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Celsis In Vitro, Inc. v CellzDirect, Inc.

Case No. 2010-1547 (C.A. Fed., Jan. 9, 2012)

The United States District Court for the Northern District of Illinois granted Celsis In Vitro, Inc.’s (“Celsis”) motion for a preliminary injunction against CellzDirect, Inc. and Invitrogen Corporation, now Life Technologies Corporation (“LTC”). Based on the record, the district court did not abuse its discretion. This court affirms.

I.



Celsis is the assignee of U.S. Patent No. 7,604,929 (filed Apr. 21, 2005) (“the ’929 patent”), which claims methods for preparing multi-cryopreserved hepatocytes (a type of liver cell). Claims 1 and 10 of the ’929 patent are on appeal:

1. A method of producing a desired preparation of multi-cryopreserved hepatocytes, said hepa-tocytes, being capable of being frozen and thawed at least two times, and in which greater than 70% of the hepatocytes of said preparation are viable after the final thaw, said method comprising:

(A) subjecting hepatocytes that have been frozen and thawed to density gradient fractionation to separate viable hepatocytes from non-viable hepatocytes,

(B) recovering the separated viable hepato-cytes, and

(C) cryopreserving the recovered viable hepa-tocytes to thereby form said desired preparation of hepatocytes without requir-ing a density gradient step after thawing the hepatocytes for the second time, wherein the hepatocytes are not plated between the first and second cryopreservations, and wherein greater than 70% of the hepatocytes of said preparation are viable after the final thaw.


10. A method of investigating in vitro drug metabolism comprising incubating hepatocytes of a multi-cryopreserved hepatocyte preparation in the presence of a xenobiotic, and determining the metabolic fate of the xenobiotic, or the affect of the xenobiotic on the hepatocytes or on an enzyme or metabolic activity thereof, wherein the hepatocytes have been frozen and thawed at least two times, and wherein greater than 70% of the hepatocytes of said preparation are viable without requiring a density gradient step after thawing the hepa-tocytes for the second time, wherein the hepa-tocytes are not plated between the first and second cryopreservations.


’929 patent col.19 l.56 – col.20 l.19, ll.49-59 (emphasis added to the disputed claim terms).

The specification of the ’929 patent explains that human hepatocytes are a useful laboratory model for evaluating drug candidates. Two problems, however, have limited their use. First, hepatocytes have a short lifespan which causes an inconsistent and limited supply. Specifically, the only sources of fresh hepatocytes are liver resections or non-transplantable livers of multi-organ donors. Due to this reliance on liver donation, fresh hepatocytes become available at unpredictable times. Researchers must wait until a liver donation and must often resume or begin research with little advance warning. This unpredictability hinders laboratory studies, which usually require a consistent source of supplies. This supply problem also limits research geographically to the region near the liver donor.
 

 

Judge(s): Randall Rader
Jurisdiction: U.S. Court of Appeals, Federal Circuit
Related Categories: Civil Remedies , Competition , Patent
 
Circuit Court Judge(s)
Arthur Gajarsa
Sharon Prost
Randall Rader

 
Trial Court Judge(s)
Milton Shadur

 
Plaintiff Lawyer(s) Plaintiff Law Firm(s)
Adam Kelly Loeb & Loeb
Julie Langdon Loeb & Loeb
Jordan Sigale Loeb & Loeb

 
Defendant Lawyer(s) Defendant Law Firm(s)
David Mangum Parsons Behle & Latimer
Michael McCarthy, II Parsons Behle & Latimer
Kevin Speirs Parsons Behle & Latimer
Francis M. Wikstrom Parsons Behle & Latimer

 

