Thursday, August 6, 2009

Bayer v. Barr Labs

This is a pharmaceutical case in which the drug formula at issue was found to be obvious to try. The drug was known in the art but an effective formulation for delivery had not been developed. There were two obstacles to oral delivery of the drug—its solubility and the potential for acid degradation in the stomach. Reducing particle size could increase the solubility but that might also cause the drug to isomerize more in the acidic stomach. An enteric-coated pill would help protect the drug from the acid in the stomach (but this process has drawbacks itself.) Bayer ultimately found that the solubility could be increased by reducing particle size and that with this solution the bioavailability of the drug was not impacted, with or without an enteric coating. (p. 5-6.) So Bayer developed a “normal pill” with reduced particle size but no enteric coating.

The court found that this solution would have been obvious to try and that the two circumstances when what was “obvious to try” does not make something invalid as obvious were not met. Those two circumstances are (1) when all the possibilities must be tried because the prior art provides no way of eliminating some and (2) when it was in general obvious to use some new technology but the results weren’t predictable. The court, citing In re O’Farrell, 853 F.2d 894 (Fed. Cir. 1988) and KSR, 550 U.S. 398 (2007), described these as follows: (1) “When what would have been ‘obvious to try’ would have been to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where 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 an invention would not have been obvious.” (p. 9.) And (2) “A finding of obviousness would not obtain where what was ‘obvious to try’ was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it.” (p. 9-10.)

The court, based on the teachings of the art, concluded that one of skill in the art would have been “funneled” to just two options (the normal pill that Bayer developed or the enteric-coated pill) and that the prior art “guided the formulator precisely to the use of either a normal pill or an enteric-coated pill.” (p. 15.)

Secondary factors were not mentioned.

Judge Newman dissented, focusing largely on the degree of certainty required for there to be a reasonable expectation of success.