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(2) district court did not commit clear er-


Only the Westlaw citation is currently ror in finding that patent disclosing use of
available. bimatoprost to treat glaucoma did not in-
herently anticipate patent;
United States Court of Appeals, (3) patent for compositions and methods
Federal Circuit. for treating hair loss using non-naturally
ALLERGAN, INC., and Duke Uni- occurring prostaglandins was invalid for
versity, Plaintiffs–Appellees, obviousness;
v. (4) district court committed clear error in
APOTEX INC., Apotex Corp., Sandoz, finding corroboration of earlier priority
Inc., and Hi–Tech Pharmacal Co., Inc., date for claimed invention;
Defendants–Appellants. (5) references did not represent inventor's
Allergan, Inc., and Duke University, own work, and thus constituted prior art;
Plaintiffs–Appellees, and
v. (6) patent for topical application of bima-
Watson Pharmaceuticals, Inc., now toprost for use to promote eyelash hair
known as Actavis, Inc., Watson Laborat- growth was invalid for obviousness.
ories, Inc., and Watson Pharma, Inc., De-
fendants–Appellants. Reversed and vacated.
Nos. 2013–1245, 2013–1246, 2013–1247,
2013–1249. Chen, Circuit Judge, dissented in part
June 10, 2014. and filed opinion.

Background: Patent owners filed action West Headnotes


against generic drug manufacturers al-
[1] Patents 291 0
leging that proposed generic versions of
their products infringed their patents for 291 Patents
drugs for treating hypotrichosis of eye- Claim construction is issue of law that
lashes. Manufacturers filed action seek- Court of Appeals reviews de novo.
ing declaratory judgment that their pro-
posed products did not infringe patents. [2] Patents 291 0
Actions were consolidated. The United
States District Court for the Middle Dis- 291 Patents
trict of North Carolina, Catherine C. In construing patent claim term, court
Eagles, J., held that patents were not in- must look at term's plain and ordinary
valid and had been infringed, 2013 WL meaning as understood by person of or-
286251, and enjoined manufacturers from dinary skill in art, unless patentee sets out
manufacture, use, offer to sell and/or sale definition and acts as her own lexico-
of proposed products, 2013 WL 1750757. grapher.
Manufacturers appealed.
[3] Patents 291 0
Holdings: The Court of Appeals, Prost,
291 Patents
Chief Judge, held that:
Phrase “treating hair loss,” as used in
(1) district court did not commit clear er-
patent for drugs for treating hypotrichosis
ror in determining that invention was not
of eyelashes, could include method of
anticipated by published patent applica-
promoting hair growth without also ar-
tion;

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resting or reversing hair loss, where spe- pressly excluded compounds disclosed in
cification defined phrase as “meaning application, and disclosure was too sparse
that the invention may arrest hair loss, re- and ambiguous for person of ordinary
verse hair loss, or promote hair growth in skill to comprehend disclosure as anticip-
the alternative.” ating patent. 35U.S.C.A. § 102.
[4] Patents 291 0 [9] Patents 291 0
291 Patents 291 Patents
Patent is invalid for anticipation if District court did not commit clear er-
single prior art reference discloses each ror in finding that patent disclosing use of
and every limitation of claimed inven- bimatoprost to treat glaucoma did not in-
tion. 35 U.S.C.A. § 102. herently anticipate patent for use of eyed-
rops containing bimatoprost for treatment
[5] Patents 291 0 of hypotrichosis of eyelashes, even
though application of eyedrops contain-
291 Patents
ing bimatoprost could result in promotion
Single prior art reference may anticip-
of eyelash hair, where there was evidence
ate without disclosing feature of claimed
that properly applied drop would not
invention if such feature is necessarily
transfer to skin, and there was no express
present, or inherent, in that reference. 35
teaching in prior patent that described
U.S.C.A. § 102.
how fluid from eyedrop could transfer to
[6] Patents 291 0 skin. 35 U.S.C.A. § 102.

291 Patents [10] Patents 291 0


Anticipation is question of fact that
291 Patents
court reviews for clear error in patent
Patent's obviousness is legal conclu-
case. 35 U.S.C.A. § 102.
sion based on underlying facts. 35
[7] Patents 291 0 U.S.C.A. § 103(a).

291 Patents [11] Patents 291 0


Statutory presumption of patent's
291 Patents
validity can be rebutted by clear and con-
On appeal from bench trial in patent
vincing evidence. 35 U.S.C.A. § 282.
infringement case, Court of Appeals re-
[8] Patents 291 0 views underlying findings of fact for
clear error, and reviews de novo district
291 Patents court's ultimate legal conclusion of
District court did not commit clear er- whether claimed invention would have
ror, in action alleging infringement of been obvious. 35 U.S.C.A. § 103(a).
patent for use of eyedrops containing
bimatoprost for treating hypotrichosis of [12] Patents 291 0
eyelashes, in determining that invention
291 Patents
was not anticipated by published patent
In determining whether patent is in-
application arising from research on pro-
valid for obviousness, court should con-
moting hair growth using latanoprost and
sider: (1) scope and content of prior art;
related compounds, even though applica-
(2) differences between prior art and
tion disclosed compounds with single
claims at issue; (3) level of ordinary skill
bond at C5–C6 position, where patent ex-
in field of invention; and (4) relevant sec-

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ondary considerations including commer- tion date, “conception” is formation in in-


cial success, long-felt but unsolved needs, ventor's mind of definite and permanent
failure of others, and unexpected results. idea of complete and operative invention,
35 U.S.C.A. § 103(a). as it is hereafter to be applied in practice.
35 U.S.C.A. § 102.
[13] Patents 291 0
[17] Patents 291 0
291 Patents
Patent's obviousness does not require 291 Patents
absolute predictability of success. 35 Issue of invention's conception date is
U.S.C.A. § 103(a). legal conclusion based on underlying fac-
tual findings. 35 U.S.C.A. § 102.
[14] Patents 291 0
[18] Patents 291 0
291 Patents
Patent for compositions and methods 291 Patents
for treating hair loss using non-naturally While party alleging that patent is in-
occurring prostaglandins was invalid for valid for anticipation bears burden of per-
obviousness, even though prior art dis- suasion to show that references are prior
closed list of thirteen chemical composi- art to patent by clear and convincing
tions for 17–phenyl prostaglandin evidence, patentee nevertheless must
F–2–alpha (PGF) analogs that were not meet its burden of production to demon-
understood at time of invention to bind to strate earlier conception date. 35
receptor other than FP receptor, and did U.S.C.A. § 102.
not clearly and unequivocally disclose
compounds that included C5–C6 satur- [19] Patents 291 0
ated bond, and certain therapeutic PGF
291 Patents
analogs failed to grow hair, where scope
When party seeks to prove date of in-
of patent's independent claims encom-
vention's conception via putative invent-
passed thousands of permutations of PGF
or's oral testimony, party must proffer
analogs, including structures with all
evidence corroborating that testimony. 35
kinds of functional groups at C1 location,
U.S.C.A. § 102.
patent's claimed invention was not unique
to PGF analogs that bound variant FP re- [20] Patents 291 0
ceptor, person of ordinary skill reading
prior art would have found it replete with 291 Patents
references to advantages of using District court committed clear error,
17–phenyl PGF compounds generally, in action alleging infringement of patent
and prior art taught that PGF analogs that for topical application of bimatoprost for
were effective glaucoma drugs could use to promote eyelash hair growth, in
grow hair. 35 U.S.C.A. § 103(a). finding corroboration of earlier priority
date for claimed invention, where only
[15] Patents 291 0 evidence that corroborated inventor's
testimony that he conceived of topical ap-
291 Patents
plication of bimatoprost in mid-2000 was
Invention date is date of conception.
his co-inventor's oral testimony, and doc-
[16] Patents 291 0 umentary evidence referred only to eye-
lash growth resulting from administration
291 Patents of eyedrops, and did not disclose claimed
For purposes of determining inven- invention of topical application for inten-

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ded therapeutic effect. 35 U.S.C.A. § 102 ular Patents


. 291k328 Patents Enumerated
291k328(2) k. Original Utility.
[21] Patents 291 0 Most Cited Cases
291 Patents Patents 291 328(2)
One's own work is not prior art, even
though it has been disclosed to public in 291 Patents
manner or form that otherwise would fall 291XIII Decisions on the Validity,
within scope of statute allowing rejection Construction, and Infringement of Partic-
of claims on ground that invention was ular Patents
described in printed publication before 291k328 Patents Enumerated
invention. 35 U.S.C.A. § 102(a). 291k328(2) k. Original Utility.
Most Cited Cases
[22] Patents 291 0 5,352,708, 7,351,404, 7,388,029.
Cited.
291 Patents
References did not represent invent- 5,688,819, 6,262,105. Cited as Prior
or's own work, and thus constituted prior Art.
art, for purposes of determining whether
invention had been anticipated by prior
art, where inventor's testimony was equi- Appeals from the United States District
vocal as to whether she alone directed Court for the Middle District of North
clinical trials and wrote internal reports, Carolina in Nos. 10–CV–0681,
inventor was not listed as co-author in 11–CV–0298, and 11–CV–0650,
one reference, and journal article listed 12–CV–0321, Judge Catherine C. Eagles.
multiple authors, but not inventor. 35 Jonathan E. Singer, Fish & Richardson
U.S.C.A. § 102(a). P.C., of Minneapolis, MN, argued for
plaintiffs-appellees. With him on the
[23] Patents 291 0 brief were Deanna J. Reichel; and Juanita
R. Brooks, of San Diego, CA. Of counsel
291 Patents was Jeffrey T. Thomas, Gibson, Dunn &
Patent for topical application of bima- Crutcher, LLP, of Irvine, CA.
toprost for use to promote eyelash hair
growth was invalid for obviousness, Deanne M. Mazzochi, Rakoczy Molino
where prior art detailed at length how Mazzochi Siwik LLP, of Chicago, IL, ar-
eyedrops containing latanoprost pro- gued for defendants-appellants Apotex
moted eyelash hair growth through mech- Inc., et al.With her on the brief were Wil-
anism of fluid containing latanoprost liam A. Rakoczy, Paul J. Molino, and
making topical contact with eyelid, and Andrew M. Alul, for Apotex Inc., et al;
another prior art reference disclosed Meredith Martin Addy, Thomas Filarski,
bimatoprost's effect in growing eyelash and Brandon C. Helms, Steptoe & John-
hair, as well as reasonable expectation of son LLP, of Chicago, IL, for Sandoz Inc.;
success for topical application of bimato- Steven Roth, Hi–Tech Pharmacal Co.,
prost. 35 U.S.C.A. § 103(a). Inc., of Amityville, NY, and Thomas J.
Vetter, Lucas & Mercanti, LLP, of New
Patents 291 328(2) York, NY, for Hi–Tech Pharmacal Co.,
Inc.; and Gary E. Hood, Robyn H. Ast
291 Patents
and Mark T. Deming, Polsinelli PC, of
291XIII Decisions on the Validity,
Chicago, IL for Watson Pharmaceuticals,
Construction, and Infringement of Partic-

