Integra Lifesciences I, Ltd. v. Merck KGaA

I, LTD. LIFESCIENCES INTEGRA Institute, Burnham Appellants,

Plaintiffs-Cross Inc., Plaintiff, Pharmaceuticals,

Telios Defendant-Appellant, KGaA,

MERCK and Dr. Institute Scripps Research Cheresh, Defendants.

David A. 2002-1052, 2002-1065.

Nos. Appeals,

United States Circuit.

Federal

July

Henderson, Farabow, Dunner, Garrett & L.L.P., Washington, of DC. Flores,

Mauricio A. Campbell & Flores LLP, CA, Diego, of San plaintiffs-cross appellants Integra I, LifeSciences Ltd. and The Burnham Institute. With him on the brief was David M. Beckwith. Of counsel on the brief were Raphael Lupo, V. Mark Davis, Blinkova, G. V. Natalia McDer- mott, Will & of Emery, Washington, DC.

Of counsel was Donna M. Tanguay. Morron, Kelly L. LLP, Schiff Hardin of York, NY, New for amicus curiae Associa- tion of City the Bar of the of New York. Of counsel on the brief Miller, was E. Charles Shapiro Dickstein LLP, Morin & Oshinsky York, of New NY.

Edward Pennington, A. Swidler Berlin LLP, Washington, DC, for amicus curi- ae Bavarian Nordic With him on the A/S. brief was Robert C. Bertin. Of counsel Westerlund, was Li Director of Intellectual Property, Kvistgárd, Denmark. Sarnoff, Joshua D. Glushko-Samuelson Clinic, Intellectual Property Law of Wash- ington, DC, for amici curiae Consumer Project on Electronic Technology, Frontier Foundation, and Knowledge. Public Boudreaux, William R. Lilly Eli Company, Indiana, Indianapolis, Lilly amicus curiae Eli Company. & With him on the brief Mark J. Stewart. Eccleston, Lynn E. The Eccleston Law Firm, DC, Washington, for amicus curi- Dunner, Donald R. Finnegan, Bar ae Association of the District of Co- Henderson, Farabow, Dunner, & Garrett lumbia. himWith on the brief was Susan L.L.P., DC, Washington, for defendant- Dadio, M. PC, Buchanan Ingersoll of Alex- appellant Merck KGaA. With him on the andria, YA. Jenkins, H. brief Thomas David A. Manspeizer, and Rachel H. Townsend. Of Lawrence, III, Stanton T. Arnold & on counsel the brief were M. Patricia Porter, DC, of Washington, for amicus cu- Thayer, Heller Ehrman White & McAu- Wyeth. riae With him the brief were liffe, LLP, Francisco, CA; of San Zegger Paul J. Wagner. and Todd A.

William Rooklidge, Howrey C. Ar- Simon White, LLP, Irvine, NEWMAN, & RADER, nold Before CA. Of Lim, PROST, counsel was Esther Finnegan, H. Circuit Judges. is a factor vessels blood of undesired by filed Circuit court for the

Opinion can- diseases, solid tumor including Dissenting-in-part several NEWMAN. Judge rheumatoid cers, retinopathy, and filed Circuit diabetic opinion concurring-in-part Cheresh, in the course Dr. arthritis. Judge RADER. antibodies, had using monoclonal research NEWMAN, Judge. Circuit by is affected angiogenesis discovered by upon vacatur to us This case returns re- integrin cell surface blocking the ct^ judgment of of the cells, thereby de- on endothelial ceptors of 35 statutory construction the Court’s Dr. In 1994 cells of blood. priving 271(e)(1).1 further § We received U.S.C. peptide cyclic a RGD evaluated Cheresh and now reverse argument, briefing and Merck, found by and provided that was infringe- judgment of the district court’s inhibiting angiogen- in effective that it was ment. into Scripps entered and then esis. Merck directed to agreement sponsorship a BACKGROUND years, three within goal progressing, prior opinions, made to the is Reference subjects. Clini- with human clinical trials case, history of this discus- see n. approval of require prior trials cal science, and the issues and sion Administration, which Drug Food and stages of the at earlier arguments raised of an In- through the mechanism obtained suit, owned The five litigation. (IND) application Drug New vestigational re- Corporation, by Integra Sciences Life Regulations. in accordance with contain the peptides late to certain with the collaboration During acids, viz. the of amino sequence RGD con- Scripps at and others Dr. Cheresh (R), gly- arginine contiguous sequence charged ducted the here (D) (G), acid within aspartic and cine proceeded As the infringement. work The inventions chain. efficacy, mechanism they studied demonstrating various as are described action, pharmacology, pharmacokinetics, pep- the extracellular interactions with cell structurally related three safety and matrix, ways promoting including tide duly se- The peptides. RGD collaborators attachment, attachment, blocking cell cell EMD 121974 peptide designated lected the The validi- cell attachment. disrupting and develop- properties for having optimum as was sustained ty Integra patents National Can- In October 1998 the ment. claim, here trial but for one clinical tri- agreed sponsor cer Institute issue. 121974. als for EMD litigation, preceding In activities Merck, Scripps, Integra sued In 1996 (a company) German Merck KGaA infringement of one and Dr. Cheresh were collabo- Scripps Research Institute Integra patents, report- five more related to studies rating in research In the dis- edly negotiations. failed after Scripps and others at Dr. David Cheresh were principal defenses trict two an- court inhibition of conducting on the first, early scientific presented: growth giogenesis.2 development KGaA, I, I, Ltd., Integra v. Merck Ltd. 1. Merck KGaA Lifesciences Lifesciences 26, 2001). (S.D.Cal. 96-CV-1307 Mar. 162 L.Ed.2d 545 U.S. I, (2005), vacating Integra Lifesciences development “the Angiogenesis is defined (Fed.Cir. KGaA, 331 F.3d Ltd. v. Merck Heritage of the blood vessels.” The American affirmed, 2003). had oth Circuit Federal (Houghton Dictionary Medical Stedman's judgment damages, the than the er amount 1995). Co. Mifflin Scripps studies at peptides are “FDA” Exemption. prevail To on this subject patent infringement, based defense, Merck prove must by prepon- on the law exemption; common derance of the evidence that it would be second, that the ensuing studies were objectively reasonable for a party in conducted of drug develop- furtherance Merck’s and Scripps’ situation to believe trials, projected ment and the clinical there was a prospect decent exempt are from infringement under the the accused contribute, activities would (or harbor”) FDA Exemption “safe estab- relatively directly, to the generation of 271(e)(1): lished 35 U.S.C. the kinds of information that likely 271(e)(1). 35 U.S.C. It shall not be to be relevant in processes by which an act infringement make, use, of to the FDA would decide whether ap- to sell, offer to or within sell the United prove product the in question. import States or into the United States Each of the accused activities must be a patented ... solely invention for uses evaluated separately determine reasonably related to the development whether the exemption applies. and submission of information under a Merck does not need to show that the Federal law which regulates the manu- information gathered from particular facture, use, or drugs sale of or veteri- activity was actually submitted to the nary biological products. FDA. defense, As to the first the district court assigned Neither side error this instruc- ruled that all but one of experiments the tion, although objected Merck to the ver- by conducted Dr. Cheresh before dict form grouped which the accused activ- is, initial his of angiogenesis studies any ities such that if experiment one were by inhibition cyclic the first found not entitled to the FDA Exemption, provided by Merck (designated EMD infringement by could be found jury. the 66203), were of the nature of basic scienti- Although parties the continue to argue fic research and within the common law about this aspect, it is by mooted the exemption. appeal No was taken rulings Court’s and our conclusion in light ruling, from this early and these experi- thereof. ments are not subject included the mat- charged ter with infringement. At Although the trial both presented expert sides in the district court Scripps had argued testimony concerning the FDA Exemption, that at least some of the ensuing argued fact, studies theory, and application of were also shielded infringement by 271(e)(1). from Integra’s position was that the common exemption, law research FDA Exemption the apply did not argument was not presented appeal on to Scripps experiments toor most of them. Court, the Federal Circuit or the of experiments Some the were with RGD and is not at issue. peptides subject the an of defense, application,

