Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center v. Eli Lilly & Co.
121 U.S.P.Q. 2d (BNA) 1800
Fed. Cir.2017Background
- The ’903 patent (LAB) claims a method to "arrest or regress" penile tunica or corporal fibrosis by administering a PDE5 inhibitor in a continuous long-term regimen up to 1.5 mg/kg/day for at least 45 days. Claim 1 is the only independent claim; four dependent claims refine drug/type, condition, administration mode, and duration.
- Lilly petitioned the PTAB for inter partes review, arguing claims are obvious based on Montorsi (review article), Whitaker (abandoned application claiming chronic low-dose PDE5 use), and Porst (published abstract on daily tadalafil). The PTAB found all claims obvious.
- LAB sought priority to an October 2002 provisional; the PTAB denied priority because the provisional did not adequately disclose the dosage limitation (up to 1.5 mg/kg/day).
- The PTAB construed key claim terms broadly: it treated "an individual with ... fibrosis" as encompassing individuals with symptoms (e.g., erectile dysfunction) possibly associated with fibrosis; construed "arresting or regressing" as non-limiting intent; and read "continuous long-term regimen" to require administration without intermission sufficient to be therapeutically effective.
- The Federal Circuit majority vacated and remanded, holding the PTAB erred in claim construction (narrowing the first two terms to their plain meanings and giving weight to "arresting or regressing"), and found the PTAB failed to make necessary factual findings on whether the prior art would have motivated treating penile fibrosis and provided a reasonable expectation of success.
- Judge Newman concurred in part and dissented from the judgment: she would have affirmed the PTAB, finding substantial evidence supported obviousness and inherency (i.e., the alleged antifibrotic effect was inherent in the prior art use).
Issues
| Issue | Plaintiff's Argument (LAB) | Defendant's Argument (Lilly) | Held |
|---|---|---|---|
| Priority date (written description) | Provisional discloses rat study convertible to ~1.5 mg/kg/day human dose via Freireich conversion | Provisional lacks explicit human-dose disclosure; conversion requires extra non‑disclosed assumptions | Held: Provisional does not satisfy §112(a); no priority to Oct 2002 provisional |
| Construction: "an individual with ... fibrosis" | Means patient having penile tunical or corporal fibrosis (may be subclinical) | PTAB: covers individuals with symptoms (e.g., ED) possibly associated with fibrosis | Held: Plain meaning requires actual penile tunica or corporal fibrosis (not merely ED) |
| Construction: "arresting or regressing" | Should be limiting — requires efficacy (halt or reverse fibrosis) | PTAB: non‑limiting intended result/inherent | Held: "Arresting or regressing" is an efficacy limitation (not mere intent) |
| Construction: "continuous long-term regimen" / "constant level" | Requires maintaining steady/therapeutic plasma level (steady state) | PTAB: means uninterrupted administration sufficient to be therapeutically effective; not steady‑state plasma level | Held: Does not require "constant level" or steady state; continuous = continuous in time (at least 45 days) without importing pharmacokinetic limitation |
| Obviousness (combination of Montorsi, Whitaker, Porst) | Prior art would not have motivated treating penile fibrosis with long‑term PDE5 due to prevailing belief PDE5/nitric oxide were profibrotic; inventors achieved unexpected antifibrotic results | Prior art taught chronic/daily use, dosages, and relationship between fibrosis and ED; antifibrotic effect was inherent | Held: PTAB erred by relying on its broader claim constructions and did not make findings whether prior art would have motivated treating fibrosis or given reasonable expectation of success; remanded for further factfinding |
Key Cases Cited
- Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir.) (written‑description standard: disclosure must show inventor in possession of claimed invention)
- Tronzo v. Biomet, Inc., 156 F.3d 1154 (Fed. Cir.) (parent disclosure must describe claimed invention with all limitations)
- In re Cuozzo Speed Techs., LLC, 793 F.3d 1268 (Fed. Cir.) (PTAB applies broadest reasonable interpretation in IPR; standard of review)
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (U.S.) (framework for obviousness analysis)
- Institut Pasteur & Universite Pierre et Marie Curie v. Focarino, 738 F.3d 1337 (Fed. Cir.) (expectation‑of‑success analysis must match claimed goal)
- Rapoport v. Dement, 254 F.3d 1053 (Fed. Cir.) (claim scope limited to underlying disorder, not merely treatment of associated symptoms)
- Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368 (Fed. Cir.) (preamble or purpose language may be non‑limiting)
- Alcon Research, Ltd. v. Apotex Inc., 687 F.3d 1362 (Fed. Cir.) (known compound can be obvious for a claimed therapeutic use when prior art suggests such use)