Leo Pharmaceutical Products, Ltd. v. Teresa Stanek Rea (USPTO)

Docket No. 2012-1520

August 12, 2013

Brief summary: BPAI claim construction reversed because it was tied to a single example and not the plain and ordinary meaning. BPAI obviousness decision reversed due to lack of motivation to combine the prior art and secondary indicia, including “[t]he length of the intervening time between the publication dates of the prior art and the claimed invention.”

Summary: Leo Pharmaceutical Products (“Leo”) appealed BPAI claim construction and obviousness findings regarding its US 6,753,013 relating to “storage stable” compositions (“wherein said pharmaceutical composition is storage stable and non-aqeous”) for treating skin conditions such as psoriasis by simultaneous treatment with vitamin D and corticosteroids. Leo recognized a storage stability problem (doctors were prescribing vitamin D and corticosteroids separately) and “discovered that a new set of solvents, including polyoxypropylene 15 stearyl ether (POP-15-SE) solved the storage stability problem” but that other ingredients (aqueous alcohol-based solvents, propylene glycol / almond oil) did not. The Board construed the terms “storage stable” and “non-aqueous” and rejected Leo’s claims as obvious over three prior art references (Turi, Dikstein and Serup). Turi disclosed compositions of a steroid and POP-15-SE is “antifungal, antibacterial, nonirritating, and lubricating” (rendering “additional preservatives unnecessary”) “but it does not teach the use of vitamin D”. Dirkstein disclosed dermatological compositions comprising a vitamin D analog and corticosteroids (and almond oil, propylene glycol and/or water) for treating psoriasis “but it does not teach using vitamin D to treat side effects of corticosteroids” or “the use of POP-15-SE or any other solvent that could solve the storage stability concerns.” Serup disclosed aqueous compositions of a vitamin D analog and a steroid, and “the use of vitamin D analogs for treating skin atrophy, a well-known side effect of steroid treatment…but does not address any storage stability concerns”. The BPAI found “the reason for combining Turi with Serup was ‘for [Turi] solvent’s advantages and ‘to obtain a more effective preparation without…causing skin atrophy.” And it found Turi and Dikstein would have been combined because Dikstein teaches the combination of a vitamin D analog and a corticosteroid achieves a more complete skin healing. It also acknowledged Leo “provided ‘extensive experimental evidence’ that water, alcohol, and polypropylene glycol cause unacceptable degradation of vitamin D and steroid compositions” but found the objective indicia of nonobviousness did not overcome the prima facie case (results not unexpected). The FC panel first considered the Board’s construction of the term “storage stable” (not defined in specification but showed composition maintained the components “without degradation”) and found it “impermissibly narrow” because it was based on one example and not the ordinary and customary meaning. Regarding obviousness, the opinion first noted that “an invention can often be the recognition of a problem itself” (Cardiac Pacemakers, FC 2004) and that “the prior art either discouraged combining vitamin D analogs and corticosteroids” or attempted combinations “without recognizing or solving the storage stability problems”. And “because neither Dikstein nor Serup recongized or disclosed the stability problem, the record shows no reason for one of ordinary skill in the art to attempt to improve upon either” disclosure (“To discover this problem, the ordinary artisan would have needed to spend several months running storage stability tests…Only after recognizing the existence of the problem would an artisan then turn to the prior art [for solutions]…Instead this invention does not appear for more than a decade.”) The FC panel also found that the Board “brush[ed] aside the storage stability issue” and thereby “erred by collapsing the obviousness analysis into a hindsight-guided combination of elements.” It also concluded that, given the “divergent compositions with express disclaimers of the other’s contents, “the record showing that Turi, Serup and Dikstein describe compositions for the same therapeutic purpose does not rise to the level of a motivation to combine.” In addition, “the breadth” of the available “choices and numerous combinations indicated that these disclosures would not have rendered the claimed invention obvious to try” (Rolls-Royce PLC, FC 2010; In re Cyclobenzaprine (FC 2012); Abbot Labs., FC 2008) (“Here, the ‘background of useful knowledge’…was published decades before the ‘013 patent….” and “This court and obviousness law in general recognizes an important distinction between combining known options into ‘a finite number of identified, predictable solutions,’ KSR…and ‘merely throwing metaphorical darts at a board’ in hopes of arriving at a successful result, Cyclobenzaprine….”) In conclusion, “[b]ecause the problem was not known or finite, and the solution was not predictable, it would not have been obvious for a person of ordinary skill to make the claimed invention.” The FC panel also explained that “consideration of the objective indicia is part of the whole obviousness analysis, not just an afterthought” (Cyclobenzaprine, FC 2012; Ortho-McNeil, FC 2008; Crocs, Inc., FC 2010). During reeexamination, Leo reproduced the Dikstein and Serup formulations and showed significant degradation (“a strong indication that the ‘013 patent’s combination of known elements yields more than just predictable results”). Leo also provided evidence of commercial success and a long felt but unresolved need. And “[t]he length of the intervening time between the publication dates of the prior art and the claimed invention can also qualify as an objective indicator of nonobviousness” (Ecolochem, FC 2000) and, here, “speaks volumes to the nonobviousnes of the ‘013 patent”. Thus, the court reversed the Board’s obviousness determination.

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