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Tibotec Pharmaceuticals v. The Assistant Controllelr of Patents,Designs and Trademarks &Nors

Court
High Court of Delhi
Decided
15 July 2010
Bench
S. Muralidharauthor
Case no.
W.P.(C) 1020/2010

Judgment

ORDER

15.07.2010 In terms of the colnmon judgment rendered today in Writ Petition (Civil) 351612007 titled' "Dr. (Miss) Snehlatu C. Gupte v. (Jnion of India & Ors' along with eight connected writ petitions, this writ petition is dismissed with +'- costs of Rs. 20,0001-which will be paid by the Petitioner to Respondent No. 3 Cipla within a period of four weeks. A copy of the judgment passed in W.P. (C) No. 3516 of 2007 be placeci forthwfth on the file. JULY 15, 20I0 dn S.MURALIDHAR,J' ' Certify that the digital file and physical file have been compared and the digital data is as per the physical file and no page is missing. I I . [N TT{E {dNGX{ COURT OF DEN.X-II AT NE\4/ D[T[,I-JI[ 17, Reserved ou. 29ol' Apr:il and 3"' .lurtc. 20l0 Decision on:'15t" Jnly, 2010 I W.F. (C) No. 3516 of 2007 ' DR. (Miss) SNEHLATA C GUPTE '.. . Pctitiorrer' . Tlrough. Mr. Pravin Anaud ancl Mr'. .1. Sagar' rvith I\&'. Sagar Chandra. Adrzocates. versus .. UMON OF INDiA & ORS .... Respottdeirts il,I"ilfJi..,H.,lxl,i"Yl]l ?1il1',,,, o -o Ms. Pratibna M. Siirgh, Achrocate {br li-5. . uL@ TINION OF INDIA & ORS. ... h.".po,rdents 'Iluough: Nfi'. Rucbir MiShra rvitli ivh-. Rahul Jain, Advocatc.s fol R- ['to [t-zl Ms. Pratibha M. Sirigh, Advocare for R--s ' W.F. (C) No. 5_422 of 2007 DR. GIzuSH J. RIND,^J{I .:... Ircritrorrc,' *l;iHl #;,ia;l#:11#i.',Tl sasa VETSLIS r'INIoN oF INDIA & ..ffr, Mr. R*crit,. t;rfriiPo'clents iV[r'. Ralrul.iain, Advocertes for P.- | to R-4 ( , i{s. Pratibha}rI. Singh, Advocerte for lt-5. W.n'>, (C) hto. 5423 of 2007 /\rY!\'.nF .. DR. (l'"{iss) SNEHLATA C. GUPTE .... Peri'riorrer. Throrrgh: I\{r'. Pravin An:urcl arid ir{,'. -!. Sagirr- ' with Mr. Sagar-bhandra, Adrrocates. w-P.(c) Nos. 3576, g577,5422, s42.3 of 2007 & t03gg, 10400 & 704s0 of 2009 & 1020 o! z0J0 . ttoge .t of 40 . versus ^<v tl() tv I .t ..... Respondents UNION OF INDIA & ORS ,... Respondents Tlrough: iW'. Ruchir Mistrra witlr IW. Rahul Jain, Advocates for R-I to R-4. .Ms. Pratibha M. Singh, Advocate for [1.--5 ' W:F. (C) No. 10399 of 2009 ZEPHYR BIOMEDICALS Tlrrough: I\ft'. Sanjeev l(runar Tiwali, Advocate versus I-ALIT MAHAJAN & ANR. ... Rcspondertts \ . Tluough: i\ft'. Maninder Singh, Senior Acivocate with lrls.' Saya Chaudhary and Nir. Jaspreet Singh, Advocate for R- | . i\{r. A.S. Chandhicl<, ASG with 1\4r'. Jatan Singh, CGSC for R-2. rff.F. (C) No. 10400 of 2009 ZEPH\aR BIOMEDIC,ALS ..... Petiliotter' 'Tluough: 1W-. Sanjeerr l(unal Tiwali, Advocate. versus LALIT MAI-IAJAN & ANR. ..... I{espotrdents Through: Ms. Saya Chaudhaly and IW Jaspreet Sirigh, Advocate fot'R- | . Nft..A.S. Chandhiok, ASG with : ,. A&-. Jatan Singh, CGSC for R-2. W,F. (O No. 10450 of 2009 ZEPHYR BIOMF,DICALS .... l)etitiolrer rnar Tiwari. Through: IW. Sanjeev l(uttrat Tiwarr auieev l(urrtar f iwari, jeev I(u Aclvocate- . versus LALIT MAHAJAN & ANR. Through: i\{r-. Maninder Singlt, Serrit')l' I vr Advocate witli Ms. Saya Chaudlralv arrd Mr'. {t.p.rc) Nos. 3576, 3577,5422, 5423 of 2007 &.70399, 10400 & 10450 of 2009 & L020 of 20LD '; page 2 of 4o '.,. -t /0I t) t, JasPreet Singh, Advocate for R-l ' M'. A.S. Ghandhiok, ASG rvith Mr' Jatan Singh, Advobate for R-2-N . . W.P. (C) i{o' [020 of 2010 TIBOTEC PHARMACEUTICALS "" Petitiorrer Tluough: M" Rajiv Nayyar and Mr' Strdhir ' Nandrajog, Senior Advocates with Mr' Pragyttn , Pradip Sharma and 1W-. Rupesh Grqlta, Advocates. ': VETSUS TIIE ASSISTANT CONTROLLER OF PATENTS, DESIGNS & TRADE MARI(S & ORS ""' Ilesponclents Through: IW. A.I( Bhardwaj with Ms. Jagrati Singh, Advooates for R-I & I{-2' ' M'. S. Majurndar-r'vith AzIr. Saurabh Banerjee, Advocate for R:3' COR.AM: JIJSTICE S. MUR.A'LIDFXAR

¶1Whether reporters etf localpaper inay be alloivecl' to see the.judgnent? ,'/ -,- L\J J|vV Lllv.J Llu6urvrrr; .v ' .,, '

¶2To be refered to the repofter or not? t'l

¶3Whether the judgrnelt should be referred i1 ttre cligcst? JUpGMtrNT' l. The short but interestrng'cluestion of ia* colllllloll to all tlrese petitions: When can a patent be saicl to be grantecl ttuder tlrc Patents Act' . 1970 (.Act,)? The question arises rn the context of the clisnrissal ol'P|e- . grant oppositions by the Controller of Patents.('Controller') orl the ground that they wele tirne-barred under Section 2I ofth'e Act. '

¶2T[e factual backgroturd in eaclt set of petitions is necessary to be set . W.P.(C) Nos. 3516, 9577,5422, 5423 of 20.07 & 70399, 70400 & 70aSd of 200t . :::r2"{:;:: P' ogt in order to appreciate how the question arises for cletellnittation irt each of them. lilrit Petitiort (C) Nos. 3516, 3517, 5422 mrcl 5423 of 2007 (1" Set qf titiorts)

¶3J. Mih'a & Compan{ Resporident No.5 in W.P. (C) No. 3516 ol'2007 filed two patent Application ltros. 590/Del/2000 and 593lDell2000 irr the . Cffice of the Controller cn 14tl' .June 2000. The patent speciticatiorts involved i1 tire two applications wele published in the official gazette orr 20u' Norr.r ber.2004 in tsrins of Section 11A of tbe Act. At tlrat stagc, , Sectibn 25 ofthe Act had'notlbeen arirended. Under Section 25 tr.f'tlte , pre-arnended Act, an oppositicn to the grant of patent hacl to be filod \r,ithtn fcl-r. rnolths ftom th.at day i.e., the date of aclvertisentent (plblication) which period could be extended by otte tnorttlt ttporr tlte Coltroller being satisfied by the reasons given forsuch delay.

4.SparrDiagnosticsLtd.(.SDL,)fi1edapre-grarrtopposjtjoirw|ric|r , came. to be rejecteci by the Controller on 23'd August 2006. 'l'lre . operative portion of the order fassed by the Coltrolier reacls as ttttclcr': '"In view of the abcve discussion and in consideratiorr oi t5. submissions of boih the parties. I hereby grcler to grant [Patent No. 194639] on Patent Applicatiott No. 590De112000 with the following condition: .) The Applicants shall give cross referenc,e to the patetrt application no. Sg3ipel/Z"b}} or page 2 o[' tlre corhplete specification and sr.,brnit tltc amended/retyped pzige(s) within a rveek'fi-ont the clalc of these orcler. Tlie Opposition oit Pateut Applicatiolr W,P.(C) Nos.3516, 3577,5422, 5423 o! 2007 & 70399, 10400 & 10450 of 2009 - jn\::;: No. 5901DeU2000 (194639) tenns. No order to cost." is disposed of itl above 5 hr terms of Section 43 of the Act, where the applicatiott I'or a pateut ' , .has been found to be in order for grant of patent ancl if the apptiparLion has either lot been reftised by the Controller or'has'not beeu lound in coltravention of the Act, the.patent shall be gtanted as expeclitiously n5 possible "with the seal of the patent office and the date on rryltich the i patelt is gralted shall be entered in the Register". Under Sectiorl 43(2), upon thl fant of patent, the Controller "shall f.tlllttt the fact that tlre patelt hls been granted and thereLlpoll the application, specificertion and other docnrnents related thereto shall be open for public ins;lection". Under Rlle 55(5) of the Patents Rule.s 2003 ('Rules'), the Corrtroller rvill examine the statement atd evidence filed by the.applicu,r, 1fur. the grant cf patent) and may either refuse to graut .the pateut ol reuuit'e the conplete specification to be amended to his satisfaction before tltc llateltt 'is gralted. Under Rule 5.5 (6), the Controller shall, zrfter cousicleriug tite representation (i.e. tire pre-grant opposition, if any) arrcl subrttissiorts macle c1ui1g the hearing if so rsquested, '.'proceed ftrrth.er sitnultarteotrsly either rejectirrg the representation and granting the patent or accelltilrg the represeltation and refusing the graut of patent on that application, . ordilarily within one rnonth from .the cornpletion' of thq 'above proceedings".

