Delhi High Court
Bayer Corporation vs Union Of India And Others on 12 August, 2015
Author: G. Rohini
$~S.B.-1.
* IN THE HIGH COURT OF DELHI AT NEW DELHI
% Date of Decision:12.08.2015
+ LPA 804/2014 & C.M.No.21003 /2014 (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 INDIA & ORS. ..... Respondents
Through: Mr.Ripu Daman Bhardwaj, Adv. with
Mr.T.P.Singh, Adv. for R-1/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 SAHAI ENDLAW
JUDGMENT
:Ms.G.ROHINI, Chief Justice (Oral)
1. This appeal is preferred against the order of the learned Single Judge
dated 05.11.2014 in CM No.9687/2014 in 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 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
Section 84 of the Patents Act, 1970 for manufacturing the pharmaceutical
product covered under the patent held by the Bayer Corporation, subject to
certain terms and conditions, including that the said licence be used solely
for the purpose 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.
3. W.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.1 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
directing the pleadings to be completed, passed the following interim order
on 26.03.2014 -
"Keeping in view the categorical conditions on which
compulsory licence under Section 84 of the Patents Act, 1970
has been granted, respondents No.1 to 4 are directed to ensure
that no consignment from India containing „Sorafenat‟ covered
by compulsory licence is exported.
The respondent No.5 is given liberty to apply to this
Court for permission to export the drug 'Sorafenat' as and
when it obtains permission from the Drug Controlling
Authority for clinical purposes." (emphasis supplied)
4. On 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
by order dated 29.05.2014. Thereafter, 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.
5. On 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
Act in 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."
6. The said interim order has been extended from time to time and thus
continued to be forced all through 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,
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
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.
8. The learned counsel for the parties also submitted that the Drug
Controller General of India, who is the competent authority to issue NOC
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 necessary parties for deciding
the issue involved in the writ petition effectively and conclusively. We
agree with the learned 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 learned standing counsel for Union of India has
accepted notice for the Drug Controller General of India and he undertakes
to file the necessary counter affidavit within two weeks from today. So far
as the Director, Drugs Control Administration, Government of Andhra
Pradesh is concerned, notice returnable in one week be issued. The learned
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.
10. Since the writ petition is directed to be disposed of within a time
frame, it is represented by Sh.Anand Grover, the learned Senior Counsel
appearing for respondent No.5 - NPL, on instructions, 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 learned senior counsel is
placed on record.
11. 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 petition
be listed before the learned Single Judge on 07.09.2015.
(ii) The pleadings in the writ petition shall be completed by all the
parties, including the impleaded respondents, by 07.09.2015.
(iii) 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 learned Senior Counsel for the
appellant/writ petitioner and Sh.Anand Grover, the learned 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.
(v) The writ petition shall be decided uninfluenced by any of the
findings/observations/reasons assigned by the learned Single Judge in
the order under appeal.
(vi) The statement of Shri Anand Grover, the learned Senior
Counsel appearing for the respondent No.5 that NPL will not export
its product „Sorafenate‟ to China for any purpose whatsoever till the
disposal of the writ petition is hereby placed on record.
12. A copy of order be given under the signature of the Court Master.
CHIEF JUSTICE
RAJIV SAHAI ENDLAW, J
AUGUST 12, 2015
kks
