*1 first in line or ensure pened to be losing be a one. For
first contract would that, mul- by hypothesis, benefits
research contracts, both commercial
tiple potential allocating general re- governmental, costs in that man- development
search and policy as a matter. is not sensible
ner policy ar-
Accordingly, government’s persuade us
guments do performance of a “required
phrase of IR & D costs in the definition
contract” meaning the same
should not be accorded in the definition of phrase
as the identical
B & P Because the research costs. in this case
development costs issue to the Mitsubishi contract but
were related required by con- specifically
were not
tract, the trial court’s decision uphold IR & D those costs were indirect meaning pertinent
costs within the
regulatory provisions.
AFFIRMED. PHARMACEUTICALS, INC.,
ARIAD
Massachusetts Institute of Technolo
gy, The Whitehead Institute Research,
Biomedical and the Presi College,
dent and Fellows of Harvard
Plaintiffs-Appellees, COMPANY,
ELI LILLY AND
Defendant-Appellant.
No. 2008-1248. Appeals,
United States Court
Federal Circuit.
March *2 Whealan, MD,
John M. Spring, Silver argued for plaintiffs-appellees. With him Dabney, the brief were James W. Ste- Rabinowitz, phen Randy S. C. Eisen- smith, Frank Fried Harris Shriver & Ja- LLP, York, NY, cobson of New and John F. Duffy, Washington, DC. Of counsel Ben-Ami, Carson, were Leora Patricia A. T, Sr., Christopher Jagoe, Matthew McFarlane, Suh, Kaye and Howard S. LLP, York, Scholer of New NY. Lipsey, Finnegan, Charles E. Henderson, Farabow, Dunner, Garrett & L.L.P., Reston, VA, argued for defen- dant-appellant. him on With the brief Bajefsky, were Robert D. David S. For- man, Levine, Howard Laura P. Masu- W. Johnson, rovsky, and Jennifer A. of Wash- DC, Swan, ington, Jennifer S. Palo Alto, CA. Of counsel on the brief were Cantrell, R. Voy, Paul Gilbert T. and Alex- Wilson, ander Eli Company, Indianapolis, Sanya IN. Of counsel was Henderson, Sukduang, Finnegan, Fara- bow, Dunner, L.L.P., Garrett & of Wash- ington, DC. School, Richmond, VA, for Freeman, Attorney, mond Law Appellate
Mark R. Division, Staff, Depart- States Christopher Cotropia. United A. Civil Professor DC, Justice, ar- Washington, ment of Wamsley, Prop- Intellectual Herbert C. curiae United States. *3 for amicus gued Association, Washington, of erty Owners Ravel, Ann the brief were him on With DC, Proper- for amicus curiae Intellectual General, Attorney Acting Assistant were ty Owners Association. On the brief McIntosh, Attorney. Of counsel Scott R. F. Pappas, Long, Peter William G. Toupin, A. Gener- on the were James brief Lester, Elizabeth A. Sutherland Asbill & Chen, Counsel, Raymond T. Solici- al LLP, Atlanta, GA, of and Steven Brennan tor, and Trademark Patent United States Phillips, Miller and Richard F. Intellec- W. Office, VA. Arlington, of Association, tual of Property Owners Park, CA, Morris, of Menlo Roberta J. Washington, DC. Morris, Esq., for amicus curiae Roberta J. Atkins, Pillsbury Winthrop P. William PhD. LLP, McLean, VA, Shaw Pittman of for Mion, Burchfiel, Sughrue Kenneth J. Medtronic, Inc. him amicus curiae With on PLLC, DC, Washington, for amicus cu- of Barufka. the brief was Jack S. him on the brief Novozymes riae With A/S. Liivak, School, Oskar Cornell Law of T. was John Callahan. Ithaca, NY, for amicus curiae Lii- Oskar Holman, University M. of Christopher vak. Law, City of of Missouri-Kansas School Kramer, LLP, Howrey MO, Robert F. of San City, for amicus curiae Law Kansas Francisco, CA, Christopher M. Holman. for amicus curiae RealNet- Professor works, him Inc. With on the brief were Janis, University Mark D. Indiana R. I. Yang. David Stewart and Irene Law, Bloomington, of of Maurer School IN, D. for amici curiae Mark Janis Brookshire, E. Federal Circuit James Timоthy R. Holbrook. Association, DC, Washington, Bar of for Bar amicus curiae Federal Circuit Associa- Weiss, Kenyon Kenyon A. &
Charles LLP, York, tion. With him on the brief were Edward NY, of New for amicus curiae Mehta, Weil, Property New York Intellectual Law Asso- R. Reines and Sonal N. him L. LLP, ciation. With on the brief was Dale Manges Gotshal & of Redwood Carlson, LLP, Wiggin and Dana of New Shores, CA. Haven, CT. Dellinger, O’Melveny Myers & Walter Pasahow, Lynn H. Fenwick & West DC, LLP, Washington, of for amicus curi- View, CA, LLP, amici of Mountain Hynix Inc. him on ae Semiconductor With University of of Regents curiae The Srinivasan, the brief were Sri Mark S. California, al. him on the brief et With Davies, Tarbert; Kathryn E. and Ken- Carolyn
were Heather N. Mewes and C. Roeder, Nissly L. of Menlo neth and Susan P. Chang. Of counsel on the brief was Park, counsel on the brief were CA. Of Jr., Simpson, Regents Martin The Brown, Han, Theodore G. III and Julie J. Oakland, California, University of CA. LLP, Townsend and Townsend and Crew Thomason, Spalding
Charles Lee & Tho- Alto, of Palo CA. On the brief for amicus mason, Bardstown, KY, amici curiae Samsung curiae Electronics Ltd. was University Kentucky Intellectual Powers, Matthew D. Gotshal & Weil Society, al. Property Law et Shores, LLP, Manges of Redwood CA. him on the brief were Steven S. With
Christopher Cotropia, A. Intellectual Berezin, Institute, of New Property University Cherensky; of Rich- Robert S. Bremer, Rea, York, NY; & Moring E. Teresa Stanek Crowell and Carmen Dallas, LLP, DC, Washington, TX. for amicus curi- Property ae American Intellectual Law College of Moy, R. William Mitchell Carl Association. Of counsel on the brief was Paul, MN, Law, for amicus curiae of St. Kaspar, Alan American J. Intellectual Law, College Mitchell Intellec- William Association, Property Arlington, Law him the Property Institute. With tual YA. Jay Erstling. brief was A. Lee, Picker- F. Wilmer Cutler William Clement, LLP, Paul D. King Spalding & Boston, MA, LLP, Dorr ing Hale and DC, Washington, for amici curiae Goo- *4 amicus curiae Abbott Laboratories. for Inc., Communications, gle and Verizon Inc. him on the brief were William G. With With him on the brief were Erin E. Mor- McElwain, Moss, Amy D. K. Randolph T. Weingaertner, row and Scott of New of and Thomas G. Saunders Wigmore, York, NY. Of counsel for Verizon Commu- counsel on the brief Washington, DC. Of nications, Thorne, Inc. was John Verizon Witty, Eric P. Martin and Peter N.
were Communications, Inc., Arlington, of VA. Of Laboratories, Park, IL. of Abbott Abbott Google counsel for Inc. was K. Michelle Linck, Rothwell, Nancy Figg, Ernst & J. Lee, Inc., View, Google of Mountain CA. DC, Manbeck, P.C., Washington, of Sys- the brief for amicus curiae On Cisco Company. curiae With amicus Monsanto tems, Jameson, Inc. was Lоuis Norwood brief were Minaksi Bhatt and her on the LLP, Atlanta, Duane Morris of GA. Cassidy. Martha Of counsel on the brief Sarnoff, Joshua D. Glushko-Samuelson Hoerner, Compa- was Dennis R. Monsanto Clinic, Property Washing- Intellectual Law Louis, ny, MO. of St. Law, University, ton College American Knowles, GlaxoSmithKline, of Sherry M. DC, for Washington, amicus curiae Pub- Prussia, PA, curiae King of for amicus lic Patent Foundation. GlaxoSmithKline. Trela, Jr., Sidley L. Austin Constantine MICHEL, Judge, Before Chief LLP, IL, curiae Chicago, for amicus NEWMAN, MAYER, LOURIE, RADER, him on the Corporation. Microsoft With BRYSON, GAJARSA, LINN, DYK, Tacy brief were Richard A. Cederoth and PROST, MOORE, Judges. Circuit Flint; Kushan, Jeffrey F. P. of Wash- ington, DC. Of counsel on the brief was Opinion by for the court filed Circuit Culbert, Corpo- Andrew Microsoft Thomas LOURIE, Judge Judge in which Chief ration, Redmond, WA. NEWMAN, Judges and Circuit MICHEL Samp, Washington Legal A. Richard MAYER, BRYSON, GAJARSA, DYK, Foundation, DC, for ami- Washington, PROST, join. and MOORE Additional Washington Legal curiae Foundation. cus by Judge views filed Circuit NEWMAN. Popeo. him on the brief was Daniel With J. Concurring opinion by Judge filed Circuit Jr., LLP,
Lloyd Day, Howrey Dissenting-in-part, R. of East GAJARSA. Alto, CA, Amgen concurring-in-part opinion by amicus filed Circuit Palo curiae RADER, in Judge Judge Inc. him on the brief was Linda A. which Circuit With Sasaki-Baxley. joins. Dissenting-in-part, Of counsel on the brief LINN Watt, Whiteford, concurring-in-part opinion L. A. filed Circuit Wendy were Stuart LINN, Katz, Cordray, Judge Judge L. A. in which Circuit Monique and Gail Inc., Oaks, joins. RADER Amgen of Thousand CA.