As to the second IND and Integra presented the district opinion court submitted to the jury question testimony the most or of the challenged whether the pro- activities were could not be the basis of an by tected the FDA Exemption. The court application IND because work did not jury instructed the as follows: Laboratory conform to the Good Practices protocols FDA, Merck and in all contends that it does not in- events fringe or induce the that the FDA infringement Exemption stage at the IND patents-in-suit, applies only based upon safety to studies admin- Food and Drug Administration subjects istration to human and thus did IND an approval experi- majority of the include in accor- out must be carried the studies properties ments, concerned which Laboratory Practices safety of the the Good not the dance with action but mode of FDA, by the inhibitor. protocols established angiogenesis candidate must be so con- Exemption were not Scripps experiments that the FDA argued court, construed, observing vari- explaining narrowly The district ducted. generic is to shield testimony presented purpose ous conflicts infringement patent drug producers it deferred to stated that parties, the mar- to enter they preparing while A jury. split findings credibility on estab- expiration affirmed, ket Circuit of the Federal panel removed purpose quite products lished sponsored Scripps “the work holding —a Merck for which from the activities supply testing by Merck was not clinical seeking to invoke now Scripps were FDA, only general but information to Exemption. phar- identify new research to biomedical Integra, 331 F.3d compounds.” contrary maceutical presented Scripps

Merck They aspects. these to all of at 866. position as testified, that their argued, and witnesses to the presentation In its 271(e)(1) of safe- to studies § is not limited informa- Court, that the Integra conceded subjects, and that informa- human

ty for applica- in the IND tion that was included pharma- efficacy, pharmacology, tion about using the selected for clinical trials tion cokinetics, of action and mechanism the was within EMD 121974 the IND properly included in the Court stated Exemption. FDA Thus Exemption. FDA subject the and thus to question as follows: Exemption includes They argued that the whether presents question case This all of the conducted with all of the studies preclinical in uses of inventions or not whether peptides, candidate RGD research, which are the results of ultimately compound particular ultimately in a submission included human trials with proposed for clinical Drug Administration the Food and that kinds of subjects. They state (FDA), infringement exempted from were selected Scripps conducted studies at 271(e)(1). § by 35 U.S.C. and oth- in with FDA officials consultation Merck, 195, 125 S.Ct. 2372. 545 U.S. advisors, comply designed er were than had question narrower This was a appli- IND requirements for the with and the litigated in the district court been cation. Circuit, to the was limited Federal infringement. The dis- jury The found using experiments infringement status of verdict, court, de- sustaining trict were selected peptides the RGD that as “in- the challenged scribed trials, using studies for clinical the FDA sufficiently qualify” for direct to that not included EMD 121974 to In- specifically Exemption, and referred IND application. testimony purpose that the tegra’s expert’s statute, Court, analyzing the ex- of clinical trials requiring FDA approval 271(e)(1) “exempted § plained that safety experimental of an to assure the patented com- infringement uses subjects; to human drug for administration ‘reasonably process to the pounds related’ many the court observed for submission” developing information to hu- experiments were unrelated Scripps FDA. 545 U.S. to the The district court safety man evaluations. original). in (emphasis testimony that expert S.Ct. also referred to the explained “reasonably Court related” the RGD peptide blocks the cell surface includes uses research are conduct- receptors, and the recognition of “par- the biological ed after mechanism and ticular physiological effect” of angiogenesis physiological effect of a candidate drug Integra inhibition. summarized in its brief recognized, have been such that if the re- “[by April Dr. 1994] it appropriately search is successful would Cheresh demonstrated that blocking cu, in a be included submission to the FDA: p3 receptor would inhibit angiogenesis in At a drugmaker least where has a rea- tumors, depriving them of the supply blood sonable that a believing patent- basis for they grow,” need to Brief at meeting work, compound may through par- ed recognition Court’s criteria of of bio- ticular biological process, produce logical physiological properties. effect, particular physiological and uses points Merck out that property of an- that, compound if suc- giogenesis inhibition blocking a specific cessful, appropriate would be in a sub- receptor was known to it and to Scripps FDA, mission to the that use is “reason- before experiment the first charged that is ably related” to the “development and infringement, citing a letter from Dr. submission of information ... under Cheresh to Merck dated June 271(e)(1). Federal law.” Integra dispute indeed, did not point; 207, 125 Id. at S.Ct. 2372. it Court, stressed to the as discussed su- Court, Before the Integra had stressed pra, by April 1994 Dr. Cheresh had was never intended as a demonstrated angiogenesis inhibition broad investigators authorization to to in- tumors, Integra citing publi- a Cheresh others, fringe and that the journal cation in the Science. strictly statute should be construed. On does not dispute on this remand that the this remand Integra repeats argu- accused experiments produced information ment, observing that a significant amount relevant efficacy, action, mechanism of of the accused experimental work was with pharmacology, or pharmacokinetics. peptides ultimately that were not trials; The Court observed Integra selected for clinical that the FDA Ex- argues that experiments emption these constitute is infringe- not directed to basic scientific ment even on the Court’s construction of development unrelated to of a 271(e)(1). § Merck responds particular drug: Court’s consistent view has been that Basic particular scientific research on a construction, warrants a liberal compound, performed without the intent and that the explicitly Court now held that to develop particular drug or a reason- the FDA Exemption is not limited to ex- able belief that compound will cause periments whose actually results are sub- the sort of physiological effect the re- FDA, mitted to the or compounds induce, surely searcher intends to not ultimately are selected for clinical authori- “reasonably to the development related zation. Merck states that and submission of information” to the statutory interpretation Court’s FDA. experiments here at permits only issue one conclusion, requires judgment of non- 205-06, However, Id. at 125 S.Ct. 2372. infringement aas matter of law. thereby the Court did not remove from the scope

