*1 SMITHKLINE BEECHAM CORPORA- P.L.C., Group, and Beecham
TION
Plaintiffs-Appellants, CORP., Apotex, Inc.,
APOTEX
TorPharm, Inc., Defendants- Appellants.
Cross 03-1285,
Nos. 03-1313.
United States Court of Appeals,
Federal Circuit. April
DECIDED: *3 Farabow, Jr.,
Ford F. Finnegan, Henderson, Farabow, Dunner, Garrett & L.L.P., DC, Washington, argued for plaintiffs-appellants. With him on the Bajefsky, brief were D. Robert Howard W. Levine, Popma, Swan, Scott J. Jennifer S. Aaron M. Raphael. Mazzochi, Lord,
Deanne M. Bissell & Brook, Illinois, Chicago, argued for de- fendants-cross-appellants. her With on Moore, Hugh the brief were L. Keith D. Parr, Balsam, Hugh S. and Kevin M. Nel- Molino, son. Of counsel were Paul J. Scott Feder, B. and Rakoczy. William A. RADER, BRYSON, Before and GAJARSA, Judges.* Circuit Opinion for by the court filed Circuit Judge Concurring RADER. opinion filed by Judge Circuit GAJARSA.
RADER, Judge. Circuit Following trial, a bench the United States District Court the Northern District Illinois ge- determined neric paroxetine hydrochloride anhydrate * 28, 2004, by Pursuant to an April order issued this era reported amended at 365 banc, present opinion replaces panel's F.3d 1306 23, 2004, prior opinion April entered on crystals with by Corp., hemihydrate comprises PHC produced to be (collec every molecule for two TorPharm, one bound water Inc., Inc.
Apotex, PHC PHC molecules. 1 of infringe will not claim tively Apotex) stable, easily (’723 more and thus more proved 4,721,723 patent) Patent No. U.S. than an- preserved, packaged Corp. and Beecham owned SmithKline hydrate. (collectively Group, P.L.C. Beecham SmithKline). Corp. SmithKline Beecham application in filed a SmithKline F.Supp.2d Apotex Corp., the British Patent Office on October (N.D.Ill.2003). on this court’s revi Based paroxetine hy- relating “crystalline trial court’s erroneous sion of the drochloride, preparation and its uses as construction, in Apotex’s product applica- therapeutic agent.” The British *4 None patent. 1 of the ’723 fringe claim tion identified the invention as both theless, patent claim 1 of the ’723 because anhydrate form of hemihydrate and the under anticipated as 35 U.S.C. is invalid PHC, mixtures that contain a as well as 102(b), court affirms the district § year form. major portion of either One Apotex. in judgment
court’s favor 23,1986, later, filed on October SmithKline to the application claiming priority
a U.S. as the ’723 application British issued I. patent The ’723 does not patent 1970s, company, late a British anhydrate In the not claim claim PHC and does Ferrosan, only invented a new class of com- forms. The mixtures of two PHC in this case is claim which including compound a that became at issue pounds, entirety: “Crystalline paroxe- in its reads U.S. Patent No. paroxetine. known as See hemihydrate.” hydrochloride tine (’196 4,007,196 patent). patent The ’196 and its salts and dis- paroxetine claims necessary completing In after antidepressant properties. closes their approval process, placed FDA SmithKline eventually developed process a Ferrosan antidepressant drug its with PHC hemih- crystalline hydrochloride produce mar- ydrate ingredient as the active on the hydrochlo- paroxetine, salt of the name Paxil®. In ket under (PHC). In ride Ferrosan licensed TorPharm, Inc., Apotex affiliate ’196 and its other PHC-related generic antide- Apotex’s manufacturer of technology to SmithKline. SmithKline be- pressant, Drug filed an Abbreviated New manufacturing gan PHC its Harlow (ANDA) FDA, under Application with the plant England. 355(j), seeking approval § U.S.C. antidepressant drug. market its own PHC Curzons, In March Alan a chem- Apotex ingredient identified the active Worthing, England ist SmithKline’s antidepressant anhydrate. as PHC laboratory, crystalline discovered new paragraph ANDA Apotex’s included IV attempting improve form of PHC while certification, see U.S.C. production. PHC Curzons’s test results 355(j)(2)(A)(IV), Apotex’s § that indicated that the new established expi- drug intent to market the before (PHC hemihydrous form of PHC hemih- drug ration of the ’723 because its an- ydrate). original Ferrosan’s form was infringe patent. would not (PHC hydrous anhydrate). PHC PHC in- anhydrate comprises crystals of PHC initiated this SmithKline under 35 fringement against Apotex action without bound water molecules. PHC 271(e)(2) Apotex’s “high on the basis of if digits” U.S.C. double alleges that filing. component ANDA SmithKline were to contribute com- Apotex’s proposed drug infringe will claim mercial value. Id. The district court im- patent. portеd 1 of the ’723 SmithKline does not significance commercial into that claim 1 of the ’723 cov- allege Apotex’s claim and held that proposed all, anhydrate. an- drug ers PHC After PHC PHC will not infringe claim 1 of hydrate discovery prior patent. found, Ferrosan the ’723 The district court —the —is patent. matter, art the ’723 SmithKline as- factual that Apotex’s PHC infringe by anhydrate serts that will manu- tablets will not contain commer- facturing cially significant PHC tablets that nec- amounts PHC hemih- contain, essarily process ydrate rejected a conversion SmithKline’s evidence below, discussed at least trace amounts of to the contrary. Id. at 1031-39. The trial PHC court also determined that claim 1 is not invalid. parties summary judg filed various motions, including ment cross motions for SmithKline contested the district court’s summary judgment interpretation that claim of the ’723 claim noting that claim 1 is (or valid) patent was invalid under 35 clear on its face encompasses *5 102(b) amount, § impermissible pub hemihydrate U.S.C. in however small 102(b) § lic use. The motions or insignificant. acknowl In rejecting pro- edged posed that clinical trials occurred more claim interpretation, the district year filing opined than one before SmithKline’s court also pro- SmithKline’s patent, date for the ’723 but disputed posed construction would render claim 1 qualified whether those tests for the ex indefinite. The district court reasoned perimental negation. use The district interpretation SmithKline’s would court Apotex’s granted place potential infringers denied motion and in the untenable motion, holding that position knowing SmithKline’s the ’723 of never whether their not invalid for public infringes use under a single because even 102(b). § The crystal district court reasoned that undetectable of hemihydrate PHC qualified the clinical trials experimental infringe. Id. at 1029-30. uses. See Beecham Corp. SmithKline To show that manufacture of an- PHC
Apotex Corp., F.Supp.2d 932-38 hydrate necessarily tablets creates PHC (N.D.Ill.2001). hemihydrate, proffered SmithKline expert
The district court testimony then held bench trial on the “seeding” so-called to determine the proper interpretation “disappearing theory. of polymorph” Under claim and to resolve the in- remaining theory, may this Ferrosan originally have fringement and validity crystalline issues. On the created a compound, namely construction, question of claim anhydrate, relatively the district PHC in a unstable claim 1 hemihydrate presently reasons, limited to PHC form. For unknown commercially significant anhydrate “morphed” amounts. the PHC into a form, SmithKline Beecham Corp., F.Supp.2d namely more stable the PHC hemih- at ydrate 1030. The trial record contained uncon- discovered in SmithKline’s facilities. testimony tested anhydrate- that a PHC polymorph this new form or With exis- hemihydrate tence, mixture would need pos- experts explained, SmithKline’s percentage sess a of hemihydrate general PHC environment became “seeded” hemihydrate. liability absolved of for the crystals PHC conse- with quences of SmithKline’s own conduct that environment, anhyd- the PHC seeded this practice prior art rendered im- to the PHC rate converts patent. without ’723 possible infringing the seeds inevitable contact with upon its The district court held that its also inher- words, hemihydrate. In other PHC powers equitable equitable ent and the anhydrate pure PHC became creation injunctions placed general nature difficult, extremely impossible; if not injunction mandated 35 U.S.C. anhydrate, PCH has effec- polymorph, old 271(e)(4)(A) within the discretion of the form disappeared pure in its because tively court. Id. at 1045-52. district poly- the new changes naturally into also sought SmithKline to assert claim morph, PCH infringement against Apotex of induced on experts applied “disap- SmithKline’s theory anhydrate that PHC tablets theory to polymorph” show that pearing convert to PHC the stom- inevitably Apotex’s PHC tablets patient ach of a due to the increased hu- hemihydrate when convert combined midity pressure inside present moisture, pressure, practically with Id. at stomach. 