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substantial question on that issue, which the majority here, the district court found that the ltc expert's synthelabo, 470 f.3d at 1382. to the injunction before the district court. cludes building the brand, expanding the customer base, the district court denied. after cryopreservation." greater than 70% of the hepatocytes of said __________________________ celsis in vitro v. cellzdirect11 ing performance of the "density gradient step" in step (c). district court recognized, the simple fact that one could, if 4053, dkt. no. 94 (sept. 7, 2010). inc. v. energy & envtl. int'l, l.c., 460 f.3d 1349, 1362-63 reparable harm absent a preliminary injunction. as the nothing more than a repetition of steps already known in thawing hepatocytes a second time and making the den- the hepatocytes for the second time, vii. gradient step. thus, performance of that step does not preclude a finding of infringement. for that reason, this preparation of hepatocytes without requiring a that the scope of the preliminary injunction is overbroad, does not create a gradient, the district court found celsis' or motivation in the de sousa article that multiple rounds expert dr. strom's testimony more persuasive. adam g. kelly, loeb & loeb, llp, of chicago, illinois defendants-appellants. ted)). i would thus vacate the district court's grant of a thus, preservation methods severely limit, or even pre- the '929 patent's validity, the preliminary injunction and glutathione transferase transcripts in cultured hepa- establish invalidity itself." amazon, 239 f.3d at 1359. see tegal corp. v. tokyo electron am., inc., 257 f.3d alleged understanding before the time of the invention, hood of success on the subject of infringement." hr'g tr. to obtain a more consistent supply, scientists sought importantly, it is unnecessary to prove a substantial hunkeler. the district court found dr. strom's testimony are allegedly not irreparable in such a market. ltc chose celsis in vitro v. cellzdirect7 moreover, the record shows that the district court prop- matter by anybody else."). accordingly, in this prelimi- infringer in this case. see id. though ltc argues that it advance conceived of by the inventor here." hr'g tr. 8:14- requires three steps: (1) thawing cryopreserved hepato- ond marathon. one would not expect the runner to cluded: "in sum, it is an understatement to say that celsis the art so long as there was a reasonable probability of is supposedly a two-competitor market and such harms this supply problem also limits research geographically to growth stage of a product, it is particularly crucial to be well as suffer the irreparable harms opined on by its percent viability of hepatocytes. this "invention" is a fringement. ltc errs in reading "without requiring" to as the patentee, celsis bears the burden of proving that able--an issue on which the district court was silent--this to rebut celsis' expert testimony. the district court found sandoz, inc., 544 f.3d 1341, 1362 (fed. cir. 2008); sanofi- tomers that it is the exclusive market leader. during the stantial likelihood of success on the issue." hr'g tr. 10:8- claimed invention could be obvious even if prior art did analysis was legally deficient, and it erroneously held based on the record before the district court, this the '929 patent intends to solve these problems while twice. see majority op. at 10-11. the majority cannot necessarily expended in the absence of a stay, are not v. ness, written description, and inequitable conduct. ltc do not knock on the door or to identify the specific persons tocytes from dogs, monkeys, and humans after cryopreser- that the accused process performs a density separation conclusion effect of outliers. once again, the unpredictability of liver defers to such credibility determinations. nilssen v. "patent for a combination which only unites old elements 1. a method of producing a desired preparation cellzdirect, inc., and 428 u.s. 106, 120 (1976). ltc did not raise this objection consideration for the judge to take into account in assess- usa, inc., 566 f.3d 999, 1010 (fed. cir. 2009); see also however substantial, in terms of money, time and energy mony that de sousa does not describe or suggest more senting opinion filed by circuit judge gajarsa. "in light of the presumptions and burdens that will inhere trict court did not err as a matter of law in relying on such rejected the rigid application of the teaching-suggestion- celsis in vitro v. cellzdirect 12 the district court found that all four preliminary in- in other words, celsis' invention uses two known skill would expect a second freezing on those damaged plaintiff-appellee, corp., 75 f.3d 1558 (fed. cir. 1996)). tist had. hr'g tr. 7:23-8:1 ("that was not the subject of injunction (loss of goodwill and reputation) would also be while the present record may not present a clear and ing the challenger's case at the preliminary injunction rate viable hepatocytes from non-viable hepato- not have 70% viability, they do not meet this limitation. cir. 2006). thus, contrary to ltc's assertions, the dis- ter the final thaw, said method comprising: (a) (filed apr. 21, 2005) ("the '929 patent"), which claims __________________________ liminary injunction. further, the preliminary record celsis is the assignee of u.s. patent no. 7,604,929 finds no reason to reverse the district court's weighing of in contrast, the district court found that mr. hunkeler products purchased daily. the district court found this argument to be "hokum" ered the claimed methods obvious at the time of the thawed to density gradient fractionation to sepa- perform the second in the same time as the first. more count of the inferences and creative steps that a person of the majority affirms the district court's erroneous cryopreservation, the de sousa article analyzes whether than one round of freezing, nor does it describe or suggest first quality baby products, llc, 431 fed.appx. 884, the motion for preliminary injunction. this court there- often resume or begin research with little advance warn- the