Ortho-McNeil Pharmaceutical, Inc. v. Teva Pharmaceuticals Industries, Ltd. ( 2009 )

NOTE: This disposition is nonprecedential.
United States Court of Appeals for the Federal Circuit
2008-1549, -1550
ORTHO-MCNEIL PHARMACEUTICAL, INC.,
Plaintiff-Appellant,
v.
TEVA PHARMACEUTICALS INDUSTRIES, LTD.,
TEVA PHARMACEUTICALS USA, INC., and WATSON LABORATORIES, INC.,
Defendants-Appellees,
and
KALI LABORATORIES, INC., PAR PHARMACEUTICAL COMPANIES, INC.,
and PAR PHARMACEUTICAL, INC.,
Defendants,
and
CARACO PHARMACEUTICAL LABORATORIES, LTD.,
Defendant-Appellee.
Constantine L. Trela, Jr., Sidley Austin LLP, of Chicago, Illinois, argued for plaintiff-
appellant. With him on the brief were David T. Pritikin, Lisa A. Schneider and Linda R.
Friedlieb. Of counsel on the brief were Jeffrey P. Kushan, of Washington, DC, and
Michael D. Hatcher, of Dallas, Texas.
John L. North, Sutherland Asbill & Brennan LLP, of Atlanta, Georgia, argued for
defendants-appellees Teva Pharmaceuticals Industries, Ltd., et al. With him on the brief
were Jeffrey J. Toney, N.E.B. Minnear, and Jason M. Prine.
James F. Hurst, Winston & Strawn LLP, of Chicago, Illiinois, argued for defendant-
appellee Caraco Pharmaceutical Laboratories, Ltd. With him on the brief was Scott R.
Samay, of New York, New York. Of counsel was Cherish M. Keller.
Steven E. Feldman, Husch Blackwell Sanders Welsh & Katz, of Chicago, Illinois, for
amicus curiae Apotex, Inc. With him on the brief was Sherry L. Rollo.
Appealed from: United States District Court for the District of New Jersey
Judge Dennis M. Cavanaugh
NOTE: This disposition is nonprecedential.
United States Court of Appeals for the Federal Circuit
2008-1549, -1550
ORTHO-MCNEIL PHARMACEUTICAL, INC.,
Plaintiff-Appellant,
v.
TEVA PHARMACEUTICALS INDUSTRIES, LTD.,
TEVA PHARMACEUTICALS USA, INC., and WATSON LABORATORIES, INC.,
Defendants-Appellees,
and
KALI LABORATORIES, INC., PAR PHARMACEUTICAL COMPANIES, INC.,
and PAR PHARMACEUTICAL, INC.,
Defendants,
and
CARACO PHARMACEUTICAL LABORATORIES, LTD.,
Defendant-Appellee.
Appeals from the United States District court for the District of New Jersey in case nos.
04-CV-886 and 06-CV-3533, Judge Dennis M. Cavanaugh.
__________________________
DECIDED: August 26, 2009
__________________________
Before MAYER, PROST, and MOORE, Circuit Judges.
Opinion for the court filed by Circuit Judge PROST. Dissenting opinion filed by Circuit
Judge MAYER.
PROST, Circuit Judge.
INTRODUCTION
This case is a patent law appeal from a district court order granting summary
judgment of invalidity based on anticipation and obviousness. Ortho-McNeil
Pharmaceutical (“Ortho”) brought suit against Teva Pharmaceuticals Industries (“Teva”)
and Caraco Pharmaceutical Laboratories (“Caraco”) alleging infringement of U.S.
Reissued Patent 39,221 (“RE’221”), directed to a combination tramadol and
acetaminophen composition for use in prescription pain relief. We vacate-in-part, affim-
in-part, and remand.
Acetaminophen is a popular non-opioid pain reliever, more commonly known by
the brand name Tylenol®. Acetaminophen has a poorly understood mechanism of
action, and interacts with other drugs in ways that could not be predicted in 1990.
