Case Information
*2 Before L OURIE , L INN , and D YK , Circuit Judges . L OURIE , Circuit Judge .
Watson Laboratories, Inc. (“Watson”) appeals from
the decision of the United States District Court for the
District of Nevada, holding on summary judgment that
the asserted claims of U.S. Patent 7,320,969 (“the ’969
patent”) were not invalid for obviousness.
Duramed
Pharms., Inc. v. Watson Labs., Inc.
,
B ACKGROUND
Duramed Pharmаceuticals, Inc. (“Duramed”) owns the ’969 patent, which covers an extended-cycle combined oral contraceptive (“COC”) regimen commercialized by Duramed as Seasonique ® . Unlike traditional 28-day COC regimens, in which estrogen- and progestin-containing pills are administered for 21 days and hormone-free pills for 7 days, extended-cycle regimens increase the men- strual cycle’s natural length by administering hormone- containing pills for greater than 21 days. Extended-cycle regimens thus postpone estrogen-withdrawal symptoms experienced by many women during the hormone-free period. The incidence of estrogen-withdrawal symptoms can also be reduced by administering low dosages of estrogen during the traditional hormone-free period. Duramed’s Seasonique ® combines an extended-cycle COC regimen with the administration of low-dose, unopposed estrogen during the hormone-free period. Specifically, the regimen consists of 84 daily pills containing 30 μ g of the estrogen ethinyl estradiol and 150 μ g of the progestin levonorgestrel, followed by 7 daily pills containing 10 μ g of ethinyl estradiol only.
On March 6, 2008, Duramed brought suit against Watson under 35 U.S.C. § 271(e)(2) after Watson filed an Abbreviated New Drug Application (“ANDA”) seeking Food and Drug Administration (“FDA”) approval for a generic version of Seasonique ® . Duramed alleged in- fringement of claims 1-9, 15, and 17-19 of the ’969 patent. Claim 19 is representative:
19. A method of contraception in a female in need thereof the method comprising administering to the female a dosаge comprising a combination of estrogen and progestin for a period of 84 consecu- tive days, followed by administration of a dosage consisting essentially of estrogen for a period of 7 consecutive days,
wherein the estrogen that is administered in combination with progestin for the period of 84 consecutive days is orally administered monophasicly in a daily amount of about 30 μ g of ethinyl estra- diol,
the estrogen that is administered for the period of 7 consecutive days is orally administered monophasicly in a daily amount of about 10 μ g of ethinyl estra- diol, and
the progestin that is administered in com- bination with estrogen for the period of 84 consecutive days is orally admin- istered monophasicly in a daily amount of about 150 μ g of levonorgestrel.
’969 patent claim 19. The ’969 patent issued on January 22, 2008, and claims priority back to an application filed on December 5, 2001.
Watson stipulated to infringement but challenged the ’969 patent’s validity under 35 U.S.C. § 103. In making its obviousness challenge, Watson relied on, inter alia , (1) a 1994 Kovacs article, which describes an extended-cycle COC regimen of 84 daily pills containing 30 μ g ethinyl estradiol and 150 μ g levonorgestrel, followed by 7 daily hormone-free pills; (2) U.S. Patent 6,027,749 (“the ’749 patent”), which discloses COC regimens of up to 77 daily pills containing 15-20 μ g ethinyl estradiol and 50-125 μ g levonorgestrel, followed by 7 daily pills containing 10-15 μ g ethinyl estradiol to reduce the incidence of premen- strual headaches; and (3) two Sulak articles from 1997 and 2000, which describe the problem of headaches re- sulting from еstrogen withdrawal as well as the use of low-dose, estrogen-only pills during the hormone-free period as a way to alleviate such headaches.
Watson’s expert witness, Dr. Michael A. Thomas,
opined on the teachings of these prior art references. He
also opined that one of skill in the art would have been
motivated to combine the Kovacs COC regimen with the 7
days of unopposed estrogen as claimed in the ’969 patent
because the Kovacs article recognized that the regimen
may result in headaches in some women. J.A. 824-25. In
addition, Dr. Thomas testified that he had personally
prescribed the contraceptive regimen claimed in the ’969
patent prior to the patent’s priority date, December 5,
2001. The district court granted Duramed’s motion to
exclude Thomas’s testimony regarding this prior use as
uncorroborated.