All of the of the FDA Exemption experi- work here at issue was done after the initial recognition Scripps actually of ments are not submitted to “particular biological process” whereby the FDA. The Court stated: in the to the FDA however, for this, ate submission from follow

It does in- 271(e)(l)’s process. from exemption regulatory either excludes categorically fringement (emphasis S.Ct. 2372 Id. at are (1) drugs that on experimentation original). subject of an ultimately the (2) com- use of or submission DISCUSSION ulti- are not experiments pounds in I FDA. mately submitted The Court 206, 125 S.Ct. 2372. Id. at remand is to focus of this that, late even at reality “the remarked on interpretation statutory the Court’s apply drug, a new development of in the stages this case. to the facts of rulings of law trial and process testing is scientific re to the issues significance particular Of id., error,” stating that: ruling is the Court’s resolution quiring 271(e)(l)’s construed, § safe Properly experi Exemption includes that the FDA space experi- for adequate harbor leaves are not ulti products mentation on the road to and failure on mentation submission, subject of an FDA mately the regulatory approval.... pro biological particular provided that thus 2372. The Court Id. at had been effect physiological cess statutory interpre- matter of rejected, aas reasonably work identified and the Scripps that the tation, position Integra’s inclusion in appropriate related to that not included that were experiments application. an IND experiments such application, IND in- charged with All of the super- that were peptides with the RGD pur- conducted for the fringement were excluded from ceded EMD candi- optimum determining poses Exemption: the FDA proceeding angiogenesis inhibitor date in the statute no simply room There is the select- development of with commercial certain information excluding regulatory compliance ed candidate phase the basis of the exemption structural- initially using three procedures, developed it in which of research argues ly peptides. related RGD in which it submission particular the on the two RGD Scripps’ experiments that could be included. than EMD 121974 are peptides other held 202,125 Id. at S.Ct. the Exemption FDA because within the that the to believe that if it reasonable was subject of an were not the peptides other may work in the study compound under negated is position This application. IND experiments will and that the intended use compound that for a holding the Court’s that are of information produce types the a basis for there was reasonable for which IND, Exemp- FDA then the relevant to an the desired believing may it have that are appropriate that applies tion to studies that “if suc- property, research biological at 125 S.Ct. 2372. Id. for submission. FDA sub- appropriate would be cessful The Court summarized: Exemption. the FDA mission” within 271(e)(l)’s infringe- exemption from § S.Ct. 2372. at 125 U.S. patented of uses ment extends in the con- holding placed The Court reasonably related to are inventions that inves- of text of the uncertainties scientific any of development the submission tigation: This under the FDCA.... information cases, neither the majority of In the vast of studies necessarily preclinical includes have nor its scientists drugmaker appropri- patented compounds that way knowing whether an initially preclinical studies of a drug’s efficacy in promising prove candidate will success- achieving particular results. battery ful over a experiments. That Merck, 203-04, U.S. 125 S.Ct. 2372. they is the experi- reason conduct The Court 312.23(a), cited C.F.R. ments .... One can not know at the states, which alia, inter that an IND particular outset that a compound will should include information about the ratio- subject be the of an application eventual structure, nale for the drug, its its toxicolo- to the FDA. gy, action, its mode of its effectiveness 206,125

Id. at S.Ct. 2372. conditions, under different effects, its side formulation, its administration, its explained The Court like Integra’s information. position criterion of experimental whether the the trial in safety is “almost vestigation of a is rea concern compound FDA,” sonably Tr. at related to the development efficacy of in is not formation considered at stage. for submission the IND Integ- to the FDA is told established at ra experiment, jury the time of the embryo chicken studies, depend and does not which subject on were the many the success or failure of the experimentation challenged experiments, or actual are not rele- submission vant experimental to human safety results. and thus are not Thus compounds eligible studies of that are of the FDA Exemp- ultimately proposed for tion. clinical trials are The Court held that position within Exemption, the FDA when incorrect there in law. FDA regulation 21 was a 312.23(a)(8)(i) reasonable basis for identifying the C.F.R. states an IND compounds working particu through must include biological lar produce process particu adequate pharmaco- information about physiological lar effect. On the Court’s logical and toxicological studies of the statutory interpretation, Exemp drug involving laboratory animals or in applies tion conducted to vitro, [including pharmacological the] ef- optimum determine the drug, candidate mechanism(s) fects and action including experiments rejected candi animals, information dates. Applying this understanding of the absorption, distribution, metabolism, and statute, the Scripps experiments with the excretion of if drug, known. compounds that were not taken to presses now argument clinical trials did not become infringing if even its position witness’ point on this when EMD 121974 was selected as the inaccurate, jury verdict must be IND candidate. jury sustained because the could have be- rejected also Integra’s Court testimony lieved his and disbelieved the position that FDA the Exemption, the conflicting testimony presented by Merck. application IND stage, applies only to ex Integra argues that to the extent that periments to show conducted that the can conflicting evidence was jury, before the drug safely didate can be administered to jury the could have found that human human subjects in clinical trials: safety data are relevant to authoriza- FDA

