Sanofi Wins False Claims Case Appealed by Rival Drugmaker

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By Eric Topor

Generic drugmaker Amphastar Pharmaceuticals has failed in its attempt to revive a False Claims Act lawsuit against Sanofi over the misrepresentation of drug patent information ( Amphastar Pharm. Inc. v. Aventis Pharma S.A. , 2017 BL 157523, 9th Cir., No. 15-56122, 5/11/17 ).

The U.S. Court of Appeals for the Ninth Circuit May 11 affirmed the dismissal of Amphastar’s FCA lawsuit based on the public disclosure of the misrepresentation allegations in an earlier patent infringement lawsuit brought by Sanofi’s subsidiary, Aventis Pharmaceuticals, against Amphastar. Aventis alleged that Amphastar’s generic version of Aventis’s blood-thinner infringed its patent. The patent was invalidated after Amphastar discovered during litigation that the patent was based on a misrepresentation by Aventis to the U.S. Patent and Trademark Office and Food and Drug Administration.

The FCA’s public disclosure bar can be an especially difficult hurdle for an FCA whistle-blower like Amphastar to surmount, though it is possible if the whistle-blower is judged to be an “original source” of the allegations. Generally, information revealed in litigation is deemed a public disclosure, and the appeals court didn’t view Amphastar’s role in revealing Aventis’s misrepresentations as sufficient to confer original source status.

Amphastar alleged in its FCA lawsuit that Aventis’s misrepresentation and improper patent caused the federal government to be overcharged for enoxaparin prescriptions. However, the trial court ruled this information was publicly disclosed in the earlier patent infringement lawsuit. The appeals court agreed the FCA’s public disclosure bar was triggered, necessitating dismissal.

Counsel for neither party returned Bloomberg BNA’s requests for comment on the decision.

Public Disclosure in Litigation

The misrepresentation concerned an expert declaration submitted by Aventis with its patent application that a new version of enoxaparin had a longer half-life than the prior version. A longer drug half-life can result in a patient receiving the same medicinal effectiveness of a drug using a lower dosage than the prior version. But Aventis didn’t disclose that the longer half-life reported was seen with a larger dosage than prior versions, and a “dose-for-dose” comparison showed no statistical difference between new and old versions of enoxaparin.

Amphastar prevailed in the patient infringement lawsuit when Aventis’s misrepresentation was uncovered during discovery, and Amphastar then filed its FCA lawsuit alleging the misrepresentation led to an improper patent monopoly and government overpayments.

The court said the patent litigation revelations were sufficient to trigger the FCA’s public disclosure bar. The only new allegation in Amphastar’s current FCA lawsuit was that the government paid for enoxaparin while it was under an improperly granted patent, which the court said was an “obvious inference.”

Amphastar also claimed it was an original source because it discovered Aventis’s misrepresentations about enoxaparin through its own experiments before the patent litigation. But the court noted, as did the trial court, that Amphastar’s evidence on this count, consisting of testimony from its chief executive officer, was undermined by other documentation from Amphastar’s own drug experiments and its own “inconsistent prior statements” about when the company discovered the problem with Aventis’s new version of enoxaparin.

Attorneys’ Fees Possible

Aventis’s request for attorneys’ fees as a successful FCA party under the FCA’s fee shifting provision was denied by the trial court, and Aventis appealed that ruling to the Ninth Circuit. The appeals court said the trial court incorrectly relied on a prior court decision, since overruled by the U.S. Supreme Court. The FCA’s fee shifting provision is available when an FCA case is dismissed on jurisdictional grounds, as it was here with respect to a prior public disclosure, the court said.

The court said Aventis met the fee shifting provision’s first requirement of being a prevailing party, but it wasn’t clear whether Amphastar’s lawsuit met the second requirement of being “clearly frivolous, clearly vexatious,” or primarily brought to harass the opposing party. The court remanded the case back to the trial court to determine whether Aventis/Sanofi should receive attorneys’ fees.

Greenberg Gross LLP represented Amphastar. Gibson, Dunn & Crutcher LLP represented Sanofi.

To contact the reporter on this story: Eric Topor in Washington at

To contact the editor responsible for this story: Peyton Sturges at

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