July 18, 2017

Unexpected Results of an Obvious Process are Non-obvious

By Bryan K. Wheelock, Principal

In Millennium Pharmaceuticals, Inc., v. Sandoz Inc., [2015-2066, 2016-1008, 2016-1009, 2016-1010, 2016-1109, 2016-1110, 2016-1283, 2016-1762] (July 17, 2017), the Federal Circuit reversed the district court, finding that invalidity was not established.

At issue was the validity of U.S. Patent No. 6,713,446 for treatment of oncology disease, sold under the name Velcade®.  The district court held that the claims were obvious because they were the inherent result of an allegedly obvious process — lyophilizing bortezomib in the presence of the bulking agent mannitol, namely — even though nothing in the prior art taught or suggested that the claimed new compound would be formed, or taught or suggested making the claimed new compound by any method, or taught or suggested that this new compound would have the properties of stability, solubility, and dissociability that it exhibited.

The Federal Circuit framed the issue as “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.”  Finding that the prior art contains no teaching or suggestion of this new compound, or that it would form during lyophilization, the Federal Circuit concluded that the invention was not obvious.

While conceding the truth of Sandoz’ argument that (1) lyophilization was generally known in formulating pharmaceutical products; (2) bulking agents were known for use in lyophilization; and (3) that mannitol was a known bulking agent, the Federal Circuit nonetheless found that the prior art does not teach or suggest that lyophilization of bortezomib in the presence of mannitol would produce a chemical reaction and form a new chemical compound, or provide a reason to make this specific new chemical compound, or that this new compound would solve the previously intractable problems of bortezomib formulation.

In the end, this is a triumph of “unexpected results” over what is technically obvious, or at least what is the inherent result of what is technically obvious.  The Federal Circuit suggested otherwise, noting that “[a] result is obvious when it is ‘the natural result flowing from the operation as taught,’ or a ‘property that is necessarily present’ when applying a process disclosed in the prior art,” and found that Sandoz “failed to show that it was obvious to use mannitol to make an ester during lyophilization, or that the ester would solve the problems experienced with bortezomib.”  The Federal Circuit’s analysis seems to put more weight on the obviousness of the unexpected results rather than the obviousness of the process that resulted in unexpected results.

While it seems right to reward someone who solves a “previously intractable problem,” it throws a kink into the obvious analysis to evaluate the obviousness of the unexpected results of an obvious process (which by definition are not obvious), rather than the obviousness of the process itself.