Nonetheless, it was a popular pain reliever and Ortho had a history of experimenting
with combining acetaminophen and other drugs.
Tramadol is an atypical weak opioid with an unclear mechanism of action.
Tramadol and methods of making and using it were first described in U.S. Patent No.
3,652,589 to Flick. Flick mentions that tramadol can be combined with other
analgesics, and often exhibits synergistic effects. The specification of Flick also
includes 23 working examples. The first 22 examples describe different tramadol
formulations. Example 23 discloses a combination of tramadol, p-acetamino-phenol,
pentobarbital sodium, and ethoxy benzamide. In 1990, Tramadol was known to have
several serious side effects, and for that reason was commonly administered through
gradual dose titration.
2008-1549, -1550 2
Ortho first claimed a combination tramadol and acetaminophen tablet in 1990, in
U.S. Patent No. 5,336,691 (“’691 patent”). The patent described one benefit of the
claimed composition as a synergistic effect between tramadol and acetaminophen.
Ortho received FDA approval for such a combination tablet and marketed its product as
Ultracet®. Ultracet® immediately became the fastest growing prescription pain reliever
and enjoyed considerable commercial success. Several generic drug companies filed
abbreviated new drug applications (“ANDAs”) to market generic versions of Ultracet®.
Ortho brought multiple different lawsuits against these companies asserting the ’691
patent against the ANDAs.
In pretrial motions, several of the drug companies alleged that the ’691 patent
was invalid for anticipation and obviousness based on Flick and other references.
During the course of litigation, Ortho discovered that the p-acetamino-phenol mentioned
in the Flick patent was actually an archaic name for acetaminophen. The ratio of
tramadol to p-acetamino-phenol in the four-compound combination of Flick’s example
23 is 1:10, which falls within the scope of some of the claims of the ’691 patent. In light
of the cited references and the fact that p-acetamino-phenol is acetaminophen, Ortho
sought reexamination and reissue of the ’691 patent. Ortho submitted to the examiner
the relevant prior art, a summary judgment motion submitted by Kali Laboratories, and a
letter submitted by Barr Pharmaceuticals arguing anticipation and obviousness of the
’691 patent.
Other prior art cited to the examiner during reissue proceedings and to the district
court includes a series of German publications based on the WHO Cancer Pain
Guidelines (hereinafter “the German references”). Collectively, these articles teach a
2008-1549, -1550 3
method of managing cancer pain using a ladder approach aimed at customizing a co-
administration of pain relievers and dosing regimens to meet the needs of each patient.
The strengths of the medications and the dosages increase as the prescriber moves up
the ladder. The middle rung of the ladder includes a non-opioid analgesic co-
administered with a weak opioid. None of the German references mentions synergy.
In reissue proceedings for the ’691 patent, Ortho canceled all but one of the
asserted claims and redrafted them to narrow the scope of the invention and attempt to
avoid the cited prior art references. Ortho also argued to the examiner that one of
ordinary skill in the art at the time of filing would not understand the prior art to disclose
the claimed invention as amended. The examiner ultimately allowed several redrafted
claims and the one previously allowed claim to reissue as RE’221.
While the reissue proceedings were pending, Teva and Caraco filed summary
judgment motions for invalidity and non-infringement of claim 6 of the ’691 patent.
Claim 6 was the one original claim allowed in RE’221, amended to independent form.
Ortho then amended its complaints to assert the new reissue claims as well as RE’221
claim 6 against Teva and Caraco (among others) in the ongoing ANDA litigation
between the parties. Ortho’s cases against Teva and Caraco were then consolidated.
Teva and Caraco filed summary judgment motions for invalidity and non-
infringement, asserting that RE’221 was anticipated and rendered obvious by Flick and
the German references. Ortho disputed Teva’s and Caraco’s interpretations of the prior
art disclosures and submitted uncontroverted expert testimony explaining that one of
skill in the art at the time of the original filing would not understand Flick, or the German
references to disclose or render obvious the claimed invention.
