THE PATENTSACT, 1970 (39of 1970) as amended bY
THE PATENTS(AMENDMENT)ACT,200s (15of 200s) (with effectfrom l-1-2005)
THE PATENTSRULES,2OO3 as amendedbv
THE PATENTS (AMENDMENT) RULES, 2006 (with effect from 5-5-2006)
ln the matter of Application for Patent bearing the number as IN/PCT/2001/00016/CHE filed on 4th OF AG NOVARTIS 2001 by January 215, 4058 BASEL, SCHWARZWALDALLEE SWITZERLAND, a Swiss Company.
And In the matter of Pre-grant Opposition by way of underSection25(1) of the PatentsAct Representation (as amended)by M/s SUN PHARMACEUTICALS Ltd., ACME PLAZA, ANDHERI-KURLA ROAD, ANDHERI (E), MUMBAI 400059, an Indian Company.
In the presence of
Agentsfor theApplicant
Miss Shakiraof M/s. DePenning& DePenning,Chennai.
Agentfor the Opponent
Mr. S. Majumdar of M/s. S. Majumdar& Co., Kolkata.
& AssistantControllerof Patents& Designs
Mr. T.V. Madhusudhan,
Examinerof Patents& Designs
Mr .K. Varaprasad
DECISION N{/s.Novartis AG of Schwarzwaldallee215, CH-4058 Basel, Switzerland,a Swiss Company, hereinafter will be referred as "APPLICANT", have entered National Phase in India on 4thJanuary2001 by claiming priority from their US application numbered09/113,893dated 10'nJuly 1998 for their invention titled as "ANTIHYPERSENSITIVE COMBINATION OF VALSARTAN AND CALCIUM CHANNEL BLOCKER". The National phaseapplication is numberedas N/PCT/2001/00016/CHE. During the prosecutionof this application the title of the invention was amendedas "A PHARMACEUTICAL COMPOSITION COMPRISING VALSARTAN AND PHARMACEUTICALLY ACCEPTABLE SALT THEREOF',. UndeT the provisionsof Section 11(B) and Rule 24(l) of the PatentsAct 1970,the applicanthas filed A Requestfor Examination by filing Form - 19 on 10!nNovember 2003 and allotted requestnumberis 1561/RQ/CHE/2003. Since the applicant has followed the stipulatedtime lines from the date of entry to National Phaseand to file A requestfor Examinationand upon the expiry of 3 1 month period from the date of priority the instant application was taken up for examination under the provisions of Section 12 of the PatentsAct and the First ExaminationReport [FER] was issuedto the agent for the applicant, M/s De Penning & De Penning on 15'nMay 2006. The applicant has 12 mon&s period from the date ofissue ofFER to amendthe application in order for the grant. Under the provisions of Section 11(A) of the Patents(Amendment) Act 2005 the instant applicationwas published in PatentOffice JournalNo: 7/2005 dated 4'n March 2005. Under the provisions of Section 25(i) Patents(Amendment) Act 2005 any person can file a pregant opposition by way of a representationeither within 6 months from the date of publication under Section 11(A) or before the date of grant of patent whichever is later. lWs Sun PharmaceuticalLtd., of Acme Plaza,Andheri- Kurla Road, Andheri (E), Mumbai, "OPPONENT" through an Indian Pharmaceuticalcompany, hereinafter will be referred as tleir natent attomev Mr. Maiumdar of M/s Maiumdar & Co of Kolkata has filed an
oppositionby way of representation on 2ndNovember2007.Sincethe patentwasnot granted by then, the pre-grantoppositionfiled by the opponentwas taken on record and the procedureas laid in sub rule 1 to sub rule 6 of Rule 55 of the Patents(Amendment)Rules, 2006madeeffectivefrom 5'nMay 2006wasfollowed. Thefinalsetof amended claimsis: l. A pharmaceuticalcombinationcompositioncomprising (i) the AT 1-antagonist valsartanor a pharmaceuticallyacceptablesalt thereof: (ii) amlodipine or a pharmaceutically acceptable saltthereof;anda pharmaceutically acceptable carrier. 2. A pharmaceutical combinationcompositionaccordingto claim 1 for oral application, comprisingfrom 1Omgto 220mg of valsartan. 3. A pharmaceutical combinationcompositionaccordingto claim 1 for oral application, comprisingfrom 1.0 mg to 180 mg of amlodipine. 4. A pharmaceutical combinationcomposition,substantiallyas hereinabovedescribed andexemplified. The opponentthroughtheir written statementhas relied on the groundsspecifiedunder (1)(b),(tXc), (t)(d), (t)(e),(t)(0, (lXg) and(1)(h)of Section25 ofthe Patents Subsections (Amendment) Act 2005that is eflectivefrom 1" January2005. Without reproducingthe contentsof the relied groundsas any personcan refer to these groundsfrom the PatentsAct, I would like to statethe gist of the contentsof the said sub-sections ashereunder. 