What will GSK ultimately achieve from this order?
It appears to me that the net effect of the order is merely academic i.e that GSK would be vindicated in its stand that the Controller was wrong in denying its applicaiton for an EMR.
To recapitulate the essence of the order, the Supremes ruled that although Indian patent law does not recognise the concept of Exclusive Marketing Rights anymore (Chapter IV A dealing with EMRs were removed by the 2005 amendments), any rights (including the right to appeal) that accrue under proceedings initiated under the old regime (the pre 2005 patent regime) would continue. In other words, although Indian patent law does not recognise EMR’s anymore, GSK could continue to puruse its right to appeal against what it thinks to be a wrong order from a controller.
Now assuming the Controller was in fact wrong and now decides that GSK is entitled to the EMR, can it grant the EMR now?
Certainly not–since EMR’s are no longer part of the patent regime and it is not within the authority of a Controller to grant such a right anymore.
If the above is not possible, can GSK claim retrospective damages from generic manufacturers such as Cipla that made generic versions of this drug during the time that its EMR might have been in force (had the Controller made the right decision and granted the EMR in question at the first instance).
Since section 11 A(7) of the Indian Patents Act that deals with retrospective damages applies only to patents and not to exclusive marketing rights, GSK will not be able to claim such retrospective damages. For those interested in a more detailed review of retrospective damages, see this article that I wrote for the Economic Times many years ago.
Can GSK sue the government for damages that it suffered as a result of a wrong decision from the Controller?
Here again, the answer is no: since the Patents Act (section 24F) clearly stipulates that one cannot sue a government officer for a wrong decision.
And now comes the really interesting question:
Can GSK claim that it was entitled to the EMR right from day one: i.e the time at which the Controller was first examining the EMR application in question (lets assume this was in January 2004)? Therefore, once the Controller decision is appealed against and held to be bad in law, the EMR would spring into operation retrospectively i.e. from the day when it was meant to be granted.
And that since an EMR is meant to last for either five years from the date of grant or till the time that the corresponding patent application is accepted or rejected (whichever is earlier), the EMR rights would be in force till 2009 (five years from the date of grant of EMR). Unless of course the patent application is rejected or accepted prior to this. If rejected, the EMR perishes. If accepted, then the EMR rights die and the patent rights come into force.
Since the duration of EMR’s is 5 years from the date of grant (unlike patents, where the term is 20 years from the date of application), the above argument in favour of a retrospective vesting of rights may not hold much water.
In any case, the government ought to immediately instruct the patent office to examine GSK’s patent application and take a call on its patentability. If patentable, a patent should issue. If not, it ought to be rejected. This is the most sensible way to put an end to the above conundrum.
Sir,
If the Controller revives/reexamines the application, will not the application becomes an application which is pending before the office? If yes, the question of grant of EMR should not arise; instead the application would be examined for patentability as required by the 2005 Amendment Act.
Regards,
J.Sai Deepak.
*become
Thanks Sai,
I personally prefer the result that you envisage. However, will such a result be tenable, given the SC ruling, which seemed to suggest that the controller’s earlier order is treated as “concluded” and the proceeding cannot be treated as a “pending” one. The court noted in pertinent part that:
“The learned Single Judge’s view that the provisions of Section 78 of the Amendment Act have no application to the proceedings which stood concluded before the appointed day appears to be the correct view governing the issue.
Since the Chapter IV-A in question was merely repealed, the situation has to be dealt with in line with Section 6 of the General Clauses Act. The provisions of Section 78 are conditional provisions and are not intended to cover cases where the application for EMR had been rejected with reference to Section 21 of the Amending enactment.”
Now, if GSK’s claim is that their rights accrued from the date of the previous order of the Controller, then under the SC logic, will the subsequent proceedings before the Controller (implementing the court order) necessarily fall within section 78?
Dear Sir,
I was thinking that pending or de novo (yet ante-dated), the application for an EMR would fall under s.78. But to be very honest, i am not sure and i doubt the patent office knows the way forward.
Sai and Shamnad,
A clarification: In the current issue there are two types of pendency one is talking about – the first is the pendency of the EMR application (which is relevant from the perspective that S. 78 deals with ‘pending’ applications and sends them on the straight road to patent examination) and the second is the pendency of the proceedings.
While the proceedings no doubt continue to be pending while parties are agitating their rights before the Single Judge and thereafter in the appellate fora, there is no doubt that the EMR application was not ‘pending’. It had been rejected, and according to the finding of the Single Judge, when read with the finding of the Supreme Court, it was rejected wrongly. Since S. 78 does not in fact apply to situations which deal with “wrongly rejected applications”, a methodology for determination of the rights of an applicant in such a case has to be outside the scope of S. 78. That, according to me, personally, is the essence of the Supreme Court’s order.