2008-1549, -1550 4
On August 12, 2008, the district court granted summary judgment invalidating
RE’221 claims 43-48, 51, 54, 67, 69, 72, and 74 as obvious over the prior art, and
invalidating claim 6 as anticipated and obvious over the prior art. 1 Ortho-McNeil timely
filed its notice of appeal on August 25, 2008. This court has jurisdiction pursuant to 28
U.S.C. § 1295(a)(1).
DISCUSSION
This court reviews a grant of summary judgment de novo. Cross Med. Prods.,
Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1302 (Fed. Cir. 2005).
Obviousness is ultimately a determination of law, though it is based on questions of fact.
Id. at 1302. Anticipation is a question of fact. Id. Because issued patents enjoy a
presumption of validity, obviousness and anticipation must be proven by clear and
convincing evidence. Impax Labs., Inc. v. Aventis Pharma., Inc., 545 F.3d 1312, 1314
(Fed. Cir. 2008). When the patent examiner has considered the asserted prior art and
basis for the validity challenge during prosecution, the burden of proving invalidity is
especially heavy. Id.; Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464,
1467 (Fed. Cir. 1990). Summary judgment is only appropriate where there are no
material questions of fact and the movant is entitled to judgment as a matter of law.
Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986); Fed. R. Civ. P. 56(c).
Inventions in most instances rely upon building blocks long since uncovered, and
combine elements that are in some sense already known. KSR Int’l Co. v. Teleflex,
1
The district court identified the asserted claims as 43-47, 51, 67, and 69,
although both parties identified the asserted claims as 43-48, 51, 54, 67, 69, 72, and 74.
We will assume that the district court intended to grant the defendants’ summary
judgment motion with respect to all of the asserted claims and not solely the ones listed
by the court in its opinion.
2008-1549, -1550 5
Inc., 550 U.S. 398, 418-19 (2007). The combination of familiar elements according to
known methods is likely to be obvious, however, when it does no more than yield
predictable results. Id. at 1739. Each case must be decided in its particular context,
including the characteristics of the science or technology, the nature of the choices
available to one skilled in the art, the specificity of the prior art, and the predictability of
results in the area of interest. Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341, 1352 (Fed.
Cir. 2008).
I. Validity of the Reissue Claims
Each of claims 43-48, 51, 54, 67, 69, 72, and 74 recites a pharmaceutical
composition with active ingredients consisting of tramadol and acetaminophen in a ratio
of about 1:5 to about 1:19. A single tablet containing only tramadol and acetaminophen
in a fixed dose ratio within the claimed range is not disclosed in the cited prior art. Flick
discloses a four-compound combination comprising tramadol, acetaminophen, and two
other active ingredients. Flick does not suggest that the pentobarbital sodium and
ethoxy benzamide are merely optional for the combination to work as desired. The
parties dispute whether Flick suggests that the composition in example 23 exhibits a
synergistic effect.
Ortho submitted uncontroverted expert testimony that one of ordinary skill in the
art would not find it obvious to try to remove two of the four active ingredients disclosed
in Flick example 23 to arrive at the claimed composition. The expert explained that drug
interactions are complicated and unpredictable. He testified that the interactions of
tramadol and acetaminophen were especially poorly understood in 1990. The expert
testified that one of skill in the art would not expect the combination of solely tramadol
2008-1549, -1550 6
and acetaminophen to have any particular advantage unless Flick or some other
reference specifically identified one. The expert testified that Flick’s broad statement
that tramadol “often” displays synergistic affects when combined with other analgesics
would not be enough give one of ordinary skill any expectations whether tramadol
combined only with acetaminophen in a 1:5 to 1:19 ratio would exhibit the synergistic
effects discovered by Ortho.
