AstraZeneca UK Ltd. v. Aurobindo Pharma Ltd.

Limited, ruling alternative IPR on the district court’s AstraZeneca UK Pharma- Inc., Shionogi Seiyaku Barlow failed to establish causation. ceuticals and Kaisha, Plaintiffs-Appel- Kabushiki lees, IV regard AFFIRM with to Bar We thus Limited, Aurobindo Pharma for race discrimination and low’s claims Defendant-Appellant, We, however, of the FLSA. RE

violation pro and REMAND for further and VERSE wrongful to Barlow’s ceedings regard Mylan Inc., Pharmaceuticals claim termination in violation discharge Defendant-Appellant, As all of Bar public policy. of Colorado and dismissed, low’s federal claims have been we leave it to the district court to decide Apotex Corp., Defendant-Appellant, it will continue the first instance whether and supplemental jurisdiction exercise over claim. See 28 state-law U.S.C. Cobalt Pharmaceuticals Inc. and 1367(c)(3) (“The may district courts de Inc., Laboratories Cobalt supplemental jurisdiction cline to exercise Defendants-Appellants, if over a claim ... the district court has it orig dismissed all claims over which has added); jurisdiction.”) (emphasis see inal Industries, Sun Pharmaceutical Technology, Inc. v. HIF also Carlsbad Ltd., Defendant-Appellant, Bio, Inc., 635, 640, 129 556 U.S. S.Ct. (2009) (“Upon 173 L.Ed.2d 843 dismissal of claim, re the federal the District Court USA, Inc., Teva Pharmaceuticals statutory jurisdic supplemental tained its Defendant-Appellant, tion over the state-law claims. Its decision statutory authority de [in to exercise Pharmaceutical, Inc., Par supplemental jurisdic

clining exercise Defendant-Appellant, tion over the state-law was not claims] jurisdictional on a defect but on its based discretionary choice not to hear the claims Sandoz, Inc., Defendant. jurisdiction

despite subject-matter over them.”). 2010-1461, 2010-1462, 2010-1460, Nos.

2010-1463, 2010-1464, 2010-1465, 2010- 1466, 2010-1467, 2010-1468, 2010-1469, 2010-1470, 2010-1471, 2010-1472, 2010- 1473. of Appeals,

United States Court Federal Circuit. 14, 2012.

Dec.

In re CALCIUM ROSUVASTATIN

PATENT LITIGATION. Breisblatt, Katten Muchin

Robert B. IL, Rosenman, LLP, argued Chicago, him on the defendant-appellant. With Jeremy Daniel and Charles brief were C. B. Paradis. Gould, Ward, Merchant &

Jeffrey S. P.C., Madison, WI, argued for defen- him the brief dant-appellant. With on J. Heneghan, were Thomas P. Edward Pardon, A. Brunner. and Shane Knobbe, Martens, Maddox, A. Steven DC, Bear, LLP, Washington, of Olson & him argued defendant-appellant. for With Payson were Lemeilleur and on the brief Bunker, Knobbe, Martens, Olson & Jared Irvine, Bear, LLP, of CA. NEWMAN, MAYER,

Before PLAGER, Judges. Circuit by Opinion of the court filed Circuit Concurring opinion Judge NEWMAN. by Judge PLAGER. filed Circuit Judge Dissenting opinion filed Circuit MAYER.

NEWMAN, Judge. Circuit litigation This arises under Act, § Hatch-Waxman U.S.C. whereby producers generic pharmaceu- of products challenge tical are authorized to federally registered of a status drug approved product, before Lipsey, Finnegan, E. Charles generic producer approval has obtained Henderson, Farabow, Dunner, Garrett & counterpart approved prod- sell its of the LLP, Reston, VA, argued plaintiff- of litigant who succeeds in generic uct. The him were appellee. With on brief granted is eliminating drug patent Frankel, M. and York M. Faulk- Kenneth 180-day period exclusivity against of other ner. Of counsel on the brief were Ford F. providers generic product. potential Farabow, Jr., Levine, of and Howard W. 355(j)(5)(B)(iv). 21 U.S.C. DC, Mary Ferguson, K. of Washington, MA, here at is the Livingstone, drug product John D. of The issue Cambridge, Crestor®, Atlanta, GA, Bourke, name Mary Connolly having “statin” the brand W. LLP, Hutz, federally for use in con- Lodge Wilmington, approved Bove & of which is DE, Renk, Celia, of cholesterol and for treatment of Henry Fitzpatrick, J. trol Scinto, York, NY, Thom- In is States Harper & of New atherosclerosis. suit United (“the Yun, 37,314 pat- Judy Patent No. '314 as Stevens and AstraZeneca Reissue Pharmaceuticals, LP, ent”), of States DE. which is a reissue United Wilmington, of (“the effects, 5,260,440 patent”). compared No. '440 duced side with other Patent Seiyaku Kabush- commercial statins. See Peter H. patentee Jones et ah, iki (“Shionogi”) Comparison Kaisha and the exclusive the Efficacy Safety Atorvastatin, and its licensee is AstraZeneca UK United Rosuvastatin Versus Sim- vastatin, subsidiary States IPR Pharmaceuticals and Pravastatin Across Doses “Plaintiffs”). (STELLAR Trial), (collectively Inc. Cardiology 92 Am. J. (2003). is the ingredient The active Crestor® compound

calcium salt of a chemical whose generic producers Several initiated rosuvastatin, the fol- challenge common name is to the '314 patent filing an lowing structural formula: Drug Application Abbreviated New

(ANDA) accompanied by a Paragraph IV certification, U.S.C. § 355(j)(2)(A)(vii)(IV). An ANDA permits generic producer drug prod- to market a uct on approval based the federal obtained by the original registrant. Submission of statutory an ANDA constitutes a act 271(e)(2) § infringement pursuant to of the Act, provides: Patent which infringement It shall be an act of submit an under [section 355(j) drug of title ... for a 21] claimed patent in a or the use of which is claimed in a ... if patent purpose approval such submission is to obtain engage under such Act to in the com- use, manufacture, mercial or sale of a prod- Rosuvastatin is one of several statin drug, veterinary biological product, or production ucts that lower cholesterol biological product patent claimed in a by inhibiting enzyme the liver HMG- patent the use of which is claimed in a working Scientists at the CoA reductase. expiration patent. before the of such laboratory in were con- Japan 271(e)(2)(A). § If the challenge 35 U.S.C. ducting research in search of a statin with fails, the ANDA cannot be compared reduced side effects as with the approved expiration patent. until products statin that were then known. In 271(e)(4)(A). research, they the course of this U.S.C.

discovered rosuvastatin and its beneficial infringement against The the sev- suits properties. Patents were obtained in Ja- generic challengers eral were consolidated countries, pan and other the '314 including in the United States District Court for the patent in the United States. District of Delaware. The Defendants are Ltd., Mylan Pharma Pharma- Aurobindo approval

Federal for sale and use in the Inc., Apotex Corp., ceuticals Cobalt Phar- granted August United States was on maceuticals Inc. and Laboratories Cobalt develop- after over two decades of Inc., Industries, Ltd., successful, Sun Pharmaceutical product highly ment. The USA, Inc., Par efficacy in low- Teva Pharmaceuticals superior lowering due to its (LDL) Inc., Sandoz, Pharmaceuticals, Inc. density and elevating cholesterol and (HDL) cholesterol, high-density argued pat- and its re- The Defendants that the '314 406-07, 1727, 167 L.Ed.2d 705 of obviousness 127 S.Ct. ground ent is invalid on the (1) reissue, (2007), viz., that the and content of improper scope and and (2) art, inequitable ordinary is unenforceable for conduct the level of skill prior (“PTO”). (3) invention, the Patent and Trademark Office the differ- in the field of the subject the claimed matter ences between The court ruled that district (4) art, any objective prior and the enforceable, valid, infringed.1 unobviousness, commer- indicia of such as infringement, all Defendants admitted need, long-felt cial success or or failure of Corp. All of the Defen- except Apotex others. validity appeal rulings dants

enforceability. The Defendants identified as closest art Patent Office Publica- European I company the Sandoz tion No. 0 367 895 of

Validity (“Sandoz 16,1990, ”), published May which challenge patent pyrimidine-based numerous sta- The Defendants describes validity compounds, including compound tin des- ground on the of obviousness. Ob ignated Compound lb Compound viousness is as a matter of law as lb. decided (methyl) on the ami- inquiries, groups based on four basic factual as set has two -CH3 chain, Co., Deere 383 no side instead of one forth Graham v. John -CH3 1, 17-18, group 15 L.Ed.2d 545 one rosuvastatin. U.S. 86 S.Ct. -S02CH3 (1966), following Compound and elaborated in KSR Interna lb has the structural tional, Inc., formula: 550 U.S. Co. Teleflex research, European application compound”

