Mylan loses its argument that "FDA invented it"
affirmed ND Ill's decision in
Cumberland Pharm., Inc. v. Mylan Institutional LLC,
137 F. Supp. 3d 1108, 1121-22, 1127 (N.D. Ill. 2015).
The outcome at district court level
At the bench trial, Mylan argued that (1) the ’445 patent
had been derived from someone at the FDA, on the
theory that it was someone at the FDA, not Mr. Pavliv,
who first had the idea to remove EDTA from the prior-art
formulation, and (2) the invention would have been obvious
in light of certain prior-art communications from the
FDA. The district court held that (1) Mylan had not
proved that anyone at the FDA conceived of the invention
before Cumberland’s inventor did, Cumberland, 137 F.
Supp. 3d at 1121–22, and (2) there was no reasonable
expectation that a formulation without any chelating
agents would be successful, given the prevailing skilledartisan
view that chelating agents were necessary to
prevent degradation of acetylcysteine, id. at 1127. The
court entered a final judgment of validity and infringement
on November 17, 2015.
As to derivation:
Mylan’s derivation challenge invokes the rule that an
applicant is not entitled to a patent if “he did not himself
invent the subject matter sought to be patented.” 35
U.S.C. § 102(f) (2006).
More specifically, it invokes the
familiar requirement that a challenger asserting this
ground show that there was a “prior conception of the
claimed subject matter and communication of the conception”
to the named inventor. Price, 988 F.2d at 1190; see
Creative Compounds, LLC v. Starmark Labs., 651 F.3d
1303, 1313 (Fed. Cir. 2011); Eaton Corp. v. Rockwell Int’l
Corp., 323 F.3d 1332, 1344 (Fed. Cir. 2003); Gambro
Lundia AB v. Baxter Healthcare Corp., 110 F.3d 1573,
1576 (Fed. Cir. 1997) (“To show derivation, the party
asserting invalidity must prove both prior conception of
the invention by another and communication of that
conception to the patentee.”). The conception requirement
of derivation borrows from the conception standard for
prior invention. Creative Compounds, 651 F.3d at 1313
(relying on the conception analysis from a discussion of
priority earlier in the opinion as sufficient in the discussion
of derivation). Conception is keyed to the claimed
invention: “A conception must encompass all limitations
of the claimed invention.” Singh v. Brake, 317 F.3d 1334,
1340 (Fed. Cir. 2003); see Taurus IP, LLC v. DaimlerChrysler
Corp., 726 F.3d 1306, 1323 (Fed. Cir. 2013);
Slip Track Sys., Inc. v. Metal-Lite, Inc., 304 F.3d 1256,
1263 (Fed. Cir. 2002); Brown v. Barbacid, 276 F.3d 1327,
1336 (Fed. Cir. 2002). Conception requires more than “a
general goal or research plan”; it requires a “definite and
permanent,” “specific, settled idea,” namely, the idea
defined by the claim at issue. Burroughs Wellcome Co. v.
Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994); see
REG Synthetic Fuels, LLC v. Neste Oil Oyj, 841 F.3d 954,
962 (Fed. Cir. 2016).
Mylan did not succeed at district court:
In this case, as the derivation issue was litigated, it
suffices to focus on the fact that the required complete
conception had to include the specific idea to remove
EDTA from Acetadote® (or a similar product that met all
the other ’445 claim elements) and not add another chelating
agent. It was that idea which Mylan had to show,
by clear and convincing evidence, was conceived by someone
at the FDA and communicated to Mr. Pavliv. See
Amax Fly Ash Corp., 514 F.2d at 1048.
The district court found that Mylan did not carry that
A request for justification
of the inclusion of EDTA, supported by data, is not the
same as a suggestion to remove it, let alone to remove it
and not replace it with another chelating agent.