Ortho’s expert also testified that no combination of the German references and
Flick would suggest the claimed combination of tramadol and acetaminophen. The
expert explained that the German references actually teach away from the claimed
composition because they emphasize the importance of flexibility in choosing
combinations and doses of medications based on individual needs. The expert testified
that the claimed fixed-dosage combination tablet was disparaged in the German
references and disfavored in the art at the time.
Ortho’s proffered reading of Flick and the German references, as well as expert
testimony regarding the understanding of one skilled in the art, raises material questions
of fact as to whether a skilled artisan would have found the claimed combination of
tramadol and acetaminophen to be obvious. We therefore vacate the district court’s
summary judgment invalidating RE’221 claims 43-48, 51, 54, 67, 69, 72, and 74 based
on obviousness and remand the case for a trial on the merits.
II. Validity of Claim 6
Claim 6 recites a composition comprising tramadol and acetaminophen in an
about 1:5 ratio. Unlike the other reissue claims, the open transitional term “comprising”
causes claim 6 to read on compositions that include active ingredients other than
2008-1549, -1550 7
tramadol and acetaminophen. Flick’s example 23 thus differs from claim 6 only by the
disclosed ratio of tramadol to acetaminophen (1:10 versus “about 1:5”). This court
previously construed the claimed “about 1:5” ratio to read on a ratio from 1:3.6 to 1:7.1.
Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1328 (Fed. Cir.
2007).
The district court found that claim 6 was invalid for both anticipation and
obviousness. We discuss each judgment in turn.
A
With respect to anticipation, Ortho contends that each element of claim 6 is not
disclosed in Flick, and therefore is not anticipated. It is not disputed that example 23 of
Flick discloses a pharmaceutical composition containing tramadol and acetaminophen,
the first two limitations of claim 6. It is disputed whether example 6 discloses the
claimed about 1:5 ratio, as that term is construed by this court.
The defendants argued to the district court that a paragraph at the end of
example 22 teaches that tramadol can be administered in a 25 mg dose and that a
preferred dose is 50 mg. Example 23 discloses 25 mg of tramadol in a four active agent
combination. The defendants argue that these two teachings together suggest that the
25 mg dose of tramadol disclosed in example 23 can be modified to a 50 mg dose.
Ortho argued that example 22 discloses a tramadol-only formulation, and the
suggestion to administer a 50 mg dose only applies to the administration of tramadol
alone. Ortho argues that the specification does not teach increasing the dosage of
tramadol past 25 mg when combining it with other active analgesics.
2008-1549, -1550 8
The district court agreed with the defendant’s interpretation of Flick and found
that examples 22 and 23 anticipate claim 6 when read in combination. The district court
improperly resolved disputed questions of fact in reaching this conclusion. What a
reference discloses is a question of fact. Para-Ordnance Mfg., Inc. v. SGS Imps. Int’l,
Inc., 73 F.3d 1085, 1088 (Fed. Cir. 1995). The parties dispute whether and how Flick’s
teachings about varying dosages apply to example 23. The parties also dispute
whether one of skill in the art would have understood the teachings of one working
example to apply to a different working example. Whether Flick discloses all of the
limitations of claim 6 is a material question of fact over which Ortho has raised a
genuine dispute. We therefore vacate the district court’s summary judgment that claim
6 is invalid for anticipation.
B
With respect to obviousness, there is no dispute that the only difference between
claim 6 and example 23 of Flick is the weight ratio—the additional compounds in the
example are irrelevant because of the transitional phrase “comprising” in the claim.
Example 23 discloses a 1:10 ratio of tramadol to acetaminophen: 25 mg to 250 mg.
Because the difference between 1:7.1 and 1:10 is so slight, Flick creates a prima facie
case of obviousness with regard to claim 6. See Titanium Metals Corp. of Am. v.