Duramed
,
The district court also granted summary judgment of nonobviousness. The court analyzed Watson’s “three most significant” prior art references, the Kovаcs article, the Sulak article, [1] and the ’749 patent, finding the remaining art “cumulative.” Id. at 1168 n.3. Regarding the Kovacs article, the court found that it did not provide support for combining 84 daily hormone pills with 7 days of unop- posed estrogen to alleviate estrogen-withdrawal symp- toms because it describes headaches throughout the menstrual cycle and fails to make any mention of using unopposed estrogen. Id. at 1168-69. Regarding the Sulak articles, the court found that, although they identify headaches as a symptom of hormone withdrawal, they mention the addition of unopposed estrogen only as a theoretical, untested solution. Id. at 1169-70. Regarding the ’749 patent, the court found that by disclosing a variety of COC regimens, the patent did not establish consistent knowledge in the community, and that it provided no basis for adding estrogen-only pills to the end of a COC regimen to alleviate withdrawal headaches. Id. at 1170. Finally, the court found that Watson’s expert, Thomas, was not a person of ordinary skill in the art, but rather an aсtive participant in research in the field of endocrinology. Id.
Watson appealed. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).
D ISCUSSION
This court reviews a district court’s decision on sum-
mary judgment
de novo
, reapplying the same standard
applied by the district court.
Iovate Health Scis., Inc. v.
Bio-Engineered Supplements & Nutrition, Inc.
, 586 F.3d
1376, 1380 (Fed. Cir. 2009). Summary judgment is ap-
propriate only “if the movant shows that there is no
genuine dispute as to any material fact and the movant is
entitled to judgment as a matter of law.” Fed. R. Civ. P.
56(a). In deciding a motion fоr summary judgment, “[t]he
evidence of the non-movant is to be believed, and all
justifiable inferences are to be drawn in his favor.”
Anderson v. Liberty Lobby, Inc.
,
“[A] moving party seeking to have a patent held not
invalid at summary judgment must show that the non-
moving party, who bears the burden of proof at trial,
failed to produce clear and convincing evidence on an
essential element of a defense upon which a reasonable
jury could invalidate the patent.”
Eli Lilly & Co. v. Barr
Labs., Inc.
,
I. Obviousness
Under the Patent Act, “[a] patent may not be ob-
tained . . . if the differences between the subject matter
sought to be patented and the prior art are such that the
subject matter as a whole would have been obvious at the
time the invention was made to a person having ordinary
skill in the art to which said subject matter pertains.”
35 U.S.C. § 103(a). Although the ultimate determination
of obviousness under § 103 is a question of law, it is based
on several underlying factual findings, including (1) the
scope and content of the prior art; (2) the level of ordinary
skill in the pertinent art; (3) the differences between the
claimed invention and the prior art; and (4) evidence of
secondary factors, such as commercial success, long-felt
need, and the failure of others.
Graham v. John Deere
Co.
,
An invention “composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the priоr art.” KSR Int’l Co. v. Teleflex Inc. , 550 U.S. 398, 418 (2007). Rather, “it can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does,” id. , although such a reason need not be explicitly stated in the prior art, see id. at 419. Furthermore, when there exists a finite number of identified, predictable solutions to a known problem, a combination that results in “anticipated success” is likely the product not of innovation, but of ordinary skill and common sense. Id. at 421.
Watson argues that it raised genuine issues of mate- rial fact regarding whether it would have been obvious to combine the Kovacs COC regimen with the administra- tion of low-dose estrogen during the traditional hormone- free period to treat estrogen-withdrawal headaches in light of, inter alia , the Sulak articles and the ’749 patent. Watson claims that the court, in granting summary judgment of nonobviousness, erred by, inter alia , (1) focusing on individual references instead of considering the teaching of the prior art as a whole; (2) improрerly requiring clear and convincing evidence of invalidity on summary judgment; (3) ignoring all but three prior art references, including the 2000 Sulak article, as cumula- tive; (4) erroneously requiring that the prior art teach a virtual guarantee, rather than a reasonable expectation, of success; and (5) failing to make a finding of the level of skill in the art.
