Bayer Corporation v. Union of India & Ors.

1. This appealis preferred againstthe orderofthe learned Single Judge dated05.11.2014in CMNo.9687/2014in W.P.(C)No.1971/2014.

2. The appellant before us is the writ petitioner (Bayer Corporation) which was granted Indian Patent No.215758 for a period of20 yearsfrom 12.01.2000 for a pharmaceutical product titled "Carboxyarly Substituted Diphenyl Ureas". Itis also notin dispute thatthe respondentNo.5(Nacto Pharma Ltd.) was granted a compulsory licence on 09.03.2012 under LPANo.804/2014 d. rage 1 of[6] 2015:DHC:11263 Secfon84ofthe Patents Act,1970for manufacturing the pharmaceutical productcovered underthepatentheld bytheBayerContomtion,subjectto certain termsandconditions,including thatthesaid licence beused solely for the puipose ofmaking, using,offering for sale and selling the drug covered bythePatentforthe purposeoftreating HCCand RCCin human beings withintheterritoryofIndia.

3. W.P.(C)No.1971/2014 was filed by Bayer Corporation (for short 'Bayer')allegingthatrespondentNo.5/NactoPharmaLtd.(forshort'NPL') wasexportingitsproduct"Sorafenat"outsideIndiainviolationoftheterms ofthe compulsory licence. Thus,a Mandamus was sought directing the respondentNos.l to4to confiscate and seize the consignmentsforexport containing product covered by compulsory licence including "Sorafenat" manufactured by NPL under the compulsory licence. This court while direchngthepleadingsto be completed,passed thefollowinginterim order on 26.03.2014- "Keepmg m view the categorical conditions on which compulsory licence under Section 84 ofthe Patents Act 1970 has been granted,respondents No.l to 4are directed to ensure hatno consignmentfrom India containing'Sorafenat'covered bycompulsorylicence is exported. The respondent No.S is given lihertv to apolv to this Courtfor permission to evnnrt the drun'.Sorafenat' a.s and When it obtains permi.ssion from the Drug Cnnfrnllina —— — V^UllUUUim? Authorityforclinical purposes." (emphasissupplied)

4. On 23.03.2014,NPL filed CM No.6198/2014 seeking permission in terms ofthe interim order dated 26.03.2014 to export a small quantity not exceeding 15 gms.of"Sorafenat"and the prayer was allowed by this court LPANo.804/2014 o -, 4-^ Page2of[6] byorderdated29.05.2014. Theteafter.NPLfiledanotherapplicationbeing CMNo.9687/2014seekingpermissiontoexport 1 kg.of"Sorafenat"toone ofItspartnersin Chinaforthepurposesofconductingdevelopment/clinical studies and trials. Though the said application was opposed byBayer on variousgrounds,thiscourtallowedtheapplicationbytheorderunderappeal dated05.11.2014. Aggrieved bythesame,Bayer(writpetitioner)filed the present appeal.

5. On22.12.2014,wepassedthefollowinginterim order; Having heard the learned counsel for both the parties it appears to us that the question whether the respondent No[5] company can be permitted to exportthe goods in question to a country outside India even under Section 107-A ofthe Patents ct m spite ofthefactthatthe compulsorylicence granted to it by the Controller ofPatents is restricted for the purpose of selling the drug within the territory of India, is an issue of importance and requires consideration. Post on 16.01.2015. Till such time,no furthersteps shall betaken pursuantto the order under appeal."

6. The said interim order has been extended from time to time and thus continued to beforced allthrough from 22.12.2014.

7. It may at the outset be mentioned that the question that requires consideration in the present appeal is whether the respondent No.5-NPL, whoIS holding acompulsorylicence subjectto the condition thatitshall be used for the purpose mentioned therein within the territory ofIndia, can claim the benefit of Section 107-A of the Patents Act for exporting its productto a country outsideIndia. Since the verysame issue is involved in LPANo.804/2014 d - Page3of[6] the writ petition,it appears to us that instead ofdeciding this appeal on merits,it would be appropriate to direct the disposal ofthe writ petition Itselfwithinatimeframe.Thelearnedcounselforboththepartiesconsented for the same. It is further represented by them thatthe writ petition now stands posted to 18.09.2015 before the learned Single Judge and that the same may be advanced.

8. The learned counsel for the parties also submitted that the Drug ^ Controller General ofIndia,who is the competent authority to issue NOG for export ofdrugs and pharmaceuticals and the Director, Drugs Control Administration,Government ofAndhra Pradesh,Hyderabad,the authority whoissued the drug licenseto NPL,arethe necessao'partiesfor deciding the issue involved in the writ petition effectively and conclusively. We agree with the leamed counsel and accordingly, we implead the said authorities suo moto as respondents No.6 and 7 respectively to the writ petition.

9. Sh.T.P.Singh, the leamed standing counsel for Union ofIndia has accepted notice forthe Dmg Controller General ofIndia and he undertakes ^ to file the necessary counter affidavit within two weeksfrom today. So far as the Director, Dmgs Control Administration, Govemment of Andhra Pradesh is concemed,notice retumablein one week be issued. Theleamed counselforthe appellant/writ petitioner is also permitted to serve the notice by electronic mail service. The appellant shall file the amended memo of partiesinthe writpetition within one weekfromtoday.

10. Since the writ petition is directed to be disposed of within a time frame,it is represented by Sh.Anand Grover,the leamed Senior Counsel appearing for respondent No.5- NPL,on instmctions, that NPL will not LPANo.804/2014 exportitsproduct'Sorafenate'to Chinaforanypurpose whatsoevertillthe disposalofthe writpetition. Thestatementoftheleamedseniorcounselis placed on record. n. Accordingly,without expressing any opinion on merits ofthe case, we dispose ofthe appeal as under:-

(i) Thehearing ofW.P.(C)No.1971/2014shallstand advancedto

07.09.2015fromthedatealreadyfixed,i.e.,18.09.2015.Accordingly, thedatefixedas18.09.2015shallstandcancelledandthewritpetitioj belisted beforetheleamed SingleJudgeon07.09.2015. (11) Thepleadingsinthe writpetition shall becompleted byallthe parties,includingtheimpleadedrespondents,by07.09.2015.

(ill) W.P.(C)No.1971/2014 be disposed ofwithin six weeks from today and all the parties shall co-operate for disposal of the writ petition within the time fixed.

(iv) Sh.Sudhir Chandra, the leamed Senior Counsel for the appellant/writ petitioner and Sh.Anand Grover, the leamed Senior Counsel for the respondent No.5 - NPL undertake that no adjournmentwould besought and thatthefullestco-operation would be extended for expeditious disposal of the writ petition. The statementis placed on record. (y) The writ petition shall be decided uninfluenced by any ofthe fmdmgs/observations/reasons assigned bytheleamed Single Judgein the order under appeal.

(vi) The statement of Shri Anand Grover, the leamed Senior