Banner, 778 F.2d 775, 782-83 (Fed. Cir. 1985) (“The proportions are so close that prima
facie one skilled in the art would have expected them to have the same properties.”);
Haynes Int’l, Inc. v. Jessop Steel Co., 8 F.3d 1573, 1577 n.3 (Fed. Cir. 1993) (“[W]hen
the difference between the claimed invention and the prior art is the range or value of a
2008-1549, -1550 9
particular variable, then a prima facie rejection is properly established when the
difference in range or value is minor.”).
Ortho-McNeil can rebut the prima facie case if it can show that the prior art
teaches away from the claimed range, or the claimed range produces new and
unexpected results over the prior art range. See Iron Grip Barbell Co. v. USA Sports,
Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004). Before the United States Patent and
Trademark Office, the district court, and now us, Ortho-McNeil principally relies on
unexpected results in the form of synergy between tramadol and acetaminophen. As
described in RE’221, the observed analgesic effect of tramadol-acetaminophen
combinations exceeds what one would predict from merely adding the effects observed
upon administering each drug individually. See, e.g., RE’221 fig. 1. Ortho-McNeil’s
problem, however, is that its own evidence indicates no perceptible difference in
synergy between a weight ratio of 1:7.1 and 1:10—and indeed over a much broader
range of ratios. Id. Ortho-McNeil does not dispute this. Thus, Ortho-McNeil has failed
to create a material dispute of fact regarding whether “the claimed range achieves
unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575, 1578
(Fed. Cir. 1990) (emphasis added); cf. Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299,
1311-12 (Fed. Cir. 2006) (“Evidence of commercial success, or other secondary
considerations, is only significant if there is a nexus between the claimed invention and
the commercial success.”).
Ortho-McNeil also relies on the declaration of Dr. Stanski, which asserts that
2008-1549, -1550 10
Flick teaches away from a ratio of about 1:5. 2 Dr. Stanski averred that one of ordinary
skill would not have increased the amount of tramadol in Flick’s example 23 because of
concerns about the side effects of tramadol. However, Flick discloses higher doses
than the 25 mg of example 23, including “preferably” tramadol-only formulations in
doses of 50 mg and 75 mg, with no reservations about safety. See RE’221 col.12 ll.24-
31. Setting that aside, and accepting Dr. Stanski’s statement as true, it is nonetheless
insufficient to rebut the prima facie case. The question is not whether Flick teaches
away from increasing the amount of tramadol; the question is whether Flick teaches
away from lowering the ratio of tramadol to acetaminophen from 1:10 to 1:7.1. This
could be accomplished by increasing the amount of tramadol, which Dr. Stanski
disparages, but it could equally be accomplished by decreasing the amount of
acetaminophen. Dr. Stanski did not opine on that option, and therefore did not create a
material issue of fact regarding whether the prior art teaches away from the claimed
invention. We have considered Ortho’s other arguments and find them to be without
merit.
For these reasons, we agree with the district court that Ortho has failed to raise a
genuine dispute of material fact regarding the obviousness of claim 6.
CONCLUSION
We vacate the district court’s summary judgment order invalidating RE’221
claims 43-48, 51, 54, 67, 69, 72, and 74 based on obvious. We remand the case to the
2
We confine our analysis to Dr. Stanski’s August 25, 2005 declaration, as
the supplemental expert testimony (submitted by Ortho when it was arguing the validity
of the reissue claims) was not before the district court when determined that no material
factual dispute existed regarding the obviousness of claim 6.
2008-1549, -1550 11
district court for proceedings consistent with this opinion. We vacate the district court’s
summary judgment invalidating RE’221 claim 6 based on anticipation. We affirm the
district court’s summary judgment invalidating claim 6 based on obviousness.
COSTS
Each party shall bear its own costs.
2008-1549, -1550 12
NOTE: This disposition is nonprecedential.
United States Court of Appeals for the Federal Circuit
2008-1549,-1550
ORTHO-MCNEIL PHARMACEUTICAL, INC.,
Plaintiff-Appellant,
v.
