Altana Pharma AG v. Teva Pharmaceuticals USA, Inc., 566 F.3d 999

Altana Pharma AG v. Teva Pharmaceuticals USA, Inc.

566 F.3d 999

Fed. Cir.

2009

Check Treatment

Docket

*4 GAJARSA, Before NEWMAN and canaliculus of the parietal stomach’s cells +, WARD,* via H enzyme Circuit District K +-ATPase. Judges, Once triggered, Judge. pump transports protons, +,H from inside parietal cell Opinion by for the court District filed into secretory the cell’s canaliculus in ex Judge opinion Concurring WARD. filed ions, +, change for potassium K which the Judge Circuit NEWMAN. pump transports the canaliculus to of portion inner the cell. The avail WARD, District Judge. ability potassium of ions within canali Plaintiffs-Appellants Altana Pharma AG migration culus is attributable of “Altana”) Wyeth (collectively, appeal potassium chloride, KCI, into the canalicu of the decision the United States District lus, also parietal from the inside of the cell. Court Jersey for the District of deny- As the K+ in pump reabsorbs the ex ing a preliminary injunction. Because the + extrusion, change for H the Cl' remains discretion, did not its abuse canaliculus, resulting in the forma we affirm. acid, hydrochloric HCI, tion of within the canaliculus, is which then secreted into the I. BACKGROUND stomach. Appellants, Altana Pharma AG and Although operation gastric Wyeth, appellees, accuse Teva Pharmaceu- acid pump was known at time of USA, (“Teva”), Inc. ticals issue, Sun Pharmaceu- invention at which mechanism (collec- Industries, (“Sun”), tical Ltd. et al. gastric PPIs pump inhibit the acid was not “Defendants”) tively, infringing of U.S. understood in the art until the effec- after (“the 4,758,579 patent”). Patent No. '579 tive filing patent. date of the Part '579 Wyeth is the exclusive licensee of the uncertainty '579 the surrounding the method of in the United States. The '579 action for PPIs attributable the fact * Ward, Texas, Judge, sitting John by designation. Honorable T. District Unit- trict ed States District Court for the Eastern Dis- ®, many drugs drug which mercialization of Prilosec prodrugs, are are that PPIs (Altana’s they Byk including form after companies, to their active Gulden that convert body, patient’s began develop within a new predecessor), are delivered PPIs pHa 5 to exhibits about typically compete omeprazole. which are acid- regard, In this PPIs about 7. Altana’s research efforts resulted in the into are converted prodrugs activated (“the 4,555,518 Patent issuance U.S. No. envi- highly form in the acidic their active patent”) '518 and the '579 The ronment, within having pH about filed application for '518 was parietal cells. secretory canaliculus patent, the '579 before contained form, PPI active Once converted its compared pharmacology section that cysteine to one or more thereafter binds compounds of 18 claimed effectiveness pump. in the acid This bind- amino acids against compounds. four The gastric operation inhibits to one of the 18 com- refers pump. acid pounds testing chosen commercialized PPI first which related is not approved was omeprazole, which *5 compounds claims '518 PPI that Drug and Adminis- use the U.S. Food structurally compounds are similar to the (“FDA”) in 1989 under the trade tration patent. Pantoprazole, in '518 claimed the first Omeprazole name ®. was Prilosec compound at issue in this litigation, (now synthesized by AB Hassle known very a exhibits structure that is similar to AstraZeneca) subject in and is of compound patent. 12 from the '518 (“the 4,255,431 pat- Patent No. '431 U.S. ent”). well There are three main structural Omeprazole or Prilosec ® is ele- PPI today drug known as a blockbuster ments molecular backbone: the patients ring, methylsulfinyl treatment of suffer benzimidazole heartburn, bridge, pyridine ring. gener- and the The symptoms as well as other PPI in reflux dis- al formula of the disclosed gastro-esophageal stem from '579 (“GERD”). com- is patent reproduced ease After the successful below: alkyl consisting a radical patent at in this An is carbon 2:5-15. issues atoms, in pyridine ring hydrogen arranged to the and a chain primarily case relate (the general on the above formula A com- right-most structure CnH2n+i. An methyl, alkoxy is compound), specifically, example the radicals locat- mon —CH3. (indicated R2, consisting alkyl group a radical of an pyridine ring ed on the is R4). R3, oxygen. simple linked to The most is me- The '579 teaches radical, l-3C-alkoxy only structural differ- thoxy, a one represents “R3 —OCH3. 12 and represents compound pantopra- R2 R4 a 1- between of the radicals ence radical) (or at repre- zole is the the 3- 3C-alkoxy radical and the other substituent ( H) pyridine ring. In com- hydrogen position a 1-3C- sents a atom or— 12, methyl group ( CH3), a alkyl pound Id. it is radical.” at 2:28-31. — in pantoprazole, methoxy compound whereas it value on a is measured scale, group ( OCH3). logarithmic degree and indicates the — willingness to ac- compound 6, 2004, April or about Teva filed an On proton. cept or donate The lower the Drug Application Abbreviated pKa of a compound, numerical the more (“ANDA”) pursuant to the Hatch-Waxman Thus, 5, acidic and less basic it is. pHat Act, FDA requesting approval sell a with a pKa of 4 more would be generic version of Protonix ® stable than the of 5. pKa with a