United States District Court, N.D. Illinois, Eastern Division
MEMORANDUM OPINION AND ORDER
ST. EVE, District Court Judge:
Mylan Inc., Mylan Pharmaceuticals Inc., and Bioniche Pharma
USA, LLC (collectively, "Defendants") have moved to
amend the Court's Amended Final Judgment in light of the
United States Court of Appeals for the Federal Circuit's
recent opinion in this case. (R. 676.) Plaintiff The
Medicines Company ("TMC") opposes Defendants'
motion and also moves for a new trial. (R. 682; R. 684.) For
the following reasons, the Court grants Defendants'
motion and denies TMC's motion.
Court assumes the parties' familiarity with this case,
but summarizes the relevant facts and procedural history. TMC
is the owner of U.S. Patent Nos. 7, 582, 727 ("the
'727 Patent") and 7, 598, 343 ("the '343
Patent"). Meds. Co. v. Mylan, Inc., 853 F.3d
1296, 1298 (Fed. Cir. 2017). The patents-in-suit concern
"pharmaceutical formulations-or 'batches'-of the
drug bivalirudin." Id. Bivalirudin is a
well-known drug covered by a different TMC patent that
expired in 2015. Id. It is typically distributed as
a dry powder that "must be compounded with a base,
before being reconstituted in a clinical setting and
administered to a patient as an intravenous injection."
Id. Reconstituting bivalirudin involves dissolving
the drug in powder form in an aqueous solvent. Id.
Because dissolving bivalirudin without a base results in an
acidic solution that is not suitable for injection into
humans, commercial forms of bivalirudin compound the drug
with a base to increase the pH of the reconstituted drug to
render it acceptable for injection. Id. The claimed
inventions of the patents-in-suit "are directed to
minimizing impurities in batches of bivalirudin that have
been compounded with a base." Id.
claimed inventions arose out of a problem TMC encountered
when manufacturing Angiomax-a base-compounded bivalirudin
drug product. The Food & Drug Administration
("FDA") "required TMC to limit the level
of' Asp9-bivalirudin'-an impurity generated during
the compounding process that shortens bivalirudin's shelf
life-to less than 1.5 percent." Id. at 1299.
Between 2001 and 2005, TMC produced Angiomax with Asp9 levels
normally below 0.6%, but sometimes the process TMC used
resulted in variable or high levels of Asp9. Id.
After producing two batches in 2005 and 2006 with Asp9 levels
above 1.5%, TMC investigated and identified the compounding
process as the source of the problem. Id. One of the
steps of compounding bivalirudin is mixing a bivalirudin
solution (the powder bivalirudin dissolved into an aqueous
solvent) with a pH-adjusting solution containing a base.
Id. As the patents-in-suit indicate, this mixing
process can result in "hotspots"-that is, certain
"concentrated sites in the compounding solution that
have much higher pH levels." Id. (quoting from
the '727 Patent as an example). These hotspots in turn
"catalyzed the degradation of bivalirudin to
Asp9-bivalirudin, resulting in the undesirable high Asp9
levels that TMC was at times experiencing. Id.
inventions at issue in the patents-in-suit concern an
"efficient mixing" process for combining the
pH-adjusting solution with the bivalirudin solution that
limits the formation of hotspots. Id. at 1299-1300
(noting that the "batch consistency of bivalirudin
products compounded using 'efficient mixing' is the
invention disclosed and claimed by the patents in suit, which
were filed on the same day and share nearly identical
specifications"). This process resulted in batches with
Asp9 levels consistently below the FDA-mandated limit of
1.5%. Id. at 1299. Indeed, TMC found that efficient
mixing resulted in batches with Asp9 levels that never
exceeded 0.6%. Id. Both the '727 and the
'343 Patents have a common claim limitation (the
"batches limitation"): "[pharmaceutical
batches of a drug product comprising bivalirudin . . .
wherein the batches have a maximum impurity level of
Asp9-bivalirudin that does not exceed about
0.6%" Id. at 1300 (quoting '727 Patent, col.
25:56-64; '343 Patent, col. 27:13-31). The
patents-in-suit also defined the term "pharmaceutical
batches" as follows:
As used here, "batch" or "pharmaceutical
batch" refers to material produced by a single execution
of a compounding process of various embodiments of the
present invention. "Batches" or
"pharmaceutical batches" as defined herein may
include a single batch, wherein the single batch is
representative of all commercial batches, and wherein the
levels of, for example, Asp9-bivalirudin, total impurities,
and largest unknown impurity, and the reconstitution time
represent levels for all potential batches made by said
process. "Batches" may also include all batches
prepared by a same compounding process.
