CAFC in Medicines v. Mylan. Claim term limited to the sole portion of the specification that adequately discloses term

The initial text of the decision in The Medicines Company v. Mylan (LEXIS cite:
2017 U.S. App. LEXIS 5947) :


The Medicines Company (“Medicines”) is the owner of
U.S. Patent Nos. 7,582,727 (“the ’727 patent”) and
7,598,343 (“the ’343 patent”). In response to an Abbreviated
New Drug Application (“ANDA”) submitted by Mylan,
Inc. (“Mylan”), Medicines filed suit in the United States
District Court for the Northern District of Illinois alleging
that Mylan’s ANDA infringed claims 1–3, 7–10, and 17 of
the ’727 patent, and claims 1–3 and 7–11 of the ’343
patent. Mylan counterclaimed seeking a declaration that
the asserted claims were invalid.

The district court held on summary judgment that the
asserted claims of the ’343 patent were not infringed
because Mylan did not satisfy the “efficient mixing”
limitation of those claims. After conducting a bench trial,
the court held that the asserted claims of the ’727 patent
were infringed because those claims did not include an
“efficient mixing” limitation.

We hold that both the ’727 and ’343 patents include a
“batches” limitation that requires batch consistency,
which, according to the patents in suit, is achieved
through efficient mixing. Efficient mixing is therefore
required by the asserted claims of both patents. We
further construe efficient mixing as defined by Example 5
of the patents’ specification. We therefore reverse the
district court’s judgment of infringement with respect to
the ’727 patent, and affirm its summary judgment of
noninfringement with respect to the ’343 patent. We do
not address the validity of the patents in suit



So, the CAFC finds "efficient mixing" is required by the claims
of the '727 patent and thus REVERSES the district court's finding
of infringement of the claims of '727.
The noninfringement of claims of the '343 is affirmed.

Thus, no infringement by Mylan.

**As to the "efficient mixing" point:


Drs. Krishna and Musso developed
an improved, “efficient mixing” process for mixing
the pH-adjusting solution with the bivalirudin solution
that minimized the formation of these hotspots. See
Medicines, 72 F. Supp. 3d at 848. This improved “efficient
mixing” process resulted in batches that consistently
satisfied the FDA’s 1.5 percent limit on the level of Asp9-
bivalirudin. Moreover, based on Drs. Krishna and Musso’s
experiments, Medicines discovered that the Asp9 level of
batches compounded using the improved “efficient mixing”
process never exceeded 0.6 percent. See id. at 848–49.

This batch consistency of bivalirudin drug 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.
See Medicines Co. v. Mylan Inc., 2012 WL 3234282,
at *2 (N.D. Ill. Aug. 6, 2012).

(...)

With respect to “efficiently mixing,” the district court
relied on two examples set forth in the patents’ specifications
comparing Medicines’ “old compounding process”
using “inefficient mixing conditions” (Example 4) with the
improved “efficient mixing” process developed by Drs.
Krishna and Musso (Example 5). See id. at *14–15; see
also ’727 patent, col. 21 l. 44–col. 24 l. 35; ’343 patent, col.
22 l. 21–col. 25 l. 3. The court ultimately agreed that
Medicines 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.” Medicines, 2012 WL 3234282, at *15.

Based on these claim constructions, the district court
held on summary judgment that Mylan’s ANDA did not
infringe the ’343 patent because the material facts concerning
Mylan’s compounding process were not in dispute
and these “undisputed facts show[ed] that Mylan’s compounding
process is more inefficient than the ‘inefficient
mixing’ process” of Example 4. See Medicines Co. v Mylan
Inc., 2013 WL 6633085, at *10 (N.D. Ill. Dec. 16, 2013).
With respect to the ’727 patent, however, 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. See id. at *20.

The district court conducted a six-day bench trial with
respect to infringement and validity of the ’727 patent.



[In passing, note that the LEXIS version of the case, as distinct
from that of the CAFC, includes LEXIS citations. For example:

This batch consistency of bivalirudin drug 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.
See Medicines Co. v. Mylan Inc., 2012 U.S. Dist. LEXIS 109749,
2012 WL 3234282, at *2 (N.D. Ill. Aug. 6, 2012).]

The issues:


The court reasoned that “Mylan’s
ANDA specification [would] allow[] it to market a drug
product with Asp9 . . . levels from 0.0%–2.0%, a range that
includes the ’727 patent’s claimed ranges of 0.0–0.6%,”
and “[w]hat a generic applicant asks for and receives
approval to market, if within the scope of a valid claim, is
an infringement.” See Medicines, 72 F. Supp. 3d at 883–85
(quoting Sunovion Pharms., Inc. v. Teva Pharms. USA,
Inc., 731 F.3d 1271, 1279 (Fed. Cir. 2013)). The court
again rejected Mylan’s argument that the claims of the
’727 patent required “efficient mixing” and entered final
judgment in favor of Medicines on all claims and counterclaims
with respect to the ’727 patent. Id. at 886–88.
Mylan has appealed the district court’s judgment of
infringement and no invalidity of the ’727 patent, and
Medicines has cross-appealed the district court’s summary
judgment of noninfringement of the ’343 patent.



