.
It thus departs from how such agreements are evaluated in litigation under the Sherman Act.
In Federal Trade Commission v Actavis (570 US 136 (2013)), the court held that such agreements must be evaluated under the "rule of reason", which requires an antitrust plaintiff to demonstrate that the agreement being challenged has actual or likely anti-competitive effects. In contrast, under California law, such agreements are now presumed to be anti-competitive and it is up to the defendant to rebut that presumption. However, despite the change to how such agreements are evaluated in litigation under the Cartwright Act, in many respects, the bill codifies factors that the Federal Trade Commission has looked at to determine whether such settlements are, in its view, anti-competitive.
The bill specifically identifies exclusive licences and agreements by the branded pharmaceutical company "not to launch an authorized generic version" of its branded product as things of 'value' that would trigger the presumption that the settlement has anti-competitive effects and violates the Cartwright Act.
That said, the bill is also explicit that agreements that allow entry of the generic product before expiration of the patent rights or statutory exclusivity periods, covenants not to sue or that compensate for reasonable litigation expenses (generally up to $7.5 million) do not trigger the presumption provided that they are not coupled with other types of agreement.
One other notable feature of the bill is that it also makes it more difficult for defendants to rebut the presumption of anti-competitive effects because it requires the courts to presume that the relevant market is limited to the branded product and AB-rated generic equivalents of that product, which may not reflect the contours of the actual market.
The bill follows the California attorney general's nearly $70 million settlement in Summer 2019 with several pharmaceutical companies based on patent settlements that the attorney general claimed violated the Cartwright Act and is yet another example of diverging interpretations between federal and state antitrust laws.
For further information on this topic please contact Robin D Adelstein at Norton Rose Fulbright's New York office by telephone (+1 212 318 3000) or email (firstname.lastname@example.org). Alternatively, contact Eliot Turner at Norton Rose Fulbright's Houston office by telephone (+1 713 651 5151) or email (email@example.com). The Norton Rose Fulbright website can be accessed at www.nortonrosefulbright.com.
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