*1 jurisdiction enjoys to review the No exclusive costs. ITA,
decisions of the its decisions on the VACATED AND REMANDED. significant of such review are of occasions authority import. Given the exclusive Trade, expertise of International it
Court
develops exclusivity and maintains from its
worthy respect. the instances when
the decisions of the Court of International Group Limited, GLAXO INC. appealed Trade are either not to this court or Plaintiffs-Appellees, wholly following appeal, are left undisturbed likely those decisions are to “serve as valu LTD., NOVOPHARM Defendant- guides rights obligations able Appellant. community.” the international trade National Baker, C orn Growers Ass’n v. 10 C.I.T. No. 94-1026. (1986). United Appeals, States Court of express terms 28 U.S.C. Federal Circuit. 2645(a) (1988) § provide that final “[a] deci April sion of the Court International Trade Rehearing Denied; Suggestion for contested civil action ... supported shall be (1) Rehearing In Banc Declined findings a statement of of fact and June (2) 1995.* law; opinion stating conclusions of or upon the reasons and facts which the decision judgment
is based.” The of the Court of satisfy
International Trade alone does not mandatory requirements of section
2645(a). holding exceptional. Our is not
The United States Court of Customs and Appeals, predecessor
Patent one of our
courts, required the United States Customs
Court, predecessor court of the Court of Trade, comply
International with section
501 of Tariff Act predecessor 2645(a).
statute to 28 U.S.C. Florea & Co. States, CCPA 153, 155, 1948
v. United WL exceptional Nor is it for this sponte
court to consider sua the issue raised 2645(a). See, e.g., section Cablestrand Wallshein, (Fed.
Corp. v.
Cir.1993) (vacating remanding a district judgment findings of fact and con
clusions of law when issue was not raised
parties appeal). provide
This court cannot effective and
meaningful appellate review of the ac- ITA’s supplied in this ease until we
tions are 2645(a).
the fruits of satisfaction of section
Accordingly, judgment of the Court of
International Trade is vacated and the case opportu-
is remanded to afford the court the
nity comply with the relevant statute.
* Clevenger, Judge, participate Circuit did not the vote.
the brief were William G. Todd and Janet B. Linn. Also on the brief were Steven P. Lockman, Porter, DC, Washington, Arnold & Eason, Joseph Allen, W. Moore & Van NC, Raleigh, of counsel. *3 Green, Leydig,
Robert F. Mayer, Voit & LTD., IL, Chicago, argued for defendant- appellant. him on With the brief were John Rosenquist Jeffrey E. and S. Ward. ARCHER, RICH, Judge, Before Chief and MAYER, Judges. Circuit Opinion by for the court filed Circuit Judge Dissenting opinion by RICH. filed Judge Circuit MAYER.
RICH, Judge. Circuit (Novopharm) appeals Ltd. judgment of the United States District Court Carolina, for the Eastern District of North Glaxo, Ltd., Novopharm, Inc. v. (E.D.N.C.1993), 4,521,431 Unitеd States Patent No. was not infringed, enjoining invalid and was No- vopharm from the commercial manufacture patented crystalline or sale of the form of hydrochloride. ranitidine We affirm.
Background (collec- Group Glaxo Inc. and Glaxo Ltd. Glaxo) tively are the owner and exclusive licensee, respectively, United States of Unit- (’431 4,521,431 patent). ed States Patent No. patent specific crystalline The ’431 claims a compound hydrochlo- form of the ranitidine ride, designated 2,” as “Form which Glaxo markets as an antiulcer medication under the patent brand name Zantac.1 The ’431 issued on June 1985. Judlowe, Calimafde,
Stephen Hopgood, B. investigating po- Glaxo chemists Kalil, Judlowe, City, synthesized Blaustein & New York tential antiulcer medications an derivative, argued plaintiffs-appellees. aminoalkyl for himWith on furan later named ran- = = = here, (1) (s medium, strong, 1. Claims 1 and 2 of the '431 in issue intensities m w = = weak, diffuse) very, reаd: v d and obtained Debye Scherrer method in a 114.6 mm hydrochloride 1. Form 2 ranitidine charac- by exposure camera spectrum diameter for 12 hours to terized an infra-red as a mull in showing and for 3 following peaks: radiation hours to radia- mineral oil main CoKa CuKa peaks] [table] tion: [list of hydrochloride pharmaceuti- The '431 also claims various 2. Form ranitidine accord- compositions using to claim 1 further characterized cal and methods of Form 2 following x-ray powder pattern hydrochloride. diffraction ex- ranitidine These claims are not pressed spacings in terms of "d” and relative at issue case. filtration and 2 had better Form Because potent a histamine itídine, proved to be suited for making it better drying properties, of stomach blocker, inhibiting the secretion decided applications, Glaxo commercial applica- an year, filed Later acid. of Fоrm commercialization proceed with in the United ranitidine a tion for hampered 1. Form was rather Form than for Kingdom. It followed however, which properties, by poor flow No. issued as patent, which United States a difficult to measure made the material (’658 December 4,128,658 patent) on Accordingly, pure form. dispense in its number of structur- patent claims The ’658 azeotrop- developed novel scientists including compounds, ally similar salt, granulate the Form ing process3 to one It salt. discloses its to make into it much easier which made hydrochlo- preparing ranitidine method compositions. This pharmaceutical *4 Example as ride, patent in the ’658 set forth applica- patent subject of a was the British 32.2 eventually without abandoned tion Glaxo public. process to disclosing the large quantities of prepared raniti- Glaxo 1977 