Section 8 of the Indian patents act requires that patent applicants disclose all information pertaining to foreign counterparts of the Indian application in issue (i.e. if the Indian application has corresponding US and EU applications covering the same or substantially the same invention, then information pertaining to such applications must be provided to the IPO).
This provision comes a close second to section 3(d) in terms of its potential to cause sleepless nights for patentees. And has been the subject matter of leading patent disputes, such as the Roche vs Cipla litigation concerning Erlotinib. However, apart from this Chemtura decision, analysed by Prashant (where Justice Muralidhar refused to grant an interim injunction to the patentee on the ground that a failure to comply with section 8 gave strong grounds to invalidate the patent), I hadn't found any decision where this section has been successfully invoked to invalidate a patent. Well, at least, not till now...
Thanks to Sandeep's excellent coverage of recent patent office opposition decisions, I was alerted to two post grant oppn decisions, where the IPO invalidated related patents of Richter Gideon, a Hungarian company dealing with compositions and processes covering Levonorgestrel, an active that is found in Cipla's (and now Piramal's) best selling contraceptive "I" pill (shouldn't Apple be suing here?).
In the decision dealing with the patent covering the "process" to create the said Levongestrel composition, the Assistant Controller, Dr Amarendra Samall held that the patent ought to be invalidated on grounds of lack of novelty and inventive step. Most interestingly, he also revoked it on the ground that the patentee had failed to comply with section 8!
I extract the relevant portion from his decision below:
"The patentee filed the PCT application through national phase entry on 09th December, 2003 providing the statement and undertaking in Form 3 on the priority data only.
Their next submission (updated information in Form 3) in this context was filed only on 25th October, 2004 mentioning its entry into several countries. Intimation of grant of such an application was send to patentee on 20th June, 2006.
Even though substantial updated information on the corresponding application filed in foreign countries were expected to be available like the information in JP and USA, the same was not informed to the Indian Patent Office. I view this irregularity by patentee as violation of provision as required under Section 8 of Patents Act. I conclude that such a ground of opposition is validly established by the opponent."
With this decision, patent applicants would be well advised to carefully adhere to the requirements of section 8. And not follow regular global strategy where patent applications and their families are kept secret to the best extent possible.
In order to be on the safe side, applicants and their attorneys ought to err on the side of abundance i.e. overload the IPO with information and keep the IPO updated on the progress of patent applications at each of the foreign offices. Counsels in each country where these applications are being prosecuted ought to be instructed to send this information in a timely manner. In any case, even without the sword of section 8 hanging over them, counsels are expected to keep their clients updated on the progress of a patent application in a timely manner! With section 8 swinging into operation, this expectation takes on a more serious turn.
Of course, this information need be provided only where the foreign applications relate to the same patent family i.e covers the same or substantially the same invention.