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Inc., et al.Of counsel were Luke T. Shan- The chemical structure of naturally
non and Harven V. Deshield, Locke Lord occurring PGF is illustrated below:
LLP, of Chicago, IL, for Apotex Inc., et
al. Tabular or graphic material set at this
point is not displayable.
Before PROST,FN* Chief Judge, The structure includes a
REYNA and CHEN, Circuit Judges. “cyclopentane ring” of carbon atoms,
which is illustrated above as the
pentagonal structure at the left of the dia-
PROST, Chief Judge.
gram. Two chains of atoms are attached
*1 Apotex Inc., Apotex Corp., San-
to the ring. The top chain is called the
doz, Inc., Hit–Tech Pharmacal Co., Inc.,
“alpha chain,” and the chain below it is
Actavis, Inc., Watson Laboratories, Inc.,
called the “omega chain.”
and Watson Pharma, Inc. (collectively
“appellants”) appeal from a final judg- By the mid–1980s, it was established
ment of the U.S. District Court for the that naturally occurring PGF could allevi-
Middle District of North Carolina finding ate intraocular pressure (IOP), which is
that appellants had infringed claims of associated with the eye disease glaucoma.
U.S. Patent Nos. 7,388,029 (“'029 pat- To develop an effective treatment and
ent”) and 7,351,404 (“'404 patent”) and minimize side effects, scientists worked
had failed to establish they were invalid. on synthesizing and testing more select-
For the reasons stated below, we reverse ive derivatives and analogs of PGF. A
the district court's findings with respect particular kind of PGF analog, 17–phenyl
to the validity of each patent. PGF analogs, proved to be particularly
useful in the treatment of glaucoma.
BACKGROUND
Bimatoprost is one such synthetic
Plaintiff-appellee Allergan, Inc.
17–phenyl PGF analog, which emerged
(“Allergan”) has U.S. Food and Drug Ad-
in the course of research by Allergan sci-
ministration (FDA) approval to sell La-
entists. In 2001, Allergan received FDA
tisse®, a 0.03% bimatoprost ophthalmic
approval to sell Lumigan ®, a 0.03%
solution, as a topical solution to treat hy-
bimatoprost ophthalmic solu-
potrichosis (i.e., hair loss or reduction) of
tion—identical to Latisse®—as an eye-
the eyelashes by stimulating hair growth.
drop to treat glaucoma, which it contin-
Bimatoprost is a synthetic ues to market.
prostaglandin F–2–alpha (“PGF”) analog.
Hair loss treatment was another area
Prostaglandins are naturally occurring
in which certain PGF analogs proved use-
molecules that bind to receptors on the
ful.In the 1990s, Dr. Murray Johnstone
surface of cells. When prostaglandins
performed studies on latanoprost, another
bind to a cell's receptors, they generate
kind of 17–phenyl analog. Latanoprost
signals that change the way that the cell
optical solution also received FDA ap-
functions, for example, by controlling
proval for use in glaucoma treatment, and
cell growth. Because of the ability of
it continues to be marketed as Xalatan®.
prostaglandins to control cell properties,
Dr. Johnstone observed that in the course
they are significant targets for pharma-
of treating glaucoma patients with latano-
ceutical research in a variety of areas.
prost eyedrops, a substantial fraction of
PGF is a particular type of prostaglandin
them grew much longer and denser eye-
that binds with the FP receptor.
lash hair. Dr. Johnstone filed a patent ap-
plication on the use of latanoprost and

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other 17–phenyl PGF analogs to promote the '404 patent. After a bench trial in the
hair growth in February 1997. consolidated Hatch–Waxman action, the
district court held, inter alia, that the as-
*2 The work that led to the '029 pat- serted claims of the '029 and '404 patents
ent, the first of the two patents asserted are not invalid for anticipation, obvious-
by appellees in this case, was conducted ness, insufficient written description, or
by researchers at Proctor & Gamble led lack of enablement, and, moreover, that
by Dr. Mitchell DeLong. Dr. DeLong and appellants infringed. Allergan, Inc. v.
his team studied the effects of a wide Apotex, Inc., Nos. 1:10–CV–681,
range of prostaglandin compounds in 1:11–CV–298, 1:11–CV–650, 2013 WL
mice. In the course of their studies they 286251, at *1 (M.D.N.C.Jan.24, 2013).
observed that administration of PGF The district court subsequently enjoined
compounds that were selective for the FP appellants, along with any persons or en-
receptor resulted in growth of longer and tities who are in privity with appellants or
thicker hair. On March 21, 2000, Dr. De- to whom appellants transfer the ANDA,
Long and others filed a provisional patent from commercial manufacture, use, offer
application on the topical application of to sell and/or sale of the proposed
compounds that bind the FP receptors to products until the latest of the expiration
treat hair loss. The '029 patent claims pri- dates of the '029 and '404 patents. Aller-
ority to this provisional application. Dur- gan, Inc. v. Apotex, Inc., No.
ing prosecution, in 2003, the parent ap- 1:10–CV–681 Permanent Inj. and Final J.
plication of the '029 patent was assigned 2–3, ECF No. 231.
to Duke University, and the patent issued
on June 17, 2008. This appeal followed, in which ap-
pellees raise issues of claim construction
The second patent asserted by ap- for the '029 patent, as well as the invalid-
pellees in this suit is the '404 patent, ity of the asserted claims of the '029 and '
which is assigned to Allergan. The '404 404 patents. We have jurisdiction under
patent arises from observations made dur- 28 U.S.C. § 1295(a)(1).
ing the clinical trials for Lumigan ®. As
had been observed for latanoprost, glauc- DISCUSSION
oma patients treated with bimatoprost I. CLAIM CONSTRUCTION
eyedrops spontaneously grew longer and [1][2] Claim construction is an issue
thicker eyelash hair. See '404 patent of law that we review de novo. Lighting
col.11 ll.5–62. The '404 patent covers the Ballast Control LLC v. Philips Elecs. N.
treatment of eyelash hair loss through Am. Corp., 744 F.3d 1272, 1276–77,
topical application of bimatoprost, and it (Fed.Cir.) (en banc); Cybor Corp. v. FAS
claims priority to a provisional applica- Techs., Inc., 138 F.3d 1448, 1454–55
tion filed on February 4, 2002. (Fed.Cir.1998) (en banc). In construing a
claim term, we look at the term's plain
Allergan and Duke University and ordinary meaning as understood by a
(collectively “appellees”) sued each of person of ordinary skill in the art. Phillips
the appellants under 35 U.S.C. § v. AWH Corp., 415 F.3d 1303, 1313
271(e)(2)(A) after they submitted Abbre- (Fed.Cir.2005) (en banc). There is an ex-
viated New Drug Applications (ANDAs) ception to this general rule when a pat-
to the FDA seeking to market a generic entee sets out a definition and acts as her
version of Allergan's Latisse® product. own lexicographer. Thorner v. Sony
Appellees asserted claims 1, 8, 14, 18, Computer Entm't Am., LLC, 669 F.3d
and 20 of the '029 patent and claim 14 of 1362, 1365 (Fed.Cir.2012).