and 1980 between hydrochloride covering patеnt application dine filed a toxicology and clinical studies. in the Unit- hydrochloride for use Form 2 ranitidine 32, 1, It filed a Example 1980. using process Kingdom of on October of ed Instead next application thereon the however, prepared this ma- United States Glaxo’s chemists ’431 eventually issued as the year, which they la- process that using a similar terial Graham Brere- patent George suit. When developed a They later Process 3A. belled ton, initially charged patent officer Glaxo’s Pro- method that called efficient more application, pursuing the United States with 15, 1980, April both Process Until cess 3B. process azeotropic granulation learned of hydro- yielded ranitidine 3B 3A and Process keep se- desire Glaxo’s origi- respects all to that identical in chloride cret, not claim that Glaxo he recommended proce- Example 32 using the nally produced Form 2 compositions of the pharmaceutical dure. violating mode re- of the best salt for fear date, however, Glaxo’s Derek believed quirement. apparently On that Brereton crystal- azeotroping process prepare of the 3B that disclosure used Process Crookes necessary it was the best visibly would because hydrochloride that was be line ranitidine way the Form 2 salt for use to make batches of the previous from all different compositions. He preparing pharmaceutical infra- confirmed The difference was salt. position at Glaxo. to another later moved (IR) x-ray powder dif- spectroscopy and red eventually amended was U.S. fraction, product the new revealed that which claims, composition pharmaceutical to include form, rani- polymorph, or crystalline a specification to not amend the but Glaxo did hydrochloride that differed from tidine azeotroping process. disclose the began to re- previously known form. 1991, 9, Form raniti- Ltd. polymorph August Novopharm new as filed to this On fer poly- Drug Application (designating the old an New hydrochloride Abbreviated dine (ANDA) 1). Drug Adminis- with the Food and Form morph as component ability of the to interact a Collin in June for its Developed David Glaxo's 2. 1977, dissolving azeotrope original mix- ranitidine mixture to form that method involves —a spirit containing methylated dis- composition in industrial of which of substances "the ture gas. Ethyl hydrogen is acetate solved chloride change upon See distillation." does not solution, hydrochlo- added Dictionary and Techni- McGraw-Hill Scientific crystalline as a precipitates solution ride from (4th 1989). proper ed. If the cal Terms by melting point a of 133- characterized solid selected, resulting azeotrope will is substance 134°C. substantially boiling point that differs have а component original mix- from desired separating Azeotroping technique for component be suc- desired can then ture. The mixture, components chemical separated azeotrope from the distilla- cessfully separate because would otherwise difficult Hawley’s Dictio- Condensed Chemical tion. See boiling points. similarity addi- An their 1987). (11th nary ed. mixture, selected tional substance is added to (FDA), seeking approval infringed, FDA tration able and and ordered that Novo- generic pharm manufacture and sell a version of refrain from commercial manufacture hydrochloride beginning Form ranitidine or sale of Form 2 ranitidine expiration date December patent expires. before the ’431 Novopharm expiration the ’658 well before the appeals. patent in 2002.
date of the ’431 Glaxo filed Discussion patent infringement on Novem- suit alleging infringement ber technicаl Example I. Anticipation patent by of claims 1 and 2 of the ’431 Novopharm’s We consider first ar filing provided ANDA as in 35 U.S.C. gument that the district court erred in hold 271(e)(2) (1988). Novopharm admitted in- ing prove did not that the claims, fringement of the but contended that claims in suit of the ’431 were antici the ’431 was invalid because it was pated by Example patent. of the ’658 anticipated by pat- the disclosure the ’658 matter, Anticipation is a factual which we ent. clearly review under the erroneous standard. Novopharm later amended its answer to Inc., Corp. Century Diversitech Steps inequitable add defense conduct aris- (Fed. alleged misleading false and affida- Cir.1988). anticipated A claim is and there *5 provided vits to the U.S. Patent and Trade- single fore invalid only prior when a art (PTO) during prosecution mark Office every reference discloses each and limitation applications patent from which the ’431 is- 102(a) (1988); of the сlaim. 35 U.S.C. 21, 1993, Finally, Novopharm sued. on June Inc., Speedsteel Kloster AB v. Crucible 793 sought summary judgment based on a third (Fed.Cir. 1565, 1571, USPQ F.2d 230 84 defense, alleged failure to disclose Glaxo’s 1986). express, The disclosure need not be practicing the best mode of the claimed in- may anticipate by inherency but where it motion, vention. The trial court denied the appreciated by ordinary would one of skill beginning and the case was tried to the court in the art. Continental Can Co. USA Inc. v. August 1993. 