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From Antitrust Law Daily, June 26, 2013

Publication, distribution of scientific article not actionable false advertising

By Jeffrey May, J.D.

The publication of a scientific journal article sponsored by a pharmaceutical company and the company's distribution of promotional materials citing the article’s findings were not subject to challenge under the Lanham Act and New York General Business Law § 349, the U.S. Court of Appeals in New York City ruled today (ONY, Inc., Plaintiff v. Cornerstone Therapeutics, Inc., June 26, 2013, Lynch, G.).

The dispute involves ONY, Inc. and Chiesi Farmaceutici, S.p.A.—two of the biggest producers of non-human surfactants, which are used to treat Respiratory Distress Syndrome (RDS) in neonatal infants. ONY produces a surfactant derived from bovine lung surfactant that bears the trade name “Infasurf.” Chiesi produces a competing surfactant derived from porcine lung mince that goes by “Curosurf.” Chiesi, an Italian pharmaceutical firm, contracts with co-defendant Cornerstone Therapeutics, Inc. to distribute and market Curosurf in the United States.

The challenged scientific journal article compared the effectiveness of several types of surfactants. It was written by doctors that had been hired by Chiesi and was published in the leading peer-reviewed journal in the field of neonatology.

ONY filed suit alleging that the article made statements about scientific findings that were intentionally deceptive and misleading, and that it therefore constituted false advertising. The article purportedly contained incorrect statements of fact about the relative effectiveness of Curosurf versus Infasurf. ONY also questioned the circumstances surrounding the article’s publication and the fact that Chiesi and Cornerstone paid for an “open access” format, which allowed the article to be viewed electronically by the general public without paying the typical fee or ordering a subscription.

In upholding dismissal of ONY's Lanham Act claims, the court concluded that, “to the extent a speaker or author draws conclusions from non-fraudulent data, based on accurate descriptions of the data and methodology underlying those conclusions, on subjects about which there is legitimate ongoing scientific disagreement, those statements are not grounds for a claim of false advertising under the Lanham Act.”

ONY did not allege that the data presented in the article were fabricated or fraudulently created. Rather, ONY challenged the inferences drawn from those data and questioned whether competent scientists would have taken into account other available variables in their analysis.

Because the article’s contents were not actionable under the Lanham Act, the statements were not actionable under New York’s General Business Law § 349 or New York state common law. New York law was more protective of free speech interests and less expansive in permitting causes of action based on speech, than federal law, the court explained.

The court also rejected ONY's challenge to the issuance of a press release touting the article's conclusions and distribution of promotional materials that cited the article’s findings. The district court did not err in dismissing ONY's tortious interference claim in light of its correct conclusions that (a) the article itself was not actionable and (b) the tortious interference claim did not separately allege any additional misleading statements.

The case is Docket No. 12-2414-cv.

Attorneys: Mitchell J. Banas, Jr. (Jaeckle Fleischmann & Mugel, LLP) for ONY, Inc. J. Kevin Fee (Morgan, Lewis & Bockius) for Cornerstone Therapeutics, Inc. and Chiesi Farmaceutici, S.p.A.

Companies: Chiesi Farmaceutici, S.p.A.; Cornerstone Therapeutics, Inc.; ONY, Inc.

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