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*3 Appellants raise a single claim “promote hair growth,” and “promote


construction issue on appeal concerning eyelash growth.” See, e.g., '029 patent at
the '029 patent. The '029 patent's asserted cols. 58 ll.17–19, 59 ll. 43–44, 59
claims are directed towards a method of ll.61–62, 60 ll.31–32, 60 ll.11–12. There
“treating hair loss.” Appellants challenge is nothing in either the specification or
the district court's construction of this the claims suggesting that the patentee
term as “ ‘arresting hair loss, reversing would have excluded these examples
hair loss, or both and promoting hair from the scope of claimed methods.
growth’ meaning that the invention may
arrest hair loss, reverse hair loss, or pro- [3] Reading the patentee's own lex-
mote hair growth in the alternative.” All icography in light of the whole specifica-
parties, as well as the district court, tion, we conclude that a method of
agreed that the specification provides an “treating hair loss” may include a method
express definition for the term: “ of promoting hair growth without also ar-
‘Treating hair loss' includes arresting hair resting or reversing hair loss. Accord-
loss or reversing hair loss, or both, and ingly, we affirm the district court's con-
promoting hair growth.” '029 patent col.3 struction.
ll. 29–30. Appellants argue, however, that
II. INVALIDITY
use of the conjunctive “and” in the in-
A. '029 Patent
ventor's own lexicography expressly
1. Anticipation
provides that the method for treating hair
[4][5][6] A patent is invalid for anti-
loss must both arrest or reverse hair loss,
cipation under 35 U.S.C. § 102 FN1 if a
as well as also promote hair growth. Ap-
single prior art reference discloses each
pellants argue that under their proposed
and every limitation of the claimed in-
construction, a generic version of La-
vention. Schering Corp. v. Geneva
tisse® would not infringe because La-
Pharm., 339 F.3d 1373, 1377
tisse® treats hair loss by lengthening,
(Fed.Cir.2003). A single prior art refer-
thickening, and darkening existing
ence may anticipate without disclosing a
healthy hair—which appellants argue
feature of the claimed invention if such
means only the promotion of hair growth.
feature is necessarily present, or inherent,
The district court agreed with the ap- in that reference. Id. Anticipation is a
pellees that the use of the word question of fact that we review for clear
“includes” in the definition of “treating error. Atlas Powder Co. v. Ireco, Inc.,
hair loss” plainly means that the patentee 190 F.3d 1342, 1346 (Fed.Cir.1999).
intended to define treating hair loss to in-
*4 [7] The presumption of a patent's
clude the possibility of one or all of ar-
validity under 35 U.S.C. § 282 can be re-
resting hair loss, reversing hair loss, or
butted by clear and convincing evidence.
promoting hair growth. Appellees argue
Microsoft Corp. v. i4i Ltd. P'ship, –––
that this comports with the plain meaning
U.S. ––––, –––– – ––––, 131 S.Ct. 2238,
of “treating hair loss,” which would be
2245–46, 180 L.Ed.2d 131 (2011). The
understood in the art as including treat-
standard of proof does not “rise and fall
ments that exclusively promote hair
with the facts of each case.” Id. at 2250.
growth. Most compellingly, even if there
In particular, “[w]hether a reference was
may be some ambiguity in how the pat-
previously considered by the PTO, the
entee defined the term, numerous ex-
burden of proof is the same: clear and
amples in the patent describe the use of
convincing evidence of invalidity.” Sciele
claimed compositions to “induce hair
Pharma Inc. v. Lupin Ltd., 684 F.3d
growth,” “darken and thicken eyelashes,”

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1253, 1259–61 (Fed.Cir.2012). doubled line in the above diagram. The


provisos within the '029 claim expressly
With respect to the '029 patent, appel- exclude such a structure. Appellants con-
lants raise two allegedly anticipatory ref- tend that even so, Johnstone goes on to
erences: (i) the published patent applica- also disclose compounds with a single
tion arising from Dr. Johnstone's afore- (also known as “saturated”) bond at the
mentioned research on promoting hair C5–C6 position: “The chain could prefer-
growth using latanoprost and related ably be a C6 –C10 chain which can be
compounds, and (ii) Allergan's earlier saturated or unsaturated, having one or
patent on the use of bimatoprost and re- more double bonds, and allenes, or a
lated compounds to treat glaucoma. We triple bond.” Johnstone at 12 ll.22–24
discuss each reference in turn. (emphasis added). As a result of this ad-
ditional disclosure, in appellants' view,
a. Johnstone PCT Application
Johnstone also teaches a single, or satur-
Dr. Johnstone's research led to the fil-
ated, bond at the C5–C6 position, which
ing of International Patent Application
would not be excluded by the provisos
No. PCT/US98/02289 (“Johnstone”) on
and consequently reads on the independ-
February 3, 1998. In particular, Johnstone
ent claims of the '029 patent.
discloses methods for stimulating hair
growth using a broad genus of Johnstone, however, contains no other
prostaglandin analogs that, among other disclosure of a structure with a single,
properties, have an alpha chain with the saturated, bond at that location. All of the
following structure (see Johnstone at 16 examples of Johnstone are drawn to com-
ll.16–22): positions in which the C5–C6 bond is a
double bond. The district court moreover
Tabular or graphic material set at this
agreed with appellees and found that in
point is not displayable.
the context of the state of the art, a person
The cited art of the '029 patent in- of ordinary skill would not read John-
cludes U.S. Patent No. 6,262,105 to John- stone as disclosing a single bond struc-
stone, which shares its disclosure with the ture. The district court accepted ap-
Johnstone PCT application.The Johnstone pellees' evidence that a PGF analog with
PCT application was also raised during such a structure would not have been
the prosecution of the '029 patent. Fol- thought to have a therapeutic effect be-
lowing issue of the initial notice of allow- cause it would not selectively bind to the
ance, the patentee filed an amendment to FP receptor. Allergan, 2013 WL
add a proviso to independent claims with 286251, at *5. The district court further
the aim of expressly excluding the com- supported its determination by citing to
pounds disclosed in Johnstone. J.A. the '029 patent's notice of allowance, in
4130–37. The examiner accepted the which the examiner indicated Johnstone
amendment and issued a notice of allow- “lacks motivation to modify the
ance for the patent with the claims prostaglandins taught therein in order to
amended to include the provisos. obtain the presently claimed prostagland-
ins.” Id.; J.A. 5559–65 at 5564. The dis-
Appellants argue that Johnstone anti- trict court found, therefore, that the dis-
cipates nevertheless. As illustrated above, closure on which appellants rely does not
Johnstone expressly discloses PGF struc- “clearly and unequivocally disclose” the
tures in which the alpha chain includes a use of compounds with the saturated
double (also known as “unsaturated”) bond. Allergan, 2013 WL 286251, at *6
bond at the C5–C6 position, shown as a (citing Net MoneyIN, Inc. v. VeriSign,

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Inc., 545 F.3d 1359, 1371 (Fed.Cir.2008) pounds. Appellants argue, however, that
). because (i) the '819 patent's disclosure
teaches the application of eyedrops con-
*5 [8] We are persuaded that in light taining compounds within the scope of
of the very limited disclosure, the court the asserted '029 patent claims, in partic-
did not commit clear error. Appellants are ular bimatoprost, and (ii) the application
correct that where a disclosure was writ- of eyedrops containing bimatoprost res-
ten to provide an optional ingredient, ults in the growth of eyelashes, the dis-
structure, or step, we have held that the closed method inherently anticipates the '
optional component still anticipates. See 029 patent.
Upsher–Smith Labs., Inc. v. Pamlab,
L.L.C., 412 F.3d 1319, 1320–21 At issue is whether promoting hair
(Fed.Cir.2005) (“[A] prior art composi- growth through topical application of
tion that ‘optionally includes' an ingredi- bimatoprost on the skin is necessarily
ent anticipates a claim for the same com- present or inherent in the method of ap-
position that expressly excludes that in- plying eyedrops containing bimatoprost.
gredient.”); Bristol–Myers Squibb Co. v. FN2 Schering, 339 F.3d at 1377. There is
Ben Venue Labs., Inc., 246 F.3d 1368, no dispute that the application of eyed-
1379 (Fed.Cir.2001) (“[A]nticipation rops containing bimatoprost can result in
does not require actual performance of the promotion of eyelash hair. Allergan's
suggestions in the disclosure.”). Indeed, own description of the conception of the '
even if the reference discloses the option 404 patent was that scientists first ob-
within the context of a reference that served that after monkeys were treated
“disparages” or “teaches away,” we do with bimatoprost in their eyes, some of
not consider those issues in the context of them showed enhanced eyelash growth.
an anticipation analysis. Upsher–Smith, Appellees' Br.13 (citing J.A. 396–98,
412 F.3d at 1323. 5617–29, 5624). Similar results were
found in clinical trials, during which
The court was not clearly erroneous, some patients who used bimatoprost eye-
however, in its determination that in this drops reported eyelash growth. Id . at 15
case, the disclosure was too sparse and (citing J.A. 525–33, 5855–71).
ambiguous for a person of ordinary skill
to comprehend Johnstone's disclosure as The '404 patent, moreover, includes
anticipating the '029 patent. Net Money- as its enabling example the administra-
IN, 545 F.3d at 1371. Accordingly, we af- tion of bimatoprost by eyedrop in a study
firm. of patients. '404 patent col.10 l.38–col.12
l.3. As such, the specification recites a
b. '819 Patent direct link between eyedrop administra-
U.S. Patent No. 5,688,819 (“'819 pat- tion and the claims directed to topical ap-
ent”) emerged from research by Allergan plication: “the course of treatment with
scientists on selective PGF analogs that eye drops” results in excess fluid gather-
could effectively treat glaucoma. The ' ing in the lid area, which in turn once
819 patent discloses the use of a set of se- wiped gets to “the adjacent skin of the lid
lective PGF analogs, including bimato- area.” Id. at col.10 ll.51–56. Appellants
prost, which is specifically identified by argue that if the '819 patent discloses a
its chemical structure. '819 patent col .7 method of eyedrop administration of
ll.44–46. The '819 patent does not refer to bimatoprost that is sufficient to enable
hair growth or treating hair loss, nor does the claims of the '404 patent, then that
it disclose topical application of any com- method must also inherently anticipate.