1264, 1268, Monsanto 20 anticipation, On the of the court (Fed.Cir.1991). USPQ2d 1749 Novopharm found that had not carried its Novopharm maintains that the inven proving by convincing burden of clear and tion claimed in the ’431 ranitidine practice Example that evidence of 32 of hydrochloride crystalline poly- in its Form 2 patent always produced ’658 2 Form morph, inherently disclosed in the ’658 hydrochloride, ranitidine so that Form 2 was patent practice Example because the 32 inherently by Example not disclosed 32. As always yields hydrochloride ranitidine in its conduct, inequitable agreed for the court 2 polymorph. Novopharm’s experts Form Novopharm present- with that the affidavits performed Example disclosed misleading ed to the examiner were and ma- 32 of the ’658 thirteen times and each terial, Novopharm but it found that had crystals, 2 time made Form not Form 1 prove any deceptive failed to intent. The as Glaxo claims. court also concluded that there was no viola- requirement tion of the best mode because But prac- the district court found that the Crookes, Novopharm proved Example yield crystals had not that tice of 32 could inventor, mode, knew polymorph. specifically of the best the statute either It found that precedent providing originally and this court’s that 1 Glaxo’s David Collin made Form knowledge by .by practicing Example the invеntor himself is and that re- Glaxo’s Accordingly, Crouch, quired. expert, the court held that Nicholas did too.4 We are invalid, persuaded findings clearly the ’431 was not was enforee- that these are Novopharm suggests wrong that the court was that art found one skilled in the would under- finding experiments in scope that these were within the procedures stand that these were consistent with Example they employed 32 because teaching Example 32. We do not see procedures departed that sometimes from the finding. where the court erred in this Example strict letter of 32. The district court significant differ- were that there correctly re- concluded The district erroneous. n a second products; two ences between defense. anticipation jected the differ- practical attested declaration polymorphs the two Conduct Inequitable ences between II. hydrochloride Form rаnitidine made the trial court contends Novopharm commercialization. preferable for declining infer law matter of erred as a material from Glaxo’s deceive an intent sur from is often inferred Intent charge the PTO. The misrepresentations mis a material rounding circumstances when from declara- arises inequitable conduct Podiatry Paragon representation is shown. Hunt, Harold by John tion submitted Lab., KLM Lab. v. group, in re- spectroscopy head Glaxo’s (Fed.Cir.1993). But an product light of the rejection in to a sponse case, every even required is not inference patent.5 of the ’658 Example in affidavit misrepresentation is when the the Form data admits that form. Glaxo con inequitable on its prevail To was not Hunt declaration with the submitted defense, had to show duct pre obtained mis convincing evidence clear and of the ’658 according Example pared during prosecu PTO rеpresented facts to the from this trial court concluded patent. The misrepresen patent, that tion of the ’431 misleading, because was that the declaration material, acted that Glaxo was tation falsely data had been that the suggested it Kings- the PTO. to deceive the intent Example 32. product of from the obtained Ltd. Hollister down Medical Consultants found that the misstatement also 1384, 1389 The court 867, 872, USPQ2d Inc., concluded But it nevertheless was material. (Fed.Cir.1988). district review We fraudulent intent that an inference of abuse ultimate determination court’s *6 persuaded been We unwarranted. subsidiary questions discretion; factual otherwise. its misrepresentation, of whether there was are re to deceive materiality, and intent spectros- as head of found that The court Amgen, Inc. v. Chu for clear error. viewed data obtained copy, was familiar with Hunt 927
gai Pharmaceutical material, including origi- 1 that from Form (Fed.Cir.), 1016, de 1028 cert. USPQ2d 18 according Example nally by Collin made 169, nied, 856, 116 112 S.Ct. the Form 1 that in each case 32. He knew L.Ed.2d 132 from that obtained different data was no found that there was Form The court 2. 1983, the examiner August On spectrum of the the IR difference between 2 Form 1 2 of Glaxo’s rejected claims and according to hydrochloride Form 1 obtained patent application as hydrochloride ranitidine ‘ by other Example 32 and that obtained light by anticipated or obvious Likewise, Example although the methods. argued patent. Glaxo disclosure of ’658 x-ray subjected was never 32 material specific crys to a were drawn that its claims by analysis, produced material diffraction hydrochloride dif talline form of ranitidine powder yielded a consistent other methods compound disclosed ferent from from pattern that was different diffraction for a patent. The examiner asked the ’658 crystals; 2 this from Form that obtained 2 Form ranitidine showing that the claimed spectrum identical an IR material exhibited patentably distinct hydrochloride was Example 32 material. to that of the prior composition. art that Hunt did court rejection, submit-' The trial concluded To overcome the any differences be- there were comparing the IR not believe ted Hunt’s declaration using Example 32 produced tween material x-ray patterns spectra powder diffraction obtained the material from he and the which crystalline The declaration forms. of the two death complicated court's trial 5. The case was inability testimony to his from Hunt due to hear According- imputed in his declaration. analyzed
data to inventor purposes Crookes for Novopharm finding ly, court found that failed to a best mode violation. proving cany its burden of intent to deceive Novopharm’s The trial court found argu сonvincing Although evidence. clear ment to have appeal” some “intuitive since debatable, conclusion is that is not suffi- enjoyed Glaxo “has monopoly the issued cient reason to reverse in the absence of firm Glaxo, patent provides.” F.Supp. belief that the district court and definite 881-82, (E.D.N.C. USPQ2d erred. 1993). Indeed, the trial court stated that if it impute
