Beyond Pay-for-Delay: Three Pharma Antitrust Cases To Watch In 2017
While courts continue to grapple with the implications of the Supreme Court’s landmark decision in FTC v. Actavis, Inc.,
Exclusive API Supply Agreements: Fresenius Kabi USA, LLC v. Par Sterile Prods., LLC, No. 16-4544 (D.N.J.)
On February 10, 2017, the district court for the U.S. District of New Jersey refused to dismiss Fresenius’s allegations that Par unlawfully restricted the supply of vasopressin — the active pharmaceutical ingredient (“API”) in Intravenous Vasopressin Injection (“IVI”) products — by entering into exclusive deals with Drug Master File (“DMF”) holders for vasopressin API. Both Fresenius and Par had previously marketed IVI as an unapproved drug, but after the FDA encouraged unapproved drug‑makers to comply with approval provisions, Par was the first to obtain approval. As alleged by Fresenius, Par then campaigned the FDA to force Fresenius’s unapproved version off the market, and due to Par’s alleged exclusive deals with two of the three available DMF holders for vasopressin API, Fresenius was unable to submit an ANDA for approval of its IVI product.
The district court has thus far allowed Fresenius’s case to move forward, finding that its allegations of monopolization, attempted monopolization, conspiracy, unlawful exclusive dealing, and unlawful group boycott, as well as a state tortious interference claim, were sufficiently well-pled to survive Par’s motion to dismiss.
Pharmaceutical Testing Standards: Amphastar Pharmaceuticals, Inc. v. Momenta Pharmaceuticals, Inc., No. 16-2113 (1st Cir.)
In July 2016, antitrust defendants Momenta Pharmaceuticals and Sandoz prevailed when the district court for the U.S. District of Massachusetts granted their motion to dismiss the plaintiffs’ claims under the Sherman Act
In dismissing Amphastar’s antitrust case, the district court held that because Amphastar’s alleged injuries flowed from government action — the FDA’s adoption of the USP standard — rather than directly from Momenta’s alleged nondisclosure of its pending patent application to the USP or its agreement with Sandoz, the antitrust claims were barred by the Noerr-Pennington doctrine.
Amphastar appealed in September 2016, arguing that the district court inappropriately expanded the scope of Noerr-Pennington immunity, whereas Momenta has countered that the doctrine was properly applied. The First Circuit heard oral argument on February 9, 2017.
Generic Drug Pricing Collusion: Connecticut v. Aurobindo Pharma USA, Inc., No. 16-2056 (D. Conn.)
On December 15, 2016, twenty states filed a complaint against six generic manufacturers in the district court for the U.S. District of Connecticut, alleging that, in violation of Section 1 of the Sherman Act, drug‑makers Heritage, Mylan, and Mayne had conspired to divide the market for generic doxycycline, an antibiotic, and that Heritage, Teva, Aurobindo, and Citron had conspired to fix prices for glyburide, a diabetes drug.
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Each of these three cases arose from alleged interactions between drug‑makers and various industry players: API suppliers; a standard-setting body and the FDA; and numerous drug‑makers. The cases highlight the need for pharmaceutical companies to be aware of the possible antitrust implications of their interactions and strategies with players across the industry — especially important in light of today’s competitive environment. We will be tracking these antitrust cases (and others) with interest over the course of this year.
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If you have any questions concerning these developing issues, please do not hesitate to contact any of the following Paul Hastings New York lawyers:
Chad J. Peterman
Patent and antitrust trial lawyer in the Paul Hastings New York office
Evan D. Diamond
Patent trial lawyer in the Paul Hastings New York office