LOURIE, Judge. tion. The inventors discovered that NF- Circuit normally éB exists cells as inactive Pharmaceuticals, Inc., Massachu- inhibitor, complex protein with a named Technology, setts Institute of the White- (“Inhibitor B”), kappa “IéB” and is acti- Research, for Biomedical head Institute stimuli, vated extracellular such as bac- and the and Fellows of Harvard President rides, “Ariad”) terial-produced lipopolysaccha (collectively, brought suit College Company (“Lilly”) through Eli & a series of biochemical against reactions District Court for the the United States that release it from IéB. Once free of its Massachusetts, alleging in- District of inhibitor, into nu- NF-éB travels the cell (“the 6,410,516 fringement of U.S. Patent cleus where it binds and activates the trial, patent”). jury After at which a '516 transcription genes containing a NF-éB but found infringement, found none of the recognition genes site. The (e.g., activated invalid, panel asserted cytokines), certain in turn help body court the district court’s reversed denial of counteract the extracellular assault. The Lilly’s judgment motion for aas matter of can, however, production cytokines be (“JMOL”) law and held the аsserted claims harmful in excess. Thus the inventors rec- *5 Ar- description. invalid for lack of written ognized artificially interfering Pharms., iad Inc. v. Eli & activity NF-éB could reduce the harmful (Fed.Cir.2009). F.3d 1366 symptoms diseases, they of certain banc, petitioned rehearing Ariad for en 21, 1989, patent application April filed a on interpretation court’s challenging this of 35 disclosing claiming their discoveries and § first paragraph, U.S.C. as contain- for regulating responses methods cellular ing separate description require- by to external stimuli reducing NF-éB ac- ment. Because of the importance of the tivity in a cell. issue, granted petition we Ariad’s and di- parties rected the to address whether brought against Lilly Ariad suit on June paragraph, first contains a written 25, 2002, day patent the '516 issued. description requirement separate from the alleged infringement of claims and, so, enablement if 95, 144, by Lilly’s and 145 Evista® and scope purpose requirement. of that Xigris® pharmaceutical products. The as- now para- We reaffirm that first serted rewritten to include the graph, contains a written description re- they claims from which depend, are as quirement enablement, separate from and follows: again reverse the district court’s denial 80. for modifying [A method effects of of JMOL and hold the asserted claims of cell, eukaryotic external influences on a the '516 invalid for failure to meet which external influences induce NF-éB- statutory require- mediated intracellular signaling, ment.
method comprising altering NF-éB ac- BACKGROUND tivity the cells such that NF-éB-medi- ated effects of external influences are The regulation '516 relates to the modified, activity wherein NF-éB gene expression by transcription reducing cell is wherein NF-éB reduced] factor NF-éB. The inventors of the '516 activity comprises reducing binding of identify were the first to NF-éB recognition NF-éB to NF-éB sites on and to by uncover the mechanism which gene genes transcriptionally regu- NF-éB activates which are expression underly- ing body’s responses immune to infec- lated NF-éB. hypothesizes three The also reducing, in euka- for method
95.
[A
potential
molecules with the
cells,
expression
types of
the level of
ryotic
decoy,
activity
extracellu-
NF-éB
cells:
are activated
reduce
which
genes
NF-eBmedi-
dominantly interfering,
specific
which induce
inhibi-
influences
lar
the method
signaling,
1.22.
intracellular
molecules. Id. at col.37 1.43-col.38
atеd
tor
activity in
NF-éB
reducing
comprising
court held a
April
In
the district
expression of said
such that
the cells
the issues of
fourteen-day jury trial on
reduced],
human
carried out on
genes is
validity.
jury
The
ren-
infringement and
cells.
finding infringe-
special
verdict
dered
reducing
bacterial
144.
method
[A
respect to
of claims 80 and 95 with
ment
expression
lipopolysaccharide-induced
144 and 145 with re-
Evista® and claims
cells, which
in mammalian
cytokines
jury
also found that
spect Xigris®.
NF-éB ac-
reducing
comprises
method
claims were not invalid for
the asserted
bacteri-
so as to reduce
tivity in the cells
enablement,
lack of
or lack of
anticipation,
expression
lipopolysaccharide-induced
al
description. The court denied
wherein
cytokines
cells]
said
opinion Lilly’s motions for JMOL
without
re-
activity comprises
reducing NF-éB
and,
alternative,
a new trial.
NF-éB rec-
binding of NF-éB to
ducing
2006, the court conducted a four-
August
which are tran-
genes
ognition sites
Lilly’s
trial on
additional de-
day bench
NF-éB.
regulated by
scriptionally
matter,
subject
in-
unpatentable
fenses of
reducing
bacterial
method
[A
laches,
conduct, and
equitable
prosecution
expression of
lipopolysaccharide-induced
in favor of Ariad on all three issues.
ruling
cells, which
in mammalian
cytokines
*6
Pharms.,
Lilly
Inc. v.
&
Ariad
Eli
reducing NF-éB ac-
comprises
method
(D.Mass.2007).
F.Supp.2d 106
to reduce bacteri-
tivity in the cells so as
court,
Lilly timely appealed to this
expression
lipopolysaccharide-induced
al
3, 2009,
part
in
April
panel
on
affirmed
cells],
in
carried
cytokines
of said
Ariad,
part.
560 F.3d at
and reversed
cells.
out on human
panel upheld
The
the district court’s
1369.
genus
encom-
The claims are thus
conduct,
inequitable
no
id. at
finding of
all substances that
the use of
passing
1380,
jury’s verdict on
but reversed the
reducing
result of
achieve the desired
description, holding the asserted
recognition
NF-éB
binding
NF-éB to
adequate
writ
claims invalid for lack of
Furthermore,
claims, although
sites.
required by 35 U.S.C.
ten
language
during prosecution, use
amended
112,
at
Ariad
paragraph,
id.
1376.
first
present
language
corresponds
banc, challeng
rehearing
en
petitioned
application. Specifically,
priority
the existence of written
ing
reducing
recite methods of
asserted claims
112,
paragraph, sep
§in
first
specifically re-
activity,
NF-éB
and more
requirement.
arate from the enablement
recog-
binding of NF-éB to NF-éB
ducing
question,
see In re
Although not
new
sites,
to external
response
in cells in
nition
(CCPA
Barker,
588,
559 F.2d
591-93
lipopolysaccha
influences
like bacterial
1977),
in re
prominence has increased
21,
April
on
specification
The
filed
rides.
Lizardtech, Inc. v. Earth
years, see
cent
goal of
similarly recites the desired
(Fed.
Inc.,
433 F.3d
Mapping,
Res.
activity
binding
reducing NF-éB
Cir.2005)
banc on
(denying rehearing en
in cells in re-
recognition sites
NF-éB
separate
whether a
question
such external
influences. See
sponse to
§in
description requirement exists
1.19;
patent col.3 1.59-col.4
eol.311.65-
'516
Rochester v.
paragraph); Univ.
1.11;
11.54-59. first
see also id. at col.2
col.32
Co., Inc.,
first,
&
(1) order to en- paragraph Whether 35 U.S.C. invention, able the description require- contains written identify is, first “what the invention separate ment from an enablement re- otherwise it quirement? person fails to inform a of skill in the art what to make and use.” Id. (2) If a separate written re- 30. Yet argues that this step first quirement statute, forth in set what “identifying” the applies only scope purpose is the require- of that (ie., priority the context of claims amend- ment? ed during prosecution; priority under 35 briefs, parties’ addition to the 119, 120; interferences) §§ U.S.C. be- twenty-five court received amicus briefs. original cause claims “constitute their own those, Of seventeen were filed in support description.” Id. at 44. Lilly, Ariad, one in support was filed Lilly, contrast, answers the court’s and seven were filed in support of neither question affirmative, first arguing party. majority, including a brief that two years precedent hundred sup- States, filed the United were filed in port the existence of a statutory written support of this court’s current written de- scription requirement separate doctrine. The court oral from en- heard arguments Thus, December ablement. argues first, requires, statute a written descrip-
DISCUSSION and, second, tion of the invention a written *7 description of how to make and use the I. invention so as to enable one of skill in the Although parties the differ in their an- art to make and use it. Finally, Lilly questions, swers to the court’s posi- their asserts that this separate descrip- written tions converge they more than ap- first requirement tion applies to all claims— Ariad, pear. in answering the court’s first original both and amended —to ensure that question, argues that para- first inventors actually have invented the sub- graph, does not descrip- contain a written ject matter claimed. requirement tion separate from enable- Thus, although parties take diamet- Yet, ment. in response to this court’s rically opposed positions on the existence question second scope on the purpose and of a written description requirement sepa- of a description written requirement, Ariad enablement, rate from agree both argues that the statute contains two de- specification must contain a scription written de- requirements: “Properly inter- scription of the invention to preted, the statute establish what requires specifica- (i) is, dispute, therefore, tion to describe invention is. The what the invention (ii) and how to make centers on Appellee applied and use it.” the standard to be and 1; (“[T]he Br. see also id. at 43 whether it applies original to claim lan- ¶ description requirement §of 1 re- guage. full, clear, concise, in and
A. such ex- [B] any person act terms as to enable skilled involving statutory case inter- any As in pertains, in the art which it or to begin with the pretation, language connected, nearly which it is most Safety itself. Consumer Prod. statute make and ... use the same Inc., Sylvania, Comm’n v. GTE U.S. 102, 108, 100 S.Ct. L.Ed.2d argues interpretation Ariad that its best (1980). 112,first reads paragraph, Section English grammar follows the rule of as follows: (here, prepositional “of the phrases inven- The shall contain a written tion,” process “of the and manner mak- invention, description of the and of it,” full, ing clear, and and “in using such process making and and us- manner terms”) concise, modify and exact another full, clear, concise, it, and ing in such (here, word sentence “written de- any person as to enable exact terms scription”), inexplica- and that it does not pertains, art which it skilled in the bly ignore “making comma after and connected, nearly it is most with which using “description it” or sever the same, to make and use and shall set that it invention” from the be contemplated by mode forth the best “full, clear, concise, terms,” and exact carrying out his inventor of invention. leaving without a legal Ariad, plain reading According standard. components: a reveals two statute (i) invention, and also argues Ariad that earlier versions of (ii) process making manner and support interpretation. the Patent Act its two using components, and it. Yet those Specifically, Ariad contends the first must be goes argument, judged Ariad’s Act, Patent adopted imme- phrase; writ- prepositional final both successor, 1793, required diate adopted full, be “in descriptions ten a written of the invention clear, concise, exact terms as to enable (i) accomplished purposes: two to distin- any in the art ... make person skilled art, guish prior from the Specifically, the same.” Ariad use (ii) person to enable a skilled the art to as follows: parses the statute make and use the invention.1 then contain shall assigned Congress asserts when a written