Id. (citation omitted) (quoting '727 Patent,
col. 5:24-36; '343 Patent, col. 5:24-36).
Defendants' ANDA and the Litigation Before
submitted an ANDA to the FDA in 2010, seeking to market a
generic version of Angiomax. Id. Defendants stated
that they would limit the ASP9 level of its generic drug to
less than 2% and certified either (1) that their product
would not infringe the patents-in-suit, or (2) that the
patents-in-suit were invalid. Id. TMC filed the
current lawsuit asserting infringement of the '727 and
'343 Patents under 35 U.S.C. § 271(e)(2), and
Defendants filed counterclaims seeking declaratory judgments
of invalidity. Id. The parties disputed the claim
terms "pharmaceutical batches" and
"efficiently mixing." Id. at 1300-01. With
respect to the former, this Court's claim construction-to
which both parties consented-"clarif[ies] that the
definition requires a particular process." Id.
at 1301. With respect to the latter disputed term, the Court
looked to two examples set forth in the patents'
specifications comparing TMC's "old compounding
process, " which used "inefficient mixing
conditions" (Example 4), with the new "efficient
mixing" process (Example 5). Id. The Court
ultimately concluded that TMC "had disclaimed the
'inefficient mixing conditions' of Example 4 and
adopted Mylan's proposed construction of 'efficiently
mixing' to require 'not using inefficient mixing
conditions such as described in Example 4.'"
Id. at 1301 (quoting (R. 119, Aug. 6, 2012 Op.,
on the claim construction of "efficiently mixing, "
the Court granted summary judgment of non-infringement to
Defendants with respect to the '343 Patent. (R. 309, Dec.
16, 2013 Op., 18); see also Meds. Co., 853 F.3d at
1301. Specifically, with respect to literal infringement, the
Court explained that "[t]he only question is whether
Mylan's compounding process is as inefficient (or more
inefficient) than the compounding process described in
Example 4, " and "[t]he undisputed facts show that
Mylan's compounding process is more inefficient than the
'inefficient mixing' process described in Example
4." (R. 309 at 19-20); see also Meds Co., 853
F.3d at 1301. With respect to the doctrine of equivalents,
the Court struck as untimely the declaration of TMC's
expert supporting TMC's doctrine-of-equivalents argument.
(R. 309 at 22-23.) The Court went on, however, to reason that
even considering TMC's expert's belated opinions,
TMC's infringement claim under the doctrine of
equivalents would fail under the second prong of the
"function/way/result test"-that is, the test
requiring that the patentee show the accused device
"performs the substantially same function in
substantially the same way with substantially the same
result"-because Defendants process "does not use
'efficient mixing.'" (Id. (quoting
Energy Transp. Grp., Inc. v. William Demant Holding
A/S, 697 F.3d 1342, 1352 (Fed. Cir. 2012)).)
Furthermore, the Court concluded that "even if
Mylan's compounding process did meet the
function/way/result test, TMC cannot claim infringement under
the doctrine of equivalents because the '343 patent
specification and prosecution history expressly disclaim
'inefficient mixing' conditions such as Example 4 in
order to get around anticipation by prior art." (R.
23-24 (quoting Retractable Techs., Inc. v. Becton,
Dickinson & Co., 653 F.3d 1296, 1307 (Fed. Cir.
2011), for the proposition that "when a specification
excludes certain prior art alternatives from the literal
scope of the claims and criticizes those prior art
alternatives, the patentee cannot then use the doctrine of
equivalents to capture those alternatives").) TMC
therefore could not "claim that Mylan's compounding
process, which is more inefficient than the 'inefficient
mixing' process in Example 4, is substantially equivalent
to the 'efficient mixing' process claimed by the
'343 patent." (Id. at 24.)
regard to the '727 Patent, the Court "held that
'efficiently mixing' was not a claim limitation and
determined that factual disputes concerning the Asp9 level of
Mylan's ANDA product precluded summary judgment."
Meds. Co., 853F.3datl301. The Court then conducted a
bench trial with respect to infringement and validity of the
'727 patent. The Court rejected Defendants'
invalidity contentions and concluded that Defendants'
ANDA infringed the '727 Patent as a matter of law.
Id. With respect to infringement, the Court noted
that "TMC did not advance arguments at trial regarding
infringement under the doctrine of equivalents, [so]
TMC's infringement allegations for the asserted claims
are treated as allegations of literal infringement." (R.
590, Oct. 27, 2014 Op., 72 n.29.)
The Federal ...