1014-15. district hemihydrate seeds. ubiquitous PHC court excluded SmithKline’s evidence on evi- court found that SmithKline’s district issue, finding that SmithKline would “disap- “seeding” and the dence on likely showing “gas- not meet its burden supported pearing polymorph” theories infringement.” trointestinal Id. 1014- anhyd- Apotex’s Finally, the inference district court considered trace, constructions, other alternative will contain at least even rate tablets which would allow claim 1 to cover PHC undetectable, hemihyd- of PHC if amounts *6 hemihydrate in detectable either amounts Thus, Id. at 1042-43. under Smith- rate. at the time the methods available ’723 construction, the district Kline’s by any was filed or means that later Apotex’s held that PHC court The became available. Id. at 1052. rec- 1 infringe claim of the ’723 drug would that presented ord shows SmithKline patent. Id. samples Apo- results of tests on various Alternatively, if 1 construed claim was to tex tablets. These tests showed PHC any amount of PHC cover product. Apotex The was, therefore, infringed, the district rejected court evidence as district un- equitable a new purported court create reliable, mainly because SmithKline’s infringement Apotex. in favor of defense to counsel excluded tablets from the certain defense, at 1043-45. Under this new explanation. Id. testing without reasonable producing for at 1032-42. trial court responsible SmithKline Id. found which, represent these excluded hemihydrate, by virtue of tablets Apotex upon manufacture polymorph” “disappearing SmithKline’s approval. Accordingly, the ANDA Id. dis- the environment. Conse- theory, seeded held did trict court that SmithKline alleged SmithKline caused the in- quently, Apotex’s that prove tablets will contain court fringement. district reasoned hemihyd- any of PHC detectable amount prac- enjoy right should rate. by manufacturing art prior tice the under its alterna-
anhydrate. Accordingly, presents arguments five on SmithKline First, defense, court erred in equitable аppeal. tive the district court the district
1337 Thus, limiting commercially significant claim 1 to one and denied the other. the rec Second, of PHC conceded, amounts ord parties shows contrary ruling, to the district court’s found, the district court that no material claim construction that covers PHC hemih- factual issues remain in dispute. See ydrate amount does not render Aircraft, Beech F.2d 1245. If this Third, claim 1 indefinite. court district court determines that no material facts creating equitable defense to erred dispute, may proceed remain in to deter infringement based on SmithKline’s contri- mine entitlement to judgment under the causing infringement. bution Labs., law. Lilly See Eli & v.Co. Barr Fourth, holding the district court erred in Inc., (Fed.Cir.2001) 251 F.3d injunctive required that the relief under 35 (“[RJeversal required if the district court 271(e)(4) § is within the district U.S.C. ‘engaged faulty in a legal analysis apply Fifth, court’s discretion. the district court ing the law to the facts and a correct excluding its discretion in Smith- abused application of the law might to those facts infringement. induced Kline’s evidence of ” bring a (quoting different result.’ Litton Prods., Indus. Sys. Inc. v. Solid State Apotex argues In cross-appeal, Corp., (Fed.Cir.1985))); 755 F.2d granting erred in the district court sum- Inc., Liberty see also Anderson v. Lobby mary judgment clinical SmithKline’s 477 U.S. 106 S.Ct. qualified experimental tests as an use. (1986). L.Ed.2d 202
particular, Apotex asserts that claim of public the ’723 is invalid for use reviews a district 102(b) §
under 35 U.S.C. as a matter of court’s judgment following a bench trial jurisdiction law. This court has over these clearly errors of law or erroneous find 1295(a)(1). appeals under 28 U.S.C.
ings of fact. See Allen Eng’g Corp. v. Indus., Inc., Bartell 1343- II. infringement Patent First, proceeds analysis. under a two-step Review Standards of the court interprets the claims to deter summary judgments This court reviews mine their proper scope meaning. See *7 without deference. See Beech Aircraft Techs., Inc., Cybor v. Corp. FAS 138 F.3d 1237, Corp. Corp., v. EDO 990 F.2d 1245 (en (Fed.Cir.1998) banc). 1448, 1454 (Fed.Cir.1993). course, a Of denial of Next, the court measures the accused summary itself, judgment, by is not a final product process against or the standard of judgment appeal grant amenable like properly interpreted claims. Id. However, summary judgment. when parties summary judgment, both move for This court reviews claim con independently each motion “must be as struction without deference. See Mark on sessed its own merit.” v. California Instruments, Inc., man v. 52 Westview (Fed. States, 1377, 271 United F.3d 1380 (Fed.Cir.1995) (en 967, banc), F.3d 979 Cir.2001). circumstances, In such this 370, 1384, aff'd, 517 U.S. 116 S.Ct. 134 summary judgment court reviews under (1996). L.Ed.2d 577 This court reviews the standard rules of Fed. R. P. Crv. step, the second measurement of the ac claim, case, product process against In this cused parties sought both sum- mary judgment; granted question Eng’g, the district court as a of fact. See Allen 299
1338 However, Mills, percent before 1985. Curzons 1343-44; Inc. v. Hunt- Gen. F.3d at (Fed.Cir. 978, undisputedly serendipitous made his dis- Wesson, Inc., F.3d 981 103 making covery hemihydrate while under PHC 1997). of indefiniteness review 2, anhydrate presumably pursuant PHC proceeds as paragraph 35 U.S.C. . More- teachings patent. of the ’196 deference See without of law question over, does not although Curzons Kimberly-Clark Corp., v. Solomon (Fed.Cir.2000); hemihydrate until have discovered PHC Personal F.3d Communications, samples further review of v. Int’l March LLC Media ized (Fed. anhydrate revealed Comm’n, SmithKline’s PHC 161 F.3d Trade unwittingly plant Harlow had Cir.1998). SmithKline’s early as De- made PHC undisputed facts con- 1984. These cember Findings Factual anhydrate clusively that PHC establish matter, this court holds an initial As in accordance with the ’196 made record, part, supports the for the most hemihydrate both with converts into PHC findings. partic- court’s factual district Accordingly, seeding. and without clearly did not err ular, court the district appeal in this legal decides the issues court anhyd- Apotex’s PHC concluding that background as deter- against the factual amounts of include trace will rate court. mined the district on the record hemihydrate based PHC & Claim Construction Indefiniteness form inevita- anhydrate that the evidence hemihydrate form. into the bly changes interpretation requires Claim Corp., 247 Beecham Sеe SmithKline the claim meaning court to ascertain F.Supp.2d at 1019-23. art at the ordinary skill to one of ResQNet.com, Inc. v. time of invention. clearly also did not court The district (Fed.Cir. Lansa, Inc., 1374, 1378 346 F.3d Apotex’s finding err 2003); v. Hunts Petroleum Co. Phillips quan- detectable not contain product will Polymers Corp., man because tities (Fed.Cir.1998). requires This task Apotex selectively tested the SmithKline language in its place the claim explaining its reasons without samples temporal context. proper technological from the products excluding some are the enterprise for this The best tools the district Specifically, examination. and, forms of intrinsic evidence various of Smith- discretionary exclusion court’s See extrinsic evidence. appropriate, when on this issue evidence Kline’s unreliable Inc., Vitronics, Conceptronic, Corp. factual subsequent render does not in F.3d clearly erroneous. finding *8 itself, evidence, “i.e., in patent the trinsic clearly ac- and, court Although claims, the district if specification the the cluding “disappearing theories of evidence, history true the ... cepts prosecution as the in it did not “seeding,” legally and of the polymorphs” significant most source the regarding precisely findings of fact claim lan meaning disputed make of operative hemihydrate first came or when PHC guage.” how Id. Indeed, traces of PHC
into existence. times, course, lan at all the pills were Of anhydrate hemihydrate PHC scope governs claims their guage of the less than five in amounts not detectible Rather, v. Sum mercial meaning. Dow Chem. Co. embodiments. the ’723 and See Co., 257 F.3d PHC specification hemihydrate Chem. discloses itomo evi compound the intrinsic Unless as without reference to its conclusion, contrary the compels a applications. dence commercial For example, ac language meaning carries the claim the specification “present states that the the usаge those words in of skilled provides corded crystalline paroxetine invention id.; at of the time invention. See artisans hydrochloride hemihydrate novel Vitronics, at compound.” patent, ’723 col. II. 57-58.