TEVA PHARMACEUTICALS INDUSTRIES, LTD.,
TEVA PHARMACEUTICALS USA, INC., and WATSON LABORATORIES, INC.,
Defendants-Appellees,
and
KALI LABORATORIES, INC., PAR PHARMACEUTICAL COMPANIES, INC.,
and PAR PHARMACEUTICAL, INC.,
Defendants,
CARACO PHARMACEUTICAL LABORATORIES, LTD.,
Defendant-Appellee.
Appeals from the United States District Court for the District of New Jersey in case nos.
04-CV-886 and 06-CV-3533, Judge Dennis M. Cavanaugh.
MAYER, Circuit Judge, dissenting.
The claimed invention does nothing more than combine two well-known pain
relievers—acetaminophen and tramadol—in a single tablet. Since the prior art clearly
and unequivocally taught that these two analgesics could be combined for effective pain
relief, the claimed invention is the epitome of obviousness. I therefore respectfully
dissent.
Ortho-McNeil Pharmaceutical, Inc. (“Ortho”) did not invent acetaminophen and it
did not invent tramadol. Long before the critical date for U.S. Patent No. RE39,221 (the
“RE221 patent”), acetaminophen had been combined with other pain relievers, including
opioid pain medications such as tramadol. Such compositions include Tylenol® with
Codeine, Tylox® (acetaminophen with oxycodone), and Vicodin® (acetaminophen with
hydrocone bitartrate). Prior to the effective date of the RE221 patent, it was widely
recognized that the combination of a peripherally-acting non-opioid analgesic, such as
acetaminophen, and a centrally-acting opioid analgesic, such as tramadol, was an
effective way to treat pain that did not respond to the use of non-opioid pain relievers
alone.
In fact, a patent issued in 1972 specifically discloses the use of tramadol in
combination drugs including phenacetin—which metabolizes into acetaminophen in the
human body—to achieve synergistic effects. U.S. Patent No. 3,652,589 (the “Flick
patent”) teaches that acetaminophen can be combined with other analgesics including
phenacetin, and instructs that such combinations are “proven to be of considerable
therapeutic value.” Example 23 of the Flick patent discloses a combination of
phenacetin and acetaminophen in a ratio that falls squarely within that claimed in the
RE221 patent. The only alleged difference between the tablet disclosed in the asserted
claims of the RE221 patent and the tablet disclosed in example 23 is that the latter also
contains two additional ingredients, pentobarbital sodium and ethoxy benzamide. Given
that ethoxy benzamide was a known carcinogen and pentobarbital sodium was known
to have antagonistic interactions with analgesics, it would have been obvious to remove
these two drugs from Flick’s formulation.
2008-1549,-1550 2
Indeed, Flick teaches that its four-agent tablet was merely an example of a
possible combination tablet, stating that example 23 “illustrates the composition” of a
combination tablet “without, however, limiting the same thereto.” Flick also teaches that
ingredients can be varied as desired. The patent states: “Of course, by variation and
calculation of the ingredients tablets and other compositions are prepared containing
lower or higher amounts of the essential active agents as desired.” Nowhere does Flick
state that pentobarbital sodium and ethoxy benzamide are required components in a
tramadol/acetaminophen tablet. “If a person of ordinary skill can implement a
predictable variation [of the prior art], § 103 likely bars its patentability.” KSR Int'l Co. v.
Teleflex Inc., 550 U.S. 398, 417 (2007). Here, the removal of pentobarbital sodium and
ethoxy benzamide was a predictable and simple variation on the Flick formulation. See
id. at 421 (“A person of ordinary skill is . . . a person of ordinary creativity, not an
automaton.”); Bayer Schering Pharma AG v. Barr Labs., Inc., No. 2008-1282, 2009 U.S.
App. LEXIS 17372 (Fed. Cir. Aug. 5, 2009) (affirming an obviousness determination
where the patentee was confronted with a limited number of options for modifying a
prior art pharmaceutical composition).
