INTHE HIGH COURT OF DELHI AT NEW DELHI TANo, 11607 of 2012 1N (5 (08) No.2279 of 2009 ‘In the Matter Bristol-Myers Squibb Compary & Ors Prats Vera [Link] & Ane Defendants SLN » Page Ni 1, Reply on bea ofthe Defendants tothe Appliaion 1-8 filedon behalf of he Plant under Order 39 Rule 1 22 ‘ead wth Section IS1 of Code of Civil Procedure, 1918 2, annexure -RI(Colly) Expr affidavit wih Bio-da ofthe 9-16 Expert on bal ofthe Defendant along with the ‘ompositonof Defendant's dug DASANAT NOTE: All concerned partes have been served ‘Next ite of earng: 01.08.2012 Defendants Tous Pace: Belles (nba Ba ee Soro Daat * For GLA Law Offices stu DdsIN THE HIGH COURT OF DELHI AT NEW DELHI TANo. 11607 of 2012 1N (5 (08)'No.2279 of 2009 1c Matter of Bristol Myers Squibb Company & Ors Paints Versus MeMAdinarayan & Ane Defendants [Reply on behalf of the Defendants to the Application under ‘Order 39 Role I & 2 read with Section 151 of CPC filed by the is ‘The Defendants above nied submit as under 1) Atte out it is submited thatthe present aplication isnot maitinale tall sine the cause of setion for fling of the present application is diferent and dehors the suit filed by the Plain. 2), Fare, the Plain has suppressed material facts and ied 10 projet ony fet convenient tothe Paitif soa Yo misnd the court, The Pll suppressed the fic that he atl prodact manufac and sold by them in the markt i polymorph of Dasatib, whic is a Mono deat, thus not covered or claimed by the su patent. Fates, he Pisin has without any analysis or testing of the Defendant's svoduct proceeded 10 fe the resent aplication, for which ean its misconceived and ill-a * » 5 2 founded, On these grounds the Plant s not entitled to any refi tal [At the averments made inthe application bythe Pani are wrong and denied. None of he averments way be deemed tobe hit or want of traverse “he contents of part | and 2 ae denied save and except mates of soar, is end thatthe sult le by the Pi? was mininble a all. The same was brought by making false egatons. With seg to the contents of prs 3, 9 brine that in the ‘sar 2009 the Defendants had not developed the product and therefore no compastion cold be fie at hat tne, Enclosed roi isthe expe affidavit on bel ofthe Defendant long with the composition of Defendant's dug DASANAT as Amnexure-R 1(Colly). ‘he contents of para 4 ar wrong and dei. In this regard itis ibid thatthe sit filed by the Plintf8 was self premature ‘in that it was fled when the Defendant nad only applied! for ‘marketing iense which astviy is penisible in Saw. It is submited that the sut was not mainuinable since activites Alege tbe ininging by the Pini wee activites protected nde Section 107A ofthe Patents Act. Fur, the suit was filed ty making false avermeats that the Defencants have launched aD 3 product called DASANAT in Ukraine, Assuming that the Defendants had launched the product in Ukraine, the suit for Iningement could have been brought ony in Ukraine; however {0 hares this Defendant, and even though the patent of the Phi extended only to India the suit was brows in Delhi as also alleged that the Defendant was advertising and ‘rblishing materi about such dug, All of hese statements were fase asthe Defendant a that point never engaged in ay of the ‘tvs alleged in the pint, In the ight ofthese facts, the Defendant ied its writen statement denying the avermens of the plant and the fact tht it had Iaunched the product DASANAT or advertised the same. It is denied tht the Slaements made in the writen statement were fae, The ‘otements made in the writen statement were based on fits nd circumstances that existed st that point. Sine the institon of ‘he suit by the Paint, many changes ook ple end the writen sntement could not ave reflected fitre events. All of these ‘verments sated inthe writen statement were amet 1s submited that Defendant supplies vast numberof dug to needy pte sufrng fom various disses such as Cane. ‘was found tat patents of Blood Cancer eqied higher level of ‘rement and accordingly this Defendant ook up the project of ‘anufictiring polymorphic foem of Dastnib, Te Defendant as granted the license to manuficue and market the drug DASANAT on 2" Sepienber 2011 and theater, now in May 2012 the Defendant lmnched the product