More puzzling questions about Sugen’s Sunitinib patent

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Going through Sugen’s Sunitinib patent file, once again, I came across a few more irregularities. I’ve blogged about the previous irregularities over here and here.

Normally, post 2005, after a patent application is filed before the India patent office it is published in the patent office journal after which any person can file a pre-grant opposition under Section 25(1) until such time that the patent was granted. After the publication, the patent is referred to an Examiner by a Controller. The Examiner is supposed to examine the patent application for anticipation and obviousness and submit his report to the Controller who will then conduct a hearing with the applicant and decide to grant or reject the patent. If the patent is granted, it is effective from the date it is published under Section 43(2) in the patent office journal.

Here’s the timeline on which the Sunitinib patent proceeded:

Most of the above events can be confirmed by reading the correspondence file available over hereand here.

(i) 9th August, 2002: The patent application was filed and sent to the mailbox, to be opened on 1stJanuary, 2005 when India became TRIPs compliant;

(ii) 7th September, 2005: Sugen files a Form 18 requesting for examination of the patent application;

(iii) 17th May, 2006: An examiner of the patent office sent Sugen’s patent agent a First Examination Report (FER);

(iv) 1st June, 2006: Sugen replies to the FER;

(v) 16th June, 2006: Examiner of the patent office who issued the FER, makes a file noting that he has discussed the file with the patent agent for Sugen and that the matter can proceed to grant. On the same day, the patent examiner sent Sugen a letter informing them that its patent had been granted subject to “completion of statutory time limit as mentioned under Section 25(1)”.  (I’ll get back to this later in the post)

(v) 16th June, 2006: On this very same day on which the Examiner decided to grant the patent, Sugen’s patent agent makes a request in Form 9 to the Patent Office seeking publication of its patent under Section 11A.

(vi) 19th January, 2007: The patent office publishes Sugen’s patent application under Section 11(A);

(vii) 1st August, 2007: On this day, Sugen’s patent agent writes to the Patent Office seeking grant of the ‘Letters Patent Document’ and states (a) that the patent had already been granted by the patent office; (b) that it had been published by the patent office; (c) that no opposition had been received till date.

(viii) 5th October, 2007: On this day, the grant of Sugen’s patent was published under Section 43(2) of the Patent Act and Sugen was now entitled to enforce its patent.

What are the glaring violations of the Patents Act in the above process?

(i) Examination before publication under Section 11A – no opportunity for a pre-grant opposition: The publication under Section 11A happened after the patent was granted instead of happening before the examination of the patent application. Rule 24B of the Patent Rules, 2005 clearly states that “A request for examination under Section 11B shall be made in Form 18 after the publication of the application”. Why was this procedure not followed by the Patent Office? Why did Patent Office begin with the examination process before publishing the patent application? The practical effect of concluding the examination process before the publication of the patent was to rob generic competitors with a right to file a pre-grant opposition to the patent in question. In 2007 generic pharmaceutical companies were filing pre-grant oppositions regularly but given the manner in which the patent office granted the patent and then published the application, most companies appear to have been robbed of an opportunity to file a pre-grant opposition.

(ii) Examiners do not have the power to conduct Section 15 hearings: Prior to Kurian’s tenure as the Controller General, the patent office used to basically follow its own version of the Patent Act and this is exactly what happened in this case. If you read the Patents Act from Sections 11 to 15 it is quite clear that Parliament envisaged a two-tiered screening of all patent applications i.e. the patent application goes to a Controller who assigns its to an examiner who is required under statute to examined the patent application for anticipation and obviousness, prepare a report and forward it to the Controller. The Controller then communicates to the patent applicant the gist of the Examiner’s report and grant the patent applicant a hearing if required. After that the Controller may accept or reject the patent application in question.

This is not what happened in the Sunitinib case. As is obvious from the file-noting on page 1 of the correspondence file, the Examiner has conducted the hearing himself and issued the letter of grant by himself. There has been no involvement of a second officer from the Patent Office. Like I’ve discussed earlier, this alone is a ground to have a writ court set aside a patent.

(iii) Did Sugen even know that the Patent Act, 1970 was amended?

What really surprised me while going through this file, was this line from Sugen’s letter to the Patent Office (page 16 of the correspondence file)

This application was accepted by the respective Examiners/Controllers way back in June 2006 and we also received a letter of intimation of grant.

The above application has been published in the Patent Journal on 19.01.2007 and no opposition has been received till now.

There are many infringers in this market and we would like to pursue the infringers. However, we are unable to take any action since the final LPD document has not been issued to us.

We earnestly request this Office to kindly expedite the matter and issue LPD document as soon as possible” (sic)   

I am not sure about this, and am open to correction but doesn’t the above procedure as outlined by Sugen in its letter, dated 1st August, 2007 actually refer to the procedure followed in India before the Patent Act was amended in 2005. The procedure before 2005 was that the patent application was examined by the Patent Office and was published in the patent office journal only after the patent application was accepted by the Patent Office. After its publication or ‘advertisement’ as it was then called, a ‘person interested’ had up to 4 months to file an opposition. If there was no opposition the patent was sealed and the patentee could then enforce his patent.

