Thursday, January 09, 2020

Hospira loses appeal at CAFC. Concept of "harmless error".

Hospira lost its appeal at the CAFC:

Hospira Inc. (“Hospira”) appeals from the judgment of
the United States District Court for the Northern District
of Illinois that claim 6 of U.S. Patent 8,648,106 (“the ’106
patent”) is invalid as obvious. Hospira, Inc. v. Fresenius
Kabi USA, LLC, 343 F. Supp. 3d 823 (N.D. Ill. 2018)
(“Opinion”). Because we find that the district court’s
factual findings were not clearly erroneous and that those
findings support a conclusion of obviousness, we affirm.

At the district court level:

The district court held a five-day bench trial on Fresenius’s defense that claim 6 of the ’106 patent is invalid as
obvious over the prior art combinations of Precedex Concentrate in combination with the knowledge of a person of
ordinary skill in the art and Precedex Concentrate in combination with Dexdomitor. After the parties submitted
their post-trial briefs, the court issued its findings of fact
and conclusions of law, holding that Fresenius had proven
by clear and convincing evidence that claim 6 would have
been obvious over the prior art.
The district court determined that “to prove that a
claim covering multiple alternative embodiments is invalid,
a defendant need only prove that one of the embodiments is invalid.”
Opinion, 343 F. Supp. 3d at 845–46
(citing In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1281
(Fed. Cir. 2015)). Thus, the court focused on one allegedly
obvious embodiment of claim 6, namely, “a ready-to-use,
sealed glass container—made from Type I glass and a
coated rubber stopper—with 4 µg/mL dexmedetomidine
HCl,” which the court referred to as the “4 µg/mL preferred

As to review of findings of fact:

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. Braintree Labs., Inc. v. Novel Labs., Inc.,
749 F.3d 1349, 1358 (Fed. Cir. 2014) (citing Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120,
1123 (Fed. Cir. 2000)). “A factual finding is clearly erroneous when, despite some supporting evidence, we are left
with a definite and firm conviction that the district court
was in error.” Alcon Research Ltd. v. Barr Labs., Inc., 745
F.3d 1180, 1186 (Fed. Cir. 2014) (citing Alza Corp. v. Mylan
Labs., Inc., 464 F.3d 1286, 1289 (Fed. Cir. 2006)). “The
burden of overcoming the district court’s factual findings
is, as it should be, a heavy one.” Polaroid Corp. v. Eastman
Kodak Co., 789 F.2d 1556, 1559 (Fed. Cir. 1986). “Where
there are two permissible views of the evidence, the factfinder’s choice between them cannot be clearly erroneous.”
Anderson v. Bessemer City, 470 U.S. 564, 574 (1985) (citing
United States v. Yellow Cab Co., 338 U.S. 338, 342 (1949)).

As to the use of later-discovered information:

As a threshold matter, we agree with Fresenius that
the district court did not err in relying on data obtained
after the priority date of the ’106 patent in its inherency
analysis. Extrinsic evidence can be used to demonstrate
what is “necessarily present” in a prior art embodiment
even if the extrinsic evidence is not itself prior art. See
Monsanto Tech. LLC v. E.I. DuPont de Nemours & Co.,
878 F.3d 1336, 1345 (Fed. Cir. 2018) (allowing “non-prior
art data” to be used to support inherency); Schering Corp.
v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir.
2003) (finding that the prior art need not recognize the inherent property).
Moreover, the work of the inventor or the
patentee can be used as the evidence of inherency. See, e.g.,
Alcon Research, Ltd. v. Apotex Inc., 687 F.3d 1362, 1369
(Fed. Cir. 2012) (analyzing inherency based on the disclosure of the “patent itself”);
Telemac Cellular Corp. v. Topp
Telecom, Inc., 247 F.3d 1316, 1327–28 (Fed. Cir. 2001)
(finding that features were inherent “as evidenced by [the
patentee]’s own documents”). The later evidence is not itself prior art;
it only helps to elucidate what the prior art
consisted of. Therefore, it was not legally incorrect for the
district court to rely on non-prior art data from Hospira’s
NDA and Fresenius’s ANDA as evidence of the inherent
stability of the 4 µg/mL preferred embodiment.

Of error by the district court:

The court thus conflated the
standards for inherency and reasonable expectation of success. However,
that was harmless error that did not infect
its inherency analysis and findings. See Vanderbilt Univ.
v. ICOS Corp., 601 F.3d 1297, 1308 (Fed. Cir. 2010) (“The
district court’s findings demonstrate that under the correct
legal test, [the plaintiff] did not carry its burden. Thus, any
erroneous interpretations of our case law were harmless
error.”); see also Environ Prods. v. Furon Co., 215 F.3d
1261, 1266 (Fed. Cir. 2000) (“When the error as to the
weight of proof could not have changed the result, the erroneous instruction is harmless.”
(citing 11 CHARLES ALAN
PROCEDURE § 2886 (2d ed. 1995))). If a property of a composition is in fact inherent,
there is no question of a reasonable expectation of success in achieving it. The claimed
dexmedetomidine formulation already is, as the evidence
in this case shows, possessed of the about 2% limitation.

Of obviousness:

It is well-settled that the inclusion of an inherent, but
undisclosed, property of a composition does not render a
claim to the composition nonobvious. Atlas Powder Co. v.
Ireco Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999) (“[T]he discovery of a
previously unappreciated property of a prior art
composition, or of a scientific explanation for the prior art’s
functioning, does not render the old composition patentably new to the discoverer.”
(citing Titanium Metals Corp. v.
Banner, 778 F.2d 775, 782 (Fed. Cir. 1985))). A patent can
be invalid based on inherency when the patent itself makes
clear that a limitation is “not an additional requirement
imposed by the claims . . . , but rather a property necessarily present.” In re Kubin, 561 F.3d 1351, 1357 (Fed. Cir.
2009); see also Persion Pharm. LLC v. Alvogen Malta Operations Ltd., Case No. 18-2361, slip op. at 13 (Fed. Cir. Dec.
27, 2019) (“[T]he district court did not err by finding that
the pharmacokinetic limitations of the asserted claims
were inherent and added no patentable weight to the pharmacokinetic claims.”); Alcon Research, 687 F.3d at 1369
(“[T]his claim language does not impose any additional requirement because the ’805 patent itself defines mast cell
stabilization as a property that is necessarily present at
those concentrations.”); In re Kao, 639 F.3d 1057, 1070
(Fed. Cir. 2011) (“Substantial evidence supports the
Board’s finding, based upon the specification, which confirms that the claimed ‘food effect’ is an inherent property
of oxymorphone itself . . . .”).


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