Tyco Healthcare Group Lp and Mallinckrodt, Inc. v. Mutual Pharmaceutical Company, Inc. and United Research Laboratories, Inc.

United States Court of Appeals
for the Federal Circuit
__________________________
TYCO HEALTHCARE GROUP LP
AND MALLINCKRODT, INC.,
Plaintiffs-Appellants,
v.
MUTUAL PHARMACEUTICAL COMPANY, INC.
AND UNITED RESEARCH LABORATORIES, INC.,
Defendants-Appellees.
__________________________
2010-1513
__________________________
Appeal from the United States District Court for the
District of New Jersey in Case No. 07-CV-1299, Judge
Stanley R. Chesler.
___________________________
Decided: June 22, 2011
___________________________
H ENRY J. RENK , Fitzpatrick, Cella, Harper & Scinto,
of New York, New York, argued for the plaintiffs-
appellants.
JEREMY C. LOWE, Axinn, Veltrop & Harkrider LLP, of
Hartford, Connecticut, argued for defendants-appellees.
With him on the brief were JAMES D. VELTROP and

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TYCO HEALTHCARE v. MUTUAL PHARMA 2
FRANCIS H. M ORRISON , III,. Of counsel were THOMAS K.
H EDEMANN and JASON T. M URATA.
__________________________
Before NEWMAN , BRYSON , and GAJARSA, Circuit Judges.
BRYSON , Circuit Judge.
Tyco Healthcare Group LP and Mallinckrodt, Inc. (col-
lectively, “Tyco”) appeal from a summary judgment in-
validating the two claims of U.S. Patent No. 5,211,954
(“the ’954 patent”) for obviousness. We affirm.
I
Temazepam is a hypnotic (sleep-inducing) drug that is
one of a class of compounds known as benzodiazepines.
Pharmacological formulations of temazepam have been
marketed internationally for the treatment of insomnia
since the 1970s, and in the United States since 1981
under the name Restoril®. Tyco holds the rights to the
’954 patent, which has two claims for temazepam formu-
lations. Claim 1 reads:
A hard gelatin capsule containing a temazepam
formulation consisting essentially of 6 to 8 milli-
grams of crystalline temazepam having a surface
area of from 0.65 to 1.1 m 2 /g and 95% of the te-
mazepam having a particle size of less than 65
microns in admixture with a pharmaceutically ac-
ceptable carrier therefor.
Claim 2 is identical except that it recites a composition
containing 7.5 milligrams of crystalline temazepam. The
’954 patent issued in May 1993 with a priority date of
September 1986. Tyco’s predecessor-in-interest began
marketing Restoril® in 7.5 mg dosages in 1991.

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TYCO HEALTHCARE v. MUTUAL PHARMA 3
In November 2006, Mutual Pharmaceutical Company,
Inc., filed an Abbreviated New Drug Application
(“ANDA”) with the U.S. Food and Drug Administration
(“FDA”) seeking approval to manufacture and sell a
generic version of 7.5 mg temazepam capsules. Tyco
responded in March 2007 by filing an infringement action
against Mutual and United Research Laboratories, Inc.
(collectively, “Mutual”). In July 2009, after Mutual had
received tentative FDA approval of its ANDA, Tyco moved
for a preliminarily injunction to prevent Mutual from
selling its generic temazepam capsule. The district court
denied Tyco’s motion based on uncontroverted evidence
that Mutual’s ANDA disclosed a product that could not
literally infringe the ’954 patent because the ANDA
required the surface area of the crystalline temazepam to
be at least 2.2 square meters per gram. See Bayer AG v.
Elan Pharm. Research Corp., 212 F.3d 1241, 1249 (Fed.
Cir. 2000).
Mutual then moved for summary judgment of non-
infringement and invalidity. The district court granted
Mutual’s motion with respect to invalidity, concluding
that Mutual had shown by clear and convincing evidence
that the ’954 claims were obvious and that no reasonable
trier of fact could find to the contrary. In reaching that
conclusion, the court noted, first, that Restoril® capsules
had been sold in the United States in 15 mg and 30 mg
dosages more than a year before the priority date of the
’954 patent. Second, the court looked to a 1983 volume of
the British National Formulary (“BNF”), a medical refer-
ence book published in the United Kingdom, which di-
rected physicians to the use of temazepam at a dosage
between 5 and 15 mg for the treatment of insomnia in the
elderly. Third, the court observed that the parties did not
dispute that “physicians always seek to prescribe the
lowest effective dose of any medication, particularly