Furthermore, nothing prosecution the earlier, As stated claim of history the patent of ’723 defines in- “Crystalline patent paroxe- ’723 reads: commercially vention in terms of signifi- hydrochloride hemihydrate.” tine Thus, reading cant quantities. claim 1 in ambiguous is not but rather de language evidence, of the context the intrinsic very The specific compound. scribes inescapable conclusion is that the claim en- repeatedly record shows that artisans limitation, compasses, without PHC hem- technology area of of the tipie ihydrate crystal of paroxetine hy- form —a would have understood that invention drochloride that contains one molecule of embraces without PHC every bound water for two molecules of further limitation. hydrochloride crystal in the structure. proceeds The to the re inquiry of mainder the intrinsic record to deter openly district court dis The applicant if these patent gave mine policies cussed the that led its insertion unambiguous unexpected words some defi commercially significant quantities of as a court claim 1 nition. district limited meaning on the of the limitation claimed commercially significant amounts of Beecham compound. Corp., SmithKline hemihydrate. The trial court found PHC F.Supp.2d at 1028-30. The district of support portions for this limitation that a claim construction observed pharma ’723 that discuss the of that covers trace amounts PHC hemih- properties of PHC ceutical commercial ydrate likely preclude attempts Corp., Beecham SmithKline prior art make com F.Supp.2d example, at 1029-30. For pound. Id. After explaining “in terro- specification superior discusses the rem of such a claim con effect” “broad” handling properties struction, rеjected the district court improve form the manufacture scope literal of claim 1 because would references, however, Those not PHC. do produce “absurd results” would “not com compound
redefine the terms of its policy serve law.” Id. Claim properties, emphasize mercial but construction, however, policy-driv not a compound charac new exhibits favorable earlier, it inquiry. en As stated is a con A description teristics. characteristics interpretation language. textual compound does redefine a with scope claims can neither be unambiguous established structural nor on broadened narrowed based abstract definition. *9 policy regarding considerations the effect Moreover, Quan particular meaning. of a See nothing the ’723 Rodime, PLC, 1577, compound com- v. 65 Corp. limits structural to its tum F.3d 1340 (Fed.Cir.1995) construction, is well to difficult C‘[I]t
1584 settled amenable however may great matter task be.” Exxon Research & temptations that no how States, Eng’g v. 265 F.3d policy making, or courts do not Co. United of fairness (Fed.Cir.2001). case, claims.”). reason, In 1375 this the claim precise For this redraft To covers a definite chemical structure. a has that a repeatedly this court stated field, plain in this claim is on chemist this court must construe claims without consid- Thus, its claim 1 face. of the ’723 implications covering a ering partic- for cannot be invalid indefiniteness under process. NeoMagic ular See Inc., Microsys. Corp. v. 287 F.3d Trident § 112. (Fed.Cir.2002); SRI v. Int’l Morton, In court affirmed a this 775 F.2d Corp.,
Matsushita Elec. judgment district court’s of indefiniteness (Fed.Cir.1985). “one skilled art could not because given compound determine whether a justified also The district court scope within the of the claims.” 5 F.3d at commercial-significance pre limitation to Thus, 1470. claims át issue were “not validity in the a serve the claim’s face of sufficiently potential to a precise permit challenge § to its definiteness under competitor to determine or not whether he essence, second the district paragraph. case, infringing.” Id. The Morton the claim if court considered indefinite therefore, inability not does hold that the construed cover undetectable trace compound to detect the claimed in the In other amounts infringing compound device a renders words, that potential the trial court feared Rather, claim indefinite. Morton stands -able to infringers would not be determine for proposition the unremarkable a avoid) (and if infringement they cannot claim, definite, compound ap to be must compound. detect the claimed See Morton prise a artisan of skilled the bounds Int’l, Co., v. 5 F.3d Inc. Cardinal Chem. claim. The record in Morton contained 1464, 1469-70 This rea showing “considerable evidence that those purpose soning proper misses the of the skilled in the art could not make the requirement. definiteness compounds procedures using claimed of the specification, and no evidence that § paragraph second even at 1469- compounds such exist.” Id. requires specification particu “conclude with more one or claims distinctly claiming larly pointing out and similarity little This case bears to Mor- applicant re matter which Here, ton. claim 1 identi- unambiguously as his gards invention.” U.S.C. fies of the It the bounds claim. states: ¶ (2000). requirement, satisfy To “Crystalline hydrochloride claim, specification, light read in Thus, recites hemihydrate.” this claim in the apprise must those skilled art of the clear terms discernible chemical struc- Labs., scope of the claim. Miles Inc. See imagine ture. It would be difficult (Fed. Shandon, Inc., more clear and definite claim. Cir.1993). Moreover, claims not need “be on their in order to con
plain face avoid The test indefiniteness does indefiniteness; rather, potential infringer’s demnation for what on a abili depend ac- ty that the of its own has] asked is claims ascertain nature [this *10 product infringement, now, cused tо determine fringes logically prior the art should but instead on whether the claim delin- have anticipated the claim before the filing patent. eates to a skilled artisan the bounds of of the ’723 See Bristol-Myers case, Squibb Labs., Inc., In problem the invention. this the Co. v. Ben Venue (Fed.Cir.2001) Apotex is that it cannot F.3d accurately as- (restating the axiom certain the nature of its that “that which product. literally own if clear; infringe later in scope anticipates of this claim is in- time if earli er”). At trial, Apotex fringement Apotex product asserted that is not. Ferro- process san’s making anhydrate if Even a claim is broad PHC enough to em- inherently resulted in trace brace undetectable trace amounts amounts of the “[bjreadth hemihydrate to invention, prior the ’723 claimed is not indefi- thus inherently anticipated Gardner, patent. niteness.” re 57 C.C.P.A. court, however, The district (CCPA 1970). determined Apotex present did not clear and con precisely, Stated more claim this is nei- vincing evidence of anticipation. inherent narrow, ther broad nor but definitive of According to the district findings, court’s particular this chemical structure. For “no one knows when hemihydrate form structure, inventing disclosing this existence, came into although enjoys inventor the exclusive right it is a reasonable inference that it did not practice that patent’s invention for the exist a detectable amount until” Smith- Accordingly, limited term. “serendipitous” Kline’s discovery. Smith above, construed is not indefinite under 35 Kline Corp., Beecham 247 F.Supp.2d at U.S.C. paragraph. second
1022, 1025. Apotex does not dispute that hemihydrate PHC was first detected Infringement Equity Curzons or that it is unable Having interpreted claim 1 cov prove precisely when PHC er PHC limi without further came into existence. tation, this court infringement. turns to argues SmithKline practicing In anticipation scenario, very this the T96 infringes claim 1 of the ’723 performed district court infringe a factual patent, but that the ’196 does not analysis ment based on this correct claim anticipate claim 1 of patent. the ’723 construction. The district court held “disappearing SmithKline uses the poly- Apotex’s evidence showed that PHC morph” theory justify apparently its tablets would contain trace positions. hand, inconsistent On the one amounts of Smith SmithKline asserts that the creation of a
Kline Beecham Corp., F.Supp.2d prior compound art will result ain above, 1043. As indicated sup record containing at least trace amounts of their ports court, factual finding. patented compound. hand, On the other therefore, affirms the district court’s find SmithKline contends that the creation of ing that Apotex’s product infringe will un prior compound art before Smith- der this court’s claim construction. discovery Kline’s compound did not
Because practice seeks to reason, have the same result. For this art, prior and because that in- practice district court understandably uncom- fringes, logical the next inquiry involves fortable allowing about claim to1 embrace anticipation. is, That if prior art in- scope. its literal The district court feared
1342 § in “a con- 101 other patentability would result under with under a construction such Act, in Patent as 35 patent provisions in the the such effective siderable extension § U.S.C. 102. The concurrence admits might it be- because term synthetic, a man- that PHC is impossible manu- difficult or even to come patent compound eligible protec made for anhydrous the form after pure facture the fact, In claimed is tion. the invention expired.” Id. at 1019. patent Ferrosan question “composition a of matter” without certainly legiti- are concerns While these the or an article of “manufacture” within construction, before, mate, noted claim Accordingly, § terms of 101. the claimed implica- policy of its proceeds independent represents subject eligi invention1 matter had Fortunately, the court tions. district § patent protectiоn ble for under analy- foresight to consider alternative the conclusion, inquiry the under With in this unique ses situation. § ends. 101 court, in in- alternative The district found in- fringement analysis, properly however, concurring opinion, fringement, equitable but created a new subject expand eligibility would the matter liability for defense to from shield § analysis encompass 101 to some under In Id. 1043-45. infringement. To the scope review of of the claims. short, apply where defense subject contrary, matter falls “[e]ither caus- patentee significantly contributed Ani within Section 101 or does not.” all, Smith- ing infringement. After Legal F.2d Quigg, mal Fund 932 Def. form of the Kline’s creation The scope 930 of the a environment of PHC created seeded subject is matter claims not relevant that, by this district under the facts found eligibility. Subject matter does not take court, art practice prior of the makes adjust a eligibility on different status with infringement, arguably precluding an while scope proposed in the of the claim. ments inherency. operation anticipation by § eligibility simply Patent under unprecedented circum- In this an issue this case. unique stance, understandably the trial remedy to equitable reached out to find 102(b) Anticipation §— event, notwith- protect Apotex. if A claim not valid standing equi- merit a new potential patented “the or described invention in- in this unprecedented table doctrine publication country ... printed this stance, this case court can resolve year prior ... more than to the date one 1 is because claim application
without its
application
the United
inherently
under 35
anticipated
invalid as
102(b) (2000).