¶6It is the c.ase of the Respor:rient Nq.5 J. Mitra & Co. that rryhert ott'23''l Augdst 2006 the Controlier rejected the pre-grarit opposition filed by w.p.(c) N.os. 3576, 3s77,s422, 5423 of 2007 & 703gg, 70400 & L0450 of 2009 a lbzo o.f 2070 Page 5 of 4O ,\.P, Y A'l 7tl .lt I SDL. and in fact in the order used the wor:ds "I'ltQreby orcler to grant patent...", this.was simultaneous with the rejection ol' tlre 1ll'e-gralrt opposition in tenns of Rule 55(6) of the Rules aud, therefot'e, 23"rAtrgtrst 2006 was the date on which the patent was granted to J. Mitra & Company. l. On the very next day, i.e. 24tt'August 2006 Dr. Snbhlata Gupte, [lte. Petitioner in W.P. (C) No. 3576 of 2907,fiIed a pre-gra,tt oppo*ition vru'- a-yi.sPatent No. 194639 filed by J. Mitra &. Co. According to Dr'. Gupte, in terms of the arnendments introduced in Sectio n 25(l). ol' the Ac;t by way of the Patents (Arnenclment) Act,2005 with effect fi'ortr l".lattttal'y 2005,the time period for filing a pre-grant opposition stood extendecl till the grant of the.patent. According to the Petitioner, the patent was ttot grantod till such tirne it was not sealed and enterecl in tlre Ilegister irt' terms of Section a3(1) of the Act. It is stated that as on the date'of the filing of the pre-gtant opposition by Dr. Gupte, i.e..241t' August 2006, the paterit in favour of J. Mitra & Comp?ny had not beeu grantecl siltce it hacl not yet been sealed and entered in the Register. .;

¶8On 5tl' September 2006, Dr. Gilish Rindani, Xhe Petit'ionet in Writ Petition (C) No. 5422 of 2007 filed a pre-grant opposition vis-i-vis tlre patent application of J.Mrtra & Co.. \

¶9It is not.in digpute that Company was entered in W.P.(C)'Nos. 3575, 3577,5422, 5423 Patent No. 194638 granted to J. Mitra & Register on 22"u Septernber 2006. Paterrt of 2007 & 70399,'70400 & 70450 of 2009 & 7020 of 20Lo poge 6 of 40 .the ihe &Ao Nq. 1 94639 gralted to it was entered in the Registdr on'27't' Septenrber 2006. Certified.copies of the relevant entries in the Rbgister ha.ve lreert placed on record. In terms of Section a3(2j of tn. Act, the saitl trvo petitiols of J. Mitra & Cornpany were published in the JottrrlaiJ of the Patent Office clated 17tl'Novetnbet 2006-

¶10On 16tl' October 2006, the pre-grant opposition of both Petitjotters weie rejected by the Controller. o[ the gtound of maintairrability. This was do1e, howeyer, without affording the two Petitioners alr opportrrttill' of being heard. 31't October 2006, both Petitioners vrrrote to tlte Controller seelcilg a. hearing belbre . rejection oF' tlre llre-grant oppositiorrs. On23'd January 2007,the Controllei granted the Petitiorrcrs a lrearing. Ihereafter 01 30tl' April 2007 ald 3''d May 2007, r'vrittett staternents were filed and subrnissions were advatrced by .both tlte PLtitionerS before the Controller. !

¶11Writ Petition (c) Nos. 3516 and 3517 of 2001 wefe filecl by Dr. Snehlata Gupte challenging the order dated 16'l; Octobcr 2006 with reference to the Patent No. 794639 aud 194638 respectively. on 22"" May 200 7, the Coirtroller passed fi-esh orders rejecting the pre-grant oppositions of the Petitioners on the ground that thg opllositiolls were time-bameci. Both Petitioners i.e. Dr. Rindani and'Dr. Gupte clrallerrged tlre sairj or:der Catecl 22"d }/ray 2007 by filing Writ Petition (C) Noi. 5422 and5423 of 2007 resi:ecti.rely. ' I w.P.(c) Nos-3576, 3577,5422, 5423 of 2OO7 & 7\3gg, 7O4AC & 70450 of 2009 & 7020 of 2070 " 23, .

¶12The above petitions have been resisted by Respoudent No-5 J. Mitr'a. & 9o.'tt is co[tended that the order of the Controller was consistetrt rvitlt the correct p.ositiol in law. According to Respondent No..5, the t'ilirrg of ' the two pre-grant oppositiclns by Dr. Gupte and Dr. Rinclaui rvas also art ' abuse of the process of law. It is alleged by J. Mitra & Ct't. tltat SD[-, which is i1 the business of sale and purchase of varjons phannaccuticals products, is a habitual infringer and is deliberatell, atrd corlici0trsly violating various iutellectual ploperties of J. Mitra. & Co. SDL, i.s allegecl to be continuing to infringe the rights of Respondent No.5 with ilrlpunity. It is coltended that each and e1-ery product in respect of wltioh J-Mitra 8{. Co. has applied.for ald/or has been gtanted a.patettt is either being opposed or infi-inged bY SDL. .

¶13Patent No. 194368 is for an invention titled "A DevjQe tbr llie detectiol of altibodies of Hepatitis C virus in hutnan serrur. aucl plaslrta.". Patent No. 194639 is for an-inventiou titled "A device fbr the clcteotion of Hepatitis C virus". After the gr:hut of the aforetnentjoned patetrLs in its favoru, J. Mitra & Co. fileci Civil Suit (OS) No.72020 ol'2006 ih this Court against Kesar Menclicaments (I(M) and SDL ioi patcrrt ' inf ingement. By a judgrnent dated .22"t February 2008. Lhjs Court gralted arr. injuncti.on restraining I(M and SDL fiom tnatttrftrr:tttritrg, sellilg, offering for sale. ther HCV Signal or ally. other product which. . was in infiingernent of J. NIitla & Co's Patent No. I 94638. It is stated - that in.tire said suit SDL has filecl a countet' clainr for tevocatiorl ol'the patent. lAl.P.(C) Nos.3516, g.5.77,5422, 5423 of 2007 & 10ggg, 70400 & L0450 of 2009 & L020 ol2010 I Poge I of 40 3\r Subtitissioris of Counsel in the 7't Set o.f petitions tW.!. (C) hto. 3 5I 5 of 2007 etc.J

¶14Appearing for J. Mitr-a & 9o., Ms.Pratibha Singh, leauted cottnsel, submitted that both Dr. Snehlata Gupte and Dr. Rindani are oonnected to SDL. Dr. Gupte is stated to be rinning the Surat Raktadan Kendra, the . Chainnan of which is M'. Pradeep K. Desai wlto is tlre , ChainnanAvlairaging Director of SDL. It is stated that Dr. Gtrpte was aware of SDL's opposition to J. Mitra & Co's patents. Ms. Sirrgh pointett out that upon the said pre-gra:rt oilposition being rqected ort 23"1 August 2006 the patent had to proceed for registration. However, to coutittue tlte serial oppositions, first Dr.Gupte filed a pre-graxt oppositioll oll the very next day r.e.24tr' Adgust 2006. Dr. Rindani, who is also stated to be connected'to SDL, filed a separate pre-grant opposition oir 5ti'sellLenrber 2006. It is subrnitted that the filing of serial opposilions by persoris connected to SDL after its pre-grant opposition had been ...|..t"d *os rnalafide and if such app'lications'wdre qernritted to be eutertained, tltere would be no end to the filing of such pre-grant oppositions paltictrlatll' since after the arnendment to Section 25(I) in 2005, a pre-gratrt opposition can be filed by 'any persont. It is subrnitted that il'tlre statrd of the Petitionerc i, u.r.pted, it would defeat the objective of tlte Act which is to grant a patent rather than refusing it. .

¶15Ms. Singh pointed out thal in the'rejoinder to its counter afllcJavit,.the Petitioners do not deny that Dr. Gupte is connected to SDL. It is only .Y stated that such avennents are rnisleading "ald that they have no bearing .on the present case". It'is ftirther pointed out that the petitionet-s cotttcttcl W.P.(C) Nos. 3576, 3577,5422, 5423 of 2007 & 70399, 7O4OO & 70450 of 2OO9 Bt L020 of 2o1o . tr i1 the rejoinder that "it is imnaterial for the puposes of tlte prescttt u'rit petition whether a person who files.a pre-grant opposition is recorclccl to or 1ot recorded who is interested in the concemecl patent being op;losecl"

¶16Referring to the. decision in I(.D. Sharma (2008) 12 SCC 481. Nls.Singh subnritted that the Petitioners have, by not disclosing their , lelaticnslrip rvith SDL, not come to the Court u,ith cleart ltattc-ls ancl, theretbre are disentitled to the reliefs praygd for'in lhe writ petitions. ' Referring to the decisions in Bhagwar{i ltislt.uuii T'halelcar v. ' Pravincltartdra 'fivarfiltui Patadia (lggL) 2 GLI| . 1438 att<l \' Ertertainntent Nefiuorlc (India) Ltd v. Sapbr Cassette trfudustries Ltd.

