Court Opinion

ID: 4215027
Source: CourtListenerOpinion
Date Created: 2017-10-26 15:02:07.181294+00
Date Added: 2024-06-11T14:41:54.072237
License: Public Domain

United States Court of Appeals
      for the Federal Circuit
                ______________________

         MERCK SHARP & DOHME CORP.,
               Plaintiff-Appellant

                           v.

                   HOSPIRA, INC.,
                  Defendant-Appellee
                ______________________

                      2017-1115
                ______________________

    Appeal from the United States District Court for the
District of Delaware in Nos. 1:14-cv-00915-RGA, 1:14-cv-
00916-RGA, Judge Richard G. Andrews.
                 ______________________

               Decided: October 26, 2017
                ______________________

    JESSICA LYNN ELLSWORTH, Hogan Lovells US LLP,
Washington, DC, argued for plaintiff-appellant. Also
represented by CATHERINE EMILY STETSON; JOSEPH D.
ENG, TONY VALENTINE PEZZANO, MICHAEL P. DOUGHERTY,
NITYA ANAND, New York, NY; GERARD M. DEVLIN, JR.,
ALYSIA A. FINNEGAN, RAYNARD YURO, Merck & Co., Inc.,
Rahway, NJ.

    THOMAS J. MELORO, Willkie Farr & Gallagher LLP,
New York, NY, argued for defendant-appellee. Also
represented by MICHAEL JOHNSON.
                ______________________
2              MERCK SHARP & DOHME CORP.   v. HOSPIRA, INC.

    Before NEWMAN, LOURIE, and HUGHES, Circuit Judges.
     Opinion for the court filed by Circuit Judge LOURIE.
     Dissenting opinion filed by Circuit Judge NEWMAN.
LOURIE, Circuit Judge.
    Merck Sharp & Dohme Corp. (“Merck”) appeals from
the decision of the United States District Court for the
District of Delaware concluding, after a bench trial, that
claims 21–34 (“the asserted claims”) of U.S. Patent
6,486,150 (“the ’150 patent”) are invalid under 35 U.S.C.
§ 103 (2006). See Merck Sharp & Dohme Corp. v. Hospira
Inc., No. CV 14-915-RGA, 2016 WL 5872620, at *21 (D.
Del. July 10, 2016) (Decision). Because the district court
did not err in its conclusion of obviousness, we affirm.
                      BACKGROUND
    Merck owns the ’150 patent, which is directed to a
process for preparing a stable formulation of ertapenem,
an antibiotic compound, shown below:

Ertapenem is known to be unstable because of two degra-
dation reactions—hydrolysis of the lactam nitrogen (high-
lighted by a red circle) and dimerization via the
pyrrolidine nitrogen (highlighted by a blue square).
    The prior art taught that ertapenem can be stabilized
from dimerization by reacting the pyrrolidine nitrogen
with carbon dioxide to form a “carbon dioxide adduct.”
MERCK SHARP & DOHME CORP.      v. HOSPIRA, INC.          3

The method of the ’150 patent claims a manufacturing
process for a final formulation of the antibiotic that pur-
portedly minimizes both dimerization and hydrolysis
degradation pathways. See Appellant’s Br. 12–14. Claim
21 is representative and reads as follows:
   21. A process for preparing a final formulation
   product of a compound of formula Ia,

   or its pharmaceutically acceptable salt, or hy-
   drates wherein, R4, R5, and R6 are independently:
       (a) hydrogen
       (b) (C1–C6)-alkyl, or
       (c) alkali-metal or alkali earth-metal
       wherein the alkali-metal or alkali earth-
       metal is sodium, potassium, lithium, ce-
       sium, rubidium, barium, calcium or mag-
       nesium;
   comprising the steps of:
       (1) charging a solution of carbon dioxide
       source having a pH range of about 6.0 to
       about 12.0 into a reaction vessel;
       (2) adding an effective amount of a mole
       ratio of a base and an active ingredient in-
       to the reaction vessel containing the solu-
       tion of carbon dioxide source to maintain
       pH at about 6.0 to about 9.0 and a tem-
4                MERCK SHARP & DOHME CORP.   v. HOSPIRA, INC.

