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Alcon itself admitted that variation in parameters including pH, preservatives, and buffers can have a substantial impact on the chemical stability of a prostaglandin in an ophthalmic formulation. The data in Table 7 therefore were not evidence that Barr's product, if and when approved, would infringe the asserted claims. We thus conclude that the district court did not clear- ly err in finding that the data in Alcon's Table 7 had no bearing on whether Barr's proposed generic product infringed Alcon's patents.
The formulations tested in Alcon's stability study were meaningfully different from the product described in Barr's ANDA and thus provided no basis from which to draw any reliable inferences regarding whether the PECO in Barr's composition would chemically stabilize the prostaglandin. The patents also identify the various prostaglandins and PECOs that can be used and a range of suitable concentrations for both components, including narrow preferred embodiments.
In light of those disclosures, the district court's non-enablement ruling was premised on testimony that many "variables" including the number of prostaglandins and the range of PECOs encompassed by the claims, as well as "[v]arious parameters including pH, buffer, buffer concentration, preservatives, chelating agents, and other excipients may affect the chemical stability of prostaglandins in ophthalmic formulations.
Barr adduced no evidence at trial that changing any of the "variables" or "[v]arious parameters" identified by the district court would render Alcon's claimed invention inoperable, nor was there any evidence that experimenting with those variables was required for an ordinarily skilled artisan to be capable of increasing the chemical stability of a prostaglandin by adding PECO.
Adjusting variables may be relevant to optimizing the stability of a given prostaglandin composition, but Barr proffered no evidence that any experimentation, let alone undue experimentation, with those variables would be necessary in order to practice the claimed invention. Without that evidence, there is no foundation for the district court's nonenablement ruling.
Barr argues that it is entitled to an affirmative judgment that Alcon's ' and ' patents are not infringed because Alcon neither put forward evidence of infringement nor formally obtained a dismissal of the claims involving those patents from its complaint prior to trial.
Alcon responds that the district court correctly denied Barr's motion because Barr never filed a counterclaim seeking a declaratory judgment of noninfringement, which could have preserved its ability to seek an adjudication of the ' and ' patents after they were removed from the case. Had Barr invoked that right during the pendency of the action below, the district court might have exercised its discretion differently. If an accused infringer has filed a counterclaim, then the patentee has notice that, even if it drops its infringement claims, the issue of infringement remains to be litigated.
On the other hand, if the accused infringer does not file a counterclaim, then it is up to the patentee to decide what claims are to be litigated and decided at trial. South Africa. New Zealand. Medical technology.
Implantable devices. Medical preparations. Therapeutic chemical compounds. Unspecified technologies. Diagnosis and surgery. Object sterilising. Optical systems. Inhibitors of protein kinase c-delta for the treatment of glaucoma. Modulation of polysialylated neural adhesion molecules psa-ncam as a regulator of ocular disease. Use of connective tissue mast cell stabilizers to facilitate ocular surface re-epithelization and wound repair.
Punctal plug comprising a water-insoluble polymeric matrix. Packaging materials for formulations containing 2-pyrrolidone derivatives. Have unique indigo plant-purple by with the intraocular lens of blue light transmissison characteristic.
Self-preserved aqueous pharmaceutical compositions.
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