DASANAT. It is» » 1) 4 submited tht the product of the Defendant does not infiage Indian Patent No.209257 In this regard, i is peinent to mote that even the Plainifl does not manure the prodact ‘omesponing to the suit patent. In any case the suit pte is invalié and scour claim challenging the validity ofthe pate is aeady on record. AS such, the Plainiff cannot enfre its "ht in epost ofthe suit patent. In view ofthese avermens, the content of para ae wrong and denied, Ii submited that he product DASANAT doesnot violate Paints patet 0203637 2s the Defendant produces a hydeate polymorph ie monohydiate of DASATINB which snot covered bythe aforesaid suit patent. “The contents of pra 6 are wrong and denied It is denied hat as of June 1, 2012, the Defeaduats had not entered the make. The Information dined by he invertigator is incorrect nd denied, “The contents of para 7 are wrong and denied Is denied that Hoa'ble Coutts passed any order etsining the Defendant in With read othe contents of para 8 is subited that te Defendant's roduct were alkeay launched inthe market. Te Pini having file to obtain desired order ftom this Hone our trough fst stent on June 13,2012, have led he Prescot appliation making fale elegans and tying opt i tere woe second ach of produ by the Defindat, ‘which fs ceest and denied. Im any ese, the product of theny 2 13) s Defendant is got covered by the suit patent and ence these allegations by the Pant re not tenable al “The coments of para 9 & 10 are wrong and denied It is submited tha the Defendant ad already launced thr product 8 of June 2012, The Plaintiff is only tying to exaggerate xing Sets and mislead the Hon'ble Court, ‘Te contents of par 1 sre wrong and denied. Is submited tat the Defendant have ot suppressed any materi facts. AS such the Defendants were not esned and on account ofthe market demand, bined cen fora polymorphic form of Dasani. The sme ot covered by the suit pate ‘The contents of ara 12 ae wrong and denied. tis submited that ‘ese averments reflect the bed fh and misconduct of the Plaintiff than the Defendant 1s denied tht the Defendant suppressed or concealed any fats rom the Drug Controle. Is submited that under the Drags & Cosmetics Act, 1940, thee is fo requirement for disclosure of any patent stu. Such information is not ale for bythe Drog Controle is futher submited thatthe Planiff having filed to obtain sppropite coeds aguas this Defendant on June 13, 2012, approached the Drug Controle, A perusal of the sbow cause noice date 20.06.2012 cel seval that he notice was sued tthe behest ofthe Pit Fares, the Drug Licensing Authority had eso letter suspending the licence ofthe Defendants. This oder wat1%) 15) a tallenge inthe High Cou of Utarakhand andthe High Cout of Uitaraktund fas pased an order dated 25° July, 2012 irecting thatthe sa order (of suspension of Hence) shall ‘eran in ayanee. Te Hon'ble High Coit of Utaand has remanded he mater tothe Drug Licensing Authority directing it 1a consider he reply ofthe Defenan tothe show case nice and to pas reasoned and speaking order after hearing the Defendant ‘The conten of para 13 are wrong and denied tis denied that the ast of manufictre or sle of DASANAT by the Defendant mounts to infingement of any rights ofthe Plait since the Pisa ile! to grove that the product of he Defendant is covered by he st Patent “The content of pra 14 & 1S are wroag snd denied. Is dened ‘at the Defendant hes indulged in any Stn ininging sive alleged tis denied hat Defendants are disobeying any ones af this Honble Court, It denied that any loss or har willbe caused to the Psitif or tit they would lose substi Is submited thatthe Pani aso ate eaters to hardly 59 of ptens Hence, there sno question of any los 1 alleged by the Pi ti fare submited tha the produce OF the Piaf cots around RS.1,57,000/ per month (fr 60 lables). The cost et year to a piet is about R22 las, ‘Whereas he produ ofthe Defendant costs Rs8,80-per month 1o spate. Being a drug for wentment of disease sich as Blood4 ‘Caner, te products required for the publi at lage and needy tints cannot be let without any testmeat. The Phin has ot estblished any pra fice case, The balance of convenience and ees rin favour of the Defendant In view ofthe pubic ‘interest