Molecular Diagnostics Lab v Hoffman La Roche (D.D.C. 2005)
By S. Richard Carden
MDL, a purchaser of Thermus aquaticus DNA polymerase or "Taq" (a component used in performing polymerase chain reaction), brought suit against Roche, Applera and others for violations of the Sherman Act, allegedly arising from Roche's enforcement of U.S. Patent No. 4,889,818 ("the '818 patent") knowing that it had been procured through inequitable conduct. The '818 patent claims a thermostable DNA polymerase isolated from the Thermus aquaticus bacteria. Defendants moved to dismiss the complaint on several bases including (1) lack of standing, (2) tolling of the statute of limitations, (3) failure to sufficiently allege a conspiracy, and (4) failure to comply with the pleading requirements of Rule 9. The D.C. District Court denied Defendants’ motion in its entirety, with a minor exception that precluded MDL from seeking damages for the period prior to the four year statute of limitations period prior to its filing of the suit.
On appeal from the District Court’s grant of a preliminary injunction against generic manufacturers/distributors Ranbaxy and Teva, the Federal Circuit concurred with the lower court’s finding of likelihood of success and irreparable harm and thus affirmed the PI grant. Perhaps the most significant portion of the decision related to the Circuit’s clarification of dedication of subject matter to the public for the purposes of the doctrine of equivalents, as recently set forth in Johnson & Johnston Assocs. Inc. v. R.E. Serv. Co.(Fed. Cir. 2002) (en banc).