        perature range of about –3° C. to about
        15° C.; [and]
        (3) lyophilizing the solution of Step (2) to
        yield the final formulation product of a
        compound of formula Ia with less than
        about 10% of moisture content.
’150 patent col. 18 ll. 11–43.
    On May 29, 2014, Hospira, Inc. (“Hospira”) notified
Merck that it had filed an abbreviated new drug applica-
tion (“ANDA”), seeking approval to engage in the com-
mercial manufacture, use, or sale of generic versions of
Merck’s Invanz® product, the principal component of
which is the carbon dioxide adduct of ertapenem. In
response, Merck sued Hospira for infringement of two
patents—the ’150 patent and U.S. Patent 5,952,323 (“the
’323 patent”). The district court concluded that the as-
serted claims of the ’323 patent were not invalid and were
infringed and that the asserted claims of the ’150 patent
would also be infringed, but were invalid as obvious over
the ’323 patent and PCT publication WO 98/18800
(“Almarsson”). See Decision, 2016 WL 5872620, at *11,
*16, *21.
    The district court found that, while none of the three
steps of claim 21 of the ’150 patent was individually
taught by the prior art, the “recipe” for the final formula-
tion was disclosed and the three steps leading to that
formulation were nothing more than conventional manu-
facturing steps that would have been obvious from the
disclosures and thus were the product of routine experi-
mentation. Id. at *17–20. The court found that both
references expressly taught that the formation of the
carbon dioxide adduct is pH-dependent and requires a pH
range of about 6.0 to about 9.0; sodium hydroxide could be
used to adjust the pH; and the carbon dioxide adduct
could be produced using “standard lyophilization tech-
niques.” Id. at *16–17. The court also found that, while
MERCK SHARP & DOHME CORP.    v. HOSPIRA, INC.              5

the claimed temperature range was not explicitly taught
in the prior art, it was understood that degradation is
minimized at low temperatures, so one of ordinary skill
would have wanted to keep the temperature as low as
possible without freezing. Id. at *18.
    Regarding the dependent claims, the district court
noted that Merck “focused entirely on the validity of claim
21” and thus provided no evidence rebutting Hospira’s
expert’s testimony that each of the dependent claims’
narrower limitations was either expressly disclosed by the
references or would have been obvious from routine
experimentation. Id. at *21.
     The district court reviewed Merck’s objective evidence
and concluded that commercial success and copying by
others were shown, but that the objective evidence could
not overcome the “strong prima facie case of obviousness”
established by Hospira. Id. The court found that, while
there was commercial success tied to the asserted claims,
the evidence was “weak[ened]” by the “blocking effect” of
U.S. Patent 5,478,820 (“the ’820 patent”)—directed to
ertapenem itself—of which Merck was the exclusive
licensee. The court explained that no other entity aside
from Zeneca, the original patentee, and Merck would have
had any incentive to develop a formulation of ertapenem
for fear of infringing the ’820 patent. Id. at *9.
    The district court also found copying by others be-
cause Hospira tried five alternative formulations in an
attempt to avoid copying the ’150 patent, but ultimately it
had to rely on the accused process, which the court found
would infringe the ’150 patent. Id. at *10. However,
while the court found that Hospira’s “decision to copy
[Merck’s] formulation and process ‘is an indicium of
nonobviousness,’” it concluded that the evidence could not
overcome the strong showing of obviousness presented by
Hospira based on the prior art. Id. at *10, *21 (first citing
Diversitech Corp. v. Century Steps, Inc., 850 F.2d 675, 679
6               MERCK SHARP & DOHME CORP.    v. HOSPIRA, INC.