[A] defining function the invention invention, Congress [i] amended the requirement so process that it of the manner and [ii] *8 it, using single served a enablement.2 making purpose: and provided, provided, the 1793 Patent 2. Section 6 1836 Patent Act Section 3 of Act of the inventor, part: any in relevant inventor shall “[E]very "[BJefore part: in he relevant before any receive a new such ... can shall deliver a writ- receive discovery, or a written he shall deliver de- invention, description ten of his and of the scription discovery, or his invention and of using, process compounding or manner of making, process manner and construct- terms, same, full, clear and in such exact same, using, ing, compounding the and distinguish as the same all to from other full, clear, terms, avoiding and exact known, things any per- and to before enable unnecessary any person prolixity, as to enable science, son in the art or of which it is skilled apper- to which it skilled in tains, art or science branch, nearly which it is or with most nearly it most or with which is connect- connected, make, compound, to and use ed, construct, make, compound, and use same.” the same.” exists, § Lilly disagrees, arguing that first ment not for its own sаke as an paragraph, separate contains three re- independent statutory requirement, but quirements. Specifically, Lilly parses the only identify the invention that must as statute follows: comply with requirement. the enablement (1) specification “The shall contain a But, Ariad, nothing unlike we see invention, description written of the language grammar statute’s that unam- ” and biguously adequacy dictates that the (2) specification “The shall contain a description “written of the invention” must description written ... of the man- solely by be determined whether that de- ner process making using and and scription identifies the invention so as to it, full, clear, concise, in such and enable one of skill the art to make and any exact as to person terms enable prepositional phrase use it. The “in such pertains, skilled the art to which it full, clear, concise, and exact terms as to nearly or with which it is most con- any person enable skilled the art ... nected, same, to make and use the make and use the same” only modifies “the ” description ... of the manner and (3) “The specification ... shall set forth process of making using [the inven- contemplated by best mode tion],” argues, without violating carrying inventor of out the inven- grammar. the rules of adequacy That the tion.” pro- the manner and Lilly argues that ig- Ariad’s construction making cess of and using the invention is long judicial nores a line of precedent in- judged by whether that en- terpreting the predecessors statute’s ables one skilled the art to make and a separate contain re- use the same parallelism follows from the quirement, an interpretation Congress of the language. adopted by reenacting the current lan- agrees While Ariad require- there is a § guage of paragraph, first without invention, ment to describe the a few amici significant amendment. appear suggest only description agree We with Lilly and read the a requirement to describe give statute to effect language to its Congress enablement. If had intended specification “shall contain a written enablement to be the sole description re- description of the invention” and hold that quirement §of first paragraph, first paragraph, contains sepa two statute would have been written different- rate description requirements: a “written ly. Specifically, Congress could writ- have invention, [i] [ii] read, ten the statute to “The the manner and process making shall contain a using [the invention”]. 35 U.S.C. invention, full, clear, concise, in such ¶ added). 1 (emphasis point, On this exact terms as to any person enable do not read position Ariad’s to be in dis skilled in ... the art to make and use the agreement as Ariad concedes existence same,” or “The shall contain a of a written description requirement. See *9 (“Under description of pro- the manner and Appellee Br. 2 plain a reading of statute, making cess of using invention, a and patent specification ... must (i) full, clear, concise, invention, contain a description of the and exact terms as (ii) and process any person the manner and to enable of mak skilled in the art ... it.”). ing and using Instead Ariad con make and use the same.” Under the tends that the description require- amicis’ construction a portion of the stat-
1345 claims; pro- public and the to understand “and of manner and ute—either making using upon “[a and it” or and to improve and the invention cess invention” —becomes description] paten- the claimed boundaries of the avoid statutory violating the rule surplusage, rights. tee’s exclusive use does not Congress construction B. v.
unnecessary words.
States
See United
538-39,
Menasche,
528,
75 S.Ct.
348 U.S.
argues
prece-
that Supreme
Court
(“It
(1955)
duty ‘to
513,
615
is our
99 L.Ed.
comports
reading
with its
of the stat-
dent
effect,
every
if
clause and
possible, to
give
provides no
for a written
support
ute and
”)
Montclair v.
(quoting
of a statute.’
word
description requirement separate from en-
Ramsdell,
391,
147, 152, 2
107 U.S.
S.Ct.
Specifically, Ariad asserts that
ablement.
(1883)).
431
27 L.Ed.
Wheat.)
Eaton,
(7
356,
v.
20
Evans
U.S.
Furthermore,
Act
since
the Patent
433-34,
(1822),
Supreme
poses
Am., 86, 98-102, 306 U.S. 59 S.Ct. part know what of the field of invention (1939) L.Ed. 506 (holding invalid claims unoccupied. amended to include structures “not within Id. at 25-26. application” Finally, recently the invention described in most small). Festo, even though the variations were the Court recited three require- Although the not expressly Court did state ments for first paragraph, and non- 3. provided, specific Section 26 of the 1870 Patent Act telegraph instrumentalities de- part: any in relevant ”[B]efore inventor or claim, veloped by eighth Morse. The in con- discoverer shall receive a for his inven- trast, every way claimed print- conceivable discovery, tion or he shall ... file in the ing intelligible characters at a distance office a written [his in- galvanic use of an electric or current. Id. at discovery], vention or and of the manner and rejected 112. The Court the latter claim as process making, constructing, compound- too broad because Morse claimed "an exclu- it, clear, full, concise, ing, using in such right sive process to use a manner and which any person exact terms as to enable he has not described and indeed had not in- skilled apper- in the art or science to which it vented, and therefore could not when describe tains, nearly or with which it is most connect- patent.” he (emphasis obtained his Id. at 113 ed, make, construct, compound, and use added). rejection implies Such a a distinct the same.” for a of the inven- Yet, conclusion, Morse, reaching tion. Act, decided under the 1836 can also Court also detailed how the claim interpreted involving be covered separate made, (15 How.) yet indicating inquiry. inventions not 56 U.S. the addi- L.Ed. 601. The at issue tional failure of the contained enable such eight only of which seven recited the a broad claim. See id. at 113-14.
1347
enablement,
from
separate
quirement
sepa-
requirement
ed a written
it now.
uphold
us to
impels
decisis
stare
others:
from the
rate
that this has been
acknowledges
Ariad
describe,
application
[T]he
Br.
see
forty years,
Appellee
law for over
mode of
best
enable,
and set forth
dis
24,
change course now would
and to
These latter
the invention.
out
carrying
invent
expectations
rupt the settled
before
satisfied
must be
requirements
it in
community, which has relied
ing
pat-
for exclusive
patent,
issuance of
conclud
patents,
drafting
prosecuting
and
for
exchange
given
are
rights
ent
rendering
and
licensing agreements,
ing
public.
to
disclosing the invention
As the
infringement opinions.
validity and
applica-
claimed
isWhat
admonishing
this
stated
Supreme Court
what is dis-
be the same
tion must
court,
adopt
be cautious before
we “must
otherwise
specification;
closed
expec
disrupt
the settled
ing changes
also
not issue.
patent should
community.” Fes
inventing
require-
if the other
tations
not issue
should
1831;
to,
739, 122
see also
at
S.Ct.
535 U.S.
§ 112 are not satisfied....
ments
States,
74, 82,
552 U.S.
v. United
Watson
(emphasis
736,
1831
122 S.Ct.
535 U.S.
(“A
(2007)
472
169 L.Ed.2d
128 S.Ct.
omitted).
added) (internal
aAs
citations
...
opinion
within
Court
difference
court,
may
so
not
federal
subordinate
another
open
the door
keep
does not
but
as dicta
such statements
easily dismiss
construction,
stare
statutory
where
try at
Con-
them. See Stone
follow
are bound to
legisla
special
[since]
has
force
States,
decisis
v. United
Corp.
tainer
re
Congress
and
implicated,
power
tive
(Fed.Cir.2000). While Ariad
1345, 1349-50
done.”
alter
we have
mains free to
what
cases
other
to statements
points
omitted)).
(internal
law
If the
quotations
18-19, not
view,
Br.
Appellee
support
changed,
to be
description is
of written
separate
aof
the existence
one disavows
uniform
contrary to sound
and the
policy
requirement.
court,
expecta
of this
settled
holdings
description require-
separate
A
investing com
inventing and
tions
the func-
conflict with
also
ment
does
munities,
deci
practice,
and PTO
¶
the claims.
U.S.C.
tion of
would
good reason and
require
sion would
that, af-
subject matter
Claims define
Congress.
rest with
examination,
to meet
found
has been
ter
рatent.
statutory requirements
D.
Inc.,
Tool,
Mach. &
In re Vamco
See
that an incorrect
argues
next
(Fed.Cir.1985).
Their
n. 5
Ruschig, 54 C.C.P.A.
of In re
reading
therefore,
function,
provide
tois
principal
(1967),by
predeces
our
F.2d 990
right
boundaries
notice
Pat
court,
of Customs
the Court
sor
limits;
it is not
to define
exclude and
(“CCPA”),
then
ent
orig-
Appeals
invention,
their
although
describe the
court,
the first written
created
descrip-
language
inal
contributes
from enablement.
separate
requirement
it.
cases satisfies
certain
tion and in
asserts,
Lil
response
circumscribe,
Yet Ariad also
the writ-
define
Claims
Moore, 33
In re
ly’s argument
teaches.