25(1)(b):prior publicationbeforethe prioritydate. afterfiling the applicant'sapplication...buthasprior 25(1)(c):prior claiming---published priority date. 25(1)(d):publiclyknownor publiclyusedin Indiabeforethe priority date. 25(1)(e):inventionis obviousandclearlydoesnot involveany inventivestep. 25(1)(f):not an inventionwithin themeaningof the Act. 25(1)(9):doesnot sufficientlyandclearlydescribethe invention. theforeignfiling parliculars. 25(1)(h): failedto disclose Theopponenthasreliedon the followingFOURDOCUMENTS:Vol 60, No-3, Sep. 1996, and Therapeutics, Dl: Coreaet al, ClinicalPharmacology Pages341-346 D2: ChemicalAbstracts,Vol-17,Number124,22 April 1996,Columbus,Ohio,USabstractNo. 2200'73,FujimuraY et al, Yakuri To Chiryo, Vol 23, No. 12, 1995, Pages3241-3247 D3: DatabaseMedline,Tarif n. et al, "Preservationof renal function:the spectrumof effects by calcium channel blockers" & Nephrology dialysis, transplantation: Official publicationof the Europeandialysisand transplantassociation-European 12No. 11,Pages2244-2250 1997,Vo1. renalassociation, D4: DrugsToday(Barc).1998Jan34(1):5-9
In reply to the Written statement by the Opponent, the applicant has filed his Reply Statementalong with an enclosurenamedas Annexure I. AnnexureI:
A photocopy of a publication by Express Track online publication; Clinical Therapeutics/ Volume 29; publishedon 4'n November 2007 by Thomas Phillip et al.,
Title: Two Multicenter, 8-week, Randomized,Double-Blind, Placebo-Controlled,Parallel Group StudiesEvaluating the Efficacy and Tolerability of Amlodipine and Valsartan in Combination and as Monotherapy in Adult Patients with Mild to Moderate EssentialHypertension. Mr. Majumdar with reference to claim I has stated that no range with respect to the percentagesof the ingredients of the composition is provided therein and in other words it should be understoodthat any range has to work the invention. Referring to the paragraph4 of page 4, paragraphs2 of pages9 and 10 of the complete specification wherein it is stated ,'the combined administration" is, as is explained that the simultaneous by the applicant that or sequentialuse of the ingredients of the composition. Hence the description is not clear whetherthe applicant is interestedin claiming the composition per se or the simultaneoususe of two known ingredientsin any range or use of the ingredientsin a sequentialorder in any rangeand to understandthe synergisticeffect, if any, ofthe allegedcombined composition.It was further stated that according to the applicant and as claimed in claims 2 and 3 the preferredweight of valsartan is 10 mg to 220 mg and the weight of amlodipine is 1 mg to 180 mg respectivelyare the preferred range of weights only. Further it was statedthat since the amendedclaim 1 is restricting ccB to amlodipine,the omnibus claim needsto be deleted as the complete specification describes a list of ccBs that can be used in the alleged combination composition. The agent for the opponenthas statedthat he has no problem in retainingthe list of CCBs in the complete specificationif the applicant is ready to deletethe omnibus claim. To this the agentfor the applicanthasagreedto deletethe omnibus claim The title of D1 is "Valsadan, a new angiotensionII antagonistfor the treatment of essential hypertension:A comparativestudy ofthe efficacy and safety againstamlodipine." since this documentis mostly relied upon, I would like to reproducecertain paragraphsfrom it and is provided as below; Objective: To compare the antihypertensiveefficacy of a new angiotensionII antagonist, Valsarlan, with a referencetherapy,amlodipine. Methods:
wererandomly hypertension withmildto moderate adultoutpatients sixty-eight onehundred allocatedin doubleblind fashionand equalnumberto receive80 mg valsartan or 5 mg amlodipinefor 12 weeks.After 8 weekstherapy,in patientswhoseblood pressureremained at 4, uncontrolled,5mg amlodipinewasaddedto the initial therapy.Patientswereassessed