district court did not find the testimony of ltc's numerous articles authored or assembled by dr. li or dr. single round of freezing severely damages hepatocyte cells but, the district court invited ltc to present additional tary damages does not defeat a motion for preliminary least two times, and in which greater than 70% of said method comprising: under 35 u.s.c. 103, a patent claim is invalid "if the thawed at least two times, and in which and results in lower cell viability. celsis provided a opine on the final determination, which lays in the realm that the public interest would disfavor enjoining ltc, hindsight." hr'g tr. 8:17-18. the district court concluded disclose either of these hindsight theories. tion based upon an error of law. id. hepatocytes become available at unpredictable times. invitrogen corporation, trial judge can virtually never be clear error.") (quoting greater than 70% of the hepatocytes of said in that skeletal reference suggests or even hints at the gap. ltc's expert dr. sanjeev gupta opined that the only stating that obviousness depends on whether the "differ- francis m. wikstrom, parsons behle & latimer, of witnesses dr. gupta and dr. albert li. without more, narily by the challenger.") ing the hepatocytes. both cryopreservation and density performing the claimed process or documenting their predictable while simultaneously asserting that a person forced to break in order to compete with ltc. the record should not issue. id. at 1350-51. see also genentech, inc. in bulk and at irregular times, such that the loss of a that rule here. found that the hepatocytes were viable. this process is son on irreparable harm. in contrast, ltc did not offer to celsis would include price erosion, damage to ongoing name implies, the irreparable harm inquiry seeks to added to the disputed claim terms). thus, the district court found that celsis is likely to obviousness. denial of a preliminary injunction is within the broad will have an opportunity at the merits stage to expand cells to kill even more cells than the first freezing. celsis mean "prohibiting." the claim language is not susceptible to introduce a new method or advance in cryopreservation ing prior art references relating to cryopreservation); j.a. of the claim elements were present in the prior art. from injunction, celsis would lose the value of its patent as 2001). thus, if ltc raises a substantial question as to testimony of both sides' expert witnesses, we accord the the issue on appeal is whether the district court erred specifically, dr. gupta (opining specifically on the de power comm'n, 259 f.2d 921, 925 (d.c. cir. 1958)). the court must defer heavily to the trial court's credibility and establishing one's reputation and leadership in the at the time of the invention, nor could they find any only reference in the prior art that allegedly disclosed article in 2002 that he co-authored ("the malhi article"). donations are unlikely to occur at the same time. there- than 70% viability, they meet this limitation; if they do in my judgment, the district court abused its discre- pressure to solve a problem and there are a finite number and an improper attempt to insert a limitation not in the this court has recognized that proof of obviousness does pooling. instead, de sousa only discloses a single cryopre- market was particularly sensitive because customers buy stage; it is not an evidentiary burden to be met prelimi- which the majority fails to recognize. ksr explicitly vestment in drug research and development must be f.3d 1368, 1383 (fed. cir. 2006). of the district court in the first instance. 7:3-5. who do not reorder because of the existence of the in- in finding celsis likely to succeed on non-obviousness in f.3d 1231, 1239 (fed. cir. 2010) ("ksr and our later teaching away from multi-cryopreservation. succeed in proving that ltc's accused process performs likely, the runner would not even finish the second mara- discretion of the district court. in this case, however, the opinion for the court filed by chief judge rader. dis- (a), because it separates viable from nonviable hepato- 2010-1547 in terms of geography and time. see singleton v. wulff, vations, and wherein greater than 70% of single-cryopreserved hepatocytes can replace fresh hepa- mine whether hepatocytes could be frozen multiple times cryopreserve hepatocytes.1 majority op. at 11. this is incurred by celsis absent a preliminary injunction. ordinary skill in the art likely would not have found the 1 the majority also claims that the failure of ltc's article does report on the "poor viability of hepatocytes applied that term to the accused process. he testified the district court rejected ltc's attempt to fill that at trial on the merits," the '929 patent will withstand __________________________ preparation are viable without requiring a credibility findings have been made."); agfa corp. v. creo present in the prior art, its obviousness defense lacked patent. the patent spells out clearly--as does celsis' court sees no error in the district court's finding that opposed to clear and convincing evidence of its invalidity. moreover, all of the claimed elements were present in on an enzyme or metabolic activity thereof, stance of cryopreservation can jeopardize the need for a did not find convincing or credible the opinion of rpr's despite having the financial, scientific, and professional eli lilly & co. v. teva pharm. usa, inc., 619 f.3d 1329, "really didn't offer anything in the way of opinions to which usually require a consistent source of supplies. process"). for confidentiality reasons, this decision does (a) subjecting hepatocytes that have been an explicit teaching, suggestion, or motivation for multi- rader, chief judge. simply by a showing of some degree of unpredictability in 1292(c)(1). majority continues to compound the error. appeal from the united states district court for the after the second cryopreservation than after the first, thus the majority attempts to complicate the simplicity of considered ltc's defenses: non-infringement, obvious- judgment in weighing relevant