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TYCO HEALTHCARE v. MUTUAL PHARMA 4
hypnotics such as temazepam.” Based on those undis-
puted facts, the court concluded that it would have been
obvious to a person of ordinary skill in the art to combine
the preexisting 15 mg Restoril® capsule with the dosage
range identified in the BNF reference. Tyco appeals the
district court’s order invalidating the ’954 claims.
II
The only physical feature distinguishing the ’954
claims from the Restoril® 15 mg capsules is the amount of
temazepam contained in the capsule. In 1987, Tyco’s
predecessor-in-interest filed a Supplemental New Drug
Application with the FDA for manufacture and sale of 7.5
mg temazepam capsules within the scope of both ’954
claims. The application stated that:
[t]he formulation and manufacture of Restoril®
Capsules, 7.5 mg are similar to that used for the
15 and 30 milligram capsules . . . . The formula-
tion differs only in the reduction of the dose. . . .
The capsule manufacturing method is exactly the
same as has been described for the currently mar-
keted doses.
Given that uncontested description, the only limitation of
the two ’954 claims that was not fully disclosed by the
prior art Restoril® capsules is the lower dosage of te-
mazepam.
The BNF is a medical reference book published semi-
annually by the British Medical Association and the
Pharmaceutical Society of Great Britain. The Preface to
the BNF explains that it serves as “a pocket book for
rapid reference . . . for prescribing and dispensing” drugs,
and that its entries “are intended to help in the choice of

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TYCO HEALTHCARE v. MUTUAL PHARMA 5
appropriate treatment of each patient.” The 1983 BNF
entry for “temazepam” reads as follows:
Indications: insomnia (useful in the elderly)
Cautions; Side-effects: see under Nitrazepam,1
but except at high dosage hangover is uncom-
mon and doses less cumulative. Less appropriate
in patients with early wakening
Dose: 10-30 mg (elderly patients 5-15 mg), in-
creasing in severe insomnia to 60 mg, 30 min-
utes before bedtime
BNF at 127 (emphasis added). The district court con-
cluded that “[t]his entry plainly tells one of skill in the art
to treat insomnia in the elderly by administering a dose in
the range of 5 to 15 mg.”2 The court noted that a physi-
1 The BNF entry for “nitrazepam” reads, in relevant
part:
Cautions: hangover may affect a patient’s ability
to drive or operate machinery and increase the
effects of alcohol; avoid prolonged use and
abrupt withdrawal thereafter. Caution in neu-
romuscular disease, respiratory disease, preg-
nancy, breast-feeding, patients with a history of
drug abuse; reduce dosage in elderly and debili-
tated patients . . . .
Side-effects: hangover with drowsiness, dizzi-
ness, ataxia (particularly in the elderly); occa-
sionally confusion, dry mouth, hypersensitivity
reactions. Prolonged use may give rise to cumu-
lation, tolerance, rebound insomnia, and de-
pendence.
BNF at 127 (emphases added).
2 The district court’s interpretation of the BNF ref-
erence is consistent with evidence in the record of a
statement made in 1984 by an FDA representative to a
group that included the named inventor of the ’954 pat-