were to others inventor the ’431 clearly “then III. Best Mode required the court would be to find a best Glaxo mode violation.” Id. at 882. The trial court Novopharm next that asserts concluded, however, practicing statute, failed to disclose the best mode of invention, is, azeotroping process paragraph, U.S.C. first and this Instruments, in Texas holding it uses to formulate the claimed Form 2 court’s Inc. v. United States International Trade Commis pharmaceutical ranitidine into sion, (Fed. compositions. best The mode defense arose Cir.1989) just little more than permit using two months before trial do not imputed knowl produced edge after analysis. documents based on in a best mode The district Novopharm Novopharm filed a motion for sum court concluded that “as a mat mary- judgment invalidity for failure to ter of law ... failed to show the ’431 disclose best mode. Less than a week should be invalidated based on a best mode trial, denied Novo violation.” Id. at 882. On before court appeal, district Novo- pharm’s stating pharm motion court “the can asserts that the district court erred as not hold as a matter of law that Dr. a matter in holding Crookes of law that a best mode azeotroping process knew that the was the defense cannot be found in the absence of manufacturing hydro proof best mode of that the inventor knew of that mode. chloride, summary judgment must there statutory provision at issue sets forth Glaxo, Inc. fore be denied.” that: Ltd., (E.D.N.C.1993). specificatiоn ... shall set forth the The district further stated that it re contemplated best mode the inventor of “ruling served for trial on the *7 carrying out his invention. knowledge whether and to what extent the 112, (1988). § paragraph 35 U.S.C. first employees agents may other be statutory language could not be imputed purposes to Dr. Crookes for of find carrying clearer. The best mode of out an [sic, Id. analysis a best mode violation].” invention, one, indeed if there is to be dis trial,
At Novopharm produced “contemplated by evidence closed is that the inven azeotrop- that officials at knew of “belongs” the tor.” That the best mode to the ing process and it support previous considered to be the best inventor finds consistent in making 2 hydro- statutory mode of Form language Additionally, as well.6 pharmaceutical composition. chloride into a commentary the on the 1952 Patent Act Novopharm argued court, in district it respect provi as states with to the best mode here, knowledge does that the of the requirement, “[t]his azeo- sion that it should be troping noted, absolute, process by only requires Glaxo officials should be since it any 6. The 1793 Act stated: "in the case of ma- and the several modes in which he has contem- fully explain princi- plated [the inventor] chine shall application principle the the of the or charac- ple, and the several modes in which he has by may distinguished ter which it be from other contemplated application principle 4, 1836, 357, 6, the of that or July § inventions.” ofAct ch. 5 character, by may distinguished it which from Stat. 117. 21, 1793, 11, other inventions.” Act of Feb. ch. changed Act of 1870 the “several modes” 3,§ 1 Stat. 318. provision previous present-day of the Acts to the machine, 7, 1870, 230, 26, any July § The 1836 Act stated: "in case of "best mode.” Act of ch. fully explain principle, [the inventor] shall 16 Stat. 198. 1050 inquiry is mode That the best by сontemplated mode best disclosure inventor is knowledge of the in filing grounded inventor, at the time presumably contrasting best upon Federico, more evident even P.J. Commen- application.” the enable §of 112 requirement Act, mode 35 U.S.C.A. Patent tary New Chemcast, of that section. requirement ment (1954). 1, §§ 25 926, USPQ2d “En at 1035. at 16 comply with did not arguing that Glaxo In subject matter placing looks to ablement 112, first requirement of mode the best possession of generally in the of the claims Amgen, Inc. Novopharm relies on paragraph, F.2d at Spectra-Physics, 827 public.” F.2d 927 Chugai Pharmaceutical v. 1532, mode looks USPQ2d at 1742. Best 3 (Fed.Cir.), de cert. 1200, USPQ2d 1016 18 and tech specific instrumentalities whether 169, 856, 116 nied, 112 S.Ct. 502 U.S. developed the inventor niques have been (1991), proposition for the L.Ed.2d 132 filing as to him at the time and known heart at requirement lies mode the best Id.; carrying out the invention. way of best quo of the statutory quid pro of the 927-28,16 USPQ2d Chemcast, at F.2d at 913 However, enough. true system. This is thus, requirement, 1036. The enablement statute, speaks of Amgen, consistent with knowledge of one of objective looks of the requirement terms mode the best art, the best mode ordinary in the while skill by the inventor. contemplated best mode one, looking to subjective, factual inquiry is 1210,18 USPQ2d at 1024
Amgen, 927 F.2d
In
mind of the inventor.
of the
the state
(“Our
interpreted the best mode
case law has
addressing
deed,
recently
this court
no
that there must be
mean
requirement
had to be
applicant’s
mode
best
whether
inven
mode known
of a
concealment
upon filing a continuation
updated
that which is dis
than
tor to be better
requirement “fo
that the
mode
affirmed
best
added).
fact,
closed.”)
we
as
(emphasis
Transco
the inventor knows.”
cuses on what
stated,
purpose
sole
previously
have
Inc.,
Contracting,
Prods. Inc. Performance
requirement “is to restrain
mode
the best
1077,
551, 558,
USPQ2d
1083
32
while at
applying
patents
inventors
added),
(Fed.Cir.1994) (emphasis
cert. de
concealing
public
from the
the same time
—
1102,
-,
nied,
115 S.Ct.
U.S.
of their inventions
preferred embodiments
(1995).
