Drug Experts to Testify Against Former Clients

ATLANTA (CN) - A federal judge refused to disqualify several experts and attorneys in an antitrust litigation stemming from a patent dispute over AndroGel medication used to increase testosterone production.

In 2000, the Food and Drug Administration approved Solvay Pharmaceuticals' application for an exclusive three-year license to sell AndroGel for the treatment of male hypogonadism, a medical condition in which the body fails to produce normal levels of testosterone.

After Solvay's product exclusivity expired in February 2003, the FDA approved generic versions of AndroGel, including products manufactured by Paddock Laboratories and Par Pharmaceuticals.

In August 2003, Solvay filed a patent-infringement action against Paddock and other companies that planned to distribute AndroGel. Paddock and other distributors settled with Solvay in 2006, agreeing not to market AndroGel until 2015. The companies also signed several business promotion agreements to share profits of AndroGel.

These agreements spurred the Federal Trade Commission and several private parties to file antitrust actions against the three companies in 2009, alleging that the patent litigation was a sham and the defendants "unlawfully delayed competition by settling Solvay's baseless lawsuits and agreeing to stay off the market with their generic versions of AndroGel until 2015."

In February 2010, a federal judge dismissed the claims of the Federal Trade Commission and several indirect purchasers, but allowed direct purchasers to move forward with the lawsuit.

Remaining as plaintiffs, the direct purchasers tried to retain Dr. Bozena Michniak-Kohn and Dr. Howard Maibach as expert witnesses in topical drug delivery.

Par, Paddock and Solvay objected to both witnesses, claiming the doctors had served as their expert consultants during the patent litigation.

Michniak-Kohn served as a nontestifying consultant for Par and Paddock for six months, while Maibach advised Solvay for four months during the patent lawsuit. Although neither expert offered a formal report, they signed retention agreements with the manufacturers, protecting all confidential information discussed during the lawsuit, the defendants claimed.

Maibach eventually agreed to advise the plaintiffs and concluded that Solvay's AndroGel patent was invalid, citing several references.

Parr, Paddock and Solvay alleged that Michniak-Kohn and Maibach received confidential information as a result of their participation in the patent litigation and moved to disqualify both experts.

U.S. District Judge Thomas Thrash agreed that Michniak-Kohn had a confidential relationship with Parr and Paddock, but concluded that the companies had failed to prove that the witness had access to confidential information.

"The bald assertion that Par/Paddock transferred 'mental impressions, legal analysis, and case strategy,' without mention of any specific communications, is not sufficient to carry the defendants' burden of showing that Dr. Michniak-Kohn received confidential information from Par/Paddock," Thrash wrote.

Moreover, the difficulty of finding a topical drug delivery expert outweighs the risk of retaining a witness who briefly served as a nontestifying expert in a separate but related lawsuit, the order states.

The court applied the same standard to Solvay's relationship with Maibach. Moreover, Solvay admitted that it had not given Maibach any confidential documents, according to the order.

Thrash also declined to disqualify the plaintiffs' counsel based on their contact with Maibach.

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