(2005) 13 SCC 30 itis subrnitted that a purposive constluctiorr woulcl avi: to be adopted and it has'to be helcl that in terurs of Rule 55 ((r) ot' t' the Rirles read with section 43 (1) of the Act the patentjs grantecl onoe an order to that effect is passed by the Controller siunrltaneous with the ' rejec.tibn of the'first set of pre-grant oppositions which are cleciclecl by the i. ' ' Controller. It is subrnitted thai there has to be arr outer tiure linri, lor .filing a. pre-grant oppositiou which in any event cauuot be bcyotrct the ate of the Controller passing an order on.file .granting t'lrq p31s11t. "l'lte sealing anC eltering of the patent in the Register eue lnere ntinisteiial ac:ts r,vhich make no diff.r.uce to the date of the glant of the pat"r,t. 1?. N4s. Singh refers to an order..dated 2."'r March. 2A09 passecl b), tlre Supreme Court ih SLP (Civil) i{o. 3522 .of 2O09 (hdian Nefivork For People witlt IiIV/Ai.cls v. F, I{offntann-Lu RoclrclQ whiclr arose liorn w.P.(c) Nos. 3576, ss77,5422, SAZI 67 ZOOZ & 7}3gg,,70400 & 70450 of 2009 & 7020 of 2070 Page 70 of 4O /st , an order dated 30tt' Jan rary 2009.passed by the Assistant Controllel' of Patents. This was heard with SLP (Civil) No. 29851 of 2008 filecl agaitrst . the judgment dated 2"d December 2008 of the Maclras lligh Cotrrt , | ,l ^f -1,.- reported as Indian Networle {or Peolle witlt IIIIT/Aids v.. F-. [dqfftno.tt.t,- .. . La Roclrc ,4G MIPR 2009 (2) 0036. By the said judgrnetrt the Madrars High Court set aside an order granting Roche a patent withotrt clisposing. the pre-grant oppositions filed by the Indian Network for People with IIIV/Aids under Section 25(I) of the Act. Thereafter by ari ortler clatccl 30tl' January 2009; the 'Assistant Controller rejected the pre-grattt opposition. The Suprerne Court, without going into the tnerits ol'the . ..ut.1tions that the Petitioners were .deprived Of an opportunity o[' raising before the Confioller numerous contentions on tlrerits, tlbser-ued that they could be given perrnission to file an affidavit arrcl raise all . contentious at the stage of post-grant oppositions rryhich had alreatly lreen ' filed and were pending before the Conttoller. On the strerrgth o1'thp above order, it is.subrnitted by leamed counsel for J. Mitra & Co. that SDL itself could file post-grant opposition before the Controller ancl, therefore, no prejudice ryas cansed by the grant of patclrt to the Respondent No. 5 by the order dated ?3'd August 2006. lrr any evellt, SDL has also' filed a counter-clairn in the suit seekiltg revoca.tion o{'. the pate-ut.

¶18IW. Plavin Aland and IvIr. J. Sagar, l'earned cotnsel for Dr. Gupte anci Dr. Rirrdani; on the other hand, pointed out to the plea raised irr the ^ f ^

a a'1 I I .l .plaint in C.S. (AS; No.2020 of 2006 filed by the Responclent No.5 .f . w.p.(c) Nos. j576, 3577,5422, 5423 of 2007 & 703gg, 10400 i TOOSO of 2009. ;nj"lrr:;:, .' ,L), Mitra & Co. lhere is a.clear adrnissiori to the effect that the 1:atent ; was therelbre been grantbd or 22"" September 2006. 'llrtt understanding of J.Mifia & Co. itself.

¶19Learned counsel for the Petiiioners also attackecl the bouatides ol'.1. Mitra & Co. alleging that it was. an infi-inger which had applied Ibr ancl obtained a plethora of patents which.were in fact copies of patetrts ancl products.available worldwiele and itr India. It is sr.rbruitted that the two patents in question relate to,a thrd and fotuth generation rJevice for tlle detection of HCV antibodies in ihe hurnan serurn and plasma. lloth the patents wele irnitations of a patent obtained by a US corupany, IIY Laboratgries, in lggl However, since EY Laboreitories clid not lrave a against J. Mitra & Co. patent in India, pro'ceedings could not be instituted for infiingernent. .:

¶20It is subrnitted'by learned counsel for the petitionbrs that all clailns of Mitra & Co. filed in the United States Patent Office hacl been rejectecl dir the grounds of obviousness and insufficiency. It is pointec1 orrt by Mr. Anald that Respondent No. 5.hac[ originally applied for. the patelts in question r.vith 14 claims followed by'reduction of clairns to 7 after which the patent was published for opposition with the said 7 claitns. When tlte patent was granted on 22"u Septenber.2006, it was granted Ibr zl clainrs. Clairn I of the 4 clairns is stated to be different frorn the published Ctai'rn t"

¶1Evel after aclanowledging this to be a mistake in its ordei <Jatecl 23"1 ' August 2006, the Patent Office has not published the clairns IbL . W.P.(C) Nos. 3576, i577,5422 542i of 2007 & 70399, 70400 & 70450 of 2009 & 7O2O of 2070 ' Psge L2 of 40 had the ,.i opposition It is stated that aftef the order dated 23'd August 2006, the patelt office was uirder obhgation not to gpant the patent withilr tlrree months of the statutory period of appeai so that an aggrieved partlr coulcl .i file an appeal. It is. alleged that the entire proces's.of grant of llatettt was done ir a quick and cl'ande.stine maluler sr: that lto one would l<trow aboLrt .( the sane. 2l.It is subrnitted by iW. A.nand that the diagnostics kit industry is a' very slnall and close knit and "everyone.knows everyoire in this ['ielcl". Clairning to be among the leading scientists in their field, the Petitiorrels state that "it is'not only their duty but also theirresponsibility to ettsttl'e that no unscmpulous trader usurps rights of other parties or tnalaficlely' stops other palties involvecl in this field." It is sLrbrnitted lhirt the iuteution of tire Petitioners is "not to stall the grant of patents bul to try and eisure that no wrongful .patents are granted to unscrupulous tra.clers in the interest of the public". It is subrnitted that a patent is a cotnplete monopolistic right and should be granted only after dLre consideration. It is for this reason that tire legislature has built in various safeguarcls lil<c pre-grarrt opposition, post-grant opposition, ievocatious, cottttter-clairtt for revocations and defences bf revocation in a suit tbr infringenrent. lt is stated that the words of the statute are clear and tiit suclt tituc the grant of the patent is rnadd known by the publica.tion iu the ofl'icial gazette, it carurot be said tc have been granted in law. It is also pointecl out that the interpretation canvassed by cornsel for respondentNo.5 lvas cotttrat'1r 1s the current practice of the Controller's office ancl 'r.vould leacl to a great ll/.P.(C) Nos. ili 6, 3577,5422, SaB of 2007 & 7tggg, 70400 & 70450 of 2009 & 7o2o of 2o7o page 7i of 40 fr fr. ')t, deal of avoidable confusion. Writ Fetitiort 1C1":wos. 103gg, 10400 attd 10450 of 2009 !2"'t set of petitiortsJ

¶22The relevaut facts ar-e that Laljt Malrajari Respondent No-l in all tlre above writ petitions filed tluee patent applications. for g1uni ol'patettts being Application Nos. 1688/De1/2007 , 1689/Del12007 ott B'r' August 2007 . In Application No. 1688 of 2007 , the invention relatecl to a de'r'ice for a'alysi'g the presence of Dengue tiG.antibodies i* h*urar se.r'' .andplasrna. ApplicationNo. 1689 of 2007 related.to the invetltion ol-a. kit for analysing the preserce of dengue Iglvi antibodies in the httnrau seruln.or plasma. Lalit.Mahajan also filed two othei applications being

74.lDel2005 and i5lDell2005 on l2triJanuary 2005 iri relatiott to a Part N4alaria Stix a1d a Tetra Malaria Stix respectively for iesting ol'trralaria.

23.LaIitlViahajeur's Application No. 16881DeV2007 r,vas published in the' Jounal o1 31't August 2001 . The patent r.vas gtanted arrd was alstl sealecl on 16tl' October 2Q0S. A prg-gant ofposition was filed by the petitiouer Zephyr Biomedicals ('Zephyr') on 12u' December 2008. The pre-gra.t opposition was rejected on 4il'March 2009.This ordel was clrallengecl lly Zephyr in Writ Petition (C) No-10399 of 2009. ...I Zi . l-atitMahaj an' s Applicarion No. l 689 lD elDOOl was p ubli shecl o u' 7 rr' Septernber 2007. The patent was granted and sealed on 16tl' Octclber . 2008. The pre-gtant opposition \vas filed'by Zephyr on [2'i' Decenrber 't 2008. It was rejected gn 4r'Ma'ch 2009. This order was challenged by w P:(c) Nos.3576, ss77,s!22, 5423 of 2007 & 7o3ss, 7040.0 & 70450 of 200t - :nz"lrr:;:, 0eJ D 10400 of2009

¶25LalitMahajan's Applications No. I 4/DeI/2005 and 1 5/Dell200-5 were plblished on 2"d June 2006. The patent was granted ald sealecl on l6'l' October 2008. The pre-grant opposition was filecl by Zephyr on 28ir' Tf was reiected t ou 16'l' Marclt 2009. IrTovember 2008. It waq rejected by the Contrqller. . This order was challenged bV Zep\yr by filing Wiit Petition (C) No' 10450 of2009. Subndssiorts in tlrc 2"d Set of petitiorts (by Zeplqtr).

