Federal Circuit Vacates PTAB Decision Based on Overly Broad Claim Constructions

In Los Angeles Biomedical Research Institute v. Eli Lilly and Co., No. 2016-1518, the Federal Circuit vacated the Patent Trial and Appeal Board’s determination of unpatentability in an inter partes review (IPR) proceeding, finding that the Board had misconstrued two key claim terms.

The patent at issue relates to treating one of the causes of erectile dysfunction (ED). The patent contains claims directed to a method of arresting or regressing a condition known as penile fibrosis.  The Federal Circuit faulted the Board for taking an overly broad interpretation of the phrase “an individual with at least one of penile tunical fibrosis and corporal tissue fibrosis.”  The Board construed the phrase as an “individual hav[ing] symptoms that may be associated with penile fibrosis, such as [ED],” but did not require that the patient be diagnosed with “penile tunical fibrosis or corporal tissue fibrosis.”  The Federal Circuit rejected the Board’s interpretation, construing the phrase to require the recited fibrosis.  The court reasoned that a patient may have penile fibrosis, ED, both, or neither.  “The patented invention targets the treatment of fibrosis, whether or not the fibrosis causes [ED].”  Slip op. at 15.  The court explained that treatment of a symptom known to be caused by a particular condition does not make treatment of that condition obvious if there are other causes of the symptom. Id. at 16 (citing Rapoport v. Dement, 254 F.3d 1053, 1059 (Fed. Cir. 2001)).

The Federal Circuit also faulted the Board for adopting an overly broad interpretation of the phrase “arresting or regressing the…fibrosis.” The Board determined that this phrase is non-limiting because it only describes the intended result of administration of the PDE-5 inhibitor.  The Federal Circuit disagreed, holding that “arresting or regressing” requires efficacy, whereas the recited maximum dose and minimum period of treatment does not.  The court distinguished the claims at issue from situations where dosage is recited and efficacy is “inherent in carrying out the claim steps.” Id. at 19 (citing Dawson v. Dawson, 710 F. 3d 1347, 1355 (Fed. Cir. 2013)).  Because a minimum dosage was not recited, the Federal Circuit held that effectiveness was not inherent.

In addition, the Federal Circuit vacated the PTAB’s finding that the petitioner had established a reasonable expectation of success for combining the references. The court reasoned that the teaching of a daily administration of an inhibitor to alleviate symptoms of ED was insufficient to establish that there was a reasonable expectation of success to arrest or regress penile fibrosis.  The court emphasized that “‘without a sound explanation for doing otherwise,…the expectation-of-success analysis must match the highly desired goal, not switch to a different goal that may be a less challenging but also less worthwhile pursuit.’” Id. at 25 (quoting Institut Pasteur & Universite Pierre et Marie Curie v. Focarino, 738 F.3d 1337, 1346 (Fed. Cir. 2013)).

The Federal Circuit held that a theory in one of the references was speculative and insufficiently connected to patients with associated corporal fibrosis. Therefore, the reference did not provide an express or implicit teaching. Id. at 27 (citing Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 655 F.3d 1364, 1375-76 (Fed. Cir. 2011) (the prior art’s “speculative and tentative disclosure of what ‘might’ or ‘may’ [explain the cause of a desired effect] does not sufficiently direct or instruct one of skill in this art”), and Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1290 (Fed. Cir. 2006) (“[L]egal determinations of obviousness…should be based on evidence rather than on mere speculation or conjecture.”).

The Federal Circuit also discussed the appellant’s argument concerning the prevailing understanding in the art at the time the challenged patent was filed. Since the argument was disputed, the Federal Circuit remanded the issue back to the PTAB for further fact finding.

As demonstrated in Los Angeles Biomedical Research Institute, claim construction can be a critical issue in appeals from PTAB decisions.  Parties should consider their claim construction positions not only in light of what might be persuasive to the PTAB, but also the likelihood that such positions will be upheld on appeal.

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