discloses and
ten
(1946); In re
1083,
E. purposes scription the invention for claims, the to amended contrast determining priority.” although And divergent views on have more parties primarily involving issue arises cases re a written application of *13 priority, Congress has not so limited the Ariad ar original to claims. quirement statute, and neither will we. University Regents that the gues of Co., 119 F.3d Lilly v. Eli & California Furthermore, true origi- while it is that (Fed.Cir.1997), require extended the part original specifi- nal claims are the beyond role of proper policing ment Gardner, cation, re trans of enablement and priority part as (CCPA 1973), that fails to truism address heightened unpredict it a formed into question original the whether claim lan- general requirement disclosure able necessarily subject the guage discloses Rather, Ariad ar place enablement. so, matter claims. Ariad that it believes the requirement the to describe what gues, arguing original identify that claims what- original to apply invention is does not state, they e.g., perpetual ever a motion original part claims because as machine, only leaving question wheth- disclosure, their original constitute applicant anyone er the has to enabled invention. own written make use such an invention. Oral Thus, Ariad, to as as the according long disagree Argument 37:26-38:00. We that appears ipsis verbis language claim Although many always case. filed, applicant as has specification satisfy the original claims will written de- a writ requirement provide to satisfied the may scription requirement, certain claims ten invention. may For a claim example, generic not. descrip- Lilly that the written responds genus vast define boundaries of a all requirement applies to claims tion yet the compounds, question chemical specification objectively requires that may specification, still remain whether actually in- applicant demonstrate including original language, claim demon- possession of—the claimed vented —was spe- applicant strates that the has invented § 112 subject Lilly argues matter. that ge- claim support cies sufficient to a to a a applying contains basis for different no problem especially acute with nus. original versus standard to amended language use genus claims that functional applying separate that writ- claims and ge- to define the boundaries of claimed requirement original ten case, In such a the functional claim nus. claiming be- keeps inventors from result, may simply clаim desired encourages yond their inventions and thus species may describing do so that without technological areas innovation in new specification achieve result. But the in- protection for actual preserving patent applicant has must demonstrate that ventions. generic made a invention that achieves Lilly. If cor- Again agree with it is we by showing and do claimed result so first paragraph, rect read species applicant has invented suffi- sep- requirement provide containing a functionally- support cient to a claim to the invention, description of the arate written genus. defined here, provides princi- no as we hold this, Recognizing held Eli pled restricting requirement basis description of a adequate that an nothing establishing priority. Certainly gener- than a genus requires claimed more supports language restriction; “The ic statement of an invention’s boundaries. say does statute nal
the context.
418
F.
(Fed.Cir.2005).
1349,
Specifically,
1357-58
required
satisfy
of
the
the level
detail
this court has
inception,
Since
112,
requirement
varies de-
para
description
written
consistently
that
first
held
re
contains a written
the
graph,
pending
scope
on the nature
enablement,
separate from
quirement
complexity
and on
predict-
“fairly
stan
a
uniform
we have articulated
ability of the
For
technology.
relevant
Id.
dard,”
affirm.
which we now
Vas-Cath
have set
a number
generic
forth
Mahurkar,
1555,
F.2d
1562-63
Inc. v.
935
for
evaluating
adequacy
of factors
(Fed.Cir.1991).
descrip
Specifically, the
disclosure,
including
existing
“the
ordi
“clearly
persons
allow
tion
field,
in
knowledge
particular
the ex-
recognize
in the art to
that
nary
[the
skill
art,
matu-
prior
and content of the
tent
is
Id. at
invented what
claimed.”
inventor]
or
rity
technology,
science
[and]
Gosteli,
In
872 F.2d
(citing
re
1563
aspect
Id.
predictability of
at issue.”
(Fed. Cir.1989)).
words, the
In other
1012
at 1359.
whether
disclo
sufficiency
test
applied
be
to each inven-
The law must
relied
reason
application
upon
sure
patent pro-
at the
it enters the
tion
time
conveys to
skilled
the art
ably
those
cess,
nov-
patented
for each
advance has a
of the claimed
possession
the inventor had
relationship
the art
el
with the state of
filing
matter
date.
Id.
subject
as of
Thus,
emerges.
it
not
from which
we do
Ralston Purina Co. v. Far-Mar-
(quoting
adjudicate
predict
all the
(Fed.Cir.
try here
Inc.,
Co,
772 F.2d
1575
Kaslow,
to which
written de-
1985));
F.2d
factual scenarios
also In re
see
(Fed.Cir.1983).
1366, 1375
applied.
could
scription
be
rules
any bright-line
do we
out
Nor
set
however, has
“possession,”
The term
example,
spe-
the number of
governing,
very
implies
enlightening.
been
It
never
a
cies that must be disclosed to describe
produce
as
records
long
that as
one can
claim,
necessarily
genus
number
of a
documenting
invention, and it
changes with each
invention,
posses-
can show
claimed
one
Compare
with
changes
progress
field.
descrip-
of written
But the hallmark
sion.
(holding an
Thus,
Lilly,
at 1567
“possession as Eli
119 F.3d
is disclosure.
tion
did not describe the
structural
common
sequence
acid
features
to the mem
amino
it),
encoding
sequence
DNA
with
re
genus.
F.3d at
Lilly,
bers
Eli
(Fed.Cir.
Wallach,
1569;
F.3d
see
Invitrogen Corp.
also
v. Clontech
2004)
(discussing how is now a “routine Labs.,
(Fed.Cir.
Inc.,
429 F.3d
sequence
to convert an amino acid
matter”
2005) (holding
re
DNA
en
sequences
into all the
can
quirement
representative
satisfied
it). Thus,
code
whatever inconsistencies
sequences
genus
number
the claimed
may
applica
to exist
appear
some
enzymes).
just
It also has
been
not
law,
inconsistencies rest
tion of
those
applied
biological
chemical and
inven
legal
not
but with the
standard
LizardTech,
See
Earth
tions.
Inc. v.
Res.
presented to
arguments
different facts and
Inc.,
Mapping,
1343-47
the courts.
(Fed.Cir.2005).
however,
are,
There
a few broad
Perhaps there is little
difference
some
principles
hold true across all cases.
describing
fields between
an invention and
We have made clear
the written de
enabling
it,
one to make and use
but that
scription requirement does not demand ei
always
inventions,
not
true
certain
examples
ther
actual
reduction to
including chemical and chemical-like inven
practice;
prac
constructive reduction to
Thus, although
tions.
way
tice that
a definite
identifies the
togeth
and enablement often rise and fall
satisfy
invention can
claimed
the written
er, requiring a written
description requirement.
Falko-Gunter
plays
vital
curtailing
role in
Inglis,
Falkner
1366-67
require
claims that do
experi
undue
*16
(Fed.Cir.2006). Conversely, we have re
use,
mentation to make and
and thus satis
peatedly
“possession”
stated that actual
or
enablement,
fy
but
not been
have
practice
to
specifi
reduction
outside of the
invented, and thus cannot be described.
Rather,
enough.
cation is not
as stated
example,
propyl
butyl compound
For
a
or
above, it is the specification itself that
may
by
process analogous
be made
a
to a
possession.
demonstrate
And while
but,
methyl compound,
disclosed
the
requirement does not de
of a
absence
statement
that the inventor
any
disclosure,
particular
mand
form of
propyl
butyl compounds,
invented
Carnegie Mellon
v.
Univ.
Hoffmann-La
compounds
such
have not been described
Inc.,
1115,
(Fed.Cir.
Roche
541 F.3d
and are not
to a patent.
entitled
See In re
2008), or that
specification
the
recite the
DiLeone,
925,
1404,
58 C.C.P.A.
436 F.2d
verba, descrip
claimed invention in haec
a
(“[C]onsider
(1971)
n. 1
the case
merely
tion that
the
renders
invention ob
specification
the
only
where
discusses
com
satisfy
vious
not
requirement,
does
the
A
pound
broadening
and contains no
lan
Airlines,
1565,
Lockwood Am.
107 F.3d
any
of
guage
very
kind. This might
well
(Fed.Cir.1997).
1571-72
enable one
in the art
skilled
to make and
characterization,
reject
We also
the
cited
C;
compounds
yet
use
B and
the class
Ariad,
by
of
the court’s written
A,
consisting of
B and C
not been
has
“super
doctrine as a
enablement” standard
described.”).
for chemical and biotechnology inventions.
requirement
The doctrine never created a heightened
also ensures that when a
a
provide
nucleotide-by-
to
claims
by
result,
genus
specifi-
nucleotide
the
its function or
the
genus
recitation of
entire
of
genetic material;
claimed
it
always
has
cation recites sufficient materials to ac-
expressly permitted the
complish
disclosure of
problem
function—a
tion,
Rochester,
see,
e.g.,
biological
arts.5
acute
the
particularly
may
Patent
not have the resources or
Examination
universities
See Guidelines
of
for
practical impli-
Under
35 U.S.C.
work out the
Applications
inclination to
Description” Requirement,
i.e.,
research,
finding
“Written
such
cations of all
(Jan.
2001).
Fed.Reg.
1105-1106
identifying compounds
able to affect
in Eli
only
not
situation arose
This
That
no
the mechanism discovered.
Rochester v.
again
University
but
law’s interpretation,
failure of the
but its
of
Co., Inc.,
F.3d 916
&
G.D. Searle
Patents are not awarded for ac-
intention.
(Fed.Cir.2004).
Rochester,
in-
held
theories, no
how ground-
ademic
matter
a method
selec-
valid claims directed
necessary
patenta-
to the later
breaking or
enzyme
inhibiting
tively
COX-2
“[A]
ble inventions
others.
is not
compound
administering
non-steroidal
license.
It is not a reward for
hunting
selectively
the COX-2 en-
inhibits
search,
compensation
but
its suc-
We
that be-
zyme.
Id. at 918.
reasoned
n.
(quot-
cessful conclusion.” Id. at 930
any
did not describe
cause
Brenner,
ing
383 U.S.
86 S.Ct.
compound capable
performing
specific
1033).
Requiring
method and the skilled artisan
the claimed
patent protection
limits
identify any
not be able
would
actually perform
those
who
difficult
specification’s
on
compound based
is,
work
“invention”—that
conceive of
description,
function
did
complete
and final invention with all
adequate
descrip-
provide
its claimed limitations—and
disclose
Id. at
claimed invention.
927-
tion
public.
fruits
that effort to the
descrip-
merely
recite
28. Such
hypotheses
qualify
That research
do not
problem
to be solved while
tion
protection possibly results
and, as
Eli
claiming
it
all solutions to
incentive, although
some loss of
any
cover
com-
Lilly and Ariad’s
any
presents no evidence of
discernable
actually
invented
deter-
pound later
impact
pace
innovation
within
claim’s functional
mined
fall
patents
number of
obtained
universi
leaving
pharmaceuti-
boundaries —
plans
ties.
research
also
But claims to
complete
*17
in-
industry
cal
to
an unfinished
research,
impose costs on downstream
dis
vention.
goal
couraging later invention.
is
Ariad
that the doctrine disad
complains
balance,
de
get
right
and
to the extent
vantages universities
by
scription
giving
doctrine does so
cannot
But
patented.
basic research
be
and
“at
incentive to actual invention
not
always
has
been directed to
patent
law
tempt[s]
preempt
the future before it
I,
Arts,”
art.
the “useful
U.S. Const.
