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Biogen, Inc., Plaintiff-Cross v. Berlex Laboratories, Inc., and Schering Ag
318 F.3d 1132
Fed. Cir.
2003
Check Treatment
Docket

*1 BIOGEN, INC., Plaintiff- Appellant,

Cross

v. LABORATORIES, INC., BERLEX Defendant-Appellant, Schering AG, Defendant. 01-1058,

Nos. 01-1059. United States Appeals, Court of

Federal Circuit. DECIDED: Jan. 2003. *2 Fried,

York, NY; and Professor Charles School, Cambridge, of Mas- Harvard Law sachusetts. Cravath, Swaine & Clary,

Richard W. Moore, York, NY, argued for de- of New on the brief fendant-appellant. With him Brooks. Roger was G. NEWMAN, Judge, Circuit

Before FRIEDMAN, Judge, and Senior Circuit RADER, Judge. Circuit by court Circuit Opinion for the filed NEWMAN. Judge PAULINE Judge by filed Circuit Concurring opinion RADER. NEWMAN, Judge.

PAULINE Circuit declaratory brought action In this Inc., appeals Berlex Laboratories Biogen, District of the United States the decision Massachusetts, District of Court summary motion for Biogen’s granting non-infringement of United of judgment (the 5,376,567 pat- '567 No. States Patents (the ent) 5,795,779 patent). and No. cross-appeal filed a conditional Biogen hаs validity. issue

BACKGROUND to re- patents relate

The '567 pro- technology and DNA combinant interferon; the condi- of human duction the issues production form tions of this Francis The inventors litigation. this Innis of A. and Michael P. McCormick Rin- M. Corporation, Gordon Cetus ac- University. Berlex gold Stanford rights in 1991. quired Cetus as to the LLP, issue principal Lee, and Door F. Hale ‍​‌‌​‌‌‌​​​‌‌​‌‌‌‌​‌‌‌‌‌‌‌‌​​​‌‌​​​​‌‌‌​‌​‌‌‌‌‌​​‍William claims directed certain Massachusetts, is whether argued plain- Boston, in Chinese human interferon him on the brief appellant. With tiff-cross correctly con- were ovary cells Of counsel on David B. Bassett. to use of as limited Jr., strued Haley, and Gerald F. were James brief a selectable to introduce both Neave, “construct” Flattmann, of New Fish & Jr. J. is, human interferon way unlinkеd co-transformation. gene into host process cell. The Berlex states that its cell and method (also whereby a DNA construct called a construed, correctly literally cover “vector” or “plas- “vector construct” or variation, alternatively *3 mid”) (called carrying foreign “heterolo- construct infringed claims are in terms of gous”) genes is introduced into accept- equivalents. the doctrine of ed a host cell is called “transformation” process “transfection.” The is called I “linked co-transformation” when THE '567 PATENT genes are linked in a single DNA con- gives plenary The court review to struct, and “unlinked co-transformation” interpretation of the of claims multiple genes

