7.2 "Obvious to Try"

Patents / Biotechnology / US Biotechnology Practice

An issue which frequently arises in the pharmaceutical field is what test to apply when there may be some general teaching in the prior art pointing vaguely in the direction of the invention but nothing too specific. Today the test can be summarized as being that the Federal Circuit will find a claim obvious if the prior art points in the general direction of the invention (thereby arguably making it obvious to try) and those skilled in the art would believe that what was pointed to by the prior art would have a reasonable expectation of success. The issue was well considered in In re O'Farrell [174]

The question is: when is an invention that is obvious to try nevertheless nonobvious?

The admonition that "obvious to try" is not the standard has been directed mainly at two kinds of error. In some cases, what would have been "obvious to try" would have been to vary all parameters or to 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 choices were likely to be successful. ... In others 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. ... Neither of these situations applies here. Obviousness does not require absolute predictability of success. For obviousness under §103, all that is required is a reasonable expectation of success.

In making the assessment of the significance of the prior art, the Court should in an appropriate case take into account the degree to which reliable prediction can be made in the field. [175]

However, optimization of what has been done before by routine experimentation does not give rise to a patentable invention. [176] Nor do unexpected results necessarily evidence patentability if there was a strong motivation in the art to carry out what was claimed at the time the alleged invention was made. [177]

[174] 7 USPQ2d 1673 (Fed. Cir. 1988). See, also, Hybritech v. Monoclonal Antibodies, Inc, 231 USPQ 81 (Fed. Cir. 1986).

[175] In re Vaeck, 947 F.2d 488, 20 USPQ2d 1438 (Fed. Cir. 1991), where the invention involved insertion of a gene known to code for an insecticidal protein into cyanobacteria. The characteristics of cyanobacteria were still not fully understood and these organisms had only recently been reclassified as an unusual type of bacteria rather than blue-green algae. Under the circumstances the court held that the insertion of the gene into such organisms was not obvious, the implication being that had it been inserted into a better characterized organism where results were more predicable the claimed invention would have been obvious.

[176] In re Aller, 105 USPQ 223 (CCPA 1955).

[177] Richardson-Vicks Inc. v. Upjohn Co., 44 USPQ2d 1181 (Fed. Cir. 1997). The alleged invention was to combine ibuprofen with pseudoephedrine. The combination proved to have unexpectedly good pain killing properties. However, combinations of pseudoephedrine and aspirin or acetaminophen were known and there was a motivation to make the new combination because ibuprofen was about to be approved for over-the-counter sales.

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