A nuance IN THIS CASE:


Shortly after the completion of briefing in this case,
the panel issued an opinion holding the ’727 and ’343
patents invalid under the on-sale bar of 35 U.S.C. § 102(b)
based on pre-critical date batches of ANGIOMAX® produced
by BVL for Medicines. See Medicines Co. v. Hospira,
Inc., 791 F.3d 1368, 1372 (Fed. Cir. 2015). Accordingly,
in this case, we reversed the district court’s judgment
with respect to the ’727 patent and dismissed Medicines’
cross-appeal regarding the ’343 patent as moot.
The full court subsequently granted Medicines’ petition
for rehearing en banc in Hospira, and on rehearing
held that Medicines’ relationship with BVL did not give
rise to an invalidating “commercial offer for sale” under
Pfaff v. Wells Electronics, Inc., 525 U.S. 55, 57–68 (1998).
See Medicines Co. v. Hospira, Inc., 827 F.3d 1363, 1373–
74 (Fed. Cir. 2016) (en banc).



An interesting point about Cardinal Chemical appears in
footnote 1:


Although Mylan’s appeal calls into question the
validity of the patents in suit, Mylan’s counsel agreed that
a finding of noninfringement would render it unnecessary
for the court to reach this issue. See Oral Argument at
1:14, Medicines Co. v. Mylan, Inc., No. 15-1113 (Fed. Cir.
Dec. 6, 2016). Under Cardinal Chemical Co. v. Morton
Int’l, Inc., 508 U.S. 83, 99 (1993), a finding of noninfringement
cannot moot a counterclaim of invalidity, but
we retain the discretion to limit the grounds upon which
appeals are decided. Here, because Mylan has agreed that
a judgment of noninfringement with respect to both
patents in suit “would be tantamount to the relief sought
on the merits” and that we need not reach the invalidity
issues, we decline to reach the merits of Mylan’s invalidity
contentions. See Old Town Canoe Co. v. Confluence
Holdings Corp., 448 F.3d 1309, 1318 n.2 (Fed. Cir. 2006).



Some interesting analysis by the CAFC:



The patentee, however, takes the position that the
batches limitation is not necessarily limited to a compounding
process that achieves batch consistency. Instead,
according to Medicines, the batches limitation is
satisfied whenever an accused infringer consistently
produces batches having Asp9 levels below 0.6 percent,
and that the claims do not require the use of a particular
process that achieves batch consistency.

We disagree, for several reasons.

First, adopting Medicines’
interpretation of the batches limitation would yield
an unworkable claim construction. Under Medicines’
interpretation, proof of infringement would necessitate
forward-looking assessments of whether an accused
infringer’s production of future or “potential” batches
would be likely to generate Asp9 levels greater than
“about 0.6%.” To illustrate, if a defendant using the same
compounding process produced fifty batches each having
an Asp9 level below 0.6 percent, each of those fifty batches
would infringe. But the defendant would not know whether
any of the batches infringed until all fifty batches had
been produced because if even one of those batches was
determined to have an Asp9 level higher than 0.6 percent,
none of the batches would infringe. See Oral Argument at
17:00–19:06, Medicines Co. v. Mylan, Inc., No. 15-1113
(Fed. Cir. Dec. 6, 2016). For an ongoing commercial com-
pounding process, this approach cannot provide “reasonable
certainty” regarding the scope of the asserted claims.
Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120,
2129 (2014); Geneva Pharms., Inc. v. GlaxoSmithKline
PLC, 349 F.3d 1373, 1384 (Fed. Cir. 2003) (“A claim is
indefinite if its legal scope is not clear enough that a
person of ordinary skill in the art could determine whether
a particular composition infringes or not.”); Morton
Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470 (Fed.
Cir. 1993) (“[C]laims. . . [must be] sufficiently precise to
permit a potential competitor to determine whether or not
he is infringing.”).

(...)
Thus, we reject Medicines’ interpretation and conclude
that the batches limitation requires the use of a
compounding process that achieves batch consistency. In
doing so, we note that our decision does not impermissibly
add a process limitation to a product claim that does not
require a process because the specification’s definition of
“batches” by itself injects a compounding process as a
limitation in the asserted claims.2


AND the CRUNCH:


The question remains as to what that compounding
process entails. Based on the intrinsic evidence of the
patents in suit, the answer is that the compounding
process must use efficient mixing.