when are introduced using grant and to summary the of judgment separate DNA constructs. Cybor based thereon. Corp. See v. FAS The district court observed that inte- Inc., Technologies, gration heterologous genes is a rare USPQ2d (Fed.Cir.1998) (en banc) event, typically successful in less than one (claim performed construction is de novo 100,000, cell and that it is both difficult appeal). important to detect whether cells have 42, 66, 68, Claims and 70 repre are successfully transformed, been as well as sentative the “method” and “cell” to claims isolate the transformed cells order to claims that Berlex as obtain an protein uncontaminated prоduct serts are not limited to the use of a single upon expression gene. A selectable carrying construct both the human gene marker has been used to aid in de- gene interferon and the gene: marker tecting isolating transformed cells. In procedure, accordance with this 42. A cells lack- method for of hu- gene a ing encodes a man substance essen- interferon in a Chinese hamster cell, tial to the cell prepared cells, ovary are as host comprising growing a Chi- and DNA construct is nese prepared ovary to em- hamster cell having incorpo- body the missing gene; then the rated cells that therein a DNA construct compris- successfully ing with humаn transformed á- or gene, á-interferon which DNA marker will placed survive when in a expression construct effective for medium is toxic to lacking said cells human interferon gene, under con- encoded substance. For patents ditions whereby the interferon gene in suit, Chinese hamster ovary said expressed. cells lack construct is gene that encodes enzyme dihydro- 66. A Chinese ovary cell hav- (DHFR) folate reductase are used as the ing incorporated therein an expressible host cells. gene encoding á-interferon, human á- or or a progeny thereof. patents in suit describe the linked A68. Chinese hamster ovary co-transformation of cell hav- Chinese hamster ing оvary incorporated cells into its using single an chromosome carry- expressible gene ing encoding both the human human inter- gene interferon feron, gene progeny or a for thereof. the marker DHFR. Biogen process genes the same are used 70. A producing method of human purpose same cells, the same but comprising terferon growing a progeny gene the interferon and the DHFR gene cell of a Chinese hamster ovary cell are introduced separate constructs, that been has transformed with ex- high of human produce levels cells expres- and an gene interferon pressible the ham- reductase, expression without interferon dihydrofolate for sible 2) interferon, single the use of a ster expression for effective under conditions genes carrying the DNA construct gene. human interferon of said and a selectable human interferon both mentions only claim 70 Of these the divi- points out marker. gene, and reductase dihydrofolate filed after sional use of a claims mentions none single DNA construct specific to However, the dis- DNA construct. application, in the had been allowed on review of the trict 4,966,848 States Patent No. now United receiving history, and (the and that the '567 patent), *4 for both testimony expert witnesses the are, be, to and of different intended were requiring claims as sides, all the construed scope. co- and linked single construct a use of responds Berlex’s asserted Biogen that interferon the with both transformation supported is not breadth claims genes. and marker if specification the and that the claims A. Claim Construction broadly pro- as Berlex interpreted as were for lack of an they would be invalid poses, that court found district description. Biogen adequate written invention only the discusses specification patent examiner did not that the states construct, linking a DNA wherein having claims the breadth as view gene, gene and the the interferon portions Each side cites now asserted. DNA into foreign the used to introduce history as specification and cells, and held ovary hamster the Chinese pro- side position, its and each supporting all the procedure that limits this person a testimony that expert vided Ber- claims. including the cell and method would understand field of the invention single construct that the argues lex in accordance with its patent record embodiment, it is and preferred position. pre- claims to the limit the incorrect to following statements in cites the Berlex district ferred embodiment. proposed of its support specification history, reviewing also of the claims: construction broad that the asserted broader concluded 1, is not warranted. 14-17: lines Col. inter- to human relаtes This in- that the '567 argues Berlex in Chinese and their ferons of the advanta- larger discovery

cludes for- therapeutic ovary hamster cells hamster geous use of cells Chinese human interfer- including the mulations interferon, and human ovary produce produced. on so 70 reflect 1-8: lines it is Col. concept. Berlex larger states embodiments, frag- DNA method to the cell and In preferred irrelevant more one or IFNs Chinese which code for transformation ments whether appropri- from by single or are ovary cell is isolated [interferons] achieved hamster cells; into CHO constructs, these claims human introduced and that ate transfection, pen- or mark- cells DNA tо use of a selectable limited carrying the of viral vectors etration states that er. Berlex by transfection fragments, aspects of the separate two describes express cells plasmids cloned into 1) hamster the use of vention: Chinese T-antigens; expressed by Accordingly, the host present pro- invention cells; expressed product is iso- vides a DNA expres- construct for the purified. lated and sion of the human interferon ovary Chinese progeny cells or Berlex stresses that the above statements thereof comprising operable linkage make no of a single mention construct and of: genes. linked Berlex also cites the state-

