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(Patent number: 209251) on Oct 5, 2007.Nearly 5 years later in a post grant opposition initiated by Cipla, this patent was revoked by the patent office.After patentees (Pfizer/Sugen) filed a writ petition before Delhi High court, the first revocation decision was set aside, on the grounds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The Sunitinib patent was revoked by the Controller of Patents for the second time around in mid-February this year.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!


Madhulika Vishwanathan

Madhulika is a registered Indian patent agent and has completed her Master’s in Pharmacology from the Institute of Chemical Technology (ICT), Mumbai. Her interests include issues involving pharmaceutical and biotechnology patent law, regulatory aspects like Hatch Waxman litigation and antitrust law.She is currently working at law firm based out of Memphis, TN.

10 comments.

  1. Rahul B

    “since that ground was not specifically pleaded by Cipla”

    I have not gone through the facts of the case and terminology used by the counsels and board. But how can IPAB equate the “ground” of Section 25(2)(b) with “ground” of section 25 (2) (e) because it takes it into its “ambit”? Just because the latter section has a referenced to the former section? One requires you to plead non-novel while the other requires you to plead obviousness. How are these two same? If someone pleads obviousness, then you should just stick to judge whether the claim of obviousness is true or not. If the opponent thinks it is Novel – that means they did not find a “single” reference which had all the limitations of the patent challenged by them. Therefore, they shifted the pleadings to obviousness claim. After SC conflated infringing disclosure with anticipatory disclosure, conflated non-prosecution history with prosecution history (in terms of using estoppel), we have IPAB telling us obviousness pleading takes in its ambit the challenge to novelty too ? Absolutely ludicrous.

    Reply
  2. Madhulika Vishwanathan

    Rahul,
    That is a good question. As I see it, Novelty is a smaller concept embodied in the broader concept of obviousness. An invention is new (novel) when it differs from the prior art. Not much difference is required.An invention is non-obvious when it is sufficiently different from the prior art (not easily deducible).The threshold for dissimilarity is higher for obviousness.
    So intuitively, obviousness analysis for a set of prior art documents does encompass novelty determination.
    Also, if the ground has been pleaded in the written statement but not listed in the grounds, the Controller may apply it, the only requirement being that the patentee should know he has met this ground. In this case the appellant wasn’t caught unawares.
    So I would say that the IPAB’s opinion was correct.

    Reply
  3. Rahul B

    ” In this case the appellant wasn’t caught unawares.
    So I would say that the IPAB’s opinion was correct.” – These are two different things. To say that ground pleaded in written statement and not listed in grounds, and the controller should still apply it- answers a separate legal question. But I do wonder whether it is governed by some precedence or just opinion.

    But the issue of putting clause b in ambit of clause e is dangerous, in my opinion. I do agree that standard of non-similarity are higher for determining obviousness but then it also takes into account, according to our law, the economic significance that an invention gives, even if the invention is plain obvious. And this conflating of two clauses will also give an automatic right to opponent to challenge a patent on basis of non-novelty even though they themselves are pretty sure that the invention is novel. So, there is chance of various frivolous oppositions. I may be wrong on this. Another thing, it leaves us – the patent law practitioners – confused while telling a client whether law separates obviousness and novelty or they look to it through same lens? I think the IPAB should have restricted their reasoning to the other reason that they gave and not gone on lengths to explain how a clause requiring obviousness as ground of opposition takes into ambit the clause requiring non-novelty as ground of opposition.

    Reply
  4. Rahul B

    Madhulika

    I have now with me the exact statement used by the counsel of the opponents in this case.

    ” The opponent submitted that ground of anticipation has not been taken in its Written Statement which is an implied admission that no single compound discloses the alleged compound of the invention. The ground of obviousness will be substantiated by combination of teachings of D1 and D3″

    It has been wrongly stated “no single compound” instead of “no single reference” – typographical error though.

    So the opponent themselves refrained from applying clause 252(b) and that too quite explicitly by the above admission. IPAB has erred in their ruling. And I also feel, on cursory analysis and based on argument submitted, that the controller has erred in reaching the correct judgment due to hindsight.

    Reply
  5. Anonymous

    Excellent reportage Madhulika! Nice touch there with Sunny Paa ji.
    Rahul: I think you should read the post again. I have been following this news for quite some time now and clearly Madhulika has covered all your points quite nicely in her post.

    Sincerely,
    Pat-man

    Reply
  6. Anonymous

    Observation made by IPAB on Section 8 are ridiculous. Sec 8(2) is not an obligation. It becomes an requirement only when Controller directs the applicant. If Controller feels the details required under Sec 8(2) are available to him there is no obligation on the controller to direct the applicant to file the same documents which is already available to Controller. IPAB once again expressed his bias towards generic under the cover of so called public interest

    Reply
  7. Rahul B

    To Pat-man

    I am not talking about Madhulika’s coverage. Like always, she has presented the facts nicely. I have reservations on IPAB’s observation on section 25(2)(e) with respect to section 25(2)(b).

    Reply
  8. Madhulika Vishwanathan

    Rahul,
    Thanks for your insightful observations. Maybe my post wasn’t quite clear on this aspect. Blame it on Sunitinib’s convoluted history.

    Previously, the patentee (Sugen) argued that the documents cited by the opponents as prior art are inadmissible since Section 25 (2) (b) of the Patents Act has not been taken as a ground either in Form 7 or in the written statement. The patentee submitted that the opponent has relied on prior public knowledge and use, but not on prior publications.

    Further the patentee asserted that the decision of the Controller i.e. the invention was obvious on the basis of prior publication was not sustainable. Exhibits D1, D2 & D3 (prior art documents) should not have admitted since Section 25 (2) (b) was not taken as a ground.

    I believe this was a feeble ground raised by the patentee because Section 25(2) (e) is a ground for revocation if the invention is obvious with regard to both prior publication and prior use.

    In this context, the IPAB rightly held that that Section 25(2) (e) clearly and unambiguously takes Section 25(2) (b) within its ambit. You would agree that Section 25(2) (e) does encompass obviousness due to prior publication.

    Hope this clears the confusion 🙂

    Reply
  9. Rahul B

    Madhulika

    Thanks for going even deeper. I could not locate the arguments by patentee. In that context, IPAB rightly interpreted the law. It was not feeble argument. I will go a step further and say it was frivolous argument.

    Reply

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