Argument Recap

Earlier this month, the Federal Circuit heard oral argument in Sun Pharmaceutical Industries, Inc. v. Incyte Corporation. In this case, the Federal Circuit is reviewing a decision by the Patent Trial and Appeal Board that the inter partes review petitioner “has shown by a preponderance of the evidence that the challenged claims are unpatentable” as obvious. Notably, in this case, Sun Pharmaceutical Industries was substituted for Concert Pharmaceuticals as the appellant to reflect a recent merger. This is our argument recap.

William Jay argued for Sun Pharmaceutical Industries. He began by arguing that the “Board took a series of shortcuts in this case” that altered how it treated motivation to combine or modify, reasonable expectation of success, and how it resolved objective indicia of non-obviousness. He explained how these shortcuts allegedly led the Board to “disregard two important categories of evidence: the uncertainty of how deuteration affects a drug’s performance in the body” and “the objective evidence about the efficacy of Concert’s deuterated product to treat alopecia areata.” He asserted that this evidence, had it been properly considered, would have led the Board to conclude that the patent claims at issue were not obvious.

The argument then shifted to the concept of reasonable expectation of success as it relates to the obviousness inquiry. One judge asked whether or not the phrase “may display,” as used by the Board, indicates “at least some reasonable probability of success.” Jay responded by arguing that “all the Board is saying” here “is that there is a potential” and that it “does not evaluate the reasonableness of that potential with respect to rate.” “If there is a motivation to pursue a desirable property” in a chemical compound, he continued, “you would not make a compound unless there is a reasonable expectation that you would succeed.”

Jay went on to argue that “deuteration as a scientific concept was known, but there was no approved deuterated pharmaceutical approved for use in the human body at the time.” Moreover, he continued, “there was still much uncertainty about how these drugs would perform in the body.” He argued this further shows that the claims in question were not obvious.

One judge sought clarity on Jay’s position. This judge asked whether his position was “that, unless you know with some degree of certainty” that a process yields “increased beneficial results even if everything else is obvious, it is still” deemed unexpected. Jay answered by arguing “more would have to be known about how a particular class of drugs performs in vivo” and “there was no evidence” in the present case.

Mark Feldstein argued for Incyte Corporation. He began by arguing that this case “is very much a factual case” based on the Board’s findings. He noted how there is evidence showing an expectation that the drug at issue “would retain the important properties of selectivity and potency.” One judge brought up the issue of reasonable expectation of success by asking if it was sufficient that the patent claim at issue “may display” the desired properties. Feldstein responded by arguing that the term “may” indicates “more than enough” of a “reasonable expectation of success.” As for why, he argued the expectation of success required by the caselaw “is that of the claimed subject matter” and there is no requirement for “absolute predictability.”

The argument then moved to the issue of motivation to combine or modify. On this issue, Feldstein argued that, “here, there was a reason to make the modification” in question. He contended “that reason was not hypothetical or artificial.” Rather, he argued, the modifications were already “taught.”

Feldstein then contended that the patent claims in question fail to satisfy any “long-felt need” because there are already treatments for alopecia areata. He further maintained that “there is no way [Sun Pharmaceuticals] can define a long-felt need that they have met” because any such need has already been met.

In rebuttal, Jay argued that the issue of obviousness “is all about ‘would’ versus ‘could.’” He argued “there are lots of things that a skilled artisan could do with the synthetic chemistry at their disposal.” He reiterated, however, his point that the Board never made a finding on “whether you would reasonably expect” the “desired properties” of the relevant drug.

We will continue monitoring this case and report on developments.