ment at col. lines 32-47: (a) a sequence nucleotide from a clon- [A]ny ing approach may be used vector which replication to intro- allows for prokaryotic cell; duce the cloned DNA into CHO cells and to grow select and the transformed (b) gene capable a first transcrip- expression cells for protein. tion and translation in Chinese hamster places particular emphasis ‍​‌‌​‌‌‌​​​‌‌​‌‌‌‌​‌‌‌‌‌‌‌‌​​​‌‌​​​​‌‌‌​‌​‌‌‌‌‌​​‍progeny cells or on the thereof operably statement, above as linked to a meaning that the '567 selectable marker cell and method claims selection of are not limited to Chinese hamster ovary (CHO) any specific method of cell introduсtion of the transformants or progeny DNA, thereof; human interferon and that larg- er invention is the use of selected Chinese (c) a human *5 gene capable interferon ovary hamster produce cells to the human transcription and in translation Chi- interferon. argues Berlex that the inter- ovary nese hamster cells or progeny changeability of linked and unlinked meth- thereof. [Col. lines 33-46] ods of co-transformation was known before The Abstract of the invention states: filed, and submit- DNA prepared constructs are op- expert ted person statements that a skilled erably link human genes, interferon se- in the field of the invention would have lective, eukaryotic genes, аnd understood that either method could be promoter expression control se- used to introduce both interferon DNA quences expression of human and marker DNA into these cells. Berlex interferon in Chinese ovary hamster also directs patent’s attention to the state- (CHO) cells or progeny [Page thereof. ment, quoted supra, that the DNA may be 1] virus, introduced means pre- of a Description The of the Preferred Embodi- expert sented testimony person that a ments states: skilled in this field would know that a The method of effecting expression selectable marker is generally not used heterologous viral genes in transformation. CHO host cells or argues Berlex рrogeny thereof above-quoted parts generally pre- specification involves paring establish DNA that the cell constructs as and method defined above operably are not linked a sequence limited to to nucleotide single use of a construct replicating for genes. prokaryotic ...; linked a cell gene ...; a marker and an interferon Biogen responds except for these gene from a human source.... This general few undeveloped sentences the en- DNA construct is then introduced in specification tire solely directed to the CHO line cells-[Col. 64 to col. invention whereby single a DNA construct line 11] carry used to linked interferоn and marker genes into the Chinese hamster specification The describes linked ovary cell, starting Summary with the sequences DNA proce- and transformation the Invention: using dures single linking hu- constructs dihydrofolate concerning prokaryot- reduc- the '843 claims man interferon sequences ic cell nucleotide selecta- to transfect Chinese genes tase marker sequences. marker-related ble Whereas ovary Although cells. there is sequences such are useful various vectors, quoted supra, as mention of viral cloning procedures, experiments complex that for bio- recognized it is well they clearly necessary are not to a to known logical processes reference '843, i.e., prime aspect “production general techniques does establish Chinese hamster cells.” techniques may be or how such whether successfully adapted particular to a activi- Amendment, 30,1992. Preliminary April Further, ty. specification acknowl- September On Berlex filed a studies failed to solve edges whereby terminal disclaimer with intro- problems “technical involved expire concurrently claims would with the ducing fragments into animal tissue examiner, finding a tech- problems ... other re- [and] culture cells disclaimer, nical flaw the terminal is- of the host IFN lating to the obviousness-type double-patenting sued specificatiоn does not [interferon].” rejection rejection. In this the examiner any present details of other describe patentably described the '567 claims as not configuration introducing genes. distinct from the '843 concedes, must, claims. The examiner stated that the '567 as it

Although Berlex simply change claims were to “functional exemplifies only co- that the language construct, language” and “effec- using transformation a linked tively the vector con- limits the history argues that the application”: struct of the '843 shows that the true of the invention *6 broadly the use of Chinese hamster is parent patent, In the the claims recite production of cells for recombinant by listing the DNA cоnstruct each ele- interferon, independent human of the con- in- construct. The ment vector The district court did not struct used. application stant seeks to remove the prosecution agree with this view of the construct ele- language detailed history. ments, Nor do we. functional replaces it with This language functional ef- language. prosecution record shows that the The fectively claims to the vector limits the pres- in to their claims suit were amended application. The construct of the '843 prosecution scope during ent construct, either described its ap- which issued from a divisional function, is physical elements or its plication pаrent filed after allowance of the prior patent the same explicit- All of the claims application. instant ly single state the construct of linked 5,1992. Action, Examiner’s October genes. terferon and marker The claims application filed 1990were the divisional in the terminal Berlex corrected the flaw limited, similarly refiling but on Berlex disclaimer, the examiner and thereafter not mention the introduced claims did claims, the DNA construct but allowed construct, single stating: rejected the other claims on an issue relat- “muteins,” ing against prior which art foregoing being The claims are added to ap- during Following cited. an interview the oversight cure an inadvertent an- was mutеins, all reference to prosecution leading plicant cestor to U.S. Pat- deleted 4,966,843.... construct claims to oversight cured the allowed ent amended reductase marker unnecessary language dihydrofolate recite the above involves Applicants’ method and cell claims are directed to a and amended the gene, vector, comprising DNA construct not all of these whereby most but claims gene, interferon and a dhfr marker linked DNA con- single included the claims gene. expressed accompanying Remarks the struct. CHO cells. The instant are simi- amendments as applicant described the 4,966,- parent Patent lar to the claims “clarifying,” thеre was no discussed (’843), the instant however art, prior and stated that “no fur- adverse dhfr, recite the marker to be required by these amend- searching ther whereas the '843 claims do not. Since a “clarified” the ments.” The also filed terminal disclaimer has been over record, had which stressed the instant claims are on an ad- linked co-transformation based held allowable. mittedly reading erroneous reference to Axel et al.: Allowability, Notice of November 1994. Thus the examiner stated that the claims aspects prosecution ... certain are directed to the DNA construct 4,996,843 No. led to ancestor U.S. Patent genes, with linked and that allowance de- merit clаrification. Where the record of pended on the terminal disclaimer. rec- No that of an- differs from ognition given applicant’s to the state- ... cestor it is the current quoted supra ment in the Remarks record which is It is not relevant.... ... depend “the current claims do not on

