A recent pharmaceutical patent case in India has highlighted the strict requirements for disclosure to the Indian Patent Office. In this case, Allergan had its patent for a combination ophthalmic therapy using Brimonidine and Timolol invalidated as failing to comply with the disclosure requirements of Section 8 of the Indian Patent Act. Section 8 requires disclosure of related patent applications pending outside of India during the pendency of the Indian patent application. Section 8 also requires the applicant to update the Indian Patent Office when these corresponding applications are issued, abandoned, or rejected. Failure to provide this information is grounds for invalidation of issued patents, regardless of the intention of the applicant. That is, simple failure to disclose is grounds for invalidation, even if the applicant did not do so intentionally, and even if the information was easily available from the Internet.
Our colleagues at De Penning and De Penning and Anand and Anand have provided practical suggestions for complying with Section 8, which can be summarized as providing the Indian Patent Office with any information known to the applicant that could show the pending claims as anticipated or obvious. This would include: search reports in corresponding applications (including PCT search reports); the references cited in these search reports; the filing, abandonment or issuance of any related patent application; and the filing of any revocation proceedings against corresponding issued patents. Disclosure under Section 8 is required during the pendency of the patent application; therefore this information could be updated when responding to Indian Examination Reports.