Fiers,
at
has arrived.”
984 F.2d
1171. As
practical
meaning inventions with
cl.
stated,
repeatedly
pur
this
has
court
Manson,
use,
v.
383 U.S.
see Brenner
pose
description require
the written
532-36,
1033,
II. cause the the '516 our Because we reaffirm written de- adequately fails to disclose how the scription doctrine, see no we reason to claimed reduction NF-eB is activity panel’s application from the of that deviate parties agree achieved. The spec facts of this ease. As ification of the '516 hypothesizes such, analysis, follows, adopt we as three classes of potentially capa molecules the decision of the en banc court. reducing
ble of activity: specific NF-eB A. inhibitors, dominantly interfering mole cules, decoy molecules. contends Lilly’s We review the denial motion that this for JMOL disclosure amounts to CytoLogix without deference. little more Inc., Corp. Sys., v. Ventana than a Med. research plan, satisfy does not (Fed.Cir.2005) (applying First patentee’s quid pro quo as described law). law, Circuit First Circuit Under Rochester. responds Lilly’s ar pursuant JMOL warranted to Fed. guments fail as a matter of law because 50(a)(1) R.Civ.P. “there legally where is no actually Ariad did not claim the molecules. evidentiary sufficient basis for a reason- Ariad, According to because there is no jury able non-moving find” for the par- term in the asserted claims that corre Pierluisi, ty. Guilloty Perez v. sponds molecules, to the it is entitled to (1st Cir.2003) omitted). (quotations claim the methods without describing the valid, presumed “A to be and this assertion, legal molecules. Ariad’s howev presumption only be can overcome er, is flawed. clear convincing evidence the con- Rochester, above, as discussed Enzo, trary.” 424 F.3d at (citing very held similar method claims invalid for Tech., Gaming WMS Inc. v. Int’l Game *18 lack description. of written 358 F.3d at (Fed.Cir.1999)); see 35 patent 918-19 (holding the invalid because U.S.C. 282. present any “Rochester did not evidence explains Ariad developing that thе sub- that the ordinarily artisan skilled would be ject patent matter of “required the '516 identify able to any compound based on years work, skill, of hard great and ex- specification’s] vague [the functional de- traordinary creativity much so that —so scription”); Fiers, see also 984 F.2d at discover, the inventors first needed to give 1170-71 claim (holding genus to a of to, names previously and describe un- supported DNA molecules not written known cellular components as a necessary description of a predicate obtaining method the their inventions.” of- molecules); fered the undisputed expert Lilly, 119 testimony of Eli F.3d at cf. David Latchman that the field of in- (holding the 1567-68 to a genus claims broad lating compliance to with the written de- material invalid because the genetic of particular only one specification scription requirement disclosed for substantial evi- attempts categorically PIN/NIP, to species). Ariad dence.” Inc. v. Platte Chem. Rochester, Fiers, Lilly, Eli distinguish (Fed.Cir.2002) F.3d, 1235, cases, explicit- in those the claims because Vas-Cath, 1563). (citing F.2d at composi- included the non-described ly Much Ariad’s evi- Rochester, in the example, For tions. dence, however, is legally irrelevant to the type of claims recited a broad method question of whether the disclosure of the inadequately that we held was compound patent conveys those '516 to skilled patent: specification of the described possession art that the inventors were selectively inhibiting 1. A method for generic April of the claimed invention on host, in a activity human com- PGHS-2 filing 1989—the effective date of the administering a non-steroidal prising patent. parties disputed '516 the ef- inhibits compound selectively that activi- patent, filing fective date the '516 and in gene ty product of the PGHS-2 to a special detailed well-crafted verdict human in need of such treatment. host form, jury was to asked choose be- added). Ariad’s at- (emphasis at 918 Id. possible tween the two April dates: is tempt distinguish these cases unavail- jury and November 1991. The Regardless whether the asserted ing. party appealed chose neither compound, Ariad still must claims recite a Presumably determination. of un- because way performing some describe date, certainty over the much of priority methods, and Ariad admits that claimed actually Ariad’s evidence wаs directed to specification suggests only use of descrip- the later date. Because written to achieve the three classes molecules the filing tion determined as of date— Thus, satisfy reduction. NF-eB 21, 1989, April this case—evidence requirement for the as- ordinary in the art knew what one skill must dem- serted provide 1990 or 1991 cannot substantial possessed that Ariad claimed onstrate by sufficiently disclosing jury methods mole- to the asserted evidence capable reducing activity NF-eB cules supported by adequate were “satisfy obligation so as inventor’s Vas-Cath, See 935 F.2d at description. technologic knowledge upon disclose (holding 1563-64 that a written based, and to demon- which analysis filing occurs date “as patentee possession strate was sought”). Capon, the invention that is claimed.” Rochester, the '516 accordance adequately describe reducing methods for NF-eB ac- claimed
C. tivity, including description of adequate Alternatively, argues the molecules Ariad admits are neces- and the '516 sary specifi- perform methods. The testimony provided of Tom expert Kadesch patent hypothesizes cation of the '516 jury with substantial evidence ade *19 potentially capa- three classes of molecules the of claimed quate activity: reducing specific of ble NF-eB patent “A determination that methods. inhibitors, mole- dominantly interfering the invalid for failure meet cules, decoy review molecules. We requirement of 35 U.S.C. ¶ of each fact, specification’s disclosure question 1 and we sub- turn to determine whether there is jury’s determinations facts re- review (“[A] support jury’s stantial evidence to ver- which renders obvious a dict that the written evidenced satisfy claimed invention is not sufficient possessed that the inventor the claimed requirement of that invention. invention.”). certainly And it does not constitute written disclosure of a method
Specific inhibitors are molecules that are
for reducing
activity using
NF-éB
I-éB.
(reduce
eliminate)
“able to block
or
NF-éB
binding”
DNA in
nucleus.
'516
Dominantly interfering molecules are “a
patent
only
col.37 11.44—45.
example
The
truncated form of the NF-éB molecule.”
a specific
given
specifica-
inhibitor
in the
'516
col.38 1.11. The truncation
I-éB, a naturally occurring
tion is
molecule
binding domain,
would
the DNA
]
“retain!
whose function is to hold NF-éB in an
but
RNA polymerase
lack[ ] the
аctivating
until
inactive state
the cell receives certain
such,
domain.”
at
Id.
col.38
As
11.13-14.
external influences.
Id. at col.37 11.48-49.
dominantly
interfering molecule
Nearly all
Ariad’s evidence regarding
recognize
“would
bind to
NF-KB
upon figure
disclosure
I-éB relies
binding
DNA], however,
site
nuclear
[on
Kadeseh,
expert,
43. Ariad’s
Dr.
testified
the binding
unproductive.”
would be
Id.
that figure
sequence
discloses
words,
at
In
col.38 11.15-17. other
the domi-
DNA that encodes I-éB and relied on this
nantly interfering molecules would block
with regard
opinion
disclosure
to his
natural
from inducing
expres-
NF-éB
the written description
was
genes.
sion of
target
its
The
specific
satisfied
disclosure of
inhibitor
provides
example
no
molecules of this
53; 57-58; 60;
molecules. See Trial Tr.
Moreover,
class.
the specification ac-
78-85,
Apr.
admits,
2006. But as Ariad
knowledges that dominantly interfering
figure 43 was not
until
disclosed
1991.
molecules can work only
DNA
bind-
“if
figure
Because
not in
was
the 1989
ing domain
polymerase
DNA
do-
application, neither it nor Dr. Kadesch’s
main of
are spatially
NF-éB
distinct
testimony regarding it can offer substan-
molecule.”
at
(emphasis
Id.
col.38 11.9-10
tial evidence for the jury determination.
added).
jury
also
Dr.
heard
Ka-
Vas-Cath,
See
any prophesized to be molecules CONCLUSION reducing activity. NF-eB The
capable
filing
of the
at the time of
was
state
art
reasons,
foregoing
For the
that
hold
uncertain, leaving
Ariad with
primitive
the asserted claims of the '516
are
supply
art
prior
knowl-
insufficient
description,
invalid
lack written
gaping
to fill
in
edge with which
holes
dowe
not address the other validity issues
Capon,
See
its disclosure.
panel.
that were before the
rein-
We also
(“It
well-recognized
is
that
in the
panel
reported
state Part II of the
decision
science,
unpredictable
appro-
it is
fields
(Fed.Cir.2009),
at 560 F.3d
affirming
priate
recognize
variability
finding
inequita-
the district
court’s
no
scope
in determining
science
of the
conduct. The judgment
ble
below is
enti-
coverage to which the inventor is
REVERSED IN PART
AF-
AND
tled.”).
FIRMED IN PART
support
jury
thin thread of
Whatever
decoy-molecule
might
hypothet
find
NEWMAN,
Judge,
Circuit
additional
simply
weight
ical
cannot bear the
views.
scope
generic
of these
vast
claims. See
join
However,
opinion.
