Section 81 of Indian Patents Act 1970 requires applicants to submit information regarding corresponding foreign applications. While this is a purely procedural requirement, non-compliance with section 8 is also a common ground for rejection of a majority of patent applications. To remain on the safer side, applicants are required to update the IPO with information and keep informing the IPO on the movement of patent applications at each of the foreign offices. Hence patent prosecution strategies for ensuring compliance with section 8 require a mechanism to verify all submissions related to section 8 every six months.
It is pertinent to mention here that the failure to disclose information required under section 8 of the Act is a ground for pre grant opposition [section 25(1) (h)], post grant opposition [section 25 (2) (h)] and revocation of patent under section 64 (1) (m) of the Act.
However, it is noteworthy that any one cannot make a bald statement that the Section 8 has not been complied. The opponent should have the knowledge of the documents which have not been submitted to comply with the Section 8 requirements. The above statement has been mentioned in some of the recent cases decided recently.
Fresenius Kabi Oncology Limited v. Glaxo Group Limited and the Controller of Patents2
In this case, Fresenius (the petitioner) argued that the respondent Glaxo failed to disclose information sought under section 8 (2) viz Korean patent application, divisional applications in US, European, Australian, Canadian and New Zealand, final denial of US application.
Fresenius filed the revocation action against Glaxo's patent arguing that the patent should be revoked for obviousness, insufficiency of description, failing to comply with the requirements of Section 8 and falling under the purview of Section 3(d) of the Act. The Board revoked Indian Patent No. 221171 entitled "Quinazoline Ditosylate Salt Compounds" for obviousness and for failing to qualify as an invention under Section 3(d) of the Indian Patents Act.However, the board had bluntly rejected the objection for Section 8 requirements in the lack of the pleading and the proof of the violation.
In proceeding, Freseniussimply argued that the Section 8 requirements were not complied and did not provide any specific proof or details as how Glaxofailed to comply with the requirements of this section.Thereupon, the Board emphasized the point that a party seeking to revoke a patent based on Section 8 is required to do more than allege that Section 8 had not been complied with. Instead, at the time of filing a revocation action, a party alleging Section 8 non-compliance should have to:
1.Provide the specific corresponding filing particulars and/or foreign office actions, claim amendments, prior art and other information that was not submitted to the Patent Office; and
2. Demonstrate that the foreign office actions, claim amendments, prior art and other information not furnished relates to the same or the substantially the same invention as that in the patent for which revocation is being sought.
According to the Board, "A bald statement will not suffice by merely reproducing the language of the section. The facts have to be pleaded and the applicant must state how the particular undisclosed application was for the same or substantially the same invention.It is also not enough to just file the documents along with an affidavit.The least that the deponent shall state is how it is the same or substantially the same."
Merck Sharp & Dohme and Glenmark over the Generic drug"Sitagliptin":3
Merck Sharp & Dohme (hereafter "MSD") aggrieved by the dismissal of interim injunction sought to obtain an interim injunction against Glenmark seeking to restrain Glenmark from selling its Generic products in the High Court. In response challenging the validity of the sitagliptin patent of MSD under Section 64 of the Patents Act 1970, Glenmark argued that Merck was guilty of suppression.
The respondent (Glenmark) argued along with other grounds that the patent is invalid under Section 64 (1) of the Indian Patents Act and MSD did not comply with its obligation under Section 8 of the Act to disclose patent applications made for the "same or substantially the same invention" – it did not disclose 5948/DELNP/2005 (for Sitagliptin Phosphate Monohydrate), 1130/DELNP/2006 (Sitagliptin Phosphate Anhydrate), 2710/DELNP/2008 (Sitagliptin plus Metformin) or subsequent international applications for these compounds either.
In judgment, the Division bench of the Delhi High court made the following observations Regarding Section 8 (foreign filing disclosures). The court observed that Merck in the modified Form 3, disclosed foreign filings for patent related to combinations of Sitagliptin and metformin. The Court further stated that Section 8 only mandates the disclosure of patent applications outside India and not within. This is clear from the wording of Section 8 itself.
The court carefully and meticulously evaluated the factors involved in grant of interim injunctions and considered it a Prima facie case. The court succinctly captured the crux of the case and noted that Merck had established a strong prima facie case on the merits of the suit claim. The court was totally unimpressed with the unsubstantiated argument advanced by Glenmark and had stated that there is no evidence by the defendant to show that such non-disclosure of the information was deliberate and for malafide reasons.
Hence, in particular it can be said that, it is not the Court/IPAB job to do findings and revoke patents:The Court/IPAB stated that the petitioners should demonstrate how Section 8 was violated, why documents related to a foreign patent application ought to have been filed by demonstrating how the foreign application and the Indian application cover the same or substantially the same invention and show that such non-disclosure of the information was deliberate and for malafide reasons.
1 Section 8, Indian Patents Act 1970.
2 ORA/22/2011/PT/KOL dated July 27, 2013
3 CS(OS) 586/2013 Oct 07, 2015
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