Duramed responds that the district court correctly granted summary judgment of nonobviousness because Watson failed to present any evidence of a rеason to combine Kovacs with 7 days of low-dose, unopposed estrogen to reduce the incidence of estrogen-withdrawal headache during the traditional hormone-free period. According to Duramed, by disclosing that headaches occurred throughout the menstrual cycle, the Kovacs article fails to suggest that the Kovacs regimen caused the headaches because of estrogen withdrawal. Rather, Duramed continues, the art taught that extended-cycle rеgimens were a cure for—not a cause of—such head- aches, including the 2000 Sulak article, which discusses extended-cycle regimens and unopposed estrogen as alternative solutions to the problem of withdrawal head- aches in traditional 28-day COC regimens. Regarding the ’749 patent, Duramed claims that it also does not provide a motivation to modify Kovacs with unopposed estrogen because it does not associate estrogen-withdrawal head- aches with any particular extended-сycle regime, let alone the extended-cycle Kovacs regimen. Finally, Duramed dismisses Watson’s expert testimony as conclusory and thus insufficient to raise a genuine issue of fact.
Duramed also disagrees that the district court made any of the errors alleged by Watson. Rather, according to Duramed, the district court (1) correctly held Watson to the clear and convincing evidentiary standard on sum- mary judgment; (2) implicitly made a finding on the level of skill in the art in Watson’s favor; (3) correctly analyzed оnly three prior art references, rejecting the rest as cumu- lative; and (4) properly required Watson to show, not absolute certainty, but a reasonable expectation that combining Kovacs with unopposed estrogen would succeed in reducing the incidence of estrogen-withdrawal head- aches.
We agree with Watson that the district court erred in its obviousness analysis and, as a result, incorrectly granted summary judgment of nonobviousness. Specifi- cally, the district court erred in assеssing the content and scope of the prior art, leading it to incorrectly analyze each prior art reference in isolation without considering the prior arts’ teaching as a whole in light of the creativity and common sense of a person of ordinary skill. The court also appears to have applied an incorrect evidentiary standard on summary judgment. Finally, the court failed to make any finding on the level of skill in the art. We address each in turn.
A. Content and Scope of the Prior Art
The district court erred in several of its findings on
the disclosure of the Sulak articles and the ’749 patent,
which then infected the court’s summary judgment deci-
sion. Regarding Sulak, the court rejected all considera-
tion of the articles’ teaching of the use of unopposed
estrogen because that use was mentioned only as a “theo-
retical,” rather than a tested, solution to estrogen-
withdrawal headaches.
Duramed
, 701 F. Supp. 2d at
1169. A reference, however, is prior art for all that it
discloses, аnd there is no requirement that a teaching in
the prior art be scientifically tested,
see PharmaStem
Therapeutics, Inc. v. ViaCell, Inc.
,
Regarding the ’749 patent, the district court first found that the patent “provides no reference or basis to a practitioner on the effects of adding unopposed estrogen to the end of an extended regimen in regards to hormone withdrawal headaches.” Duramed , 701 F. Supp. 2d at 1170. The ’749 patent, however, expressly teaches the administration of 7 days of 10 μ g ethinyl estradiol during the traditional hormone-free period following a variety of extended-cycle COC regimens. ’749 patent col.9 ll.48-52. Moreover, it teaches that the administration of unopposed estrogen is to reduce the “incidence of side effects, such as headaches within the framework of premenstrual syn- drome.” Id. The district court also found that the ’749 patent discloses a variety of COC regimens and thus concluded that the patent “does not teach any one specific combination that would establish consistent knowledge in the community.” Duramed , 701 F. Supp. 2d at 1170. However, the question is not whether there existed a consistent COC regimen in the art, but rather whether one of ordinary skill in the art would have been motivated to combine the Kovacs regimen with 7 days of low-dose, unopposed estrogen with the reasonable expectation that the addition of low-dose estrogen wоuld successfully reduce the incidence of estrogen-withdrawal headaches during the hormone-free period.
