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India – Intellectual Property Snapshots.

29 January, 2014

 

Legal News & Analysis – Asia Pacific – India – Intellectual Property 

 

  • In BDR Pharmaceuticals International Pvt. Ltd. v. M/s Bristol Myers and Squibb Company1, the Controller General of Patents, Designs and Trademarks (‘CG’), by order dated October 29, 2013, rejected the compulsory license (‘CL’) application dated March 4, 2013 filed by BDR Pharmaceuticals International Pvt. Ltd. (‘BDR’) seeking grant of a compulsory license to manufacture the generic version of the anti-cancer drug “Dasatinib”. Dasatinib is used to treat chronic myeloid leukemia and is sold by Bristol Myers & Squibb Company (‘BMS’) under the trade mark ‘SPRYCEL’.
 

On February 2, 2012, BDR had approached BMS in its request for a voluntary license of Dasatinib. On March 13, 2012, BMS responded by raising certain queries inter alia in relation to quality control, regulatory standards, safety and environmental profile, etc. However, instead of responding to queries raised by BMS and making further efforts to seek a voluntary license, BDR chose not to engage with BMS. Also, BDR did not immediately file for a CL but instead waited for a period of one year after the request for voluntary license.

 

As per Section 84 of the Patents Act, 1970 (‘Patents Act’), if despite efforts to obtain a voluntary license from the patentee, such applicant is unable to obtain a voluntary license within six months, the applicant has the option to file an application for CL. However, the applicant must have negotiated such license in good faith.

 

CG rejected BDR’s application for CL inter alia on the grounds that BDR had not made out a prima facie case for grant of CL. CG, in its order, has inter alia also observed that there was a deliberate intent on the part of BDR not to enter into any dialogue with BMS to obtain a voluntary license, that BDR did not make credible attempts to procure a voluntary license, or follow the scheme of law.

 

  • Recently, Mast Jagermeister SE (‘Petitioner’), the German company that manufactures alcohol under the “Jagermeister” brand filed a Writ Petition2 (‘WP’) against the Director General of Police before the Madras High Court for removal of images of the Petitioner’s Jagermeister bottles (with label) from the Tamil Nadu Police’s (‘TN Police’) ‘Don’t drink and drive’ signage. The TN Police had, without authorisation, used the trademarks of the Petitioner, i.e. images of the Jagermeister bottles (with label) beside pictures showing fatal accidents in their signage to promote responsible drinking.
 

Despite the Petitioner having requested the TN Police to stop using their trademarks in the signage, the TN Police failed to remove the Petitioner’s trademark, following which, the Petitioner had filed the WP seeking removal of their trademark from the signage. At the time of hearing, the TN Police agreed to remove the signage. Pursuant to the same, the Madras High Court disposed of the WP with a direction to the TN Police to comply with the undertaking given in Court.

 

  • In light of the order dated October 21, 2013, in the of Swasthya Adhikar Manch, Indore & Anr v. Ministry of health and Family Welfare & Ors.3 regarding clinical trials, the Drugs Controller General of India, by its office order F. No. GCT/20/SC/Clin./2013 dated November 19, 2013 (‘Order’) has made audio-video recording of informed consent mandatory for new subject enrollments in all clinical trials in India.
 

In addition to obtaining the written informed consent of the trial subject, the Order requires that audio – video recording of each trial subject, including the procedure of providing information to the subject and his/her understanding on such consent be done, while adhering to the principles of confidentiality. The Order further requires that all such audio – video recording and related documentation be preserved. However, the Order does not prescribe any time period for preservation or retention of such audio – visual recording or related documentation.

 

End Notes:

 

1 C.L.A. No. 1 of 2013
2 WP No. 26377/2013
3 W.P. (C) No. 33/2012 with WP(C) No. 779/2012

 

AZB

 

For further information, please contact:

 

Zia Mody, AZB & Partners
[email protected]

 

Abhijit Joshi, AZB & Partners 
[email protected]


Shuva Mandal, AZB & Partners 
[email protected]

 

Samir Gandhi, AZB & Partners
[email protected]


Percy Billimoria, AZB & Partners 
[email protected]

 

Aditya Bhat, AZB & Partners 
[email protected]

 

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