8, 12 weeks. The primary efficacy variable was change from baseline in mean sitting diastolic blood pressureat 8 weeks. Secondaryvariables include change in sitting systolic blood pressureand responderrates. Results: Both valsartanand amlodipine were eff'ectiveat lowering blood pressureat 4, 8, 12 weeks. Similar decreaseswere observedin both groups, with no statistically significant differences betweenthe groupsfor any variable analyzed.For the primary variable the differencewas 0.5 mm Hg in favor of valsartan(p:0.68; 950/oconfidenceinterval -2.7 to 1'7). Responderrates for valsartan and 60.2Yofor amlodipine (p:0.39%). Both treatments at 8 weeks were 66.'70/o were well tolerated.The incidenceof drug-relateddependentedemawas somewhathigher in the amlodipine group, particularly at a dose of 10 mg per day(2.40/ofor 80 mg valsartan; 3.60/ofor 5 mg amlodipine;0% for valsaftanplus 5 mg amlodipine; I 4.3% for 10 mg amlodipine). Conclusions: The data show that valsa(an is at least as effective as amlodipine in the treatmentof mild to moderatehyperlension.The results also show valsartanto be well tolerated and suggestthat it is not associatedwith side effects characteristicof this comparatorclass, dihydropyridine -6) (Clin PharmacolTher 1996;60:341 calciumantagonists. In page 344 of D1 two tables are provided. The Table I reflects the Patient demographsand baselinecharacteristicsand the Table Ii rellects the Mean +/_ SD sitting diastolic and systolic blood pressures(intent-totreat data set: n : 167). The conclusionsof thesetwo tables are as given in the aboveparagraph. with referenceto the opening paragraphof page 9 of the complete specificationthat reads, ,.ln this composition, gomponents(i) [the AT1-antagonistsvalsartan or a pharmaceutically (ii) CCB or a pharmaceuticallyacceptablesalt thereofl can be acceptablesalt thereof and [a obtained and administeredtogether, one after the other or separately in one combined unit dose form or in two separate unit dose forms. The unit dose form may also be a fixed combination.", the agent for the opponenthas statedthat the components(i) and (ii) can be administeredas separateunits and can be administeredin a sequentialorder. The time gap of the sequentialorder since not mentioned by the applicant, the use of independentdosescan be either immediateor with a gap of sometime. Further it was statedthat the applicantin his specification,in page 11. has provided a formulation of 80 mg valsartanand 5 mg of amlodipinethat what is preciselytaughtin D1.[Referto TablesI & II of D1]. Thereforeit was prayedthat D1 anticipatesthe use ol valsartanand amlodipine and the exact weight ratio of thesetwo specified ingredientslor the said purpose.It was fudher statedthat D 1 not only anticipatesthJ alleged invention of the applicantbut also it is a prior knowledge and obvious to the person skilled in the art. Fr-rrtherit was statedthat the applicant has failed to disclose synergisticeffect, if any, ofthe alleged combinationcomposition. It was prayed that in view D1 alone,the application for patent in question,needsto be rejected with referenceto D2 the agent for the opponenthas statedthat the use of a combination of valsartanand CCB showing antihypeftensiveeffect is known before the priority date ofthe
"Systolic blood pressureof SHR instant application for patent. The documentD2 saysthus, was depressedby the single p.o. administration of valsartan only (3 mg/kg) and rn combination with thiazide (5 mg/kg) and nifedipine (1 mg/kg) at doses without any significant effect on blood pressurethemselves,however, potentiation of the hypertensrve effect of valsarlanwas not observedin combinationwith thiazide or nifedipine. Development of hypertension in SHR was suppressedby the long term p.o. treatment for 28 days of valsartan and in combination with thiazide or nifedipine. Potentiation of the effect of valsartan was observed in the combination with nifedipine and was significant in the combination with thiazide. In conclusion, ACE inhibitors such as enalapril and captopril were shown to have a beneficial effect in combination therapy with diuretics, and valsartan was also suggestedto have almost same benefit as ACE inhibitors in combination therapy with diuretics in this study." Therefore it was prayedthat use of valsartanand nifedipine was known before the priority date of the instant application and this is obvious to a person skilled in the art to replace nifedipine with amlodipine. Both nifedipine and amlodipine are mentionedin the list of DHP representativesas