The Sandoz de- “lead for further Compound “especially compound scribes lb as an that with this selection as lead preferred change group of the invention.” of the to a embodiment -CH3 -S02 Sandoz, be- argued group at *9. The Defendants would have been obvious CH3 sug- Compound the district court that this statement cause it would make lb more gests Compound good hydrophilic. lb would be a The Defendants stated that (D.Del.2010). Litig., 1. In re Rosuvastatin Calcium Patent F.Supp.2d taught liver- would have been motivated publications numerous to combine have fewer undesir- may selective statins teachings art references effects, hydrophilic sta- able side invention, to achieve the claimed and that The Defen- tins are more liver-selective. the skilled artisan would have had a rea- argued persons ordinary dants of skill expectation sonable doing success in in this field would have been motivated to so.”). Compound hydro- make Sandoz lb more The highlighted unpredict Plaintiffs (as philic, position and that the marked C2 ability that was associated with statin de supra) logical on the molecule was the velopment. For example, pyrrole

place modify Compound lb because the based statin corresponding all other were known to parts other structure aspects structural pyrimidine-based activity. Defen- be essential to statin displayed rosuvastatin toxic side effects. argued person ordinary dants that a pointed The Plaintiffs out that at least five num- skill would have considered a limited pharmaceutical companies had abandoned substitutions, including ber of common their research on with pyrimidine statins sulfonyl “spacer” position -S02—at C2 cores, on the prevailing pyrimi belief that hydrophilicity. to increase The Defen- dine-based statins were not promising person ordinary dants argued that improved leads to products. The Plaintiffs change skill have predicted would this reference, pointed out that no or combina produce would a statin with fewer adverse references, tion of suggested pre that the effects, thereby rendering side the com- viously unknown molecule rosuvastatin pound obvious. advantageous properties. would have its In response, pointed the Plaintiffs out KSR, See 550 U.S. at S.Ct. Compound that Sandoz lb demonstrated (“A factfinder should be aware ... of the unexpected toxicity, increased and there distortion caused hindsight bias and fore was not an com encouraging lead arguments must be cautious of reliant pound. The Plaintiffs stated that other upon post reasoning.”); ex Yamanouchi compounds European appli in the Sandoz Pharmacol, Inc., Pharm. v. Danbury Co. cation, Compound such as demonstrat (Fed.Cir.2000) 1339, 1345 231 F.3d (finding potency. ed better in vitro The Plaintiffs ordinary that “an medicinal chemist” responded argument to the that 1991 expected specific would not have chem scientist would have known that Com ical structure to have the “most desirable pound hydro lb should be made more pharmacological proper combination of philic, by pointing publications to ties”) (internal omitted). quotation The lipophilic state that substituents at the C2 objective pointed Plaintiffs indicia of position, hydrophilic, the converse of can non-obviousness, including commercial suc potency. increase statin The Plaintiffs cess, need, long felt but unfilled failure of argued prior art no provided others, results, Graham, unexpected suggestion of rosuvastatin’s unexpectedly 17-18, 684, superior properties compared support as 383 U.S. at 86 as S.Ct. any Compound judgment lb or other known com the district court’s of unobvi no pound, creating thus “reasonable ex ousness.

pectation Pfizer, Apo of success.” Inc. v.

tex, Inc., (Fed.Cir. 1348, applied The district court the cor 480 F.3d 2007) (“[T]he standard, challenger rect must burden falls on the chal lenger patent by convincing clear and demonstrate clear and evi show convincing evidence that a skilled artisan dence that the invention would have been ordinary Alphapharm Pty., skill in the person

obvious to a (“[I]n (Fed.Cir.2007) involving at the time the inven new field of the invention cases Pfizer, made. 480 F.3d at 1359- necessary tion was it remains compounds, chemical (“Since valid, patent presume GO we must identify that would have some reason challenger bears the burden of patent modify compound led a chemist to a known invalidity the factual elements of proving prima manner to establish particular evidence. That convincing clear and facie of a new claimed com- obviousness to the proof paten burden of never shifts pound.”). court prove validity.”). tee to district correctly held that The district court argument discussed the Defendants’ invalidity ground obvious- patent on the sulfonyl group position of a at the insertion compound ness had not shown for the been was one of a “finite number of identi C2 ruling That is affirmed. rosuvastatin.

fied, predicable existing prob solutions” to statins, KSR, lems with the words of II 421,127 at and thus that it U.S. S.Ct. spe have been obvious to make this

would Inequitable Conduct compound properties. cific and test its argued The Defendants also The district court found that this situation permanently unenforcea to that discussed in In re was similar inequitable during ble because of conduct O’Farrell, (Fed.Cir.1988), F.2d 894 prosecution of the '440 from which explained where the court that obviousness '314 The Defen reissued. is not shown when “what was ‘obvious to inequitable dants attributed the conduct to try’ explore technology was to a new employees Shionogi’s pat two in-house general approach that seemed to be a Japan, ent staff in Ms. Tomoko Kitamura promising experimentation, where field Shibata, Mr. Takashi who did dis gave general guidance art during close three documents to the PTO inven particular form of the claimed prosecution patent. tion or how to achieve it.” Id. at 903. The of the '440 The docu Bayer Japanese Appli district court concluded that the Defen ments were Patent (filed 2, 1989, required dants did not demonstrate the cation No. HI-261377 Feb. selecting Compound motivation for Sandoz 1989), published Aug. pub the Sandoz compound, making lb as a lead or for this European application describing lished specific sulfonyl change Compound in the lb, Compound and a Patent Of European Lilly lb molecule. See Eli & v. Zenith Co. report fice search that included the Sandoz Pharms., Goldline F.3d 1379 application. The Defendants state that all (Fed.Cir.2006) a (considering pri- whether highly three documents were material to compound or art would have been chosen they patentability, intentionally were compound). as a lead during prosecution withheld of the '440 inequitable that such patent, and conduct try” ne agree We “obvious was cannot action where be cured gated by general skepticism the concern Shionogi disclosed these docu statins, the fact ing pyrimidine-based respond ments. The Plaintiffs that there pharmaceutical companies other had aban structure, was no intent to deceive or mislead the general doned this and the evi PTO, any prosecution and that error in that the art taught prefer dence was unintentional and was hydrophilic ence not for substituents but lipophilic posi by prompt filing for substituents at the rectified of the reissue C2 Indus., application tion. See Takeda Ltd. v. and disclosure of the uncited Chem. substituents, references, Shionogi as soon as discovered vastatin class but not showing specific compounds the the error. Shionogi submitted for Ki- patenting. Ms. conduct, prove inequitable To the tamura testified that because were “[t]here by clear challenger must show and con no instances of the same compounds patent applicant that the vincing evidence Shionogi,” she did not believe that (1) misrepresented or omitted information patentability problem. references created a (2) patentability, material and did so J.A. 21458-60. Ms. Kitamura prepared intent to mislead or deceive specific Japanese and filed the patent application Therasense, Becton, the PTO. Inc. v. Dick processed foreign counterparts and in- (Fed. Co., inson cluding the application. United States '440 banc). Cir.2011) (en Materiality and in patent application The '440 was filed Id. separately tent must be established. the United States on June 1992. The it materiality, at 1290. To establish must application compounds described a class of