factors or exercise discre- district of illinois granted celsis in vitro, inc.'s ("celsis") cryopreserve hepatocytes. the basic approach to deter- claimed invention, is actually probative of long felt need accused process performs the same density separation cellzdirect, inc., and the products from celsis. the record shows that the create a pool. because the pool must be used immedi- the district court did not abuse its discretion in granting the prior art. properly interpreted, the claimed invention the district court's reliance on celsis' unrebutted expert u.s. at 421 ("when there is a design need or market celsis in vitro v. cellzdirect 16 requires nothing more than measuring the viability of states, 302 f.3d 1314, 1329 (fed. cir. 2002)); bristol- are not plated between the first and second cryo- (fed. cir. 2008). to constitute an abuse of discretion, a ___________________________ to survive a second freeze. dr. li (opining generally, not "prohibited" by step (c) and therefore does not infringe. fore, the researcher must rely on preserving hepatocytes journal of cell science 2679 (2002). the malhi article the majority fails to follow ksr's mandate in deciding in june 2010, celsis sued ltc for infringement of the 106, 120 (1976). this court finds no reason to disregard address the proper interpretation of the patent's claims." added). ltc reads "without requiring" to mean "prohibit- cally, the only sources of fresh hepatocytes are liver missions from celsis' expert, ltc demonstrated that all all the steps in the asserted claims. first, dr. strom gave synthelabo, 470 f.3d at 1386 ("the amount of a bond is a united states court of appeals patent no. 7,604,929 (the "'929 patent"). the grant or __________________________ preliminary injunction. this court sees no error in the 9. when an effort is later made to restore the original price), success."). ating drug candidates. two problems, however, have united states court of appeals __________________________ discusses fetal hepatocytes as experiment models because tions deference.") (citing refac int'l, ltd. v. lotus dev. raised a substantial question as to the validity of u.s. measure harms that no damages payment, however great, clear error by the district court. and this court does not gradient step." '929 patent col.20 l.15, ll.57-58 (emphasis patent system in encouraging innovation."). such in- as to infringement, the district court weighed the tes- ticed the claimed invention, it would be anticipated, not 1331, 1349 (fed. cir. 2001) (acknowledging that the make much of "a wisp of a term that is buried in the liminary injunction. the district court's obviousness iv. means simply that the claim does not require the density but instead to focus on the advantages of using fetal 1324, 1334 (fed. cir. 2005)). thus, these determinations expert testimony in rebuttal. this court sees no error in sells products for drug research and development such which causes an inconsistent and limited supply. specifi- cytes with skepticism. in sum, the record supports the district court's conclu- plaintiff-appellee, encouraged and protected by the exclusionary rights effect of single cryopreservation on fresh hepatocytes by here, the district court found that because ltc had not for the federal circuit ltc appealed the district court's grant of a prelimi- northern district of illinois in case no. 10-cv-4053, fected by ltc's decision not to present expert testimony 2010-1547 these effects can be quantifiable in this case because this single sale in this market may be more harmful than for they can replicate in laboratory conditions (unlike mature general rule is that this court does not consider argu- synthelabo v. apotex, inc., 470 f.3d 1368, 1383 (fed. cir. of multi-cryopreserved hepatocytes, said hepa- substantial merit because two limitations of the claimed stage. the record as it now stands, however, reveals no court adopted dr. strom's expert testimony by reference ments to be nothing more than "second guessing and phase with the highest revenues and strongest market that ltc's obviousness defense lacked substantial merit. celsis in vitro v. cellzdirect3 balancing of harms favors celsis. absent a preliminary its discretion in finding a likelihood of success on in- their growth phase and will soon be entering the mature uphold the "extraordinary and drastic remedy" of a pre- determinations. . . . credibility determinations by the judges. i. likely obvious.); see also wyers v. master lock co., 616 that.'"). not one of ltc's experts testified to actually discounted prices as well as specific instances when that, at the time of the invention, a person of ordinary records. celsis presented evidence of ltc's significantly the hepatocytes of said preparation are viable af- celsis in vitro v. cellzdirect17 __________________________ clude, pooled hepatocyte products. sion that celsis has shown a likelihood of success that a 1364 (fed. cir. 2007) ("[o]bviousness cannot be avoided considering an argument raised for the first time at oral retaining substantial hepatocyte cell viability through a issue that ltc raised for the first time at oral argument. cryopreservation of hepatocytes." hr'g tr. 7:19-22 ("i the pre-ksr standard for obviousness, rigidly requiring and (4) public interest. id. at 1344. always preclude a finding of irreparable harm. as its ter the final thaw. has chosen to appeal only the first two. preservations, and wherein greater than 70% of celsis in vitro, inc., to be helpful in carefully explaining how ltc's accused record also shows that celsis had a general no-discount a method of producing a desired preparation of viability of hepatocytes that had been frozen and thawed the united states district court for the northern testimony. to substantiate its claims, celsis presented celsis offered testimony from its expert mark peter- cytes for the second time, wherein the hepatocytes made to a person having ordinary skill in the art . . . ." 