Millennium Pharmaceuticals v. Sandoz Inc., No. 2015-2066, 2016-1008, 2016-1009, 2016-1010, 2016-1109, 2016-1110, 2016-1283, 2016-1762 (Fed. Cir. July 17, 2017). Before Circuit Judges Newman, Mayer and O’Malley.

Takeaway:

• An invention, albeit the inherent result of a well-known process, is not itself obvious if the prior art references contain no teaching or suggestion regarding the claimed novel compound, PHOSITA would have been taught away, the invention was not an inherent result, and there were objective indicia of unexpected results and long-felt need.
• The decision is consistent with recent trends at the Court, reviewing both district court obviousness determinations as well as those by the PTAB at the USPTO, putting a greater emphasis on fact findings consistent with the ultimate legal question of obviousness in addition to fully satisfying the legal requirements of Section 103 of the Patent Statute.

Procedural Posture:

On appeal from the U.S. District Court for the District of Delaware. Millennium is the exclusive licensee of the ’446 patent, which claims a lyophilized compound that is a boronate ester of bortezomib, a drug product that may be administered for the treatment of certain cancers. Sandoz and other pharmaceutical companies filed ANDAs seeking FDA approval for generic versions of the drug, and alleged that the ’446 patent’s claims were invalid based on obviousness after Millennium sued them for infringement in the District Court. In separate co-pending litigations, Millennium also sued Teva Pharmaceuticals USA, Inc. and Apotex Corp. and Apotex Inc. based on their ANDA filings. In the Sandoz litigation, the District Court entered judgment against Millennium finding its ’446 patent invalid as obvious. In the Apotex and Teva litigations, the District Court also entered judgment against Millennium based on collateral estoppel. Millennium appealed.  The CAFC reversed and remanded the Sandoz case, entering judgment in favor of Millennium, and vacated and remanded the Apotex and Teva litigations.

Synopsis:

• Obviousness: The ’446 patent describes a new chemical compound as an ester of bortezomib (a boronic acid) and mannitol (a hydroxyl compound), acting as a cancer drug. After failing to develop a viable liquid formulation, researchers worked on a lyophilized (freeze-dried) formulation for injection. The discovery of this chemical compound solved the instability and insolubility problems previously presented in lyophilization of bortezomib. Giving due regard to the deference owed to the District Court on factual inquiries related to obviousness, the panel nevertheless found that the District Court had erred in applying the Supreme Court’s obviousness standard under KSR Int’l Co. v. Teleflex Inc. For the Federal Circuit:

[T]he question is 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 CAFC held that the patent was not invalid as obvious because: 1) the prior art references contain no teaching or suggestion of this new compound, or that it would form during lyophilization; 2) PHOSITA would have been taught away from this chemical modification for fear of disturbing the chemical properties of bortezomib; 3) the invention was not an inherent result because obviousness is measured objectively in light of the prior art, not the inventor’s own path; and 4) the objective indicia of unexpected results and long-felt need indicated that the invention was non-obvious.

Angel Wang contributed to this article.