L.Ed.2d 1069
conceived.” Chem
fact
wording
the statute
clear
Based on the
Corp.,
F.2d
Indus.
Corp. v. Arco
cast
law,
properly
ease
the trial
and our
(Fed.Cir.
knowledge”
Novopharm’s “imputed
rejected
added)
1990)
Gay,
(quoting In re
(emphasis
cor-
the trial court
defense. As
best mode
(CCPA
USPQ
F.2d
noted,
rectly
we held in
Instruments
Texas
1962));
Ltd. Partner
Corp. v. IPC
see Dana
the best mode
was no violation of
that there
1692, 1696
415, 419, USPQ2d
ship, 860
§ 112
requirement of
reason
denied,
(Fed.Cir.1988),
cert.
part
purported best mode on
L.Ed.2d 633
109 S.Ct.
*8
inventor,
in
employees, other than the
T.I.
manufacturing group
the inventor
when
the
inquiry
on
The
mode
focuses
best
mode.
or
this best
not
of
conceal
did
know
he
of mind at the time
inventor’s state
the
Instruments,
at
Texas
subjective
raising a
fac
application,
filed his
USPQ2d at 1262.
926,16
Chemcast, 913 F.2d
question.
at
tual
in the reсord
simply
is
no evidence
disclo
There
specificity
at 1035.
none,
us,
points
Novopharm.
to
indeed
comply
mode before
required
with the best
sure
patent knew of
of the
that the inventor
’431
the
requirement
be determined
must
azeotroping process when
the
and concealed
possession
within the
knowledge of facts
Crookes
application was filed.
Inventor
filing
applica
his
at
time of
the
the inventor
Inc.,
Novopharm’s
Coherent,
opposition
in
in a declaration
Spectral-Physics, Inc. v.
tion.
stated
summary judgment motion
1524, 1535, USPQ2d
1745 best mode
cert,
any azeotroping of raniti-
denied,
“I did
know
(Fed.Cir.),
not
benefits,
prior to
hydrochloride, or of its
dine
original). Novopharm alleged has not that Novopharm maintains that Glaxo in requirements thеse were violated. tentionally isolated knowledge Crookes from presumed Crookes, It is therefore that azeotroping process leaving “it to oth applicant, inventor and must have reviewed ers to commercialize and reduce the inven specification signed required dec- Thus, practice.” tion to Novopharm fears laration before was filed. purposefully prevented that Glaxo the inven more, Novopharm Without simply wrong is gaining knowledge tor from of the most ad alleges when it that nothing Crookes had vantageous application invention, for his determining do with what needed to be dis- azeotroping process, so that closed in application. his be maintained could as a trade That secret. Novopharm additionally contends equate fear does not with a mode viola best looking solely to the inventor’s tion. analysis mockery best mode “makes a requirement, the best mode and fosters a case, In this Crookes was unconcerned mentality ‘head the sand’ corporate with the commercialization of the claimed applicants.” It compound. undisputed is that Crookes compound invented a and was involved in However, practical reality in- processes whatever were to be used to com- every corporate ventors in most can- scenario mercially produce Therefore, it. whether technology not know of the all which their *9 deliberately walled off the inventor is employers Therefore, engaged. are whether to appli- irrelevant the issue of failure of his not, intentionally or inventors will be effec- cation to disclose tively the best known to mode isolated from research no how matter him. relevant it to in is the field which are Chemcast, phar- 7. claims at issue arе not to a directed invention. See F.2d at Therefore, compound. may maceutical there be decision, USPQ2d at 1036. In view of our how- question azeotroping process a whether the is ever, necessary it is not for us to reach this issue. carrying the best mode indeed of out claimed disclosing the respect to his behalf’ in em- which scenarios Separating working. by the Or, used in the terms from invention. unintentionally isolate inventors ployers attorney’s dissent, patent scope in which from instances relevant research i.e., inventing, ei- in- authority screen not include deliberately to does set out employers inven- research, finding supplanting best a or supplementing and ther from ventors case, ig- Rath- would invention. knowledge latter of his own in the tor’s mode violation para- § first in inventor’s er, of disclosed very words the information nore developed, it has is actu- law as application case must be which graph, patent and the the best analyzed requires that consistently has to him. The statute ally which known knowledge of in terms of requirement See an oath to effect. mode he submit Congress by (1988). the inventor. § concealment and U.S.C. inven- between the differences aware of was during relationship may exist agency An 100(d) §§ see 35 U.S.C. assignees, tors and patent PTO where the prosecution before the the best specifically limited it and and acting behalf. attorney on the inventor’s is by the contemplated required to mode 1.56(a) agency § An 37 C.F.R. See authority to extend no We inventor. exist, however, with relationship does not by limits set beyond the requirement in disclose an inventor must respect to what