35 the art. moreover, the majority perpetuates this error, affirmed. obvious. by failing to appreciate this distinction the of credibility also buttress the record for nonobviousness. judge milton i. shadur testified that use of density gradient fractionation to celsis in vitro v. cellzdirect 2 question of invalidity by clear and convincing evidence. desired result. override district court judgments on close issues, where ltc made the same argument about claim 10. policy to maintain its premium product pricing that it was district court committed legal error in granting the pre- tabolism comprising incubating hepatocytes of "principal reason" for finding a patent obvious. ksr int'l. five-day evidentiary hearing. the district court, upon experts dr. gupta and dr. li credible. the district court hepatocyte cells. hepatocytes are extremely fragile and, multi-cryopreservation. moreover, the record shows that (fed. cir. 2006) ("as for the relative weight given to the rather, the party challenging the patent's validity must district court found that the permanent, irreparable harm ing," such that the accused process performs an action testimony and submissions of celsis and ltc's fact and known steps to obtain a desired result is not inventive. body of literature was devoted to the subject of multi- invention obvious either. suggests that ltc's losses were the result of its own has wide discretion to weigh expert credibility. conoco, customers purchased from ltc instead of celsis. the stantial question of obviousness concerning the '929 2009) ("the fact that, at trial on the merits, the proof of the merits stage to expand upon the arguments it made at differences between the subject matter sought to be not teach one of its elements). dictability. as to the scope and content of the prior art, some sales. this court sees no clear error in the district invalidity will require clear and convincing evidence is a tion of the fetal hepatocytes, it could not be definitively (single) cryopreserved human, monkey, and dog hepato- uses hepatocytes from only one or two donors, the results decide whether it is more likely than not that the patent to celsis' post-hearing briefing. the district court con- celsis in vitro v. cellzdirect3 v. novo nordisk a/s, 108 f.3d 1361, 1364 (fed. cir. viable after the final thaw. standard for obviousness. moreover, requiring the defen- inc., 544 f.3d 1341, 1362-63 (fed. cir. 2008). that incen- injunction. see abbott labs., 544 f.3d at 1361-62; sanofi- inc. and invitrogen corporation, now life technologies enforcement of celsis' patent rights here. see sanofi- nary injunction context, this court determines that the ously withdraws what already is known into the field of because the court saw the witnesses and heard their district court did not clearly err in finding a person of celsis in vitro v. cellzdirect9 and remain viable was simply to pursue it. celsis did and '929 patent. celsis moved for a preliminary injunction. claim 1 of the `929 patent reads as follows: injunction because it would prevent competition with a tocytes are not plated between the first and in the district court's bond amount. see sanofi- contract obligations. see ppg indus., inc., 75 f.3d at invention. see harmeet malhi et al., isolation of human progenitor preliminary injunction hr'g tr. 4:10-12, sept. 7, 2010. not entitled to be deemed an invention. see ksr, 550 cells thawed for a second time. if the cells have more the harm to celsis and also "protectable by a bond." hr'g freezing would freeze the thawed cells a second time. man hepatocytes are a useful laboratory model for evalu- the majority perpetuates these errors and reinvigorates wherein the hepatocytes have been frozen and celsis in vitro, inc. v. cellzdirect, inc., case no. 10-cv- that "again celsis has demonstrated more than a sub- the claimed invention must be present in the prior art. 10. a method of investigating in vitro drug me- there, based on the need for multi-cryopreserved hepato- in light of the unrebutted expert testimony, this court ii. tr. 17:9-11 (citing ppg indus., inc. v. guardian indus. of success on the merits because the claimed invention is in the art." the obviousness analysis is based on underly- skill in the art has good reason to pursue the known district court has considered and properly addressed the sousa article"). on appeal, ltc does not assert its obvi- celsis in vitro v. cellzdirect 14 evaluate whether three different chemicals could induce between the first and second cryopreser- analysis, stating that "ltc will have an opportunity at court rejecting the ltc witness mr. hunkeler's claims didn't i think of that,' we get [ltc arguing] `anybody ness and rationalizes the issuance of the preliminary court found: "[n]ot a single one of that astonishingly large the hepatocytes of said preparation are preparation of hepatocytes without requir- nary injunction. price erosion, loss of goodwill, damage to reached, it is not the function of a court of appeals to direct competition. in other words, the public can obtain tocytes for the second time, wherein the hepa- "enhance viability" of cells is "well-established to everyone corp., 81 f.3d 1576, 1582 (fed. cir. 1996)). this court argument); darwin constr. co. v. united states, 811 f.2d and loss of business opportunities. as the district court tion in finding that celsis had demonstrated a likelihood trial court."). ltc argues that the bond is inadequate. an explicit teaching, suggestion, or motivation to multi- trial court broad discretion in determining credibility i. __________________________ did not abuse its discretion in finding that celsis has to accumulate a pool. specifically, the researcher must developed its liverpooltm pooled multi-cryopreserved speirs and michael r. mccarthy. ordinary skill in the art would employ." 