(Fed. Cir. 1988); then citing Wyers v. Master Lock Co., 616
F.3d 1231, 1246 (Fed. Cir. 2010)).
    Merck timely appealed to this court. We have juris-
diction pursuant to 28 U.S.C. § 1295(a)(1).
                       DISCUSSION
    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. Golden Blount, Inc. v. Robert H. Peterson
Co., 365 F.3d 1054, 1058 (Fed. Cir. 2004). A factual
finding is only clearly erroneous if, despite some support-
ing evidence, we are left with the definite and firm convic-
tion that a mistake has been made. United States v. U.S.
Gypsum Co., 333 U.S. 364, 395 (1948); see also Polaroid
Corp. v. Eastman Kodak Co., 789 F.2d 1556, 1559 (Fed.
Cir. 1986) (“The burden of overcoming the district court’s
factual findings is, as it should be, a heavy one.”). Obvi-
ousness is a question of law, based on underlying factual
findings, including what a reference teaches, whether a
person of ordinary skill in the art would have been moti-
vated to combine references, and any relevant objective
indicia of nonobviousness. Apple Inc. v. Samsung Elecs.
Co., 839 F.3d 1034, 1047–48, 1051 (Fed. Cir. 2016) (en
banc).
                             I
    On appeal, Merck argues that the district court erred
in finding that the claims would have been obvious over
either the ’323 patent or Almarsson because it is undis-
puted that none of the claimed steps is disclosed in the
prior art. Merck contends that the court erred in relying
solely on the “knowledge, creativity, and common sense”
of a skilled artisan because “common sense” is properly
invoked to provide a motivation to combine, not to supply
a missing claim limitation. Furthermore, Merck contin-
ues, the prior art focused solely on degradation by dimeri-
zation, not hydrolysis. In that way, Merck argues, the
MERCK SHARP & DOHME CORP.   v. HOSPIRA, INC.              7

prior art taught away from the claimed invention because
pH values favorable for reducing dimerization result in
increased hydrolysis, and vice versa. Merck also argues
that the narrow ranges recited in the dependent claims
are the result of the inventors’ extensive research efforts,
belying the court’s finding that routine experimentation
would have led to their discovery.
    Hospira responds that the district court properly
evaluated the claims as a whole and determined that they
recite nothing more than an obvious implementation of
the disclosures of the ’323 patent and Almarsson. Hospira
contends that claim 21 recites three broad, general pro-
cessing steps that constitute nothing more than the
routine way a skilled artisan would have implemented the
teachings of the ’323 patent.
    First, Hospira argues, the pH range recited in claim
21 was expressly disclosed in both prior art references as
the preferred pH range for forming the carbon dioxide
adduct of ertapenem. Thus, Hospira maintains, a skilled
chemist would want to first adjust a solution to the pre-
ferred pH, thereby minimizing the amount of time
ertapenem spends in solution at unstable pH levels.
Second, Hospira argues, one of ordinary skill would have
understood that the ertapenem salt is slightly acidic (as
was disclosed in the prior art), and so would have simul-
taneously added base and ertapenem to the carbon dioxide
solution, in order to maintain the preferred pH range
disclosed in the prior art. Furthermore, Hospira contin-
ues, it was widely known that lower temperatures tend to
slow degradation, so one of ordinary skill would have
sought to achieve the lowest temperature possible without
freezing. Finally, Hospira maintains that the prior art
taught that the carbon dioxide adduct could be obtained
by “standard lyophilization techniques,” and claim 21
does not require any specific lyophilization conditions.
8              MERCK SHARP & DOHME CORP.   v. HOSPIRA, INC.