relevant whether the Axel et al. art any particular nucleic acid construct con- actually em- disclosures of record figuration.” ploy only genes unlinked co-transformed responded to the (Axel examiner’s Rea generically their work. at al. do Allowance, the Notice of sons as Allow- See, genes. e.g., disclose linked such ability mentioned and the Rules authorize.1 3-31, of, e.g., cоlumn lines U.S. Patent response, apparently through This PTO 4,399,216.) Patentability No. error, was not included the certified breadth of the current claims reflect the record, and the district court expression of the first non-obviousness it give any weight declined to because the of human IFN in cells and CHO do public did not have access to it. The dis depend any particular nucleic acid *7 trict court aspect, erred on this configuration. part document is indeed of the official Remarks, 21, Applicant’s Sept. 1994. The record, in despite omitting the PTO error applicant also stated: it. Nonetheless the district exercis scope The resultant the amend- [of discretion, ing sound reviеwed the docu subject scope falls within the ments] ment, observing by ap the statement the already matter prior allowed over art. that plicant factually “as is clear from the record, telephonic There ensued a interview on involved texts of the claims of both application November and a Notice of aspects Allow- and '843 reflect issued, ability cancelling by a few claims other than those mentioned the examin Amendment, er, by Examiner’s stating e.g., application, for this methods and cells, the prokaryotic examiner’s Reasons for Allowance as no need for a sequence, etc.,” follows: applicant from which the concluded (7th ed.1998) ("comments applicant's § 1. An “comments on statement of MPEP 1302.14 may reasons for allowance” [on be submitted no statement of reasons for will allowance] file”). later application than the submission of the issue fee. See be entered in the Al patenting. establishing tion as the broad claim con- there was not double that being give to struction asserted for the '567 the district court declined though ' document, claims. it is consistent to this weight prosecution other statements with the correct that arguments Berlex is made cannot, not, indeed Berlex and does in a related not do automatical- Reasons for Allow change the examiner’s ly apply to different claims in a separate ! ance. application. applicant’s discovery the Axel reference had been miseharacter- allowing the claims did The examiner prosecution ized indeed necessi- construct, cell, distinguish among not the change comport tated a with the correct argues that it and method claims. Berlex content of the reference. Thus prosecution during made clear the had prosecution applicant pointed the out that its cell and method claims were di- Axel describes both linked and unlinked ham- broadly to use of the Chinese rected genes, argued that the difference was produce human interfer- ster cell to However, irrelevant. this correction does on, the entire but the district court viewed change specification the content of the that' showing record as using or its description invention as never so viewed the invention examiner construct for linked co-transfor- argues under examination. Berlex mation. applicant’s statements to the record, the district court misconstrued the examiner that the '567 “fall within and that the examiner’s Reasons for Allow- scope subject already matter allow- only to the construct claims. ance relate weigh heavily able over the art” Although responses examiner’s are un- against now-proрosed Berlex’s con- broad applicant’s representa- responsive to the struction. tions, Indeed, they ob- unambiguous.