expiration Sun filed position The defendants’ that Sachs similarly applications directed ANDA taught pKa value of was a desir- or about March June able characteristic a PPI it because Both Teva and Sun paragraph filed IV improve stability of a PPI conjunction certifications with their re- body to its parie- introduction to the spective applications. Following ANDA tal cells of stomach. The defendants applica- the submission these ANDA argued that Bryson further article tions, and, Altana against filed suit Teva taught to lower pKa how value. subsequently, against The district Sun. particular, they argued Bryson taught court consolidated these cases. methoxy group that a 3-position filed a motion for pyridine ring provides a than a pKa lower injunction opposition on June 2007. In methyl group that same Fi- position. motion, both Teva and Sun con- nally, argued the defendants that the '431 infringement; however, they ceded main- feasibility demonstrated the sub- tained the '579 is invalid.1 *6 methoxy stituting group methyl a for a Specifically, argued the defendants that group 3-position at the pyridine ring of the the light was obvious in in a PPI. teachings in the art following prior refer- (1) (2) ences: Altana’s '518 the The district court held a to hearing ad- (3) article,2 article,3 Bryson Sachs the dress Altana’s motion for in- preliminary (4) (covering omeprazole). the junction. After considering the evidence court, In the district arguments, the defendants’ ob- and the the de- district court viousness focused on the selection requested nied the relief. With to compound 12 merits, the '518 as a the likelihood success on the lead for modification. The de- district court found that the defendants argued fendants that pro- the Sachs article had a question demonstrated substantial vided motivation for in one of skill the art invalidity plaintiffs and the had shown not pKa to lower of a PPI 4 to a value of it lacked substantial partic- merit. provide stability ular, order to better court found that one of skill compound in patient’s body. pKa The art would have selected compound 12 as a appeal, 1. On invalidity Sun raises relating another the obviousness-type pat- double defense, obviousness-type patenting, enting double defense. statutory to a addition obviousness defense. Although Sachs, patenting double George issue was Pump Blockers and Ulcer Disease, 785(1984). briefed district court Eng. in connection with New J. Med. preliminary injunction, motion for Altana's the district court did not address it. Assum- Bryson, 3. Dr. A. Constants Ionization arguendo, ing, properly Pyridines, this issue is be- Quino- 3-Substituted 3-Substituted court, disposition fore this our of this case Isoquinolines, 4Substituted lines and 82 J. unnecessary any (1960). renders it to consider issues Am. Soc. Chem. Pharms., Inc., Next, v. the Abbott Labs. Andrx compound for modification. lead (Fed.Cir.2006). 1331, 1334 An interpre- appel- agreed with the defendants’ court reference, a seeking found lant carries heavier burden when of the Sachs tation preliminary to reverse denial of a in- motivation to one of skill provided it junction than modify seeking grant reverse the injunction. preliminary England court also pKa a of 4. The district achieve Co., Co., taught Braiding that a Inc. v. A.W. Chesterton Bryson article found (Fed.Cir.1992) (“When methoxy in the 3- group compound with injunction denied, preliminary to a is the mov- ring, opposed pyridine position only lower ant ... must not that one or methyl position, in that show group court more of the factors relied on the dis- pKa of 4. That pKa value to erroneous, clearly trict court was but also patent to show also relied on the '431 that a denial of the relief The dis- such a substitution feasible. objective sought would amount to an abuse of the trict court’s examination it reversal upon not cause court’s discretion of an erro- of non-obviousness did indicia finding.”). showing of neous disregard prima facie accordingly obviousness, the court To preliminary injunc obtain a failed to a like- that Altana establish tion, a court examines four factors: lihood of success on merits. (1) a likelihood of on reasonable success considered, but district court also merits; irreparable rejected, position Altana’s (2) an irreparable injunction harm if following argued harm. granted; not irreparable prelimi- if no harms would be (3) hardships tipping balance of its nary injunction was issued: irreversible favor; and erosion, profits, substantial loss price (4) injunction’s impact favorable share, inability to ser- in market decrease public interest. debts, layoffs, and loss of employee vice The district opportunities. research Amazon.com, Inc. v. Barnesandno See *7 irrepara- harms were not these ble.com, Inc., 239 F.3d 1350 be able ble and that the defendants would (Fed.Cir.2001) Baker, (citing Ltd. Reebok Int’l v. J. satisfy prevail Altana judgment a should (Fed.Cir.1994)). Inc., 1552, 1555 32 F.3d result, court trial. a the district at As Although applied the factors are not me Altana had failed to show concluded that chanically, a must movant establish harm if the irreparable that it suffer of both of the first two factors to existence injunction was not issued. preliminary injunction. entitled to a be Amazon, 239 F.3d at 1350. on Altana’s to establish

