“Linezolid” Patent Revoked After Post-Grant Opposition by Symed Labs

The Indian Patent Office has revoked Patent No. 281489 (Application No. 201641013830) following a post-grant opposition filed by Symed Labs. The patent was granted on 20 March, 2017 and the post grant opposition was filed on 5 March, 2018. The patentee had also amended its claims during the opposition proceedings and urged that the application under Form 13 (for amendment of claims) be disposed of so as to be certain of the final set of allowed claims for the hearing. The revocation was based on several grounds:

Lack of Inventive Step (Obviousness): The controller concluded that the patent was found to lack an inventive step, meaning the claimed invention was obvious to someone skilled in the field.

Non-Patentability Under Section 3(d): The invention also did not meet the criteria for patentability under Section 3(d) of the Patents Act, which states that new forms of known substances that do not result in enhanced efficacy.

Failure to Disclose Information Under Section 8: The patent holder failed to disclose required information as per Section 8 of the Patents Act 1970, which mandates the disclosure of including the disclosure of status of those applications, at the time of filing and during the prosecution of the patent. regarding corresponding foreign applications of this invention.

This patent pertained to Linezolid, an antibiotic used to treat pneumonia, skin infections, and drug-resistant tuberculosis. The earlier patent for Linezolid had expired on January 1, 2012. The revocation of this patent may have implications for the availability and pricing of Linezolid in India. This decision has highlighted the need for quality standards and more careful examination when it is about critical drugs, particularly in light of public health considerations and the potential for monopolistic practices.