§
States....”
35 U.S.C.
102(b).
§
this court
Accordingly,
U.S.C.
art
“it must
prior
anticipate
For
pro-
the trial court’s
declines to address
ordinary
one
be sufficient to enable
with
posed equitable defense.
practice
in the art to
invention.”
skill
remedy
concurring opinion
seeks
Mining Mfg.
Chemque,
Minn.
&
Co. v.
by ap-
(Fed.Cir.2002)
perceived inequity
this case
Inc.,
303 F.3d
arguing
Borst,
the sub-
plying 35 U.S.C.
(citing In re
52 C.C.P.A.
1965)).
(CCPA
ject
pаt-
not cover
matter of claim does
F.2d
“Whether
Unfortunately,
ques
matter.
art
is a
subject
prior
enabling
entable
reference
factual
eligibility
upon underlying
of law
confuses
tion
based
concurrence
(citing
of a
findings.”
Operations
single
Id.
Crown
closure
feature of the claimed
Solutia, Inc.,
matter.”).
Moreover,
Int’l Ltd. v.
this court
*12
(Fed.Cir.2002)).
reiterated in Schering Corp. that
Anticipation
1376
is a
inherent
anticipation
require
does not
However,
person
a
of
question of fact. See
with-
id.
ordinary skill in
recognize
the art to
the
genuine
disputes underlying
factual
out
prior
inherent disclosure in the
art at the
inquiry,
ripe
the
anticipation
issue is
prior
time the
art is created.
Id. at 1377
a
judgment
as matter of law.
(citing In
Sprout Litig.,
re
301
Cruciferous
patent
undisputed
The T96
art
prior
(Fed.Cir.2002);
F.3d
1351
102(b),
though
under 35 U.S.C.
even
MEHL/Biophile
Corp.
Int’l
Milgraum,
patent
the ’196
discloses how to make PHC
(Fed.Cir.1999);
192 F.3d
1366
Atlas
anhydrate
not
and does
discuss PHC hem-
Prods., Inc.,
Powder Co. v. Hanex
190
ihydrate.
PHC
was not even
(Fed.Cir.1999)).
1342, 1348-49
F.3d
years
discovered until
after the ’196
The district court addressed the
Nonetheless,
was filed.
the T96
case,
issue of inherent
in
anticipation
’723.patent
claim 1 of the
be-
anticipates
but it
in
found
favor
SmithKline because
of
inherently
cause the ’196
discloses PHC
Apotex
prove by
did not
clear and convinc
hemihydrate.
ing
that
it
impossible
evidence
recently
This court
set forth the stan-
pure
make
anhydrate
PHC
in the United
anticipation by inherency:
dards for
States before the critical
of
date
the ’723
patent. See SmithKline Beecham Corp.,
A patent
anticipation
is invalid for
if a
(“[I]t
went on to
that PHC
require Apotex
This court’s law does not
to
may have
existed
undetectable amounts
extraordinary
practice
take
measures to
since Ferrosan first produced
anhyd-
PHC
prior
infringing
art without
claim of
1970s,
rate in the
particularly because the
Powder,
patent.
the ’723
See Atlas
technology
to detect PCH
(affirming
F.3d at 1349-50
the district
small amounts did
exist until 1985.
finding
anticipation
court’s
of inherent
de-
The district court
may
reasoned that
spite
finding
that the inherent element
possible
also be
for
anhydrate
PHC
to
“extraordinary
by taking
could be avoided
hemihyd-
coexist with low levels of PHC
art).
practicing
prior
measures” when
conversion, thereby
rate without further
rejecting
argument
SmithKline’s
that the
SmithKline has sued
for in-
in early
fringement
absence
conversion
batches of
patent
express
of the ’723
anhydrate prove
hemihyd-
PHC
that
attempt
prevent Apotex
practicing
from
prior
rate form did not exist
upon
to 1984. See
the T96
patent
expiration.
Powder,
that
this court noted
one
Miscellaneous Issues
Atlas
underlying the doctrine of
principles
appealed
SmithKline also
the district
ensure that
anticipation is to
inherent
prevent
court’s decision to
SmithKline
makе,
or
remains free to
use
public
“[t]he
contributory infringe-
from pursuing its
compositions
processes,
art
prior
sell
above,
claim.
ment
As discussed
they
or not
under-
regardless of whether
ingestion
Apo-
claim asserted
complete makeup or the under-
stand their
anhydrate
by
patient
tablet
tex’s PHC
principles which allow them
lying scientific
hemih-
would result
conversion
PHC
1348;
accord
operate.”
ydrate. Again,
allegations of
SmithKline’s
In-
Id. at 999. that the small “possibility” the mere III. “may element have
amount of the claimed
invali-
was insufficient to
produced”
been
summary,
In
this court reverses the
anticipation.
for
Id. Simi-
date the claim
claim construction of the district court and
that SmithKline’s
larly,
undisputed
it is
patent
that claim 1 of
’723
cоvers
holds
patent
’196
Apotex’s practice
crystalline
hy-
paroxetine
amount of
production
of the claimed
results
hemihydrate
drochloride
without further
in trace amounts.