Based failure the merits either a likelihood of success on A. LIKELIHOOD OF SUCCESS harm, irreparable court de- or district ON THE MERITS preliminary injunction. nied motion for jurisdic- have appeal This followed. We a seeking pre A holder 1292(c)(1). § pursuant tion to 28 injunction U.S.C. liminary bears ultimate bur a likelihood of success establishing den of II. DISCUSSION respect patent’s merits on the with deny validity. Corp., a Inc. v. Pall 490 Entegris, or grant The decision (Fed.Cir.2007). If the al 1351 injunction is within the sound F.3d See, ques- e.g., leged infringer raises a “substantial the district court. discretion of 1006 Altana, invalidity, preliminary injunc According

tion” of the standard artic- Id; Genentech, tion should not ulated court incorrectly Inc. the district issue. A/S, placed v. Novo 108 Altana Nordisk F.3d 1364 burden on show (Fed.Cir.1997). The burden the ac obviousness defense lacks substantial merit, a infringer ques putting cused to show substantial rather than the burden on invalidity stage tion of is lower than defendants to a at this establish substantial question required invalidity what is at prove invalidity. trial. Abbott Laborato- ries, “Vulnerability prelimi majority issue at the opinion specifically is the ad- nary injunction validity while dressed the this stage, precedent is the issue of court’s Amazon.com, issue at trial.” showing F.3d at to the burden of (“In injunction likelihood resisting preliminary of success the face of an ... attack one need not make out a case of on the validity actual Abbott Labs., (“The invalidity____The showing of a substantial 452 F.3d at n. majority question invalidity opinion requires as to thus ... bound duty prece- less our proof than dent convincing exactly the clear and which proposi- show states tion.”). ing necessary to invalidity precedent establish it of this court holds self.”). infringer Once the accused that if the infringer satis accused “raises ‘sub- requirement, fies this stantial question’ concerning validity, burden shifts to en- patentee (i.e., forceability, infringement to show that or defense asserts lacks Entegris, substantial defense that merit. cannot [the movant] show merit’) F.3d at 1351. ‘lacks substantial the preliminary injunction Genentech, should not issue.” argues Altana the following alleged (citing F.3d at 1364 England require errors the reversal of the district 882-83); Braiding, 970 at see also court’s order denying preliminary in- Amazon.com, 239 F.3d at 1350-51. More (1) junction: the district court’s failure to recently, applied the court this standard in take into account an accused infringer’s Entegris. 1351. The district clear and convincing burden to inval- apply legally did not incorrect (2) idity; the district court’s selection of standard, reject and we Altana’s argu- first (3) compound; 12 as a lead ment. the district court’s interpretation of the Bryson article.