provided in the complete specification.Thus the invention being obvious to the pe|son skilled in the aft the patent right shall not be grantedto the applicant. In view of the latest amendmentsthat were placedbefore the patent office during prosecution stage,the agent for the opponenthas statedthat he is not much interestedto relay on D3 in opposing the instant application under pre-grant opposition by way of representation. However the glance ofD3 revealsthe differencesin biological effects that ale causedby two CCB]. subclassesofCCBs [dihydropyridineCCB andnon-dihydropyridine 'Drugs of Today' of 1998 and titled The documentD4 is a photocopy of a publication from as "ANTIHYPERTENSIVE COMBINATION THERAPY" authored by Matthew R. Weir,
MD. lrom'SUMMARY' of D4 arereproducedherein:The following sentences 'single agent therapeuticapproachesresult in only a 40-50% control rate after 6 months of therapy, illustrating that there is a dramatically high rate of discontinuation of antihypertensivedrugs in clinical practice. Those poor results suggestthat there are issues about inadequateeducation,insr"rfficientefficacy or poor tolerability for which we needto be concemed.' 'The problem [the agent for the opponent has stressedhere that the problem is when monotherapy failsl with the latter approach is that it lrequently results in an increased incidence of adverse events which interfere with patient tolerability and compliance. Utilization of lower dosesof two or more agentsmay provide satisfactoryreduction ofblood pressurewithout the increasedrisk of adverseevents with higher doses of the individual monotherapies.Moreover, there may be complimentary, additive, or even synergistic effects of two drugs working together by different mechanisms. Therefore, a low dose therapeutic combination may represent an optimal approach, not only for patients unresponsiveto higher doses of individgal rnonotherapies,but perhaps also to initiate treatment.
By denying all the allegationsand argumentsmade by the opponentand through their written statement,the agent for the applicant has stated that none of the documents cited by the opponentsupportsthe various groundsof oppositionas raisedherein. With respectto Dl it was statedby the agent for the applicantthat D1 teachesand compares the antihypertensiveefficacy of valsartanwith a referencetherapy, amlodipine. During the hearing the agent for the applicant has brought my attention to the two tables that are provided in page 344 of Dl and the descriptive portion of experiment provided rurder 'RESULT' in page 343 of D1. It is shown that that the Table i revealsthe demographicsof the patients and baseline characteristicsof valsartan and amlodipine. Table II reveals the therapeuticheatment of the patients of Table I wherein the patients are divided into two groupsand up to 8 weeks the first group of patientsundergomonotherapytreatmentwith 80 mg of valsartandaily and the secondgroup of patients undergo monotherapywith 5 mg of amlodipine daily. At the end of 8'n week only the patients whose blood pressure is uncontrolled in both the groups are further treated with 5 mg of amlodipine daily and the results are shown at the end of 12"'week wherein the reduction in hypertensionis recorded. In view of this the agent for tl-reapplicant has statedthat it is a comparisonstudy 'RESSULT' of D1 proves this betweenvalsartan and amlodipine and the last sentenceof view as the last sentencestatesthat," The responderratesafter 8 weeks of monotherapyalso support valsartanas being as effective as amlodipine." Moreover only the nonrespondersat the end of 8'n week were treatedwith additional therapy. Therefore this document does not destroyeither the novelty or the inventive step ofthe allegedinvention as statedby the agent for the applicant. Before proceedingfurther I would like to reproducethe first paragraph under the heading "STUDY DESIGN" as providedin page342 of Dl as hereunder:"The study was a multicenter (sevencenters),randomized,double-blind comparativetrial conductedin ltaly. After a run-in period, patients who met the inclusion criteria were randomizedin equal numbers within a center to receive either 80 mg valsarlan or 5 mg amlodipine once daily. After 8 weeks of therapy, patients in either