involved ss, 00 injunction is merited as payed for by ‘he Plaine 16) The prayerclause denied Ie is therefore, payed fat the application filed by the Pani be isms with cons. — a Pace penrnlbnrelt ioe ass reek bart ‘Advocate forthe DefenderIN THE HIGH COURT OF DELI AT NEW DELET TAH. ‘OF 2012, ™ 5 (05) No. 2279 OF 2008 IN THE MATTER OF: BRISTOL MYERS SQUIB CO. & ORS. PLAINTIFFS MR. M. ADINARAYAN & ANR, DEFENDANTS. APEDAVIT 1, Madineedi Adinarayans. aged about 50 years, R/ Howie Ro. 12-12 266, Street No. 15, Tarnska, Secunderabad, SOOQI7, presently, do hereby solemnly state and affirm as under: 1. That 1am the Defendant no. in the present suit. Tam also the Company Secretary and General Manager (Corporate Affairs) of the Defendant No.2 herein and am duly authored “aed competent to swear this efdavie on behalf of both the Defendants, 2. That the accompanying reply has been drafted by my counsel lander my instructions Ihave read and understood the seme. { hereby state thatthe said reply be read and treated as part and pareel of the present afizavit and the contents of the same it Dot epradueed herein for the ae of troy. ‘hat the contents of Use accompanying reply ae true and forect tothe best of my knowledge deri from the rreords kept by the Defendant no.2, ones DEPONENT. ———— s Verified at Hyderabad on this 24" day of July 2012, that the contents of my abovesaid affidavit are true and cerect 10 the test of knowledge and belief and nothing material has been concealed thereon vgsreD For ATCO PHARMA LIMITED eran? aes” eR, ; DEPONENTIN THE HIGH COURT OF DELHE AT NEW DELHT ORDINARY ORIGINAL CIVIL JURISDICTION (C5 (05) No.2279 of 2008 Bristol-Myers Squibp Company & Ors Paints versus eM Adinarayan & Ant Defendants APEIDAVIT. 5, Or Konakanchi Durga Prasad, aged 55 r/o Fat No.203, Plot No. SO/A, Jeisaktn! Enclave, Kalyan Nagar Venture-t Hyderabad 500018, S/0.K. Satyanarayana do hereby stote on solemn affirmation 26 under. 1, That 1am serving as Vice President, Research & Development at Natco Pharma Limited. 1 am a PhO with 22 years of experience in the fied of Synthetic organic chemistry including X-ray crystallography. aware ofthe fact that Natco Pharma has a product called “DASANAT'. 2, have been given 2 sample compound of Batch No. 700272 (of DASANAT) and have been asked to analyze the seme for AS crystal habit. Accordingly, 1 have performed X-ray crystallogrephy analysis of the compound. The same is a hydrate polymorph |e, monohydrate of Dasatnib. The relevant X-ray erystal difraction pattern is attached herewith, 2 annexure: 3. I note that Indian patent No, 203937 Is drawn to 2-amino thiazole S-carboxamide compounds. However, the claims of produced anc manufactured by the Defendant, & Sige ot DEvonenrVERIFICATION 1 say thatthe contents of Paras 1-2 are true and correct tothe best of ‘my knowleége and information as they as based on experiments performed by me. No part ofthis affidavit is false and nothing material ‘as been concealed therefrom, Verled at Hyderabad on this 19" day of July, 2012. budhyot DEPONENT safoafeaoe ions HW Wo Data ofr .Dures Prasad "Name: Konalaneh Dura Prasad Date of sith o1.07 2856 "Mato stats and Chiten: Marre andhave oe son, eational uso: + MScin Ozaie Chemistry fom Kapur Unersy nthe year 973, + PhO in chemistry rom National state of Technology, Warsgy in th eo 2008, 1 Tota30 yee of industrial enperinc ‘+ 8¥ears i. rom Api 1980 une 1986, in M/S MacMOMAN Phomacetea, Jocdimet Hyderabad worked as prove alta Chemie. "+ 7¥ears om ly 19860 ov 185, nS INGA Pharmaceteas, Nacharam Ines Estate acharam,yerba, charge Cuaty Contra abrston aed ron ecto ep 293, nS NO Geran hao Mahala Coes Road Anda tae shee ‘ata, Research and Development wing OrPata Scenic and inden ots on Natural product oto, th chraceraton and sence an Pubcon 1. Ata Crs. (207) £83, 565567 Voricnazi, sting dr ‘Ravkume, righ, 0 Pread and AK hujngs Rap. day URES Nae!2 Ina Jounal of hetrocjle Chemisty, 208, 18) 12.18 SYNTHESIS AND SPECTRAL STUDIES OF PHENYL ARYL /AKYLAMINOPYRAZOLO [340] PrAMHOINES. Modula LW Pavan Kumar Chemis disor, School of rc an Humanities, Univesity, Vtore-c3201, Prasad k Dar Nato esesch one, Mao Pherae yeraba 500638, Vioyhumar 3. 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