Seven years after the enactment of the Patent (Amendment) Act, 2005, India continues to struggle with the absolute basics of its post-grant opposition mechanism. As our readers may already be aware, the Patent Office recently revoked the patent for Sunitinib.
Although the patent has been identified in the media as a Pfizer patent, Pfizer is only the licensee. The patent is actually owned by Sugen Inc & Pharmacia & Upjohn. In its Form 27 filing with the patent office in the year 2010, Sugen did not disclose the patent was licensed to Pfizer, despite the same being a requirement. Sunitinib is supposed to cover several different types of cancer including some which are resistant to other treatments such as imatinib. Yet, despite these tall claims, Sugen imported only a mere ‘7000 units’ in 2009 into India, a country which loses more than 500,000 people to cancer every year. The relevant Form 27 can be accessed over here (last page).
After this patent has finally been revoked more than 5 years after it was first granted in the year 2007, Law et. al. reports that the patentees have filed a writ petition before the Delhi High Court asking for the decision of the Controller to be set aside on the grounds that they were not given a copy of the report of the Board of Oppositions (This is a three member board that is set up under Section 25 of the Patents Act, to scrutinize the evidence and the arguments of both parties before submitting a report on the same to the Controller).
This is an absolutely astonishing argument for the patentees to be making after the Controller has already passed her order revoking the patent. ‘Astonishing’ because the patentees should not have even argued the matter until they had a copy of the report of the Opposition Board. Who in their right minds would proceed to the stage of final arguments without being fully prepared with all the relevant information including the most important piece of information – the report of the Opposition Board. Anybody who has read a Controller’s decision in post-grant opposition matter must be aware of the importance of this document. It is a critical document and has a profound impact on the decision of the Controller in a post-grant opposition.
It isn’t like the patentee was not aware of this report of the Board of Opposition. The Delhi HC’s order, available over here, records in detail how the patentee claims to have applied for a copy of the report of the Board of Opposition via a letter and also through a RTI application. Apparently some genius in the Patent Office turned down the request on the grounds that the same could not be shared because the matter was sub-judice – there is no provision anywhere in the Patent Act or Rules which allows the patent office to withhold the report of the opposition board on the grounds of ‘sub-judice’.
Faced with this rejection, the patentee should have immediately appealed the order of rejection of the Patent Office to either the IPAB or the High Court depending on which forum would have had jurisdiction. Instead, according to the narration of facts in the order of the Delhi HC, the patentee just went ahead and argued the matter on merits before the Controller and now after losing the post-grant opposition, the patentees are crying foul over the non-disclosure of the report of the opposition board, an act which they never challenged in the first place.
What is even more utterly baffling is the fact that the Delhi High Court then proceeded to restrain Cipla from releasing its generic drug in the market – this in a writ proceeding against the order of the Controller! Effectively an interim injunction against a private party, through a writ petition!
Cipla appealed this order almost instantaneously and the Division Bench which delivered its order on the 12th of October, 2012 makes it clear that the interim arrangement suggested by the Single Judge appeared to be only an interim one till the next date of hearing. The implied suggestion being that Cipla was free to market the drug after the 15th of October unless of course the Single Judge extended his initial arrangement. had this to say about the decision of the Single Judge: “In the absence of any prayer for direction to the appellant herein not to take any steps for marketing its drugs, the learned Single Judge should not have granted such an order.” The case has been remanded to the Single Judge, who on the 15th of October, 2012 adjourned the case to the 6th of December, 2012.
Hi Prashant,
ReplyDeleteI would request you read the order of the Division Bench again. The paragraph (paragraph 4) you have quoted is not the operative part of the order and is rather a submission made by Cipla.
Prashant, correct me if I am wrong, but don't the principles of administrative law require reliance of material against a party for the breach of principles of natural justice to occur.
ReplyDeleteHi Prashant!
ReplyDeleteIt seems that you have completely misunderstood the order of the Division Bench dated 12th of October, 2012. Upon reading this order it is quite clear that the lines - “In the absence of any prayer for direction to the appellant herein not to take any steps for marketing its drugs, the learned Single Judge should not have granted such an order.” (in para 4 of the order) are not the observation of the Judges but the argument made by Cipla. Same is evident from the wording of para 4 which starts with the line – “This order is questioned on the ground that…………….”.
It is also clear from the order itself that paras 1 to 4 merely state the facts and not the observation of the Judges. The observation of the Judges start only from para 6 which start with the line - “We have considered the above submissions”. Based on the observation as given in paras 6 - 8 it seems that the Judges have not found any merit in the Appeal and therefore dismissed the Appeal.
What is even more utterly baffling is the fact that the Delhi High Court then proceeded to restrain Cipla from releasing its generic drug in the market – this in a writ proceeding against the order of the Controller! Effectively an interim injunction against a private party, through a writ petition!
ReplyDeleteHi Prashant,
ReplyDeletePlease correct me if I am wrong but the comment on the single judge's order seems to be the submissions made by the Appellant and are not the observations of the DB.
In fact the DB in a way upheld the interim arrangement and dismissed the appeal, finding no merit therein.
Regards,
Archana
Hi Anons and Archana,
ReplyDeleteYes, you are right, the two lines that I quoted are most probably from the submissions of Cipla but the Court does seem to be very clear that this restraining order is valid only till the 15th of October and no further. Unless of course the Single Judge renewed that order and from what I hear the Single Judge has not renewed that order. This means that Cipla can sell its drug - am I right in the narration of these facts?