¶26The arguments advanied by ivir'. Saljeev'I(umar 'fiwari, leat'rletl ' .counsel appearing fqr Zepityr against the orclers of the Controller rejbctrng its pre-grant application on the ground of limitatioti were nrore or less sirnilar to the argurnents advanced by counsel appearirrg for Dr. .Snehlata Gtrpte and Dr. Girish Rindani in relation to the patents grantecl to J. Mitr a & Co.

27.Inresisting the petitions, it was submitt"a Uy.Nh. Manincler Siugh, learned Senior counsel dppearing for Lalit Mahajan that alter tlre A.mendment to the Act in 2005, the tinre period for filing a ple-graltt opposition may have been reiuoved but a reasouable interpretatiorl has tcl be given to thei amended Section 25 keeping ;n uib* the coutext. |Ie places ernphasis on the words "nnless'the context othetrvise reclttires" occuning in the opening portion of Sectio.n ,2 (1) of the Act and strbttrits that the locus to challenge'a patent that has been granted gets restrictecl tcr w.p.(c) Nos. j576, 9577,5422, 5423 ol 2007 & 703gg, 70400 & 70450'of 2009 & 7020 of 2010 page L5 of 40 Zephyr in Writ Petition (C) No. a person ilterested. He submitted th.at considering tltat ttre grartt o1' a patent is a recoguition of the creative work of the.invetlter, ancl lras {o pass a fairly rigorous examination procedure througll sevcral stages wlrich by its very riature is tirne cousntniu E, t .reasollablc period as opposed ro ail mclefinite open-ended period.has to be given for the filirrg of,a pre-g'ant opposition, which is by any persbn.

¶28i\{r, Mzurinder Singh pointed out that the scherne of the Act and thd-Rules indicated that the severzil acts leading to the glant o['tlte paierrt certificate were to be performed within specific tilne periods. Refeiring .to Rule i 4 (2) of the Rules he submjtted that a patent certificate is to be ordilarily issueel within sevei days fi'om the date of grant of paterrt trttcler . Secticn -t3. tjncler'Rule'24,Lheperiod for which an applicatiorr for'patent shall not or-dinarily be open to public uuder Sectiou llA(1) shall be l8 months from the date of filing of application oi the date of prioritl' sf applicatiol, whichever is earlier. In terms of Rrilei 24-B (.lXi).a reclttest 'For examination rlnder Section 11B of the Act is ntacle withit 4S.nroliths from the date of priority of thc application or fi'orn the clate of liting of tlre application whichever is eerlier. Under Rule 2'.4'B(2)(ii, tft" pcriocl \. withil which the Controller shall refer the application and specilicrtion and other doctunents to the Examiner where strch reqtrest lbi' examiUatiol has been made shall ordiuarily be withiri one ntorrth ilom the date of its publication ,or within one tnorrth .[i'onr tlre date of exarnination, whichever is later. Under Rule 24-B (2xii), tlte Exartrinsr sl:oul.cl ordinarily. subrnit the reporl within one tnouth bul rtoi exceecling lLl.P.(c) Nos.3576, g577,5422, 5423 of 2007 & 70gg9, 70400 & 704s0 of 2oos & 7o2o of 2070 sl , q.y ', ()- three months from the clate of reference and. thereafter the Controller slrotrld, in accordance witli Rule ?4-B (2xiii), dispose 'of 'the report witlrin one month of its receipt. Undei Rule 24-B (3), tlrc lirst examination reporf is sent to the applicant within six rnonths {r'otn the date of 'reqnest for examination or publication rvhichevet is later ancl under Rgle 24-B(4), the tirne for putting an application in orcler fo,: grant nnder Section 21 shall be twelve rnonths fi-om the clate on rvhich tlle jirst statement of objection is issued to. the applicant to compl)/ with the reqnirements. It is subrnitted that given the specified _ tirtre linrits I prescribed at the stage of scrutiny of the applications for g'atrt ol'Patent 'and given the fact that the grant of a patent relates. bacl< to tlre date otr which tbe applicatiori.is filed, thd patentee hctually loses tuttch ol'this lleriod for working the patent. Given the fact that an application lcr' grant of patent oan get,published only after a period of 18 lnonths ancl that the Controller carurot take up the application for exalnination fbr a period of six months after its publication, it is necessary io reacl a reasonable time lrrnit for filing a pre-grant oppos.ition. Reference is nracle to tlre decisions in'sttrjit Sirtgh l{alra v..(Jrtiort of lrtclia g99I) 2 SCC B7 and, Directorate of Ertforcenrcnt.v. Deepnlc ll'Ialmian Altrl 1994 SC 177s. Writ Petitiort (C) No. 1020 of 2010

¶29The petitioner Tibotec Pharmaceuticals ('Tibotec') liled its 'application for graut of patent oir I ltl' Jnne 2004 for an iuvetrtiotr titJecl 'Combination of Cytochorne P.rso Orp.nAent Ijrotease lntribitors'. The w.P.(c) Nos. 3516, 9577,5422, 5423 of 2007 & 70ggg, L0400 &'70450 of 2009 & 1o2o of 2o7o . Pqge 17 of 40 93, first exarnination report was issued on 14il'March 2007.1'he apPlicirtion ' was published on 30tl'November 2007 in tertns of Section llA ol'the l t' Act. After considerilg the response of th'e Petitioner inreply to the lilst examination report, the Controller issued a letter io.the Petitionel on.28tl' n f, -1- .rrrr\o r^ rI^^ f^11^,-,;.,- ^{'f^^f'. March 2008 to the following effect: . "YoUr above Application for patent has beeu fould in order for grant. However, the Patent Certificate will be issuecl only after processing of tlre Application under Section 11(a) [sic ]LAJ and I cornpletion of thb statutory limit and disposal ol' pre-grant opposition, if any, under Section 25(1) oI' the Act."

¶30The petitioner's case is that on 30tl'May 2008, the tnandatory perioct of six nonths in terms of Rule 55(1-4.) of the Rules and tlre three conclitions in the aforernentioned letter stood satisfied: According to. the Petitioner, the paient was deemed to have been glanted fi'om such date

¶31On 26tl' Jnle 2008, Cipla Ltd. filed a pre-grant repleserttatior/ ; epposition. This was notified to the Petitioner fi-otn the Delhi Office o[' .the Coltroller.'ihr P.titioner, by its letter dated 21't October 2008, . pointed o11t to the Controller that the pre-grant opposition r'r'zrs liltte-rl. barred. The Petitioner also filed an interloctttory petition clatecl lOtr' Noven1be1 2008 prayirig for issuance of a patent certificate Lr its favour . and for rejectilg the opposition filed by Cipla. Ltd. TherEaller the ' Petitioner also filed a1 afficlavit of evidence on 7'l' .Tanuaty 2009 o{'one .' Professor David Johq Back. w.P.(c) Nos. 3576, i577,5422, 5423 of 2007 & 70399, 10400 & 70450 of 2009 & 7020 af 2070 poge 78 of 40 rr21t UI

¶32The petitioner ald Cipla Ltd. were heard by the Assistaut Cotrtr-oller of Patents on glh'Janiraly 2009 ard written submissions wele tjled by ilrem on 27t' March 2009. By an order dated 30tl' Ma'ch 2009, the Assistant Controller. allowed the pre-grant oppositjorr and refrrsed to tJre petitioler the grant of the patent oir the ground of lacl< of inveritive itep. The Controller's order dated 30tl'N{arch 2009 ltas beetl cltallerrged by _.: IlDorec rn uus petition. A.uiong'the"grounds raised in this petition is that the pre-grant opposition filed after 30u'May 2008 was not urairltajnable' . Subndssiorts of Counsel in Tibotec-'s petitiort

¶33M-, Rajiv Nayyar, lealned Senior:conusel appearing l'or tlte Pctitiorrer flUot"" subrnitted that tlrere was a distinction betweeu the 'isstiatlrce' ol'at patent certificate under Rule 74 and the 'grant' of patent for tlie pulposes of Section 43'. FIe also tefen:ed to the impugned order passccl by the . Assistant Controlier where it was' observed that "there \ry-as llQ irnpedirnent on 30tl'May 2008 to.the issuance of the.patent certificate atlcl ' that the patent Office should have done so'lvithin seven days of 30"' May 2008 as the application was published on 30tl'Novernber 2007 ancl six ( r,ouths period was over on 3'00'May 2008". It u'as furthet obselved in . th.. irnpugned order that the grant of patent by the Contloller iurcl tlte subseqlelt issuance of letters of patent have talcen lnore. time'than it could have taken ordinarily but that did not preclude the fiiing of a pre-grgnt opposition. It is acc,ordingly submitted that for all practical pl{poses the effective date of .grant of the pate[t shotrld be 30tr' Mav 2008 or the verJi ne.xt dey thereafter- : w.p.(C) Nas. i516, 5577,5422, 5423 ol 2007 & 70ggg, 70400 & 70450 of 2009 & 7020 of 2070 Poge 79 of 40 -tl 3) 34 IvIr.'Majrundar, learned counsei appeariilg for Cipla Ltcl. strbnrittctl' its exanrinaiidrt irr irritial . pha.se by the Controller, there was no third par1y. The Controller.acts as a.fact finding authority. Section 3, of the Act sets otrt the grotrucls f'or . refrisal. If the patent is refused, the order is'relatable to .Section l -5 of, the Act. The Controller could ask for an arnendment to be tnade even at that stage. The intirnation that the patent is in order is not.by itselI a gtant oI' patent. This is an order relatable to Section 15 of the Act. Acoolclirrg to trirn, tlie stage of Sectio n 43 for grant of patent is reaclted only al1cr flra rrrncesqes errvisased hv .Sectiorr l5 of the Act. Uncler cornpletion of the processes envisaged by Section 15 cf the Act. Section.45, the date of patent is already afixed date sinie rutder Scctiolt 45 (1) "every paterrt shall be dated as of the clate.on which thg applicirtiort for patent was filed". It is this date that is entered in the Registel. I-lc pointeil out that under Rule 80 to keep a patent in force, the rctlewal hes specifie.d in the First Schedule shall be payable at the expiration o[ the sec.ond year fi-orn the date of the patent anci the period for payrnertt of renewal fees may be extended u,p to six months. So the clate ol'patertt becornes critical for the payrnent of renewal fees, Where an applicarit .has not paid renewal fees, it means that he is dware that he ltas ttot been granted a patent

