Los Angeles Biomedical v. Eli Lilly (2016-1518), February 28, 2017. Before Judges Newman (concurring-in part and dissenting-in-part), Bryson, and Moore.

Takeaway:

  • The PTAB’s overly-broad claim constructions resulted in a decision that lacked the necessary factual support needed to find the claims unpatentable as being obvious under the narrower CAFC constructions. Thus the PTAB’s decision was vacated and remanded for further proceedings under the CAFC’s construction.

Procedural Posture:

Los Angeles Biomedical filed a patent infringement suit against Eli Lilly and Company alleging infringement of U.S. Patent No. 8,133,903 (“the ‘903 Patent”). Eli Lilly filed multiple inter partes review petitions challenging the validity of the ‘903 Patent. This is an appeal from the PTAB’s decision finding all claims of the ‘903 Patent unpatentable as being obvious over a combination of three prior art references. The CAFC vacated and remanded the PTAB’s decision.

Synopsis:

  • Claim Language: The CAFC found that the PTAB construed two claim limitations as overly broad, reading out two limitations from the claims. The only independent claim recited a method comprising administering a class of drugs “to an individual with at least one of a penile tunical fibrosis and corporal tissue fibrosis.” Los Angeles Biomedical Research Inst. at Harbor–UCLA Med. Ctr. v. Eli Lilly & Co., No. 2016-1518, 2017 WL 765812, at *2 (Fed. Cir. Feb. 28, 2017). The PTAB’s construction read the limitation out of the claim that the individual must have a form of fibrosis by construing the claim term as “an individual with at least one of a penile tunical fibrosis and corporal tissue fibrosis” to mean an “individual hav[ing] symptoms that may be associated with penile fibrosis, such as [erectile dysfunction], but not that the patient be specifically diagnosed as having penile tunical fibrosis or corporal tissue fibrosis.” Los Angeles Biomedical at *11. When rejecting the PTAB’s construction, the CAFC noted that penile fibrosis does not necessarily result in erectile dysfunction, and that erectile dysfunction has many causes other than fibrosis.
  • Claim Language: The PTAB construed the limitation recited in independent claim 1 of “arresting or regressing the at least one of the penile tunical fibrosis and corporal tissue fibrosis,” to have no patentable weight. This phrase was regarded as a preamble to the subsequent limitation of claim 1: “wherein the PDE-5 inhibitor is administered at a dosage up to 1.5 mg/kg/day for not less than 45 days.” The CAFC rejected this construction, noting that the “arresting or regressing” limitation requires some degree of efficacy, whereas the dosage and duration limitation does not. The CAFC found that the PTAB had not provided a substantial evidentiary basis to support its decision that the claims of the ‘903 Patent were unpatentable as being obvious, and made no findings as to whether there was an apparent reason to combine the prior art references under the proper construction provided by the CAFC. Accordingly, the CAFC vacated the PTAB’s decision and remanded the case for further findings under the proper construction.
  • Other Opinions: Judge Newman concurred-in-part, and dissented-in-part. Judge Newman argued in support of the PTAB’s finding that “treatment of ED in elderly patients or patients with atherosclerosis, as suggested by both [prior art references] would result in treatment of patients with the fibrosis, as [the prior art] teaches that corporal fibrosis is associated with ED in those patient populations.” Los Angeles Biomedical at *16 (Newman, J., dissenting-in-part). Judge Newman’s position that penile fibrosis was known to be a mechanism of causing erectile dysfunction led to his finding that the PTAB had substantial evidence for finding the claims of the ‘903 Patent unpatentable as being obvious over the prior art.