group whose blood pressurewas not adequatelycontrolled (SDBP > 95 mm Hg) received,in addition to their initial therapy,5 mg amlodipine daily in an open lashion for a further 4 weeks.Therefore nonrespondersat 8 weeks took either 80 mg valsartan and 5 mg amlodipine daily or 10 mg amlodipine daily for the last 4 weeks of the study. Patients whose SDBP was controlled at 8 weeks continuedto receivetheir initial therapy for a further 4 weeks." From the above and on application of my rnind, it is understoodthat 80 mg of valsatlan + 5 mg of amlodipine is a known composition.The sameparagraphindicatesthat the additional therapy can be either a combination therapy [i.e valsartan+ amlodipine] or a monotherapy [i.e using only 10 mg of amlodipine].Probably the information as provided therein gives me an inference that the expectedefficacy of combination additional therapy must be equal to the expected efficacy of cnhanced or high dose additional monotherapy. Though the Table II does not reflect any changeor deviation from either of the additional theraovit can be concludedthat whateverthe effects of combination additional therapymust
be equal to amlodipine additional monotherapy.The exampleas provided by the applicantin page 11 of the complete specification wherein it is shown that a tablet weighing 215 mg comprises80 mg of valsarlan and 5 mg of amlodipine and the weights of the remaining 6 ingredientsare known to the person skilled in the art for the manufacturingof tablets. Since only one example is provided the weights of the drug substancesas stated therein must be more preferredone out of the weight rangesof valsarlanand amlodipine as claimed in claims 2 and 3 respectively.Sincethe date of publicationof Dl [September1996] is prior to the Priority date [0'" July 1998] of the applicationin question,I agreewith the view ofthe agent for the opponentthat the said combination compositionas allegedly claimed by the applicant is not Novel. With respectto obviousnessor lack of inventive step as objectedby the opponent,the agent for the applicant has stated that a person skilled in the art with reference to Table II of documentDl would only be perplexedwith the results of additional therapy. It was further statedthat the diastolic blood pressureof both the groups in Table II remainsthe sameat the end of 12 weeks. The agent for the applicant has further stated that the combination composition of the alleged invention has additional benefits resulting from combined treatmentsuch as a surprising prolongation of efficacy and a broader variety of therapeutic treatment.Thereforethe allegedinvention is novel and inventive over D1. The agent for the opponenthas statedthat D2 teachesthe combination therapy of valsartan and nifedipine. The said documentD2 also teachesthe other combinations of valsadanwith hydrochlorothiazide or with propranolol. Since nifedipine falls under the class of DHP representative,a person skilled in the art can think of the alleged invention of the applicant and thus the alleged invention is obvious. Therefore it was prayed that the invention is obviousover Dl and D2 and thereforepatentright shall be refused. with referenceto D2 the agent for the applicant has stated that in view of the amended claims the said D2 document is irrelevant as it does not disclose amlodipine. Thereforethe allegedinvention is Novel over the documentD2. With respectto D4, the agent for the applicant has statedthat D4 was published in January 1998, a few months before the Applicant's priority date of filing. D4 on on page 6, left column statesas quoted below: "Despite now having six major classes of antihyperlensive drugs and growing information about the underlying pathophysiology of hlperlension, there still remains
tvpesof patients." In view ofthe aboveit wasstatedthatD4 doesnot provideany incentivesfor a personskilled in the art to arrive at the presentinvention.with the teachingsof D4, the skilled person would only remainconfusedin choosingthe bestmodeof treatment.In a summary,it was respectfullysubmittedthat documentsDl to D4 or in combinationwith eachotherdoesnot renderthe presentinventionasnot Novelor Obviousor otherwise.Thereforeit wasprayedto rejecttheoppositionandallow to proceedfor the stageof grantingthepatent.
