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In a decision Wednesday, the Federal Circuit affirmed a district court's finding of patent validity and patent infringement. The Federal Circuit found no error in the district court's holding that the reverse doctrine of equivalents was inapplicable and that claim preclusion prohibited the defendant from raising other validity challenges. Specifically, the defendant did not establish a prima facie case of noninfringement under the reverse doctrine of equivalents because it relied exclusively on the declaration of its expert witness to determine the principle of the invention instead of properly determining the principle from the specification, prosecution history, and prior art. The Federal Circuit added that the reverse doctrine of equivalents is rarely applied (and that it has never affirmed a finding of non-infringement under the doctrine).The Federal Circuit further agreed with the district court that the defendant's other claims were precluded by earlier litigation. The accused products in both the first and second litigations were encompassed by the claims of the patent, so they constituted the "same claim" for purposes of claim preclusion. The defendant also argued that because of KSR, there should be a "change of law" or fairness exception to claim preclusion. The Federal Circuit disagreed, stating that although there may be rare exceptions in cases involving "momentous changes in important, fundamental constitutional rights," KSR involved no such right.More detail of Roche Palo Alto LLC v. Apotex, Inc. after the jump.The plaintiff, Roche, owns a patent directed to a drug formulation for treatment of eye inflammation. The formulation contains a non-steroidal anti-inflammatory drug (NSAID) such as ketorolac tromethamine (KT), a quaternary ammonium preservative such as benzalkonium chloride (BAC), and the nonionic surfactant octoxynol 40 (O40). Claim 1 is representative:
An ophthalmologically acceptable non-steroidal anti-inflammatory drug formulation, comprising:
an ophthalmologically acceptable non-steroidal anti-inflammatory carboxyl
group-containing drug in an effective amount for ophthalmic treatment between 0.001% and 10.0% wt/vol;
a quaternary ammonium preservative in an antimicrobially effective
amount between 0.001% and 1.0% wt/vol;
an ethoxylated alkyl phenol that conforms generally to the formula:
C8H17C6H4 (OCH2 CH2)nOH where n has an average value of 40 [O40] in a stabilizing amount between 0.001% and 1.0% wt/vol; and an aqueous vehicle q.s. to 100%.
The limitation requiring the presence of O40 was added in response to the examiner's obviousness rejection over several prior art references. The applicant submitted a declaration stating that O40 produced unexpected results over other nonionic surfactants, specifically a clear solution. The examiner allowed the claims based on the unexpected results of O40.The defendant, Apotex, had filed two different abbreviated new drug applications (ANDAs) on two different generic drug formulations. In 2001, Apotex filed the first ANDA (ANDA-1) directed towards a generic version of Roche's ACULAR®. In 2005, Apotex filed the second ANDA (ANDA-2) directed towards a generic version of Roche's ACULAR®LS. The compositions of the two formulations and the relevant scope of claim 1 of the patent are below:
ANDA 1 | ANDA 2 | Patent | |
KT | 0.01% | 0.0063% | 0.001%-10.0% |
O40 | 0.01% | 0.004% | 0.001%-1.0% |
NaCl | 0.8% | 0.8% | ---------------- |
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