be shown that the PTO would not have with a pyrimidine core as re- HMG-CoA allowed the claim but for nondisclosure ductase applica- inhibitors. Table of the misrepresentation. Id. at 1291. To tion showed that rosuvastatin had best intent, establish intent to deceive the PTO “ inhibitory activity. HMG-CoA reductase in single must be ‘the most reasonable Ms. Kitamura left employment ference to be from the evi able drawn ” about six weeks after the application '440 (quoting dence.’ Id. at 1290 Star Scienti States, was filed in the Mr. United Co., fic, Reynolds Inc. v. R.J. Tobacco responsibility assumed Shibata these (Fed.Cir.2008)). F.3d The dis applications. He received an EPO search findings materiality trict court’s on which report applica- identified the Sandoz error, intent are reviewed for clear and the “particularly tion as relevant if taken inequitable court’s ultimate as to decision alone.” Mr. Shibata the Shionogi asked conduct is reviewed on the standard of compare scientists to conduct tests to Calcar, abuse of discretion. Am. Inc. v. Shionogi compounds preferred with the Inc., Co., Am. Motor Honda F.3d compounds described in the Sandoz and (Fed.Cir.2011). 1318, 1334 Bayer applications. argu- There was extensive evidence and No Information Disclosure Statement court, including ment before district (“IDS”) application, was filed for the '440 testimony Shionogi person- the live nor the and neither Sandoz acting inequitably. nel who were accused of PTO Bayer application provided was It that when at explained scientists appli- or cited the examiner of the '440 Shionogi obtained favorable results with cation. The '440 was issued in- pyrimidine compounds certain modified 9,1993. States on November United rosuvastatin, cluding Shionogi patent fall department patent ap- was asked to file In the of 1997 AstraZeneca Kitamura, plication Shionogi began negotiating on their results. Ms. a license During negotiation then a it employee, obtained search rosuvastatin. reports relating products. to these The was discovered that no IDS had been filed reports European during prosecution application, identified the Sandoz of the '440 lb, application Compound Bayer applica- that included the Sandoz and and that Bayer by that had not been cited the examiner. Japanese application and tions consulted, on large patent of statin com- counsel was and described class U.S. 4, 1997, appli- an pounds generically Shionogi that included the rosu- November filed 2. Intent '440 in order patent cation to reissue the to include the Sandoz to file an IDS and court found that the The district Bayer references in the examination. that either Defendants did not establish it to the PTO that had Shionogi certified withheld the Ms. Kitamura or Mr. Shibata erroneously brought these references Bayer decep references with Sandoz and attention, it and that was to the examiner’s Although deceptive intent tive intent. deceptive through error and not due evi may inferred from circumstantial be reject- reissue examiner then intent. The dence, “must not be the inference obvious in generic ed the '440 claims as evidence and be reason based on sufficient Bayer response, reference. In view of the evidence, it light of that but must able limited the '440 most reasonable infer single also be the compound rosuvastatin and its specific from the evidence to ence able to be drawn granted, salts. The reissue was convincing standard.” meet the clear and pat- the '314 reissue application issued as 1366; Scientific, F.3d at see also Star 7, 2001. August ent on Therasense, 649 F.3d at 1290. argued that the Sandoz The Defendants intent argued The Defendants material and Bayer references were inferred from three situ- deceive should be deliberately they were withheld First, point ations. the Defendants to Ms. intent, inequitable and that such deceptive Bayer refer- possession Kitamura’s conduct could not be cured. ence at the time she filed testimony in the application, and her dis- Materiality 1. duty knew she had a trict court she court, ar- In the district the Defendants to the PTO. Bayer disclose the reference gued Bayer applica- that the and Sandoz Second, to an inter- point the Defendants report highly tions and EPO search are all stating that nal memorandum The Defendants patentability. material to on S-4522 “[djevelopment [ro- information rejection examiner’s pointed to must not be leaked to the out- suvastatin] initially granted, of the claims as text side because it is included Shionogi’s scope. retrenchment claim Bayer patent unexamined published argued Shionogi’s The Defendants ” Third, application.... J.A. 2406. the De- prompt filing application of the reissue that Mr. Shibata knew fendants state recog- that Shionogi itself demonstrated Bayer about the and Sandoz references materiality nized the of these references. yet report, and the EPO search failed to taking the act Although we doubt that disclose them to the States examin- United prompt appropriately remedial action is er. that this failure to Defendants state wrongdoing, viewed an admission of as intent, deceptive disclose was due to Bayer district court found the Sandoz and delays pro- Mr. evidenced Shibata’s to material to the prosecu- references be cessing applications. agree tion of the '440 We application. testimony received compounds sufficiently the reference are The district court concerning prosecution ap- citation. '440 similar structure to warrant Shibata, Kitamura, Mr. Ms. Although plication the references were held from Tamaki, Shionogi employ- and Mr. a third negate patentability PTO not to of rosu- ante, vastatin, as we do not dis- ee. Ms. Kitamura testified that the IDS affirmed was not due when finding turb the district court’s of materi- for the '440 Shionogi. left at Mr. Shi- ality. employment she that it likely bata testified that he believed had was most that Ms. Kitamura acted Tamaki about the without deceptive been filed. Mr. testified intent. department’s heavy provid- work load and The argued Defendants also that of confusion and error. explanation

ed clearly district court failing erred in to find There was examination and cross-examina- that possessed Mr. Shibata in- deceptive concerning Shionogi. tion the events at tent. The argued Defendants that Mr. sug- The district court found that “actions intent, Shibata’s denials of deceptive his gestive of malfeasance become no more excuses, apology and should not have been mistakes, a string mishaps, misap- than credited the district court. The Defen- prehensions and on the misjudgments part argued dants that his negli- admission of inexperienced and overworked individu- gence does not avoid the inference of in- Op. als.” 528. The district court stated deceive, tent and that stress he had simply persuaded that it “is not that the comparative ordered testing. The Plain- single most reasonable inference to be report by tiffs cited a Mr. Shibata dated drawn from these is decep- circumstances (in 14, 1993, July which states the record tive intent.” Id. at 525. translation): ‘Novelty’ and ‘inventive are step’ exam- The that the argue Defendants district ined to determine patentability. It clearly court erred when it did not find an seems that the examination in the U.S. deceptive inference of intent. The Defen- fairly lenient regarding ‘inventive dants that stress Ms. Kitamura did not step’. expect slightly Since we stricter twenty years, remember details after in Europe Japan, examination we they also stress her that admission she process are in the of implementing ‘com- duty Bayer knew she had a disclose parative laboratory tests’ that we reply reference. The Plaintiffs that there can use as If countermeasures. the su- was no evidence she intended to with- periority of S-4522 is con- [rosuvastatin] hold the reference in order to deceive the tests, firmed in these can be PTO, deceptive and that intent is not “the obtained all countries in which we single most reasonable inference to be have filed. drawn from the evidence.” See Thera- argued J.A. 2752. The Plaintiffs this sense, 649 at F.3d 1290. The Plaintiffs report is not an consistent with inference point out that Ms. Kitamura left intent, deceptive but instead reflects his month after filing application, well belief that the examination the United an before IDS was due to be filed. States had been more “lenient” than was expected Europe Japan. The Plain- The court district heard testi argued by requesting compara- tiffs mony, credibility considered of the wit preparing tive tests Mr. Shibata was nesses, and deceptive concluded that intent art, confront the not to conceal it. was not the single most reasonable infer ence to be drawn from the evidence. The are argument record extensive. reassess, may “This court and indeed error has not been Clear shown incapable reassessing, finding deceptive witness credi district court’s in- shown, bility and motive issues on review.” LNP tent the single was not and was not Plastics, Mills, Eng’g Inc. v. Miller Waste most reasonable inference based on all of (Fed.Cir.2001). Inc., 275 F.3d Kingsdown the evidence. See Med. Con- sultants, Inc., have not shown clear er Defendants Ltd. Hollister (Fed.Cir.1988) (en finding ror in the district court’s it banc in rele- (“[T]he Molins, (The deceive”); 48 F.3d at 1181 be suffi- evidence “must part) vant merely not amount finding alleged of deceitful intent conduct must require cient to circumstances.”). of, or omis- improper performance all the light to under of, per- observed the witnesses to have ought district court an act one sion cross-examination, formed.”). exam- examination and documents, reasonably found

ined unenforceability that based We affirm that Mr. “equally plausible” that it was inequitable conduct was not established. on requirements believed the Shibata had been patent prosecution States United Ill court found that met. The district a more inno- “paints evidence as a whole Reissue as a new explanation cent of Mr. Shibata argued also that The Defendants attempting to inexperienced manager reissued, improperly an understaffed and overworked handle statutory arguing require that the reissue Op. 525-26. Department.” Patent intent had deceptive ment of error without that clear and convinc agree We statute, met. The at the time been that Ms. Kita- ing evidence did not show reissue, authorized the reissue of “in a deliberate mura and Mr. Shibata made operative patents, or invalid” as follows: from the decision to withhold references is, any patent through error Whenever Therasense, 649 F.3d at 1290 PTO. See intention, any deceptive without deemed (“In nondisclosure of in involving a case invalid, wholly inoperative or partly or formation, convincing evidence clear specification of a defective or reason applicant must show that the made a de drawing, patentee reason of the withhold a known ma liberate decision to claiming more or less than he had reference.”) (quoting Molins terial PLC Director right patent, to claim in the (Fed.Cir. Textron, Inc., shall, on the surrender such 1995)). sought The court in Therasense required by payment and the of the fee inequitable the law of impart objectivity to law, for the invention by requiring that “the accused conduct ... original patent disclosed in the act infringer prove patentee must that the (1999).2 § 251 The Defendants 35 U.S.C. intent to deceive the specific ed with the (2) (1) error, argued that there was no PTO,” Recognizing 649 F.3d at 1290. deceptive intent. there was patent prosecution, negli complexity argued insuffi The Defendants gence gross negligence —even —is a claim in the '440 deliberately presented intent. See deceptive cient to establish (“a overlapped products in the Kingsdown, finding patent 863 F.2d at 876 attempt get reference in an particular ‘gross conduct amounts to Sandoz justify greater an The Defendants also negligence’ protection. does not of itself deceive”); deliberately acted argued intent Lazare inference of Techs., Int’l, in the '440 obtaining only generic claims Kaplan Inc. v. Photoscribe (Fed.Cir.2010) Inc., patent in order to conceal rosuvastatin F.3d (“mistake pointed ... The Plaintiffs out poor judgment species. or exercise of specifically intent to rosuvastatin was described support does not an inference of any deceptive Congress occur "without inten- 2. In modified Section 251 error Act, 112-29, We consider the earlier version of the American Invents Pub.L. No. tion.” appeal. statutory requirement that the statute this to remove the