Based on its errors in assessing the content of these
prior art references, the district court improperly ana-
lyzed and rejected the teaching of each in isolation, con-
cluding that each alone failed to establish by clear and
convincing evidence a motivation to combine. Specifically,
while recognizing that the Sulak articles identify head-
aсhes as a symptom of hormone withdrawal, the court
ignored the articles’ suggestion of unopposed estrogen as
a possible solution, concluding instead that, because it
remained an untested solution, “the Sulak article does not
show by clear and convincing evidence that a person of
ordinary skill would have added unopposed estrogen to
the traditional hormone-free interval to alleviate the
hormone withdrawal symptoms that arise during that
period.”
Id.
at 1169-70. The district cоurt next, as de-
scribed above, rejected the disclosure of the ’749 patent in
its entirety, and thus failed to address its teaching of the
use of unopposed estrogen to treat headaches following
various extended-cycle COC regimens in light of the
teaching of a specific extended-cycle COC regimen in
Kovacs.
Id.
at 1170. Finally, the district court analyzed
the Kovacs article without reference to the ’749 patent or
the Sulak articles, concluding that because the article
taught that women on the regimen reported headaches
“scattered throughout the [menstrual] cycle,” and itself
did not mention the use of unopposed estrogen, “the
[Kovacs] article does not provide clear and convincing
support” that a practitioner would treat headaches asso-
ciated with the regimen by adding unopposed estrogen.
Id.
at 1169. Accordingly, the district court failed to prop-
erly consider the collective teaching of the prior art in
light of the commоn sense and creativity of the person of
ordinary skill in the art.
See KSR
,
The district court also appears to have applied an in-
correct evidentiary standard on summary judgment,
incorrectly placing the burden of proof on the nonmoving
party, Watson, to show clear and convincing evidence of
invalidity as a matter of law. In this case, Duramed
moved for summary judgment of nonobviousness, and
thus the burden rested with Duramed to show that Wat-
son had failed to come forth with clear and convincing
evidenсe of an essential element of its
prima facie
case of
obviousness.
See Eli Lilly
,
B. Level of Skill in the Art
A determination of obviousness requires a factual
finding of the level of ordinary skill in the pertinent art,
35 U.S.C. § 103(a);
Graham
, 383 U.S. at 17, which the
district court failed to make in this case. When a finding
of the level of skill affects the court’s ultimate conclusion
under § 103, the failure to make such a finding consti-
tutes reversible error.
See Kloster Speedsteel AB v. Cruci-
ble Inc.
, 793 F.2d 1565, 1574 (Fed. Cir. 1986),
overruled
on other grounds by Knoff-Bremse Systeme v. Dana Corp.
,
Watson argues that the level of skill was high, requir-
ing a medical degree and several years of experience in
the field of reproductive endocrinology. Duramed argued
below that even a nurse practitioner can be a person of
ordinary skill but suggests on appeal that the district
court implicitly sided with Watson. There is no evidence
for Duramed’s contention. Rather, the district court
appears to have simply rejected all of Watson’s expert’s
testimony by finding that Thomas was not a person of
ordinary skill, but extraordinary skill.
[2]
See Duramed
,
Finally, contrary to Duramed’s claim, Thomas’s expert
testimony was not merely conclusory. He connected each
claim limitation with disclosures in the prior art, and his
opinion on a motivation to combine rests on factual sup-
port in the record. J.A. 823-26, 836-38;
cf. Perfect Web
Techs., Inc. v. InfoUSA, Inc.
, 587 F.3d 1324, 1331 (Fed.
Cir. 2009) (holding expert testimony insufficient to raise a
genuine issue of fact when it relied on irrelevаnt prior art
and failed entirely to address one claim limitation).
Accordingly, this testimony should not have been disre-
garded on summary judgment.
See KSR
,
In light of the errors made by the district court, we reverse the district court’s grant of summary judgment of nonobviousness and remand. We note, however, that in reviewing the record de novo on summary judgment аnd crediting Duramed’s lower level of skill in the art, the district court on remand may well conclude that the claimed extended-cycle COC regimen would have been obvious as a matter of law.