The above procedure changed completely in 2005 when Parliament amended India’s patent legislation. The process described by Sugen in its letter dated 1st August, 2007 dates back to pre-2005. What was Sugen thinking?  

Conclusion: Given the sheer number of violations of the provisions of the Patent Act, 1970 there is no doubt that if the patent was not already revoked, any High Court in the country would have set aside the grant of the patent on the grounds that it did not conform to the scheme of the statute.

Once again, I ask – what was Sugen thinking?
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9 thoughts on “More puzzling questions about Sugen’s Sunitinib patent”

  1. Prashant,

    The last few posts have in parts been illustrative of what absence of experience of practice can lead to. And no offence meant.

    Sugen’s patent is gone. Let is RIP.

    As for those so called anomalies that you point out to including perfecting title etc., the law provides a mechanism, several in fact to establish title post-filing. The law recognises that establishing title should not be a hindrance to filing of an application.

    Finally, Cipla could in any event not have raised this ground – please read Section 25. Both clauses 1 and 2 state “but on no other ground…”. I believe that this is fairly conclusive. Again, the exercise of discretion in granting extension of time (not condonation of delay as some of my esteemed colleagues in the patent profession are fond of putting it) is not questionable – See Section 82. The Act has to be read in full – and with the Rules and with all necessary international agreements and covenants – something I have tried my best to instil those I have come in contact with over the past 19 years.

    Again, no offense meant. But the Act provides mechanisms to establish proof of right even at a later date – and this formality cannot be used to destroy an application – except by a person who claims to be an inventor or a person who claims that the invention was obtained from him/her/it.



  2. Things have returned to earlier condition after Kurien’s exit. Patent office now follows its own “convenient” interpretation of Patent act inspite of existence of many written orders by CGPDTM.

  3. Nataraj,

    I’ve said it before and I’ll say it again – if you don’t want to read this, don’t read it but don’t tell me not to write about it. It is my time and my effort, I’ll do what I want to with it. In fact, I can’t understand why you are so keen on silencing me on the issue – what do you have at stake in the matter? Who are you trying to protect.

    As for these constant barbs about the lack of my experience before the patent office, I would strongly recommend that you go and get some experience before a High Court. Such a supremely flawed patent prosecution would have been ripped apart by any High Court judge sitting in a writ court.


  4. Prashant,

    I think what Natraj is trying to say that the puzzling questions you raise are not actually puzzling for a practicing agent as it is not the first case that this has happened.

    I understand that for a high court practicing lawyer, this would seem strange, however you are probably mistaken in drawing conclusions. Let me try bringing this into context with the background.

    A person practicing before the patent office during that time (Pre-Kurian era) would remember that the patent office had a large backlog, therefore could not publish the applications in the journal after the expiry of the statutory period due to the backlogs. However this could be the reason that the application were kept in limbo for a long time after the request for examination was filed. So, in order to facilitate faster processing, the applications were examined, FERs were issued, response was filed and even an intimation of grant (this was not a grant) was given.

    Firstly, nothing in the act is stopping the examiner from examining the application before publication. If the request for examination is made then the application may be examined.

    You refer to Rule 24(B) of 2005 to interpret that examination should be done only after publication. This is incorrect because

    – the complete reading of 2005 version of 24(B) clarifies that “after publication but within 36 months.” So take for instance a scenario (eg in Sugen, and many more during that time) where the application was not published but the 36 months were due to expire. Not filing a request just because it was not published would be suicidal for the applicant.

    – the rule 24(B) of 2005 refers to when the request can be filed and has nothing to do with if the examination can be done or not

    – this rule was amended in 2006 for this exact reason to only refer to time period and have no mention of the requirement that the application be published before a request is to be filed.

    continued in next comment…

  5. …Continued from previous comment

    Secondly, please note that the patent was not granted before 11(A) publication, but the examiner had just given an intimation that the application was in order for grant and it would be granted provided that the application was published under 11(A) and there was no pre-grant opposition made. This was called intimation of grant and was clearly worded to describe when the patent will actually be granted.

    When the application was later published under 11(A), any person could file a pre-grant opposition. Actually, a pre-grant could be filed from publication till the grant of the patent. However in this case even though the patent was already examined and about to be granted, it had provided the general public more than 6 months from publication on 19th January 2007 to grant on 5th October 2007. This clearly was in accordance with Rule 55 (1A) of 2006 which notes “no patent shall be granted before the expiry of a period of 6 months for the date of publication of the application under sec 11A.” This rule 55 (1A) provides for the fact that public (generic company) get at least 6 months to file a pre-grant opposition and is designed to avoids the exact scenario mentioned by you, rob the public (generic company) from a chance to oppose the patent under pre-grant opposition.