523 keeping choose between the earlier inter- as the most effective specification filing drawings, national date without the compounds that are described the four accepting the later date with the draw- with test data. ings. attorney chose the later date argued also that delib The Defendants drawings, petition with the and the was decisions can never be prosecution erate granted. After the United States reissue, through citing the state corrected issued, sought through was Serenkin reis- Serenkin, 1359, re 479 F.3d ment In date, original filing sue to recover the stat- (Fed.Cir.2007) that “case law holds ing attorney choosing that its erred that the action of an inventor or deliberate refused, later date. The PTO and this fails attorney during prosecution generally affirmed, stating court that Serenkin was under qualify as a correctable error impermissibly “attempting to use the reis- However, § the court in Serenkin 251.” sue process consequences undo attorney during not action did hold attorney’s give up his conscious decision to correctable, princi for a prosecution is filing an earlier date so that certain mate- pal purpose of the reissue statute is rial, important which was considered at the correction of erroneous action dur permit time, would be considered with his PCT Rather, ing prosecution. the court held application.” Id. at 1365. The court to consider the na appropriate that it is stressed that the actions had been taken ture of the action to determine whether it knowledge consequences, of their and is a correctable error. The Serenkin court compared these facts with those of In re that “the extent to which the explained (CCPA Wadlinger, 496 F.2d prevents applicant reissue statute an from 1974), where that “er- explained the court claims that differ in form or obtaining “in- purposes encompasses ror” for reissue from the cancelled claims ‘neces substance advertence, accidents, mistakes,” sarily depends upon the facts in each case certainly “is inclusive of actions taken in particularly on the reasons for the ” Wadlinger full consciousness.” In (quoting cancellation.’ Id. at In re 1365. court determined that the reissue claims (CCPA Willingham, 282 F.2d scope original narrower in than the were 1960)). claims, correctable and held that this was Serenkin, On the facts of that court held the fact that “despite error under proposed “correction” did not original the cancellation of the claims was comport purposes with the of the reissue deliberate,” Serenkin, explained attorney In statute. Serenkin wished F.3d at 1365. eight drawings to add sheets of to his Treaty pending Cooperation Patent Precedent establishes (“PCT”) application, filing purposes which had a “error is established that the January pur- appel date of 1997. For that where there is no evidence pose petition intentionally he filed a with the United lant omitted or abandoned Receiving subject Corp. Office under the the claimed matter.” Ball States PTO PCT, States, 1429, 1435-36 requesting that the World Intellectu- United (Fed.Cir.1984). Here, the district court Property Organization “republish al this by failing fact that erred application showing filing date of Feb- found as Bayer the Sandoz and ruary priority citing 1998 with no claim and the to file an IDS references, claim eight drawings by omitting specific sheets of filed on 17 Febru- However, attorney species. ary preferred 1998.” Id. at 1361. The had of a that he must court found no evidence deliberate accepted position PTO’s the rosuvastatin advised of art that was discovered choice to omit or abandon filed; after the specifi- which was described species, court held that “intent to mislead” could product. cation as the most effective inferred, gross negli not be even from argument The Defendants’ In v. Bausch gence. Hewlett-Packard Co. cannot narrow the claims reissue has (Fed. Lomb, Inc., 1556, & 882 F.2d 1566 rejected variety in a of situations. been Cir.1989) patentee’s the court held that the Tanaka, See, 1246, e.g., In re 640 F.3d of affidavits to the PTO submission false (Fed.Cir.2011) (“This court also re- 1250 “eliminated the basis for reissue and ren jects the PTO’s assertion that the omission the '684 invalid” because the dered original pat- an of a narrower claim from patentee’s explanation of “error” was “fac ent does not constitute an error under 35 tually Hounsfield, untrue.” In In 699 re the omission of a U.S.C. 251 because (Fed.Cir.1983) 1320, 1323 the court F.2d dependent pat- claim does not render the held that “lack of ‘intent to claim’ is not an Medtronic, inoperative.”); ent Inc. v. Gui independent denying basis for a reissue (Fed.Cir. 1360, Corp., dant 465 F.3d 1375 251,” only section but application under 2006) (“An attorney’s appreciate failure to upon “sheds whether the claims of light the full of the invention is one of the scope are directed to the application reissue pat common of most sources defects original patent....” same invention as the ents, generally justify and is sufficient to (CCPA In In F.2d Whittelsey, re 894 Wilder, reissuing patent.”) (citing a In re 1936) patentee the court held that (Fed.Cir.1984)); 736 F.2d In re could not use to obtain claims reissue (CCPA Handel, 946 n. 2 F.2d intentionally which “were from his omitted 1963) (“adding dependent claims as original application under the belief hedge against possible invalidity original of they properly could not be included there ” proper asking claims is a reason for that a Murray, in.... In In re granted”). reissue be The district court’s (CCPA 1935) 654-55 the court held that holding affirmance of the PTO’s patentee could not use reissue to ob Shionogi had the right to a reissue tain “improve broader claims to cover which it claimed rosuvastatin and its ments the art which have occurred since salts, with law. accordance patent” the date of issuance of the original incorporated were “not to be intended colleague Our in dissent cites other original application.” None of these denied, cases in which reissue was on other supports rejection appli cases of facts and circumstances. While these for an an cation unintentional failure file cases illustrate the factual nature of a de- IDS. “intent,” precedent termination of no war- finding deceptive

rants a of intent in the The district court considered the Defen- Youman, situation herein. In In re 679 dants’ error arguments directed to both (Fed.Cir.2012) F.3d 1335 the court deter- intent, deceptive and concluded that patentee mined whether the was attempt- intentionally did not act to make reissue, ing “recapture,” through sub- the error for which it seeks reissue. The ject matter that had been surrendered testimony live from district court received Harita, during prosecution. In In re purported culprits, and found that “the (Fed.Cir.1988) F.2d 801 the court held that evidence in this case shows no adduced although, reissue was available due to such deliberate choices on the facts of [as gross negligence, foreign patent practi- and no violations of rules or ] Serenkin tioner did not assure that the PTO was statutes that would render the reissue of improper.” Op. 534. In uitable the '440 conduct. We discern no sound ba- claims, distinction, discussing scope sis for this complexities for the Kitamura district court found Ms. solicitation in stages all its have credibly testified she was unaware been shown susceptible “plague” overlap that there was between the claims opportunistic accusations. See Thera- sense, (“ art 649 F.3d at 1289 habit ‘[T]he because “the internal search re- charging inequitable conduct in almost ev- aware, port of which she was did not raise ery major patent case has become an abso- ”) patentability problem respect plague.’ Indus., lute (quoting Burlington Sandoz, copy and a full of the Sandoz Inc. v. Dayco Corp., 849 F.2d (Fed.Cir.1988)). Op. reference was not sent to her.” 526. This court has repeatedly These internal reports search do not show held in the context of inequitable conduct the chemical structures of the Sandoz ref- by nondisclosure of art itself is 2211, 2224, erence. J.A. 2242. The dis- enough not to create an inference of decep- S.D., trict court found that the evidence showed tive intent. See Mfg. Larson Co. of departure, Ltd., after Ms. Kitamura’s Inc. v. Aluminart Prods. 559 F.3d (Fed.Cir.2009) Shionogi (“[Nondisclo- was not alerted to the need for 1340 sure, itself, further attention to the Sandoz reference by satisfy cannot the deceptive “chaos, confusion, element.”); because of inexperi- Products, intent Dayco Inc. v. ence,” “lack legal training Containment, Inc., of within the Total 329 F.3d (Fed.Cir.2003) (“Intent Shionogi Patent Department, changing 1367 to deceive personnel and limited within that depart- simply cannot be inferred from the deci- ment, level,” ... ongoing confusion sion to withhold the reference where the and “unintentional miscommunications” given withholding reasons for the are plau- Shionogi’s patent between personnel. sible.”); Id. Aspex Eyewear Inc. v. Clariti findings Inc., (Fed. These have not been shown to be Eyewear, 605 F.3d Cir.2010) (“Mistake clearly erroneous. And the Defendants’ negligence, even charge that Shionogi deliberately obtained gross negligence, does not support ruling claims in the conduct.”); '440 that it knew to be inequitable Kingsdown, 863 (en invalid is not plausible. F.2d at 876 banc in part) relevant “ (holding ‘gross negligence’ even does not The district court found that “the Court justify of itself an inference of intent ultimately not that the convinced claims deceive”). Here, after all considering of the '440 that overlapped the evidence, the district court found Sandoz reference were the result of some the evidence support finding did not planned strategy or sinister motivation as (“To deceptive Op. intent. reach a opposed to mere oversight by mistake or contrary conclusion in this case would re- overworked individuals with limited train- quire the Court to credit a number of ing and expertise.” Op. 528. See Hew- inferences, unsup- which the finds Court (“The Co., lett-Packard 882 F.2d at 1565 ported by requisite clear and convinc- statute, language of the current ‘error standard.”). no ing Id. We find error. deceptive encompasses without intent’ ... ”). ‘inadvertence, accident or mistake.’ law require “The does not that no The argue competent attorney Defendants “de or alert inventor could ceptive intent” in the reissue statute re have sought avoided the error to be cor quires rigorous proof “deceptive Scripps less than rected reissue.” Clinic & Res. Found, Genentech, Inc., charges intent” in connection with of ineq- v. 927 F.2d 1565 specifically claimed.” (Fed.Cir.1991), pound is the one grounds on other overruled However, Sandoz, Inc., n. 4. this is not at 535-36 Dissent by Abbott Labs. (Fed.Cir.2009). product was preferred error where the The case disclosure, to be agreed to file an IDS was for rosu- failing “buried” massive error, promptly upon an and was rectified described as specifically vastatin was colleague dissent discovery. its Our product. specification The potent most speed of the complain about does compounds that the four tested also states error, but would hold moves to correct the Mevinolin,” a known “superior are statin have been detected that the error should commercially successful and market- to be sooner, failure of detection is this the brand name Meva- ed Merck under However, all patent. fatal to the reissue limit the The decision to patentee’s cor®. cited cases relate to the absence that was de- compound after it correcting the error diligence as the most specification scribed in the En- E.g., Principle Bus. was detected. compounds specifically de- potent of the States, ters., Inc. v. Cl.Ct. United po- is not evidence that the most scribed (“The (Cl.Ct.1985) than delay of more deceptively concealed. compound tent learned of the years plaintiffs after seven internal points dissent original patent their alleged affecting error against “leaking” documents that caution justified.”); unreasonably long is and Bayer. discovery the of rosuvastatin to Labs., B. Du Mont Radio Co. v. Allen Gen. but prudent, Such caution was indeed (3d Cir.1942) Inc., (delay 612 discovery pat- for presented when the was when “in- years of was unreasonable eight as the enting, specifically it was identified ... validity patent the have been should Cautioning sci- compound. most effective rudimentary anyone to with even a clear “leaks” is a distinct matter against entists law”); Miller v. knowledge obtaining for valid and from the concern Co., 350, 26 Bridgeport Brass 104 U.S. are strong specific claims patents, (1881) years (delay L.Ed. 783 of fifteen than broad claims that risk more reliable patentee sought when was unreasonable art. The fringe prior the citation of dis- newly to cover discov- broadening reissue Shionogi that the fact that argues sent also contrast, In the reis- improvement). ered the narrowed its reissue claims to com- promptly here was filed sue rosuvastatin, seeking without broad- pound upon discovery of the error. generic scope, deceptive er is evidence of Defendants, colleague The and our that its concern Shionogi intent. states dissent, propose that omitted examination on the uncited was to obtain ap- its specific claim to rosuvastatin from references, claims to limiting and that compound plication in order to conceal the that product implemented the preferred However, competitors. from rosuvastatin In view of circumstances concern. in the explicitly described in or- necessitating procedure the reissue preferred compound. as the specification references before bring der to the uncited identified, including its specifically It was examiner, it not clear how the limita- is synthesis test results. This is not compound the claims to the tion of col- with concealment. Our compatible suggests pri- interest commercial “[djescribing a com- league states decep- on procedures or flawed were based in the examples in the contained pound tive intent. however, unlikely be the to specification, We also take note of dissent’s flag1 narrowly claiming a com- ‘red be, “[b]y failing promptly to act if that com- concern that pound particularly would claim, Shionogi court that it is a defendant to this action overbroad to narrow its only signed because it and filed the ANDA public right experi- of the to deprived with, Apotex Apotex the com- on behalf of Canada. improve upon, and to U.S. ment claim 1.” Dissent stated that it did not “submit” the ANDA encompassed by pounds 271(e)(2)(A) However, patenting meaning does not de- within the at 538. right experiment infringe patent. Apo- of the to thus cannot the U.S.