To contrary, the the FDA requires trials, tion of clinical and that the other applicants include in an IND experiments summaries infringing. Integ- Thus of the pharmacological, toxicological, argues jury ra the verdict must be pharmacokinetic, and qualities sustained, biological is not disputed it that most of the in including] animals ... Scripps experiments were directed can protocol laboratory practices” “good rele- other than obtaining information to FDA, However, thereby exclud- an the when to safety. be submitted to human vant 271(e)(1); law is Scripps statement studies ing witness’ the expert be the law cannot incorrect, in- that view not experiments ground See the verdict. support to upon relied subject to in an IND are not cluded Brown & William- Group Ltd. Brooke 271(e)(1), whereby the §of safe harbor 209, 242, 113 Corp., 509 U.S. Tobacco son pep- using other experiments Scripps (“When (1993) 125 L.Ed.2d S.Ct. However, the infringing. be tides would by suffi- supported not expert opinion an review the did not undertake eyes it to validate cient facts con- the correct experiments accused con- record facts law, indisputable or when 271(e)(1), Court observ- struction opinion render or tradict otherwise done yet been this had not ing that jury’s support a unreasonable, cannot it process. through appellate the standard verdict.”) infringe- verdict jury’s presented on the issues review We thus on the incorrect cannot sustained ment be law. the correct application with appeal, related only experiments position FDA subject to safety in humans II stage. at the IND Exemption here experiments that the states Merck Integra’s argu- rejected The Court also designed in consultation challenged were apply Exemption can ment that the experi- consultants FDA or with with the “good that meet FDA’s only to studies The accused FDA submissions. enced in Citing protocols. laboratory practices” cat- into sixteen were divided con- background regulatory legislative and Merck, by Integra and agreed egories, curiae brief filed in the amicus tained with Merck’s statement as follows States, the Court observed the United reg- experiment parentheses: Laboratory purpose of the Practices the FDA’s Good studies preclinical apply “do ulations (cid:127) (efficacy); binding assay avp3 receptor action, efficacy, mechanism of drug’s aof (cid:127) chorioallantoic chick angiogenesis pharmacokinetics,” pharmacology, (CAM) (efficacy, mecha- assay membrane provide do regulations that “FDA action, pharmacokinetics); nism of not con- safety-related experiments even (cid:127) laboratory (efficacy and good compliance tests angio-matrigel ducted are not suitable practices regulations action); mechanism of IND.” U.S. submission an (cid:127) (efficacy); assay cell adhesion 204-05, Although Scripps (cid:127) mecha- assay (efficacy and chemotaxis meet laboratory did not that its conceded action); nism of posi- protocol, of this requirements contrary to (cid:127) trial assay at the presented embryo pharmacokinetics tion chick law. (pharmacokinetics); rejected the expressly Thus the Court (cid:127) sorting cell fluorescence-activated by the dis- mentioned legal grounds three (mechanism (FACS) action and analysis sustaining the reasons for trict court as its efficacy); purpose that the ground jury verdict: (cid:127) assay (phar- pharmacokinetics rabbit safety is to application of an IND establish macokinetics); humans, that such for administration (cid:127) im- combined growth severe tumor safety directed to human experiments not (SCID) (efficacy, mouse munodeficiency 271(e)(1); §of protection not have the do action, pharmacology); the mechanism that meet studies ground that (cid:127) (effi- growth tumor nude assay mouse and that all work that was not included in cacy, pharmacology, pharmacokinetics, and the IND is outside of the FDA action); mechanism of Exemption. Integra argues also that much of this work is properly viewed as (cid:127) mice assay (efficacy, retina vásculo “discovery-based research” and is not the mechanism, pharmacology, pharma- and “routine FDA-related work” that Integra cokinetics); states proper is the limit of (cid:127) assay (pharmacokinetics rabbit cornea even on the Court’s view of the statute. efficacy); and Integra particular takes issue with the an- (cid:127) mouse retina IF vasculogenesis assays giogenesis chick assay CAM and the tumor (pharmacokinetics); growth chick assay, CAM which total 93 of (cid:127) experiments rabbit arthritis (efficacy, the 180 experiments; accused Integra pharmacology, pharmacokinetics, safety experiments states that with chick em- action); and mechanism of bryos necessarily do not reliably or predict (cid:127) mice experiments (efficacy). arthritis safety efficacy in humans. Integra also argues that experiments using chicken em-. (cid:127) chick growth CAM tumor with mela- bryos relate to the threshold determina- (efficacy noma cells and mechanism of ac- tion of whether angiogenesis is affected tion). Suppl. Merck Br. at A. App. There drug, candidate and properly thus is dispute is no factual concerning these ex- viewed as basic science and is not insulated periments and the they pro- information 271(e)(1). §by duced. Court, responding to these same

Dr. Cherish supervised testified that he arguments, concluded that challenged the work in eleven of the categories, above experiments “were designed to evaluate and other witnesses testified as to the suitability of each of peptides categories. They other explained how the potential drug tests were candidates.... performed Accordingly, and the nature of the tests efficacy, the information measured the specificity, learned. Dr. Kessler of Scripps explained toxicity efficacy particular tests of peptides as inhibitors, were “to given angiogenesis test whether or not a drug and evaluated given could achieve a effect in an animal their mechanism of pharmacoki- action and pharmacokinetics ... po- see how the netics in animals.” 545 U.S. at tential would living sys- behave in a 198-99, 125 S.Ct. 2372. Integra’s expert tem, metabolized, how it’s how it’s excret- Dr. Dedhar testified that the chick CAM ed, ... we tried to design experiments experiments demonstrated “a substantial give would us insight some into mech- blockage amount of inhibition or of blood anisms as well.” Tr. at 1831-34. The growth vessel peptide,” with the RGD agreed witnesses that some of these tests experiments these demonstrated the provided also information relevant to hu- “by mechanism of action disrupting the man safety toxicity. Integra does not interaction of endothelial cells with the dispute that these yielded extracellular matrix.” Tr. at 910-937. In- information concerning efficacy, pharma- tegra’s expert Meyer Mr. testified that the cology, pharmacokinetics, and mechanism chicken assays CAM were relevant of action. “physical, chemical biological charac- teristics” of the- argues, drug. as it at trial candidate Tr. at did Supreme Court, before the S8469. Although Integra that all of this continues to ar- except gue work safety safety related to in hu- sole concern of the mans is outside of the FDA Exemption, FDA Exemption, the Court resolved

1344 the ex- of or relevance the reasonableness of the recognized breadth and question, determining of purposes the and to experiments periments in these obtained data inhibitor angiogenesis of the approval. FDA the properties to their relevance about argument in its Even candidates. not discuss of did The Court Practices, Integra pre- Laboratory Good not that “it will but observed experiments, used procedures criticism of no sented out to setting parties clear to always be and its rele- obtained the information or product their new for approval FDA seek Integra’s ar- drug development. to vance information, and kinds of exactly which quality of to the not directed gument was to win it will take quantities, what in- validity of the experiments or Merck, at 545 U.S. approval.” agency’s adduced, absence Intermedics, but to the formation (quoting pep- to all RGD as three Ventritex, Inc., F.Supp. FDA certification Inc. by the Court was ruled (N.D.Cal.1991), aspect 991 F.2d This aff'd, tides. (Fed.Cir.1993)). presented Exemption. the FDA evidence defeat to why and to how as trial extensive was the conclu- raised to challenge No was performed. experiments all of these Dr. experts by Merck’s presented sions testified Dr. Cheresh For example, Huston, Armitage, and Mr. Bynum, Dr. testing the Scripps focused after 1995 FDA to were relevant that all of tests con a diseased peptide on candidate RGD that would to the candidate as submission animals, developing including dition trials, for clinical optimal as be selected human in which embryos, mice chicken action, mechanism of showing the tests induced, rab and had been growth tumor pharmacokinetics, efficacy, pharmacology, induced, in had been arthritis bits in which meeting for safety, appropriate the candi to effect order ascertain in- and for requirements regulatory FDA diseased condi on the date RGD To application. in an clusion IND tion. there was cross-examination extent other testimony from several was There general it was directed these witnesses example, Dr. For Scripps scientists. Dr. issues; Integra asked example, for Brooks, the chicken CAM conducted who about effi- cares Bynum whether the exper- and some the mouse (his was stage answer cacy at the IND iments, data related explained “yes”). action, pharmacolo- efficacy, mechanism relation- about the testified Witnesses Dr. Friedlan- pharmacokinetics. gy, and Scripps done the work ship between test to the effect of the as der testified Merck, Integra argued by that done proliferated blood vessels peptide on ultimately re- Scripps was not that since retina; as Storgard Dr. in mouse IND, only work filing the sponsible vessels blood proliferated effect on can claim by Scripps, done Each witness joints of rabbits. mice 271(e)(1). However, harbor the safe results, protocols, review was asked to appli- IND much of the argument experiments, of the accused purposes by Merck was done preparation cation that all and each witness testified of the Germany is irrelevant status in- obtaining related to experiments were charged with is here work that Scripps of ac- efficacy, mechanism formation about infringement. None evidence tion, pharmacokinetics, pharmacology, or the grounds, challenged on scientific In- thereof. combination safety, or some untrue. or testimony being incorrect con- challenge the scientific tegra did not all of the Instead, argues that or experiments, purposes duct