In addition to the Flick patent, several other prior art references (the “German
references”) explicitly teach that tramadol can be combined with acetaminophen to
provide effective pain relief. Most of these references discuss combining tramadol and
acetaminophen without any additional ingredients. Although the German references
involve the administration of two separate tablets and adhere to an individualized, rather
than fixed, dosing regimen, these differences are insufficient to preclude a finding of
obviousness. When the German references are read in light of the combination fixed-
2008-1549,-1550 3
dose tablet disclosed in Flick, they clearly suggest combining tramadol and
acetaminophen in a single fixed-dose tablet. Indeed, one of the German references
laments the lack of available fixed-dose combination tablets, bemoaning the fact that
“there are few fixed combinations of analgesics on the market.”
Combining acetaminophen with tramadol was such an expected and logical step
that one of Ortho’s own research fellows, Fred Minn, M.D., Ph.D., testified that
acetaminophen was the “obvious” drug to combine with tramadol and that he could not
“think of anybody who didn’t think of it.” Minn further explained that it was a “natural
phenomenon” for Ortho to combine tramadol with acetaminophen since Ortho had a
long history “of combining [acetaminophen] with everything in the world.”
The situation presented here parallels that presented in Richardson-Vicks Inc. v.
Upjohn Co., 122 F.3d 1476, 1480 (Fed. Cir. 1997). There we held that it would have
been obvious to combine two drugs, the analgesic ibuprofen and the decongestant
pseudoephedrine, in a single tablet since the drugs had been co-administered in the
past. There, as here, it was manifestly obvious to combine two well-known drugs—
which had previously been administered together—in a single tablet. See In re
Diamond, 360 F.2d 214, 217-18 (C.C.P.A. 1966) (concluding that a combination of two
therapeutic agents for inflammatory disease was obvious).
As the district court correctly concluded, the testimony of Ortho’s expert, Donald
Stanski, M.D., was insufficient to raise genuine issues of material fact on the
obviousness question. Conclusory and unsupported expert testimony cannot serve as
a bar to summary judgment. Although Stanski asserted that the prior art taught away
from combining tramadol and acetaminophen in a fixed-dose composition, his testimony
2008-1549,-1550 4
is directly contradicted by the explicit teaching of Flick, which provides for a fixed dose
tramadol/acetaminophen combination. Likewise, although Stanski argued that the
alleged synergy of the claimed combination tablet was unexpected, Flick plainly states
that “frequently a synergistic effect is observed” when combining tramadol with other
analgesics such as phenacetin. Expert opinions must be given short shrift when they fly
in the face of explicit disclosures in the prior art. See PharmaStem Therapeutics, Inc. v.
ViaCell, Inc., 491 F.3d 1342, 1361-62 (Fed. Cir. 2007) (refusing to credit an expert’s
testimony where it could not be “reconciled with statements made by the inventors in
the joint specification and with . . . prior art references”); Ashland Oil, Inc. v. Delta
Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (“Lack of factual support
for expert opinion going to factual determinations, however, may render the testimony of
little probative value in a validity determination.”).
Indeed, when read as a whole, Stanski’s testimony actually supports an
obviousness determination. Ortho argues that one of ordinary skill in the art would not
be motivated to remove the ingredients pentobarbital sodium and ethoxy benzamide
that were listed along with tramadol and acetaminophen in example 23 of the Flick
patent. Stanski, however, noted that “it is well established that barbiturates in low doses
exhibit an antagonistic interaction with analgesics,” and that by 1991, the priority date
for the RE221 patent, a person of ordinary skill in the art would have appreciated that
ethoxy benzamide had “carcinogenic properties.” Stanski’s testimony, therefore,
supports the conclusion that a skilled artisan would have been motivated to remove
pentobarbital sodium and ethoxy benzamide from Flick’s tramadol/acetaminophen
tablet.
2008-1549,-1550 5
Simply put, there is nothing even arguably new about what Ortho claims to have
invented. I would affirm.
2008-1549,-1550 6