Leo Pharmaceutical Products, Ltd. v. Rea, 726 F.3d 1346

Background

The appeal arises from an inter partes reexamination of U.S. Patent No. 6,753,013, owned by Leo Pharmaceutical Products, challenging formulations that combine a vitamin D analogue (component A) and a corticosteroid (component B) with a specified class of non‑aqueous solvents (component C), and amended claims requiring the composition be “storage stable and non‑aqueous.”
Leo discovered that many prior solvents (water, alcohol, propylene glycol, almond oil) caused substantial degradation of vitamin D analogs or corticosteroids; it found POP‑15‑SE (a polyoxypropylene stearyl ether) and related solvents produced a storage‑stable, single‑formulation product (commercially Taclonex® ointment).
The PTO Board rejected representative claims as obvious over a combination of prior art references: Turi (disclosing POP‑15‑SE with steroids), Dikstein (disclosing vitamin D analog + steroid but using aqueous/propylene glycol/almond oil solvents), and Serup (disclosing vitamin D analog + steroid in aqueous vehicles).
The Board construed “storage stable” narrowly based on an example accelerated stability test in the specification and found a motivation to combine the references and insufficient persuasive weight to Leo’s objective indicia of nonobviousness.
The Federal Circuit reviewed claim construction de novo and factual findings for substantial evidence, reversed the Board’s claim construction as impermissibly narrow, and reversed the Board’s obviousness determination because the prior art did not render the claimed storage‑stable, non‑aqueous combination obvious and the objective indicia supported nonobviousness.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Proper construction of “storage stable”	Leo: should bear its ordinary, broad meaning covering shelf‑life stability for intended pharmaceutical use, not be limited to the example test	PTO/Board: term defined by the specification’s example accelerated stability test	Court: Board’s narrow construction vacated; example is not the sole definition and construction was impermissibly narrow
Obviousness over Turi combined with Dikstein or Serup	Leo: prior art did not recognize or solve the storage‑stability problem; prior references taught away (aqueous solvents) and would not have motivated an artisan to combine or expect success	PTO/Board: Turi taught POP‑15‑SE and excluding aqueous solvents; Serup/Dikstein taught combining vitamin D and steroids—thus a skilled artisan would combine them for known benefits	Court: Reversed Board; prior art did not supply motivation and the combination reflects hindsight—claimed invention not obvious
Role and weight of objective indicia (unexpected results, commercial success, long‑felt need)	Leo: submitted extensive experimental data showing degradation in prior formulations, commercial success (Taclonex®), and long‑felt unmet need—these weigh strongly toward nonobviousness	PTO/Board: objective indicia insufficient to overcome prima facie obviousness; Turi provided reason to use POP‑15‑SE	Court: Objective indicia are highly probative, avert hindsight, and collectively support nonobviousness; Board undervalued them
Whether invention was "obvious to try"	Leo: problem was not recognized; many unpredictable variables and lengthy testing required—no reasonable expectation of success	PTO/Board: prior art provided choices and guidance making it obvious to try combinations	Court: Not obvious to try—prior art gave only general guidance and experimentation lacked reasonable expectation of success; long intervening time supports nonobviousness

Key Cases Cited

KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (framework for obviousness and discussion of ‘‘obvious to try’’)
Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (1998) (claim construction reviewed de novo)
In re Suitco Surface, Inc., 603 F.3d 1255 (2010) (PTO must give claims broadest reasonable construction during reexamination)
Graham v. John Deere Co., 383 U.S. 1 (1966) (Graham factual inquiries for obviousness)
In re Kubin, 561 F.3d 1351 (2009) (obviousness inquiry and application)
In re Mouttet, 686 F.3d 1322 (2012) (substantial‑evidence review of Board fact findings)
Cardiac Pacemakers, Inc. v. St. Jude Med., Inc., 381 F.3d 1371 (2004) (recognition of a problem can be inventive)
In re Cyclobenzaprine Hydrochloride Ext.‑Release Cap. Patent Litig., 676 F.3d 1063 (2012) (limits on relying on obvious‑to‑try without reasonable expectation of success)
Crocs, Inc. v. Int’l Trade Comm’n, 598 F.3d 1294 (2010) (objective indicia can avert hindsight and be highly probative)
Ortho‑McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358 (2008) (objective indicia as independent evidence of nonobviousness)