2. District Analysis Court’s Obviousness Burden Proof challenges district Altana first argues obviousness the merits. *8 court applied an incorrect in argues standard Altana that the district court clear assessing ly whether had shown a erred when it determined that the de likelihood of success the merits. The fendants’ obviousness defense had substan district court set forth the standard it tial merit. In particular, Altana argues applied: “In order to establish likelihood the district court allowed the defen merits, of success on the Plaintiffs must dants to select 12 compound of the '518 show that invalidity Defendants’ defenses as a compound prior lead when the words, lack substantial In merit. other art suggested availability of numerous if Defendants have raised a compounds substantial other that were at least as question of invalidity, Plaintiffs promising compound are not as modify 12. In (ci- entitled to a preliminary injunction.” addition, Altana contends that the district omitted). tations court’s findings with to the teach-

1007 Bryson clearly are erroneous. ing We Obviousness based on structur al argument. similarity may proven by examine each be the identifi cation of some motivation that would have ultimately Obviousness ordinary led one of in skill the art to select law, question underlying based on factu modify and a known compound partic in a al Inc. determinations. Richardsom-Vicks way ular to achieve the claimed compound. (Fed. 1476, Co., v. 122 F.3d 1479 Upjohn Eisai, 533 F.3d at 1357. requisite Cir.1997). factual determinations any motivation can come from number of legal the basis of the conclusion of form necessarily sources and need not explic be (1) scope include obviousness con it in (citing the art. Id. Aventis Pharma (2) art; prior tent of the of ordi level Ltd., Deutschland Lupin, GmbH v. 499 (3) art; nary in skill the differences 1293, (Fed.Cir.2007)). 1301 Instead, F.3d pri- the claimed invention and the between “it is sufficient to show that the claimed (4) art; secondary evidence of or fac art prior compounds possess a ‘suffi tors, objective known as indicia of non- ciently close relationship ... to create an Co., obviousness. v. John Deere Graham expectation,’ light totality 1, 17-18, 684, 383 U.S. 86 S.Ct. 15 L.Ed.2d art, that the compound new will have (1966). recently This court explained 545 properties.’ ‘similar to the old.” (quot Id. “[w]here, here, issue Dillon, (Fed. 688, In re 919 F.2d compound, a chemical claims Cir.1990) (en banc)). (the of the third Graham factor differences Our review the district court’s deci- pri- between the claimed invention and the limited, sion is important and it is place art) or often turns on the structural simi the district findings in perspective. larities and differences between the Applications for preliminary injunctions compound claimed and the art.” Ei typically presented are on an abbreviated Labs., Ltd., v. Dr. Reddy’s sai Co. Ltd. record without the benefit of a full trial. (Fed.Cir.2008). 1353, Thus, 1356-57 case, In this the district carefully prima to establish a facie case of obvious explained that its obviousness findings involving ness cases new chemical com preliminary. were court, the district pounds, infringer the accused must identi the defendants attempted that the fy some reason that would have led a claims were vulnerable because one of skill modify chemist to known in a would have selected a number of particular manner. See Yamanouchi compounds disclosed in the '518 Co., Pharmacal, Danbury Pharm. Ltd. v. including compound starting point as a Inc., (Fed.Cir.2000). development. for further Based on the This standard legal is consistent with the it, record before the district court found principles Supreme announced that “Defendants have raised a substantial Court’s decision in KSR Int’l Co. v. Tele argument awas natural Inc., 550 U.S. 127 S.Ct. flex choice for further development in this re- (2007). L.Ed.2d 705 See Takeda Chem. gard.” Indus., Ltd., Alphapharm Pty., Ltd. v. *9 (Fed.Cir.2007); Eisa, 1356 Ample supported 533 evidence finding. (“In words, First, F.3d at post-KSR, 1359 other patent '518 claimed that its com- prima facie case of pounds, including obviousness for a chem compound were im- still, compound ical in general, begins provements art, prior specifically over the (the PPI). the reasoned omeprazole identification lead com first successful pound.”). addition, compound 12 was disclosed as 1008 potent eighteen velopment