prive public tex also improve upon patented Apotex sub- U.S. stated Canada with Ag infringement cannot liable for ject matter. As discussed J.E.M. be this Int’l, party action because it is not a Inc. v. Pioneer Hi-Bred to this suit. Supply, Inc., S.Ct. U.S. Apotex district court found U.S. to (2001), re- L.Ed.2d 508 disclosure “[t]he Apotex be the ANDA “submitter” because pro quired by quid the Patent Act is ‘the actively partici- U.S. filed the ANDA and ” exclude,’ right quoting of the Ke- quo pated Apotex preparation Canada in Corp., v. Bicron 416 U.S. wanee Oil Co. ANDA, of the in- Apotex U.S. 470, 484, 1879, 40 L.Ed.2d 315 94 S.Ct. directly from- ANDA tends to benefit (1974). necessary It to wait for the is not by selling drug product in the United expire knowledge before the con- upon approval States of the ANDA. The in the can be touched. The tained Apotex court found that acts as the U.S. explained by to exclude was patent’s right Apotex and distribution arm of marketing Cutter, Story in Justice Whittemore States, relationship in the Canada United (C.C.D.Mass.1813): F. Cas. disputed. Apotex that was not Canada is never have been the intention could

[I]t party not a to this suit because the a man legislature punish who infringement against Apotex case Canada merely such a machine for constructed was transferred to the Southern District of or the philosophical experiments, for Canada, request Apotex Florida at the of ascertaining sufficiency of purpose personal juris- which the absence of pled its produce of the machine to described diction Delaware. In re Rosuvastatin effects. Litigation, MDL OS- Calcium Patent No. (D.Del. 1949, 19, 2010 WL 661599 Feb. 1121; Id. at see v. United Chesterfield (Ct.Cl.1958) (ex States, 371 F.Supp. 159 2010). perimental study infringement). is not Apotex argues that it cannot be U.S. by judgment court’s of bound district sum, correctly

In the district court infringement only signed because it and available, that and that found agent Apotex filed the ANDA as of scope of the reissue was in accordance ruled that Canada. The district court law.

Apotex infringement can be liable for U.S. 271(e)(2)(A), § because under IV Apotex entity signed U.S. is the that Infringement ANDA, it in- filed the but also because from the Apotex application of tends to benefit exception With (herein U.S.”), product manufac- “Apotex selling all of the the rosuvastatin Corp. The dis- 6 tured its relative. infringement Defendants admit of claims Canadian testimony by Apotex is a trict court referred patent. and 8 of U.S. U.S., Apotex of who stated States affiliate of the Canadian President

United (herein “made the decision to ‘de- company Apotex “Apotex Apotex Inc. Can Canada ada”). generic velop in the Rosuvastatin calcium as Apotex U.S. stated district States, Inc. v. Watson Apotex generally Cephalon, for

product for United Pharms., Inc., 338, F.Supp.2d in the StatesThe U.S. sell United (D.Del.2009); Cyclobenzaprine Hydrochloride In re district court found that U.S. ac- Apotex Capsule Extend ed-Release tively participated in activities related to 409, 417 conjunction Litig., F.Supp.2d the ANDA submission in with Patent (D.Del.2010). Canada, referred to Apotex activities Krishnan, manager regula- Mr. Kiran Apotex argues U.S.C. U.S. U.S., tory affairs for at the head- Apotex § 355(j) applicant identifies the as “the quarters Apotex preparing Canada ANDA, an person entity who submits regula- the ANDA consultation with the what the must do to applicant establishes tory Mr. Apotex staff of Canada. Krish- ANDA, an incentives to submit creates signed Apotex nan the ANDA on behalf submission, encourage pro- ANDA U.S., agent. The as the authorized U.S. patent certainty.” vides a means to obtain Apotex district court concluded U.S. Apotex Apotex argues Br. 15. U.S. may infringement for be held liable under 271(e)(2)(A) § incorporates 35 U.S.C. 271(e)(2)(A) Section as a “submitter” of an § 355(j), consequently defines who

ANDA. Apotex explains submits an ANDA. U.S. similarly that the Hatch-Waxman Act de- Responding Apotex argument an applicant fines its section related to pro- that the Hatch-Waxman Act does not “submit,” drug applications, new which states “[t]he vide a definition of the district with the applicant shall file adopted court for a legal standard expiration number and the date of “submitter” set forth in In re Rosuvasta- any patent drug which claims the tin Litig., Calcium Patent WL (D.Del. 2008) applicant applica- which the submitted at *10 Nov. 355(b)(1) (“Rosuvastatin § tion ....” 21 I”), (emphasis U.S.C. and in Astrazeneca U.S.). Ltd., by Apotex Apotex argues U.S. Pharms. LP v. Aurobindo Pharma 271(e)(2)(A) (D.Del. makes no mention of “active 2009 WL at *3 Feb. 2009). involvement,” “parent-subsidiary,” “princi- In cases the court those district pal-agent,” or intent to benefit from held that ANDA approval, argues and these wholly-owned subsidiary of a foreign factors are irrelevant to the “submitter” ANDA applicant, signs which an ANDA issue. agent parent-applicant, as the of its and directly which intends to benefit if the Apotex argues regula- U.S. that FDA approved by participating ANDA is in identify applicant person tions the as the manufacture, importation, distribu- ANDA, entity citing or who an submits generic drug tion sale of the [i]s and/or 314.3(b) § (“Applicant any C.F.R. means 271(e) subject § to suit under as the one person application who an or ab- submits