I
the court’s
I
LizardTech, 424 F.3d at
that
(holding
separately
write
because
real issue of
patent,
person
reading
“[a]fter
important
this case is too
submerged
be
skill in the art
not
would
understand” the
in rhetoric. The issue
patentee
generic
recognized by
to have invented a
meth
was
Ariad,
patent only
complained
od where the
disclosed one
who
that
the written
it);
Reiffin,
embodiment of
F.3d at
description requirement “has severe ad-
(noting
“scope
1345-46
that
consequences
verse
for research univei'si-
right to
exclude”
not “overreach the
prevents
ties” because it
the patenting of
scope of the inventor’s contribution
type
“the
that
discoveries
universities
field of art as
described
make,”
is, prevents
patenting
Fiers,
specification”);
practical RADER, Judge, with whom Circuit goals idity device and better serves LINN, joins, Judge, dissenting-in- Circuit priori to the when confined the Patent Act statutory concurring-in-part. inter part a matter of ty context. As however, cannot limit pretation, of the United States Constitution cases, only priority courts, Congress, power gives such a limit could establish Congress but progress of the useful arts promote ¶ 112, 1’s enablement by statute. Section *24 securing rights to inventors exclusive adequate vehi is a more than 8, I, Art. cl. limited times. Yet for that invalidating are broader cle body court the re- proclaims this itself Sup Ag J.E.M. than their disclosure. See achieving “right balance” sponsible Hi-Bred, Inc., Int’l, Inc. v. Pioneer ply, upstream and inno- downstream between 124, 142, 122 S.Ct. 151 U.S. 534 Act, at 1353. The vation. Ante Patent (2001)(identifying enabling an L.Ed.2d 508 however, already has established the bal- quo pat quid pro of the disclosure as by requiring patent application ance that a Corp. monopoly); ent Martek Biosciences “a of the inven- contain written Nutrinova, Inc., 1363, 1378 tion, process and of the manner and (“To (Fed.Cir.2009) the enablement meet it, clear, full, making using in such of a requirement, concise, any and exact terms as to enable in the art how to must teach those skilled person per- skilled in art to which it scope of claimed make and use the full ... tains make and use the same.” 35 experimenta without undue ¶ added). (emphasis 1 U.S.C. tion.”). Confining description to written statutory rejecting that favor of balance provide priority greater context would description” “written an undefined doc- clarity practitioners, courts and to district trine, ignores problems this court currently trudge left to both of whom are making and standardless decision serious through a thicket of written with other areas of law. conflicts provides no conclusive jurisprudence Act already supplies Patent Because the ap encourages shotgun answers and test, respectfully I dissent. better Yet, this litigation. thicket proach our efforts to construe the result of best I. statute; only Congress ambiguous an it. wields the machete to clear de- The frailties of court’s “written exhaustively have majority’s scription” doctrine been Accordingly, because See, previous opinions. interpreta- a reasonable documented opinion provides occasions, Circuit, twenty-two upholding while by the Federal district courts whether Holman, only nine times. Id. at 26-78. According them over or BPAI. nine-year rejected period, Federal Circuit Furthermore, Holman discusses each description-based challenges on six written the BPAI where a cases before the courts and occasions, challenges in upheld while challenge re- under only During period argues four cases. same quirement upheld was excluding time those decisions addressed would have also been most cases the Circuit, rejected the Federal district courts for lack of enablement invalid description challenges substantially occa- blurred the line on ten court or BPAI sions, description. upheld Finally, the and written them once. between enablement description challenges Id. at 78-79. rejected BPAI 1362 Biochem, process Inc.
e.g., Enzo
v. Gen-Probe
ner and
making
using the
(Fed.Cir.2002)
Inc.,
F.3d
976
323
judged by
invention are both
whether they
(Rader, J., dissenting from
of re
denial
full,
concise,
clear,
are in such
and exact
banc);
(Linn, J.,
hearing en
id. at 987
terms as to
person
enable
skilled
dissenting
rehearing
from denial of
en art to make and use the invention. The
banc); Moba, B.V. v.
Automa
Diamond
reason for a
doctrine is clear:
(Fed.Cir.
tion, Inc.,
F.3d
fully
to ensure that the inventor
discloses
2003)
J.,
(Rader,
concurring);
id.
1327 the invention in
exchange for
exclusive
(Bryson, J., concurring); Univ.
Roch
right. The test
adequacy
for the
Co., Inc.,
ester
Searle
v. G.D.
&
F.3d
specification that
describes
invention is
(Fed.Cir.2004) (Rader,
J.,
dis
also
Is
clear:
sufficient to
banc);
senting
denial of
en
rehearing
from
person
ordinary
enable
skill in the art
(Linn, J., dissenting
id. at
from denial
to make and use the claimed invention?
Lizardtech,
banc);
of rehearing en
Inc. v.
paragraph require
Nowhere does the
Inc.,
Mapping,
Earth Res.
satisfy
quixotic
the inventor
posses-
some
(Fed.Cir.2006) (Rader, J., dissenting
*25
requirement.
sion
banc);
rehearing
from denial
en
of
court, however,
This
the
calves
“written
Pharms.,
Inc. v. Eli
560
&
F.3d
description of the
language
invention”
out
(Fed.Cir.2009)
(Linn, J.,
1380
concur
of its context in
paragraph.
the rest of the
ring).
earlier writings
These
document
In this court’s
reading,
strained
the prepo
embárrassingly
the
thin (perhaps even
phrases
apply
sitional
only
follow
to a
mistaken) justifications
minting
for the
of
description
“written
...
the
of manner and
description
this new
in 1997
doctrine
and
process of making
using”
and
the inven
the extensive academic
of
criticism
tion,
description
not to a “written
of the
product
judicial imagination.
of
For pres
practical
invention.” The
effect of the
I
purposes
only
ent
will
recount
those
interpretation
court’s
is that
the written
relatively
frailties of this court’s
recent
of
description
the invention contained in
justifications
for doctrine of its own mak
specification
the
need not
full. It
be
need
ing.
not be clear.
It need not be concise.
It
foremost,
First and
the separate written
need not be exact.
Phillips
But see
description requirement
pe-
that the court
(Fed.Cir.
Corp.,
AWH
today
statutory
trifies
has no
support. As
2005) (en banc) (“The
kinship
close
be
noted,
paragraph,
first
reads as fol-
tween the
written
and the
lows:
claims is
statutory
enforced
re
shall contain a written
quirement
describe
invention,
of the
and of the
‘full, clear,
the claimed invention in
con
process
manner
of making
and
and us-
cise,
”)
added).
(emphasis
and exact terms.’
it,
full, clear, concise,
ing
in such
and
And,
course,
of
it need not
In
enable.
exact
person
terms as to
any
enable
stead,
satisfy
vague possession
it must
skilled in
art
pertains,
to which it
notion.
connected,
nearly
which it most
same,
to make and use the
shall
and
set
statute,
its
support
reading
To
contemplated by
forth the best mode
court relies on a new
of statutory
doctrine
carrying
inventor of
out his invention.
interpretation
“parallelism.”
it calls
cumbersome,
today,
This
while
at 1344.
language,
parallelism
is un- Ante
Before
ambiguous.
says
It
that the
de- would have been simply
disfavored under
scriptions
invention and of the man-
the maxim that the
law does
use re-
requirement
a maxim that has actu-
invention”
language,
dundant
(Indeed,
by courts before.
ally been used
a person
when it tells
of skill in the art
it
this maxim when fits
the court uses
even
words,
what the invention is.
other
1844-45.) If
see ante
Con-
purpose,
proper reading
statutory description
only
to test
enablement
had intended
gress
recognizes that
requirement
enable-
the written
sufficiency of
ment
identifies
making
process
manner and
and
ordinary
person
and tells a
skill what to
invention, then it would have
using the
course,
original
make
use. Of
...
required “a
simply
statute,
always, by
“particu-
making
process
the manner and
larly point[
distinctly
out
]
claim[ ]
full,
concise,
clear,
it in
using
subject
applicant regards
matter which the
any person
terms
to enable
skilled
exact
as
¶
his
invention.”
Schriber-
art
...
to do so.” Note also that
Schroth,
acknowledges,
as the court
dealt
“it” in
the comma after
the statute as
MacKay
with amended
as did
Ra-
meaningless
written is
under
court’s
Am.,
Corp.
dio & Tel. Co. v.
Radio
interpretation.
(1939),
U.S.
59 S.Ct.
L.Ed.
Moreover, if
indeed the
“parallelism” is
Wells,
(22 Wall.) 1,
Gill v.
89 U.S.
test,
with the court’s
right
then
conflicts
(1874).
only
L.Ed. 699
These cases stand
de-
separate argument
proposition
for the unremarkable
that an
has
scription of the invention test
been
applicant cannot
new
to an
add
matter
test
from the enablement
since
separate
original
Supreme
disclosure. Thus
Court
A close look at
1793 Act.
Section 3
fully
precedent
logi-
consistent with the
“parallelism”
the 1793 Act reveals
*26
clause to
reading
there connects
enablement
cal
and impeaches
statute
description requirements:
both
this
imposition
court’s ultra vires
of a new
inventor,
[E]very
he can receive a
before
description requirement
origi-
for
...
shall
deliver a written de
patent
nal
in
imposition
that first arose
invention,
scription
his
the Regents
v.
University
of California
using,
process
manner
or
of com
Co.,
1559,
Eli
&
1566-69
same,
full,
pounding the
in such
clear
(Fed.Cir.1997).
any
...
per
and exact terms
enable
At
point,
this
this dissent could once
make, compound,
...
son skilled
Enzo,
document,
again
every
that
use, the same.
case before this court’s fabrication
1997
27, 1793,
318, 321-22,
Act of Feb.
Stat.
actually applied
description”
the “written
added).
11, § 3 (emphasis
ch.
1982,
police
Before
priority.
doctrine
reality,
sidesteps
In
court
simply
predecessor
this court’s
referred to this
position
conflict between its
lan-
prohibition
doctrine as
new matter
by suggesting
of the statute
guage
Rasmussen,
respect to claims.
In re
See
settled this
Supreme
precedent
Court
has
(CCPA 1981) (“The
1212,
F.2d
course,
at 1344-45. Of
that is
issue. Ante
rejection
proper basis
a claim
Supreme
to an-
question
Court
recite
to be
thought
amended to
elements
swer,
the statute as it is
reading
but
writ-
original
support
without
disclosure
fully
ten is
fact
consistent with cases
112,
paragraph,
is
first
like Schriber-Schroth Cо.
Cleveland
Co.,
47,
8,
properly
132....
is
[The
section]
83 L.Ed.
latter
Trust
305 U.S.
59 S.Ct.
(1938).
objection
employed as
basis for
abstract, specifications,
to the
amendments
Specifically,
doctrine un-
....”)
added).
In
drawings
(emphasis
reading
of the statute shows
der
correct
not even
Lilly,
tragically
Eli
this court
did
that a
satisfies
“written
breaking
realize that it was
new ground.
first paragraph.
See 535 U.S.
It
really
was not until Enzo that the court
(2002).*
S.Ct.
1365
“
(1928).