(...)


After considering the same intrinsic evidence we have
just summarized, the district court concluded that Medicines
had disclaimed inefficient mixing. See Medicines,
2012 WL 3234282, at *12–14; see also Southwall Techs.,
Inc. v. Cardinal IG Co., 54 F.3d 1570, 1576 (Fed. Cir.
1995). Whether we view the patentee as having disclaimed
inefficient mixing or construe “batches” to require
efficient mixing, see Trustees of Columbia Univ. v. Symantec
Corp., 811 F.3d 1359, 1363–64 (Fed. Cir. 2016), at
bottom, the compounding process must be one that uses
efficient mixing.



General Electric v. Wabash arises:


Divorcing efficient mixing from the batches limitation
would also have the impermissible result of “extend[ing]
[Medicines’] monopoly beyond the invention” disclosed,
and potentially to the prior art.4 Gen. Elec. Co. v. Wabash
Appliance Corp., 304 U.S. 364, 371 (1938); Plummer v.
Sargent, 120 U.S. 442, 449 (1887); Cochrane v. Badische
Anilin & Soda Fabrik, 111 U.S. 293, 309–11 (1884).

For all these reasons, the reading of the batches limitation
that “most naturally aligns with the patent’s description
of the invention” is one that requires “efficient
mixing.” Phillips, 415 F.3d at 1316. And “[a]lthough [the
’727 patent’s] claim language does not expressly recite
[efficient mixing], that is what they mean . . . The situation
here involves specifications that in all respects tell us
what the claims mean, buttressed by statements made
during prosecution . . . Accordingly, to attribute to the
claims a meaning broader than any indicated in the
patents and their prosecution history would be to ignore
the totality of the facts of the case and exalt slogans over
real meaning.” Ormco Corp. v. Align Tech., Inc., 498 F.3d
1307, 1316 (Fed. Cir. 2007).



Finally,


The next question is what is meant by “efficient mixing.”
Medicines argues that the patents’ common specification
defines “efficient mixing” as “mixing [that] is
characterized by minimizing levels of Asp9-bivalirudin in
the compounding solution,”



Of interest to practitioners:


Medicines argues that the patents’ common specification
defines “efficient mixing” as “mixing [that] is
characterized by minimizing levels of Asp9-bivalirudin in
the compounding solution,” i.e., below 0.6 percent (...)
Medicines argues that this definition is controlling. We disagree.

Although this statement is taken verbatim from the
specification, e.g., ’727 patent, col. 9 ll. 34–35, it does not
purport to be definitional because it does not accord with
the linguistic formula used by the patentee to signal the
designation of other defined terms—including “batches.”
See ’727 patent, col. 5 ll. 24–36; see also, e.g., id. col. 5 ll.
37–38 (defining “drug product”); id. col. 5, ll. 46–53 (defining
“carrier”). As the district court observed, in defining
terms, “the patentees use[d] a similar format: the defined
term in quotation marks, followed by the terms ‘refers to’
or ‘as defined herein.’” Medicines, 2012 WL 3234282, at
*9; see also ’343 patent, col. 5 ll. 24–53. Because it departs
from this format, the statement Medicines relies on lacks
the clear expression of intent necessary for a patentee to
act as its own lexicographer. See, e.g., Merck & Co. v. Teva
Pharms. USA, Inc., 395 F.3d 1364, 1370 (Fed. Cir. 2005).
More importantly, Medicines’ construction is problematic
because it amounts to a mere recitation of the
results obtained from “efficient mixing” rather than a
definition of what the efficient mixing process is.

(...)
More importantly, Medicines’ construction is problematic
because it amounts to a mere recitation of the
results obtained from “efficient mixing” rather than a
definition of what the efficient mixing process is. Before
the district court, Medicines “conced[ed] that its proposed
definition . . . construes that term functionally—i.e., by its
intended result.” Medicines, 2012 WL 3234282, at *11.
Although functional limitations in patent claims are
not per se objectionable even when the means-plus-
function format is not invoked,6 they cannot be “so broad
that [they] cause[] the claim to have a potential scope of
protection beyond that which is justified by the specification
disclosure.” In re Swinehart, 439 F.2d 210, 213
(C.C.P.A. 1971). Here, Medicines’ construction would
expand the scope of “efficient mixing” to cover any way of
mixing that achieves a compounding solution having an
Asp9 level of less than 0.6 percent. The patentee’s construction
of “efficient mixing” thus attempts to claim all
solutions to the identified “impurities” problem, without
describing the entire range of solutions to that problem.
Medicines’ construction is therefore not permissible. See
Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336,
1352–53 (Fed. Cir. 2010) (en banc) (“Such claims merely
recite a description of the problem to be solved while
claiming all solutions to it and . . . cover any [solution]
later actually invented and determined to fall within the
claim’s functional boundaries—leaving it to [others] to
complete an unfinished invention.”); see also Bayer CropScience
AG v. Dow AgroSciences LLC, 728 F.3d 1324,
1330–31 (Fed. Cir. 2013). Rather, efficient mixing must be
defined in terms of the particular process or processes
identified in the specification.