PHC
findings
limitation. Based on the factual
court,
of the district
this court affirms the
Schering Corp.,
patentee
As noted
finding
Apotex’s
an
district court’s
that
PHC
may
patent protection
obtain
for
inher-
infringe claim 1
ently
compound through prop-
anhydrate product will
anticipated
that broad construction. Notwith-
er
COSTS for, applied February Ferrosan and on 8, 1977, assigned, was U.S. Patent No. bear its own costs. party Each shall (“the 4,007,196 ’196 patent”). Paroxetine among compounds that Ferrosan AFFIRMED discovered and that the 196 pro- In granted tected. Ferrosan Beec- GAJARSA, concurring. Judge, Circuit (now SKB) Group part ham Limited court, of the join judgment I make, made, exclusive license to to have however, judgment by I a differ- reach use, and paroxetine throughout to sell trial court road. I would find that the ent (save specified world for Scandinavian construing Claim 1 of the ’723 erred in countries). construction, correct patent. Under the began manufacturing pa- SKB (“SKB”) proven Beecham has SmithKline (U.K.) hydrochloride in roxetine its Harlow Apotex’s product facie case that prima early plant. manufacturing These activi- 1, however, infringe
will Claim Claim ties did not lead to a commercial subjeсt it encompasses invalid because immediately. pharmaceuti- Before a new unpatentable under 35 matter market, drug placed cal can be on the U.S. § 101.1 I would affirm the district U.S.C. it must undergo testing elaborate for safe- judgment court’s favor of on the Quantities ty efficacy. encompasses unpatent- basis Claim hydrochloride were distributed to different pursuant §to 101 con- able matter world, U.S., parts including trary finding majority in clinical use trials. SKB scientists also 102(b). pursuant invalid claim is *16 experimented paroxetine hydrochlo- with majority the factual Although the outlines (i.e., prior ride in form its form to its bulk necessary I to background, deem add being pills) improve pro- into to made specificity more to the historical back- duction of the bulk material. ground. experimentation pa- on bulk form SKB’s 1970s, In the scientists at the Danish discovery. (“Ferrosan”) important roxetine led to company of Ferrosan A/S 29, 1985, May On an SKB scientist named synthesized first a new class of chemical Alan a memorandum enti- Curzons issued compounds. At least some of these com- In Polymorphism.” tled “Paroxetine pounds reported selectively were to inhibit memorandum, paroxe- serotonin, Curzons stated reuptake naturally of a oc- tine “had been shown to exist two dis- curring chemical in the brain. Several crystalline polymorphic creet antidepressants [sic] commercial common at the FORMS,” stable, nonhygroseopic a hemih- reuptake time inhibited the neuronal ydrate anhydrate. in- laboratory hygroscopic serotonin. Ferrosan’s tests and a Cur- thereof, any improvement may a 1. "Whoever invents or discovers new and obtain manufacture, therefor, machine, process, useful or to the conditions and re- matter, composition quirements title.” U.S.C. new and useful of this May confirmed bound water molecule. Cur- zons’s tests paroxetine, a hemihydrate were indeed distinct zons made batch of added and the alcohol, solvent, isopropyl and found that crystalline paroxetine. forms crystallized hemihydrate the batch as a understanding Crystallinity is central anhydrate. rather than as an Curzons polymorphism both Curzons’s reference immediately significance of recognized the “Polymorphs” are distinct and this case. hemihydrate superior handling —its containing crystalline structures the same potential its for a properties' well as —as These structural differences molecules. patent relating properties. new those crys- properties can various of the affect tals, properties melting points superior handling and hardness These are such crys- diamonds are both natural effects of water bonded into the (e.g., graphite and carbon). anhydrous paroxetine hemihydrate. The two forms of The talline forms hydrochloride crystalline paroxetine hydrochlo- that Curzons dis- form of paroxetine technically “pseudopoly- (“paroxetine anhydrate”) hygro- ride covered were is, though pseudopolymorphs scopic; are it attracts water. This morphs,” (an loosely appar- paroxetine not attached to polymorphs often called water is anhydrate by ently common looseness that the district molecular bonds. As re- sult, easily dispersed by and that I have the water is heat- adopted retained Pseudopolymorphs only ing paroxetine anhydrate significantly at a opinion). arranged differently temperature required lower than would have their molecules slightly have a different molecular to liberate the water molecule bound in but also hemihydrate crystals. A an- composition. type pseudopo- common solvate, crystal in lymorph hydrate’s hygroscopicity is a which is a makes it difficult defining crystal process; to handle in manufacturing which the molecules “trap” molecules of a solvent. measures must be taken to control humidi- structure moisture, crystal ty molecules and the solvent mol- and other sources of lest crys- “soggy” anhydrate degrade then bond to form an altered into other ecules ways trapped compounds might impair talline structure. When the water, safety efficacy product. solvent is the solvate is or the Be- bonded hydrate. Hydrates cause is not bonding hygroscopic, called one every precau- water molecule two of the other it is easier to handle with fewer constituting crystal tionary protecting safety molecules the unit cell measures hemihydrates. hy- efficacy. are called Paroxetine (“paroxetine *17 drochloride applied Beecham for a British on
hemihydrate”) crystalline is a structure 25, 1985, discovery Curzons’s on October binding every one water to molecule two and for a on U.S. October 1986. hydrochloride paroxetine molecules. De- 26, 1988, January On the Patent and U.S. molecules, of spite presence water a (PTO) Trademark Office issued the ’723 solid, a powder, at room “Anti-depressant Crystal- entitled patent, temperature. Hydrochloride Hemihyd- line Paroxetine rate,” which, Abstract, discovery, only according Prior to Curzons’s to the paroxetine hydrochloride “provides crystalline hydrochlo- form of paroxetine known had an anhydrate, crystalline hemihydrate, processes prepa- been form ride for its ration, paroxetine of compositions containing that does not contain a same pearing polymorphs tend to be more stable anti-depres- as an therapeutic use and its crys- than earlier Because a stable ones. patent. sant.” ’723 likely change talline form is not as to into issued were identical The claims as versa, a less stable one than vice there The ’723 original application. in the those tends to be a “natural” drift toward more (Claims 1, product claims patent combines Second, polymorphs. impurities stable re- (Claim 4), 5), and claims process crystallization, crystalliza- including tard 6). (Claims Only 5 and Claim claims use Technolоgical prog- tion into new forms. It litigation. at in the current issue manufacturing including in chemical ress — reads: manufacturing manufactur- allowed —has impurities prod- to reduce in their ers hydrochloride Crystalline paroxetine 1. purity ucts. Because of this increased hemihydrate. technology increasingly creates favorable conditions for the. “natural” drift towards taught Subsequent experimentation Third, stability. significantly and most parox- lessons about a few additional SKB case, once a new and more stable First, learned SKB etine should, mixed, crystal emerges, it be even likely existed least old, very quantities, with the less small (and possibly ear- early as December 1984 crystal, may stable the old form convert to ner), identify did not though even Curzons the new. Second, until and more it as such learned that the two significantly, SKB process “seeding” a batch of the through a paroxetine forms of are related new, crystalline structure with its sta- old “disappearing poly- known as phenomenon polymorphs can serve as a method ble times, appearance At morphs.” manufacturing polymorph the new (or pseudopolymorph)— polymorph new “converting” old into the new. Seed- process hemihydrate may affect conversion can also be accidental ing and — poly- the old previously used to make new, crystals side-effects of stable becom- result is such morph anhydrate. The “contaminating” the labo- ing airborne — longer pro- no process that the same will crystal the old ratory plant which here) (as polymorph the old least duce controlled being manufactured. While —at pure in its form. are obvi- the former case conversions methods, natu- ously production desirable polymorphic mechanism of The causal may in the latter ral conversion case clear. and transformation is not creation produc- undesirable interferences with yet Modern science does not understand polymorph. tion of the old full of the atomic interac- complexity poly- play phenomenon Seeding tions at in the and conversion are central morphism, specifically disap- single crystal paroxetine A this case. polymorphs. hemihydrate can seed an environment pearance of some Scientists pro- have, however, be- conversion—and to render identified three factors induce First, pure later-ap- duction of significant. lieved to be *18 Bernstein, Bernstein, (2002); J.D. Dunitz & J. "Dis- of SmithKline's ex- 2. Dr. Joel one trial, authority pert is an on appearing Polymorphs,” witnesses the 28 Accounts of "disappearing polymorphs.” (1995). See Joel Bern- Chem. Res. 193 stein, Crystals Polymorphism in Molecular 89- token, tighter While it is the same with much controls impossible. that environment less, no, maybe place conversion will take theory, to build possible, at least often despite presence Finally, of the seeds. which unseeded environments clean district court noted that the clearest case forms produce pure of process old will of conversion occurs there limited where possibility that often original polymorph, are no water molecules in the environment theory; of seeds only a matter remains anhydrate. of the frequent- the environment introduced into ly parts globe all of the and permeate ease, purposes For the of the dis- this develop such clean impossible render it proffered expert trict court admitted all it No one knows whether environments. testimony concerning disappearing both clean environ- possible today is to build a polymorphism phenomenon scientific pharmaceutical company ments which paroxetine, and its applicability paroxetine anhydrate. produce pure could explanation found it to be a of credible matter, Nor, anyone is certain for that various factual occurrences in the discov- crystal of precisely what caused the first ery spread paroxetine hemihyd- and the of hemihydrate though paroxetine form— rate. likely crystal from that appear does language straightforward, is all paroxetine hemih- December 1984 batch containing only four Claim words—is laboratory prior 1— ydrate seeded Curzons’s straightforward plain the most of all. The paroxetine of the to his initial identification of a claim language asserting rights to hemihydrate polymorph. “crystalline paroxetine hydrochloride hem- noted, uncertainty sur- As scientific ihydrate” “crystal- claims amount of disap- phenomenon rounds the entire paroxetine hydrochloride hemihyd- line particu- pearing polymorphs, as well as plain language rate.” The of this Apotex’s in paroxetine. lar manifestation theory that precisely “single crystal” fact, phenome- expert,3 in testified rejected the district on other paroxetine, non does not manifest itself grounds. explicitly The district court rec- anhydrate paroxe- paroxetine and that ognized plain language the claim’s happily in a tine can coexist single crystal hemihyd- included even paroxetine. single batch of rate; rejected the district court that con- grounds on the that it would have struction weighing testimony After of all of consequences.” “absurd hypothesized experts, the district court presence paroxetine that while hem- suggested The district court that even ihydrate seeds a batch of expressed SKB had some discomfort with likely, only percent- a small implications “single crystal” of the con- likely age paroxetine anhydrate result, through- struction of 1. As a Claim convert to under normal con- litigation, out par- the course both humidity, pres- or temperature, ditions of judges ties and two trial have considered hy- sure. The district court continued to into multiple limitations that could be read humidity, pothesize given enough claim—eаch of a mini- proposed which heat, may considerably larger continue mum amount than a pressure, conversion crystal. summary judg- percent, single During until it and that reaches 3. Dr. Terence Threlfall. *19 uncertainty Kocoras dismissed hearing, Judge “zone[s] desirable which
ment
enterprise
experimentation may
such limita-
and
en-
attempts to introduce
several
only
infringement
ter
at
risk of
the.