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*6 The district court rejected appel- for clear error. In this case, the district
lants' arguments. The district court found court found that it was at least possible to
that appellees' expert witness, Dr. Noeck- administer eyedrops in a way as to reduce
er, had persuasively testified that a the flow of liquid to the eye to close to
“properly applied drop” would not trans- zero. Cf. Glaxo Inc. v. Novopharm Ltd.,
fer to the skin. Allergan, 2013 WL 52 F.3d 1043, 1047 (Fed.Cir.1995). The
286251, at *6. The district court addition- district court also found no express teach-
ally found that Lumigan ® clinical trials ing in the '819 patent that described how
only showed that a fraction of patients fluid from the eyedrop could transfer to
experience eyelash growth. Id. The dis- the skin. MEHL/Biophile Int'l Corp. v.
trict court found that because a bimato- Milgraum, 192 F.3d 1362, 1365
prost eyedrop only may contact skin, the ' (Fed.Cir.1999). We cannot say either of
819 patent does not inherently anticipate these findings, nor the conclusion that the
as inherency “may not be established by prior art does not necessarily include the
probabilities or possibilities.” Id. (citing claimed limitations, is clearly erroneous.
Bettcher Indus., Inc. v. Bunzl USA, Inc., Accordingly, we are not persuaded that
661 F.3d 629, 639 (Fed.Cir.2011). the district court committed clear error in
finding that the '819 patent does not in-
Appellants argue that the district herently anticipate the claims of the '029
court erroneously required certainty as a patent, and we affirm.FN3
prerequisite for inherent anticipation. In
their view, the district court should not 2. Obviousness
have relied on the finding that only some [10] Appellants alternatively allege
patients who received eyedrops experi- that the aforementioned references render
enced eyelash growth. obvious the asserted claims of the '029
patent. A patent is invalid for obvious-
Appellants are correct that inherent ness “if the differences between the sub-
anticipation can be found based on a trace ject matter sought to be patented and the
amount. For example, we have held that a prior art are such that the subject matter
chemical process that produces only as a whole would have been obvious at
“trace” amounts of a compound inher- the time the invention was made to a per-
ently anticipates that compound. son having ordinary skill in the art to
SmithKline Beecham Corp. v. Apotex which said subject matter pertains.” 35
Corp., 403 F.3d 1331, 1344 U.S.C. § 103(a). Obviousness is a legal
(Fed.Cir.2005). All that needs to be conclusion based on underlying facts.
shown is that the outcome of the process Graham v. John Deere Co., 383 U.S. 1,
be a “natural result flowing from the op- 17, 86 S.Ct. 684, 15 L.Ed.2d 545 (1966).
eration as taught in the prior art.” Id.
(citing In re Oelrich, 666 F.2d 578, 581 *7 [11][12] On appeal from a bench
(CCPA 1981)). We have also held that a trial, we review the underlying findings
product would be inherently anticipated of fact for clear error, and we review de
where it was a natural result of the prior novo the court's ultimate legal conclusion
art process, even when it would be pos- of whether the claimed invention would
sible to prevent the formation of the have been obvious. Novo Nordisk A/S v.
product through “extraordinary meas- Caraco Pharm. Labs., Ltd., 719 F.3d
ures.” Atlas Powder, 190 F.3d at 1349. 1346, 1354 (Fed.Cir.2013). Underlying
factual inquiries include (i) the scope and
[9] We review the district court's content of the prior art; (ii) the differ-
findings of fact on inherent anticipation ences between the prior art and the claims

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at issue; (iii) the level of ordinary skill in “pharmacological differences are espe-
the field of the invention; and (iv) relev- cially significant in the hair growth
ant secondary considerations including field,” as “hair growth is and was unpre-
commercial success, long-felt but un- dictable and mysterious,” pointing to data
solved needs, failure of others, and unex- that showed that certain glaucoma drugs
pected results. KSR Int'l Co. v. Teleflex, based on prostaglandin analogs only res-
Inc., 550 U.S. 398, 406, 127 S.Ct. 1727, ult in low levels of eyelash growth. Al-
167 L.Ed.2d 705 (2007); Graham, 383 lergan, 2013 WL 286251, at *10. The
U.S. at 17–18. district court determined that secondary
considerations additionally weighed in
The district court held that the '029 favor of non-obviousness, based on its
patent was non-obvious, based princip- finding that the invention of the '029 pat-
ally on its finding that there was no mo- ent was an unexpected result (for the
tivation to combine Johnstone and the ' same reasons that it found a lack of reas-
819 patent due to “pharmacological dif- onable expectation of success), as well as
ferences” between the compounds that the commercial success of Latisse® and
each reference discloses. Allergan, 2013 the paucity of competing hair growth
WL 286251, at *9. Specifically, the '819 treatments.
patent discloses a list of thirteen chemical
compositions for 17–phenyl PGF ana- The district court reached its conclu-
logs, which were like those disclosed in sion of nonobviousness by looking only
Johnstone in that they contain a C5–C6 at properties of the C1–amide group and,
double bond and have demonstrably high particularly, bimatoprost. In doing so, the
pharmaceutical activity in treating in- district court erred by failing to take into
traocular pressure with minimal side ef- account the full scope of the '029 patent
fects. '819 patent col.3 ll.9–18, col.7 claims.FN4 “[T]he person of ordinary
ll.19–57. However, the '819 patent's com- skill need only have a reasonable expect-
pounds contain a C1–amide group where- ation of success of developing the
as Johnstone generally discloses com- claimed invention. ” Allergan, Inc. v.
pounds with esters or carboxylic acids at Sandoz Inc., 726 F.3d 1286, 1292
the C1 location. The district court was (Fed.Cir.2013) (emphasis added). The '
persuaded by Allergan's expert that it was 029 patent is not limited to compounds
understood at the time of the invention of with a C1–amide group, such as bimato-
the '029 patent that because of this prost or the broader class of compounds
C1–amide group, bimatoprost and the described in the '819 patent. The scope of
other 17–phenyl PGF analog composi- the independent claims of the ' 029 patent
tions disclosed in the '819 patent were encompasses thousands of permutations
thought to bind to a receptor other than of PGF analogs, including structures with
the FP receptor. all kinds of functional groups at the C1
location, such as carboxylic acids, alkyl
As a result, even though the '819 pat- carboxylates, and hydroxyls.FN5 Given
ent compounds were like the Johnstone the breadth of the '029 patent's claimed
compounds in that they were 17–phenyl invention, appellants did not have the ex-
PGF analogs that had proved effective in acting burden of showing a reasonable
treating glaucoma, the district court expectation of success in using the nar-
agreed that a person of ordinary skill row class of PGF analogs with C1–amide
would not have been motivated to use groups to treat hair loss, let alone a reas-
any C1–amide compounds to treat hair onable expectation of success in using
loss. The district court found that such bimatoprost in particular. Appellants in-

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stead had the burden of showing that any have found it replete with references to
compounds within the broad genus the advantages of using 17–phenyl PGF
claimed by the '029 patent, including compounds generally, including those
those that did not have C1–amide groups, with carboxylic acids, esters, and other
were obvious at the time of the invention. related groups at the C1 location—all
covered by the '029 patent' s claims. We
*8 The district court's reasoning was do agree with the district court that John-
especially problematic because the fea- stone does not “clearly and unequivocally
ture of bimatoprost that it relied on was disclose” compounds that also include a
that it and the other PGF analogs with a C5–C6 saturated bond to the extent that it
C1–amide group disclosed in the '819 would anticipate the '029 patent, as ex-
patent bind to a variant of the FP recept- plained above in section II.A.1.a. This
or.FN6 Neither the district court nor ap- does not diminish, however, the fact that
pellees explain the nexus between this Johnstone does suggest the possibility of
finding and the broad scope of '029 pat- using a PGF analog structure that would
ent's claimed invention. The '029 patent's include such a bond, merely without ad-
claimed invention is not unique to PGF equate explanation within the reference
analogs that bind the variant FP receptor. itself. See Johnstone at 12 ll.22–24. A
The '029 patent also claims compounds motivation to combine may be implicit in
that do bind the garden-variety FP recept- the prior art—silence does not imply
or, such as C1–esters and C1–carboxylic teaching away. Syntex (U.S.A.) LLC v.
acids. Indeed, almost every disclosed ex- Apotex, Inc., 407 F.3d 1371, 1380
emplar in the '029 patent describes one of (Fed.Cir.2005); Alza Corp. v. Mylan
the latter compounds. The district court's Labs., Inc., 464 F.3d 1286, 1291
improperly limited analysis meant that it (Fed.Cir.2006) (rejecting the necessity of
did not answer the question prerequisite an express disclosure of motivation
to its conclusion. The district court where it “may be found implicitly in the
needed to have found that other embodi- prior art”). Johnstone's mere disclosure of
ments falling within the claim will be- alternative preferences does not teach a
have in the “same manner” as compounds person of ordinary skill away from the
with C1–amide groups, in order to estab- broad swath of compounds within the
lish that evidence of unexpected results scope of the '029 patent. In re Fulton, 391
“is commensurate with the scope of the F.3d 1195, 1201 (Fed.Cir.2004).
claims.” FN7 In re Huai–Hung Kao, 639
F.3d 1057, 1068 (Fed.Cir.2011). The dis- *9 Johnstone does not even teach
trict court failed, however, to make a away from compounds that bind variant
finding on how the C1–amide com- forms of the FP receptor. On the contrary,
pounds' property of binding to the variant Johnstone even provides an alternative
FP receptor necessarily applied to the preference for the PGF analogs that were
reasonable expectation of success for the known to have different FP receptor
full scope '029 patent's claimed invention, binding properties—the vasodilatory
which included the utility of compounds compounds taught in the parent of the '
that bound the normal FP receptor to treat 819 patent, U.S. Patent No. 5,352,708.
hair loss. Johnstone at 17 ll.13–15. FN8 The con-
clusion of Johnstone's detailed descrip-
The district court compounded its er- tion makes this clear. What Johnstone un-
ror by taking an overly cramped view of equivocally teaches is that
what the prior art teaches. The person of “[p]rostaglandin derivatives that exhibit
ordinary skill reading Johnstone would high pharmacological activity and no or