Prashant
Before writing on such sensitive matters, my sincere advice would be to check and double check the facts before reporting and commenting. Spicyip being followed by a majority of people, it is your responsibility to give the correct facts if not all the facts.
ReplyDeleteFYI, interim order continues and in view thereof, Cipla is restrained from marketing Sutent.
Hi Prashant, it will depend on why the matter was adjourned and if the interim orders were continued. It is quite typical for interim arrangements to continue till an effective hearing is held.
ReplyDeleteHi Anon (10:14)
ReplyDeleteIf people like you are not even ready to leave comments under your real name, how do you expect me to get information about what is happening in Delhi.
If lawyers and companies aren't willing to talk, I'll base my blogging on second hand information.
Otherwise, you give me your contact details and I'll call you to confirm information before I put it up on the blog. How does that sound? I'm being serious here.
Prashant
ReplyDeleteAn expected reaction from you Prashant!! Your audacity to defend your writings amuses me no end.
How about considering to STOP blogging if you lack reading and comprehension skills (of simply reading the order) rather than misinforming the readers? How does THAT sound my friend? And i am serious too.
Anon @10:14
Dear Prashant
ReplyDeleteAs regards the report of Opposition Board,sometime back IPAB has also made their observations that before conducting hearing the copy of such report should be given to both parties.However I have a doubt about the same. If you read section 25(3)(b),opposition board is consituted for examination of documents submitted by both parties and to give recommendation thereon to the controller and on receipt of the same the controller shall hear the matter.Since it is a report to controller,the providing the copy of this report to the parties at this stage would probably paralyse the entire proccdings of post grant opposition since either party which is aggrieved by this recommendation at once would go to court at that stage itself against the report for redresal and consequently resulting in a situation where the controller would never be in a postion to finally decide the case on merit.Further it might also be possible that some court can issue some directions on the recommendation of opposition Board.Therefore it appears that unless the controller decides the casefinally this document does not become public. Can you through some light on it.Do not become totally against the Patent office .Pl think from this angle as well.
Prashant, if there is an issue with anonymous comments, then I'm sure one can remove that option. Often people can't openly comment owing to reasons which I'm sure you are aware of.
ReplyDeleteI'm sure you will agree that while freedom of press is important, it is equally important to report correctly. I hope that accurate reporting is an equally important aim of your blog. Sometimes inaccurate reporting can lead to sensationalism. That's usually the advantage I've seen with Spicyip over newspapers, since in the past Spicyip did not indulge in sensationalized reporting.
Anon
@ Anon (10:14 AM) - I'm sure you would love to see me stop blogging but tough luck, that's not happening any time soon.
ReplyDeleteAlso, I've made this point a thousand times earlier, you have no business giving me lectures when you don't have the guts to reveal your name.
Prashant
Dear Anon (1:19 PM),
ReplyDeleteThis is not about being for or against the patent office. This is a simple question of the law. Unlike the Examiner's report, the law does not deem the report of the Opposition Board to be a confidential document. Thus what is the legal basis for the Patent Office to not disclose this document? If you want to hold back a document from both parties, you have to identify a provision of law which allows the patent office to do so.
Prashant
@ Anon (1:36 PM): I don't quite understand your point. The moment the commentators pointed out that there was an error in the post, I acknowledged it and corrected the post. What else do you expect me to do?
ReplyDeleteAs for anonymous comments, as long as they are civil and make a point I have no issue but if these anonymous chaps (not you!) think they can take the moral high road under the veil of anonymity they are highly mistaken.
Prashant
The point is simple Prashant. Only requesting you to confirm the facts obtained from second hand sources through official sources like Court orders posted on the website. Court orders may be posted on the official websites a little while later, but they do save you the trouble of having this protracted discussion on the blog.
ReplyDeleteI am sure you do realize that in this polarized world (and particularly on the issue of pharma patenting), people have strong opinions and the comments on this post are a function of that.
Prashant, also please do not treat one's anonymity as one's weakness. I believe anonymous comments add as much value to your blog as named ones. The point is accurate reporting followed by intellectual discussions. The anonymity of the comment ought not to make a point of view any less worthy to read.
I also look forward to your views on the comments by Anon @1.19 and Anon @4.57.
Hi Anon (4:40 PM),
ReplyDeleteThe aim of the blog is to try and publish information as soon as possible. It is not always possible to wait for information to be posted on the Court's website. As for errors in the posts, we've generally been very open to people pointing out any errors. so that is an automatic correction mechanism.
As for anonymity - it cannot and should not be used as a guise for attacking and abusing us - if you want to attack and abuse, you can do so only after disclosing your name and your stake in the matter - Period!
Prashant
Dear Anons:
ReplyDeleteWe're all human. We all make mistakes. Prashant admitted this and rectified the error. Why don't we therefore end this discussion and move on to a more productive engagement with the issues at hand. Thank you very much.
Hi Prashant,
ReplyDeleteWhat is the correct time for a party in post - grant opposition proceedings to approach a writ Court regarding non - supply of the Opposition Board recommendations?
Is it not necessary for the Board recommendations to be relied on against a party in order for him to show that he is aggrieved by
"non - supply" thereof?