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TYCO HEALTHCARE v. MUTUAL PHARMA 6
cian would be motivated to prescribe a temazepam dosage
lower than 15 mg because of the preference for the lowest
effective dose, particularly in the case of elderly patients
sensitive to the side effects of hypnotic medications.
Ordinarily, “where there is a range disclosed in the
prior art, and the claimed invention falls within that
range, there is a presumption of obviousness.” Iron Grip
Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed.
Cir. 2004); accord Lazare Kaplan Int’l, Inc. v. Photoscribe
Techs., Inc., 628 F.3d 1359, 1380-81 (Fed. Cir. 2010).
That presumption is rebuttable either by a showing that
the prior art taught away from the invention or by a
showing of new and unexpected results relative to the
prior art. Iron Grip Barbell, 392 F.3d at 1322. Tyco
argues first that the BNF reference does not direct a
person of ordinary skill in the art to temazepam hard
capsules in the 5 to 15 mg dosage range. It then argues
that the prior art as a whole taught away from a range of
6 to 8 mg. Finally, Tyco contends that secondary consid-
erations of new and unexpected results and commercial
success support a finding of non-obviousness.
A
Tyco contests the district court’s interpretation of the
BNF reference. It relies on the declaration of its expert,
Dr. William Orr, who stated that “[a] person of ordinary
skill in the art would not interpret [the BNF] reference as
ent. According to notes of a meeting to discuss a “pro-
posed course of action to further characterize the profile of
[Restoril],” Dr. Hillary Lee of the FDA stated that “the
doses proposed in [the] studies may be too high, citing
that in Great Britain, temazepam doses from 5-15 mg are
recommended for geriatrics and doses from 15-30 mg for
adults.”

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TYCO HEALTHCARE v. MUTUAL PHARMA 7
recommending any particular dose.” The district court,
however, concluded that Dr. Orr had not offered a factual
basis for his conclusion or explained his rationale and
therefore discredited his characterization of the BNF.
In support of his interpretation of the BNF reference,
Dr. Orr stated that the BNF reference “nowhere states
that a temazepam dose of 5 mg, 6 to 8 mg, or 7.5 mg, is
effective in treating insomnia,” nor does it “state that 7.5
mg was effective.” He added that the BNF reference
provides “[n]o clinical or statistical evidence . . . demon-
strating that a dose within a range of 5-15 mg would
work” in treating insomnia.
Those statements by Dr. Orr correctly describe the
contents of the BNF reference, but they do not undermine
the district court’s conclusions as to obviousness. The
’954 claims do not discuss the intended use of the capsules
in a particular treatment regimen. The manufacture of a
7.5 mg temazepam capsule with the disclosed claim
limitations would infringe both claims of the ’954 patent,
irrespective of the efficacy of the product. Dr. Orr’s
statements did not contest the fact that the BNF refers to
dosages of temazepam between 5 and 15 mg.3 His state-
3 At oral argument, Tyco’s counsel argued that Dr.
Orr’s declaration should be interpreted to mean that the
reference to “5-15 mg” did not disclose all dosages be-
tween 5 and 15 mg. Counsel argued that the BNF refer-
ence, “while it has 5 dash 15, a person of ordinary skill in
the art would know that it cannot refer to 7.5 specifically.
It refers to 5 arguably, perhaps a 10, perhaps a 15 . . . .”
That argument is silly. Not only is it contrary to the
ordinary understanding that a dash joining two numbers
signifies the end points of an inclusive range, but it also is
at odds with Dr. Orr’s own reference to “5-15 mg” as
constituting a “range.”

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TYCO HEALTHCARE v. MUTUAL PHARMA 8
ments are directed to the utility of temazepam as a
treatment for insomnia.
Tyco argues that all the properties of a composition of
matter relevant to patentability must be considered in
evaluating whether that composition would have been
obvious in light of the prior art, and that the unclaimed
property of effectiveness in treating insomnia renders the
claims at issue nonobvious. That argument is unavailing.
“The discovery of a new property or use of a previously
known composition, even when that property and use are
unobvious from the prior art, can not impart patentability
to the known composition.” In re Spada, 911 F.2d 705,
708 (Fed. Cir. 1990) (noting that “a new use of a known
composition . . . may be patentable as a process”). The
recommendation in the BNF of a range of temazepam
dosages that include the dosages claimed in the ’954
patent renders obvious the claims to those dosages even
in the absence of documentation in the BNF of the effec-
tiveness of such dosages.
Dr. Orr noted that the BNF reference listed several
brands of commercially available temazepam formula-
tions, which had dosages of 10 mg and 20 mg, but not 5
mg. That observation, however, does not call into doubt
what the BNF reference disclosed. Tyco does not dispute
that, at the time the BNF was published, 5 mg temaze-
pam hard capsules had been sold abroad for more than a
decade under the name Levanxol®. In addition, the
record contains two prior art publications discussing
experimentation with 5 mg capsules: a 1970 Italian study
(“Senini”) and a 1974 Indian study (“Sardesai”).
Finally, Dr. Orr stated that one of skill in the art,
reading the Preface to the BNF reference, “would under-
stand that one must look to other, ‘specialised publica-