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only very small side effects, such as [ growth is generally an unpredictable en-
latanoprost] and its carboxylic acid es- deavor—the question is more narrowly
ters, are also presently particularly pre- whether the success of using selective
ferred, especially in use in large areas of PGF analogs to treat hair loss would be
the skin and the scalp.” Id. at 22 ll.21–23 reasonably unpredictable. The district
(emphasis added). Johnstone discloses a court and the dissent commit the same er-
preference for PGF analogs that had ror of examining the state of the art be-
already been identified and were known fore the time of the invention. See Dis-
in the art to have selective pharmacolo- senting Op. at 9. Once Johnstone was
gical activity, irrespective of whether published, the general characteristics of
such activity was due to binding to the FP the hair growth art ceased to be relevant.
receptor or a variant, as well as whether Johnstone taught that PGF analogs could
there was a saturated or unsaturated bond be used to grow hair. Indeed, Johnstone
at the C5–C6 location. The dissent inap- even more specifically taught that PGF
positely emphasizes the complexity of analogs that were effective glaucoma
changing a bond at this location, imply- drugs could grow hair. Therefore, the
ing that the '029 patent represents com- correct question, at the time of the '029
pounds that are newly isolated or syn- patent's invention, was whether there was
thesized over those of Johnstone. Dis- anything “unpredictable and mysterious”
senting Op. at 5–6. However, following about a PGF analog that could treat
Johnstone, there was nothing left for a glaucoma growing hair.
chemist to do. As discussed above, John-
stone taught squarely towards a new util- *10 [13] On this point, the district
ity for a finite set of already identified court chiefly cited the failure of certain
and isolated compounds with properties therapeutic PGF analogs to grow
that had already been characterized—for hair—remarkably, even though eyelash
example, as disclosed in the '708 and '819 growth was a known potential side effect
patents. of one of the two cited examples. FN9
Even so, “[o]bviousness does not require
The district court also did not find absolute predictability of success.” In re
any express teaching away in the art as a O'Farrell, 853 F.2d 894, 903
whole. The district court did find that the (Fed.Cir.1988). What does matter is
prior art included PGF analogs other than whether the prior art gives direction as to
those disclosed in Johnstone that had what parameters are critical and which of
identical physiological effects, as evinced many possible choices may be successful.
by the '819 patent's disclosure of thirteen Id.; Pfizer, Inc. v. Apotex, Inc., 480 F.3d
such compounds, including bimatoprost, 1348, 1366 (Fed.Cir.2007). Johnstone did
that could be used in reducing intraocular not make a general exhortation covering
pressure and thereby treating glaucoma. thousands of possibilities—its teaching
However, the district court concluded focused on specific classes of composi-
that in the context of hair growth as a tions of PGF analogs with specifically
generally “unpredictable and mysterious” described structures and properties that
art, any difference in the chemical activ- guided persons of ordinary skill in the art
ity of a PGF analog, even one with a to compounds with similar structures that
structure very similar to one claimed by would fall within the scope of the '029
the '029 patent, would be sufficient to patent's claims. See Altana Pharma AG v.
teach away. Teva Pharm. USA, Inc., 566 F.3d 999,
1007 (Fed.Cir.2009) (“Obviousness
But, it does not matter whether hair based on structural similarity may be

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proven by the identification of some mo- court weigh towards the conclusion of
tivation that would have led one of ordin- obviousness. The validity of the '029 pat-
ary skill in the art to select and modify a ent rests on the provisos that exclude cer-
known compound in a particular way to tain PGF analog structures from its claim
achieve the claimed compound.”). While scope, which were designed to avoid anti-
success in employing the disclosed com- cipation by Johnstone. As discussed
pounds to treat hair loss may not have above, however, Johnstone contains a
been guaranteed, Johnstone's teaching plethora of teaching towards PGF analog
provided sufficient guidance as to what structures that are outside the scope of
parameters would lead to a reasonable ex- the provisos, including an express sug-
pectation of success. gestion to employ compositions with sat-
urated C5–C6 bonds, as well as teaching
The district court's findings on sec- to PGF analogs that are selective in hav-
ondary considerations suffer from the ing maximized therapeutic effect with
same infirmity of lacking a nexus with minimized side effects. The '029 patent
the scope of the '029 patent's claimed in- claims many different kinds of PGF ana-
vention. It is the established rule that log structures, including PGF analogs
“objective evidence of non-obviousness with both unsaturated and saturated
must be commensurate in scope with the C5–C6 bonds, as well as PGF analogs
claims which the evidence is offered to that both bind the FP receptor and its
support.” Application of Tiffin, 58 variant. The district court's finding that
C.C.P.A. 1420, 448 F.2d 791, 792 (CCPA bimatoprost and the '819 patent's other
1971); see also MeadWestVaco Corp. v. disclosed compounds only bind the vari-
Rexam Beauty & Closures, Inc., 731 F.3d ant FP receptor is not relevant to the '029
1258, 1264–65 (Fed.Cir.2013); In re patent's actual claimed invention. Ac-
Huai–Hung Kao, 639 F.3d at 1068; In re cordingly, the district court made no find-
Peterson, 315 F.3d 1325, 1331 ing that would diminish the more probat-
(Fed.Cir.2003); In re Hiniker Co., 150 ive facts supporting a person of ordinary
F.3d 1362, 1369 (Fed.Cir.1998). As dis- skill's substantial reasonable expectation
cussed above, the district court's findings of success and motivation to use PGF
on unexpected results, which were analogs with high pharmacological activ-
closely intertwined with its analysis of ity and structures similar to those dis-
motivation to combine and reasonable ex- closed in Johnstone to treat hair loss.
pectation of success, were not commen- Even if we were to determine that the
surate with the full scope of the patent's aforementioned flaws in the district
claims. court's analysis do not rise to the level of
clear error, the evidence of commercial
In sum, even if the district court did
success cannot on its own remedy the dis-
not commit clear error in its findings of
trict court's other errors leading to its
fact, failure to consider the appropriate
overall conclusion of non-obviousness.
scope of the '029 patent's claimed inven- FN10
tion in evaluating the reasonable expecta-
tion of success and secondary considera- *11 We therefore reverse the district
tions constitutes a legal error that we re- court's finding that the asserted claims of
view without deference. the '029 patent are non-obvious.
[14] Taking an appropriate view of B. '404 Patent
the scope of the '029 patent's claimed in- 1. Brandt References
vention, the facts found by the district The '404 patent emerged from the res-

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ults of Allergan's clinical trials evaluating The first two Brandt references are in-
the safety and efficacy of bimatoprost disputably prior art under § 102(b), as
eyedrops for glaucoma treatment, which they were published more than one year
were subsequently marketed as Lumigan before the priority date of the ' 404 patent
®. Appellants identify four publications , February 4, 2002. These references do
of clinical trials that they allege disclose not, however, expressly refer to bimato-
the ability of bimatoprost to promote eye- prost. A person of ordinary skill hence
lash hair growth (collectively the “Brandt would be unaware that the results repor-
references”). Appellants argue that, ted therein were associated with bimato-
among other grounds for invalidity, the prost. With respect to the more fulsome
Brandt references would render the '404 May and June 2001 references, the dis-
patent obvious in light of Johnstone. The trict court found that the '404 patent was
Brandt references include the following: invented prior to their publication date
and, therefore, that the references were
a presentation given by Dr. James not prior art under § 102(a).FN11
Brandt, a clinical investigator working
on Lumigan®, to the American a. Date of Invention
Academy of Ophthalmology Meeting [15][16][17][18] The invention date is
on October 23, 2000, disclosing three the date of conception. Invitrogen Corp.
month results from a bimatoprost eye- v. Clontech Labs., Inc., 429 F.3d 1052,
drop trial, which identifies the drug 1063 (Fed.Cir.2005). Conception is “the
only by the name “ Lumigan,” stating formation in the mind of the inventor, of
that more than 5% of patients experi- a definite and permanent idea of the com-
ence eyelash growth; plete and operative invention, as it is
hereafter to be applied in practice.” Bur-
a press release issued by Allergan on roughs Wellcome Co. v. Barr Labs., Inc.,
October 23, 2000, containing the same 40 F.3d 1223, 1228 (Fed.Cir.1994). The
information as the October 23, 2000 issue of the conception date of an inven-
presentation; tion is a legal conclusion based on under-
lying factual findings. Taurus IP, LLC v.
a publication by Drs. Sherwood and
DaimlerChrysler Corp., 726 F.3d 1306,
Brandt entitled “Six–Month Comparis-
1322 (Fed.Cir.2013). While defendants
on of Bimatoprost Once–Daily and
bear the burden of persuasion to show
Twice–Daily with Timolol
that the Brandt references are prior art to
Twice–Daily in Patients with Elevated
the '404 patent by clear and convincing
Intraocular Pressure” in Survey of Oph-
evidence, the patentee nevertheless must
thalmology in May 2001 disclosing that
meet its burden of production to demon-
in a six month glaucoma study, eyelash
strate an earlier conception date.
growth was reported in between 35 and
Mahurkar v. C.R. Bard, Inc., 79 F.3d
48% of patients receiving bimatoprost,
1572, 1577 (Fed.Cir.1996).
depending on dose;
*12 [19] In evaluating the patentee's
a publication by Drs. Brandt, VanDen-
evidence of conception date, courts “must
burgh (a named inventor of the '404
give due regard to the trial court's oppor-
patent), Chen, and Whitcup in Ophthal-
tunity to judge the witnesses' credibility.”
mology in June 2001 disclosing that in a
Fed.R.Civ.P. 52(a)(6). The court's inquiry
three month study, eyelash growth was
is guided by the principle that “[i]t is well
reported in between 25.6% and 33.7%
established that when a party seeks to
of patients receiving bimatoprost, de-
prove conception via the oral testimony
pending on dose.

