Bayer Corporation v. Uoi& Ors

JUDGMENT cMs.G.ROHINL Chief Justice (Oral)

¶1This appeal is preferred against the order of the learned Single Judge dated 05.11.2014 in CMNo.9687/2014 in W.P.(C) No.1971/2014.

¶2The appellant before us is the writ petitioner (Bayer Corporation) which was granted Indian Patent No.215758 for a period of 20 years from

12.01.2000 for a pharmaceutical product titled "Carboxyarly Substituted Diphenyl Ureas". It is also not in dispute that the respondent No.5 (Nacto Pharma Ltd.) was granted a compulsory licence on 09.03.2012 under d . rage 1 of 6 Secfon 84 of the Patents Act, 1970 for manufacturing the pharmaceutical product covered under the patent held by the Bayer Contomtion, subject to certain terms and conditions, including that the said licence be used solely for the puipose of making, using, offering for sale and selling the drug covered by the Patent for the purpose of treating HCC and RCC in human beings within the territory of India.

¶3W.P.(C) No.1971/2014 was filed by Bayer Corporation (for short 'Bayer') alleging that respondent No.5/Nacto Pharma Ltd. (for short 'NPL') was exporting its product "Sorafenat" outside India in violation of the terms of the compulsory licence. Thus, a Mandamus was sought directing the respondent Nos.l to 4 to confiscate and seize the consignments for export containing product covered by compulsory licence including "Sorafenat" manufactured by NPL under the compulsory licence. This court while direchng the pleadings to be completed, passed the following interim order on 26.03.2014- "Keepmg m view the categorical conditions on which compulsory licence under Section 84 of the Patents Act 1970 has been granted, respondents No.l to 4 are directed to ensure hat no consignment from India containing 'Sorafenat' covered by compulsory licence is exported. The respondent No.S is given lihertv to apolv to this Court for permission to evnnrt the drun '.Sorafenat' a.s and When it obtains permi.ssion from the Drug Cnnfrnllina —— — V^UllUUUim? Authority for clinical purposes." (emphasis supplied)

¶4On 23.03.2014, NPL filed CM No.6198/2014 seeking permission in terms of the 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 o -, 4-^ Page 2 of6 by order dated 29.05.2014. Theteafter. NPL filed another application being CM No.9687/2014 seeking permission to export 1 kg. of "Sorafenat" to one of Its partners in China for the purposes of conducting development/clinical studies and trials. Though the said application was opposed by Bayer on various grounds, this court allowed the application by the order under appeal dated 05.11.2014. Aggrieved by the same, Bayer (writ petitioner) filed the present appeal.

¶5On 22.12.2014, we passed the following interim 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 export the goods in question to a country outside India even under Section 107-A of the Patents ct m spite of the fact that the compulsory licence granted to it by the Controller of Patents 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 further steps shall be taken pursuant to the order under appeal."

¶6The said interim order has been extended from time to time and thus continued to be forced all through from 22.12.2014.

¶7It may at the outset be mentioned that the question that requires consideration in the present appeal is whether the respondent No.5 - NPL, who IS holding a compulsory licence subject to the condition that it shall be used for the purpose mentioned therein within the territory of India, can claim the benefit of Section 107-A of the Patents Act for exporting its product to a country outside India. Since the very same issue is involved in d - the writ petition, it appears to us that instead of deciding this appeal on merits, it would be appropriate to direct the disposal of the writ petition Itself within a time frame. The learned counsel for both the parties consented for the same. It is further represented by them that the writ petition now stands posted to 18.09.2015 before the learned Single Judge and that the same may be advanced.

¶8The learned counsel for the parties also submitted that the Drug ^ Controller General of India, who is the competent authority to issue NOG for export of drugs and pharmaceuticals and the Director, Drugs Control Administration, Government of Andhra Pradesh, Hyderabad, the authority who issued the drug license to NPL, are the necessao' parties for 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.

¶9Sh.T.P.Singh, the leamed standing counsel for Union of India has accepted notice for the Dmg Controller General of India and he undertakes ^ to file the necessary counter affidavit within two weeks from today. So far as the Director, Dmgs Control Administration, Govemment of Andhra Pradesh is concemed, notice retumable in one week be issued. The leamed counsel for the appellant/writ petitioner is also permitted to serve the notice by electronic mail service. The appellant shall file the amended memo of parties in the writ petition within one week from today.

¶10Since 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 export its product 'Sorafenate' to China for any purpose whatsoever till the disposal of the writ petition. The statement of the leamed senior counsel is placed on record. n. Accordingly, without expressing any opinion on merits of the case, we dispose of the appeal as under:-

(i) The hearing of W.P.(C) No.1971/2014 shall stand advanced to

07.09.2015 from the date already fixed, i.e., 18.09.2015. Accordingly, the date fixed as 18.09.2015 shall stand cancelled and the writ petitioj be listed before the leamed Single Judge on 07.09.2015.

(11) The pleadings in the writ petition shall be completed by all the parties, including the impleaded respondents, by 07.09.2015.

(ill) W.P.(C) No.1971/2014 be disposed of within 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 adjournment would be sought and that the fullest co-operation would be extended for expeditious disposal of the writ petition. The statement is placed on record.

(y) The writ petition shall be decided uninfluenced by any of the fmdmgs/observations/reasons assigned by the leamed Single Judge in the order under appeal.

(vi) The statement of Shri Anand Grover, the leamed Senior Counsel appearing for the respondent No.5 that NPL will not export its product 'Sorafenate' to China for any purpose whatsoever till the r

¶12disposal of the writ petition is hereby placed on record. A copy of order be given under the signature of the Court Master. uv CHIEF JUSTia AUGUST 12,2015 kks RAHV SAHAIENDLAW, J

dy IN THE HIGH COURT OF DELHI AT NEW DELHI % + Date of Decision-19..08.2Q15 LPA 804/2014 & C.M.No.21003 72014 (stay) BAYER CORPORATION Appellant. Through: Mr.Sudhir Chandra, Sr.Adv. with Mr.Sanjay Kumar, Ms.Arpita Sawhney, Mr.Arun Kumar Jena, Advs. Versus UNION OF INDU & ORS. Respondents Through. Mr.Ripu Daman Bhardwaj, Adv. with Mr.T.P.Singh, Adv. for R-l/UOI. Ms.Sonia Sharma, Adv. for R-2 to 4. Mr.Anand Grover, Sr.Adv. with Ms.Rajeshwari, Mr.Tahir A.J., Advs. for R-5. CORAM: HON'BLE THE CHIEF JUSTICE HON'BLE MR. JUSTICE RAJIV SAHAIENDLAW