¶35I\&'. MajurnCar poinfud out that lJnder Rule 122, the Contloller cal correct clerical elrors. Likewise, iurder Section 146 the Controller can call {br information regar-dirig the conlrllercial workfug oq [he pa.tenr-rvithin two months frorn the date of srich notice. Notwithstanclitrg tl,ris, W-P.{cl Nos-3576, 3577,5422, 5423 af 2OO7 8t 7E3gg,7O40O S. 70450 of 2009 & 7020 of 2070 ' page 20 o! 1o ' . e(l (/ rurder Section 146(2) every patent holder has to furnish statcttletlLs. in such manner and form ancl in not less than six tuotttlts as tllaJ/ be prescribed as to the extent to which the iatented inveutiorr ltas lreett worked on a colnmercial scale in India. If no such reports are I'iled, theu it i, ptulrr that no patent has been granted. The working o['the llatent arises only where it is grairted. Ivfi'. Majurnclar pointecl out that uttcler nlte 130 an application for review of the Controller's order has io be made within one month fi'orn the date of couruturicatiott of tlre decisjorr to the applicant

¶36It is subrnitted by tW. Maju,mdar that in the instant case there. wirs rro presumption of grant of patent only on the basis of the.letter clatecl 2B(r' . March 2008 as it was only an informal intirnatioq to the Petitionel'rvhich was in fact not required to be nade in law. It is only as a long stancling practice.that'the Controller has been issuing such' cotntuttuications btrt there is no grralantee that patent'would be granted only o,', ,a."o,,ttt ol' such cornmunication. Secondly, without the.completion of the procedtrre envisaged under Section 25(1) and Section 11A, there car be uo grant o[. u putort .Itris subrnitted that for the purposes of the Act "tlte date o[ ' ' grant of the patent is the date on which the Respondeut authorities Flss ' the.order.of grant. It is only after such an order is p.assed, that a;ratenl is treated as granted 1o rnatter l'hen the certific.ate of grant is issuecl or when the grant is'recorded or.notified." It is accordingly strblttitted that as or the clate o{tn! filing of pre-grant.opposition, t1o graut ol'patettt hacl - taken place as erivisage4 by t[e Act. . w.P:(c) tuoi. ssto, i577,5422, 5423 of 2007 & 70ggg, 70400 & 70450 of 200t . jn\":rr:;:" q). . u ((

¶37The writ petition is also.resisted on the ground of laches. it is slatetJ that the Petitioner chose to challenge the order dateil 30'l' March 2009 only on 22"d I1ntuy 2010. Relialce is placed ou.the judgrnclrt o['tlre Suprente Court instate of M.P. v. Nandlal faiswal (1986) 4 SCC 556. Wken.can a patent be sgid.to be grunted?

38.-The bornrnon qriestion that arises in all these petitions is when carr it be said that a patgnt has been granted? Sectioir 2 (1) ol'the Act oPens with the r.rrcrds "unless the context other-wise requires". Tltis has to be read with Section 2 (I) (m) which defines a 'patent' as "'a patent l'or arry invention gradted nnder this Act". The date of gant of patent is critical' fcr deterrnining the tirne within which a pre-grant opposition l.ras tb be fiied in terms of Section 25(1) of the Act. After the amenchnenL to the Act ancl iq particular to Section 25 (1) with effect fi-orn.l't January 2005, a significant change has been brought in this regarcl. Ptior to its amendineut, under Section 25(I) the pre-grant opposition.hacl to be I'ilcd rvithil fou nonths [r'om r-he date of advertisenient of tltc rtcceptatlce trl' ! the bonrplete specification.'This advertiseuretrt in'the oflieial gazeLLe crl' tire ac,ceptanoe of complete spebification whs undet Section 23 ol'tlre Act, prior to its amendment 4 ftirther maximum periocl of one ttro'lttlt could be allo'wed by the Controller for rnakirig the pre-grant oppo.sitiorr. Such prc-grant opposition could be made only by ,r.;'1r"rrn,, ittterested".

¶39The significant'c,hange brought about by the amdndtnertt to Sectiorr 25 in 2005' is that the lrre-grant.'represeutation' (or opposition) against I W.P.(C) Nos. 3516, 35L7,5422, 5423 of\2007 & 70399,.70400 & 70450 of 2009 & L020 of 2070 .: CT q\ <J : the grant oipat"nt can.be rnade by "any petsott". 'The publicatiod ol'tlre complete specification now takes p.lace under Section 11A of 'the Act. Uncler Rule 24 of the Patent Rules 2003 the publicatiotr happens ttot earlier. than 18 months fi-om the date of filing of the applicatiort or the rt' clate of priority of the application, whichever is earlier.

¶40fhere *. ,p..ific'time lirnits for the stepS to be taken for the .le complete sp publicatiorl by the acceptance of the complete specification for Coltroller. ThiS iS followecl by a tequest made by the ap;rlioant fol : exarnination in tenns of Section.lL-B of the Act. This is foJlorvccl b,r' 11'," exarnination. of the application urder Section 1'2 of the Act which has to ake place within the specified tirne lirnit as prescribed iu Rtrle 24-B ot t1e Rules. Without going into the specific details of tni, tirne periocl, lbr . tle pu{poses of the present petitions it is sufficient to'note that where it is intended that there sholld be a specific tirrre linit within which a step has to be taken either by the applicant for the gant of patent cr b} llis Controiler then such tirne limit is clearly indicated in the Act and tl:e . Rule.s, '41. There is anotherprovision which is relevant in this context. LJnder Rule 55(1-4), no patent shall be !5rarited before the expiry of a periocl oi' six months fi'oui the date of publicatiorr of the application ttttcler Sectioir 11A. As a result, at least for a period of'2 yeu's aftel filing ol'the application for grant of patent, no patent can be grrinted. lt is cluring this . period that the steps for exhrnination of the patent in ternts ol Sectio[ l2 ' *,p1cJ Nos. gs16, JFL7,s4zz, s4zg ol 2007 & 70sgg, 70400 & 70450'of 2009 & 7020 of 2010 poge 23 of 40 E1r and thereafter the consid,eration by the Coltroller of the report of tlre Examiner under Section 14 foltowed bf atuettclttlettts, i['alty, are all undertaicen. It is during this time also that the pre-grant opposition.is expected to be filed.

42.Thefact of the acceptance of the cornplete specification, ars indicaled by the applicalt for grarrt of a patent, havilg. been a.ccepted lbr publication is 'evidelt fi'orn the advertisernent of suclt specification in the Patents Journal in terms of Sectiol 11A of the'Aqt. l'|erelbre, arl)/ persbn who is seeking to object to the grant of the patent is expected to keep the tr-aclc of publication of snch. complete specification. .flris Cotrft has been inforrnecl that'publication also takes place on the website, irt addition to being published in the Journal.

¶43Tlrere is a further time restrictiol. Under Rule 24, the periocl lbL which an application for patent "shall not ordinalily be opell to llublic under sub-section (1) of Section t t-n shall be 1B montlts fi'ortt the clate of filing of the application or the date of the priority of the applicatiott, whichever is earlier." In effect, therefore, it will. not be possible for a person seekilg.to object to the grant of a patent to make 'reptesentzrt'iott' earlier than a period of 18 months after the date of the filing ol such application. In any event since iu tenns of Rule 55(1-A) uo patetrt cart be granted beifore the expiry of a period of six monihs fron tfie clate of publication and the Coutrollel is expected to publish the applicatiott within one month fi.orn the date of expiry bf the said periocl, tltel'e is at W.p.(C) Nos. JSt6, 35t7,5422, 5423 of 2007 & 733gg, rciOO A 70450 of 2009 & 7020 of 2070 Ya, lehst a.period representation. six months thereafter for opposer lo tile. the of the --,o -^r.o,-a rha o l5 to Secliott 2-5 oittre

¶44Given the above siheme, the amendment in 2005 to Section 2-5 r Act lvas appbreltly rnade r,vith a vierv to extending the tirne pe;iod within which an cpposition to the grant of patent had to be macle. Uncler the pre-alnended Section25,.the persons interested in opposiug the grarnt of patent.had to necessarily file such opposition within four ntotttlts' a period extendable only by one tnonth, whet'eas under tlre a.nteltclecl Section 25 thatperiod is clearly extended at least up to six urouths'

¶45Giveu tlre practical aspect of the matter, no patent is ustrally grarltecl , f | 1:--1i irnrnediately on the expiry of six rnonths f}orn the date of publication of tli.e application. It is usnally a illrtch longer period. The atnettcltneltt in Sectiol 25 clearly, therefr-rre, cnlarges the tine for filing of ir pl'e-grattt opposttton.