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of a putative inventor, the party must Pittsburgh v. Hedrick, 573 F.3d 1290,
proffer evidence corroborating that testi- 1298 (Fed.Cir.2009). Rather, this is a
mony.” Shu–Hui Chen v. Bouchard, 347 case in which there is no corroborating
F.3d 1299, 1309 (Fed.Cir.2003). In par- document that shows anything about the
ticular, the “definite and permanent” idea claimed invention. The only corrobora-
required for conception “must be suppor- tion of the claimed invention is the oral
ted by corroborating evidence.” Bur- testimony of an inventor, which we must
roughs Wellcome, 40 F.3d at 1230. treat with skepticism due to the possibil-
ity of an inventor's self-interest in obtain-
The district court found that the con- ing or maintaining an existing patent.
ception date of the '404 patent was in Shu–Hui Chen, 347 F.3d at 1309; Price v.
mid–2000 based on the following facts: Symsek, 988 F.3d 1187, 1994
(i) Dr. Woodward's credible testimony (Fed.Cir.1993).
that he reached a “concrete conclusion”
that topical application of bimatoprost [20] The district court, therefore,
would grow hair in mid–2000, (ii) Dr. committed clear error in finding corrob-
VanDenburgh's credible testimony of oration of an earlier priority date in docu-
meeting with patent attorneys between ments that collectively do not include any
late 2000 and early 2001 to discuss the description of the claimed invention of
invention, and (iii) internal Allergan the '404 patent. As the only other poten-
memoranda reporting eyelash growth in tially corroborating evidence of concep-
clinical trials, which were received by tion is the oral testimony of a co-in-
Drs. Woodward and VanDenburgh in ventor, we reverse the district court's
early 2000. Allergan, 2013 WL 286251, finding that the ' 404 patent was con-
at *7. ceived prior to the date of publication of
the May and June 2001 Brandt refer-
The problem is that to the extent there ences.
is any documentary evidence, it does not
relate to the claimed invention of the '404 b. Authorship of the Brandt References
patent—the topical application of bimato- *13 [21] Appellees argue that even if
prost for use to promote eyelash hair the '404 patent cannot claim an earlier
growth. The Allergan memoranda refer priority date, the later Brandt references
only to eyelash growth resulting from the are still not § 102(a) art as they represent
administration of eyedrops. The memor- the work of the inventors themselves.
anda reported the side effects of bimato- “[O]ne's own work is not prior art under
prost used in eyedrops and did not dis- § 102(a) even though it has been dis-
close the claimed invention of topical ap- closed to the public in a manner or form
plication for intended therapeutic effect. which otherwise would fall under §
The only evidence that corroborates Dr. 102(a).” In re Katz, 687 F.2d 450, 454
Woodward's testimony that he conceived (CCPA 1982). Appellees claim that the
of topical application of bimatoprost in Brandt references are the product of the '
mid2000 is the oral testimony of his co- 404 patent's co-inventor Dr. VanDen-
inventor, Dr. VanDenburgh. This is not burgh's work in designing and directing
one of the cases cited by appellees in the Lumigan® clinical trials. Appellees
which corroborating evidence is found rely predominately on Dr. VanDen-
through multiple written documents, such burgh's testimony regarding her role in
as a collection of engineering notebooks. the clinical trials, in which she described
Spansion, Inc. v. Int'l Trade Comm'n, 629 her role supervising and managing the
F.3d 1331, 1356 (Fed.Cir.2010); Univ. of work being done by various clinical study

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locations, including writing internal alone directed clinical trials and wrote in-
memoranda and reports. This, appellees ternal reports. J.A. 508, 540–41. Second,
contend, amounts to Dr. Brandt and other while she was at least a co-author of one
authors of the Brandt references being a Brandt reference in dispute, along with
“pair of hands” for the '404 patent's in- two other Allergan scientists, Dr.
ventors, in particular Dr. VanDenburgh. VanDenburgh was not listed as a co-
Mattor v. Coolegem, 530 F.2d 1391, 1395 author at all in the other one. Brandt's
(CCPA 1976). May 2001 journal article includes one co-
author, Dr. Sherwood, also unaffiliated
Appellants argue that, as an initial with Allergan. The author line of the lat-
matter, appellees did not timely raise this ter article describes it as being written
issue. To the extent that appellees did ar- “for the Bimatoprost Study Group 1 or
gue this point, it appears to have been 2,” referring to a long list of study group
during closing arguments and post-trial members—a list in which Dr. VanDen-
briefing.FN12 However, under Fourth burgh's name does not appear. J.A.
Circuit law, appellees may have waived 2413–14. The fact that a reference does
the issue of the Brandt references' author- not list any co-inventors as authors, or
ship by not presenting it in pretrial brief- that it lists other authors, is certainly not
ing, even if appellees raised it later. See dispositive in itself. However, in this
McLean Contracting Co. v. Waterman case, whether Dr. VanDenburgh super-
Steamship Corp., 277 F.3d 477, 480 (4th vised the logistics of the clinical trial on
Cir.2002) (“Failure to identify a legal is- her own or not, appellees have not pro-
sue worthy of trial in the pretrial confer- duced evidence that shows she was re-
ence or pretrial order waives the party's sponsible for directing the production of
right to have that issue tried.”). either article's content, which includes the
design, trial, and analysis of results.
[22] Even if appellees did not waive
There is no evidence, therefore, that ap-
this issue, their belated arguments raised
pellees' explanation of the Brandt refer-
towards the end of trial are unavailing.
ences is in any way consistent with the
First and foremost, the question is not
content of the articles and the nature of
whether, as appellees seem to argue, Dr.
the publications. In re Katz, 687 F.2d at
VanDenburgh or Dr. Brandt was the first
455.
to recognize bimatoprost's potential
therapeutic value for eyelash hair growth. *14 Since appellees have produced no
Appellants do not argue that the Brandt evidence—unsurprising given their be-
references expressly teach bimatoprost's lated recourse to this argument—and
intentional use to grow hair—that is, they provided no supported explanation
do not argue inventorship. The relevant demonstrating that the Brandt references
inquiry must be whether the Brandt refer- were in fact printed publications authored
ences, which describe the methods, de- by Dr. VanDenburgh for the purposes of
tailed results, statistical analysis and dis- § 102(a), we see no reason to remand to
cussion of bimatoprost clinical trials, make further findings on this issue. The
were solely Dr. VanDenburgh's work and question of whether a reference is a work
hers alone. In re Katz, 687 F.2d at 455. of others for the purposes of § 102(a) is,
On this, appellees' explanations strain like that of inventorship, a question of
reason. law based on underlying facts. Ethicon,
Inc. v. U.S. Surgical Corp., 135 F.3d
First, Dr. VanDenburgh's testimony
1456, 1460 (Fed.Cir.1998). Even if ap-
was at best equivocal as to whether she
pellees had not waived their arguments

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on this point, the evidence appellees eyelid. Johnstone at 22 ll.28–35. John-


presented at trial could not support the stone also discloses the topical applica-
legal conclusion that the Brandt refer- tion of latanoprost to treat hair loss. In
ences represented Dr. VanDenburgh's light of the Brandt reference's disclosure
own work. See Soverain Software LLC v. of bimatoprost's effect in growing eyelash
Newegg Inc., 705 F.3d 1333, 1337 hair, a person of ordinary skill in the art
(Fed.Cir.2013) amended on reh'g, 728 would have had substantial motivation to
F.3d 1332 (Fed.Cir.2013) and cert. follow Johnstone and use topical applica-
denied, ––– U.S. ––––, 134 S.Ct. 910, tion of bimatoprost to grow eyelash hair.
187 L.Ed.2d 779 (2014) (declining to re-
mand for further factual findings on obvi- Likewise, the Brandt references
ousness where there was no material fac- provided a reasonable expectation of suc-
tual dispute and the legal conclusion was cess for the topical application of bimato-
apparent). Accordingly, we hold that the prost. Clinical trials showed that nearly
Brandt references are prior art to the '404 50% of patients using bimatoprost in eye-
patent. drop form were experiencing eyelash hair
growth. Johnstone additionally taught
2. Invalidity that fluid contacting the eyelid from eye-
[23] The district court's findings on drops was the likely mechanism of hair
the obviousness of the '404 patent were growth. Appellees' only remaining argu-
limited to reiterating that the May and ment for nonobviousness in light of the
June 2001 Brandt references were not pri- Brandt references is the secondary con-
or art (as a consequence of its finding on sideration of commercial success, which
the mid–2000 invention date of the '404 is unavailing on its own.
patent) and that the '404 patent was not
obvious in light of Johnstone alone. Al- *15 Given the overwhelming weight
lergan, 2013 WL 286251, at *10. The of evidence, remand is unnecessary “as
district court did make findings regarding here, the content of the prior art, the
inherent anticipation in light of the two scope of the patent claim, and the level of
earlier Brandt references. Paralleling its ordinary skill in the art are not in material
reasoning on inherent anticipation by the ' dispute, and the obviousness of the claim
819 patent, as discussed above in section is apparent in light of these factors.” Sov-
III .A. 1.b, the district court found that erain, 705 F.3d at 1337 (citing KSR, 550
the disclosure of 48.4% incidence of eye- U.S. at 427). Accordingly, we reverse the
lash growth did not inherently anticipate. district court's finding that the '404 patent
Id. at *8. While we need not reach the is not invalid for reasons of obviousness.
question of whether the district court's in-
CONCLUSION
ference represents clear error, we do note
For the foregoing reasons, we reverse
that the Brandt references disclose a sub-
the district court's invalidity findings on
stantial rate of eyelash hair growth as a
the asserted claims of both the '029 and '
side effect of using bimatoprost in eyed-
404 patents, and we vacate the court's in-
rops.
junction accordingly.FN13
Johnstone details at length how eyed-
REVERSED AND VACATED
rops containing latanoprost (marketed as
the glaucoma drug Xalatan ®) promote CHEN, Circuit Judge, dissenting-in-part.
the eyelash hair growth through the I join the majority opinion except for
mechanism of fluid containing latano- Part II.A.2, which reverses the district
prost making topical contact with the court's conclusion that Appellants failed