who has “submitted” the ANDA. application breviated or an amendment or supplement part Rosuvastatin I at *10. Other have them courts under this applied liability drug also to the ANDA FDA of a new or an approval “submit- obtain ter” signs drug any person who the ANDA and intends to antibiotic and who owns directly approved application ap- benefit from the ANDA. See an or abbreviated Ltd., Wyeth Lupin F.Supp.2d v. plication.”). Apotex Apo- U.S. states (D.Md.2007); 306-07 Paragraph Aventis Pharma tex IV certifi- Canada made Ltd., cation, Lupin Paragraph Deutschland that a IV certification is GMBH (E.D.Va.2005); 271(e)(2), § F.Supp.2d infringing 492-94 see act under and Apotex agent cannot be da. As an for the applicant, Apotex therefore U.S. by any judgment patent infringe- argues of U.S. that it is an applicant bound ment. therefore cannot an infringer. be deemed question The of an agent-filer- whether argues that the district Apotex U.S. also Apotex submitter such as U.S. can be a is unfair because its orders ruling court’s party liable infringement under Canada, Apotex can affect the interests of 271(e)(2) § question is a impression of first court, Delaware who is not before the in this court. thus that the district court violated the due Apotex of process rights Apotex Canada. The statute nowhere addresses argues Apotex U.S. also Canada is a question in agency of the submission of an necessary party against Apotex to the suit 271(e). However, application under U.S. creating infringement artificial act of properly The district court deemed ANDA, by the submission an the statute arguments these The court unpersuasive. does add the following qualifier related to Apotex found that the interests of Canada the applicant’s purpose making the sub- agent action are its represented this mission: “It infringe- shall be an act of U.S., subsidiary, Apotex and that Apo- ment to submit an ... application if the tex participated preparation U.S. purpose of such submission is to obtain ANDA represented that it would sell approval ... to engage in the commercial product in the That use, United States. manufacture, drug or sale of a ... relationship is not denied. patent....” (emphasis claimed Id. added). phrasing leaves unclear what We conclude that the district court did consequences are if the party who holding Apotex not err in U.S. is application submits the is not the same as properly named as a defendant in this the principal party “engage who will in” judgment infringement action. The drug the manufacture of the at issue. against all of the Defendants is affirmed. AFFIRMED. Thus question becomes whether the statute is intended to include within its PLAGER, Judge, concurring. Circuit 1) scope any agent simply who submits files) (ie., join I Newman. an for another who opinion Judge manufacturer; principal commercial I clarify my understanding write to 2) agent an who on files behalf of such why Apotex U.S. should be treated as another, who but has financial interest having an application for an “submitted]” beyond simply acting for the commercial ANDA, and therefore be held liable as an manufacturer, situation, and in this latter 271(e)(2). § infringer under 35 U.S.C. qualifies what as a in- sufficient financial whether, statute, question is the under terest. Apotex application U.S. an “submitted] ... for a ... claimed in a drug or first, regard With to the there can be no the use of which is in a claimed many doubt in applications are fact expiration before the If patent.” such by attorneys the FDA submitted to so, the statute an deems that to be act of acting agents party others as for the real infringement. Id. ie., interest, in the commercial manufac- that, Apotex argues filing U.S. the turer at generic drug of the issue. It ANDA, application simply for the it was an would make little sense to read the statute agent for the the applicant, Apotex making agents true Cana- such liable for artifi- made Apotex therein. tex and that Canada infringement”

cial “act of created Canada attorney drug] an or other “to as a Though presumably develop the decision [the States, principal commercial agent representing for the for generic product United could fashion some sort of manufacturer Apotex U.S. to sell the United ” provision employment in the hold-harmless Op. See at 527-28. Further- States.... contract, unnecessary complication such more, court, Apotex in its brief to this U.S. associated potential and the mischief relationship: “Apotex acknowledged this Congress be what had therewith cannot to market the de- hopes product [U.S.] prepares and agent simply mind. An who ... day scribed in the ANDA some [and] is an application the as such submits day product to one market the desire[s] party it is the real in interest— applicant; Appellant’s in the ANDA....” described is the the commercial manufacturer —who Br. at 12. Reply ap- the statutory applicant who “submit[s]” applied following The district court infringe-

plication and commits the act of legal determining liability standard for for us, ment. In the case before there is no of an ANDA: submission principal Apotex doubt that Canada is party engage in interest and intends “to wholly-owned subsidiary foreign of á manufacture, use, or sale” the commercial applicant, signs ANDA which an ANDA drug, applicant of the and thus is an under agent parent-applicant, as the of its the statute. if directly which intends to benefit inquiry. participating But there remains second ANDA is approved by— agent manufacture, of the who has a financial importation, What distribu- interest in the manufacture or distribution generic drug tion sale of the [is] and/or — subject drug 271(e) of the is subject to suit under as one Here, Apotex ANDA? U.S. did indeed as- who has “submitted” an ANDA. Apotex planning, prepa- in the sist Canada (modification in Op. original). at 528 This

ration, application, and submission of the approach was a standard derived from the above, that cannot but as discussed alone several other district had taken. courts case, however, liability. In this create there more—it is clear from the record that, logic position There is some merely an Apotex agent U.S. is not agent expects when such a related to fi- who the manufacturer in submit- assisted nancially approval benefit from the ting an under the statute. way, by ANDA in a significant example if becoming major not sole distributor of U.S., Apotex

The record indicates States, generic product in the United relationships virtue of the between it- broadly can be Canada, statute understood Apotex corporate self and both enough agent to include an as a statu- otherwise, such entity— will become the indeed, tory agent Such an could “submit[ter].” will party a real in interest —that may party thus be considered a who be in the drug use and sell the United States. found, statutory infringe- held liable for the act of court on the testi- The trial based U.S., mony appli- that ment virtue of submission of the Apotex President of Apotex marketing Apo- is the arm of cation.1 U.S. away Drug Approval process, the Apotex

1. U.S.’s effort to divert attention to the New misses 271(e) parts § from to other of the statutes— point scope § is the of "submit” in 271 —it including regarding Paragraph provision the the is issue. 355, relating § IV and 21 U.S.C. certifications

531 wholly- (“Shionogi”) not a Kabushiki Kaisha has forfeit- Although Apotex U.S. is Canada, they subsidiary Apotex of the to right owned ed obtain reissue its failure through complex related cor- closely are in diligence seeking to exercise due to statutory structure.2 Both the porate in rectify alleged pat- the defect analysis suggested here and the evidentia- ent. the district

ry support record in this case bringing Apotex within the court U.S. I. party the who submits an ANDA ambit of a deemed subject liability thus is limited “Congress reissue to instances infringer. patentee could an where demonstrate ” any ‘error without deceptive intention.’ however, directly, in this case More Youman, (Fed. 1335, In re 679 F.3d 1342 in, clearly engage intends to Apotex U.S. Cir.2012) 251); § (quoting 35 U.S.C. see ANDA for presumably submitted Serenkin, 1359, also In re 479 F.3d 1363 of, drug purpose selling approved (Fed.Cir.2007) (concluding that reissue was speaks States. The statute the United patentee’s attorney not available where a engaging not in terms of commer- accept made a “conscious decision” to manufacture, but, disjunctively, cial later for Hew- filing application); date his drug’s in the “use or engaging terms of Lomb, Inc., lett-Packard Co. Bausch & acknowledged agent an sales for sale.” As (Fed.Cir.1989) (em- 1556, 882 F.2d 1565 applicant, Apotex U.S. can be primary seeking that a phasizing party simply an having “submitted]” treated as must establish “inadvertent error in con- purpose an ANDA for the application for 1320, duct”); Hounsfield, In re 699 F.2d ... “engag[ing] the commercial sale (Fed.Cir.1983) (explaining that reis- drug patent.” ... claimed in a [the] an designed sue is “correct inadvertent analysis, court Under either the district original patent”); error in the In re Whit- in concluding Apotex did not err U.S. (C.C.P.A.1936) telsey, 83 F.2d infringement.3 an act of is liable for (concluding improper reissue was MAYER, Judge, dissenting. Circuit “there was no or mis- where inadvertence in a to omit cer- patentee’s take” decision respectfully I dissent. There can be no original application); tain claims from his No. infringement of U.S. Reissue Patent (C.C.P.A. Murray, In re (the 37,314 patent”) “'314 because that 1935) may be (explaining that a improper reissue. is invalid purpose correcting reissued “for § 251 Reissue is available under 35 U.S.C. judgment”). Prior to errors rectify from resulting an “error” inad- vertence, accident, specifically provided reissue statute or mistake. No such through correctible reissue were No. defects present error was in U.S. Patent “ (the 5,260,440 those that had resulted from “inadver- '440 so there is patent”), tence, accident, or it be mistake.” U.S.C. upon properly no basis which could (1946); Weiler, F.2d Furthermore,'Shionogi Seiyaku In re reissued. Canada, regarding judgment Apotex opinion

2. the district court at 11 for a make no See suit; description corporate in- any structure party law who was not a to this volved. rights obligations may when and if it have involving brought it into a law suit infringer finding Apotex an 3. In U.S. liable as subject are product is the of this case having virtue of “sub- under statute its questions time. for another ANDA, for the we mitted]” 532 (Fed.Cir.1986). Shionogi A internal search it enacted sec- ent. June 1991

1582 When 251, prior provision, the current Sandoz as relevant report tion identified Congress intended to retain the “inadver- a Shionogi In received art. October accident, tence, that (“EPO”) or mistake” standard search European Patent Office the earlier statute.1 had existed under of Sandoz. report copy with an attached Hewlett-Packard, 1565; F.2d at see In as an “X” report This identified Sandoz Wadlinger, 496 F.2d re reference, meaning that the reference was (C.C.P.A.1974) that when (emphasizing if taken alone.” “particularly relevant for Congress substituted the word “error” report received the EPO search Shionogi “inadvertence, accident, the words or mis- counter- European time when the second take,” “a it did not intend to make substan- published '440 was part patent change”). tive January 1993. Here, Shionogi judg- made an error in Kitamura, Shionogi em- Tomoko prosecute it to a broad ment when elected ployee application, who filed the '440 tes- genus pyri- claim which covered trillions of trial, stated that she tified at but never compounds clearly midine and which over- disclosure or misapprehended Sandoz reference, prior with a known art lapped appreciate overlap that she failed to Application No. European Published patent. it claim 1 of the '440 between (“Sandoz”). There is no evidence that contrary, To the the record shows overlap between claim of the was well aware of Sandoz at the the result of '440 and Sandoz was Kitamura the '440 application. time filed inadvertence, than ignorance or rather report A November 1991 internal search attempt patent rights to obtain deliberate prior Sandoz as relevant art and scope possible. that were as broad in listed single patent prosecutor “pyrimidine Not a inventor or it explained disclosed unknowingly testified that he or she or activity. skeleton” with statin Given the inadvertently overlap introduced the be- overlap obvious between Sandoz and Indeed, tween Sandoz and claim 1. credulity accept claim it defies to trial, testify inventor to at Haruo Kitamura, years had who had several Koike, stated that he did not believe that experience prosecuting pat- preparing any patent. there was error in the '440 degree ent and who holds a applications App. Joint 22763-65. organic synthesis, chemical would fail appreciate that claim 1 was directed to undisputed It subject previously matter disclosed in prosecuted aware of Sandoz it when of the pat- obtained the broad claims '440 Sandoz.2 251, during peri- application, unexpired part of the