¶46the thrlst of the Act is thaL the rnete grant of patent cloes not ellsttte its valiclittr,. This is plain fron: section 13(4) of tJre Act' Evert tlre grant of a pateirt does not ensLre that there will beiro ftiither challenge. Urtclet Section ZS 1Zl of the Act, against the gtant of apatent ancl tlie rejectiorr of a. pre-grant opposition, a post-grant opposition call be liled by any pefson . interested before the Intellectual Property Appellate lloard licatiorr'for revccation ca,n t:e frr"O before the IPAIS b1'

(IPAB). A,,n application for revccation ca'n L:e hle any person lnte.l'ested rurtler Section 64 cf the Act. If the patent holcle r t t.P.(C) ttos.3515, ss77,5422,5423 of2007 8t 70399,70400 & 70450 of2C09 & 7020rof 2.0L0 page.25 of 40 files a suit for infi-ingement the Defendant in counter clairn challenge the valiclity of grant with section 64 of the Act). \.1 I such a suit can bY rvaY o1'a of patent (Section 107 rea.d

¶47The scheme of the Patents Act, therefore, i's such that there are several hurdles to.cross before the grant of a patent cau be saicl to be filal. There are two other provisions that require to be noticecl. Undcr Sectiol 53, terrn of every patent "shall be 20 years fi'om'the claLe of I'ilirrg of the application for the patent". Under Section 45 "errery patent shall be dated as of the date on *iii"h the application for patent was filed''. Since this date canlot possibly be chauged, a patent holder tttay .ettd ttp lot being able to work the. patent during the .tine w-hen it t'entaitts clrallenged,.oritsgrairtisStallgdorwlretrtlrepaterrtholcleristtot confident to exploit it commercially till'ail the challenges to its valiclity are ov6rcoine. Since tfiere is already'a loss of time for the patent bolcler in tire above processes, the time period envisaged by Section 25(l) ol'.tire Act for fililg of a pre-gr"ant opposition carurot pbssibll' be libelallv construed, notwithstalding that there is ilo specific tjne periocl rnentioned therein. The outer lirnit is the date ott which the patent is' granted.

¶48A careftrl look at Sectjon 43 of the Act shows that in the first place art application for.patent has to be found "to be in order fclt grant". 'fhis ' :, incJldi:s the period duing *hich cornplete specification is acce;lted lbt publication'in ter-ms of Section 1lA,followed by the examittation ol'the w.P.(cl Nos. 3576, 3577,5422, 5423 of 2007 & 7Eggg, L0400 & 70450 of 2009 & L020 of 2070 . poge 26 of 40 o patent which tal<es place within the tirne-fiame set ottt in Rule 24-B ol' the Rules. A reftisal at that stage will be governed by Sectioir | 5 o'1'the \L/ Act. If the patelt is not refused at that stage and no pre-grant opposttlott has been filed, the patent proceeds for registration. ,. ,-

¶49Where an), pre-grant opposrtron ls filed in the lot'ut o[ a. representation underl Section 25(I) of the Act, then it has to be examiDeci . following the prbcedue outlined in Rule.55 (1) The representatiotr sholld inclgcle a staternent of evideUce a:rd a requeSt for hearing. Urtcler' Rule 55 (2), the Contr-oller is to consider such tepreseutatiou "only wltetl . arequest for examination of an application has been filec[". . A notice is ' , given to the'applicant "for'gralt of pateut" wltere the Controller'lornls all opilion, upon considering the pre-gralt opposition, ihat the patent shotrld be reftised or amended. This happens under Rule 55 (3). The applicant for grant of patent then responds to the notice by filing his staterrrettt ol' evidence under Rule.55(4) within three months fiorn the clate ol' the notice. Under Rule 55 .(5), the Conh'oller may, on cotlsjderatiorr o['the stateri.Lent ald evidence filed by the applicant, either refus'e to grant a patent or require the complete specification to be amended belbre tlre patent is granted 50'. Thel we have Rule 55 (6) which is relied upoir extensirrely by the learned cottnsel for the parties and which reacls as nnder: . "55(6) After cousidering the representation attcl slbmission.made durilg the hearilg if so tequestecl, fte Contrcller shall proceed fuither simtrltzureously w.P.(c) Nos. 3576, 3577,5422, 5423 of'2007 & 10399, 7O4OO & 7O45O"of 2OO9 & 7O2O of 2o7o page 27 of 4O either rejecting the patent or acceptilg the grant of patent within ong rnonth .: proceedlngs." representation and grant'ing the the representation and refi.rsing on that application, ordiriarilY frour the completion of above

¶51It is plain, therefore, that once the fre-grant oppo.sition is clecidecl, the Contr-ol|er simultaneously proceeds to either reject such rept9sentatiott and grant the patent or acbept the representatiou.and reftise the paterrt. The language of Rule 55 (6) leaves no rnanner of doubt that these tr,vo . actions i.e. the consideration of the representatiou aid the fnral clecision Itttltaneorrsly. on the application for grant of patent take place sir l .52.It i,s possible.that tfuere are rnore thair one representatiotrs by way of pre-grant opposition. Ideally, the C<lntroller wifl bunch them together, hear them sequentially and express a final opinion on each of thelrr as far' as practicable, on the sdme date. It is like a court hearing a'batch o[' petitions seeking sirnilarlrelief. It is possible that evell after tlte healing on one brinch of pre-gra.nt oppositions has concluded and order has been reserved thereon, alother pre-grant opposition or a set of oppositions is fileci pr-ior to the pronolutcernent'by the Controller of the decision on tlrt> first set of pre-grant'oppositions. Then the schemd of the Act l'eqtrires Llre Controller to deal rviflr such subsequently filed pr"-grurri oppositions as rvell. However, once a final decision is pronounced on the pre-gl-attt ./ oppositious, the ColrtrolJer shoulcl, consisteirt with tlie requit'ettrent of' { R.ule 55 (6) sirnulta.neotrsly prononnce the decisiorr oti the application lbr W.P.(C) Nos.3576, j577,5422, .5423,of 2007 & 70399, 70400 & 70450 of 2009 & 7020 of 20i0 ' .il1 grant of patent. The Controller should clearly state, sinultanecusly, that the application is forurd in order and that the patent is being.granted.

¶53Reverting tp S"ttion 43 (1), the'language used is that "a patent sltall ' be granted as expeditiougly.as possible." Therefore.the paterlt has to tle granted oltce it is found'that either the application has not been reltsecl in tenns of Secticn 25(1) read with Rule 55 (6) or it.has not been founcl in contravention of any piovision of the Act. In other wofds, at this stage the Conh-oller is not expected to delay the pronouucentent of the ['inal 'decision. The tluust of Section 43 (1) and Rule 55 (6) is that of expeditious decision making by the Controller. Sectiort 43 ( l) inclicates that the "patent shall be granted.....with the seal of thb patent office and ' the date on which the patent is granted slrall be eutered in the Register". When read continuously, the language of Section 43 (1) cloes appear to indieate tirat it is the decision talceri by the Controller on lile r,vhich is tlrq determinin.g event for ascertaining 'the date of grant of patent.' The sealing of the patent and'the entering of the pateut. in llr. l-tegister obviously follows tire. act of the Controller passiug'atr orcler to thc efl'cct that the patent has been granted. In other words, the sealing of the ptttertl. and the entering of the patent in the Register are, givetr tlre lauguagq of Section.43 (1) of the Act, iutended to be rninistetial acts evidbncing the : antgrior to those ininisterial acts. grant of patent, ryh.ich is at a stage antgrior to those.