    We agree with Hospira that the district court did not
err in finding that the claimed process would have been
obvious at the time the invention was made. The court
found that both references expressly taught minimizing
dimerization by forming the carbon dioxide adduct of
ertapenem at pH 6.0–9.0, that sodium hydroxide could be
used to adjust the pH, and that the final adduct was to be
obtained using “standard lyophilization techniques.” See
Decision, 2016 WL 5872620, at *16–17. The court also
found that, while the claimed temperature range was not
explicitly taught in the prior art, it was understood that
degradation is minimized at low temperatures, so one of
ordinary skill would have wanted to keep the temperature
as low as possible without freezing. Id. at *18. Those
findings are supported by substantial record evidence.
    Merck argues that the specific order and detail of the
claimed steps constitute a novel solution to minimizing
degradation by hydrolysis—a problem not addressed by
the prior art—while operating in the pH range of 6.0–9.0,
as disclosed in the prior art for minimizing dimerization.
While that may be so, Merck’s problem is that the pur-
ported “solution” for minimizing both degradation path-
ways constitutes nothing more than conventional
manufacturing steps that implement principles disclosed
in the prior art.
    Merck does not dispute that the ’323 patent and
Almarsson taught exposing ertapenem to a carbon dioxide
solution, while maintaining a pH range of 6.0–9.0, fol-
lowed by lyophilization. Merck also does not dispute that
hydrolysis was a known degradation pathway that one of
ordinary skill would have sought to minimize. See Oral
Arg. at 3:45–3:55, http://oralarguments.cafc.uscourts.gov-
/default.aspx?fl=2017-1115.mp3 (Merck’s counsel stating
that “open ring degradation was something that was
known in the prior art to affect all beta-lactams”).
MERCK SHARP & DOHME CORP.   v. HOSPIRA, INC.             9

    Merck’s purported solution for minimizing both hy-
drolysis and dimerization was to create the carbon dioxide
solution first, at the pH range disclosed in the prior art;
then simultaneously add the ertapenem and a base to the
solution, in order to maintain the pH range taught by the
prior art; maintain a low temperature during the process;
and lyophilize the final product to contain less than 10%
moisture content. The only elements of that process that
were not expressly disclosed in the prior art are empha-
sized in italics above—namely, the order of the steps, the
simultaneous addition of base, the specific temperature
range, and a final moisture content of less than 10%. But,
as the court found, those are all experimental details that
one of ordinary skill would have utilized via routine
experimentation, armed with the principles disclosed in
the prior art.
    Thus, it was reasonable for the district court to de-
duce from the evidence that the order and detail of the
steps, if not already known, would have been discovered
by routine experimentation while implementing known
principles. The court’s analysis thus involved no legal
error.
                            II
    We next address the district court’s treatment of
Merck’s objective evidence. Merck maintains that the
court improperly discounted Merck’s objective evidence,
which it found to be persuasive, when weighing the obvi-
ousness factors.
    Hospira responds that the district court correctly
found that Merck’s evidence of secondary considerations
could not overcome Hospira’s strong showing of obvious-
ness based on the teachings of the prior art. According to
Hospira, that finding warrants deference on appeal and
Merck has pointed to no clear error in the district court’s
findings.
10              MERCK SHARP & DOHME CORP.    v. HOSPIRA, INC.

    Considering all the evidence, we conclude that the
court did not err in finding the invention to have been
obvious at the time the invention was made.
     The district court found that there was commercial
success of Merck’s Invanz® product, and that it was
sufficiently linked to the asserted claims of the ’150
patent. Decision, 2016 WL 5872620, at *8–9, *21. How-
ever, the court found that this evidence was “weak[ened]”
by the “blocking effect” of the ’820 patent, which is di-
rected to ertapenem itself, the point being that commer-
cial success was not due to the qualities of ertapenem, but
rather to the fact that Merck had control of another
patent that precluded competition from others. Id. at *9.
     Merck’s evidence of commercial success should not
have been discounted simply because of the existence of
another patent of which Merck was the exclusive licensee.
We have previously held that where “market entry was
precluded” by another patent and by exclusive statutory
rights stemming from FDA marketing approvals, “the
inference of nonobviousness . . . from evidence of commer-
cial success[] is weak.” Merck & Co. v. Teva Pharm. USA,
Inc., 395 F.3d 1364, 1377 (Fed. Cir. 2005).
    But developers of new compounds often obtain a
package of patents protecting the product, including
compound, formulation, use, and process patents. Often
such patents result from Patent Office restriction re-
quirements relating to the technicalities of patent classifi-
cations and rulings that various aspects of claiming an
invention cannot be claimed in the same patent. Or they
may result from continuing improvements in a product or
process. Thus, multiple patents do not necessarily detract
from evidence of commercial success of a product or
process, which speaks to the merits of the invention, not to
how many patents are owned by a patentee. Commercial
success is thus a fact-specific inquiry that may be relevant
MERCK SHARP & DOHME CORP.    v. HOSPIRA, INC.             11

