Saturday, May 04, 2019

Endo and Mallinckrodt prevail at CAFC in hydroxymorphinone case

Of interest:

The District Court, relying on intrinsic and extrinsic
evidence, determined that a PHOSITA would understand
the 14-hydroxymorphinone limitations stated in claims 1–
2 and 5 to mean “14-hydroxymorphinone hydrochloride,”
i.e., the “salt form” of 14-hydroxymorphinone. Endo, 2017
WL 3731001, at *14 (internal quotation marks omitted).
Actavis argues that this limitation requires no construction
because of “[t]he plain language of the claims, and the undisputed
chemical difference between 14-hydroxymorphinone [i.e., oxymorphone ABUK] and its
hydrochloride salt.” Appellants’ Br. 67. We disagree with

Judge Stoll dissented:

I respectfully dissent. The FDA set a regulatory requirement that ABUK content in oxymorphone products be
less than 0.001% (10 ppm). Mallinckrodt then claimed this
requirement in the ’779 patent. Not only does the FDA’s
mandate disclose every limitation of claim 1, but it is the
only prior art reference that discloses the 0.001% oxymorphone ABUK limitation.
Compare J.A. 2736, 2895,
with ’779 patent col. 37 ll. 58–59. Yet, the district court determined
that this mandate did not disclose “anything substantive relevant to obviousness.” Endo Pharm. Inc. v.
Actavis Inc., No. CV-14-1381, 2017 WL 3731001, at *7
(D. Del. Aug. 30, 2017) (“Decision”). It further erred by imposing a requirement that a reference must teach how to
solve a problem to provide a motivation to combine,
conflating enablement and reasonable expectation of success requirements with motivation. See id. at *12. Finally, the
district court applied an erroneously heightened standard
for reasonable expectation of success by requiring a “definitive solution” and proof of actual success. Id. at *9. The
majority would disregard a number of these errors as
harmless, affirming on the lack of a reasonable expectation
of success. Given the significance of the court’s errors, however, I cannot agree. While we owe deference to a district
court’s factual findings, such deference is not due where
the trial court applies the incorrect standard to arrive at
those findings. I would vacate the district court’s decision
and remand for a proper analysis under the correct legal


Whether a reference teaches how to achieve the claimed invention speaks
to enablement or reasonable expectation of success—entirely
separate inquiries from motivation to combine. “[O]ne
must have a motivation to combine accompanied by a reasonable expectation
of achieving what is claimed in the patent-at-issue.” Intelligent Bio-Sys., Inc. v. Illumina
Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016) (emphasis added).
Motivation to combine refers to “a reason
that would have prompted a person of ordinary skill in the
relevant field to combine the elements in the way the
claimed new invention does.” KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 418 (2007). A reasonable expectation of success, on the other hand,
addresses whether a person of ordinary skill in the art would have understood that the
proposed combination or modification would have been reasonably likely to be successful.
See, e.g., UCB, Inc. v. Accord Healthcare, Inc., 890 F.3d 1313, 1325–26 (Fed. Cir.


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