Congress. invention, patent a on his order to obtain imputing argues that The dissent includes, course, any mode of best than the inventor knowledge others Therefore, being in to § 112. addition under considering what purpоses of for inventor above, explained § as inconsistent with a best the inventor” “contemplated was relationship not exist agency does because an ap necessary under analysis “may be mode patent in a purposes of what is disclosed for circumstances, pub protect propriate improper impute a application, it would seeing patent interest ‘paramount lic’s attorney’s knowledge of a best mode patent backgrounds free from spring monopolies finding a best purposes for to the inventor inequitable conduct.’” fraud other from or violation. mode knowledge that such dissent contends case, any the dissent’s princi under imputed to the inventor can be analysis of principles to the general agency that, agent’s stating “[a]n ples agency law § an en- under is disclosure best mode imputed to the knowledge can be acts еxisting not law. tirely and is new idea necessary protect the inter principal when others, long the acts or knowl so as ests of noted that correctly here The trial court scope of the fall within the edge absence of “found that the this court has (Sec authority,” citing agent’s Restatement knowledge by the inventor showing of actual ond) § 261. Agency, best mode dispositive of the defendant’s agency “the “does defines as and held that law argument” The Restatement ” in a best using imputed fiduciary permit which results relation Glaxo, 881- person to consent one mode defense. manifestation added). (emphasis his shall act on behalf at 1135 that the other another consent, reject- control, correctly subject to his therefore The district court (Second) defense. to act.” Restatement ed the best mode the other so Agency, 1. analysis is that Conclusion the dissent’s IV. The flaw in agen- attorney8 intо an does not enter judgment the United Accordingly, the pur- inventor for cy relationship with the District District Eastern States Court the inventor’s is disclosed in poses of what affirmed. of North Carolina inventor nev- Simply, the patent application. AFFIRMED. attorney “act on his er authorizes relationship, agency rather is an not mean there this term "patent agent" within A is subsumed attorney-client relationship, between attorney than patent agent acts as inventor's as a *10 purposes. all agent” individual for "patent does inventor such label before the PTO. The
1053
MAYER,
Judge, dissenting.
Circuit
the named
inventor of the ’431
Collin, his
supervisor.
immediate
After
ease,
corporate
the court
With this
blesses
Glaxo
sought protective order,
resisted and
a
games resulting
organizational
shell
the district court
Novopharm any
denied
dis-
gerrymandering
ignorance by
and willful
covery, and the case proceeded to trial on
monoрoly
which one can secure the
of a
9,1993.
August
At the
Novopharm’s
close of
hiding
patent
practic-
while
the best mode of
defense,
case-in-chief on its best mode
expects
the invention the law
to be made
court decided to
question
rule on that
as a
public
protection.
return
its
Because I
law,
matter of
no factual
remaining.
issues
perverse
believe
a
interpretation
this is
presented
Glaxo
no evidence on the issue.
law, I
dissent.
The court held that because Crookes had no
requirement
The best mode
arises from
personal knowledge
mode,
of the best
there
(1988),
paragraph
the first
of 35
112
U.S.C.
requirement
was no
that it be disclosed.
provides
patent specification
that the
suggests
Glaxo first
azeotropic
“shall
forth the
contemplated
set
best mode
granulation process was not
appropriate
carrying
the inventor of
out his inven
candidate for disclosure because it fell out-
inquiry
tion.” The best mode
is twofold:
scope
side the
first,
claimed invention.
did
preferred
the inventor know of a
Rather,
says
process
Glaxo
simply
is
invention;
a
mode or embodiment of the
production technique useful in
second,
the formula-
did the inventor disclose that mode
hydrochloride
tion of
pharma-
into
sufficiently to
allow those skilled
the art to
compositions.
ceutical
says
It
process
is
practice
Corp. v.
it. Chemcast
Arco Indus.
relevant,
all,
therefore
if
only
to the claims
923, 928,
Corp.,
USPQ2d
913 F.2d
of the ’431
(Fed.Cir.1990).
that cover
composi-
such
The first
here,
tions. No such claims are at issue
so
subjective,
largely
looking to the inventor’s
says
Glaxo
the best mode should not be
knowledge and belief. The second is more
considered.
objective, focusing
scope
on the
of the inven
tion and the level of skill in the art.
Id.
But
statutory language
demands that
Compliance
requirement
with the best mode
“carry
disclose the best mode of
question,
is a factual
which we review for
ing out” the claimed invention. As the dis
Engel
clear error.
Indus. Inc. v. Lockformer
recognized,
trict
language
encom
1528, 1531, USPQ2d 1300,
946 F.2d
passes
only
making
modes of
the inven
(Fed.Cir.1991).