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to meet their burden of proving that the for treating hair loss. But that reference
prior art rendered the '029 patent obvious does not teach or sufficiently suggest us-
by Johnstone, either alone or in combina- ing a prostaglandin with a saturated (i.e.,
tion with the '819 patent. In my view, single) C5 –C6 bond on the alpha chain,
Johnstone's teachings are simply too as claimed in the '029 patent. Instead,
vague and equivocal to justify invalidat- Johnstone serves up a menu of seemingly
ing the patent. Therefore, I respectfully unlimited possibilities. For example,
dissent. when it comes to the alpha chain, John-
stone states that the good ones are those
To begin with, issued patents enjoy a characterized by “the presence or lack of
presumption of validity, which can only various modifications of the alpha chain.”
be rebutted by clear and convincing evid- J.A. 2293. Then, for the omega chain,
ence. Microsoft Corp. v. i4i Ltd. P'ship, Johnstone again states that preferred
––– U.S. ––––, –––– – ––––, 131 S.Ct. prostaglandins are those characterized by
2238, 2245–46, 180 L.Ed.2d 131 (2011). the “presence or lack of modifications to
A party challenging a patent's validity their omega chain.” Id. Such a broad,
must do so with “evidence which pro- generic disclosure would appear to cover
duces in the mind of the trier of fact an almost any conceivable prostaglandin.
abiding conviction that the truth of [the] And among a variety of other possible
factual contentions are highly probable.” modifications for the chains, Johnstone
Buildex Inc. v. Kason Indus., Inc., 849 vaguely states that the alpha chain “could
F.2d 1461, 1463 (Fed.Cir.1988) (citing preferably be a C6 –C10 chain which can
Colorado v. New Mexico, 467 U.S. 310, be either saturated or unsaturated, having
316, 104 S.Ct. 2433, 81 L.Ed.2d 247 one or more double bonds, and allenes or
(1984)). This is not a burden that is easily a triple bond.” J.A. 2293. This lone sen-
satisfied. tence does not provide a sufficient blaze
mark for using a saturated C5 –C6 bond.
Moreover, the majority relies heavily
For the same reason that I agree with the
on Johnstone alone, but the Patent Office
majority that Johnstone does not anticip-
specifically considered that reference
ate the claimed compounds—it does not
during the prosecution of the ' 029 patent
“clearly and unequivocally” disclose a
and came to the same conclusion that the
compound with a saturated C5 –C6
fact-finder did below: Johnstone does not
bond—I would find that it does not sug-
render the claims obvious. As a review-
gest one either. The specification con-
ing court, we should be particularly care-
tains no other language or examples of
ful before overturning the verdict under
saturated alpha chains and certainly no
these circumstances. See Tokai Corp. v.
references to saturating the specific bond
Easton Enterprises, Inc., 632 F.3d 1358,
at issue. The dozens of figures and sum-
1367 (Fed.Cir.2011) (explaining that the
mary of the invention only depict an un-
burden of proof to invalidate a patent
saturated (i.e., double) C5 –C6 bond, and
claim is more difficult to meet when the
Johnstone's claims cover only compounds
challenge is based on the same prior art
with this bond. The steady and persistent
considered by the Patent Office during
message from the entirety of Johnstone's
examination).
teachings is clear: when it comes to the C
The majority is correct that Johnstone 5–C6 bond, keep it unsaturated.
contemplates a large class of prostagland-
*16 Also, as the majority recognizes,
ins—the 17–phenyl PGF2 analog com-
the patentee amended the claims during
pounds—citing latanoprost in particular,
prosecution to add a proviso carving out

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the Johnstone compounds, which resulted –C6 bond in Johnstone's compounds


in a notice of allowance. The notice of al- would have destroyed the critical binding
lowance even pointed out that the property of the compounds. Id. at 30
amended claims were not obvious over (“Before [the inventor of the ' 029 patent]
Johnstone: discover[ed] that saturated prostaglandin
F analogs could bind, this double bond
The prior art teaches the use of was thought vital for FP-receptor bind-
prostaglandins for treating hair loss (see ing.”). The '029 patent's compounds have
for example, WO 98/33497 [Johnstone] saturated C5 –C6 bonds but do, in fact,
). However, the prior art lacks motiva- bind to the FP-receptor (contrary to popu-
tion to modify the prostaglandins taught lar belief at the time), which further sug-
therein in order to obtain the presently gests nonobviousness. See DePuy Spine,
claimed prostaglandins, and thus, does Inc. v. Medtronic Sofamor Danek, Inc.,
not teach or suggest the presently 567 F.3d 1314, 1326 (Fed.Cir.2009) (“An
claimed invention. inference of nonobviousness is especially
strong where the prior art's teachings un-
J.A. 5564. In light of the particularly
dermine the very reason being proffered
heavy burden to show obviousness over a
as to why a person of ordinary skill
reference disclosed during prosecution
would have combined the known ele-
and discussed by the examiner, Appel-
ments.”). The majority finds no clear er-
lants have not shown that Johnstone now
ror in the district court's acceptance of
somehow teaches or suggests the very
this undisputed fact for purposes of anti-
structural feature that the patentee
cipation. See Majority Op. at 10. I would
claimed to distinguish the Johnstone
also find that the district court correctly
compounds.
concluded that it would not have been ob-
Nothing in the record compels a dif- vious to a person of ordinary skill at the
ferent result. Allergan's expert, Dr. Mac- time of invention to change the unsatur-
Donald, testified that a person of ordinary ated C5 –C6 bond in Johnstone's com-
skill would not have saturated John- pounds to a saturated bond. See DePuy,
stone's C5 –C6 double bond because “[i]t 567 F.3d at 1326 (suggesting nonobvi-
was considered to be a very important ousness “if the prior art indicated that the
parameter in binding to the FP receptor.” invention would not have worked for its
J.A. 1773. Prostaglandins bind to recept- intended purpose or otherwise taught
ors on the surface of cells, and that bind- away from the invention”); Eli Lilly &
ing creates a signal to the cell to change Co. v. Zenith Goldline Pharm., Inc., 471
its properties or functions. At the time of F.3d 1369, 1378 (Fed.Cir.2006) (holding
invention, it was well-understood that prior art supplied no motivation to modi-
identifying which receptors a fy compound to include claimed structur-
prostaglandin can bind to is key to al features because no reasonable expect-
designing a drug that affects the cells. See ation of success).
J.A. 23 (“Studying receptors is central to
*17 This is not a situation in which
pharmacology—the science of drug
there are a finite number of identified,
therapeutics—because knowing what re-
predictable solutions. See KSR Int'l Co. v.
ceptors are associated with a biological
Teleflex Inc., 550 U.S. 398, 421, 127
effect aids in designing a drug to [bind
S.Ct. 1727, 167 L.Ed.2d 705 (2007).
to] those receptors and produce or inhibit
Rather, the single sentence in Johnstone
that effect.”). And, at that time, the state
actually proposes hundreds of thousands,
of the art suggested that saturating the C5
or even millions, of variations on the al-

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pha chain.FN1 Cf. Eli Lilly, 471 F.3d at notion that it would be obvious to treat
1376 (prior art reference that disclosed hair loss using any prostaglandin that ex-
millions of compounds did not spell out hibits “high pharmacological activity.”
“a definite and limited class of com- See Sanofi–Synthelabo v. Apotex, Inc.,
pounds that enabled a person of ordinary 550 F.3d 1075, 1088 (Fed.Cir.2008)
skill in the art to at once envisage each (“Only with hindsight knowledge that the
member of this limited class”). The com- dextrorotatory enantiomer has highly de-
pound in Johnstone could have a satur- sirable properties, can Apotex argue that
ated bond at any position on the alpha it would have been obvious to select this
chain, an unsaturated bond at any posi- particular racemate and undertake its ar-
tion, a triple bond at any position, or even duous separation.”).
a combination of any of these bonds. As a
result, a person of ordinary skill in the art I also depart from the majority's com-
was not faced with a “small or easily tra- bination of Johnstone with the '819 patent
versed” number of options based on . Following the Appellants' argument, the
Johnstone. See Bayer Schering Pharma majority links Johnstone's methods of
AG v. Barr Labs., Inc., 575 F.3d 1341, treating hair loss and the '819 patent's
1347 (Fed.Cir.2009) (“[A]n invention methods of treating glaucoma by looking
would not have been obvious to try when to the vasodilation properties shared by
the inventor would have had to try all the compounds in those references. Ma-
possibilities in a field unreduced by dir- jority Op. at 19–20. I find Johnstone's
ection of the prior art.”). In this instance, discussion of vasodilation too ambiguous
covering everything effectively tells us to amount to a clear motivation to com-
nothing. See Bayer, 575 F.3d at 1347 bine.
(“When what would have been obvious to
*18 For example, Johnstone states
try would have been to vary all paramet-
that “PGF2 alpha analogs can cause a
ers or try each of numerous possible
vasodilation effect and through that
choices until one possibly arrived at a
mechanism may provide enhanced perfu-
successful result, where the prior art gave
sion to the region of the hair bulb and
either no indication of which parameters
thus stimulate increased trophic activity
were critical or no direction as to which
in the hair follicles.” J.A. 2291–92
of many possible choices is likely to be
(emphasis added). That Johnstone frames
successful an invention would not have
his vasodilation theory in somewhat un-
been obvious.”) (internal quotations omit-
certain terms (“may”) is not surprising
ted).
since he later acknowledges that his rep-
The majority further reasons that it resentative prostaglandin derivative,
would have been obvious to select the latanoprost, “was specifically tailored to
claimed compounds because they, like eliminate ... vasodilation.” Id. at 2290.
Johnstone's compounds, also “exhibit Ultimately, Johnstone surmises that there
high pharmacological activity and no or are “several possible mechanisms that
very small side effects.” Majority Op. at may individually or in concert explain the
20. But the fact that we now know that altered growth pattern of hair follicles ob-
the claimed compounds contain highly served in the current clinical study.” Id.
desirable properties should not compel us at 2291. This level of uncertainty in John-
to conclude that this would have been ob- stone cannot then establish motivation to
vious at the time of invention, especially combine with the '708 patent and then
when there is no expert testimony or oth- with '819 patent. Unlike the Brandt refer-
er evidence in the record supporting the ences, which suggested that bimatoprost