Though
adopted
he himself never
tions.
claims.”
Binney
United Carbon Co. v.
construction,
ruling
his
that SKB could
Co.,
228, 236,
& Smith
317 U.S.
63 S.Ct.
infringement developed
admit evidence of
(1942).
165,
ness must be
invariably
descriptions into claims
written
by statute as clarified
provided
work
Simply
leads to misconstrued claims.
recently explained that
law. We
our case
specification
in the
pointing to discussions
if,
read in
is indefinite
when
“[a]
history
or
cannot rebut
the
prosecution
it does not rea-
specification,
the
light of
should
afford-
presumption that claims
in the art of
sonably apprise those skilled
Fitness,
ordinary meanings. CCS
ed their
Inc. v.
scope
Amgen
of the invention.”
thе
Corp.,
Brunswick
288 F.3d
Inc. v.
Roussel,
Hoechst Marion
(Fed.Cir.2002).
recognize that
1366
“We
contrapositive
The
1342
a fine line
there
sometimes
between
claim,
If
is also true.
this statement
specification,
a claim in
of the
reading
light
light
specification,
reason-
read
reading
a limitation into the claim
in the art of the
ably apprises those skilled
specification.”
from the
Comark Commu-
invention, it
within
scope of the
is definite
Corp., 156 F.3d
nications v. Harris
112(2).
meaning
of 35 U.S.C.
omitted).
(Fed.Cir.1998) (citations
1187
case,
little doubt
that
this
there is
standard,
that
district
Given
that line.
district court crossed
The
lan-
plain
court’s error is evident.
“single crystal” theory provides
It
guage
unambiguous.
of Claim is
entirely
only interpretation that is
consis-
“crystalline paroxetine hydrochlo-
claims
language
with the
of Claim of
tent
hemihydrate,”
unambiguously
ride
interpretation
meets
patent.
the ’723
meaning
“crystalline paroxetine hy-
all
statutory requirement
for definiteness.
hemihydrate,”
any
drochloride
without
It
in the art on
puts those skilled
notice
Nothing in
claim lan-
exceptions.
patent protects crystalline
the ’723
straightforward
guage contradicts
paroxetine hydrochloride hemihydrate,
matter,
interpretation
nor,
for
—
amounts,
manufacture,
all
and that
patent’s
written
anything
does
use,
compound including
or sale of this
—
patent’s
description,
figures,
manufacture, use,
inadvertent
or sale—
history.
prosecution
There is no rea-
infringe
patent.
the ’723
The cor-
anyone,
much less one skilled
son
to the
rect construction Claim adheres
art,
plain language
in the
to read this
crystal
single
theory.
else,
meaning anything
nor to be-
every
claims
Because the ’723
lieve that
meant
to exclude
single crystal
hemihydrate,
of paroxetine
crystalline
small or
trace amounts of
Apotex’s paroxetine product
and because
hydrochloride
hemihydrate crys-
contains at least some
coverage.
from its
Those skilled
tals,
Apotex’s prod-
proven
SKB has
certainly
aрpreciat-
the art should
have
infringes
uct
facie
1 is
prima
Claim
—if
if
scope
ed the
of the invention —even
enough
Because
1 broad
valid.
Claim is
they
damag-
also viewed its breadth as
encompass
patentable
unpatent-
both
experimen-
ing to their own efforts
matter, however,
I would
able
find
tation and invention.
§ 101.
it is invalid under 35 U.S.C.
court read limitations from
The district
I.
claim lan-
description
the written
into the
Authority
appear
for reasons that
to have
guage
public
from its
concerns.
policy
stemmed
question
patentability
under sec-
often,
not arise
and a court’s
notwithstanding,
The court’s motivation
tion
does
do not bind this court
sponte
it sua
is even less
but retain
to raise
decision
*21
value,
centrality
persuasive
of
raised section 101
patentable
The
issues'
common.
scope
parties
of the
that the
had not
subject matter to the entire
addressed.
there are times Ninth Circuit announced that “it is the
suggests
law
that
patent
duty
patent
critical. The Su-
of the court to dismiss a
in
inquiries
such
are
when
long ago
fringement
affirmatively
that
suit whenever
preme Court established
invention,
appears
patent
that
invalid.”
the
which
the
Bar
question
“the
whether
1,
controversy,
keij
Corp.,
in
v.
210 F.2d
subject-matter
Lockheed
is the
Aircraft
(9th Cir.1954).
always
According
to the
2
to
open
or not is
the Second
patentable
“[ejven
Circuit,
court, whether
the
were section 101 not raised
consideration of the
by
by appellees,
the answer or not.”
it was not error for the dis
point
is raised
R.R.,
649,
107 U.S.
trict court to consider it since it had the
Slawson v. Grand St.
(1882).
652,
663,
power
2
[t]he ignore ques- Accordingly, party answer.... when a willing to have been patent alleging infringe- on a patentability present brings tion as to suit ment, case, validity litigated merely and to have it is accountable for the of invention, of on the question priority patent.... of assumption pat- that the invention was Co., v. 369 Borden Co. Cheese Clearfield entable. But neither the Circuit Court (3d Cir.1966). 96, F.2d 99-100 question court can nor this overlook the independently The Federal Circuit has patentability. raised section 101 concerns without Wooster, 693, 698, Hill v. 132 U.S. 10 S.Ct. parties at least once prompting from (1890). law, L.Ed. 502 In our 37 33 Ban Corp. before. In Titanium Metals 41.77(b) an specifically C.F.R. allows ad- ner, (Fed.Cir.1985), F.2d 775 we con 778 patent judge to raise the issue ministrative rejected that the had sidered PTO patentability sponte sua as to claims anticipated both under 102 and as Section designated correspond to a count of an under 103. Id. at 776. obvious Section interference. reversed, The district court and issued authorizing order the Commissioner Beyond proceedings, administrative pat to issue the courts have found the occasional need to Patents Trademarks sponte Corp. Metals v. Mossin raise section 101 issues sua ent. Titanium —even (D.D.C.1984). F.Supp. 91 subsequent ghoff, to the 1952 revisions to the appealed. The matter government Patent Act. At least three of our sister The circuits, reached this court on issues rele- rulings prior whose on law therefore patents public from the arena. In Cardi 102 and not to section
vant to sections
however,
Int’l, Inc.,
explained,
nal Chem.
v. Morton
We
Co.
L.Ed.2d
U.S.
S.Ct.
imposes
law
certain funda-
[t]he
(1993),
Supreme
Court reversed our
pаtentability, para-
mental conditions
findings
invalidity
practice
vacating
being
condition
among them
mount
non-infringement
where the
found
sought
patented,
what
public
light
strong
interest
resolv
claims,
be new. The
determined
*22
ing questions
validity.
of
In
patent
Blon
applicable
of Title 35
provision
basic
Labs.,
der-Tongue
Inc. v. Univ.
Ill.
appli-
101 .... The title of the
here is
Found.,
313,
1434,
402
28
U.S.
91 S.Ct.
Alloy,”
“Titanium
cation here involved is
(1971),
Supreme
L.Ed.2d 788
the
Court
Surprisingly,
a
of matter.
composition
length
commented at
on the wasteful con
evidence, nobody discussed
in all of the
validity
the
a
sequences
relitigating
alloy
key
issue of whether
it
patent after
has once been held invalid.
new,
of the antici-
is the essence
which
Ltd.,
Group,
v.
410
United States Glaxo
pation issue....
52, 57-58,
861,
93 S.Ct.
35 L.Ed.2d
U.S.
