Analysis of the Leaked U.S. Paper on Eliminating Patent Pre-Grant Opposition

[1] an important tool for preventing patent applicants from gaining patent monopolies based on weak or erroneous information, for improving the quality and efficiency of patent office examinations, and for safeguarding access to medicines.

The leaked paper is available at:
 

Pre-grant opposition procedures that permit broad participation allow any person, including researchers, NGOs, health organizations, and market competitors to oppose a patent application by submitting information and analysis to patent examiners, under an adversarial administrative process. Pre-grant opposition helps improve patent quality and the accuracy of patent claims. This process helps to prevent pharmaceutical monopolies based on unmerited patents that contribute little to innovation but greatly to price.

The U.S. proposal would eliminate pre-grant opposition from the laws of TPPA negotiating countries, including New Zealand, Australia, Peru, Chile and Vietnam. The U.S. attack on pre-grant opposition, like other U.S. positions on intellectual property in the TPPA, can also be read as an effort to isolate India’s system of more rigorous patent standards.

Eliminating pre-grant opposition procedures benefits giant pharmaceutical companies at the expense of public health programs and access to medicines. For example, India is the developing world’s leading supplier of affordable generic medicines. Pre-grant oppositions filed in India by health groups have warded off lengthy monopolies based on follow-on patents filed for HIV/AIDS medicines, including lamivudine/zidovudine, paediatric nevirapine, tenofovir, darunavir, and recently heat-stable lopinavir/ritonavir. The opposed patent application for lopinavir/ritonavir had sought years of monopoly protection for presenting an old medicine in a new form.