1345 expert law, Merck/Scripps employee and wit- ment as a matter of such that ‘the disqualified and nesses should be their tes- inquiry same’,” under each is citing timony ignored for purposes review of Inc., Anderson v. Liberty Lobby, 477 U.S. verdict, jury they were because “inter- 242, 250-251, 2505, 106 S.Ct. 91 L.Ed.2d Integra jury ested.” states could (1986). 202 Thus the pointed out testimony pre- have disbelieved the entire that “the court must draw all reasonable sented on behalf of Merck and Scripps, inferences in favor of the nonmoving party, and that the of appellate rules review re- may and it not credibility make determina- only quire favoring jury evidence evidence,” Reeves, tions or weigh the 530 considered, verdict be and all else must be 150, 2097, at U.S. 120 S.Ct. but cautioning disregarded. Integra cites Reeves v. “although the court should review the Products, Inc., Sanderson Plumbing 530 whole, record as a it disregard must 133, 151, 2097, U.S. 120 S.Ct. 147 L.Ed.2d evidence moving favorable party (2000), court, proposition 105 for the that a jury required not to believe. verdict, reviewing jury required See 9A A. Wright Charles & Arthur R. disregard under Federal Rule 50 to “all Miller, Federal Practice Procedure moving party evidence favorable to the (2d ed.1995). 2529, p. is, That jury believe,” that the required court should give credence to the evidence Sartor Arkansas Natural Gas favoring the nonmovant as well as that 620, 627-28, Corp., 321 U.S. 64 S.Ct. ‘evidence supporting the moving party that (1944), L.Ed. 967 to the effect that is uncontradicted and unimpeached’.” Id. when a witness is interested this creates a (citations omitted). credibility jury. determination for the In- tegra testimony states when the of all criteria, Applying these there was no of the witnesses on behalf Merck is evidence at trial in conflict with the evi- disregarded inadequate remaining there is dence that all of the experiments here at support ruling, “safe harbor” even on issue were conducted after it had been construction, statutory the Court’s discovered that a RGD shrank tu- jury therefore that verdict must be model; indeed, mors in an animal Integra sustained. so conceded to the primary Court. The jury The rule that a verdict is re Integra argument on this remand is that support by viewed for “substantial evi the FDA is in safety interested data dence” does not mean that reviewing the IND stage; although court ignore must the evidence does that argument was unambiguously dis- Reeves, support the verdict. See 530 posed trial, At jury Court. (“in 150-51, U.S. 120 S.Ct. 2097 enter Court, remand, before the and on this taining a judgment motion for as a matter dispute does not that the accused law, the court should review all of the experiments yielded relating data to effica- record”). evidence in the The Court in cy, action, mechanism of pharmacology, or Reeves stated that analogous con “[i]n pharmacokinetics. At the trial the admis- summary text of judgment under Rule sibility of the scientific evidence and its we have stated that the court must review premises challenged. were not whole’,” the record ‘taken as a citing Mat Integra’s cross-examination of Dr. Cher- sushita Elec. Industrial v.Co. Zenith Ra work, esh was not directed to his scientific 574, 587, Corp., dio 475 U.S. but was limited to (1986), exploring familiarity 89 L.Ed.2d his and observed FDA procedures laboratory’s that “the standard granting summary his judgment judg- ‘mirrors’ the standard for lack of Laboratory Good Practices certifi- pre- was purpose experimental Dr. issue of states that Integra Although

cation. Court, de- the Court between the position, his sented to changed Cheresh trial, concerning whether the ef- and that “the measured position concluded tests scientific for basic experiments were these of the toxicology ficacy, specificity, approval, FDA obtaining for studies or Merck, 545 U.S. at particular peptides.” validity of to the not directed criticism was 198-99, 2372. 125 S.Ct. Dr. Friedlander obtained. the information trial, In- Reviewing proceedings understanding of challenged on his was jury was argument to the principal tegra’s certification, Laboratory Practices Good is directed to Exemption that Dr. Friedlan- that Integra also states safety for humans to demonstrate tests as to testimony was inconsistent der’s closing told in jury The clinical trials. assay experi- rabbit cornea of the purpose ' ap an IND considering that in argument experi- ments and mice-retina-vasculo point that is the over “[s]afety at plication However, no ex- Integra provides ments. concern, of the riding, almost the contrary testimony. no and cites planation Meyer] emphasized FDA.... And [Mr. of impeachment an cannot discern We safety is the again and over how over testi- indeed the extensive credibility, and thing....” Tr. 3496. paramount the ex- bases of mony as to the scientific such, not “Efficacy, as is jury was told: and the information performed periments by any challenged stage. Mechanism they was not considered at produced contrary action, witness. thing. The touchstone is same district court safety.” Tr. at 3505. credibili- only challenge to the