jective reading prosecution history court The district found recognized that shows that the examiner single DNA construct was the basis on supportable scope of which all of the '567 claims were allowed scope was for ‍​‌‌​‌‌‌​​​‌‌​‌‌‌‌​‌‌‌‌‌‌‌‌​​​‌‌​​​​‌‌‌​‌​‌‌‌‌‌​​‍the linked construct. This examiner, and declined to was recited the Reasons Allowance interpret the cell and method claims as applied by the district court. Mfg. of this limitation. Modine free See Comm’n, im-

Berlex states that the district court Co. v. Int'l Trade (Fed.Cir. USPQ2d properly arguments prose- relied on the 1996) (“when prеferred cution of and erro- embodiment is neously limited the '567 claims to the same described as the inven itself, necessarily tion the claims are not scope as the '843 claims. than that argued had entitled to a broader em *8 bodiment”). correctly court single that the use of a linked construct of viewed history prosecution DNA was a distinction the not examin interferon/marker intent, applicant’s subjective advantage from and over the use of multi- er’s or the record that is created in ple unlinked constructs shown the Axel but as an official that its audience is not knowledge art. Berlex states that it later dis- the examining ap and the applicant patent covered that the had misunder- the officials Axel, public. interested See plicant, stood and corrected the error the but the Instruments, Inc., The district v. '567 record. Markman Westview 967, 985-986, 1321, correction, USPQ2d acknowledged court which 52 F.3d 34 banc) (“The (Fed.Cir.1995) (en ante, quoted is but did not view the correc- 1334-1335 1140 claims, are so limited. See Net of the inventor when he

subjective intent word, Corp., is of little or no 242 F.3d term LLC v. Centraal particular used a (Fed. determining 1352, 1076, the weight 1347, USPQ2d probative 58 1079 in the (except Cir.2001) as documented of a claim (“Although specification the need history).... focus is on [T]he present every permu embodiment ordinary one of objective test what the and the claims are tation the invention at the time of the invention the art skill in preferred not limited to the embodiment understood the term to have would invention, neither do the claims en the mean.”) (citations omitted), 517 U.S. large patented beyond aff'd what is what the 1384, 577, 38 134 L.Ed.2d 116 S.Ct. invention.”) inventor has described as the (1996). Any ambiguity, as USPQ2d 1461 (citations omitted); Sys., SciMed cf. Life arises, dispute when re may be raised Sys., v. Inc. Advanced Cardiovascular objec decisionmaker to focus quires the Inc., USPQ2d 242 F.3d 58 specification and tively on the (Fed.Cir.2001) (“Where 1059, 1062-63 the claims, the specification the basic for specification makes clear that the inven and the presentation by applicant, the feature, particular tion does not include a product final of a represent the to be outside the feature deemed imperfect process. Represen sometimes reach of the claims of the even enlarge cannot during prosecution tations though language the of the read specification, the of the content specification, to the without reference in relying on the district court was correct enough might be considered broad to en See, analyzing the claims. specification compass question.”) the feature in Mfg. Co. v. Kinkead Indus e.g., Slimfold We affirm the district court’s construc- 1113, 1116-17, tries, Inc., 1 810 F.2d 42, 66, 68, tion of of the (claims (Fed.Cir.1987) USPQ2d specifica the interpreted light Instruments, tion); Inc. v. Int’l Texas Infringement B. Comm’n, 1369, 1371-72, 6

Trade (invok (Fed.Cir.1988) USPQ2d On the district court’s correct claim con- ing principle the of the reverse doctrine of struction, summary judgment holding that “when the equivalents and infringement there is not literal necessari- broadly than claims are written more follows, ly and is affirmed. they may be con disclosure warrants” validity preserve strued “to of the granted also district court in respect original claims with to their Biogen’s summary motion judgment scope”). prin tended Implementing non-infringement under ciples, the court construed the district equivalents, pros the doctrine of based on claims to conform with the basis history estoppel. ecution The court found presentеd specifi invention was during prosecution cation. application, applicant had disclaimed the use of constructs. As we have correctly The district court ruled that observed, prose in the '843 defines invention as argued advantages cution single of a use of a DNA construct to intro- construct, in distinguishing duce the Axel refer *9 gene the linked human interferon and However, in prosecuting selectable into the host ence. the '567 Chi- cell, application pointed ovary nese hamster and that out the errone in understanding method and cell as well as the ous of the Axel reference

