In a significant decision CAFC granted summary judgment in favor of Roche's for their patent on US5110493: which covers 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.
Apotex developed ACULAR (ketorolac tromethamine opthalmic solution) and ACULAR LS by designing around said patent. The two formulations differ in their proportion of preservative (benzalkonium chloride) and a surfactant (octoxynol 40).
When Apotex filed ANDA on said product Roche sued Apotex for the infringement of ‘493 patent. Earlier, in 2007 the CAFC affirmed for ACULAR that ‘493 patent is neither invalid and nor unenforceable and court further affirmed infringement.
For Acular LS Apotex argued that the district court erred in failing to find noninfringement under the Reverse Doctrine Of Equivalents (RDOE). The RDOE can be used to limit the scope of claim coverage where the device/element is so far changed in principle from a patented article that it performs the same or a similar function in a substantially different way, but nevertheless falls within the literal words of the claim. Apotex argued that their formulation will not infringe as per RDOE. However CAFC found no support for this principle in the patent specification, prosecution history or information in public domain. Further, CAFC concluded that Apotex relied exclusively on the declaration of its expert, who wrongly opined that Apotex will not infringe as per RDOE. As this RDOE has not get victory for any generic firm till date, Apotex should have checked prosecution history and prior art to substantiate its claim of non-infringement. Based on these facts, the court agreed that Apotex failed to make out a prima facie case of noninfringement under the RDOE, summary judgment of infringement of ‘493 was affirmed.
During trial, Apotex also tried to changed the line of defense with the benefit of the new KSR standards for obviousness. The court, however, refused this attempt by finding the claims precluded as per Res Judicata (when two similar parties are litigating on same patent which was earlier decided for similar product, the second suit with in same parties is not allowed and earlier decision remains affirmed). The Res Judicata doctorine was also used by Pfizer in Caudet (Atorvastatin and Amlodipine) litigation against Ranbaxy on '893 patent, where Pfizer said that Court has affirmed the validity of '893 patent earlier and now Ranbaxy Can't attack same patent for Caudet.
Apotex developed ACULAR (ketorolac tromethamine opthalmic solution) and ACULAR LS by designing around said patent. The two formulations differ in their proportion of preservative (benzalkonium chloride) and a surfactant (octoxynol 40).
When Apotex filed ANDA on said product Roche sued Apotex for the infringement of ‘493 patent. Earlier, in 2007 the CAFC affirmed for ACULAR that ‘493 patent is neither invalid and nor unenforceable and court further affirmed infringement.
For Acular LS Apotex argued that the district court erred in failing to find noninfringement under the Reverse Doctrine Of Equivalents (RDOE). The RDOE can be used to limit the scope of claim coverage where the device/element is so far changed in principle from a patented article that it performs the same or a similar function in a substantially different way, but nevertheless falls within the literal words of the claim. Apotex argued that their formulation will not infringe as per RDOE. However CAFC found no support for this principle in the patent specification, prosecution history or information in public domain. Further, CAFC concluded that Apotex relied exclusively on the declaration of its expert, who wrongly opined that Apotex will not infringe as per RDOE. As this RDOE has not get victory for any generic firm till date, Apotex should have checked prosecution history and prior art to substantiate its claim of non-infringement. Based on these facts, the court agreed that Apotex failed to make out a prima facie case of noninfringement under the RDOE, summary judgment of infringement of ‘493 was affirmed.
During trial, Apotex also tried to changed the line of defense with the benefit of the new KSR standards for obviousness. The court, however, refused this attempt by finding the claims precluded as per Res Judicata (when two similar parties are litigating on same patent which was earlier decided for similar product, the second suit with in same parties is not allowed and earlier decision remains affirmed). The Res Judicata doctorine was also used by Pfizer in Caudet (Atorvastatin and Amlodipine) litigation against Ranbaxy on '893 patent, where Pfizer said that Court has affirmed the validity of '893 patent earlier and now Ranbaxy Can't attack same patent for Caudet.
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