328,
170,
reconfirmed,
‘in
48 S.Ct.
72 L.Ed.
must be read
view
298
claims
”
their
blocking
to determine
can
even
specification’
This
condition
exist
(quoting
F.3d
1315
meaning.
original
415
to con
patentee
where
“failed
Instruments, 52
v. Westview
Markman
an
in
template”
additional element found
see,
(Fed.Cir.1995));
e.g., id.
F.3d
979
A.B.
improvement patent.
Dick Co. v.
(“Claims
light
always be read
(Fed.
Burroughs Corp., 713 F.2d
703
Here,
specification.
Cir.1983).
appellants
plain
did
makes
what
Blocking
conceivably occur
conditions
....”)
Fout,
(quoting
not invent
In re
did
patent
where a
a
pioneering
often
claims
(CCPA 1982) (alteration
F.2d
300
and an
later
genus
improvement
Inc.,
Sandoz,
v.
Labs.
original));
Abbott
See,
species
genus.
of that
e.g.,
claims
(“[T]he
(Fed.Cir.2009)
F.3d
(Fed.
Hiraga,
F.2d
Utter
enlarge
patented
what
claims cannot
Cir.1988)
that in an
(holding
interference
inventor
described as
beyond what the
has
“[tjhere
inconsistency
is no
proceeding
omitted).
invention.”) (quotation
inventor,
awarding
generic
count to one
this
followed its
rule and
If
court
own
awarding
patentably
spe
while
distinct
what
enlаrge
do not
ensured that claims
another.”);
cies count
W.L.
& As
Gore
described,
inventor
then the claims
has
socs.,
Garlock, Inc.,
Inc. v.
scope
that exceeds the
would never have
(Fed.Cir.1983) (“Assuming
first-
[the
specification.
in the rest of the
disclosure
dominating
in-time
patent,
is]
Thus,
never
a claim
this court would
find
infring
of law is
that an
rule
clear
accused
(again,
support”
that “lacks
whatever
employment
process
er’s
of the
of a domi
means)
rest of
document.
nating patent does not render that em
words, this
In other
court’s new
ployment
anticipation of an invention
if
only
meaning
description doctrine
has
in an improvement
described
claimed
ignores
court
its own claim construc-
patents
patent.”).
blocking
These
often
essentially claims
tion rules. This court
by pressuring
serve the market well
both
power
unfettered
to err twice—both
their
inventors
license
innovations
construing
claims so
as to ex-
broad
and beyond.
each other
rest
scope
specifica-
ceed the
however,
Eli
value of
Lilly,
After
tion and then to invalidate those
blocking
will
un
failing
disappear
these
situations
because
reads
“support”
patentee
this court’s own
con-
pioneering
“possessed,”
broad
less the
subject
claim,
ception of the claimed
matter.
yet for some
chose not
reason
*28
situation,
course,
improvement. That
an
‘blocking patent’
patent
“A
is
earlier
ever,
rarely,
happen.
if
would
See Roch
practice
that must
licensed
order to
be
ester,
(Rader, J.,
F.3d
375
at 1312
dissent
occurs,
in
patent.
later
This often
(“Inventors
they
know when
have
ing)
stance,
pioneer
and an
patent
between
they
an
made
invention and realize that
II,
improvement patent.”
Prima Tek
it
properly
losing
disclose
or risk
it
Co.,
1372, 1379
n.
L.L.C. v. A-Roo
F.3d
entirely.”). Unfortunately
Eli
the new
(Fed.Cir.2000).
Supreme
has
Court
effectively
-Lilly
prevents
doctrine
this
long acknowledged
“well established”
precept
patent
law. For
long-standing
improver
appropriate
rule that “an
cannot
se
example, although “[i]mprovement and
patent
the basic
of another and
ubiquitous
patent
inventions are
lection
infringer
a license
an
improver without
law;
do not cast doubt
developments
Elec.
may
be
as such.” Temco
sued
invention,”
Mfg.
original
Apco
Motor Co. v.
275 U.S.
on enablement
CFMT,
Yieldup
Corp.,
subjective/objective
Int’l
The court
Inc. v.
makes the
(Fed.Cir.2003),
they ap-
confusing by
nature of the test
more
even
parently do cast doubt
the written de- perpetuating
question
the test’s status as a
original
scription
related,
invention.
See
objective
of fact.
inquiries
Other
I,
also
Ltd. v.
Integra
Merck
that focus on the
corners of
speci-
four
Lifesciences
KGaA,
(Fed.Cir.2003),
fication, such as claim construction and
grounds,
vacated on other
545 U.S.
enablement,
questions
are
of law.
If the
(2005)
125 S.Ct.
L.Ed.2d 160
right
court is
that the written
(“The
genus
patent
patent.
'525
Such
objective,
of the invention test is
then ei-
genus patents
estop
applicant
do
ther
the court misclassifies written de-
improvement
filing
from later
an
scription or claim construction and enable-
...
species
particularly
to claim
use-
Moreover,
ment.
if the test
truly
were
rule,
properties.”).
ful
Without
new
objective, this court would not have such
upstream
downstream and
innovators in
stands,
defining
trouble
As it
it.
this case would have benefited from the
inadequate description
court’s
of its writ-
ability to cross license. Under the new ten description requirement acts as a wild-
regime,
improvements
likely
mere
will
in-
may rely
card on which the court
when it
genus patents.
validate
The principle of
a patent
faces
feels is unworthy
that it
consequences
again
unintended
once
coun- protection.
against judicial
sels
adventurism.
statute,
A reading of the
on the other
hand, supplies
strong
enablement
test
III.
neutral,
with a
empirical,
predictable
doctrine, patent
Under this new
appli-
test:
cants will face a
difficult burden
discern-
already requires
Enablement
inventors
ing proper
procedure
claiming
under this
to disclose
(reproduce,
how to make
re-
unpredictable
court’s
written description of
manufacture)
plicate,
and how to use the
requirement.
invention
The court
(by
rendering
definition
it a
talks out of
both sides
its mouth as it
art”). Therefore,
“useful
because the
lays
hand,
out
the test. On
one
competitor
invention,
can make the
require
test seems to
the fact finder to
can
acquire
then
DNA sequence
or
a subjective inquiry
make
about what the
any other characteristic whenever it de-
possessed.
inventor
Ante at 1350-51. On
sires.
competitor
Meantime the
can
other,
the court states that
the test
(outside
use, exploit, commercializе
requires
objective inquiry
into the four
term)
improve upon
and de-
corners of
from
per-
(within
term)
sign
around
spective
ordinary
of a person of
skill in the
much of the invention as it cares to
art.
subjective
But a test
no
becomes
less
words,
make.
In other
the statutory
merely
because it asks
fact finder to
sufficiency
standard for
of disclosure
subjective question
answer
objectively.
serves masterfully the values of the pat-
This court still asks the fact finder to
system.
ent
*29
imagine what a
of
in
person
skill
the art
Enzo,
(Rader, J.,
description in In supplies the the a of statute test for course description operated definition marvelously describes the exact that has decades, same invention according to this for if court’s not centuries. If this court rules). claim construction perceives a need for renewed attention to varying positions amici take it should The either description requirements, jurisprudence its enablement this Br. strengthen side of debate. See of Amicus rules. Invention making new instead (parsing statutory Roberta Morris 4-9 strengthens and ad- technologies new no separate descrip- text to show arts,” invention of the “useful but vances requirement); tion Br. of Amicus Christo- and frustrates confuses new doctrines Cotropia 17-20 that a pher (arguing law. grammatically correct “plain, reading” mandates a distinct standard for written LINN, Judge, Circuit with whom description). RADER, joins, dissenting- Judge, Circuit vigorous parties argu- offer While in-part concurring-in-part. and § 112, grammar para- ments about the major- statutory arguments The graph only interpretation reasonable today justify enshrines fail to establish- ity Ariad, is the one offered both because it separate require- ing a the long-recognized purpose conforms beyond and apart ment from enablement the statute in new policing matter viola- context, fail that priority and to tether it tions because tethers the “written requirement to a work- description of the invention” an under- For and the legal able standard. these full, concise, clear, stood standard: “such follow, I respectfully that dissent reasons Lilly and exact terms so as to enable.” majority’s I opinion, from Part that not necessarily remarks statutes do re- appeal believe the should have been tests, thеir own and that specify legal “the panel turned to the for resolution for are position applying developed I no standards them question. enablement take Ariad’s compliance Lilly’s on the merits of over Al- by courts time.” Br. 28. 1; however, § I paragraph 35 U.S.C. might this true though generally, be Con- inequitable in affirmance of no concur provide legal gress did such standard conduct. statute, majority’s and the creation of separate, additional a—with Statutory
A.
Language
unnecessary
poorly defined standard —is
majority,
par-
Like the
I start with the
view,
my
ill
no
advised.
there is
in-
statutory interpretations.
ties’
statute,
reading
justification
be-
“ordinary
English
that
rules of
sists
suggested by
yond
priority
context
grammar”
“plain reading”
anything
other
requiring
U.S.C.
paragraph
show that
than a written
sufficient to en-
judged only by
the invention is
enable-
to make and use the
able
skilled artisan
“in
whether
it
namely,
describes
ment —
particularly pointed
out and dis-
full, clear, concise,
and exact terms
tinctly
claims.
recited
art
any person
as to enable
skilled
requirement provides
The enablement
it
it is
pertains,
to which
with which
propriety
an established standard
connected,
nearly
and use
most
make
sup-
the written
offered to
same.” Ariad’s
Br. 2-3.
Principal
Wands,
In re
port
set
claims. See
statutory inter-
relies less on
While
(“The
(Fed.Cir.1988)
term
delin-
pretation,
responds
the text
experimentation’
appear
does not
‘undue
description require-
two written
eates
statute,
well
but it is
established
ments —“of the invention” and “of
requires
enablement
using
and process making
manner
make
teach those
the art to
and use
ap-
it”—-but
the enablement standard
*30
only
experimenta-
Br. 27-28.
without undue
plies
Lilly’s
the latter.
invention
tion.”).
requirement
language
majority
also
The
that the
The enablement
uses
extent
explain
ensures that the full
of claims as
as shown in
“possession
the disclo-
utility,
have
by
applicant
serted
an
only
justify
sure” not
separate
fails
that
make and use
public
test,
can
distinguish
also fails to
the test for
See In re
invention recited therein.
