Genzyme alleged that Shire violated the Lanham Act by publishing a press release falsely advertising the superiority of Shire’s Gaucher disease drug VPRIV over Genzyme’s competing Cerezyme. (There’s a related corporation that’s dismissed for lack of jurisdiction, which I’ll ignore.) Gaucher disease is caused by an enzyme deficiency that causes harmful levels of lipids to build up in the body. Symptoms include liver and spleen enlargement, reduced bone density, and weakened bones. Cerezyme has been FDA approved since 1994 as a long-term enzyme replacement therapy. VPRIV was approved in 2010, and is Cerezyme’s main competitor in long-term enzyme replacement therapy.
Shire issued a press release, “Shire's VPRIV (velaglucerase alfa for injection) Shows Significant Improvement in Gaucher–Related Bone Disease.” The subhead said, “[i]n a head-to-head trial between VPRIV and Cerezyme (imiglucerase), only patients treated with VPRIV experienced statistically significant improvement in lumbar spine bone mineral density at 9 months.” Further, it announced “new data that show VPRIV … significantly improved selected markers of Gaucher-related bone disease in patients.” The press release was distributed to PR Newswire and to patient organizations serving the Gaucher community.
Shire argued that the release didn’t count as commercial advertising or promotion, and was First Amendment-protected “scientific speech.” In order to report the results of its research, Shire needed to identify the products, and thus, Shire argued, any commercial elements were inextricably intertwined with noncommercial scientific speech.
Genzyme responded that the secondary dissemination of scientific research can be commercial speech if it has a “pecuniary gloss” and is targeted to consumers for marketing purposes. This is consistent with Gordon & Breach, the classic Lanham Act case defining “commercial advertising or promotion,” which found that journal articles became covered by the Lanham Act when reused for marketing purposes targeted at core consumers. Thus, while the original presentation of the comparative data at a scientific convocation was protected scientific expression, its secondary dissemination in a press release wasn’t. The press release wasn’t a scientific publication; it named the primary competitors and listed Shire’s stock symbols on its first line. It was selective dissemination of information favorable to VPRIV/harmful to Cerezyme to an audience including doctors who prescribe Gaucher treatments and patients who might request specific treatments.
Shire also argued that Genzyme failed to allege falsity, because the press release accurately reported the underlying scientific analysis and results. But unless it’s perfectly clear that no reasonable person could be misled, falsity wasn’t appropriately resolved on a motion to dismiss. Answering the falsity question here “involves a delving into murky scientific data and analysis.”
Shire then argued that Genzyme failed to allege consumer deception because physicians who treat Gaucher disease are sophisticated. But selective promotion of favorable information could mislead even sophisticated and experienced doctors. Also, patients are less sophisticated and also constitute part of the relevant audience because they’re the ultimate consumers.