The Finnigan case is mentioned:



In our view, these portions of the specification’s detailed
description of efficient mixing are “vague and
unhelpful.” Finnigan Corp. v. ITC, 180 F.3d 1354, 1364
(Fed. Cir. 1999). Rather than teaching what efficiently
mixing is, the detailed description provides a laundry list
of mixing techniques that individually (or in combination)
may (or may not) constitute efficient mixing. Thus, unsurprisingly,
neither the district court nor the parties
relied on this portion of the specification to ascertain the
meaning of “efficient mixing.” See Medicines, 2012 WL
3234282, at *8–14. We similarly decline to do so.


In the realm of "be careful what you wish for":


On appeal, Medicines repeatedly criticizes the court’s negative
construction as failing to define what “efficient mixing”
is, as opposed to what it is not.7 Although there is no
per se rule against negative constructions, see Amgen Inc.
v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1329 (Fed.
Cir. 2003), Medicines’ argument carries some force. The
logic of the argument suggests that that we should look to
the specification’s only clear delineation of what “efficient
mixing” is—Example 5.

Critically, Medicines relied on the mixing parameters
of Example 5 to overcome prior art cited during prosecution
and did not cite any other examples of efficient
mixing—including the generic teachings of the detailed
description. In response to an anticipation rejection based
on inherency, Medicines argued that the properties of the
batches obtained from the mixing conditions of Example 5
were not “inherent . . . but rather [were] influenced by the
process used to generate the product.” J.A. 20182.

(...)

We conclude that one of ordinary skill in the art
would rely on Example 5 to ascertain the metes and
bounds of “efficiently mixing.” As the only embodiment of
efficient mixing, Example 5 is “highly indicative of the
scope of the claims.” Johns Hopkins Univ. v. CellPro, Inc.,
152 F.3d 1342, 1355 (Fed. Cir. 1998).8 Example 5, however,
is not merely the only disclosed embodiment of efficient
mixing—it is the only description of efficient mixing in the
patents in suit that casts light on what efficient mixing is
and that enables one of ordinary skill in the art to achieve
the objects of the claimed invention. Although the specification
provides that Example 5 is “non-limiting,” e.g., ’727
patent, col. 16 l. 6, no other part of the patents’ written
description sufficiently teaches the affirmative steps that
constitute efficient mixing. In this circumstance, we think
it entirely appropriate to limit the term “efficiently mixing”
to the sole portion of the specification that adequately
discloses “efficient mixing” to the public. See Alloc, Inc. v.
ITC, 342 F.3d 1361, 1370 (Fed. Cir. 2003); SciMed Life
Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d
1337, 1344–45 (Fed. Cir. 2001).



Note separately:


The district court reasoned that, like the infringing ANDA in Sunovion,
“Mylan’s ANDA specification seeks approval for a bivalirudin
drug product made from pharmaceutical batches
allowed to have . . . [an] Asp9 within the scope of the ’727
patent’s issued claims.” Id. at 885–86. The court therefore
held that “Mylan infringes as a matter of law.” Id. at 886.

This holding rests on an incorrect claim construction
of the ’727 patent that does not require “efficient mixing.”10
See id. at 887. Under the correct claim construction,
Sunovion is inapplicable because that decision “only
applies when an ANDA specification defines a compound
such that it meets the limitations of an asserted claim.”
Ferring B.V. v. Watson Labs., Inc.-Fla., 764 F.3d 1382,
1387 (Fed. Cir. 2014) (internal quotation marks omitted).
Mylan’s ANDA does not on its face establish that Mylan’s
compounding process uses efficient mixing since, for
example, nothing in the ANDA speaks to whether Mylan
uses high-shear mixing as required by Example 5.
Instead, “[w]hen an ANDA is silent with respect to infringement
. . . the correct analysis is . . . [whether] the
ANDA applicant would likely sell an infringing composition
pursuant to an approved ANDA.” Id. at 1387–88
(internal quotation marks omitted) (quoting Glaxo, Inc. v.
Novopharm, Ltd., 110 F.3d 1562, 1570 (Fed. Cir. 1997))




Note footnote 10:



While we also disagree with the district court’s
construction of “efficient mixing” as “not using inefficient
mixing conditions such as described in Example 4,” the
district court correctly concluded that Mylan did not
infringe the ’343 patent under this construction because
Mylan’s compounding process was “more inefficient” than
Example 4. Medicines, 2013 WL 6633085, at *9.