Filing of Multiple ANDAs May be Explicitly Enjoined

In Abbott Laboratories v. Torpharm, Inc., et al. (October 11, 2007), the Federal Circuit
affirmed the district court’s authority to make contempt holdings for the filing of a repetitive Abbreviated New Drug Application ("ANDA") with the Food and Drug Administration ("FDA") in violation of an injunction barring commericalization of divalproex sodium infringing Abbott’s U.S. Patent Nos. 4,988,731 and 5,212,326 until their expiration.

In 1997, Apotex filed Abreviated New Drug Application No. 75-112 seeking FDA approval to manufacture and sell a generic version of Depakote®. In its ANDA, Apotex made a "paragraph IV certification" that the Abbott patents are invalid. Abbott responded by filing suit against Apotex for patent infringement under 35 U.S.C. § 271(e)(2)(A) and a judgement was ultimately granted in favor of Abbott on both validity and infringement where the the district court entered the following injunction:

TorPharm, Inc., Apotex, Inc., Apotex Corp., and their respective affiliates, successors in interest, and assigns are enjoined from commercially manufacturing, using, selling, or offering to sell generic divalproex sodium which the Court has found to be infringing within the United States, or from importing such product into the United States, until Abbott’s U.S. Patent Nos. 4,988,731 and 5,212,326 expire and defendants have received final approval from FDA to market generic divalproex sodium.

The effective date of any approval by FDA of ANDA No. 75-112, or any other application concerning defendants’ generic divalproex sodium which the Court has found to be infringing, shall be no earlier than January 29, 2008, the date of expiration of Abbott’s U.S. Patent Nos. 4,988,731 and 5,212,326.

Apotex then attempted to design around Abbott’s patent claims by developing a polymer form of the drug. However, rather than filing a new ANDA itself, Apotex entered into an informal agreement with Nu-Pharm, Inc. ("Nu-Pharm") whereby Apotex would pay for costs associated with preparation of a new ANDA filing but Nu-Pharm would take on what Apotex characterizes as the "litigation risks" arising from such a filing.

Abbott then filed another complaint for patent infringement under 35 U.S.C. § 271(e)(2)(A) against Nu-Pharm in the Northern District of Illinois on June 24, 2005, alleging that the Nu-Pharm ANDA also infringed the Abbott patent claims. The case was routinely assigned to District Judge Pallmeyer.

Shortly thereafter, on May 3, 2006, Abbott filed a second section 271(e)(2)(A) action for patent infringement, this time against both Nu-Pharm and Apotex, who Abbott apparently had just learned were acting in concert. The latter case, also filed in the Northern District of Illinois, was assigned in the normal course to District Judge Guzman and then reassigned for "related case" treatment before Judge Pallmeyer.

On August 15, 2006, Nu-Pharm moved before Judge Pallmeyer for summary judgment of noninfringement of the Abbott patent claims. The same day, Abbott filed a "Motion to Enforce Its Injunction Order" before Judge Posner (still sitting by designation in the Northern District of Illinois in the original case), and filed a motion to stay the proceedings before Judge Pallmeyer.
Meanwhile, contempt proceedings continued before Judge Posner, who issued a decision on October 6, 2006 finding Apotex in contempt for violating the injunction.

Judge Posner characterized the injunction as extending to "any ‘generic divalproex sodium’ manufactured by Apotex that has been ‘found to be infringing.’" He then found that there was no difference between Apotex’s old product and its new product (let alone a "colorable" difference), and that, based upon the evidence presented by the parties, Apotex’s "new" product would infringe the claims of the Abbott patents. Accordingly, October 6, 2006, the district court "extend[ed] the injunction to embrace" the Nu-Pharm ANDA. Specifically, the expanded injunction prohibited Apotex from:

commercially manufacturing, using, selling, or offering to sell generic
divalproex sodium which the Court has found to be infringing, including
divalproex sodium products synthesized using the processes employed in
connection with ANDA No. 77-615, within the United States, or from importing
such products into the United States, until Abbott’s U.S. Patent Nos. 4,988,731
and 5,212,326 expire and defendants have received final approval from FDA to
market generic divalproex sodium.

No sanctions were imposed. Instead, the district court stated that should the violation continue, Apotex "will be risking heavy sanctions for its willful disobedience of the injunction."

According to the appellate decision by Chief Judge Michel:

The district court found that "Apotex’s choice of Nu-Pharm to file the ANDA was a subterfuge intended to give Apotex a crack at another district judge" who might find that Nu-Pharm ANDA drug noninfringing. Abbott V, 455 F. Supp. 2d at 835. We do not disturb that finding, and conclude that the district court did not abuse its discretion in electing to try issues relating to the Nu-Pharm ANDA in a contempt proceeding. See also Additive Controls & Measurement Sys., Inc. v. Flowdata, Inc., 154 F.3d 1345, 1349 (Fed. Cir. 1998) (need for expert testimony not dispositive).

. . . However, we cannot and do not purport to rewrite the original injunction because Apotex had no explicit notice that it was enjoined from filing a second ANDA. Accordingly, the district court’s judgment of contempt is REVERSED.