1. Section the relevant time ed for od, original patent. term of the No new matter provided: shall be introduced into the is, any patent through with- Whenever eiror reissue. intention, any deceptive wholly out deemed added). (emphasis § Pursuant 35 U.S.C. invalid, partly inoperative by or or reason Act, Leahy-Smith America Invents specification drawing, of a defective or 112-29, 20(d), Pub.L. No. 125 Stat. claiming patentee more or reason (2011), any deceptive the words "without right less than he had a to claim in the intention” were deleted from the statute. shall, patent, the Director on surrender trial, payment and the the fee of such believed 2. At Kitamura stated she law, required reissue the for the that none of the art cited in internal original patent, reports "patentability concerns” invention disclosed search raised Shionogi's pyrimidine respect and in with a new and amend- statins. accordance Shionogi July patentee Kitamura left A cannot When establish correctible primary Takashi Shibata assumed “error” simply by under section 251 dem- responsibility prosecution of the '440 onstrating original patent that his contains application. Shibata received the EPO Hewlett-Packard, a defect. 882 F.2d at report declaring “par- Sandoz to be search (emphasizing that the fact pat- that a art, ticularly relevant” stand-alone ent is “defective” does not “give[ rise to ] Shibata, moreover, specifically instructed ”); Weiler, an inference of ‘oversight’ Shionogi compare scientists test F.2d at 1582-83 (concluding reissue preferred compounds disclosed Sandoz was not permitted patentee where a failed '440 application. with those disclosed to establish that he had unintentionally trial, he, Shibata at like Although testified omitted subject matter from his original Kitamura, that he never stated failed claims); Mead, In re 581 F.2d appreciate scope of the invention dis- (C.C.P.A.1978) (holding that a “conscious closed or that he was choice” not to file a continuing application overlap unaware of the obvious between error); did not constitute correctible In re claim 1 and Sandoz. (C.C.P.A.1956) Byers, 230 F.2d (emphasizing that the deliberate amend- 1997, Shionogi In Zeneca Limited ment of a claim did not constitute correcti- (“Zeneca”)3 entered into discussions re- error). Instead, ble reissue is warranted garding licensing agreement that would patentee where a ... “supplies facts allow Zeneca to commercialize rosuvasta- accident, ... indicating ignorance,” how or tin, promising compound the most dis- mistake caused an error his claims: patent. closed in the '440 During these negotiations, Zeneca raised concerns that patentee’s] reliance on allegations [The potentially invalidating prior Sandoz was ignorance the inventors’ of drafting App. response, art. Joint 2285-86. In claiming technique ig- and counsel’s Shionogi conceded that it “had been aware norance of the invention unavailing. ... prior filing [Sandoz] ['440 allegations Those could frequently be application]” and that there an overlap made, and, accepted if establishing between claim 1 of the '440 error, require grant would of reis- “the disclosure and claims of [Sandoz].” Id. anything sues on and everything men- asserted, however, at 2290. tioned in a patentee] disclosure. [The paid” “not so much attention was to San- supplies indicating ig- no how the facts doz because it believed that rosuvastatin any norance relied on error.... caused scope “did not fall within the of [Sandoz].” pat- 251 does not authorize the [Section] Id. when Significantly, responding to entee to his re-present application. concerns, invalidity Zeneca’s did Weiler, at 4 (emphasis 790 F.2d 1583 n. not assert it previously had misunder- added); In Wittry, see also re stood the scope of the Sandoz disclosure or (C.C.P.A.1974) 1299, 1302 (holding that it unintentionally inadvertently had overlap claims invalid where “the declarations [did] introduced between Sandoz any and claim 1. not present explanation reasonable App. Contrary majority’s predecessor Joint 21458. 3. Zeneca is the to AstraZeneca assertions, 523-24, however, ante at Kitamura UK Limited. appreciate never testified that she failed to patent overlapped that claim 1 of the '440 with Sandoz. intentionally pursue claims original in the claims which the cant would any errors overcome”). argument known to be invalid.” This is reissue would First, unpersuasive for two reasons. Serenkin, 1362-65, in- 479 F.3d at is overlapped fact that claim 1 with Sandoz There, prosecut- structive on this issue. necessarily did not render that claim inval- attorney accept filing chose to a later ing genus prior id. A of a broad art subset to in- exchange being date in for allowed potentially patentable. See compounds drawings applica- clude additional with his Lilly Regents, Eli & v. Bd. 334 F.3d Co. reissue, patentee sought tion. The later (Fed.Cir.2003). 1264, Indeed, during 1270 arguing attorney that his had “made the Zeneca, negotiations Shionogi’s with wrong procedural accepting choice” attorney that claim 1 of patent U.S. stated rejected filing later date. M at 1362. We necessarily invalid patent the '440 was not argument, explaining that reissue is this in view of Sandoz “because it be [could] genu- where there has been “a appropriate that ours is a invention from said selection error,” patentee where a ine but not his Joint genus App. within the of [Sandoz].” deliberate, attorney has made “a but sub- 5187. sequently disadvantageous, found to be

choice.” M at 1364. Second, infrequently not in- patentees tentionally very independent draft broad analysis

A here. applies similar Shiono- claims, “hedge” against invalidity by but gi judgment made an error in when it drafting dependent narrower claims. See genus maintained a prosecuted and broad Tanaka, In re 640 F.3d 1249-51 clearly overlapped, claim that with a known (Fed.Cir.2011). Here, Shionogi believed any art reference. prior Absent evidence genus that even if the broad claim con- showing overlap that this the result of was mistake, subsequently tained in claim 1 was found however, inadvertence or Shiono- invalid, subgenus to be claims gi right pro- had no to invoke the reissue Sandoz, “deliberate, overlap which did not with would remedy cess in order to its but rosuvastatin, protect important its most subsequently disadvantageous, found to be 20513-15; Id.; compound. App. See Joint Hewlett-Packard, choice.” 882 F.2d 8532-37; 20208-09. (rejecting argument that “an at presumed, error in conduct must be absent II.

affirmative evidence that the defect in the which is asserted the reissue concluding In that the '440 was intentional”); application was see also Yon- reissued, properly majority conflates man, at (explaining guilty the issue of whether requirement section 251’s “error” covers with inequitable question conduct mistake,” “inadvertence or not “deliberate” requirements whether it met the for reis- patentee). choices made As we Shionogi failed to sue under section 251. clear, previously have made section 251 any prior cite relevant art to the United panacea not enacted as a all “was Office States Patent and Trademark patent prosecution problems, nor as a (“PTO”) prosecuted appli- when it grant patentee opportu- of a second Indeed, suggests cation. the record nity prosecute original ap- de novo his Shionogi acted with intent to deceive the Weiler, plication.” 790 F.2d at 1582. highly it PTO when failed disclose appeal, Shionogi argues Bayer application, Japanese On that the ov- material see erlap Application No, with Sandoz must have been uninten- Published Patent 1989- patent appli- report tional because “no rational and the EPO search identi- however, Shionogi ultimately relevant stand- cancelled all highly as a fying Sandoz of the claims of the '440 patent including art reference. Prior to Thera- alone — Co., 3 which sense, Becton, overlap claims did Dickinson & Inc. v. (en (Fed.Cir.2011) replaced Sandoz—and them with new

F.3d 1290-93 narrowly claims directed to rosuvastatin. banc), surely would have been this conduct overlap If the with Sandoz were the result office. as fraud on the censored Shionogi inadvertence mistake and Shionogi’s arguendo that accepting Even merely attempting rectify was to this al- satisfy the was insufficient to malfeasance error, leged presumably it would have sim- inequitable for conduct articulat- standard ply revised claim 1 and left claims 2 and 3 Therasense, however, this does not ed intact. validly the '440 was reis- mean that to de- Shionogi

sued. Whether intended Shionogi’s initial failure to a nar- obtain by failing to Sandoz ceive the PTO disclose row claim directed to rosuvastatin was not wholly separate a issue from whether it is mistake, the result of error or but was deliberately overlap introduced an between a part instead of deliberate effort to avoid patent. and the '440