Metals,
scientific remain matters of controversy within the scientific communi- II. general as a ty, phenomena both seeding applied paroxetine: and conver- Infringement Theoi'y of in- See id. at 1021-23. Under this sion. proper Because construction fringement theory, the form paroxetine crystal” theory, “single Claim follows was, indeed, pure discovered the 1970s prove Apotex’s product SKB must that anhydrate; hemihydrate did not until exist and will continue to contain at least 1984. does late inevitable, infringement. spontaneous We
5. The district court’s maze of alternative finding Apo- claim constructions and theories face We ad therefore a choice. can either plus theory infringement, tex not liable for explain why dress the issue head-on and an by majority, unique attest added to the attempt patent unpatentable matter circumstances case. district anomalies, many apparent leads to so or we opinion, particular attempt court's and in its try aspects can law contort defense, equitable to introduce a novel Smith by parties raised in order to avoid those Corp. Apotex Corp., Kline Beecham anomalies. I the law is best believe (N.D.Ill.2003) ("SK F.Supp.2d 1043-45 by adopting straightforward ap served II"), strongly imply something "feels proach. wrong" holding infringer about liable expert] required Dr. Bernstein testified that is to cause conversion is so [SKB’s ‘absolutely minute.... was convinced’ that he hemihydrate had existed before De- no Id. at argues 1020. SKB therefore Threlfall, Dr. Terence 1984... cember any paroxetinе manufactured a seeded expert polymorphism, on testi- Apotex’s inevitably environment must contain at Dr. Bernstein’s absolute cer- fied [that] hemihydrate, least some that this condition ... No tainty is not tenable. one knows only prevailed has since some time in late paroxe- form of when the Apotex’s and that facilities have been existence, although into it tine came inevitably will become seeded. that it did not reasonable inference exist SmithKline, According to plant BCI in a amount until then. detectable anhyd- which [in manufactures forward, at From that date how- Id. hemihydrate crys- is seeded with rate] ever, impossible produce pure it tals Apotex, because was there that anhydrate in a “seeded” environment be- exercising experimental- the broadened cause even under normal climactic condi- privilege use conferred the Hatch- tions, least some Act, hemihyd- Waxman used and made “convert” to become rate in developing anhy- the course of product. drous ‘seeding’ the old with process is, new can can be deliberate —that Id. at 1024. *24 manufacturing the poly- method of new adventitious, a of morph result —or III. crystals fact that some of become proof supporting theory SKB’s this must airborne and ‘contaminate’ the laborato- upon rest factual demonstrations. anAs ry crystal old plant or which the court, appellate accept we all facts found being manufactured.... rel- [T]he seeds by they the district clearly court unless are evant to this case are seeds that cause Arcan, Inc., Shockley erroneous. polymorph one to convert to another and F.3d The dis- crystals these seeds are of the form to court, however, trict signifi- stated its most single tiny A which conversion occurs. finding cant an hypothesis: as seed, crystal, single might constituting induce The creation of conversion.... conflicting testimony of Bernstein polymorph likely the new to make the ... on the one hand and of Threlfall on laboratory plant produced or where it is can largely other be reconciled on seeded, with the result that efforts to the following hypothesis: pres- while the produce may polymorph the old instead hemihydrate ence of seeds a batch of one, produce the since it is the more new anhydrate likely, provided the am- principle stable form. it should be humidity temperature bient are no possible polymorph, to re-create the old lower than temperate is normal just by procedure the exact replicating zone, produce conversion within a created, by only time, which it used to be this short once the amount converted time in a environment.... seed-free percent [I]n reaches a few of the mixture practice poly- efforts to re-create old unlikely further conversion is without succeed, morphs always probably do not substantially greater humidity, tempera- ture, because pressure. the critical mass of molecules or added). II, plant.” Find- F.Supp.2d (emphasis 1022-23. leaves Id. SK conclusion, But hypotheses pose par- syllogistic fact stated as concrete ings of challenging problems appel- for evidence is ticularly support “[t]his sufficient accept Did the district court that will making late courts. BCI be at least inference upon legal tiny a fact which hypothesis amounts if it is rest, permitted can arguments anhydrate.” and conclusions manufacture the added). merely trying (emphasis was the district court to Id. testimony scientific
make sense found, The district court therefore as a experts proffered? the two fact, paroxetine matter of anhydrate legal The district court’s own conclu- in a seeded by environment characterized accepted make it that the court sions clear normal climactic conditions can convert it- facts, by stating, example, thеm as spontaneously paroxetine self into hemih- “[Apotex’s] plant is seeded as a result BCI ydrate. Id. The district court further id. at experiments,” of the mid-1990s 1032 found that SKB had met burden added), (emphasis and that “the proving, by preponderance of the evi- proceeds through process as it [at dence, that such conversion was inevitable junctures at several be plant] BCI will at Apotex’s manufacturing facility. BCI enough air that contains water exposed to Id. at 1042-43. anhyd- permit
molecules to conversion of The district court next turned to consid- hemihydrate.” rate to Id. These state- Apotex’s er “If ... defenses. claim is if only ments make sense the district court valid and will ... infringed single seeding that both and conversion are found crystal ... [then] facts, applied scientific at least as valid complete has a affirmative defense purposes for the this case. infringe- SmithKline is the cause of the district court’s understandable ment.” Id. at 1052. This conclusion makes *25 hedging language dealing of its when with only finding Apo- sense after a factual controversial scientific theories neverthe- legal experimentation tex’s with Paxil6 less led it to definitive factual conclusions: plant. seeded the at 1024. “Apo- BCI Id. ‘making’ be at 'probably “BCI will least crystals tex cannot eliminate all of hemih- hemihydrate crystals some and therefore ydrate; single-crystal under a interpreta- facie, patent at infringing, prima least tion of claim SmithKline is the sole [and] if interpreted single claim is to cover (em- infringement.” cause of Id. at 1044 crystals hemihydrate.” (empha- Id. in phasis original). added). anhyd- sis “Some conversion from Finally, explained the district court likely
rate to is to occur in a difficult, facility anhydrate may in it in it seeded which the is is and some cases air; seeded; exposed plant impossible (paroxetine hydrochloride BCI’s is and anhydrate hemihydrate may manufactured there is ex- be one of those knows), posed destroy air before it all nondehumidified cases-—no one Act, (FDA). generic 6. Under the Hatch-Waxman The district court viewed this statuto- license, II, drug experiment ry permission implied manufacturer is allowed to as an SK drug patented prove planned F.Supp.2d with a that its at and attributed liabili- product bioequivalent already ap- ty seeding consequent to one for the to SKB. Id. at proved by Drug the Food and Administration premises.... Dr. Bern- disclosed and what has been claimed is seeds seeded Apotex, desperate public that if the essence of notice. It stein testified tells the infringement public products charge processes to avoid a built which plant infringe new in Antarctica where no hemih- and which had ever been and started would not. ydrate seeds there, manufacturing anhydrate and a Int’l, Computer PSC Prods. v. Foxconn depressed plant dropped worker When floor, might Paxil on the the result tobe product the claimed can be “made” via the plant impossible seed the and make spontaneous noninfringing conversion of a then on to produce pure from one, product infringing adequate into an there. if impossible notice is the claimed —even initially synthesized at in a Id. 1020-21. labo ratory. short, four district made (1) findings: Hemihydrate Long critical factual before when Section for- crystals description did not exist before their first malized the modern written re- emergence laboratory quirement, Supreme in an SKB late Court observed (2) 1025; Hemihydrate at that: id. seeds spread easily, increasingly large parts Whoever that a certain useful discovers seeded, becoming of the environment are art, produced, any result will be ma- (3) 1020-21; at normal climactic id. Under chine, manufacture, or composition environment, in a conditions seeded matter, means, by the use of certain anhydrate crystals least some will convert it; a patent provided entitled to he to become spontaneously specifies the means he uses in a mannеr (4) 1022-23; crystals, Apotex’s id. at exact, so full one skilled seeded, manufacturing facilities have been can, appertains, the science to which it at 1024. id. by using the specifies, means he without to,
any addition
or subtraction from
IV.
them, produce precisely the result he
if
describes. And
this cannot be done
findings
highlight
These
of fact
describes,
the means he
unique challenge
infringement
done,
if it
void. And
can be
then the
analysis
patent poses: infring-
of the ’723
*26
right
confers on him the exclusive
ing
tendency
matter has an unusual
to
to
specifies
produce
use the means he
“appear” even where it is unwanted. Such
describes,
the result or effect he
spontaneous appearance
patented
a
of a
nothing more.
vitiates the
notice
product
public
function
Morse,
62, 119,
O’Reilly v.