to an inference of nonobviousness, even given the exist-
ence of other relevant patents.
     Nonetheless, we do not discern clear error in the dis-
trict court’s determination that Merck’s evidence of com-
mercial success could not overcome the weight of the
evidence that the claimed process was substantially
described in the prior art and required only improvement
by the use of established variations.
     Thus, even giving the evidence of commercial success
its full and proper weight, the court did not err in conclud-
ing that the claims would have been obvious at the time
the invention was made in light of the merely ordinary
experimentation required to arrive at the ’150 patent,
starting from either the ’323 patent or Almarsson, for the
reasons discussed above.
    Second, the district court found that there was evi-
dence of copying by others because Hospira tried five
alternative formulations in an attempt to avoid copying
the ’150 patent, but ultimately had to rely on the accused
process, which the court found would infringe the ’150
patent. Decision, 2016 WL 5872620, at *10. Hospira
argues that “evidence of copying is not compelling in the
context of ANDA cases because the [Hatch-Waxman Act]
requires generic drug manufacturers to copy the approved
drug.” Appellee Br. 55–56.
    We do not agree with Hospira’s argument, nor did the
district court. The Act does not, as the court noted, re-
quire the generic manufacturer to copy the NDA holder’s
process of manufacturing the drug. In any event, as with
the evidence of commercial success, the district court
found that the evidence of copying could not overcome the
weight of the competing evidence of obviousness of the
claimed process. We agree with the district court. The
claimed process differs from the disclosure of the ’323
patent only in routine details, the implementation of
which would have been well within the capabilities of one
12              MERCK SHARP & DOHME CORP.    v. HOSPIRA, INC.

of ordinary skill in the art. Thus, we conclude that the
district court did not err in its conclusion of obviousness.
                       CONCLUSION
    We have considered the parties’ remaining arguments
but find them to be unpersuasive. For the foregoing
reasons, we affirm the decision of the district court.
                       AFFIRMED
  United States Court of Appeals
      for the Federal Circuit
                 ______________________

         MERCK SHARP & DOHME CORP.,
               Plaintiff-Appellant

                            v.

                    HOSPIRA, INC.,
                   Defendant-Appellee
                 ______________________

                       2017-1115
                 ______________________

    Appeal from the United States District Court for the
District of Delaware in Nos. 1:14-cv-00915-RGA, 1:14-cv-
00916-RGA, Judge Richard G. Andrews.
                 ______________________
Newman, Circuit Judge, dissenting.
    It is time to remedy our inconsistent treatment of the
procedures and burdens in applying the evidentiary
factors of obviousness, despite the clarifying precedent in
Graham v. John Deere Co., 383 U.S. 1 (1966). The Court
in Graham resolved prior inconsistencies and established
what was seen as a wiser standard of obviousness. The
Court established the factual premises and fixed the
placement of the burdens. It is time to restore this salu-
tary rigor.
2               MERCK SHARP & DOHME CORP.    v. HOSPIRA, INC.

    In Graham, the Court discussed the four factual
premises of obviousness 1 and explored the interaction
among these factors, explaining that each may affect the
weight of the others. The Court also clarified its own
precedent, which had separated the objective considera-
tions from the other factual criteria. See Great Atl. & Pac.
Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 153
(1950) (“[C]ommercial success without invention will not
make patentability.”); Jungersen v. Ostby & Barton Co.,
335 U.S. 560, 567 (1949) (patent invalid despite “consid-
erable commercial success”); Cuno Eng’g Corp. v. Auto-
matic Devices Corp., 314 U.S. 84, 91 (1941) (replacing
“flash of creative genius” standard with the Graham
factors).
    The Graham Court recognized that the objective indi-
cia are “more susceptible of judicial treatment than are
the highly technical facts often present in patent litiga-
tion” and such indicia “may lend a helping hand to the
judiciary.” 383 U.S. at 35–36. Contemporaneous scholar-
ship explained that “[t]he expressed relevance of the
‘secondary considerations’ in the determination of nonob-
viousness and the impact of their application in Adams
was in striking contrast to the Court’s prior standards for
the determination of ‘invention.’”      Herbert Mintz &
Charles L. O’Rourke, After Black Rock: New Tests of
Patentability—The Old Tests of Invention, 39 Geo. Wash.
L. Rev. 123, 142 (1970).
    Many Federal Circuit cases have recognized and cor-
rectly applied the Graham factors; e.g., Apple Inc. v.

