Wednesday, January 03, 2018

The Millennium case was a popular blog topic in 2017

The National Law Review [NLR] reviewed its top five IP blog posts for 2017; number five related to
Millennium v. Sandoz, of which IPBiz had written

** MILLENNIUM PHARMACEUTICALS scores win at CAFC in '446 (Velcade® ) case; Judge Newman explicates obviousness , including the text:

The district court held that the claims were obvious
because they were the inherent result of an allegedly
obvious process, viz., lyophilizing bortezomib in the presence
of the bulking agent mannitol. Millennium argued
that a person of ordinary skill would avoid lyophilization
in developing a formulation involving bortezomib because
“bortezomib was known to be unstable even in the dry
state as a freestanding solid compound.”
The district court stated that Millennium “conceded
as a matter of law that the ester is the ‘natural result’ of
freeze-drying bortezomib with mannitol.” Dist. Ct. Op. *8.
However, “[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 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

** Comments on inherency in the Millennium decision [ 2017 U.S. App. LEXIS 12702 ]

IPBiz notes that obviousness relates to that which is known or reasonably foreseeable. Inherency (in an anticipation context) does NOT require this. In Millennium, the formation of, and the inherent properties of, the bortezomib-mannitol ester were not known or reasonably foreseeable. On these facts, the mere invocation of inherency was legal error.

As pointed out in a 2012 post in IPBiz on In re Daniels:

Appellants are correct insofar as that a retrospective (retroactive or backwards) employment of inherency by the Solicitor is incorrect in a § 103 analysis. Appellants are also correct that employment of inherency is incorrect in a § 103 analysis when it is not known in the art that the inherent part is in fact inherent. Newell, 891 F.2d at 899 quoting In re Spormann, 363 F.2d 444 (C.C.P.A. 1966), (“That which may be inherent is not necessarily known. Obviousness cannot be predicated on what is unknown.”).

Separately, from blawgsearch on 3 January 2018:


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