Welcoming the new Patent Act Ordinance, Organisation of Pharmaceutical Producers of India (OPPI ) suggested that India should join other leading countries in moving away from pre-grant opposition.
India will continue to lag behind in ushering in world class IPR standards if it fails to address three major problem areas, OPPI noted in an official release.
Ordinance as announced will provide representation by third parties and lengthen time for grant of patent.
The second area of concern for the industry are the existing Compulsory Licensing (CL) provisions that go much beyond national emergency and extreme urgent situations, public health crises and anti-trust situations.
For example amongst the many triggers for Compulsory Licensing, one as mentioned in the Ordinance is - "CL shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems, provided a CL has been granted by such a country". This provision can be misused and lead to product copies entering countries with strict patent laws.
Thirdly, the research based manufacturers is that a new proviso has been added in the Ordinance that treats patent holders in respect of mail box applications on a discriminatory footing in so far as them being denied the rights and privileges from the date of publication retrospectively.
OPPI expressed hope that the Ordinance is converted into a full fledged law by Parliament.
Decisions on fresh investment, focus on R&D, clinical trials and productive collaboration between Indian and International companies will all take place only if there is an assured climate of world class patent protection, the release added.