Saturday, August 4, 2012

Circuit Split Watch: Can Drug Companies Pay for Delay?

This article first appeared in the August 1, 2012, issue of the National Law Journal’s Supreme Court Insider.

When a drug company pays a manufacturer to delay launching a generic, is it the act of an illegal monopoly or merely a settlement benefiting both parties?

The U.S. Court of Appeals for the 3rd Circuit recently ruled on these so-called “pay-for-delay” deals, splitting from three other circuits. If not revised en banc, the decision will likely warrant Supreme Court review.

Schering-Plough (now Merck) manufactures K-Dur, a patented high blood pressure medication. More than a decade before Schering’s patent was set to expire, two manufacturers attempted to enter the market early via generic versions of K-Dur. Schering sued for patent infringement.

The parties settled the patent cases. The manufacturers agreed not to bring the generics to market for several years, while Schering agreed to pay them millions. Supporters argue that such agreements are simply dispute settlements, which courts generally favor.

The Federal Trade Commission disagrees. According to the FTC website, pay-for-delay deals are a top priority for the agency, since they are “anticompetitive” and “cost consumers and taxpayers $3.5 billion in higher drug costs every year.” The FTC filed an amicus brief in the 3rd Circuit, in support of plaintiffs challenging the K-Dur agreements.

Those plaintiffs include CVS, Rite Aid, wholesale drug companies, and others. They argue that pay-for-delay deals violate antitrust law and prevent competitive pricing.

On July 16, a unanimous three-judge 3rd Circuit panel deciding In Re: K-Dur Antitrust Litigation found that pay-for-delay deals are “prima facie evidence of an unreasonable restraint of trade.” Showing that the payment has a purpose other than delaying generic entry or has some pro-competitive benefit can rebut this evidence.

The 3rd Circuit rejected the “scope of the patent test” adopted by the Federal, 2nd, and 11th Circuits. (The Federal Circuit, with its specialized docket, is not frequently involved in circuit splits, but this case is an exception.)

The court also pointed to other circuit cases, but acknowledged that they did not address settlement of patent litigation, the backdrop of the K-Dur fight.

The patent-scope test accepted in other circuits focuses on the patent holder’s exclusive rights to the patent before it expires. If a patent holder company can exclude everyone else during that period, why can’t it fend off litigation to protect its exclusivity?

Citing an NYU Law Review article, the 3rd Circuit said that “this approach nominally protects intellectual property, not on the strength of a patent holder’s legal rights, but on the strength of its wallet.”

“Many patents,” the 3rd Circuit explained, “are later found to be invalid or not infringed.” A pay-for-delay deal preserves a monopoly “without any assurance that the underlying patent is valid.” It is in the public interest to judicially test and eliminate weak patents, the court wrote.

Because of the circuit split, the tremendous financial stakes, and the FTC’s pay-for-delay priority, the 3rd Circuit decision could very well catch the Supreme Court’s attention, unless it is reversed en banc.

The Supreme Court has declined to review cases that accepted the patent-scope test, which may indicate that the Court does not object to the test and perhaps sees it as the companies do—as allowing settlement. The Court could, of course, reach a different result after briefing and argument.

*Update: On August 3, after this article was originally published in the National Law Journal, Merck gave notice to the 3rd Circuit that it intends to proceed directly to the Supreme Court with a petition for certiorari.