1141 explained and Festo issued soon after district court’s proseсution, the '843 decision, Corp. not relevant Festo v. Shoketsu Kinzoku aspect of Axel was Co., 558, Kogyo the '567 claims. Kabushiki 234 F.3d 56 patentability of (Fed.Cir.2000), USPQ2d 1865 and Berlex based estoppel arises Whether claim appeal conceded on this its applica in a related arguments made on by equivalency was defeated the Festo ab- circumstances, and is depends tion bar, leaving solute the issues unbriefed. Corp. v. of rote. See Read not a matter Upon Supreme vacatur of our Court’s 816, 824, Portec, Inc., USPQ2d 970 F.2d 23 bar, rejection decision absolute (Fed.Cir.1992) 1426, (“Every state 1433 Festo, 722, 1831, ‍​‌‌​‌‌‌​​​‌‌​‌‌‌‌​‌‌‌‌‌‌‌‌​​​‌‌​​​​‌‌‌​‌​‌‌‌‌‌​​‍122 535 U.S. S.Ct. 152 patentee during prosecu aby ment made 944, (2002), USPQ2d L.Ed.2d 62 1705 Ber- distinguish prior art reference tion to аrguments concerning equivalency lex’s estoppel. Ar separate not create a does court, may considered the district be context.”) guments must be viewed along any with relevant defenses. Thus appli prosecuting a related summary judgment we vacate the on this raising argu from new cant is not barred issue and remand for determination of correcting past or errors. When ments fringement of the '567 under the different claims seeking equivalents. doctrine of application, estoppel generally a divisional not arise from the does II Middleton, Inc. v. Minnesota

parent. See Co., Mining Manufacturing 311 F.3d THE '779 PATENT (Fed. 1138, USPQ2d 1141 The '779 is a continuation of Cir.2002) (considering meaning of word and claims the Chinese continuing “uniform” as used composition cell culture patents, limiting estoppel argu to the human the transformed cells wherein beta- art). ments needed to overcome interferon is secreted the concentration patentee, having Thus the '567 150,000-600,000 of medium. range of IU/ml linked prosecution argued that a 1 is the broadest claim is suit: Claim multiple un advantages construct has over composition A constructs, thereby estopped 1. CHO cell culture linked is not (a) cells transformed comprising that the CHO asserting from IFN-a, encoding human infringes equivalents. under the doctrine of with (b) thereof, com- Cambridge progeny medium Corp. Laitram v. Wire See Co., producеd by expression of USPQ2d prising IFN-a Cloth (Fed.Cir.1988) (inefficient DNA, composition di- in said said culture of said rectly resulting from secretion fringement may infringement). still be IFN-a from said CHO cells and wherein estoppel that no to asser- We conclude 150,000- the amount of said IFN-a is of the '567 claims arose equivalence tion of 600,000 of medium. IU/ml argument distinguishing the based on the The district court decided the issue Axel reference in construing the '779 infringement upon equivalency claims. The facts of were 150,000-600,000 who sum- claims to mean reviewed the district IU/ml activity after is the interferon obtained marily question decided the as matter is, superinduction,”2 “confluence and estoppel. This court’s en banc decision reach their maximum point at transformed CHO cells 2. "Confluence” is the *10 1142 Cir.1994), deliberately that process. The were

at the end of prosecution by final interferon con- composition’s expedite limited order to Biogen 1,200,000 Biogen avoiding regain centration exceeds examination cannot that IU/ml. product passes through stipulated that its infringement purposes. 150,000-600,000 range en route IU/ml claim in- On the district court’s correct The district its final concentration. to terpretation, summary judgment of it is irrelevant court held patent must non-infringement of the '779 passes through the Biogen composition question infringement affirmed. The be concentration, Biog- granted claimed doctrine of of the '779 under the summary judgment of non- en’s mоtion for adversely also decided to equivalents was infringement. Berlex the district is composition that a argues appealed. concentration of interferon has the claimed during production process any at time SUMMARY 1. The district court de- infringes claim affirm the district court’s claim con- We interpretation contrary as scribed Berlex’s patents. struction for the '567 and the '779 language, specification, to the claim summary judgment that there is not prosecution history. specifi- infringement patent, literal of the '567 reports cation the interferon concentration infringement no is af- completion experimental at the of several runs, summary judg- firmed. We vаcate the and describes these measurements non-infringement pat- ment of activity super- as the after confluence and recognized equivalents, The court that a ent under the doctrine of induction. composition higher activity normally will question. remand for determination of this moot, it range being Biogen’s traverse a lower while cross-appeal conditional 150,000-600,- produced, and described the and is dismissed. meaningless claim limitation as IU/ml party Each shall bear its costs. activity

