Bone Care International v. Roxane Labs, et al.

Analysis Group client Bone Care International, LLC, a subsidiary of Genzyme Corporation, received a favorable decision in a patent infringement matter involving Hectorol, a drug used to control hormone production in patients with kidney disease. At issue were the patent claims contained in an abbreviated new drug application filed by a group of drug manufacturers seeking approval to produce a generic version of Hectorol. The plaintiff filed a consolidated lawsuit against codefendants Anchen Pharmaceuticals, Inc., Roxane Laboratories, Inc., and Sandoz, Inc., seeking to block the pharmaceuticals firms from making or selling a generic form of Hectorol until its patent expires.

A team from Analysis Group, led by President Pierre Cremieux and Vice President Lisa Pinheiro, was retained by Fitzpatrick, Cella, Harper & Scinto on behalf of the plaintiff to evaluate whether a key published study supported the defendants' claims regarding the relative efficacy and safety of Hectorol, and to analyze clinical trials data to specifically address the questions raised by the defendants regarding the patent-at-issue. Dr. Cremieux also testified at trial on his statistical analyses.

After considering issues of inducement, prior art, and obviousness, Chief Judge Gregory Sleet of the District of Delaware upheld the validity of Genzyme's patent, rejecting the defendants' counterarguments and clinical evidence. Noting that, unlike plaintiffs' expert, Dr. Cremieux incorporated clinical input and conducted analyses to verify his findings, Judge Sleet said "the court finds Dr. Cremieux's testimony and findings to be reliable."

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