IP Hotline
September 08, 2004
Removal of the Patent's Controller over grant of EMR
India's first Exclusive Marketing Right (EMR) in the pharma sector was granted to multinational Novartis for its anti-cancer drug Glivec in November. The allegations of irregular grant of this EMR and other allegations regarding the Controller General of Patent , Designs & Trade Marks' decisions, have been instrumental in the removal of the Controller General by the Government of India with effect from September 01, 2004. Wockhardt and Eli Lilly were the other two pharma companies that received EMRs during the tenure of the Controller General .
Upon receipt of the EMR, Novartis had obtained an ex parte injunction from Madras High Court restraining six companies from selling generic versions of the drug in India. On the other hand, the EMR grant to Novartis has been challenged in Courts by generic industry producers of the drug, mainly on the ground that the compound, being just a derivative of a molecule known prior to 1995, did not satisfy the novelty criteria set under the Indian Patents Act, 1970. This matter is currently sub-judice.
There has been continuous debate that the Patent Act, as amended in 2002, is ambiguous with respect to definitions of patentibility, with terms like "novelty", "industrial application", "prior art", being interpreted by the patent authorities in inconsistent manners. The domestic pharma industry wants the law to be re-looked at in the Patent Amendment Bill, 2003 which has been referred to a Group of Ministers.
Earlier, some of the MNCs had also challenged the denial of EMR. GlaxoSmithKline had challenged the denial of EMR to Rosiglitazone (Avandia) in Delhi High Court and a writ petition of Hoffmann La Roche against denial of EMR to Saquinavir mesylate is pending disposal in the Kolkata High Court.The removal of the Controller General, the subjective evaluation of EMR applications and the plight of pharma companies who are forced to approach the courts against such irregular decisions have brought into light the shortcomings within the Patent office and the urgent need for improvements in the Indian Patent Act. The Indian Government needs to study the Patent Amendment Bill, 2003 seriously and while complying with TRIPS, endeavour to remove room for subjective interpretation of the law and set higher standards and accountability criteria for the officials of the Patent Office.
Vivek Kathpalia or Avadhut Sawant
Disclaimer
The contents of this hotline should
not be construed as legal opinion. View detailed disclaimer.
This hotline does not constitute a
legal opinion and may contain information generated
using various artificial intelligence (AI) tools or
assistants, including but not limited to our in-house
tool,
NaiDA. We strive to ensure the highest quality and
accuracy of our content and services. Nishith Desai
Associates is committed to the responsible use of AI
tools, maintaining client confidentiality, and adhering
to strict data protection policies to safeguard your
information.
This hotline provides general information
existing at the time of preparation. The Hotline is
intended as a news update and Nishith Desai Associates
neither assumes nor accepts any responsibility for any
loss arising to any person acting or refraining from
acting as a result of any material contained in this
Hotline. It is recommended that professional advice
be taken based on the specific facts and circumstances.
This hotline does not substitute the need to refer to
the original pronouncements.
This is not a spam email. You have
received this email because you have either requested
for it or someone must have suggested your name. Since
India has no anti-spamming law, we refer to the US directive,
which states that a email cannot be considered spam
if it contains the sender's contact information, which
this email does. In case this email doesn't concern
you, please
unsubscribe from mailing list.
|