Integra’s to issue a correc request declined Merck’s “in- they were witnesses ty of the ef evidence to this tive instruction. The they employ- were either in that terested” incorrect, fect, by shown to be (a challenge to which experts paid ees or immune). jury verdict. See support As we have ob- cannot neither side is Co., 440, served, presented opposing no evi- Integra Marley 528 U.S. Weisgram (2000) charged with 1011, dence as 145 L.Ed.2d 958 S.Ct. . raised has infringement. Integra (“the to direct authority appeal courts sup- that could credibility considerations entry judgment as a matter law uncontradicted port ignoring extensive which, on excision extends to cases in its Merck states scientific evidence. admitted, erroneously there re testimony the rel- “Integra disputed brief never support mains insufficient evidence these experiments to of the accused evance verdict”). jury’s action, [efficacy, mechanism of topics four jury that the FDA Integra also told the pharmacokinetics], nor pharmacology, only after there has Exemption applies any of the ten so much as cross-examined product been a final selection subject. Integra Nor witnesses on the did trials, stating that proposed clinical to dis- present any affirmative evidence that, at least “Dr. said Cheresh himself currently be- pute experiment that each times, in the course of the four or five reasonably expected to fore the Court was trial, identify the they trying one of these yield evidence on at least They weren’t fo- drug best candidate. key ex- subjects. Integra’s Even scientific particu- for a approval on FDA data cused experi- that each of the pert conceded argument Tr. at This drug.” lar on how well ments revealed information Court, by the which disposed too was worked and what mechanism.” statute, stated, construing Remand at 14. does Merck Brief “ 271(e)(l)’s adequate leaves safe harbor challenge these When statements. space experimentation giogenesis. and failure on Although readily agrees Merck the road to regulatory approval.” that the scientists never lost interest in the 207, 125 545 U.S. at S.Ct. 2372. scientific understanding of their observa- tions, agrees that the experi- various Reviewing entirety record, ments enhanced that Reeves, understanding, 580 U.S. at negate does not the relevance applying judgment the criteria of of the stud- as a law, matter of ies to Liberty Lobby, development 477 regulatory U.S. and 251, 2505, in the compliance. absence of That experiments con- support substantial evidence to the verdict tributed to scientific knowledge does not infringement, judgment as a matter of deprive them of the safe-harbor benefit of law is rendered in of Merck. favor 271(e)(1) § requirements when the there- Abtox, for are met. See Inc. v. Exitron

Ill 122 Corp., 1019, (Fed.Cir.1997) F.3d 1030 Integra alternatively proposes that (as long as the activity is reasonably relat- each of Scripps experiments should be ed to obtaining FDA approval, a competi- “discovery” classified as either or “rou party’s tive or a patented invention’s “in- tine,” and that those de tent or alternative uses are irrelevant discovery, entirely routine, void of and can qualification its to invoke the section subject be Exemption. FDA How 271(e)(1) shield”); Inc. Amgen, v. Hoechst ever, in the Court’s explanation of the Roussel, Inc., Marion 104, 3 F.Supp.2d 271(e)(1), § criteria of the safe harbor does (D.Mass.1998) (the 107-08 safe un- harbor depend on a distinction between “dis § der 35 permits U.S.C. a range covery” “routine,” and but on whether the (such of activities as testing, animal clinical threshold biological physio property trials, or analysis), chemical even when a logical already effect had recognized been party may have “ulterior motives or alter- as to the candidate drug. The Court rec native purposes” “may be related to ognized that experiments are run in order than, FDA approval other [or] or in addi- information, to learn stage whatever the to, tion obtaining approval.”); FDA cf. Merck, 202, the research. 545 U.S. at 125 Turner Safley, 482 U.S. S.Ct. S.Ct. 2372. The variety experimental (1987) (a 96 L.Ed.2d 64 “reasonable activity may apply specific relationship” is one that is not arbitrary or biologic or physiologic investigation rein irrational). forces the fact-dependency inquiry. The Court parties agree held A Merck explained: witness “The transi peptides tions the RGD between were not used as a development research and transitions, flowing are often research tool.3 disposed and in pre-phase may it have development aspect been a with the statement: project officially.” but not (Testimony of Respondents argued have never Noll.) Dr. Gabriele RGD peptides were used at Scripps as case, tools,

In apparent all of research challenged experi- it from performed ments were discovery after the the record that were not.... they We cyclic that a inhibited an- need not—and do express a view not— libraries, 3. The National (such of Health Institutes defines DNA cloning clones and tools “research tools” as methods, "tools that scientists PCR), use laboratory equipment and lines, laboratory including cell mono- 72,090, Fed.Reg. machines.” 64 n. antibodies, models, reagents, clonal animal (Dec. 23, 1999). factors, growth chemistry combinatorial drugs. On development of new extent, ing whether, what about U.S.C. the law of 35 infringement 271(a)(1) exempts develop- jury could find 271(e)(1), tools’ no reasonable of ‘research the use regulatory .challenged experi- ment of information than other Exemption. process. ments are within infringe- judgment of court’s 7, 125 The district 205 n. S.Ct. 545 U.S. ment is reversed. colleague our position of Contrary to the ap- ruling and our dissent, Court’s REVERSED “large shadow” casts no thereof plication RADER, dissenting-in- Judge, tools.”' On Circuit subject of “research