Kovacs teaches the claimed administration of 84 daily pills containing 150 μ g levonorgestrel and 30 μ g ethinyl estradiol. The ’749 patent teaches the claimed admini- stration of 10 μ g ethinyl estradiol for 7 days during the traditional hormone-free period. Moreover, this admini- stration follows a variety of extended-cycle COC rеgimens to treat estrogen-withdrawal headaches, which the 2000 Sulak article confirms for traditional 28-day COC regi- mens are “more common during the hormone-free inter- vals compared with the active-pill weeks.” J.A. 1240-41. The 1997 Sulak article also teaches that women on ex- tended-cycle COC regimens experience headaches during the hormone-free period. [3] J.A. 1225. And Watson’s expert opined that one of skill in the art would have been motivated to combine the Kovacs COC regimen with the 7 days оf unopposed estrogen taught by the ’749 patent and the Sulak articles to arrive at the claimed invention because the Kovacs article recognized that the regimen resulted in headaches in some women, J.A. 824-25, al- though “scattered throughout the [menstrual] cycle,” J.A. 229.
Thus, on the record before us, there appear to be no genuine issues of material fact that, based on the teaching of Kovacs, the ’749 patent, and the Sulak articles, one of ordinary skill would have been motivated to combine the Kovacs regimen and 7 days of 10 μ g unopposed ethinyl estradiol with a reasonable expectation that the combina- tion would reduce the incidence of headaches associated with that regimen. Yet, Watson did not move for sum- mary judgment of obviousness and stated at oral argu- ment that it was “absolutely not” requesting that this court hold the asserted claims obvious as a matter of law. Oral Arg. at 1:12-1:43. In light of this procedural posture, Duramed did not have an opportunity to challenge Wat- son’s prima facie case of obviousness or introduce any secondary considerations of nonobviousness. Accordingly, we leave that determination to the district court on re- mand.
II. Exclusion of Testimony
A decision to exclude evidence raises an issue not
unique to patent law, and thus we apply the law of the
regional circuit in which the district court sits, in this
case, the Ninth Circuit.
Juicy Whip, Inc. v. Orange Bang,
Inc.
, 382 F.3d 1367, 1370 (Fed. Cir. 2004). A district
court’s decision to exclude evidence is reviewed for abuse
84 days of hormone-containing pills as claimed in the ’969
patent. J.A. 1225
of discretion.
United States v. Pang
,
The district court excluded Thomas’s testimony re-
garding his prior use of the claimed invention as uncor-
roborated in light of the “general rule” that “corroboration
of oral testimony regarding prior invention or use is
required before the evidence is admissible.”
Duramed
,
Yet, Watson acknowledged that it was not relying on
this testimony to support either its opposition to summary
judgment or its
prima facie
case of obviousness. Oral Arg.
at 22:25-23:35. We therefore decline to decide to what
degree such evidence may or may not contributе to a
determination of obviousness by clear and convincing
evidence, concluding instead that Watson failed to meet
its “particularly high hurdle” to demonstrate that the
district court abused its discretion in excluding testimony
on prior use.
Texas Digital
,
C ONCLUSION
For the foregoing reasons, we reverse the district court’s grant of summary judgment of nonobviousness, affirm the court’s exclusion of Watson’s expert testimony on prior use, and remand for further proceedings consis- tent with this opinion.
REVERSED IN PART, AFFIRMED IN PART, and REMANDED C OSTS Costs to Watson.
Notes
[1] The district court cites the 1997 Sulak article, but it appears to have relied on a combination of the 1997 and 2000 Sulak articles. Accordingly, we refеr to these arti- cles together as the Sulak articles.
[2] The district court limited its discussion to the tes- timony of Thomas’s prior use of the claimed extended- cycle COC regimen. Accordingly, it is unclear from the opinion whether or not the court credited other aspects of Thomas’s testimony.
[3] Watson stated at oral argument that the 1997 Su- lak article tested the Kovacs regimen. Oral Arg. at 5:00- 5:30. The article does list Kovacs in Table 1 as one prior art regimen, but it does not state that the women in its study were on the Kovacs regimen. Moreover, many of the women in the study did not stabilize on a regimen of