But this
assumes
cor
tion,
using
but of
it as well. See Christian
understanding
law,
rect
of the relevant
which son v.
Operating Corp.,
Colt Indus.
822 F.2d
Spectra-Physics,
we review de novo. See
1544, 1563,
(Fed.Cir.
USPQ2d 1241,
Coherent, Inc.,
Inc. v.
3 1987), vacated
grounds,
on other
(Fed.Cir.1987).
USPQ2d
108 S.Ct.
Novopharm says
did
azeotroping process
not disclose the The
way
was the best
practicing
best mode of
hydrochloride
invention —the
formulate raw ranitidine
into
azeotropic granulation process
pharmaceutical compositions
it used to for-
suitable for use
pharma-
mulate ranitidine
into
drug
patients,
as a
in human
only
use
compositions.
ceutical
This
contemplatеd
defense became Glaxo
for the invention. Glaxo
when,
only
game
relevant
late
generally
June
admits the
was not
known
2,1993,
produced
some
Accordingly,
documents that
skilled in
those
the art.
indicated that
it had withheld information
court could have found that disclosure of the
granulation process.
about
Novopharm process
required by
long
section
so
summary judgment
other,
moved for
subjective,
based on as the
elements of the best
violation,
Chemcast,
best mode
which the district court mode test were met.
Cf.
Glaxo,
denied,
Ltd.,
(“Whether
Novopharm
Inc.
830 at
at 1038
char-
(E.D.N.C.1993),
data,’
but
‘manufacturing
allowed No-
aeterizable as
‘custom
vopharm present
requirements,’
secrets,’
the best mode defense at
er
or even ‘trade
in
trial.
discovery
necessary
tried to take
practice
on formation
the best
issue,
disclosed.”).
including
deposition
Crookes,
simply
mode
must be
*11
no
there is
prоposition that
unremarkable
what
begins with
inquiry
mode
The best
knew
inventor
where the
violation
applica-
his
mode
filed
best
he
when
inventor knew
the
it to
consider
inquiry
and did not
alleged
of the
mode
part
of the
subjective
This
tion.
It
preferred embodiment.
of the
part
on the factual
a
traditionally rests
be
a
contemplated
knowl-
actually
specific
nothing
whether
says
inventor
the
about
whether
Chemcast,
at
assign-
corporate
mode.
a
preferred
a best mode
edge of
not
inquiry is
But
the
to the inven-
may
imputed
at
ee/employer
knowledge.
actual
inventor’s
any
precedent
limited
other
tor/employee. Nor does
this court.
Instruments, Inc.
Texas
believes
The court
Com-
Trade
International
United States
“Glaxo,
recognized,
court
the district
As
USPQ2d 1257
mission,
...
direct-
individually,
both
not
Crookes
mode
(Fed.Cir.1989),
best
expressly limited
enjoyed
has
prosecution and
the
ed
that
knowledge, but
actual
the inventor’s
to
patent provides.”
issued
monopoly the
the
merely
We
limitation.
no such
case includes
employees
F.Supp. at 881-82. Glaxo
In-
that Texas
Commission
agreed with the
during
Crookes
agents for inventor
acted as
patents
component
computer
strument’s
They
application.
the U.S.
prosecution
the
disclose
failure to
invalid for
not
were
Glaxo,
assignee of
the
agents for
also
were
mode,
“word boost”
a so-called
alleged best
the owner
and later
application
the
“
dis-
does not
feature,
record
‘[t]he
because
the crucial
And that
is
patent.
the ’431
or concealed
knew of
applicant
that the
close
Crookes, brought
suit
Glaxo,
point:
”
not
than he disclosed.’
a better mode
infringement
against
(quoting Com-
1061, USPQ2d at 1262
at
Accordingly,
conduct
Glaxo’s
patent.
findings).
mission
to
important
during prosecution is
knowledge
reading one sen-
problem arises
case;
irrele-
it is not
of this
resolution
the
out
Instruments
opinion
the Texas
tence of
vant,
says.
as the court
that
fact
“[t]he
that
We said
of context.
a
may
agrees, that it
says,
have manufactured
court
and the
Texas Instruments
azeotroping pro
better form
containing a different or
disclose the
DRAM
not have to
did
to whether
pertinent
not
that
boosting
not know of
means
did
cess because Crookes
mode
best
compo
disclosed” the
specification
pharmaceutical
preparing
the
method
Id. court
hydrochloride.
inventors.
known
the
2 ranitidine
of Form
sitions
case—
us,
facts of our
parallel
the
before
one
reads this
wonders how
the record
On
inventors
of the named
employer
that
Crookes
been sure of what
could
have
wholly with-
mode
alleged best
developed
Brereton,
employee
the Glaxo
knew.
knowledge,
that there
out the inventors’
application for
initiating the
charged with
in-
problem
mode
because
no best
was
not
he did
testified that
the ’431
it.
know of
ventors did not
inventor,
any
Crookes,
at
named
consult
Instead,
with Glaxo’s
in accordance
time.