on the court, emphati- concurring-in-part. parties part to this remand tools were cally confirmed over large shadow casts This decision See, Mauri- Letter from e.g., at issue. not overly expansive by its protection patent to the Flores, Integra, A. Counsel cio of the 35 interpretation U.S.C. 2006) (June 13, (“Integra agrees panel today this court particular, In exemption. appropriate not this is an that with Merck beyond the Su exemption the expands on the issue make new law in which to case provision to limits on the preme Court’s tools to research claims patent of whether in tool for research protection eliminate defined) (however may term be that stated “that Supreme Court ventions. of Section the ambit excluded 271(e)(l)’s infringement exemption from 271(e)(1). has ruled Supreme Court inventions patented of to all uses extends issue. not raise does case develop reasonably related to the that are outside the Su- Hence, its resolution any of information ment submission Integra has nev- mandate. preme Court’s Food, Drug and Cos under the [Federal contend, that not now does argued, er (FDCA) In Merck KGaA ].” metic Act belong to a class any its issue of claims Ltd,., 193, I, 545 U.S. tegr Lifesciences the reach of outside patent claims 162 L.Ed.2d There is no “dev- statutory exemption.”). (2005). Thus, covers activi exemption inven- research tool impact on astating that will ulti develop information ties that indeed, 5; the issue is not tions,” dissent FDA, pat mately be submitted inapt. the criticism present, and beyond the and tools processes ented Conclusion compounds” that “patented scope of the record, for the entirety of the On the the stat placed within discussed, was not there reasons have we case, of the In this two utory exemption. to sustain on which substantial evidence that deserve patents are tools application on jury verdict remand with court should protection. This The chal- statutory Court’s construction. court examine the district instructions that con- all of lenged experiments, which patents. tool these research protect anti-angiog- discovery of the ducted after even examine Sadly this court does not experimental property enesis n This in this case. patents at issue crite- peptide provided meet court, on claims as emphasis for its noted reasonably to research being ria of related ironically scope, does definers patent successful, that, appropriate would be if of these analyze claims not recite or FDA. This in a include submission Moreover this slightest. patents recognizes statutory both construction about in broad terms speaks court imple- process scientific nature of the specifying and results without encourag- legislative purpose ments patented compound or method compound may work, which ed through par- experiments. in use in the A careful ex- biological ticular process, to produce a patents amination of the shows two of particular effect, physiological and uses have no at all application them outside of a the compound that, in research if suc- laboratory. If in this case are cessful, would be appropriate to include tools, not research then of course this FDA, in a submission to the that use is quickly court could construe the claims ‘reasonably related’ to the [exemption they and show that claim drugs or other criteria]. products likely clearance, to undergo FDA Id. at (emphases S.Ct. 2372 add- simply laboratory methods. Unfortu- ed). In the sentences, next few the Court nately even a cursory analysis pat- reiterates repeatedly that its decision af- (undertaken dissent) ents shows fects “a compound in experi- two them have no out- ments are not themselves included laboratory. side the ” a ‘submission of information’ and “uncer- claims, Rather than usually construe the ” tainties” “selection a specific case, the first task in patent this court and “the use patented compounds in on a letter parties relies from one of the preclinical 207-208, studies.” Id. at that it explaining rely does not wish to added). S.Ct. 2372 (emphases Thus, the exception. the research tool This suppos- Supreme Court makes clear that its read- edly authoritative letter appeared after the ing exemption applies to the selec- argument oral before court in an at- perfection tion and patented com- tempt rectify to counsel’s unresponsive pounds preclinical in studies leading to performance. patents already With approval. FDA Supreme The Court expired, Integra may pursue strategy to not, however, addressing patented meth- protect its entire multi-million-dollar ver- processes ods or tools—that If Integra really dict. had not wished to —research measure, analyze, and assess the charac- rely patents, on research tool then it would teristics of those compounds during ex- place. have asserted them in the first event, any perimentation In patents development. because four are case, part of this this court has a responsi- words, In other the Supreme Court re- bility By to construe their treating claims. versed this earlier court’s decision that these research tools the drugs same as would not have exemption extended the to clearance, potentially needing FDA early experiments embrace to find a opinion poses danger court’s to the en- Supreme candidate. Instead the Court ex- industry. tire research tool tended the exemption up back the experi- mentation chain to par- include selection of I ticular species approval for FDA out of a Supreme After the Court “extended] patented genus. Supreme The Court did ... exemption] to all uses of patented [the not, however, exemption extend the to en- reasonably inventions that are related to any compass process method or or other process]”, explained [FDA clearance it might research tool that be used in a phar- that its decision “provides a wide berth for laboratory. maceutical the use in drugs activities re- point To drive this home with more than lated to the federal regulatory process.” repetition, Supreme Court an added). included (emphasis Id. Supreme The Court important footnote: explained: then further At least where a We therefore drugmaker has a rea- need not—and do not— believing whether, sonable basis for that a patent- express a view about or to to the submission “reasonably related” as exempts from extent, § what hand, the other On tools” FDA information. of “research use infringement are research patents for of 'information and '734 the '237 development lit- protection bear that deserve process. tools regulatory processes. FDA relationship to tle, any, if (emphasis 7, n. S.Ct. Id. at 205 added). simply did Supreme remand- have Although this court should tools, research address to even not intend analyze the court the district ed to tools valueless alone, research render let relationship to for their reasonable patents test only use—to their one submissions, a brief examination FDA com- candidate about information ascertain relationship the tenuous shows patents pounds. process- FDA of the research tools is to purpose primary exemption’s claim meth- '784 The '237 and es. perform manufacturers permit generic laboratory experiments, specific ods for FDA pipeline for drugs research on processes. subject to compounds the House Com According to approval. pure methods These inventive the ex provision, that initiated the mittee patent the '237 example, tools. For activi pre-market only deals emption claims: testing so amount ty “a limited cells detaching animal A method can establish manufacturers generic they are to which a substrate substitute.” generic of a bioequivalency mediated Arg-Gly-Asp an bound reprinted H.R.Rep. No. contacting said manner, comprising House Commit at 2692. The U.S.C.C.A.N containing with a solution cells bound the interfer “nature of tee noted that consist- non-naturally occurring peptide patent holder” rights of ence with amino acid se- essentially of the ing “substantial,” mini- “de but not be would Arg-Gly-Asp-Y, [wherein Y][sic] quence 2714. The Id. mus.” peptide that the any amino acid such is statutory exemption this extended activity. has cell-detachment reasonably relat activities to as well reach cells detaching animal A method for KGaA, 545 Merck function. ed to that they are to a substrate which 125 S.Ct.2372. atU.S. Arg-Gly-Asp" mediated in an bound manner, contacting said comprising II consisting peptide a cells with bound devastating impact Sadly this court’s sequence amino acid essentially of the really even is not tool inventions research X zero to wherein is X-Arg-Gly-Asp-Y opinion. As face of on the evident thirty and Y is one of thirty amino acids court, for its atten- noted, celebrated this acids, has that the amino such analyze does scope, patent tion to activity. promoting cell detachment passing a examination Even these claims. unmistakable con- 11.62-68, claims leaves the col. 1.16- Patent col. 10 '287 only apply patents added). that two The (emphases clusion claims col.12 1.5 any possi- laboratory methods without to for de- begin: “A method patent '237 the FDÁ. Two of bility of submission A from a substrate.” taching animal cells definition, would be under patents, grow- laboratory a medium for is substrate tools. research tissues, or organisms, ing maintaining instance, the spec- In as cell cultures. this ease patents this analysis of the An sustains the substrate explains, ification of the '525 and Merck’s shows that use and detached must attached cells that be exemption may fall within patents '997 terms, testing. simple ty In column.” Patent study Abstract. Puri- '73k encompass inventive method does not receptors operate laboratory fied cell in a body that enter the human any substances compounds determine that will bind to it and need FDA clearance. This invention (and may thus useful drugs). Many be as simply laboratory a method facil- instead