The Sunitinib Saga continues: Third time’s the charm?

The IPAB has set aside the revocation of Sunitinib patent due to procedural lapses again!!(IPAB order can be accessed here). As Sunny Deol would drawl “tariq pe tariq, tariq pe tariq...” (movie buffs you know what I’m talking about).Well Justice Prabha Sridevan also expressed a similar sentiment albeit in different way and stated that the Sunitinib litigation has been delayed endlessly owing to procedural lapses in the IPO and this is unfair to both the patentee and the challenger and also detrimental to public interest.

Sunny Deol Image from here

Sunitinib’s protracted journey

Pfizer/Sugen was granted a patent on anti-cancer drug Sunitinib (Patent number: 209251) on Oct 5, 2007.Nearly 5 years later in a post grant opposition initiated by Cipla, this patent was revoked by the patent office.After patentees (Pfizer/Sugen) filed a writ petition before Delhi High court, the first revocation decision was set aside, on the grounds that the recommendations of the opposition board were not furnished to the patentee. 

The Sunitinib patent was revoked by the Controller of Patents for the second time around in mid-February this year. We had blogged about this decision over here and here.On April 5, 2013 the IPAB stayed the revocation of Sunitinib patent. Sugen’s appeal against the revocation was fixed for hearing on May 14th 2013 subject to the undertaking given by the appellant (Sugen) that they will not use the revoked patent against the second respondent (Cipla) in other proceedings.

According to the appellant (Sugen/Pharmacia) the opposition was not sustainable (second revocation decision) due to the following grounds, which are detailed below:

Consideration of Section 25(2) (b):

Sugen argued that Section 25(2) (b) should have not been taken into account by the Controller since that ground was not specifically pleaded by Cipla (respondent); and hence the decision of the Controller based on prior publications wasn’t valid. Bachhaj Nahar v. Nilima Mandal (2008) was cited to show that in absence of pleadings, no evidence can be considered.

The IPAB however held that S 25(2)(e) had been raised by the respondent, and Section 25(2)(e) is a ground for revocation if that the invention so far as claimed in any claim of the complete specification is obvious and clearly does not involve any inventive step, having regard to the matter published as mentioned in clause (b) or having regard to what was used in India before the priority date of the applicant's claim; The IPAB thus held that Section 25(2)(e) clearly and unambiguously takes Section 25(2)(b) within its ambit and rejected this ground. It also held that if a ground has been pleaded in the written statement, but not listed in the grounds then the Controller may apply it provided the patentee is in the know.

Should the Controller have received the reply evidence under Rule 59?

The appellant (Sugen) argued that respondent (Cipla’s) reply statement had been filed beyond time and request for extension had not been made within prescribed period and therefore should not have been considered by Controller. Patentee’s reply statement was served on the respondent on 5th November 2008 and hence the extension petition should have been filed within prescribed period, which is one month from the date of delivery to the opponent of a copy of the patentee’s reply statement i.e. on or before 5th December 2008.Sugen contented that the reply evidence was filed by Cipla only on 16th December 2008 and therefore time could not have been extended. 

Placing reliance on 2011(46) PTC 70(Mad) – (Nokia Corporation Vs. Deputy Controller the IPAB stated that a true interpretation of Rule 138 would be that application for extension is to be filed within one month after the expiry of the prescribed time. The IPAB held that by applying the Nokia case standard, the reply evidence had been filed by Cipla within time and the Controller hadn’t erred.

Failure to forward Expert’s affidavit to Opposition board

Sugen then argued that the failure to forward a crucial expert affidavit Cui 2, (filed under Rule 60) to the Opposition board for its recommendations had resulted in injustice. Pursuant to Section 25(3) (b) the Controller is required to forward the notice of opposition along with all the documents to the Board so that the board could give its recommendations. Sugen realized that the expert affidavit had not been forwarded to the Board only after the report was furnished (previous revocation decision was set aside because the report was not furnished); hence Sugen was completely justified in raising this ground. The IPAB lambasted the patent office for this procedural lapse and held that “The unexplained non-forwarding the reply evidence of the appellant would render the Opposition Board’s recommendation defective. Therefore the Controller’s decision which is arrived at after consideration of the defective recommendations also becomes flawed. As we have stated earlier, there is no reason why this affidavit was not sent to the Board. On this ground we have no option but to set aside the order”

Section 8 disclosures: Achilles’ heel

The IPAB also stated that the respondent’s appeal against the Controllers finding on Section 8 disclosures, should be heard de novo right from the stage of the Constitution of the Opposition Board. In its past decisions the IPAB has clearly emphasized the importance of S8 disclosures. The IPAB criticized the patent office for its observation that S8 information is available on the internet(Howler!).It stated that “This is not the law. This duty under Sect 8 cannot be breached and if violated results in revocation. It deserves to be accorded due respect.” Readers may remember that Prashant had made similar observations in his post earlier.

While it is indeed frustrating for a patentee to comply with S8 requirement, any slackness in compliance will adversely affect the validity of the resultant patent.

Image from here

Conclusion: The IPAB expressed disapproval at the manner in which the Controller had dealt with the opposition proceedings and reiterated the importance of providing sound reasons for arriving at conclusions. Now this is something we have lamented about here, here and here.The IPAB then held that the Opposition Board should be constituted again and a different Controller should hear the matter afresh within a strict time-frame. To quote “We make it clear that we have not even examined the findings in the impugned order regarding obviousness and the relevance of the prior arts, so the Controller is free to decide the issues in accordance with law uninfluenced by the earlier decisions”

As they say the devil is in the details, so procedural formalities should not be taken casually!