Instruments
opinion in Texas
But as our
conferred
patent policy, Brereton
standard
the word
shows,
did know
the inventors
all of the
superiors to obtain
with Crookes’
it was
that
feature,
did not believe
but
boost
necessary
to secure
(“[T]hat
information
Id.
mode.
part of the best
incongruous
me
invention.
It strikes
as
not consider
did
inventors themselves
knowledge
rely
inventor’s actual
on the
part of the best
to be
feature
‘word boost’
thought that
here if Glaxo indeed
any argument
their invention refutes
mode of
it did
even merit
insignificant that
was so
concealed
‘knew of and
the inventor
applic
during preparation of the
”).
consultation
Accord-
than he disclosed.’
better mode
lеast,
very
district
At
only for the
ation.*
ingly, Texas Instruments
stands
*
regulations speaks
the best mode re-
requir-
these
regulations
in the
comfort
The court finds
attesting
Crookes could
sign
quirement.
are we told how
oath
Nor
inventor
application,
C.F.R.
consulted
sign
if he was
he has
§§
such an oath
never
reviewed
(2),
1.51(a)(2)
1.63(b)(1),
reasoning
1.41(a),
Perhaps
&
application
filed.
before
review
Crookes
least let
charge
ineq-
that Glaxo must
grounds
upon
for a
court has hit
it was
But none
before
filed.
*12
given Novopharm
public.
should have
the chance at
go
But he
beyond
must
simply in-
discovery
just
about
what
in
forming
Crookes
fact
public
the
of the bare outlines of the
knew.
invention. He must also tell what he be-
lieves to be the best embodiment of the
But I believe that even absent further
invention, and he must
way
do so in a
that
discovery the district court could have found
public
practice
allows the
that embodi-
a best mode violatiоn in this case. As the
prevents
ment. This
the inventor from ob-
stated,
district court
taining patent protection with a minimal dis-
however,
undisputed,
[i]t is
Brereton and
only
closure that reveals
inferior forms of the
other officers within Glaxo believed azeo-
invention,
retaining
while
for himself the
troping was the
preparing
best mode of
advantageous
most
carrying
modes of
the
pharmaceuti-
ranitidine
for
practice.
invention into
In Gay,
re
309 F.2d
use,
actually
cal
and
utilized
Glaxo
this
769, 772,
(CCPA
USPQ 311,
1962).
135
315
production
method in the commercial
pinched
reading
court’s
of the best mode
hydrochloride.
These officials
requirement surely violates at least
spirit
the
within Glaxo made a deliberate choice not
public’s
this rule at the
expense.
to reveal what
believed to be the best
making
invention,
patented
mode of
the
Imputing
agent’s
knowledge to the
protect
but instead to
knowledge
as a
principal has sound
in
roots
law
equity.
trade secret.
agent’s
An
acts and knowledge
imput
can be
880
suggests
881. This recitation
ed to
principal
necessary
protect
when
that Glaxo set out to isolate Crookes from
.others,
the interests of
long
so
as the acts or
any knowledge
azeotroping
about the
tech-
knowledge
fall within
scope
nique specifically to avoid the best mode
agent’s
(Second)
authority. Restatement
requirements.
true,
disclosure
If
these cir-
Agency, §
(principal
261
agent’s
liable for
justify
cumstances would
imputing knowl-
scope
(knowl
fraud within
agency), §
edge to Crookes from Brereton and the other
edge
agent
acquiring property
princi
for
employees
agents
who acted as
pal imputed to principal); see also American
during
application process.
Crookes
I Soc. Mechanical Engineers,
Hydrolevel
Inc. v.
would remand to allow the district court to
rp.,
556, 566, 102
Co
1935,
456 U.S.
S.Ct.
necessary
make the
findings
factual
and de-
(1982)
uitable conduct else missed. azeo- from the inventor to screen set out ASSOCIATES, process for VILLAGE BRIGHTON to conceal technique troping Cofield, Gold, James M. F. Juan Herbert itself. Trustee, Jr., Herbert F. Cofield, E. of best version that Glaxo’s problem is Plaintiffs-Appellants, Trustee, Gold, adopts, would mode, court now which the *13 employers to isolate allow, encourage, if not di- research employee/inventors
their STATES, Defendant- The UNITED advantageous ap- most finding the rected Appellee. inventions, knowledge for their plications have had probably would that the inventors No. 94-5142. keep employer’s efforts but for Appeals, Court of United States may result, aAs work secret. inventors Federal Circuit. the real only perspective limited have accordingly inventions, and can their value of April with the perspective only limited share this while, employer/assignee public. All the fully big picture, view
will supe- employees, of
aware, through its other But the invention. practicing
rior modes of obligation to under assignee be no will This public. modes to the those
disclose statutory disclo- of the subversion
deliberate the benefits public of deprive the would
sure invention. practicing the the best mode why court should is no reason
There public trust. such abuse condone Cf.
Precision Instrument at 997-98.
S.Ct. truly was such a if there
I would hold of informa- concealment
pattern of deliberate known have been otherwise
tion would inventor, those who and who that information
sought to conceal may be attempt to enforce
now district inventor. The
imputed to the and should
can refuse enforce do so with opportunity to given the understanding powers. of its
correct