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could be used to grow hair, the '708 and ' the '819 patent.
819 patents have nothing to do with hair
growth. These patents concern treatment It is undisputed that the field of hair
methods for glaucoma. Appellants have growth is “unpredictable and mysteri-
not established by clear and convincing ous.” See J.A. 38. The majority errs in
evidence that a person of ordinary skill in minimizing this unpredictability. Major-
the art would look to these references for ity Op. at 21 (“But, it does not matter
solutions in the hair growth field. This is whether hair growth is generally an un-
especially true when the correlation predictable endeavor....”). Our case law
between vasodilation and hair makes plain: unpredictability is a factor.
growth—the alleged link between John- Eisai Co. Ltd. v. Dr. Reddy's Labs., Ltd.,
stone and the '819 patent—is so speculat- 533 F.3d 1353, 1359 (Fed.Cir.2008) (“To
ive. See Star Scientific, Inc. v. R.J. Reyn- the extent an art is unpredictable, as the
olds Tobacco Co., 655 F.3d 1364, 1376 chemical arts often are ... potential solu-
(Fed.Cir.2011) (reference's discussion of tions are less likely to be genuinely pre-
what “might” or “may” or “seems” to dictable.”). In light of our case law and
lead to nitrite and TSNA production does the unpredictability of hair growth, Ap-
not suggest obviousness). pellants have not satisfied their burden of
showing clear and convincing evidence
Appellants further assert that one of of obviousness.
ordinary skill in the art would use the
compounds disclosed in the '819 patent *19 Accordingly, looking at the evid-
with Johnstone's method of stimulating ence of obviousness as a whole, I would
hair growth because Johnstone refers to find that the district court did not clearly
the '708 patent, which is the parent of the err in holding the asserted claims of the '
'819 patent. 029 patent nonobvious. For these reasons,
I respectfully dissent.
But Johnstone's link to the '819 patent
via the '708 patent is tenuous at best.
FN* Sharon Prost assumed the po-
Johnstone describes “preferred derivat-
sition of Chief Judge on May 31,
ives” for hair growth as those compounds
2014.
lacking a phenyl ring structure in their
omega chains, such as those described in
the '708 patent. J.A. 2298. Any motiva- FN1. The America Invents Act
tion to combine Johnstone with the com- (“AIA”), Pub.L. No. 112–29, took
pounds of the '819 patent via the '708 pat- effect on September 16, 2012. Be-
ent is then confined to those compounds cause the applications for the pat-
lacking a phenyl ring structure. The '819 ents at issue in this case were filed
patent, however, teaches bimatoprost, before that date, we refer to the
which has a phenyl ring structure in its pre-AIA versions of §§ 102 and
omega chain. Thus, as the majority con- 103.
cedes, “the list of compounds expressly
disclosed [in Johnstone] as being vas- FN2. Not all asserted claims of
odilatory in the '708 patent exclude the the '029 patent are limited to top-
17–phenyl PGF analogs that the '819 pat- ical application, and irrespective
ent discloses.” Majority Op. at 20 n.8. of the answer to this more narrow
Consequently, Johnstone's reference to question, those claims may be in-
the '708 patent simply does not amount to herently anticipated by the '819
a motivation to combine Johnstone with patent' s disclosure of systemic

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administration. Appellants do not patent, which describes the func-


raise this issue, and in any event, tional group at the C1 location as
appellees assert claim 14, which is “R 1,” recites that it claims struc-
so limited. tures “wherein R 1 is selected
from the group consisting of
FN3. Appellants raise the same ar- C(O)OH, C(O)NHOH, C(O)OR 3,
guments regarding inherent anti- CH2OH, S(O)2R 3, C(O)NHR 3,
cipation of the asserted claim of C(O)NHS(O)2R 4, tetrazole, a
the '404 patent, which similarly cationic salt moiety, a pharma-
claims the topical application of ceutically acceptable amine or es-
bimatoprost specifically as a ter comprising 2 to 13 carbon
method of promoting eyelash atoms, and a biometabolizable
growth. We affirm the district amine or ester comprising 2 to 13
court's finding of no inherent anti- atoms.”
cipation of the '404 patent on the
same grounds as explained for the FN6. Appellees take the position,
'029 patent. which appellants dispute, that
bimatoprost interacts with a splice
FN4. The record before us does variant of the FP receptor, i.e., a
not demonstrate that the appel- form of the FP receptor in which
lants' obviousness arguments re- the sub-units of the structure re-
garding the '029 patent were lim- ceptor have been rearranged. See
ited to the obviousness of bimato- Appellees' Br.19, n .2.
prost. Rather, it appears the dis-
trict court failed to account for the FN7. This is in contrast with cir-
full scope of the '029 patent cumstances such as those in Ge-
claims despite appellants' raising netics Institute, LLC v. Novartis
such an assertion in its pretrial Vaccines & Diagnostics, Inc., 655
brief, post-trial brief, and pro- F.3d 1291, 1308–09
posed findings of fact. See Letter (Fed.Cir.2011). There, the court
from Appellants, Ex. A (Excerpt noted that unexpected results ap-
of Defendants' Amended Proposed plied across the full scope of a
Findings of Fact and Conclusions claimed protein structure, since
of Law) 6–7, 11–12, ECF No. 94 any exceptions were limited to
(contending that the asserted minor variations within only
claims of the '029 patent are obvi- “10%” of the claimed structure.
ous over Johnstone alone in view
of the knowledge of those of or- FN8. To be sure, we agree with
dinary skill in the art); see also Al- appellees (and the dissent, which
lergan, Inc. v. Apotex, Inc. ., No. addresses this issue at length, see
1:10–CV–681 Defs.' Opening Dissenting Op. at 7–8) that appel-
Post–Trial Br.47–48, ECF No. lants fail to show that this is a suf-
190 (arguing that plaintiffs did not ficiently clear reference to the '
show a nexus to unexpected res- 819 patent itself, since the list of
ults and other secondary consider- compounds expressly disclosed as
ations within the scope of the '029 being vasodilatory in the '708 pat-
claims). ent exclude the 17–phenyl PGF
analogs that the '819 patent dis-
FN5. For example, claim 1 of '029 closes, such as bimatoprost.

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Rather, the point is that the ana- of the '404 patent. Allergan, 2013
logs disclosed in the '708 patent WL 286251, at *7.
and its progeny, including the '819
patent, had different chemical FN12. Letter from Appellees,
structures and proper- ECF No. 93 (attaching “excerpts
ties—including, for example, the from the closing argument tran-
binding of variant FP receptors. script, Allergan and Duke's post-
This is especially salient because trial brief, and Allergan and
the district court's conclusion re- Duke's post-trial findings of fact
lied so heavily on its finding and conclusions of law” regarding
that—even in light of Johnstone's this issue).
disclosure—the utility of a com-
FN13. Because we reverse the
pound that binds a variant FP re-
court's invalidity finding on both
ceptor was an unexpected result.
asserted patents on the grounds of
FN9. See Allergan, 2013 WL obviousness and thus vacate the
286251, at *10 (“The label for the court's injunction, we need not
glaucoma drug Rescula® includes reach appellants' arguments re-
a warning that 10–14% of patients garding insufficient written de-
had increased length of eyelashes, scription for the asserted claims of
7% had decreased length of eye- the '029 patent and inadequate en-
lashes, and 80% showed no re- ablement of claim 14 of the '404
sponse whatsoever.”). patent, as well as the question of
whether the court abused its dis-
FN10. The district court made a cretion in granting a permanent
further finding that Latisse® was injunction.
the only drug approved by the
FDA and marketed for eyelash
FN1. To the extent that the major-
hair growth. It further noted that
ity maintains that Johnstone does
latanoprost, the subject of the
not cover thousands of possibilit-
Johnstone PCT, has not been ap-
ies, Majority Op. at 22, I respect-
proved. It is unclear from the dis-
fully disagree. True, Johnstone
trict court's opinion whether this
reaches specific classes of com-
finding related to commercial suc-
pounds, but Johnstone's suggested
cess or long-felt need. In any
modifications, which the majority
event, however, it is undercut by
relies on, cover many more vari-
Allergan's exclusive license of the
ations.
patent that issued from the John-
stone PCT. See Merck & Co., Inc.
v. Teva Pharm. USA, Inc., 395 C.A.Fed. (N.C.),2014.
F.3d 1364, 1376 (Fed.Cir.2005). Allergan, Inc. v. Apotex Inc.
--- F.3d ----, 2014 WL 2579287
FN11. The district court opinion (C.A.Fed. (N.C.))
suggests that it found that all four
“Brandt references are not prior END OF DOCUMENT
art under 35 U.S.C. § 102(a),”
even though the first two refer-
ences were published more than
one year before the priority date

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