Last November, the Federal Trade Commission (“FTC”) with the “concurrence” of the Antitrust Division of the Justice Department, and over the strenuous objection of Pharmaceutical Research and Manufacturers of America (“PhRMA”), issued final changes to the Hart-Scott-Rodino Act premerger notification rules limited solely to pharmaceutical industry.  Those special rules relate to the transfer of certain pharmaceutical patent rights, which the FTC treats as asset acquisitions for HSR reporting purposes.  A few days before the new rule took effect on December 16, PhRMA filed suit in federal district court challenging the new rule claiming, among other things, that it exceeds the scope of the FTC’s authority by burdening the pharmaceutical industry “alone.”  PhRMA has now moved for summary judgment asking the court to declare the new rule unlawful, to vacate it, and to enjoin enforcement of it in all respects.

So, what’s at stake here?  Plenty, according to PhRMA’s filing.  Beyond the added delay imposed by complying with the new rule, PhRMA estimates that the additional expense imposed on the pharmaceutical industry will range on average from roughly $2.4 million to $3.6 million annually.  And, if the FTC issues a “second request,” which PhRMA’s filing says should be expected each year, the expense would be even more.  According to estimates cited by PhRMA, compliance with such a request can range from $5 million per transaction up to $20 million in very complex cases.