    So, were the public robbed of the chance to file a pre-grant opposition? No.

    Sugen in its letter mentions to the application which was accepted (note: not granted) was published (note: under 11(A) – pre-grant publication) and no opposition (note: pre-grant) had been filed till date (note: atleast 6 months) therefore, it was time that the LPD be issued (note: the patent be granted).

    Did Sugen know that the act was amended? I think they very well did. They also knew the rules, so they waited for 6 months after the 11(A) publication to send a letter asking for issuance of LPD.

    About the hearing being conducted by the examiner, I don’t think there is anything to add to your previous argument. As you had already noted, it had happened in lot of cases earlier and this is not the first one.

    So as I explained above, taking in context of the background, the amendments of law and the working of the office, this was indeed nothing puzzling for a practicing agent.

    Patently Yours

    P.S : I have nothing to do with the applicant

  6. Prashant,

    On a personal note, I, like many other practicing agents, do not comment often and just ignore the post even though there are some clearly incorrect interpretation.

    But I recommend that with something relating to practical aspect, that you bounce off your ideas with someone who practices, so that it does not look novice before you post them. And there is nothing to get offensive about when someone comments on your lack of practice.

    P.S This is a personal comment addressed to you and not for posting on the blog.

  7. Patently yours,

    Its interesting how this one post, is drawing a lot of first time comments but in any case thank you for your detailed comments minus the barbs.

    As someone who has had some limited practice before the High Court,let me assure you that judges aren’t really bothered about backlogs or staff shortages or patent office practices. They are more likely to look at the statute and interpret only the text. If one were to follow only the text, it is quite obvious that this patent would have been set aside by a writ court. You can’t file a Form 1 and title to assignment 40 months late and expect a High Court judge to allow for it.

    I stand by my interpretation of Rule 24B, according to which examination of the patent application can happen only after publication. The ‘within 36 months’ is secondary to the initial publication of the application. It makes no sense to have the publication after examination of the patent and after the examiner has already decided to grant the patent. If you remember the judgment of the Delhi High Court in the Snehalata case, a patent is considered to be granted once the letter of intimation of grant has been issued. This means that you can’t file a pre-grant opposition any more and have been robbed of any opportunity to file a pre-grant. You are left only with a post-grant opposition after this.

    The entire procedure followed in the prosecution of this patent is pre-2005. The patent was first examined, accepted for grant, then advertised and sealed.


  8. Dear Prashant,

    Again, I am surprised by your reaction. This is the first post that I have put here. Did think about it over the past few days, but have not placed them. Secondly, I have no interest in the Sugen prosecution, their attorneys, or in the invention.

    Take a friendly bit of advise – when someone tells you what prosecution of patents involves – try not to get personal. As for assuming the level of experience I have before the High Court or otherwise, I really do not wish to enter into what is a cat fight. Just check with Shamnad prior to posting comments.

    Please understand, even a writ court will not strike down patent grant simply because a Form 1 was filed 40 months after the filing date – unless it can be demonstrated that the reasons for the delay and the exercise of discretion by the Controller were without any basis. Actually neither will the IPAB – you can see some of their orders on delay in filing of docs. While both the IPAB and Courts are strict about delays, they also recognise that these can on occasion be the result of factors that are truly outside an applicants control.

    Vis a vis publication. Agree with Patently Yours that publication is not a precondition for examination. You may differ in your interpretation – that is ok. The fact remains that publication was not a precondition for examination. Finally, in the context of mailbox applications please do check – there was a notification in the first few weeks of 2005 which expressly stated that all mailbox applications were now open to public inspection and were deemed published. How will a person know – they would because prior 2005 the essential biblio of all patent applications were published – except for the abstract. Fairly easy to keep track considering priority data was also published as was the title. In fact, several generics did do that and this resulted in the spate of pre-grants in 2005.

    Again, Prashant – no offence meant but it does not hurt to just cross check what practice is prior to posting. Yes, it is your time and your effort – but a pity if other excellent efforts by you are lost because of an error in interpretation.

    Finally, and this time really final, I am not offended by your comments on my so called lack of expertise in the High Court. So no worries. Like I said, just check with Shamnad. Some of us do really like to be low key. It also depends on which High Courts you are talking about – Delhi, Mumbai, Kolkata, Chennai etc.



  9. Natraj,

    If you are going to ask me to ‘RIP’ on the matter, I am not going to do it.

    As for a High Court setting aside the matter, I made it very clear that there were a multitude of reasons for them to set aside the patent not just the patent delay in filing the Form 1.

    Like I said in the post, the entire patent application has gone through only an examiner. That is enough of a reason for the patent to be set aside.

    As for my interpretation of Rule 24, we can agree to disagree.


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