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TYCO HEALTHCARE v. MUTUAL PHARMA 9
tions’—i.e., scientific publications relating to the effec-
tiveness of temazepam doses—in order to determine
whether any particular dose is effective.” Again, Dr. Orr’s
position does not undermine the BNF as a supporting
reference. First, as already discussed, the ’954 claims are
not tied to product efficacy, so the absence of any particu-
larized discussion of efficacy in the BNF reference is
immaterial to obviousness of the composition here
claimed in light of the prior art showing general efficacy
for the same use. Second, none of the specialized publica-
tions cited by Dr. Orr and Tyco undermine the teaching of
the BNF reference that a person of ordinary skill in the
art could consider temazepam dosages between 5 mg and
15 mg to treat insomnia.
B
Two of the specialized publications cited by Tyco are
articles from the 1970s by the same authors (“Nicholson
1976” and “Nicholson 1979”). The first reference, Nichol-
son 1976, described a sleep study conducted with six
males between the ages of 19 and 43. The experimenters
administered 10 mg and 20 mg doses of temazepam to the
subjects. The experiment disclosed that 10 mg temaze-
pam doses produced a “marked reduction in sleep onset
latency”—i.e., the time it takes a person to fall asleep—
but resulted in “little or no increase in total sleep time.”
Tyco argues that Nicholson 1976 taught that 10 mg
capsules were “ineffective because they do not affect the
‘key’ requirement of total sleep time.” According to Tyco,
“effectiveness as a sleeping pill requires both that sleep
latency is decreased and total sleep time is increased.”
Tyco cites the ’954 patent, Dr. Orr’s declaration, and a
1983 publication (“Matejcek”) in support of that proposi-
tion. The ’954 patent discusses experimental findings

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TYCO HEALTHCARE v. MUTUAL PHARMA 10
that 7.5 mg temazepam capsules reduced sleep onset
latency and increased total sleep time. ’954 patent, col. 2,
ll. 32-34. Dr. Orr declared that “[t]he only means to
conclusively verify a hypnotic agent’s effect on sleep
patterns is to conduct studies specifically designed to
record additional polysomnographic parameters such as
total sleep time and sleep latency” because only such
studies “give reliable indications of whether any particu-
lar treatment is effective.” Matejcek, discussed further
below, stated that “effects on the sequence, duration, and
relative depth of individual sleep stages . . . have been
used to estimate latency to sleep onset and the relative
potency and duration of drug activity.” Although each of
those sources refers to both sleep onset latency and total
sleep time, none states that a sleeping pill must achieve
improvement on both parameters in order to be consid-
ered effective. Therefore, the evidence in the record does
not support Tyco’s contention that Nicholson 1976 taught
away from 10 mg temazepam doses.
Tyco also points out that Nicholson 1976 taught that
20 mg temazepam capsules are effective for treatment of
insomnia. The study found a statistically significant
increase in total sleep time and decrease in sleep onset
latency following administration of 20 mg temazepam
capsules. However, that result is not pertinent to the
issue in this case because it does not teach away from the
efficacy of 7.5 mg capsules.
The second reference, Nicholson 1979, described a
sleep study conducted with six middle-aged males be-
tween the ages of 45 and 55. The experimenters adminis-
tered 10, 20, and 30 mg doses of temazepam. The
experimental results revealed no statistically significant
change in total sleep time or sleep onset latency after
administration of any of those dosages of temazepam. All