The agent for the opponent has drawn my attention to the left column of page 8 of D4 "Most drug classesdo work well with one another with the possible wherein it is statedthat exceptionof the thiazide diuretic-calciumchannelblocker combination. ...These therapeutic relationshipshave allowed much lower dosesof the individual componentsto be combined and provide a much more substantialability to reduceblood pressurewith a lower incidence of adverseevents." Therefore it was prayed that tlie alleged invention ofthe applicant is not novel and obvious and henceneedsto be refusedthe grant ofpatent. "COMBINATIONS" in the explanation that is Referring to the presence of the word provided under Section 3(d) of the PatentsAct, the agent for the opponenthas statedthat the allegedcomposition of the applicant attractsthe said provision and hence,even if treatedas an invention, is not patentableunder the PatentsAct. It was further stated that the alleged composition of the applicant attractsthe provisions of Section 3(e) of the PatentsAct as the applicant has failed to prove synergistic effect, if any. The applicant has also failed to disclose the advantagesor the synergistic effect of the alleged composition, if any, in the description.In view of this it was statedthe complete specificationof the applicant which is in questionfails to meet the requirementsunder Section l0 of the PatentsAct and therefore under the clause of insufficient disclosure the patent right shall not be granted to the applicant. By denying in toto of the allegationsmade by the opponent,the agent for the applicant has stated that it was misinterpretedby the agent for the opponent as Section 3(d) relates to combinationofnew forms of a known substanceand not combination of dilferent substances and thereforethe invention of the applicantdoes not lall under Section 3(d). With respectto Section 3(e) it was stated by the applicant that the composition of the present invention results not only in a synergistic therapeuticeffect but also in additional benefits resulting from combinedtreatment such as a surprisingprolongationof efhcacy and a broadervariety of therapeutic treatment. The claimed composition exhibits synergy in treating various disorders related to renal, hemodynamic, antiproliferative, antithrombotic and antiatherogenicproperties. To supporl this, the agent for the applicant has referred to Arnexure I of the reply statementand also hasfiled a publication by R.Webb et. al.. A publication document by R.Webb et al, which contains the first experimental details conducted on rats to prove the synergy between valsartan and amlodipine, the alleged composition of the invention in question. The said publication is from Joumal of 2000 Vol l8 (suPP4). Hypertension 'Results' of P4.33 of the publication by R.webb et al it is statedthat "For Under the caption example,to reduceblood pressureby l4 mmHg in SHR required a dosageof 8 mg/kg/day of Amlo or 20 mglkglday of Val. However. only 4 mg/kg/day of Amlo was required when combined with 10 mg/kg/day of Val. Aortic hypertrophy (SHR vs WKY) was seen at baselinewhereas6 week antihypefiensivetherapy significantly (p<0.05) regressedvascular hypertrophy ratios ( 13.9+_ 0.5 and 11.4+_0.2 in vehicle and comb-treatedrats, respectively). . . ..Thus, combinationtherapymay enablecomparableantihyperlensiveefficacy to 6e achievedin patientswhile minimizing the side effect profile of high dosageamlodipine monotherapy."
Under the caption
"CONCLUSIONS" of the publication by T.Philipp et al., which readsas:-
"ln thesetwo similarly designedstudiesin adult patientswith mild to moderateessential hypertension, the combination of amlodipine and valsartan was associated with significantly greater BP reductions from baseline compared with both amlodipine and valsartanmonotherapy and placebo. The combination was generally well tolerated and was associatedwith a lower incidence of peripheral edema compared with amlodipine monotherapy." 'RESULTS" wherein it is statedthat "With In the right column of page 1 under the capation, the exception of a few combinations that included amlodipine 2.5 mg, the combination regimens in both studies were associatedwith significantly greater reductions in MSDBP [mean sitting diastolic blood pressure]and MSSBP [mean sitting systolic blood pressure] comparedwith their individual componentsand placebo (P<0.05). A positive dose response was observedfor all combinations.The highestresponserate in study 1 was associatedwith the highest dose of combination therapy (amlodipine 5mg + valsartan 320 mg;91.3Vo). Amlodipine 5mg, valsartan 320 mg and placebo were associatedwith responserates of respectively.In study 2, the 2 dosesof combinationtherapywere 71.9%,73A% and 40.9o/o associatedwith similar responserates (amlodipine 10 mg + valsartan 160 mg; 88.5%; amlodipine10 mg + valsartan320 mg; 87.5%).Amlodipine 10 mg was associatedwith a responseftte of 86.90 ; valsartan 160 and 320 mg were associatedwith responserates of 74.9Yoand 72.0Yorespeclively;and placebo was associatedwith a responserute of 49.30 . Control ratesfollowed a similar pattern." On studying of all the documentsand pr"rblicationas provided by both the applicant and the opponentthe following are my conclusions:It is known before the date of priority about the combinationtherapy. It is known about the advantagesof combinationtherapy over the monotherapy' It is known to use amlodipine and valsartanas a composition. The exact ratio of 80 mg of valsartan and 5 mg of amlodipine as a composition therapyis known. 5) The applicant has failed to show synergistic effect, if any, in the complete specificationor in his suppofiing documentsin combatingthe pre-grantoppositionby way of representation,it is so, none of his documentsis able show the effects of the allegedratio of valsartanand amlodipineover the other ratio of such combination.
1) 2) 3) 4)
Therefore I agree with the argumentsput forward by the agent for the opponent. Hence I herebyorder that the instant application filed for the grant ofpatent is refusedwith no costs. Dated 30thday of March 2009.
--- 1"-filJr-= (T.V. MADHUSUDHAN)
ASSISTANT CONTROLLER OF PATENTS & DESIGNS.
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