unless it is directed to the PART, AFFIRMED IN VACATEDIN product. final PART, REMANDED; CROSS-AP- Berlex states the district PEAL DISMISSED interpretation court’s renders the subor superfluous, dinate claims violation of RADER, Judge, concurring-in- Circuit differentiation, оf claim doctrine and part. arguments support pro offers other to its I agree my colleagues with the out-

posed example, view of the claims. For decision, I although come of this reach that during prosecution wrote the slightly reasoning outcome with different activity examiner that limits were infringement on the issue expedite included the claims equivalents. under the doctrine of However, prosecution. per we are not Summary Berlex added a new suaded of error the district court’s inter Genentech, pretation original pat- of the claims. As in the Invention section to its Ltd., Inc. v. WellcomeFoundation ent as a continuation-in-part, (Fed. USPQ2d ultimately issuеd as the '843 density "Superin- chemically produce on the culture medium. stimulated to interferon. duction” means that those have cells been *11 all, patents later filed a divisional claims. After both claim the a continuation of continuation-in-part, subject Moreover, same matter. a broad patent. as the '567 At issue which issued reading patent of the '567 claims would are the 80 new claims Berlex added to this prohibition run afoul of against intro- patent application in a 1992 continuation duction of new matter in amended claims. amendment, preliminary and an additional The claims at issue were added between during prosecution 39 new claims added years ten аnd filing twelve after the date through- 1994. The examiner made clear priority application. the 1982 The dis- pendency patent appli- '567 out the trict correctly court determined that newly cation that added claims were specification does support interpre- not patentably not distinct from the claims tation of these new claims that encom- patent. that issued the '843 passes multiple In constructs. the final analysis, the '843 and patents simply that arguments This court reasons made cannot concurrently “patentably recite prosecution patent of the '843 “do distinguishable” substantively claims of automatically apply not to different claims Therefore, scope. different on remand for separate application.” Opinion at 12. assessment Supreme of the Court’s Festo abstract, Here, however, I agree. factors, I would have the district court the record indicates that the '567 claims fully arguments consider pat- made patentably previ- are not distinct from the entee in the patent ously pat- issued '843 claims. These two infringement by determine the issue of ents, evidence, according to record claim equivalents. subject the same matter. Members

public reading the file histories of these patents

two not a difference would discern between these '567 claims and the nor do I. To extend the '567 claims to ens- II, Southpac PRIMA TEK L.L.C. multiple nare unlinked constructs under International, Inc., Trust as Trustee equivalents, the doctrine of the fact finder Family Trust dated U/T/A disregard patentee’s must comments 12/8/95,Plaintiffs-Appellants, distinguish made to linked con- v. patentably indistinguishable struct of the POLYPAP, S.A.R.L., Philippe Charrin, claims from the art. Charrin, and Andre Berlex, ‍​‌‌​‌‌‌​​​‌‌​‌‌‌‌​‌‌‌‌‌‌‌‌​​​‌‌​​​​‌‌‌​‌​‌‌‌‌‌​​‍Defendants- having surrendered con- Appellees. patent prosecution, structs can- recapture by filing such constructs No. 02-1164. patentably indistinguishable claims in a re- Appeals, United States Court of lated Because the claims Federal Circuit. patents patentably '567 and '843 indis- tinguishable, history of the DECIDED: Feb. 2003. parent application may apply well to its En Rehearing Rehearing Banc progeny. Denied: March 2003. reason, suggest For this I write to estoppel distinguishing the '843 claims may

from the Axel reference well affect equivalence calculus for

Case Details

Case Name: Biogen, Inc., Plaintiff-Cross v. Berlex Laboratories, Inc., and Schering Ag
Court Name: Court of Appeals for the Federal Circuit
Date Published: Jan 31, 2003
Citation: 318 F.3d 1132
Docket Number: 01-1058, 01-1059
Court Abbreviation: Fed. Cir.
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