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TYCO HEALTHCARE v. MUTUAL PHARMA 11
three dosages, however, resulted in statistically signifi-
cant reductions in the duration of awakenings during the
night.
Tyco contends that “the temazepam soft capsules pro-
duced in the older group a ‘marked reduction’ in total
sleep time and an ‘increase’ in latency to certain sleep
stages, exactly the opposite of what one wants in a sleep
aid.” The portion of Nicholson 1979 from which those
quotations were drawn, however, discusses a comparison
of general sleep patterns between young adults (ages 20
to 29) and middle-aged adults, using a placebo treatment
for both groups. Apart from that mischaracterization of
the Nicholson 1979 reference, the only point that Tyco
makes about that study is that no dosage of temazepam—
10, 20, or 30 mg—yielded a statistically significant im-
provement in total sleep time or sleep onset latency.
Tyco also relies on Matejcek, which described a day-
time experiment administering various dosages of te-
mazepam to 12 males between the ages of 20 and 30.
That study, like those disclosed in the Sendai and Sard-
esai references, included the use of 5 mg capsules of
temazepam. Tyco seizes on a remark in the “Results”
section of the article in which the authors stated that
“temazepam 5-mg values were excluded from the test
procedure [measuring a particular type of brain wave
activity], since this dose is known to be of no clinical
importance as a hypnotic.” Contrary to that statement,
Matejcek did include 5 mg temazepam capsules in its test
procedure and displayed results for those capsules in two
tables in the article. Those tables revealed a statistically
insignificant decrease in “alpha-activity” for 5 mg dosages
of temazepam and statistically significant decreases for
15 mg and 30 mg dosages.

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TYCO HEALTHCARE v. MUTUAL PHARMA 12
Tyco argues that “Matejcek would have directly dis-
couraged [a person of ordinary skill in the art] from the
idea that hard capsules with 7.5 mg of temazepam would
be effective to treat insomnia.” That argument is predi-
cated on the position taken by Tyco in this court that the
effectiveness of particular doses of temazepam depends on
whether the capsule is hard or soft. According to Tyco,
each milligram of temazepam delivered in soft capsule
form is equivalent to 1.5 mg delivered in hard capsule
form. Therefore, Tyco asserts, the fact that the 5 mg
temazepam capsule had statistically insignificant effects
on certain brain wave activity would have cast doubt on
the efficacy of the claimed 7.5 mg capsules.
There are two problems with Tyco’s argument. First,
the Matejcek study did not identify whether hard or soft
capsules were used in its experiment. The prosecuting
attorney for the ’954 patent represented to the PTO that
Matejcek “clearly state[s]” that the capsules used were
soft capsules, but there is no support for that statement in
the record. After Mutual pointed out the lack of evidence
on that point in its brief, Tyco refrained from characteriz-
ing the Matejcek capsule as a soft capsule in its reply
brief.
Second, the only prior art reference in the record be-
fore this court that could conceivably have given rise to
Tyco’s alleged 1:1.5 efficacy ratio is a published article
from 1977 (“Fuccella 1977”). That reference disclosed an
experiment on six males between the ages of 21 and 33
using both soft and hard capsules of temazepam, and the
last paragraph of the article states:
It is interesting that in a study of its effect on
sleep, temazepam 20 mg in Scherer capsules was
significantly better than 30 mg of the same sub-

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TYCO HEALTHCARE v. MUTUAL PHARMA 13
stance in hard conventional capsules according to
a subjective evaluation of quality of sleep, awak-
ening from sleep and impairment of behaviour
[reference]. The results of these studies are in
keeping with bioavailability from soft gelatin cap-
sules and the pharmacokinetic profile of temaze-
pam.
Essentially, Tyco’s argument is based on a passing men-
tion in an article of a subjective sleep evaluation study
described in another article in which 20 mg soft capsules
performed better than 30 mg hard capsules. However,
Tyco did not refer to either of those articles as relevant
prior art in its opening brief. Moreover, according to
Tyco’s own argument that measurement of several objec-
tive sleep parameters (e.g., sleep onset latency and total
sleep time) is required to evaluate the efficacy of a sleep-
ing pill, the subjective sleep evaluation study that could
ultimately have led to Tyco’s 1:1.5 ratio would not have
been able to measure sleeping pill efficacy with accuracy.
Nor did the Matejcek study measure those parameters.
In sum, Tyco’s argument that the Matejcek reference
teaches away from use of a 7.5 mg hard capsule of te-
mazepam to treat insomnia is not supported by evidence
in the record.
Furthermore, none of the relevant references cited by
Tyco4—Nicholson 1977, Nicholson 1979, and Matejcek—
4 Tyco argues that “as late as 1989 the FDA rec-
ommended a ‘usual’ hard capsule adult dose of 30 mg . . .
[and] counseled that a hard capsule dose of 15 mg ‘may be
sufficient in some patients.’” In support, it cites to a page
of the 1989 edition of the Physicians’ Desk Reference, a
medical reference book published commercially. The
passages quoted by Tyco do not suggest that dosages less
than 15 mg would be insufficient in all patients. In fact,

