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Saturday, March 2, 2024 | Back issues
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AndroGel Monopoly Suit Finally Reaches Its End

ATLANTA (CN) - A federal judge dismissed the remaining claims in a nearly 10-year-old dispute over competition on AndroGel, a drug that boosts testosterone production.

In the 1990s, Unimed Pharmaceuticals and Belgian drug maker Besins developed a testosterone replacement gel to treat male hypogonadism, a condition associated with low testosterone levels in men. After Solvay Pharmaceuticals acquired Unimed in an attempt to expand its American pharmaceutical business, Besins licensed Solvay to sell AndroGel in the United States.

In 2000, the Food and Drug Administration approved Solvay's new drug application for

AndroGel, and the company applied for a patent in the United States.

But before Solvay's patent issued in 2003, Watson Pharmaceuticals, Paddock Laboratories and other drugmakers began developing generic versions of AndroGel, for which they sought FDA approval.

Solvay filed a patent-infringement action against Paddock, its partner Par Pharmaceutical Cos. and Watson in 2003, automatically preventing the generics from entering the market for 30 months.

The distributors eventually withdrew their challenge to Solvay's patent and agreed in a 2006 settlement to stay off the market with their generic versions until 2015. The companies also signed business promotion agreements to share profits of AndroGel.

The settlements prompted the Federal Trade Commission and several private parties to file antitrust actions against Solvay and the generic distributors, alleging that the companies had conspired to fix the price of AndroGel and its generic equivalents by settling "baseless lawsuits." The plaintiffs claimed that Solvay had filed sham infringement actions against Watson, Paddock and Par, and had paid them millions of dollars to keep their products off the market for years.

In February 2010, a federal judge dismissed the antitrust claims of the Federal Trade Commission and several indirect purchasers, but allowed direct purchasers to move forward with claims challenging the validity of the underlying litigation and the settlements.

In pursuing the remaining claims, the plaintiffs argued that Watson, Paddock and Par had settled Solvay's claims despite knowing that Solvay's patent was invalid and did not cover AndroGel or its generic versions. In addressing Solvay's enforcement action, they claimed that the patent contained fatal errors and "was so facially invalid that an objective litigant would not have attempted to enforce the patent."

But U.S. District Judge Thomas Thrash said the plaintiffs could not sustain their claim that the underlying patent litigation was objectively baseless and constituted sham litigation.

Thrash agreed that Solvay's reliance on a certificate of correction in the underlying lawsuit was reasonable, even though Solvay had filed its lawsuit before the certificate was issued.

And though the plaintiffs had argued that Solvay's expert witness had been discredited by providing inconsistent or confusing testimony, they did not prove that Solvay or the distributors were convinced the testimony would be disqualified, according to the 46-page ruling.

Thrash also rejected claims that a 1995 supply agreement between Besins and Unimed, which they labeled as a commercial offer for sale, invalidated Solvay's patent, noting that Unimed did not pay Besins for any drugs until the FDA approved AndroGel in 2000.

And though the AndroGel placebo was available for over a year before Solvay sought the patent, it did not include the active ingredient, and AndroGel's composition was not obvious to others in the industry, the ruling adds.

Thrash also refused to disqualify Solvay's witness, noting that the expert's allegedly inconsistent testimony affected the credibility, not the admissibility, of the opinion.

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