Tuesday, December 19, 2017

Genzyme/Reddy's case on "how much" it takes for a suggestion to have a reasonable expectation of success

The post Hypothesis alone Does not Make the Results Obvious on the Genzyme/Reddy's case has some interesting comments, including one which states:

Seems like the correct decision. The determination that there was an apparent reason to modify/combine the prior art and the determination that there was a reasonable expectation of success in so doing are separate factual inquiries. The objective evidence must support, by a preponderance, both conclusions. Too many examiners, and APJ’s, collapse both inquiries into one, meaning they conclude that because there is evidence that one of ordinary skill in the art would (at least try to) modify/combine the prior art, then that evidence also supports the conclusion that there was a reasonable expectation of success in doing so. Lots of PTAB decisions where the APJ’s conclude that appellant didn’t present any evidence that there wasn’t a reasonable expectation of success. Of course, the burden of proof on that issue is on the examiner, not the appellant.

The standard for an appellant to prevail at the CAFC on a factual determination by the district court [here, Judge Sleet of D. Del.] is "clearly erroneous," as pointed out by the CAFC in the case:

Here, the district court found that a skilled artisan would not have
had a reasonable expectation of success that plerixafor
would mobilize stem cells. DRL has not shown that this
determination was clearly erroneous.


Its view that there was no reasonable expectation
of success, based on the evidence presented at trial on a
combination of Hendrix and the ’304 Patent, was not
clearly erroneous.


After reviewing the record surrounding the prior art
and analyzing the arguments of the parties, we conclude
that the district court’s factual conclusions regarding an
insufficient reasonable expectation of success were not
clearly erroneous. That evidence is sufficient to uphold
the district court’s determination against the arguments
DRL has presented for reversal, and we need not review
the district court’s analysis of secondary considerations
that, if sound, could only further undermine DRL’s argument
for obviousness.

The CAFC is not weighing whether or not there was a preponderance of the evidence supporting Genzyme.
As the Federal Circuit has held, this Court "as part of its clear error review, must review the Board's weighing of the evidence; it may not weigh any evidence itself." Deloach, 704 F.3d at 1380
To reverse, the CAFC must have a definite and firm conviction that a mistake was made by the district court.

The CAFC did not reference Gypsum in this case. Note the case Merck v. Hospira, 874 F.3d 724
(Oct. 2017) , which stated:

On appeal from a bench trial, we review a district court's conclusions of law de novo and its findings of fact for clear error. Golden Blount, Inc. v. Robert H. Peterson Co., 365 F.3d 1054, 1058 (Fed. Cir. 2004). A factual finding is only clearly erroneous if, despite some supporting evidence, we are left with the definite and firm conviction that a mistake has been made. United States v. U.S. Gypsum Co., 333 U.S. 364, 395, 68 S. Ct. 525, 92 L. Ed. 746 (1948); see also Polaroid Corp. v. Eastman Kodak [page 1493] Co., 789 F.2d 1556, 1559 (Fed. Cir. 1986) ("The burden of overcoming the district court's factual findings is, as it should be, a heavy one.").Obviousness is a question of law, based on underlying factual findings, including what a reference teaches, whether a person of ordinary skill in the art would have been motivated to combine references, and any relevant objective indicia of nonobviousness. Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034, 1047-48, 1051 (Fed. Cir. 2016) (en banc).

[Compare also the Allergan case:
A factual finding is clearly erroneous if, despite some supporting evidence, we
are left with a definite and firm conviction that a mistake
has been made. United States v. U.S. Gypsum Co., 333
U.S. 364, 395 (1948); Alza Corp. v. Mylan Labs., Inc., 464
F.3d 1286, 1289 (Fed. Cir. 2006)]

Other circuits have interesting discussions of "clearly erroneous":

The most creative (and perhaps, most
deferential) of these is the Seventh Circuit’s “dead fish” test which
states that “[t]o be clearly erroneous, a decision must strike us as
more than just maybe or probably wrong; it must, as one member
of this court recently stated during oral argument, strike us as
wrong with the force of a five-week-old, unrefrigerated dead
fish.”21 Alternatively, a two-part test arising from the Fifth Circuit
contracts deference, providing for clear error either if there is a
“definite and firm conviction of mistake” or if the “account was
implausible based upon the entirety of the record.”22

from Kenneth Jennings, 14 N.C. J.L. & TECH. ON. 301 (2013)


A clear error of judgment in weighing relevant factors is also a ground for finding an abuse of discretion. Where it is not evident that a district court has applied the correct legal standard in exercising its discretion, the Federal Circuit may vacate and remand for the district court to do so in the first instance, especially where further factual findings may be warranted under the correct legal standard.

And one recalls the Kemps case:

Needless to say, the Federal Circuit was not pleased. The court noted that "the briefing of the entire case by the USPTO under the incorrect standard was inappropriate." n67 The court faulted the USPTO for "unfairly burdening the applicant" who "felt like "a bystander to some long-running dispute to which he really is not a party.'" n68 The court also faulted the USPTO for failing to argue for en banc consideration: "the USPTO simply declared that the standard of review was "arbitrary and capricious,' briefed the case as such, and [page 1072] effectively disregarded the substantial precedent behind the court's standard of review, with only a footnote recognizing the correct standard." n69 Ultimately, the Federal Circuit concluded that this case would have been decided the same way under either standard; therefore, the issue was not ripe for decision. n70 The court concluded,

from Holbrooks, 66 Am. U.L. Rev. 1061 (2017)

See also Field, 27 Fordham Intell. Prop. Media & Ent. L.J. 555 (2017)

Note Sung has written: With regard to the Federal Circuit's review of the USPTO's factual findings, the clearly erroneous standard is more stringent than the APA's arbitrary and capricious or substantial evidence standard. from 48 Am. U.L. Rev. 1233 (1999)


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