one of the more of the efforts.- finding sup- This by ported compound which evidence that 12 compounds patent of the '518 for was one of potent compounds the more PPI provided during prosecution. data was disclosed in the Moreover, patent. Although '518 examiner relied potency dispositive, is not the district court compounds patent during of the '518 unreasonably believed-—not po- prosecution of the '579 —that Cf. tency compound a factor was Eisai, (“Indeed, 533 F.3d at 1357 Teva’s have led one of skill in the art to ... pharmacology expert opine declined to compound select 12 group from the lansoprazole’s relevance to an examiner study. further It bears mention that Alta- assessing patentability rabepra- compound na itself had selected zole.”). efforts, development further although the evidence, Beyond this the district court ultimately inventor stated that he devel- opinions qualified considered the ex- oped pantoprazole by using an unwanted perts. supported their defendants ob- by-product up from his scale work as a argument viousness with the Declaration starting point, compound rather than Mitscher, of Prof. Lester A. Ph.D. Dr. suggests prior art would amply qualified Mitscher express was not have directed one of skill the art to opinions subject on the matter involved in compound select approximately over the this case. Dr. expressed Mitscher his compounds claimed improvements to be (which opinion that Altana’s '518 or, patents, '518 and other art 12) compound disclosed “on was the cut- matter, for that over the thousands of ting edge development of PPI in June other compounds included in the art 1984.” Dr. provided Mitscher the district disclosures. In light of Dr. Mitscher’s dec- court with an history overview of the laration, however, the district court had a PPIs and the state of the art as of June evidentiary sufficient rejecting basis for particular, 1984. In Dr. Mitscher stated Moreover, position. to the extent Al- that one of skill in the art would have suggests tana that the prior art must point (in- exemplary selected the compounds only single lead for further 12) cluding compound '518 efforts, development that restrictive view omeprazole over pursue which to fur- of the lead compound present test would ther development efforts designed to im- rigid test similar to the teaching-sugges- quality and effectiveness of tion-motivation test the Supreme PPIs. Although expert Altana’s suggested KSR, explicitly rejected Court in KSR. Cf. that one of skill in the art would have (“The 550 U.S. at S.Ct. obvi- omeprazole selected compounds over the analysis ousness cannot be confined patent, part because toxic- conception formalistic of the words teach- ity concerns, apparently the district court motivation, ing, suggestion, and or accepted Dr. Mitscher’s contrary opinion. overemphasis on the importance pub- The district court’s reliance Dr. on Mitsch- explicit lished articles and the content of opinion er’s clearly was not erroneous. patents. diversity issued of inventive Beyond finding that those of skill in pursuits and of modern technology coun- would have pursued the 18 exem- against sels limiting in this plary compounds in the the way.”). The district court in this case district court also found that one of skill employed a approach flexible —one the art would have found admittedly preliminary —and particular, a natural choice for further de- the defendants had raised substan- *10 4) pKa (namely pKa that one skill art lower value a that question