¶54Sectiou j (2) talks of the publishing by the'Contr-oller ol"'the l'a'ct tlrat the parent has been granted". The.language of Sectiorr 43 (2) is plairr. W.P.(C) Nos.5976, 3s77,5422, 542j of 2A07 & 7C399, i0400 & 70450 of 2009 & 7020 of 2070 page'29 of 4O lr( 1u 'fhe act of ptrblication "l.uriy follows the grant of patent. Per' lolce tlle gralt of patelt is anterior to the publication and has to necessdiily be at a poilt eallier to the publicatiol. It is, therefore, not'possible to agrce with the subrnissions rnade on behalf of the pre-grailt opposers in the present batch of'Qases flrat the patent camot'be said to have been granted till this fact is published in the official gazette. Giu.,t tltat the interpretation of the provision has io be contextual, this Cor,u-t holcls that the date of gralt of patent is the date on which the'Controller passes itrl order to ihat effect on the file. This Court now proceeds to deal.rryith the apprehended practical problerns that the office of the Coritroller rtray fhce on account of the interpretation placed by tiris Cour-t bn Section 43 ol' the Act. Freviotts awrcuncenrcnt of tlrc dnte of pronouncelnent of orders '55. It was snbmitted that an order does not become effective till such 'time it is cornnunicated or rnade kiown, becanse it thel gives valtrable. rights to both the'holder of the patent as well as ary llersop irtterestecl irt opposing the grant of patent. Whilp it is. corect that.the knowleclge of an order gralting a patent is irnportaut fi'om .the point of view of both the ,. .applicalt for grant of patent and the opposer, it is unlikeiy that the applicalt is not present, either in person or tluough a lepreselttatirre, ott tle date on which an order is passed bV tfe Coutroller or tlie Assjstant Controller granting the patent. In order to obviafe any difficulty on this score, this Court would" like to impress lpotl the Controllcr ancl thc Assistant. Controllers to list cases for pronouncernent of ordel's and ltttrl<e w.P.(c) Nos.3576, 3577,5422, 5423 of 2007 & 703gg, 70400 & 70450 of 200s & 7020 of 2070 that fact known by pnblishing a "'chuse list' of strch cases under the headilg "for prono.,ncernent of ordets" tlte previous eveniug both oll tlre websile as well the notice Board of the Office of the Control ler, j trst as it 't happens in the Coruts. Therefore both the applicant for grant of patent.as well as flre pre-grant opposer would be aware of the. date ort rvhich [he orders ale to l"re pronounced. Since it will be at least the prdviotrs .r I '. I e\/enlng on which the list is available on the website aucl also placetl ort the notice boar-d of the Office of the Controller, thete will be s.trfficiellt ' notice to such parties. ' , Deatirtg rvitlt Review Petitions, 56-If an approach similal to.that followed.by courts in hearing cases altd p4ssing orders thereon is adopted, mnch of the problems I'aced by the Contrgller can te resolved. For instance, once a final orcler is protrotrrrccd ou a petition by the Court, then no further applications rvltether lor intervention, impleadrnent, oppositior or any other relief is eutertaiqecl . I by such coirt. The only exception is the filing of a review applicatictr by .: a party to the case. Likewise, once a final order granting patent is passccl by the Coirh-oller on the file, tlere is no qubstidn o[' tlterealier entefiaining a pre-grant oiltrlpsition as it is barreci utider Section 25 (l) witli no discretion given to. the Controller. If a review petition is liled under Sectiori 77 (1) (f) readwitlrRule 130, it will be by those rvho are partieis to the order of the Controller or the Assistant Contlollei-thc review.of whic,h is souglrt..If such revier.v petition is entertatr;ecl, and tlre ' order is i'ecalJ.ed then as it happens with judicial oi'ders. b), cotrrts, tite t' W.P.(C) Nos, 3576, 35!.7,5422, 5423 of 2007 &!0299, 70400 & 70450 oJ 2009 & 1020 t! ,:! \7, clock is put bagk to the stage where the original order was. passed aucl all ' ' legai conseciuences would flow. This by no meails alters tlie fact that the date of the grant of patent is the clate on which the Conholler or Assistiirrt coltrqller passes an order on tile granting the'patent. lilbrdirtg of the Jinal order grlntins patent

¶57There is one other aspect which requires to be adverted to" rvlrich is the wording of .the order glanting patent. The Controller shoulcl pass tlte ' cfinal order' saying that "the patent is hereby granted" only aller'all amendrnerits have been carried out to the satisfaction of the Controller by O ilre applicant. The Controller wiil, therefore, ttot clispose. o{' tlie r'--ri pass a final order till sLrch tinre the Applic.atrt has llot .., apprlcanonor caried out the.amendments to the sltisfaction of the Contro[ler. It rvill have to be a tirne-bound order for that purpose. A failure to ceut'y otrt ttre amendment to the specification.as directed by the Controller or Assistarti Coltroller within the tirne gralted rnight result in t'ej'eqtiolr o1'thc patent which cOntingerrcy is covered rurder S. 15 of the Act.' Flacing tlt.e digitatly signed orders..srt dlrc net

¶58In order to minirnise any unuecessary tirne-gap betweeu the sigtrirlg by the Controller or Assistarit Controller of the final ord'el' grantirrg patent an{ the 'publishing' of such order, it is clirected that every linal , .l , ^ orcler glauting the patent passed by the Controller or tire Assistalrt Controlier, as the case may b", should be digitally sigrred b)' the Coutroller or the Assistant Coniroller ancl placed ori tlie website ol'the W.P.(C) Nos.3576, 3577,5422, 5423. of 2007 & 70399, 10400 & 70450.of 2009 & 7020 of 2070' \ls' ContrOller on the very Same day without ally nlneces$atlr delay' '['he i-procedue in this regald be strearnlined for being followed uniforurly by ') all the.officers and necessary instructions/pra.ctice directions shoulcl be issued by the Controller. I Rights of post-grant opposers protected

¶59The rights of such of those post-grant opposers who al'e persolls 'interested' are sufficiently protected under Section 25(2). Since the period of lirnitation for filing a post-grant opposition is one rnonth "llotn the date of publication of gralt of a patent", the legislature has, tlrerelbrc, already taken care of the iirterests of the post-gtaut opposers atttl Ittacle the period of lirnitation run only frorn the date of publicalion of the grant of patelt which is expected to talie place in terms o.f Sectjon 43 (2) oI tlre Act.

¶60It rnust be understood that prior to the amendtnent in Section 25 irt' tlre year 2005, even a pre-grant opposition could be filed orrly by any person 'interested'.'It is only after the arnendment irr 2005 that arry person call now fite the pre-gralt.opposition. Tlie Act, therefore, ntakes' a distinctiol betWeen.an. opposer at the stage of pre-grattt o;lposiliorr, u,ho could be 'any' person, and the opposer at the.post-grant stage, lvlto colld only be a 'person interested'. The legislative intent is that ttro ligirt rnt opposition uncler Section 25 (2)is restrictecl Lo anv to file a post-grant opposition uncler Section 25 ( person interested. The fact that the restriction of the time to file a ;:r'e-gralt whicfu results fi'orn the interpretaticin given by this cottl't ttlay W.p.(c) Nos. 35t6, gs77,s4zz, s42g oi zlu a rcsgg, 70400 & 70450 of 2009 & 1020 of 2070 poge i3 of 40 \?, irnpact the two classes of pre-grant opposers differently is consistent with the'above distinction. t

¶61While restriciing the tinte period for filing a pre-grant olrposition to tirne. rvhen such pateirt is g1anted may inconrreuience "alty pel'solt" ' : who wishes to file a pre-grant opposition, it is certainly' not going to , ltt '. inbonvenience a "person interested". Even if such 'interestecl'' persol . rnisses the bus at the pre-grant stage, the right of such person to oppose at itre post-grant stage is preserved uncler Sectiori 25 (2) oI the Act. , Therefore, the interpretation placed by this Cotrrt certailtll' caltnol prejudice a person interested in opposing.the gtarlt.of pa[ent. As regarcls any person, other than a persou interested, the legislatii,e irltcttt appcal's to restrict the scope of such person coufined to the stage of ple-glant. It would be necessil'y, therefore, for such persoll '(rvho ffis1r pe1 be alt . 'interested' person) to be vigiiant and to watch out for the date of aclvertisement of the cornplete specification and understancl that the lirnitation fbr filing a pre-grant opposition begins.to rtut'fi'onr that cla.te onwards. : Neeel to discorir;age Jilirtg of serial oppositioris

¶62Accepting the submissions of pre-grant opposels'in tlte present balch . . of cases that till such tirne the gant of patent is not entered ilr the Register, and notwithstancling that an order hhs ah'eady been passed on / file by the Controller gtanting a'1iate.rtt, they can contitrt:e tc file the pre-grant represerrtations in Lerms of Section 25 (1) rlright tcsult irr the . W.P.(C) Nos. 3576, 3577,5422, 5423 of 2007 & 70399, 70400 & 70450 of 2009 & 7020 of 2070 ' Poge 34 of 40 o 6D/ phenornenon 3f 'serial oppositions', as has happened in the cttse ol'the applications filed opposing the patents appliecl for by .f Mitra Cornpany. Within a day after the Controller iejected the ;lte-gr-ant opposition fiIed by SDL, Dr. Gupte'filed a pre-grant opposition." Soou therealter Dr. Rindani filed his pre-grant oppositiori. In other worcls, iI' this Court were to hold that the date of the gr-ant of patent is only the clate on which the factun of such glant is entered in the Register, then there ' rvould be no end.to filing of pre-grant oppositions as long as oll accottttt of some delay on th9 achninistrative side the factum of grant of patent is not entered in thc Register.. Given the scheme.of the Act, attcl llte tttttrttrer ' .of hurdles an applicant for gtant of a patent had to overcoltle, even if ttre application is found to be 'in order for grant', it is not possible [o accept the interpretation put. forth by the pre-grant opposers.

¶63Then we have one more situation as in the case.of Tibotec. 'l'he tllere comrnunipation by the Controller to the applicant fbr graut ol'patenl. tirirt : the applioation has been'fould in order subject of qourse to the clecisiort on pie-grant opposition, if any filed, cannot be csnstrired as the bflicial \ decision of the Controller glanting the patent. Ihere has to.be arr order on file passed by the Controiler holding thht the palent hirs beetr lbulrcl.i.tr order and that patent is gralted.' Until and unless sirch atr orcler is passecl on file, it gannot be said that the patent has been'gtanted.

6.1. in adopting the above iuterpretation of Section 43 and other relatecl provisious of the Act tliis Court has kept in 'view the fbllgwirrg W.P.(C) Nos. 3576, 9517,5422, 5423 of 2007 & 7}3gg, 70400 & 1-0450'of 2009 & 7020 of 2070 poge 35 of 40 tl , '.observations of the Supr'eme conrt in Entertuirtnrcnt Networle (f1dio) . trtd.v, Sttper Cussette nulustries Ltd. (2005) 1.3 SCg 30, irt paras 137 ald 139, which though made in the context of the Copyright Aot rnay well apply to the pr;esent cases as well: ' "I37. Furtherulore,',the court while interpretl'ng a statute will put itself in the annchair of the . to be reasoriabtg. It is now trite law that literal interpretation should be avoided wheu it leads to absurdity... ...