    1   The four Graham factors are: (1) the scope and
content of the prior art; (2) the differences between the
claimed invention and the prior art; (3) the level of ordi-
nary skill in the field of the invention; and (4) objective
(“secondary”) considerations such as commercial success,
failure of others, and long-felt need.
MERCK SHARP & DOHME CORP.    v. HOSPIRA, INC.               3

Samsung Electronics Co., 839 F.3d 1034, 1048 (Fed. Cir.
2016) (en banc) (“A determination of whether a patent
claim is invalid as obvious under § 103 requires consider-
ation of all four Graham factors, and it is error to reach a
conclusion of obviousness until all those factors are con-
sidered.”); In re Cyclobenzaprine Hydrochloride, 676 F.3d
1063, 1077 (Fed. Cir. 2012) (“[A] fact finder must consider
all evidence of obviousness and nonobviousness before
reaching a determination.”); and Leo Pharmaceutical
Products, Ltd. v. Rea, 726 F.3d 1346, 1357–58 (Fed. Cir.
2013) (“Whether before the Board or a court, this court
has emphasized that consideration of the objective indicia
is part of the whole obviousness analysis, not just an
afterthought.”).
    The Court’s analysis was reconfirmed in KSR Interna-
tional Co. v. Teleflex Inc., 550 U.S. 398, 399 (2007) (listing
the four Graham factors and stating “[w]hile the sequence
of these questions might be reordered in any particular
case, the factors define the controlling inquiry”).
     However, some Federal Circuit decisions appear to
have sought a shortcut, and converted three of the four
Graham factors into a self-standing “prima facie” case,
whereby the objective considerations must achieve rebut-
tal weight. This path of analysis was followed by the
district court herein, finding that Hospira “made a prima
facie showing” based solely on the prior art. Merck Sharp
& Dohme Corp. v. Hospira Inc., No. CV 14-915-RGA, 2016
WL 5872620, at *19–21 (D. Del. July 10, 2016). The
district court stated that “[w]hile the copying and com-
mercial evidence supports the argument for non-
obviousness, ‘secondary considerations of nonobviousness
. . . simply cannot overcome a strong prima facie case of
obviousness.’” Id. at *21 (citing Wyers v. Master Lock Co.,
616 F.3d 1231, 1246 (Fed. Cir. 2010)). Thus, the district
court weighed that evidence against the conclusion that
the order and detail of the steps would have been discov-
ered by routine experimentation, and placed the obliga-
4               MERCK SHARP & DOHME CORP.    v. HOSPIRA, INC.

