A factor in analyzing obviousness
Obviousness is based, in part, on the path a person having ordinary skill in the art (PHOSITA) would have taken based on the prior art, and not the path the inventor actually took. In the following case, the patent owner took a commonly known path to produce a stable version of a known drug compound but in taking that path created a new compound which the inventor discovered could stabilize the known drug formulation for commercialization.
Facts of Millenium Pharm. Inc. v. Sandoz
In Millennium Pharmaceuticals, Inc. v. Sandoz Inc. (Fed Cir. 2017), the patent owner (Millennium) invented a stable version of a known compound for effectively treating cancer. The known compound was bortezomib. The FDA had not previously approved bortezomib compound for treating cancer because no stable formulation was yet developed for transportation, storage and administration to patients under conditions of clinical use and distribution.
To come up with a stable formulation, Millennium and others attempted to create a stable liquid formulation. After attempts at finding a stable liquid formulation were unfruitful, Millenium tried other previously known, alternative processes to achieve storage stability. One path that the patent owner tried was lyophilizing (i.e., freeze-drying) using a known bulking agent – mannitol. In pursuing this path, the patent owner discovered that a new compound was formed during the freeze-drying process, namely, D-mannitol ester of bortezomib. This new compound was effective at making the active ingredient (i.e., bortezomib) stable enough for commercialization.
Known process produces new compound
The case turned on the question of obviousness. Whether despite the lyophilizing (i.e., freeze drying) being a known obvious alternative process to stable liquid formulation, would the new compound (i.e., D-mannitol ester of bortezomib) produced by the obvious alternative process still be considered nonobvious, and thus patentable.
Obviousness is based on path taken by PHOSITA based on prior art
Many factors are considered in deciding whether the combination of multiple references would be obvious. This case makes clear that one of the factors is the path that a person of ordinary skill in the art would have followed based on the teachings of the prior art. The Fed. Cir. made a clear distinction between the path taught by the teachings of the prior art versus the path that the inventor took to come up with the invention.
The Federal Circuit explained that:
“[t]he inventor’s own path itself never leads to a conclusion of obviousness; that is hindsight. What matters is the path that the person of ordinary skill in the art would have followed, as evidenced by the pertinent prior art.” Otsuka, 678 F.3d at 1296. This oft-cited principle is explained in, for example, In re Kratz, 592 F.2d 1169, 1175 (CCPA 1979):
However, making weight of the method appellant used in finding the invention is beside the point. The last sentence of 35 U.S.C. § 103, with great clarity, excludes such methodology in stating that “(p)atentability shall not be negatived by the manner in which the invention was made.”
Sandoz [defendant] argues that although lyophilization in the presence of mannitol produced an unexpected result, the result was “inevitable” and thus “inherent,” and thus not “inventive.” Sandoz Br. at 1, 12-17. However, invention is not a matter of what the inventor intended when the experiment was performed; obviousness is measured objectively in light of the prior art, as viewed by a person of ordinary skill in the field of the invention. “Those charged with determining compliance with 35 U.S.C. § 103 are required to place themselves in the minds of those of ordinary skill in the relevant art at the time the invention was made, to determine whether that which is now plainly at hand would have been obvious at such earlier time.” Interconnect Planning Corp. v. Feil, 774 F.2d 1132, 1138 (Fed. Cir. 1985). No expert testified that they foresaw, or expected, or would have intended, the reaction between bortezomib and mannitol, or that the resulting ester would have the long-sought properties and advantages.
The above discussion places the focus of the inquiry on the path a person skilled in the art would have taken based on the teachings of the prior art. That path is only one factor of a multi-factorial approach in analyzing obviousness. The Federal Circuit based its opinion “on the entirety of the record” including but not limited to unexpected results, long felt need, expert testimony, etc. and found the compound non-obvious and patentable.
I highlight this portion of the case because in my opinion, it may be beneficial to clarify this distinction with USPTO examiners when arguing nonobviousness during patent prosecution. In sum, the path that the inventor took is not relevant to the obviousness inquiry. Rather, the focus of the inquiry is the path suggested by the prior art. Here, even when the parts used to make the patented product were known in the prior art, the prior art failed to suggest combining those parts in the same way as required by the claim, thus the resulting compound was patentable.
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