14
at
How.
patents.
of
See id.
1028. Under nor-
(1853).
circumstances,
Supreme
L.Ed. 601
Court
mal
explained
further
ordinary
of
skill in
art
one
should be
description
patent,
[a]ecurate
able to read
discern which
of the invention is
law,
required by
matter is disclosed and discussed in the
important
several
description,
recognize
purposes:
government may
written
and to
1. That the
granted,
which matter has been claimed. The
what
will
know
and what
ability
public property
to discern both what has been
the term
become
when
prod-
conversion of
prevent
That
has tried
expires. 2.
licensed
monopoly
of
patented
principal
to the
form and a
uct
the inven-
desiring
practise
persons
it
issue in this case is whether
has succeed-
during the term how to
may know
tion
ed;
suggestion
there is no
construct,
make,
the invention.
and use
II,
F.Supp.2d
desires conversion.” SK 247
what
may know
That other inventors
(emphasis
original).
at 1015
is unoccu-
field of invention
part of the
pied.
1 therefore cannot be valid. But
Claim
consequence
of its
the failure of notice is
Coe,
31, 39,
ent
V.
us, for
hemihydrate forces
Paroxetine
Subject Matter
Patentable
time,
requirement
to confront
the first
any
discovers
new
“Whoever invents or
so full
specify
a manner
patentee
that “a
machine, manufacture,
process,
and useful
exact,
skilled in the sci-
any
one
matter,
composition
of
or
new and
can, by
appertains,
[avoid-
tó
ence which
thereof,
improvement
may obtain
useful
O’Reilly, 15
specifies,”
he
ing the means
]
....” 35 U.S.C.
101. The
patent thereof
601,
produc-
avoid
at
L.Ed.
How.
interpreted this statu
Supreme Court has'
Otherwise, there
product.
ing the claimed
subject
tory
patentable
matter to
range
way
[to]
for “other inventors
will be no
broad,
“In
hardly
but
universal.
quite
the field of invention is
part
know what
as ‘manu
choosing
expansive
such
terms
Bates,
Effec-
intellectual
process
tools of scientific and
blur the line between a natural
the basic
they are
synthetic
a
product,
work.”
v. Ben
nor is it the first
technological
Gottschalk
63,
son,
253,
engender
patent
confusion in
93
34
law.
409 U.S.
S.Ct.
(1972).
In
Century,
the Nineteenth
conflation
single
A
standard
L.Ed.2d 273
principles
of the natural acoustical
of tele-
applies
product
process
claims and
phony
telephone
with the invention of
patents
claims alike.
Id.
are
“[WJhether
equipment gave rise to
litigation.
massive
subject
[challenged
allowable for
matter]
Cases,
Telephone
See
discretion,
U.S.
S.Ct.
not a matter of
but of law....
(1888).
disentangling
ject syn matter is that or natural force or a scientific fact cannot thetic, processes patenta are products proceeds have a for that.” But it ble, products processes while of nature exception nugatory by to make this con- Chakrabarty, 447 at are not. See U.S. (or the natural founding process scienti- 2204; J.E.M. AG v. Pio Supply S.Ct. fact) fic with the process invented Int’l, 124, 130, neer Hi-Bred 534 U.S. working apparatus; sustaining the (2001). 593, 151L.Ed.2d 508 S.Ct. patent for the last a construсtion upon blindly sweeps which in the first. a
The district court found as matter of
likely in
point,
fact that at some
late
270-71,
at
Id.
Chakrabarty, inescapable 447 U.S. 100 S.Ct. lead added). conclusion—a conclusion that the majority (emphasis 65 144 L.Ed.2d attempts question dismiss as a ruling confirming hybrid plants recent “scope,” patentability. rather than of subject matter under sec patentable are “synthetic Had SKB claimed or non-natu 101, Supreme noted that tion Court rally occurring crystalline paroxetine hy “[hjybrid generally ... do not re plants hemihydrate,” drochloride would i.e., produced produce true-to-type, seeds only subject patentable have covered mat reliably yield by hybrid plant do not ter, and would be entitled hybrid characteris plants with the same judgment of noninfringement. Had SKB Thus, contin tics. a farmer who wishes to explicitly crystals claimed the converted growing hybrid plants generally ue needs facilities, in Apotex’s as “the either natu seed.” J.E.M., buy hybrid more 534 process ral of converting paroxetine an- 128, 122 U.S. at S.Ct. 593. hydrate to paroxetine hemihydrate” or principle unifying these statements “crystalline paroxetine hydrochloride hem- 1930,1980, made in patentability about ihydrate arising through natural conver 2001, sion,” capable being products unpatentability under section 101 manifest; man,” by by though would be “reproduced nature unaided claimed composition, matter would be a useful 303, 2204, 447 100 Chakrabarty, U.S. S.Ct. would be one that occurred nature. 144, patentable subject are not 65 L.Ed.2d 309, Chakrabarty, 447 See U.S. at 100 Though matter under section 101. 2204; Bros., 130, S.Ct. Funk 333 at U.S. question have not briefed this di parties By 68 claiming simply “crys S.Ct. 440. they rectly, and the district have paroxetine hydrochloride talline hemihyd- more than facts to ob provided sufficient no rate” with reference to how it was dispositive legal tain a and incontrovertible produced, effectively “crys SKB claimed determination that Claim 1 of the ’723 paroxetine hydrochloride hemihyd- talline patent is invalid under section 101. non-naturally occurring rate whether construed, patent, correctly The ’723 arising through natural conversion.” every crystal single claims 1, issued, Claim therefore combines hemihydrate, including crystals those aris- patentable unpatentable mat ing through natural conversion. The dis- ter, 101. and is invalid under section properly prof- trict court admitted SKB’s majority “confusion” to which the alludes testimony the scientific expert fered about should never arise because we cannot conversion, reach Section 102 unless the claimed mat underlying mechanism natural II, 1019-20, ter can overcome the hurdle of section F.Supp.2d 247 at under SK Pharmaceuticals, Daubert v. Merrell Dow 2786,
509
113
125 L.Ed.2d
U.S.
S.Ct.
products
to claim
wishing
Inventors
(1993),
Joiner,
469
and General Electric v.
synthesized
can
either be
laboratories or
522 U.S.
118 S.Ct.
139 L.Ed.2d
generated by
processes may pro-
natural
(1997),
conjunction
it in
weighed
with
by incorporating negative
tect themselves
contradictory testimony
proffered
Apo-
like “non-natural” or
limitation terms
II,
experts,
F.Supp.2d
tex’s
SK
at
they
“non-human” into the claims that
sub-
that at
and concluded
least some of
v.
Amgen
mit for examination. See
Inc.
Apotex’s anhydrate
Roussel,
convert itself
Hoechst Marion
II,
(Fed.Cir.2003);
F.Supp.2d
Legal
SK
Animal
Def.
Fund,
923;
Wakefield,
1022-23.
932 F.2d at
In re
made no such dis-
tinction. II, conversion, SK INC., Plaintiff-Appellant, seeding tion of all paroxetine claimed F.Supp.2d at including both those hemihydrate crystals, *31 without hu- natural conversion “born” of HOLDINGS, PLC, Limited, ARM Arm those “made”
man intervention and Arm, Inc., Defendants- human effort. laboratory through explicit Appellees. claim to a SKB further demonstrated No. 04-1101. naturally occurring possessory right litigation, crystals by pursuing Appeals, United States Court explicitly during oral articulated this claim Federal Circuit. argument. breadth of Claim makes The asserted April 2005. only under the erroneous belief
sense may protect products spread
patents by directly natural
reproduced processes, our well established under-
contradicting by
standing imposed of the limits section trends, current scientific such
101. Given easily could lead to misdirected
a belief investments, inappropriately
research patents, widespread and to a
issued crippling entire industries
terrorem effect artisans learn that even their best
whose rights may not respect patent
efforts to inadvertent, liability from
save them infringers.
inevitable As the district court
recognized, patents the notice function of environment, SK meaningless such
II, F.Supp.2d The lack of 1028. innovation, easily notice could chill
suitable
inquiry, experimentation, and commercial
development. law does concept infringe-
sanction the of inevitable
ment. single
Because SKB’s assertion
crystal theory provides the correct con-
struction of the ’723 claims Claim crystals repro- by unpat-
duced nature unaided man — entable matter —and is therefore
invalid under 35 U.S.C.