tion of achieving rebuttal weight on the fourth Graham
factor.
    However, as the Court established, it is incorrect to
consign the objective evidence to rebuttal against the
other three Graham factors. Merck is correct that the
question is not whether the evidence of copying and
commercial success “could not overcome the weight of the
competing evidence of obviousness of the claimed pro-
cess.” Maj. Op. at 11. The question is whether the entire-
ty of the evidence relating to the Merck process, including
the evidence of copying and commercial success, establish
obviousness. The analysis whereby less than the full
factual record is consulted for the “prima facie case,” with
one of the four Graham factors shifted to rebuttal, distorts
the placement and the burden of proof.
    Merck correctly points out that “the district court ei-
ther accorded insufficient weight or failed to acknow-
ledge” the objective indicia of nonobviousness. Merck
Reply Br. at 17. The objective indicia of nonobviousness
play a critical role in the obviousness analysis. They are
“not just a cumulative or confirmatory part of the obvi-
ousness calculus but constitutes independent evidence of
nonobviousness.” Ortho-McNeil Pharm., Inc. v. Mylan
Labs., Inc., 520 F.3d 1358, 1365 (Fed. Cir. 2008). Indeed,
objective indicia “may often be the most probative and
cogent evidence in the record” and are “to be considered as
part of all the evidence, not just when the decisionmaker
remains in doubt after reviewing the art.” Stratoflex, Inc.
v. Aeroquip Corp., 713 F.2d 1530, 1538–39 (Fed. Cir.
1983).
    The Federal Circuit has strayed, leading the district
courts into error. Illustration is seen in the case now at
bench; and also, for example, in Cubist Pharmaceuticals,
Inc. v. Hospira, Inc., 805 F.3d 1112, 1130 (Fed. Cir. 2015)
(“We sustain the district court’s determination that the
secondary consideration evidence did not overcome the
MERCK SHARP & DOHME CORP.   v. HOSPIRA, INC.              5

showing of obviousness based on the prior art.”); Novo
Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd.,
719 F.3d 1346, 1353 (Fed. Cir. 2013) (“In this case, the
court found that Caraco’s prima facie evidence, if unre-
butted, would be sufficient to establish that the rep-
aglinide/metformin combination was obvious to try . . . .
Having so found, it was entirely appropriate for the court
to next consider whether Novo’s countervailing secondary
consideration evidence of unexpected synergy (i.e., its
‘attempt to prove unexpected results’) was sufficient to
‘overcome’ Caraco’s prima facie case.”); Wm. Wrigley Jr.
Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364
(Fed. Cir. 2012) (“[T]he district court properly discounted
the evidence of commercial success as a secondary consid-
eration rebutting Cadbury’s showing that the claimed
invention would have been obvious.”).
    Also, Otsuka Pharmaceutical Co. v. Sandoz, Inc.,
678 F.3d 1280, 1296 (Fed. Cir. 2012) (“Because we agree
with the district court that the Defendants failed to prove
that claim 12 of the ’528 patent would have
been prima facie obvious over the asserted prior art
compounds, we need not address the court’s findings
regarding objective evidence of nonobviousness.”); Tokai
Corp. v. Easton Enterprises, Inc., 632 F.3d 1358, 1370
(Fed. Cir. 2011) (“[E]ven assuming the existence of a
nexus, we see no error in the district court’s determina-
tion that Tokai failed to establish ‘that any of these sec-
ondary factors are significant’ . . . in light of the strong
showing of prima facie obviousness.”); Wyers, 616 F.3d at
1246 (Fed. Cir. 2010) (“[S]econdary considerations of
nonobviousness—considered here by the district court—
simply cannot overcome a strong prima facie case of
obviousness.”); Muniauction, Inc. v. Thomson Corp., 532
F.3d 1318, 1327 (Fed. Cir. 2008) (“Under the foregoing
analysis, we conclude that [defendant] has clearly and
convincingly established a prima facie case that claims 1
and 31 of the ’099 patent are obvious as a matter of law.
6               MERCK SHARP & DOHME CORP.     v. HOSPIRA, INC.

Accordingly, we turn to [plaintiff’s] attempt to rebut this
prima facie case with secondary considerations of nonob-
viousness.”); Aventis Pharma Deutschland GmbH v.
Lupin, Ltd., 499 F.3d 1293, 1302 (Fed. Cir. 2007)
(“Aventis has thus failed to show unexpected results that
would tend to rebut a prima facie case of obviousness.”);
Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299, 1311
(Fed. Cir. 2006) (“A nonmovant may rebut a prima facie
showing of obviousness with objective indicia of nonobvi-
ousness.”).
     It is time to restore conformity to precedent, in the in-
terest of stability of practice and procedure, and predicta-
bility and fairness of result. I would reestablish the
proper analytic criteria under the four Graham factors,
and would remand to the district court to apply the cor-
rect law.