550 u.s. at 418. market. as to non-obviousness, the district court reviewed the the district court analyzes four factors when consider- (i.e. increase activity of) two different enzymes. tative pool of hepatocytes. of course, multiple liver donations jeopardizes the effort to accumulate a represen- evidence and fact finding that celsis would suffer irrepa- perfect web techs., inc. v. infousa, inc., 587 f.3d 1324, hepatocyte products, which it asserts are covered by the serted an alternative non-infringement defense based on rable harm absent a preliminary injunction. claim [is invalid]."); kimberly-clark worldwide, inc. v. reputation, and loss of business opportunities are all valid dr. gupta opined on a "more resistance" theory, and step (c). ltc presented documents showing that the sufficient showing at this preliminary injunction stage in the presence of a xenobiotic, and determin- tive would be adversely affected by taking market benefits rect, inc., no. 2010-1547, 2010 wl 5080944 (fed. cir. motion for preliminary injunction for an abuse of discre- celsis in vitro v. cellzdirect7 the preliminary injunction stage, while validity is the viii. ing the metabolic fate of the xenobiotic, or the such evidence. mon sense, in lieu of expert testimony." (citations omit- the differences between the claimed invention and the density gradient step after thawing the hepa- dus., inc., 75 f.3d at 1567. cytes, celsis repeats the well-known steps to obtain its 1226, 1236 (fed. cir. 2003) ("moreover, the district court burden to prove that the public interest would favor a before the district court. nor did it offer alternative forms preparation are viable after the final thaw, the preliminary injunction stage." majority op. at 10. or adult hepatocytes). the essence of the article was not sity gradient fractionation optional after the second thaw. (b) recovering the separated viable hepato- co. v. teleflex inc., 550 u.s. 398, 416 (2007). repeating away from the patentee and giving them to the accused cryopreservation." hr'g tr. 7:15-17. but, the district ltc's own expert dr. gupta opining that malhi was the liver epithelial cells with extensive replication capacity convincing case for obviousness, it certainly raises a prior art; and (4) objective evidence of nonobviousness. vi. accused process performs an "isodensity" separation that pressed, compute a money damages award does not celsis in vitro v. cellzdirect5 cases establish that the legal determination of obvious- i respectfully dissent from the majority's decision to cytes, (b) recovering the separated viable this court reviews a district court's decision to grant a position. the record also included testimony that this directly contrary to the supreme court's opinion in ksr, of freezing would somehow increase rather than decrease salt lake city, utah, argued for defendants-appellants. before rader, chief judge, gajarsa, and prost, circuit issue at trial") (citations omitted). testimony.") (quoting energy capital corp. v. united celsis in vitro v. cellzdirect 18 the hepatocytes of said preparation are viable af- evidence. further, the mere possibility of future mone- "revisionist history is unpersuasive." hr'g tr. 10:7-8; see substantial merit. but as explained supra, this is not the 1567. in fact, the district court allowed ltc to complete to offer proof that the '929 patent was vulnerable, as shown a likelihood of success on nonobviousness. ltc would have been obvious at the time the invention was age to celsis' price, reputation, and business opportuni- the effect on reputation and business due to celsis being the defendant. instead, the district court must simply that any asserted harm to ltc was "of lesser scope" than (stating the same and that "[v]ulnerability is the issue at evidence to substantiate a higher bond. ltc presented no multi-cryopreserved hepatocyte products. see ppg in- multi-cryopreservation. instead of disclosing multi- invitrogen corporation invention were not present in the prior art: freezing and determination that rests within the sound discretion of a erosion. he also testified to the difficulty in quantifying incentive to do so. the district court found that ltc's jvw enters., inc. v. interact accessories, inc., 424 f.3d that de sousa discloses multi-cryopreservation. this then, celsis proffered expert testimony on the dam- the district court found that ltc was attempting to nary injunction. it moved for a stay pending appeal, indeed, the patent act precludes such a requirement by reference in the prior art suggesting that any other scien- gupta or by any of the other scientists who participated the prior art are such that the subject matter as a whole as an initial matter, this court acknowledges that the matter as a whole would have been obvious at the time with no change in their respective functions [and] obvi- in th[e] field."). the last "step" of the claimed invention upon the arguments it made at the preliminary injunction options within his or her technical grasp," the invention is the prior art, followed by repetition of those steps until a multi-cryopreserved hepatocytes, said hepato- suasive and, as to the malhi article, found that "nothing celsis' patent. see sanofi-synthelabo v. apotex, inc., 470 may not be representative of the larger population. to ltc's challenges to its validity. see amazon.com, inc. v. avoid this, the researcher needs a pool of hepatocytes from the second problem is outlier data. if a researcher in the consortium about which dr. li testified, or for that its monopoly," great atl. & pac. tea co. v. supermarket of the prior art; (2) the level of ordinary skill in the art; (3) the '929 patent's invalidity. by affirming the injunction, and differentiation into mature hepatocytes, 115 (13) ing a preliminary injunction: (1) likelihood of success on tion. abbott labs. v. sandoz, inc., 544 f.3d 1341, 1345 implicitly recognizes. by relying on the patent and ad- not give the details of the accused process. 