'318
requirements
from the
Litig.,
Infringement
Patent
583 F.3d
for enablement.
level of detail
“[T]he
re-
(Fed.Cir.2009) (“Enablement
1323-24
is quired
satisfy
the written description
closely
related to
for utili
requirement,” according
majority,
to the
ty....
requirement prevents
The utility
“varies
depending
scope
nature and
being patented.”).
mere ideas from
of the
the complexity
сlaims and on
predictability of the relevant technology.”
Proposed
B.
Majority’s
Written
considerations,
Maj. Op. at 1351. These
Test
Description
however, mirror
the Wands factors for
I
majority
credit the
acknowledging enablement,
include
which
“the nature of
“possession”
test “has never been
invention,”
claims,”
breadth
“the
very enlightening” and for attempting to
predictability
and “the
or unpredictability
clarify
“possession
that
as shown in the
of the art.”
1369
requirement
Acts
Act
the
First,
history
the Patent
ter the 1836
added
the
descrip-
separate
a
written
Supreme
applied
not reveal
the
this
does
for
Court
Be-
original
for
claims.
requirement
tion
requirement
from en-
separate
1836,
not re-
patent
the
did
statutes
fore
Maj. Op.
example,
at 11. For
ablement.”
At that
to contain claims.
patents
quire
Lilly
majority
rely
the
on Schriber-
time,
satis-
patent’s
Co. v. Cleveland Trust
305
Schroth
(1)
distinguish
“to
requirements:
two
fied
8,
(1938),
47, 59 S.Ct.
L.Ed. 34
U.S.
83
from all other
same [the invention]
the
patents
with two
which dealt
to Gulick
(2)
known,”
“to enable
things before
Maynard
pistons
in internal combus-
...
skilled
the art or science
any person
“extremely
Gulick
engines.
tion
described
make, compound,
use the same.”
elements in
in his
rigid”
pistons
web
the
1793,
321-22,
27,
318,
1
Act of Feb.
Stat.
original application, but later amended
11,
Accordingly,
Supreme
ch.
3.
application to include “flexible” webs.
Id.
recognized Evans v. Eaton that
Court
56,
Maynard
at
has not Lilly described.” 1346 n.4. have we original forced claims over a passages high- cites from Morse and description extending beyond hurdle en- lights every instance of the words “de- ablement.
scription” Lilly’s or “described.” Br. 8.
However, places too much in stock Original D. Claims these words and that assumes “describes” rejecting addition to majority’s meant majority 1854 what the would precedent-based arguments, ways I part today. like it to mean description Morse’s majority’s policy justifications for was deficient because it did not enable the applying description written original (to scope full of his broadest claim all claims. The majority accepts Lilly’s argu possible telegraphs), electrical not because that, ment “while an original part claim is equivalent failed the of a present-day specification, this fact does not mean “possession” test for written description. original claims must always be an that majority The suggests also that the Su- adequate written of the inven preme Court ratified our current written tion.” Lilly’s Br. 35. This debate is not description doctrine in Corp. Festo new. See Univ. Rochester v. G.D. Co., Shoketsu Kogyo Kinzoku Kabushiki (Fed.Cir. 1303, Searle & 375 F.3d 1307 722, 1831, 535 122 U.S. S.Ct. 152 L.Ed.2d 2004) (Lourie, J., (“Thus, concurring) (2002). 944 But that decision addressed fact that a statement of an invention is scope prosecution history estoppel original an claim necessarily does not end under equivalents. the doctrine of inquiry all as to the satisfaction of the extent of the Court’s allusion to written requirement.”). How description is a recitation applications ever, the policy reasons applying “describe, enable, and set forth the a requirement original claims remain mode,” best and that “exclusive unconvincing. rights are given exchange disclosing beyond It is dispute original public.” 736, invention to the Id. at part are patent’s of a 122 disclosure. S.Ct. 1831. Neither See id. of these state- (Lourie, J., (“As concurring) ments a holding propo is for the sition that applies originally claims, original part filed claim is even clear.”). that enablement written description, is not the sole measure of And disclosure. predecessor With all due our respect, charac- court repeatedly held terizing that, Festo as an part endorsement of mod- disclosure, “original ern written description is at best mis- claims constitute their own description.” placed. Koller, (CCPA In re 819, 613 F.2d 1980); Smith, see also In re 481 F.2d Until our 1997 Lilly, decision in ap we (CCPA 1973) (“Where the claim is an plied a doctrine from claim, original the underlying concept of § paragraph to control appli insuring filing disclosure as of the date is priority, cants’ claims to but not to invali satisfied, and the description requirement date originally filed and without has satisfied.”); likewise been held any to be perceived inconsistency with the stat Gardner, (CCPA In re E.g., Rasmussen, ute. 475 F.2d In re 1973) (CCPA 1981) (“The (holding that an original claim proper suffi ba rejection ciently itself, sis for of a claim described “[njothing amended and that thought recite elements more is sup necessary to be without for compliance with the port disclosure, original therefore, requirement of the para first first paragraph....”). Only graph 112”), denied, since 35 U.S.C. reh’g 1973) (CCPA (“Un language tional to define the boundaries of 879-80 circumstances, consider the genus,” disclosing “spe these a claimed without der adequate claim ‘written original itself support Maj. cies sufficient to claim.” *33 invention.”). of the claimed description’ atOp. agree I that such claims 1349. before, Thus, original have “[f]or as I said polices should be invalid—but enablement pos ... the evidences] claim itself effectively. Any those claims claim that filing the as of the of invention session purely language, uses functional or covers Biochem, Enzo Inc. Gen-Probe date.” genus support a broad without sufficient (Fed.Cir.2002) 956, Inc., 323 F.3d ing E.g., will not be enabled. In examples, J., (Linn, dissenting). (Fed.Cir. Vaeck, 488, re 495-96 1991) say filing that on its (affirming rejection It is inconsistent to enablement date, claims). not show that the patent does genus “possessed” subject matter that inventor several amici that the and caution actually encompass claims and the the the protects doctrine fully Doing per- enables. so public requiring patentees provide unnecessary tension between petuates specific scope their inven- notice and as the claims the written See, Medtronic, e.g., tions. Br. of Amicus patented invention. the definition of Inc. misplaced. 11-12. This concern is also § para. (requiring 35 U.S.C. See Generally, 122(b), pat- under 35 U.S.C. out “particularly pointing claims and dis- applications publish ent months eighteen matter”); tinctly claiming subject Aro the filing “from the earliest date for which Replacement Mfg. Top Co. v. Convertible Therefore, benefit sought.” public is the U.S. 81 S.Ct. original receives notice of claims within a (1961) (observing that “the L.Ed.2d specified Br. time. See of Amicus Mon- made in are claims the the sole breadth, (“Regardless santo Co. 8 of its Indeed, the grant”). the ma- measure language original puts of an claim confusing reinforces notion that jority skilled on notice inventor artisans that the claims is primary purpose pro- “to subject the in- claiming is matter as right notice the boundaries vide invention.”). ap- ventor’s own Even if the ... to exclude not to describe inven- plication publish pat- does not before the 1347; Maj. Op. Br. of Ami- tion.” at cf. issues, original part ent claims remain (“The claims cus Oskar Liivak 15 are not public prosecution history notify conceptual logical, the invention public the invention’s scope. matter.”). practical Again, since the 1836 Act, pur- have served government Patent claims The an amicus submitted invention, pose “distinguishing” brief which it asserted that the written as a while whole must “necessary per- doctrine “enable.” mit perform USPTO to examina- basic tion function” and claimed that the Patent original might
The fear that even applies paragraph Office to over what it does “claim[] “400,000 applications year.” each is,” Lilly’s than rather what it Br. Br. of 19-20. How- Amicus United States satisfy unfounded because all claims ever, argument at government oral requirements enablement other applications could not cite the number of agrees majority patentability. annually rejects PTO on satisfy “mаny original claims will the writ- reject description grounds cannot express- but requirement,” ten at 22:42- may Arg. “func- another See Oral applicants es concern use basis. government agreed 24:50. The also leaves unanswered again once the critical “enablement is a large available address question presented first panel number of these problems.” Id. 28:01- whether the asserted claims of the '516 Indeed, study argu- released after patent meet the enablement requirement. ment that appeals reviewed over 2800 view, my question before the en Appeals the Board of Patent and Interfer- banc court should have been answered (“BPAI”) during ences 2009 found that negative appeal and the returned to only 4.3% of those cases decided written panel for resolution of the enablement issues, and that none of those question Lilly’s remaining invalidity *34 if change outcomes would the PTO could and noninfringement concur, defenses. I rejections continue to issue new matter however, majority’s reinstatement of Crouch, § under 35 U.S.C. 132. Dennis D. panel’s affirmance of inequitable no An Empirical Study the Role reasons, conduct. For these I respectfully Description Requirement Written in Pat- dissent from Part I of majority opin- (Univ. ent Prosecution of Mo. Sch. of ion, concur in ruling inequitable no Legal Law Paper Studies Research conduct, position and take no on the merits No.2010-06, 2010), http://ssrn. available at compliance Ariad’s with 35 U.S.C. study con- com/abstract=1554949. paragraph 1. that, cludes “in the context of appli- BPAI, appealed cations impact separate re-
quirement negligible apart from its role
in policing the addition of new matter.”
Id. 3. only While this research ad-
dressed a small sample applications
did not consider description rejec- TRADING, LLC, by JADE through, applicants tions that overcome or do not appeal, these Robert government’s results and the W. ERVIN and Laura Kava lack empirical naugh evidence undermine the Ervin on Capi behalf of Ervin government’s hypothesis that tal, our LLC, Partners Other Than the system examination grind would to a halt Partner, Tax Plaintiffs-Ap Matters if written description no longer applies to pellants, originally filed claims. The Patent Office survived well enough before when it STATES, UNITED Defendant-Appellee.
was understood that written description was a basis rejecting broadening No. 2008-5045. amendments to claims or specifications, original Rasmussen, claims. United States Appeals, See Court of F.2d at 1214. Federal Circuit. March
* * * granted The court petition for re-
hearing in this case to address whether paragraph 1 contains a written de-
scription requirement separate from an en- and,
ablement requirement so, if the scope
and purpose of requirement. such a
affirming requirement, majority