Sandoz Bayer, its inter- alerting competitor, of its very est in the compound. Shionogi was that it failed to disclose Shionogi asserts Bayer concerned that if discovered that art to the PTO prior material because Shionogi focusing was on rosuvastatin it that ensued the “chaos” and “confusion” try compound would to include that in the resigned July after Kitamura 1992. As- pending patent claims of its application. Mylan traZeneca Pharms. LP v. Pharms. memorandum, In a November 1991 (D.Del.2010). Inc., F.Supp.2d Shionogi advised its example, employees Kitamura, however, already had filed the prevent be “on maximum alert” to “leaks overlap '440 its —with relating secrets status Shionogi. Sandoz—when she left There is be- Shionogi development” [rosuvastatin] any that confusion no evidence there was “Bayer might cause make an effort to as- Shionogi patent depart- in the or chaos sert” that rosuvastatin was included within Thus, departure. ment before Kitamura’s pending application. the claims of its Shionogi patent while confusion within the Indeed, at trial Shibata App. Joint 2241. department may have led to the failure to Shionogi was concerned acknowledged art, disclose material there is no Bayer Shionogi “that if found out that was overlap that it led to the between evidence [rosuvastatin], Bayer try would focusing on claim 1. Sandoz and ... pending to cover in their [rosuvastatin] III. application.” App. Joint 20760. ap- that the failure to Shionogi

When submitted its reissue There is no evidence stating it filed a declaration include a claim directed rosuvastatin plication, “error” or mistake. In- right it had “claimed more than had a was the result of [it] stead, evidence strong to claim reason of the disclosure of the record contains Shionogi Shionogi specifically failed to claim App. Joint 2812. [Sandoz].” “tipping to avoid off” overlap could have remedied the with San- rosuvastatin order Instead, by simply revising Bayer compound.4 claim 1. about its interest in the doz plausible Bayer described in presents 4. no alternative because rosuvastatin was Describing specification. explanation specifically patent’s claim for its failure to Instead, Shionogi argues compound examples contained in the that it rosuvastatin. however, unlikely attempt specification, to be the did not to conceal rosuvastatin from provide an ade patentee had where a failed Bayer application It was after the was of what his error quate “explanation decided to been withdrawn (emphasis why it occurred” to rosuvastatin and how add narrow claims directed omitted)). Thus, is invalid a reissue salts. and its where, here, a fails to substan patentee assertions, majority’s Contrary to the original of “error” in the tiate assertions 523-24, presented at the situation ante Hewlett-Packard, 882 F.2d at claims. See presented different from that here is far (“[A] not make applicant does There, we concluded that reissue Tanaka. error in conduct prima case of facie proper patentee where a retained his statement merely by submitting sworn claims, depen- but added a narrow original statutory language.”); parrots which In Ta- dent claim. 640 F.3d at 1249-51. (concluding 489 F.2d at 1302 Wittry, naka, however, supported the inventor his “the improper reissue was where declara by filing claim of error a declaration ex- present any reasonable ex tions [did] fully appreciate that he “did not plaining any original of errors in the planation according to process claiming the of U.S. ” which the reissue would over claims Here, by practice.... Id. at 1247. con- come”). Here, claims Shionogi obtained trast, overlap that the there is no evidence obviously overlapped which with a known any to misunder- Sandoz was due intentionally prior art reference and failed standing requirements proce- of PTO preferred to a claim to its seek directed experience dures. had extensive competitive compound gain in order to Indeed, patents. before prosecuting U.S. marketplace. Such ma advantage the November 1993 when the '440 is- an abuse of the reis chinations constitute sued, Shionogi for and re- applied had contrary process wholly and are sue patents. Signif- ceived more than 200 U.S. 251, predi a statute objectives of section

icantly, the same time approximately at equity of principles cated “on fundamental application that Kitamura filed the for the Weiler, 1579; fairness,” 790 F.2d at disclosed in the pyrimidine compounds (em Serenkin, also 479 F.3d at 1362 see patent, application '440 she also filed an remedial function of phasizing “the pyrrole compounds. directed to statin the statute is not without limits” pyrrole application This contained a nar- [reissue] pyrrole “the deliberate action of an inventor or preferred row claim directed to the Kitamura, therefore, clearly attorney during generally fails compound. prosecution error under specifical- qualify understood how to draft a claim to as correctable 251”); Harita, 801, ly compound to a In re 847 F.2d 809 preferred directed (Fed.Cir.1988) (“In case, any the yet given failed to do so when she filed the '440 application. applied statute should be so [reissue] justice the will be done both to facts extraordinary procedure “Reissue is an public.”). and the patentee by the adequately supported and must be validly-issued patent The claims of a circumstances detailed [section 251].” function, States, notice alert- Corp. important Ball 729 F.2d serve an United (Fed.Cir.1984) (footnote omitted); and bounds of ing public 1435 see metes Hewlett-Packard, discovery. Superior at an inventor’s See also 882 F.2d 1566 Co., Majestic Prods. (concluding permitted Fireplace that reissue was not Co. v. claiming pound specifically claimed. flag” narrowly "red a com- is the one be, pound particularly if that com- would (Fed.Cir.2001) (“This 1358, 1371 claims, court “usurpfs] right F.3d he of the public graze in the field propriety erroneously has noted the of inde claimed previously private preserve.” Principle Bus. En public notice pendently considering ters., States, Inc. v. United 7 Cl.Ct. stat interpreting function (Cl.Ct.1985) (citations and internal utes.”). public This notice function will be omitted); Radio, quotation marks Gen. if requirement subverted the “error” F.2d at (emphasizing that failure to paten read out the reissue statute and prompt take action to overly narrow broad given reign tees are free to rewrite their gives claims a patentee an “unwarranted they expedient claims whenever find it claim of monopoly”). Indus., Stein, do so. See Hester Inc. v. (Fed.Cir.1998) Inc., Here, Shionogi learned of the Sandoz (“[H]ere, attorney second reference no later than June draft[ed] 1991 when an internal search nearly report claims a decade later and issued in [reissue] connection with the '440 advantage having with the distinct be identified Sandoz as relevant prior importance art. The product fore him the exact offered Sandoz to the claims of the '440 now accused infringer.”). received,

was made clear when October report EPO search IV. “particularly identified Sandoz as a rele- Equity patentee dictates that a exercise vant” prior standalone art reference. On diligence seeking rectify due a defect 21,1996, February rejected the many EPO patent. v. Bridgeport his See Miller of the claims in the European counterpart Co., 350, 351, Brass 104 U.S. 26 L.Ed. 783 to patent based upon Sandoz. (1881) (explaining that where a “mistake Shionogi thereafter narrowed claim 1 in instantly was so obvious to be as discerni- European application the and added a ble on opening letters-patent,” any claim specific to rosuvastatin. It waited right to have the patent reissued “was however, years, for over August two until abandoned and lost unreasonable de- 1998, patent. to seek reissue of the '440 lay”); Radio B. Gen. Co. Allen Du Mont Thus, Shionogi maintained the broad Labs., Inc., (3d Cir.1942) F.2d patent claims of the '440 for more than (“It has long been settled that due dili- years seven after of the learning Sandoz gence must be exercised in discovering reference, years for more than six after in a patent mistake and that an unreason- receiving report identifying the EPO San- delay making application able for reis- particularly doz as relevant stand-alone patent.”). sue invalidates the reissue art, years for more than five after reasons for requiring prompt action to cor- issuance of the '440 patent, and two “may rect a just great defect be years surrendering after the correspond- in a patentee case where the seeks to ing European application claims in the due narrow his as where he claims seeks to proffered Sandoz reference.5 It has Radio, broaden them.” Gen. 129 F.2d at adequate justification no for its failure to patentee unjustifiably 613. Where a de- rectify alleged error in the '440 lays seeking overly timely broad manner. appeal, Shionogi overlap

5. On asserts that it of the Sandoz and was between claim overlap aware of the between Sandoz and when it received the 1997 letter October from claim 1 until October 1997. This contention pointing overlap. App. Zeneca out this Joint Testimony belied record. at trial 20463. already established that was aware correcting an acknowl- privilege “The inmay original patent error in

edged [an] validly conditioned interest be public proceeding promptly.”

upon patentee Radio, During at 613.

Gen. its over-

years Shionogi maintained when claim, and wide- strong there was

broad new development in the

spread interest App. effective statins. Joint more

20148-51; By failing to act 1755-57. claim, overbroad to narrow its

promptly right

Shionogi deprived public with, improve upon, and to

experiment by claim l.6 Be- encompassed

compounds delay seeking to reme- Shionogi’s

cause in the '440

dy alleged defect unreasonable, right it has forfeited 251. reissue under section

to obtain ABRAMS, Petitioner,

Richard L. SECURITY

SOCIAL

ADMINISTRATION,

Respondent.

No. 2011-3177. Appeals,

United States Court

Federal Circuit. 28, 2012.

Dec. apparent "intervening rights,” have been deterred because of see 35 6. The doctrine Bus., patent,” Principle nothing expansiveness of the protect "the U.S.C. does wrongfully may rights Cl.Ct. at 438. of others unknown who

Case Details

Case Name: AstraZeneca UK Ltd. v. Aurobindo Pharma Ltd.

Court Name: Court of Appeals for the Federal Circuit

Date Published: Dec 14, 2012

Citation: 703 F.3d 511

Docket Number: 2010-1460, 2010-1461, 2010-1462, 2010-1463, 2010-1464, 2010-1465, 2010-1466, 2010-1467, 2010-1468, 2010-1469, 2010-1470, 2010-1471, 2010-1472, 2010-1473

Court Abbreviation: Fed. Cir.