It Ain’t that Obvious to Try

In Sanofi-Aventis Deutschland GmbH v. Glenmark Pharms Inc., the Federal Circuit followed previous precedent in holding that the combination of compounds is not “obvious to try” if unexpected properties are supported by evidence. The patent-at-issue was directed to an antihypertension drug, Tarka®, which is the combination of an angiotension-converting enzyme inhibitor (such as trandolapril or quinapril, both double-ring compounds) and a calcium channel blocker. The jury found that the patent had not been proven invalid and defendant, on appeal, argued that “if a combination of classes of components is already known, all selections within such classes are obvious to try . . . .” The Federal Circuit found that there was substantial evidence supporting the jury’s verdict that obviousness had not been proved by clear and convincing evidence because of the unpredicted “longer-lasting effectiveness” achieved with the drug.

The court first explained that “obvious to try” applies when the prior art “present[s] a finite . . . number of options easily traversed to show obviousness . . . [but] it would not be ‘obvious to try’ when ‘the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful.’” Defendant argued that the inventor’s testing itself is evidence of obvious to try, but this was unpersuasive to the court as “[p]atentability does not turn on how the invention was made, but on whether it would have been obvious to a person of ordinary skill in the art.” The Federal Circuit also rejected defendant’s argument that any post-filing benefits, such as the better blood vessel and kidney function obtained from Tarka®, cannot be considered in the obviousness analysis because “patentability may consider all of the characteristics possessed by the claimed invention, whenever those characteristics become manifest.” The court then distinguished and analogized to prior precedent, noting that “obvious to try” turns on whether “unexpected properties” are supported by evidence. Here, there was expert testimony that a person of ordinary skill in the art at the time of the invention would not have predicted “longer-lasting hypertension control” given the double-ring structure of the compounds. Accordingly, the court affirmed the jury’s verdict.

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