It may look like a case of taking advantage of the market — drug maker Sanofi dominates American treatment of Fabry disease, while rival drug maker Shire controls the European market. But one consumer advocacy group believes the two sides, as well as the Icahn School of Medicine at Mount Sinai, are colluding to keep competition down and prices up for the treatment worldwide.

Knowledge Economy International has urged the Federal Trade Commission’s (FTC) Antitrust Division in a letter to investigate the relationship between Sanofi and Shire. The organization writes that Fabry patients are losing because of potential collusion between the parties.

“U.S. patients are depending upon a single supplier for treatments, and are disadvantaged because there is both a lack of potential competition among suppliers and a less secure supply chain,” the letter says.

Antitrust claims are nothing new. However, how the two drug makers got to this point, and how the Icahn School of Medicine is involved, provides a new wrinkle for the FTC to snuff out.

As pointed out in the Wall Street Journal’s Pharmalot blog, the medical school developed the original Fabry treatment in conjunction with the U.S. National Institutes of Health and was awarded a patent on the medicine in the mid-1990s. Once developed, the school licensed exclusive rights to a drug company named Genzyme.



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Soon, though, Genzyme fell on hard times. In 2009, the company encountered serious manufacturing problems that led to a shortage of the drug. The FDA then asked Shire, which held European regulatory approval to market and sell a Fabry treatment, to apply for U.S. approval as well. Then, in 2011, the tide switched once again, as drug maker Sanofi purchased Genzyme. Simultaneously, the medical school began litigating to enforce its patents in Europe, attempting to snuff out Shire’s market share.

So were the two sides destined to battle back and forth? It seemed that way… until in May 2012, Shire suddenly withdrew its request for U.S. approval, while the medical school withdrew its patent litigation. And it’s these withdraws that Knowledge Economy International finds fishy.

“KEI asks the FTC to investigate the decision by Shire to withdraw its application to sell Replagal in the United States… to determine if a conspiracy existed whereby Shire agreed to withdraw its application to compete in the U.S. Fabry market if Mount Sinai granted a license to use an [National Institutes of Health]-funded invention in European markets,” the investigation request reads.

This case will be one to watch for in-house counsel moving forward, whether the FTC finds any evidence of collusion between the two parties.