tial of the of methyl a potent compound group [sic] the more com- a with at would have used that patent, including position.” The district conclud- of the '518 com- pounds ed Bryson’s teachings “[w]hen are starting point a which to pound combined with the of compound structure development efforts. That pursue further 12 and combined Dr. teach- Sachs’s clearly finding was not erroneous. ings, a Defendants have raised substantial The court determined that the district question that this -combination was at the taught those of skill in the Sachs article very try least obvious to and that such PPI should have a art an effective predictable to a would lead variation of pKa of 4 a of would lead to pKa because 12, i.e., compound compound a with better stability of the within the better pH5 stability.” Thus, body. to the according district correctly Altana out points that the dis- court, of skill the art would have one trict findings Bryson court’s discloses modify the been motivated pKa the lowering through to 4 the substi- pKa to It is compounds to reduce their 4. tution of a are methoxy group in- error. disputed that the author of the not Sachs Bryson actually discloses values of 4.83 article, George Sachs, is one Dr. of the simple pyridine rings 4.91 for contain- leading PPI develop- researchers in the ing methoxy group a 3-position. such, ment field. As the district court was pKa Because are values measured on a entirely selecting justified Sachs scale, logarithmic very there is a substan- Moreover, article as relevant art. tial mathematical difference in magni- although disputed teachings Altana of pKa tude of a value of versus a pKa court, Altana Sachs before district value of A 4.83. value of 4.83 is over 6.7 challenge on appeal does not larger times than a of 4. value findings with Sachs Instead, teachings. error, however, contends that This does not require a factual the district court made error reversal unless Altana also shows that the Bryson interpreting the article which re- requested district court’s in- denial quires We now turn to that is- reversal. junction anwas abuse of discretion. New Co., sue. England Braiding at Notwithstanding the district court’s state- Bryson pKa article teaches val- ments, the declaration of Dr. Mitscher groups, including ues of various chemical clearly does not an make such error in its methoxy 3-position at a groups, Bryson Rather, reference. simple pyridine ring. The defendants ar- presented by evidence defendants that a gued Bryson taught methoxy supports finding that oné of skill in the pyridine ring at group 3-position Bryson art would read to teach the lower- pKa have a lower value than if it pKa through the substitution of a a methyl group position. had at that methoxy group methyl at the group accepted argument, district court this but 3-position pyridine ring. “[a]ccording Bryson, pKa stated val- methoxy group position “Bryson ue of a at such a Dr. Mitscher stated indi- 4; however, methyl cates pKa group methoxy group at that the addition of a position 3-position pKa is 5.” The district court also decreases the (with “Bryson pyridine by units undisputably pKa stated: 0.27-0.35 an taught methoxy group average pKa 3-methoxy pyridine with a at the 3 4.87).” ring would Dr. position pyridine have Consistent with Mitscher’s *11 prerequi- precedent is under this court’s discloses statements, Bryson article Accordingly, relief. accurately preliminary expert also site for that. The precisely pKa Ataña that some agree of the with Bryson’s although disclosure we described methyl ring findings with pyridine values of of the district indicates “Bryson 3-position: incorrect, group at we do not dis- Bryson were to at the methyl group aof that the addition decision on this the district court’s turb pKa increases 3-position pyridine ground. (with an pKa units by 0.34-0.53 pyridine 5.66 3-methyl pyridine of for