Therefore it is wrong to suggest that the application now gets revived, goes back to the controller, becomes “pending” and therefore has to be rejected as the law has changed. That was precisely the patent office’s argument to justify why they disobeyed the Single Judge’s order for a third remand, which argument the DB upheld, but which the Hon’ble Supreme Court rejected.
The test, even on today’s date is when the right of the applicant actually accrued and the answer to that is 28th December 2004 when it was rejected after re-consideration by the Patent Controller under the orders of the Single Judge.
So any action on the EMR even on today’s date by the Patent office will have to be taken on the basis of the law as it then stood. And so an automatic rejection cannot any longer be a way out for the Patent Office to convert the Supreme Court’s decision into a paper decree.
Dear Madam,
So according to you:
1.The EMR application was wrongly rejected
2. Yet the proceedings are concluded (of course in Para 9 of the judgment thats what the Apex Court says)
3. SO the patent office has to travel back in time to 28th Dec 2004 (or is it on the date of filing of the application?) and decide the merits of the application in accordance with the Pre-2005 law.
So for how long can the patent office judge the application under the pre-2005 provisions?
Also, in the aftermath of this case, it now seems like there could have certain EMR applications which the patent office “wrongly rejected” before th 2005 Act. So can all those applicants file an appeal and again seek examination of their applications? Because GSK did the same thing. The appeal was filed on June 9, 2005.
I just seek clarity in my concepts. So I humbly request you to explain as to what is the current date of the GSK appplication and what would happen if the controller again shoves it into the wheelie bin?
One quick clarification Sai (and I’ll wait for Shwetashree’s more detailed and informed response on the others):
Appeals are normally time bound. So if you’re not within the time limit (one month-3 months in most cases), you cannot reopen an EMR issue that concluded many years back. So the threat of the GSK ruling opening up other EMR proceedings may not be that “real”.
True Sir, which is why i am asking as to how did GSK file a petition after 6 months? Does “petition” fall within appeal?
Dear Sai,
I’ve read Shwe’s comment again. This is clearly a case of a writ petition and not an appeal–since there are no appeals from an EMR order. However, even writs cannot be filed at any time–rather, a writ has to be filed within a reasonable time–and is not maintainable if the delay is significant. What is significant delay varies from case to case. However, courts by and large have accepted writs within 3-6 months. Any period thereafter is excused only if the petitioner has a valid justification for the delay.
So courts may not be particularly sympathetic to someone challenging a 2004 order in the year 2008. And to this extent, the fear of resurrecting old EMR cases may be misplaced.
I’ve also gone through the dates again carefully and I think the best way for the government to reject the resurrection of the EMR by GSK is to clearly state that the order was first passed in 3rd May 2002. And even assuming the retrospective argument were to hold good and we treat 3rd May 2002 as teh date of grant, such right would terminate after 5 years–in May 2007. This appears to be the simplest way to dispose of this case.
I find myself in complete agreement with you Sir. My post too had stated that pendency of EMR proceedings and pendency of a right from the proceedings are not the same. It said:
“accordingly, an application which has been rejected by the office and has moved on from an administrative forum to a judicial forum cannot be brought within the aforesaid provision since this is not in line with the concept of pendency.”
Now Ms.Majumdar has presented a summary of my views and your post but the key question remains to be answered by her. If the application proceedings have been concluded, as the SC held and as Ms.Majumdar reiterated, can one impute the earlier date of the application to the current proceedings? If yes, how can the proceedings be termed as “concluded”? This could probably mean that “wrong rejections” do no “conclude proceedings” and that the SC was not fully aware of the implications of such a decision. In the alternative, it is quite possible that i have not understood the concept in entirety and am losing sight of the forest for the trees. Either ways, I think we may need to adopt aarohan padhathi here and go by a step-by-step argument with no gaps in between. I eagerly await Ms.Majumdar’s reply for i am sure she has the answers or atleast better propositions and is possibly held up with work.
Wishes,
J.Sai Deepak.
Dear Sai and Shamnad,
Being involved in the issue at the current moment and given that a lot of your questions are in fact inextricably linked to strategic decisions I find myself unable to respond in a neutral and purely academic manner to the issue – I respect your efforts to bring clarity to the subject and will be happy to discuss what I can when I am ethically in a position to.
Best
Shwetasree
Dear Madam,
I must thank you for taking time out to read through the posts and the comments and for explaining your position to us. I shall patiently wait for the situation to unravel itself.
Sincerely,
J.Sai Deepak.