1330-31 (fed. cir. 2009) (finding obvious a claimed inven- on the preliminary record that the art was a crowded field sampson v. murray, 415 u.s. 61, 90 (1974) ("the key ences between the subject matter sought to be patented and tocytes as laboratory models, by comparing fresh versus 886-7 (fed. cir. 2011) (prost, j.) (nonprecedential opinion) ately, any unused cells are discarded; otherwise, re- public's interest in obtaining an adequate supply of pooled not to properly raise this before the district court. the junction factors favor celsis. this court sees no reversible 1336 (fed. cir. 2010). court has not seen ltc identify any teaching, suggestion, matter of the challenged claim, for a court can take ac- that it would have to shut down operations upon a pre- substantial merit to [its] assertion that the . . . patent ltc to a clear and convincing standard of proof regarding the region near the liver donor. tion that required performance of three steps known in celsis in vitro, inc., 1997) ("[w]ith regard to [the alleged infringer's] validity specifically on the de sousa article) claimed that the same reasonably skilled in the art would have thought of yet obviousness does not require that each element of techniques for long-term storage of hepatocytes in the dec. 8, 2010). this court has jurisdiction under 28 u.s.c. northern district of illinois in case no. 10-cv-4053, servation. even ltc's expert dr. gupta did not testify celsis in vitro v. cellzdirect 2 the district court found that celsis had carried its cytes by density. though mr. hunkeler testified that the ing factual inquiries including: (1) the scope and content the district court concluded that "plainly the balanc- court did not abuse its discretion. this court affirms. vague references to "market need" and testimony from its not require that every element be present in the prior art. the district court correctly emphasized and found based after the first thaw (step a) and the second thaw (step c) injunction. ltc moved for a stay pending appeal, which ousness argument based on the malhi article, despite lihood of success on the merits. the district court also (c) cryopreserving the recovered viable hepa- osram sylvania, inc., 504 f.3d 1223, 1231-32 (fed. cir. hepatocytes due to their replication abilities. the malhi strom who testified that due to the independent replica- celsis in vitro v. cellzdirect 4 malhi article." hr'g tr. 8:2-3. it deemed ltc's argu- and protein synthesis, the aim of this article was to myers squibb co. v. rhone-poulenc rorer, inc., 326 f.3d celsis in vitro v. cellzdirect 4 this record shows that the district court did not abuse the specification of the '929 patent explains that hu- view of g. de sousa et al., increase of cytochrome p-450 1a more than once. dr. gupta also conceded this same point. 15. the district court instead credited celsis' expert dr. credibility determinations, and we accord such determina- 2981 (celsis invitro, inc.'s ("celsis") expert dr. strom that to avoid a preliminary injunction, ltc needed only iii. this reference to "market need," properly linked to the that ltc had not proven that its obviousness defense had desired result was obtained). for the federal circuit thon. similarly, as celsis' expert dr. strom testified, one the claimed invention by asserting that the art was un- the merits, (2) irreparable harm, (3) balance of hardships, cytes from non-viable hepatocytes, type of liver cell). claims 1 and 10 of the '929 patent are motion for a preliminary injunction against cellzdirect, donors. due to this reliance on liver donation, fresh as to the bond, this court sees no abuse of discretion conveyed in valid patents. see abbott labs. v. sandoz, enough.") (quoting va. petroleum jobbers ass'n v. fed. error in the district court's findings. based on this record, density gradient step after thawing the hepato- cryopreserving hepatocytes. majority op. at 11. obviousness. of course, had ltc's experts actually prac- gradient fractionation" in step (a) of claim 1. then, he of identified, predictable solutions, a person of ordinary this preliminary record shows that the district court fact and expert testimony as well as specific financial liminary injunction because, in my judgment, cellzdirect, celsis' flagship products and that the products are in district court's conclusion. the public interest favors the ruled from the bench and granted celsis a preliminary second, with that claim construction in place, ltc as- celsis in vitro v. cellzdirect 8 ii. corporation ("ltc"). based on the record, the district of ordinary skill in the art would have predicted low person of ordinary skill in the art would not have consid- number of cells that survived the first freeze would sur- defenses, the question on appeal is whether there is fringer." hr'g tr. 16:25-17:4. patented and the prior art are such that the subject the prior art taught away from multiple freezings. a ing a process infringing the '929 patent ("the accused viable hepatocytes to thereby form said desired district court decision must either make a clear error of method of multi-cryopreserving hepatocyte cells. celsis present invention is in an art well-known for its unpre- '929 patent col.19 l.56-col.20 l.20. the district court held appeal from the united states district court for the precluded from marketing to potential and existing cus- ing of harms tilts heavily in celsis's favor." hr'g tr. included evidence that the liverpooltm products are both ltc and celsis sell the same products and are in ness may include recourse to logic, judgment, and com- equip. corp., 340 u.s. 147, 152-153 (1950), which is a alone does not require a holding that the invention is not v. gajarsa, circuit judge, dissenting. ties. mr. peterson testified to the irreversible price the invention was made to a person having ordinary skill error in the district court's reliance on dr. strom's testi- celsis in vitro v. cellzdirect 8 the district court found that celsis had shown a like- dant to prove obviousness improperly shifts the burden to decided: january 9, 2012 celsis in vitro v. cellzdirect5 has shown substantially more than a reasonable likeli- cytes; (2) using density gradient fractionation to separate affect of the xenobiotic on the hepatocytes or celsis in vitro v. cellzdirect 6 will be proven invalid at trial. see titan tire corp. v. cell viability. instead, to make this leap, ltc makes process meets all the limitations of the asserted claims. v. would expect lower cell viability and a greater loss of cells (c) includes the language "without requiring a density to this unnatural reading. instead, "without requiring" erly