Obviousness: A Primer by the Federal Circuit
March 22, 2007

In a case before the Federal Circuit, the district court's holding that a patent was valid and enforceable was rejected, not only because the Federal Circuit found the holding incorrect, but also because the holding reflected a serious misconception regarding the proper burden of proof each party bears in patent litigation. The Federal Circuit set forth a primer for an obviousness analysis in rejecting the district court's holding to include discussions of burden of persuasion; motivation to combine prior art references; reasonable expectation of success; obvious-to-try; and secondary considerations.

More details of the case after the jump.

Pfizer filed suit against Apotex in district court alleging infringement of Pfizer's '303 patent when Apotex sought approval from the FDA to commercially sell a generic version of Pfizer's drug product prior to the expiration of the patent. In Apotex's application to FDA for approval, it certified that it believed the '303 patent to be invalid and unenforceable. Prior to trial, Apotex stipulated that if the '303 patent was found to be valid and enforceable, its product would literally infringe the '303 patent. Following a bench trial which found the '303 patent to be valid and enforceable, the district court ordered any approval of Apotex's FDA application fall later than the expiration of the '303 patent and enjoined Aprotex from making, using, offering to sell, selling, or importing into the US any product comprising the ingredients of the drug covered by the claims of the '303 patent.

Apotex appealed the district court's judgment that it failed to prove by clear and convincing evidence that the claims of the '303 patent would have been obvious and therefore invalid, and that Apotex failed to prove Pfizer committed inequitable conduct before the USPTO. In the Federal Circuit's rejection of the district court's holding regarding obviousness, it opined on some relevant points to establish a prima facie case of obviousness. Briefly these included:

Burden of proof – the presumption of patent validity remains intact and on the challenger throughout the litigation, and the clear and convincing standard does not change; however a patentee is well advised to introduce evidence sufficient to rebut that of the challenger;

Motivation - a suggestion, teaching, or motivation to combine relevant prior art teachings to achieve the claimed invention does not have to be found explicitly in the prior art references sought to be combined, but rather may be found in any number of sources, including common knowledge, the prior art as a whole, or the nature of the problem itself;

Reasonable Expectation of Success - obviousness cannot be avoided simply by a showing of some degree of unpredictability in the art so long as there was a reasonable probability of success;

Obvious-to-Try - this is not the proper standard by which to evaluate obviousness but is somewhere between obvious-to-try and absolute predictability of success taking into consideration the particular facts of the case.

To read the full opinion in Pfizer, Inc., v. Apotex, Inc., click here.

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