pharmaceutical drugs by work binding to a itating study of cells on substrate. receptors on the surface of certain human specification The '237 further character- Therefore, cells. a laboratory needs meth- the invention as a method to facilitate izes study binding ods to process and to by controlling research the attachment or choose candidates. purified These detachment of cells on substrates. '237 cell do not receptors operate “patented Also, col.4,11.1-15. specification Patent compounds” approval themselves, for FDA points appli- out invention finds “[t]his but experimental targets rather as to test production cation of cell lines for for attachment characteristics. Pat- '73k (em- col.10 research.” '287 Patent 11.34-37 ent regulation col.l 11.56-58.The of cell added). section, phasis In the discussion growth by and differentiation selectively patent explains '237 use of the inven- manipulating the research environment tive method to control cell attachment ac- functions) (i.e., types, cell cell of the inven- time, rate, location, cording to or amount. tion advances the state of the art of re- Patent '237 col.9 11.53-54. laboratory search environment. As Thus, only operates method as a such, isolating this method of cell surface research, “patented tool for not a com- receptors only a tool to conduct research pound” approval. on biological systems. and chemical a mi- analogous patent method is on a patents only '234 and '734 claim croscope; microscope’s sole a use is as in laboratory settings. methods for use Clearly, patent tool for research. on an As tools, microscope innovative ren- patents pro- should be these deserve dered exemp- such, useless tection. I respectfully As dissent Similarly, patent only tion. the '237 has respect to the '237 and '734 one use—as research tool. and would remand back to the district portion court to determine what patent The '734 has one claim: damages judgment applies to the use of 1. A substantially purified cell surface protected these research tools. receptor mesenchymal derived from capable binding tissue and of to a properly This court also needs to ana- peptide containing the amino acid lyze patents the claims of the other two in sequence Arg-Gly-Asp, comprising First, patent genus this case. the '525 is a glycoprotein composed a of at least covering large compounds. a number two of about polypeptides 115 and Representative claim of the '525 patent kD, respectively, as determined reads: reducing SDS-PAGE under con- selectively substantially pure peptide ditions which 8. A includ- binds to vi- tronectin, but not to fibronectin. ing cell-attachment-promoting as the sequence constituent the amino acid Patent col.6 11.58-65. Similar to the '73k Ser, Arg-Gly-Arg-R Cys, wherein R is patent, patent puri- '237 the '734 covers a acid, Thr peptide or other amino said receptor. fied cell In the of the words having cell-attachmentpromoting activi- patent, patent the '734 “[a] method ty, being said a natural- isolating receptors utilizing cell surface a peptide sequence ly short occurring peptide. bound to an affini- represents This invention cov- research tool. patent As a 11.50-55. Patent col.8 '525 invita- patent is an a lifetime for its inventors the '525 the work of genus, a ering in a species budget the beneficial to find most of the research perhaps tion within the broad species A genus. broad department or university serve as a could patent of this genus of dol- millions company perhaps small — The selection of approval. requiring of the in investment. The use lars patented genus a species a suitable com- pharmaceutical invention tests other the Su- which the situation apparently fighting can- for effectiveness pounds placed within preme Court fight not itself The invention does cer. Thus, involving activities exemption. cancer, identifies the simply but instead exemption fall within the well patent could in other fighting characteristics cancer Indeed Supreme Court. by the as defined patented invention compounds. This finding. makes opinion this court’s would, course, great use to the be by a have made That should been finding industry. It would also pharmaceutical finding proce- fact proper district court by identifying cancer public benefit level, dures, appellate at the rather than course patent system treatments. may support invention at least the '525 but this invention and protect would wish to exemption. activities within finding a more investment give incentives for a new “contemplates patent The '997 kind of valuable research developing this alters the polypeptide a which composition, tool. activity of cells to various attachment cell the Su- Sadly today’s opinion misreads binding of its independent substrates This court reads preme Court’s decision. phagocytosis, affects cell collagen, broadly Supreme decision too Court’s essentially of an isolated consists which the exemption it includes within because X-Arg-Gly-Asp-Ser-Y tetrapeptide are obvi- patents, the '237 and '734 which or more amino acids X is H or one wherein in- This overbroad ously amino acids.” research tools. Y or one or more is OH patent col.2 11.21-27.This em- all value for terpretation '997 Patent could obliterate compound braces a medical method with above hypothetical invention discussed fact- group. Although some having RGD development and with it the incentives district court level would finding at the pharma- of these inventions outside understanding of this improve this court’s industry pharmaceuti- ceutical itself. invention, have a rea- apparently it could course, itself, industry cal still needs relationship processes. to FDA sonable develop- invest in their these tools will Thus, majority while I concur with ment, community, re- but outside that respect patents, to the '525 and '997 In other search tools will have no value. might wisely more remand these this court words, could shift all control of opinion prop- case to ascertain the and this facili- research and the tools that er Court’s stan- pharmaceutical tate research to the insular exemption. dards for the industry. independent Universities have to understand that researchers will Ill likely tools is to their work on research hypothetical example help A will illus- (but to a charitable nonde- amount protecting re- importance trate the ductible) gift pharmaceutical to the indus- rights. Suppose a uni- patent search tool try. versity professor independent or small or small com- university professor The and obtains a company research invents for the life- extremely pany might expect a reward patent for a novel and useful ion pro- proper protections of labor and investment for these time inventions. tool. The inventor duced the research particular, In protect these decisions re- might hope also to use that reward to search tool inventions when used for their pioneer further his research. These bene- intended purpose allowing experi- while and that public fits to the inventor would mentation improve to the tool itself. Jona- patent’s flow from the to exclude that right McPherson, than Impact produce royalties. would reasonable How- Hatchr-Waxman Act’s Harbor Provi- Safe ever, today’s opinion, exemption under sion on Biomedical Research Tools after would swallow lifetime of labor and I, Merck KGaA v. Integra Lifesciences investment the nature of the use because Ltd., 369, 10 Mich. St. J. Med. & Law 382- itself, any object without concern for the (2006). For example, Germany, invention, gauge would be the statutory research exemption patents upon exemption which the would be meas- origin finds its in Article 31 of the Commu- Majority Opinion, slip ured. op. See nity Patent paraphrase Convention.1 To effect, In hypotheti- use of the the law and a seminal case interpreting automatically cal invention would translate law, protection these tools obtain when non-infringement to based on this court’s used to conduct research as specified by expansive of 35 U.S.C. invention, fall experimen- but within an 271(e)(1). tal exemption when studied to learn their Supreme Court in Merck did not operation method of improve to their Instead, expect such broad result. (Clini- operation. See Klinische Versuche above, Supreme noted specifical- Court I), cal Supreme Trials Federal Court of ly “whether, did not address or to what 11, Germany, July 623; [1997] R.P.C. extent, exempts infringe- (Clinical II), Klinishe Versuche ment the use of ‘research tools’ in Trials development of regula- information for the Federal Germany, April Court of KGaA, tory process.” Merck U.S. 1998, [1998]R.P.C. 423. Thus,

205 n. upon S.Ct. 2372. re- I concur in the respect result with mand, responsibility this court has the to '525 respectfully and '997 dis- analyze carefully the apply claims and sent with respect to the '237 and '734 exemption protect “pat- the selection of patents with a recommendation to remand compounds” preclinical ented even in the analysis to the district court for further stage, while continuing protect tools. responsibility This court has the to view of the Supreme opinion. protect FDA processes and research tool

patents alike.

IV

Lastly, this court does not need ad-

dress these issues in a vacuum. Several opinions

noted from other courts of inter-

national distinction pro- show the value of

tecting research exempting tools while infringement.

some activities from These

decisions from other national courts exam-

ine research tools more detail and fash- Community patent

1. The Patent Convention influ- enees German law.

Case Details

Case Name: Integra Lifesciences I, Ltd. v. Merck KGaA

Court Name: Court of Appeals for the Federal Circuit

Date Published: Jul 27, 2007

Citation: 496 F.3d 1334

Docket Number: 2002-1052, 2002-1065

Court Abbreviation: Fed. Cir.