In a precedential decision that may bolster certain patent claims in the life sciences, the U.S. Court of Appeals for the Federal Circuit on July 17, 2017, held in Millennium Pharmaceuticals, Inc. v. Sandoz Inc. that the lyophilized D-mannitol ester of  bortezomib, –the active ingredient in Velcade®—was non-obvious.

Sandoz and other pharmaceutical companies sought to create generic versions of Velcade®, arguing that some of the patent claims held by Millennium were invalid because the drug resulted from allegedly well-known processes and ingredients.  The U.S. District Court for the District of Delaware agreed and invalidated several of Millennium’s claims in US Patent 6,713,446 as obvious “because they were the inherent result of an allegedly obvious process.”  But the Federal Circuit, with Judge Pauline Newman writing for the Court, reversed that decision, ruling that the unexpected properties of an unexpectedly produced new D-mannitol ester compound, and the ensuing pharmaceutical efficacy and benefit, negate a finding of obviousness.

What all parties agreed upon is that Millennium developed a new drug that was found to benefit sufferers of two oncology diseases, multiple myeloma and mantle cell lymphoma.  After numerous failures elsewhere, Millennium produced the drug by creating a formulation of bortezomib using a well-known lyophilization process with the common bulking agent mannitol.

What is obvious and what is non-obvious varies based on the observer.  Critical in patent law, however, is who is doing the observing and when.  At issue, as set forth by Judge Newman, was “whether a person of ordinary skill, seeking to remedy the known instability and insolubility and to produce an efficacious formulation of bortezomib, would obviously produce the D-mannitol ester of bortezomib, a previously unknown compound.” The Court pointed out that lyophilization of bortezomib in the presence of mannitol produced a chemical reaction and formed a new chemical compound corresponding to the mannitol ester of bortezomib; and that the new ester compound had the long-sought properties of stability and solubility, while sufficiently dissociating rapidly in the bloodstream to release bortezomib at an effective rate.

Judge Newman provided well-reasoned rationales for a holding of non-obviousness, including that the cited art provided: no teaching suggestion or reason to make the claimed compound; a teaching away from the claimed invention; a lack of inherency/improper hindsight analysis.  For example, the Court reasoned that:

The prior art contains no teaching or suggestion of this new compound, or that it would form during lyophilization. Sandoz identifies no reference or combination of references that shows or suggests a reason to make the claimed compound. No reference teaches or suggests that such a new compound would have the long-sought properties of stability and solubility, and sufficiently dissociate to release bortezomib at an effective rate in the bloodstream, all critical to effective use for treating multiple myeloma.

Judge Newman also relied on objective indicia of unexpected results and long felt need to support the finding of non-obviousness.

These various rationales for non-obviousness set forth by the Federal Circuit, via Judge Newman, in Millennium may prove useful to other life-sciences patent applicants when facing their own challenges related to overcoming obviousness rejections.

Judge Newman holds a Ph.D. in Chemistry from Yale University, and worked as a research scientist before earning a law degree from New York University and becoming a practicing patent attorney, prior to becoming a judge on the Federal Circuit; her IP experience is well-reflected in this Millennium decision.