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TYCO HEALTHCARE v. MUTUAL PHARMA 14
studied the effects of temazepam on elderly patients. The
BNF reference specifically directed readers to a lower
dosage of temazepam for the elderly, given the increased
risk of side effects such as ataxia. Even if the references
cited by Tyco could be viewed as teaching away from the
use of 7.5 mg temazepam capsules generally, it would not
cast doubt on the BNF reference’s dosage range for eld-
erly patients. To the contrary, Nicholson 1979 cited other
studies “suggest[ing] that hypnotics may have an en-
hanced effect in old age,” including “increased sensitivity”
and an increased “effect on performance.” If anything,
such statements, viewed in light of the undisputed prefer-
ence of physicians for prescribing the lowest effective
dosage of temazepam, point toward the use of lower-
dosage capsules.
C
Tyco argues that secondary considerations support a
finding of non-obviousness of the ’954 claims. It contends
that the experimental results described in the ’954 patent
were unexpected. In support, Tyco cites the patent speci-
fication’s description of the inventor’s experimental re-
sults as “unexpected.” ’954 patent, col.2, ll.34-36.
Unsupported statements in the specification, however,
cannot support a finding of unexpected results. In re De
Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984).
Tyco also contends that “experts expressed skepticism
about . . . possible effectiveness at the time the invention
was made.” It first cites a memorandum prepared by the
original assignee of the ’954 patent memorializing a 1984
the reference notes that “the risk of development of
oversedation, dizziness, confusion and/or ataxia increases,
substantially with larger doses of benzodiazepines in
elderly and debilitated patients . . . .”

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TYCO HEALTHCARE v. MUTUAL PHARMA 15
meeting. That document relates the opinion of a “sleep
expert consultant” that transient insomniacs might
require a higher dosage of temazepam for treatment than
chronic insomniacs. Since the products disclosed by the
claims at issue are not limited to treatment for transient
insomnia, that statement is of little relevance to the
question whether 7.5 mg capsules were unexpectedly
effective. In any event, the district court did not find
evidence in the memorandum casting doubt on the effi-
cacy of 7.5 mg capsules.
Tyco next points to a 1985 letter sent by an FDA ex-
pert to the company employing the named inventor ask-
ing the company to “provide the rationale for the choice of
the 7.5 mg dosage” in its experiment. The motivation for
that request was not disclosed in the letter. That letter
provides no indication that the FDA expert would have
been surprised at the results disclosed in the ’954 patent.
Tyco also cites Dr. Orr’s declaration that, in light of
the prior art already discussed, the results of the inven-
tor’s experiment would have been surprising at the time.
That statement is entitled to little weight in light of the
lack of support in the record for Dr. Orr’s interpretation of
the prior art. Tyco does not supply further evidence of
unexpected results other than citations to the prior art
previously discussed. On the evidence and argument in
the summary judgment record, Tyco has not overcome
Mutual’s clear and convincing showing of obviousness.
Finally, Tyco argues that the commercial success of
Restoril® 7.5 mg capsules supports a finding of non-
obviousness. It notes that over the past decade, annual
sales of the capsules have averaged more than $30 mil-
lion. The district court acknowledged the product’s com-
mercial success but properly found that the evidence as a
whole did not overcome Mutual’s strong prima facie case

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TYCO HEALTHCARE v. MUTUAL PHARMA 16
of obviousness. See Ryko Mfg. Co. v. Nu-Star, Inc., 950
F.2d 714, 719 (Fed. Cir. 1991); see also KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 413 (2007) (upholding district
court’s summary judgment of invalidity for obviousness
despite evidence of commercial success); Anderson’s-Black
Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 61
(1969). We therefore uphold the summary judgment
determination of the district court that the two claims of
the ’954 patent are invalid for obviousness. In light of our
decision, Mutual’s motion to strike portions of Tyco’s reply
brief is denied as moot.
AFFIRMED

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