Abbott Labs. v. Apotex, Inc., __ F.Supp.2d __, 2006 WL 2884317 (N.D. Ill. Oct. 6, 2006) (Posner, C.J.).
Judge Posner, sitting on the Northern District by designation, extended the injunction he issued after a bench trial, No. 97 C 7515 (N.D. Ill. Mar. 31, 2004), aff’d by 122 Fed. Appx. 511 (Fed. Cir. 2005), to include Nu-Pharm, defendant Apotex’s "stalking horse" from making, using or sell the patented drug, divalproex sodium. In 2004, the Court enjoined Apotex from making, using or selling the patented drug. At some point thereafter, Apotex slightly changed its manufacturing process and had an entity it formerly owned, and apparently still controlled, file an Abbreviated New Drug Application ("ANDA") with the Food and Drug Administration ("FDA"). Neither Apotex nor Nu-Pharm tested the drug to determine whether the altered manufacturing process resulted in a drug with sufficiently different characteristics to avoid plaintiff’s claims.
The Court found that Apotex used Nu-Pharm to attempt to get a hearing before a new judge who might rule that the Apotex/Nu-Pharm drug was not an oligomer and, therefore, did not infringe plaintiff’s patent. Apotex’s plan failed, however, when plaintiff eventually learned that Nu-Pharm was Apotex’s "straw man" after suing Nu-Pharm in a separate case and brought a motion for contempt seeking to enforce the injunction against Nu-Pharm.
The Court held an evidentiary hearing, at which plaintiff’s tests showed that there was no statistical difference between Apotex’s infringing drug and Nu-Pharm’s drug with the altered manufacturing process. Because the Court found no "colorable" difference between the original infringing drug and Nu-Pharm’s drug, the Court was able to summarily resolve the infringement issue without referring the matter to a separate suit for more comprehensive evidentiary proceedings. The Court held that because an enjoined party has a duty to make good-faith efforts to comply with the injunction, Apotex had a responsibility to test its "new" drug to determine whether it was outside the claims of plaintiff’s patent. But even after Nu-Pharm was sued and plaintiff filed its contempt motion, Apotex did not test its "new" drug. Finally, Judge Posner gave Apotex, and other parties facing injunctions, a stiff warning:
If Apotex can elude a finding of contempt, enjoined infringers need make only a trivial change in the process by which their infringing product had been made and present shoddy scientific evidence that the new product is different. Such infringers would not even need to have a good faith belief that the changes in the process had resulted in a noninfringing product. They would scour the scientific community for new experts and new tests that gave the desired result and go from judge to judge arguing that what was in reality the same substance held to have infringed was actually noninfringing.