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In a precedential opinion, the Federal Circuit reversed a Patent Trial and Appeal Board (PTAB) finding of obviousness invalidating a patent’s method claims for administering a drug for treating non-small cell lung (NSCLC) cancer.<a href="#_ftn1" name="_ftnref1">[1]</a> The PTAB found that it would have been obvious to combine pharmaceutical references. The Federal Circuit, however, noted that the “asserted references do not disclose any data or other information about the drug’s efficacy in treating NSCLC [the cancer].” (Emphasis in original.)<a href="#_ftn2" name="_ftnref2">[2]</a> Without any preclinical animal data, human clinical data or even in vitro [test tube] results, success could not reasonably have been expected. To the contrary, the Federal Circuit noted that 99.5% of Stage II clinical trials for treating that particular type of cancer failed. Only “failure, not success,” could be expected.

The first prior art reference cited never discussed treating NSCLC, the particular type of cancer in issue.<a href="#_ftn3" name="_ftnref3">[3]</a> The second prior art reference did not disclose any “data regarding the use of [the compound] to treat NSCLC.”<a href="#_ftn4" name="_ftnref4">[4]</a> Neither did any of the references cited by the second reference. Similarly, the alternative combination reference, the patent holder’s Form 10-K, did not disclose any data regarding the compound’s effect upon NSCLC.<a href="#_ftn5" name="_ftnref5">[5]</a> Without a factual substrate, the PTAB’s holding could not be supported.

The Federal Circuit reviewed the PTAB’s fact findings for “substantial evidence.”<a href="#_ftn6" name="_ftnref6">[6]</a> The Supremes appraised “substantial evidence” as evidence that “a reasonable mind might accept as adequate to support a conclusion.”<a href="#_ftn7" name="_ftnref7">[7]</a> In an inter partes review, the PTAB’s legal conclusion of obviousness needed support under a “preponderance of the evidence” showing. Without supporting data and with a Stage II drug trial failure rate of 99.5%,<a href="#_ftn8" name="_ftnref8">[8]</a> fact-findings were unsupported.

The Federal Circuit reasoned that without any supporting evidence, the PTAB’s finding was made in ”hindsight” rather than with a sober prospective assessment of the chances of success in treating cancer with the compound. Without any data, the Federal Circuit did not agree that a “reasonable factfinder could conclude that a person of ordinary skill in the art would have reasonably expected success based on the combination …”<a href="#_ftn9" name="_ftnref9">[9]</a> The Federal Circuit carefully stated that it was not adopting a per-se rule that efficacy data would be always required to demonstrate a “reasonable expectation of success.”<a href="#_ftn10" name="_ftnref10">[10]</a> It reversed the PTAB’s finding of obviousness for lack of factual support of a reasonable expectation of success that was supported by substantial evidence.

<a href="#_ftnref1" name="_ftn1">[1]</a> Osi Pharmaceuticals, LLC v. Apotex Inc., et al., (Fed. Cir. Oct. 4, 2019).
<a href="#_ftnref2" name="_ftn2">[2]</a> Id. at 13.
<a href="#_ftnref3" name="_ftn3">[3]</a> Id. at 7.
<a href="#_ftnref4" name="_ftn4">[4]</a> Id. at 8.
<a href="#_ftnref5" name="_ftn5">[5]</a> Id. at 9.
<a href="#_ftnref6" name="_ftn6">[6]</a> Citing Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1366 (Fed. Cir. 2016).
<a href="#_ftnref7" name="_ftn7">[7]</a> Consol. Edison Co. v. N.L.R.B, 305 U.S. 197, 229 (1938).
<a href="#_ftnref8" name="_ftn8">[8]</a> Osi at 13.
<a href="#_ftnref9" name="_ftn9">[9]</a> Id.
<a href="#_ftnref10" name="_ftn10">[10]</a> Id. at 18.

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Federal Circuit Holds Lack of Efficacy Data Defeats ‘Substantial Evidence’ Showing of a Reasonable Expectation of Success Needed To Support PTAB’S Finding of Obviousness