considered ltc's interest in fulfilling its current after a month of discovery, the district court conducted a '929 patent. ltc also sells pooled multi-cryopreserved hepatocytes, and (c) cryopreserving the recovered ing a density gradient step after thawing celsis in vitro v. cellzdirect 6 of sales or potential growth to ascertain the people who u.s.c. 103(a) (2006) (emphasis added). furthermore, able to distinguish oneself from competitors. this in- these reasons, i dissent. this court also declines to reach the joint infringement vation, 12 cell biology and toxicology 351 (1996) ("the de patented process which may be proven to be invalid. for consideration of the testimony and written submissions, a larger group of different liver donors to minimize the prods. inc., 451 f.3d 1366, 1379 (fed. cir. 2006) ("this expert. the losses alleged by ltc upon a preliminary with him on the brief were david g. mangum, c. kevin celsis in vitro v. cellzdirect 10 cytes, and dr. li opined on a "mathematical calculation" theory. barnesandnoble.com, inc., 239 f.3d 1343, 1350 (fed. cir. the majority also faults ltc for failing to point out with respect to the de sousa article, this court sees no ___________________________ obvious. see pfizer, inc. v. apotex, inc., 480 f.3d 1348, 17:11-12. this preliminary injunction factor is also af- calculated risk in selling a product with knowledge of and in so doing applies the wrong standard for obvious- resections or non-transplantable livers of multi-organ subjecting hepatocytes that have been frozen and '929 patent col.19 l.56 col.20 l.19, ll.49-59 (emphasis methods for preparing multi-cryopreserved hepatocytes (a only in a different medium. in contrast to step (a), step show that the patent is vulnerable, which "requires less provides a helpful analogy. imagine a runner who fin- ing. this unpredictability hinders laboratory studies, synthelabo v. apotex, inc., 470 f.3d 1368, 1382-83 (fed. see henry v. doj, 157 f.3d 863, 865 (fed. cir. 1998) (not determined whether the same cells were cryopreserved limited their use. first, hepatocytes have a short lifespan testimony of ltc's marketing director markus j. grounds for finding irreparable harm. abbott labs. v. under objective criteria analysis and supportive of non- researchers must wait until a liver donation and must sousa article) claimed that cells that survived the first have properly laid stress on `multi.'"). case new holland, inc., 566 f.3d 1372, 1379-80 (fed. cir. word in this consideration is irreparable. mere injuries, inc. and invitrogen corporation (collectively, "ltc") thawed at least two times, and wherein argued for plaintiff-appellee. with him on the brief was explained: "there is no effective way to measure the loss defendants-appellants. this court declines to review ltc's new argument court need not reach ltc's subsequent argument concern- time of the invention. see '929 patent col.2 ll.41-54 (list- customer relationships, loss of customer goodwill (e.g., viable and non-viable cells; and (3) refreezing and rethaw- experts to practice the claimed invention weighs against frozen and thawed to density gradient celsis would suffer irreparable harm absent a prelimi- brief--that there was a need in the art to multi- celsis in vitro v. cellzdirect15 sufficient level of viable hepatocytes. for this reason, the district court found that celsis would suffer ir- experts in this field met initial attempts to freeze hepato- judge milton i. shadur. 2007) ("while an opposite conclusion could have been tocytes to thereby form said desired fore affirms. ments not raised below. see singleton v. wulff, 428 u.s. second cryopreservations. laboratory. the option of cryopreservation (freezing) did combine frozen hepatocytes with fresh hepatocytes to hepatocyte products, which celsis alleges involve perform- have it both ways. to the extent the art was unpredict- celsis in vitro v. cellzdirect13 gradient fractionation were well known in the art at the could address. see altana pharma ag v. teva pharm. timony of celsis' expert dr. steven c. strom against the a multi-cryopreserved hepatocyte preparation claims. hr'g tr. 5:13. in finding for celsis, the district expert witnesses. it noted the "vast proliferation of not work well because freezing extensively damages which this court denied in celsis in vitro, inc. v. cellzdi- ishes one marathon and then immediately begins a sec- motivation test, explaining that "the analysis need not experts did not predict the results of the claimed methods 593, 596 n.1 (fed. cir. 1987) (same). jordan a. sigale. of counsel was julie l. langdon. vive the second freeze. the de sousa article does not freeze would be "more resistant" and therefore more likely for many years and yet there was not one reference to expert . . . . [t]he district court is best suited to make evaluating differences in cell viability, cell attachment, on appeal: fractionation to separate viable hepato- __________________________ techniques, repeats them, and happens to obtain 70 proof than the clear and convincing showing necessary to this court declines to reach ltc's new argument that also hr'g tr. 7:11-13 ("instead of a more candid `why the district court also erred in failing to appreciate that satisfies the "density gradient fractionation" in step the district court did not clearly err in finding the the district court found dr. gupta's testimony unper- cytes. specifically, while previous studies determined the reference to multi-cryopreservation in the prior art is an cytes, being capable of being frozen and thawed at authors and articles dealing with hepatocytes and use of preliminary injunction. shown that every element of the claimed invention was wherein the hepatocytes are not plated seek out precise teachings directed to the specific subject testimony on the proper reading of the term "density 2006) ("we have long acknowledged the importance of the once damaged, do not recover. thus, even a single in- under the flexible approach of ksr, there is a sub- tocytes, being capable of being frozen and


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