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India – Intellectual Property Updates.

9 February, 2015

 

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

 

  • In Bayer Corporation v. Union of India and Others9, the Supreme Court of India (‘SC’) by an order dated December 12, 2014 dismissed the Special Leave Petition (‘SLP’) of Bayer Corporation (‘Bayer’) against the order of Bombay High Court (‘Bombay HC’) dated July 15, 2014 (‘Bombay HC Order’) in the Writ Petition No. 1323 of 2013. The SC, while stating that it is not inclined to interfere with the Bombay HC Order, has however observed that it is “keeping all questions of law open”.

 

The Bombay HC Order had earlier upheld the order dated March 4, 2013 of the Intellectual Property Appellate Board (‘IPAB’), which in turn had upheld the order of the Controller General of Patents and Trade Marks (‘Controller’) dated March 9, 2012 granting the compulsory license (‘CL’) in favour of Natco Pharma Limited under Section 84(1) of the Patents Act 1970 (‘Patents Act’) for manufacturing and selling Nexavar at a price of INR 8,800 per month of therapy as against INR 2,84,000 per month of therapy.

 

  • On September 25, 2014, the Ministry of Health and Family Welfare (‘MoHFW’) has notified the Drugs and Cosmetics (Fourth Amendment) Rules, 2014 (‘Fourth Amendment Rules’) introducing certain changes to the existing regulatory framework applicable to medical devices under the Drugs and Cosmetics Rules, 1945 (‘DCR’). The Fourth Amendment Rules have inter alia introduced the following key changes:

 

i. The MoHFW has made it mandatory for the manufacturers of medical devices listed in Schedule C and Schedule C1 of DCR to employ a whole time employee, having prescribed minimum qualifications, under whose supervision the manufacture or testing is conducted.


ii. Under the old rule, the manufacturers of medical devices were required to comply mainly with the labeling specifications specified by the Bureau of Indian Standards (‘BIS’), in addition to any other requirement prescribed under the DCR. It has now been notified that if there are no standards specified by BIS, then the medical devices will have to conform to the International Standards, like International Organization for Standardization, or other International Pharmacopeia Standards and such other standards as may be specified for this purpose. In case, national or international standards are not available, the medical devices must conform to the manufacturer’s validated standards. Further, the MoHFW has prescribed an exhaustive list of labeling particulars to be printed on the label or the sticker. The medical devices that are exported have to comply with a separate list of labeling particulars.


iii. Under the old rule, no shelf life for medical devices was prescribed. However, under the Fourth Amendment Rules, the shelf life of such medical devices must not exceed 60 months from the date of manufacture.


iv. The MoHFW has recognized application of custom made medical devices that are made in accordance with a duly qualified medical practitioner’s written prescription under his responsibility, in accordance with specific design characteristics and intended for sole use of a particular patient. Such custom made devices, when imported or manufactured bearing the label ‘custom made device’, will be exempt from the regulatory framework applicable to medical devices.


End Notes:

 

1 SLP No. 30145/2014 (challenging the Bombay High Court order dated July 15, 2014 in the Writ Petition No. 1323 of 2013).

 

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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