average pKa HARM B. IRREPARABLE pKa of 5.18 average to an compared Thus, the differ- pyridine).” unsubstituted argues Ataña that appeal, On methyl values of average pKa ence it discretion when district court abused its pyridine rings methoxy substituted failed to demon that Ataña had 0.79. by Bryson is disclosed The district irreparable harm. strate methoxy pKa Bryson, Under findings irreparable supported court its substantially ring is pyridine substituted plaintiffs had not by stating harm that the methyl pyridine than the substituted lower unable to that the defendants were shown references The district court’s ring. money damages, that respond in “4,” although not of “5” and pKa values exaggerat were harms to the defendants accurate, in fact correlate with technically ed, likely had a business and that Ataña magnitude pKa in the difference launch of to deal with the plan place de- pyridines values of the substituted competition. generic Indeed, Bryson. elsewhere scribed difficulty accepting the fact also had opinion, the court stat- the district court’s during Ataña Nycomed, purchased which stability via pH5 “if teaches ed that Sachs case, had failed to pendency of this ring, and pKa pyridine lowering generic launches. potential account for pKa, such Bryson teaches how to lower the district court argues Ataña unexpected property purportedly then the legal by categorically error committed a prop- expected is in fact an pantoprazole erosion, dismissing price certain as well as the dis- erty.” The defendants harms — share, profits, market loss of loss loss of understood that the obviousness trict court possible lay- opportunities research teaching depended Bryson’s position as not ir- Ataña would suffer offs—that value way substantially pKa lower the primary Atana’s contention reparable. thus pyridine ring.4 The evidence incorrectly stated district court de- overriding the district court’s supports are as a matter of types that the of harms had made out cision that the defendants The district court irreparable. law not of obviousness to defer sufficient case Circuit, well as “the Federal as stated: merits, opposed matter for trial on the district, have declared courts sought relief granting Plaintiffs of harms advanced types Moreover, the district plaintiffs. irreparable are not in the instant lawsuit that Ataña had failed to court found thus, grant- the basis for cannot form explain, harm. As we shall irreparable injunction.” an clearly erroneous and finding is not rings been relevant evidentiary support dine would have 4. We also find sufficient finding implicit designing the district court's a PPI. medicinal chemist pyri- Bryson's relating simple discussion *12 Altana views the district court’s state- impact generic entering versions isolation, ment but careful review of market on Altana’s business was not clear- district court’s entire on this ly erroneous. point reveals that the district court cor-

rectly up- understood that this court has III. CONCLUSION findings irreparable held harm based on very these factors. Sanofi-Synthelabo See reasons, For the aforementioned we af- Inc., Apotex, v. 470 F.3d 1382-83 firm. (Fed.Cir.2006) (affirming district AFFIRMED based, finding irreparable courts harm erosion). part, price on Far sup- case, porting a reversal of NEWMAN, this the law Circuit Judge, concurring. by highlights cited the district court this In view of the discretionary weight that court’s deference to a district court’s de- given must be to a district court’s decision termination whether a movant has suffi- grant whether to a plain- ciently shown irreparable Compare harm. request lite, tiffs pendente relief I con- Lilly id. with Eli Cyanamid & Co. v. Am. cur in the court’s affirmance of the district Co., (Fed.Cir.1996) 1578-79 court’s injunction. denial of the Although (affirming the district court’s finding that the evidence presented to the district court the movant failed to irreparable establish not, my view, does invalidity establish based, harm in part, on the loss of re- pharmaceutical product Here, opportunities). search we find no see, pantoprazole, Gonzales v. O Centro error in the district findings court’s Espirita Uniao do Vegetal, Beneficente irreparable these harms are not to Altana. 418, 429, 546 U.S. 126 S.Ct. argues Altana further that the district (2006) (“the L.Ed.2d 1017 burdens at the court erred in weighing Altana’s aware- injunction preliminary stage track the bur- ness of the future harm it would incur at trial.”) dens at this stage expiration of the Hatch-Waxman Act deference is warranted to the district stay, which followed the filing of the defen- weighing of the conflicting expert applications. dants’ ANDA The district opinions interpreting the evidence. On court, however, directly rely did not basis, this I concur in sustaining this dis- these facts to show that Altana would not cretionary action. irreparably Rather, be harmed. the dis- trict court argument Altana’s

that its business would be crushed

entry generic versions of Protonix ® exaggerated in light expiration stay.5 Hatch-Waxman The manner

in which the district court addressed the

credibility argument of Altana’s regarding July hearing In the generic, conducted own "it analy- would be a different court, unequivo- district Altana's counsel According sis.” briefing before cally court, however, stated partners neither it nor its had just Altana did that. Subse- any plans generic quent to launch a version of Pro- to the district court's denial of Altana’s ®, any guise.” tonix "not under preliminary injunction, counsel's motion for licensee, Altana’s court, exchange with the Wyeth, he admitted generic launched a version of to the district court that if Altana launched its Protonix ®.