¶139In this case, however, the meattittg of ttre statute is neither clear ior sensible. It is a statute ' where a pruposive coustrliction is warauted. lt is a .case whetie sub-section (2) should be kept confirlecl ' to clanse (a) for that purpose. The statute has to be read down. It is not a case of improper interpolation so as to take away a prirnary purpobe of' tlre legislative intent. It is expedient to give effect to the ' intent of the statute. This itself says that creases can be'ironed out. While underlaking the said exercise, the Court's endeavour r,vould be to give a meaning to the urovisions and not reuder it otiose.... .65. This cour{, for the aforementioned reasons, holds that l'or tlre prqposes. of Section 43 (1) of the Act, the patent is 'g'antecl' ott the clate .; on which the'Contrbller passes a final oi'der to that effect on the [ile. Cortclusiorts: First set of petitiorts

¶66The facts in the first set of petitions have alreacly been discussed. lrr ' the first set of petitions, the order dated 23'd August 2006 passecl by the w p (g Nos,3576, 951.7,5422, 5423 of 2007.& 70399, 70400 & U)ASO o7 ZOO9 & 7020 of 2070 poge 36 of 40 Coniroller, whiie dismissing the pre-grant opposition that "1 hereby orcler' to g:ant patent (Patent No. L94638) o11 batch Application No-5931De112000" must be taken to be the clate on wiriclr the pateut u'as granted. Although, as pointed out by learned cotursel for tlrc Pe{.itionet's, the said order requires the applibant (J,Mitra & Co.) to atlencl the specification to include a cross reference, it cloes not malerially aLfbct the facturn of the gr.ant of patent. The fact that it was entered in the Register on22'd Septernber 2006 would not make any difference to this position-'Further the statemqnt by J.Mitra & Co. in the plaint in C-S. (OS)No.2020 of 2006that the paient'was grantecl o1 22"d September 2006 wotrlc[ also not rnake a difference to the position in law. The date of the glant ol'the patent i1 question to J.Mitra & Co. should be takeri as 23''d Atrgust 2006-

¶67Colsequently, any pre-graff opposition Jilecl after 23rcl Atrgrrst 2006 '; was clearly barred under Sqction 25 (1) of the Act. 'l herelbre the irnpugled orders" of the Controller rejecting the pre-grant op1:ositions filed by tlie petitioners are Valid and clo not call for interferellcc'

¶68Notwithstanding the above.conclusion, this Court also lrolcls tlrat lhc fiiing of pre-grant opposition by Dr. Gupte aucl Dr-Rindani subseclr-rettt to 23'd August 2006 was, apatt fiom being uot tnaintainable in law, alscr an abuse of the."process of law. This court is not convincecl o1' 1he bonafides of 'either of the Petitioners..There has.not beetr apy effectivc denial of the fact that both Petitioners were assobiated with SDL in sottlc ,r't rt ' t -- -^^- capaclty ot U1e other. It ts tmpossible to cornprehend thzrt either of lhcsc w.P.(C) Nos, 3575, g.577,5422, 5423 of 2007 8| 70ggg, 10400 & 70450 of 2009 & 7020 of 2070 Poge 37 of 40 f7/' Petitioners was unawa.re of the opposition .by SDL or of flre SSt fact that the filing ol' lhe ;lre-grant ' fact that it lias been Lerltetr Llp tbr' gonsideration'by tire Controller of Patents or of the fact that [he ordet'ott strch pre-gratrt oppositioll were pencling.

¶69pven according to thqse Petitioners, the cotnmr:ttiLy of those iltelested in the development of the test kits is a small otte aud overy step taken by each cornletitor wor.rld be known to the other. 'fhis itsell'bclies the fact that either Dr. Gupte or.Dr'. Rindani was ultaware of the pre- (. grant oppcisitions already filed by qDL in relation to Llrc pa[ertt. applications of J. Mitra & Cornpany. Given the long history of liLigatiort between tn" purti"s, it.creates further cloubts on the bonaficles oi-thcse two Petitionels.

¶70For all of the above. reasons, this Court finds .absolutely no merit itr the four Writ Petition (C) Nos.3 5}6,3517, 5422 and 5423 o'f 2007 in the first set and they are disrnissed with costs of Rs.20,000/- each ivhiclr rvill ' be pai{ by each gf the Petitioners to J. Mitra & Co. within a pcriocl o[- .n .bur weeks. Conclusions: Second set of peti.tiorts TI.Inthe secbncl set of petitions by Zephyr, the pot"lt itl flavoLrt' of l.,alit 'j I\4ahajan was grantecl ancl sealecl on 16tr' Octbber 2008 rvhereas. the Pre- ^-th ^t, grant opposltlon was filed in one case on 28tl'Novdrnber 2008 atrcl itr [u'o other cases on 12tl' December 2008. Thete can be no ltlallller of clor-rbt that.the filing of sucli pre-grant oppositioll was subseqttent to tlrc grartlt of w.P.(c) Nos. 3576, g577,s422, 5423 of 2007 & 70ggg, 70400 & 70450 of 2009 & 7020 of 20L0 . poge 38 of 40 t1 / patent and was bared rurder Section 25(1) of the Act. 'l"herc is absolutely, therefore, no enor in the orders passed by the Controller rejecting the pie-grant oppositions.

¶72Thethree W1rt Petition (C) Nos. 10399,10400 ancl 10450 ol'2009 are disrnissed with costs of Rs. 20,0001-each which tvill be paict by the Petitioner Zephyr to Respondent No.1 Lalit Mahajan withitr tbLrr weeks from today. 'Cortclusiorts in l|trit Petitiort (C) No. 1020 of 2010

73.Inview of what has been held above, tlte comunurication clatecl 28th :' March 2008 written by the Controller to the Petitioner catttrot.be held to be the date of grynt of the patent. It was merely a comrn[tnicatiott stating that the application has been forurd in order for grant. It'is not att otder to grant patent. Therefore, when the pre-grant opposition r.vas liled by : Cipla Ltd on 26tl' June 2008 there was no grant of patent by that dute attcl, therefore, such application was.rnaintainable in terms of Section 25(l ) of tlre Act-Although there is a.n observatiol blr 11" Controller that after-301r'' May 2008 th.ere was il.o'legal irnpedirnent in the Controller passilrg arr order for gant of patent becd:use on that date.there was lto pre-grarrt opposition, the.fact rernains that on file no such ot-cler was passecl. It cannot, therefore, be said that the filing of Jhe pt'e-grant <lppositiou on 26tl' Jrure 2008.by Cipla was titne barred. ;

¶74There is. yet another'gro.rn,i for not erttertaining tfie ltlea ol-tlre w,P.(c) Nos, 3576, 9577,5422, 5423 of 2007 & 70399, 70400 & 70450 of 2009 & 7020 of '2070 poge 39 of 40 sf: Petitioler. 'fhe challelge is to an order reflisilg the grant of pateut rrylricli is relatable to section 15 of the Act. This is appealable before the IPAB as has been held bY this CourL rn UCB +rncler Section i17A of the Act .Fnrchirtt,Sa v-Cipla Lttl-167 (2010) DLT 459'

¶75Iror the aforernentioned reasons, the writ petition is dismissed witlr costs of Rs.20,000/- which will be paicl by the Petitionet.to Respolldent' Cipla Ltcl. within four weehs' Diractions to'the Controller of Patents T6.fheControllerofPatentswili,withinaperiodoftwoweeksfi-our' toctay issue necessaly practice clirections/instructio": :o all o.fficcrs auij cor.rcerned authorities in terms of this jud$ment and particularly iu terms of what has been hell by this Court in paras 55 to 58 there<lf' Such' '. . . practice directions/ instructions will also be placed sitnr-rltaneously ou the website of the Co^troller of Patents. They will be prospective i' the .selse they will.not reitrlt in the teopening of orders granting patetlt thai: have attainecl finalitY' TT.Acertifiedcopyoftlrisorc]erwillbecleliveredto'tlreControllcrc..t' Patents by a special messenger forthwith'for compliance' _t\ l-- -' "-.:a - - \_-1 " i s-MURALIDI{AI{,J' '; I L_ -- ,- J ULv I 5, 20x.0 cln W.P.(c) Nos. 3576, g517,5422,'542i of 2007 & 7l3gg, 7O4OO & 70450 of 2O0g & 7020 of 2070 / --.:,.-.- I

Case details

Parties and counsel

lf, IN THE HIGH COURT OF DELHI AT NEW DELHI Reserved on:29th April and 3'd June, 2010 Decision on: 15th July, 2010 W.P. (O No. 1020 oi20to TIBOTEC PHARMACEUTICALS .... Petitioner Through: Mr. Rajiv Nayyar and Mr. Sudhir Nandrajog, Senior Advocates with Mr. Pragyan Pradip Sharma and Mr. Rupesh Gupta, Advocates. versus TI{E, AS SI STANT C ONTROLLER OF PATEN T 5,,-..--". DESIGNS & TRADE MARKS & ORS . _.--' Respondents Through: IVIr. A.K,Bhfdwaj with Ms. Jagrati Singh, Advocates for R-1 & R-2. \ik. S. Majumdar with Mr. Saurabh Banerjee, Advocate for R-3. CORAM: JUSTICE S. MURALIDHAR

Source: High Court of Delhi, through the eCourts High Court services, via the Indian High Court Judgments open dataset by Dattam Labs (CC BY 4.0). Text was extracted from the official PDF and may contain conversion errors. Check the official PDF before relying on it.