Continuing from our earlier post, yesterday’s hearing saw Cipla’s counsels continue arguments before an appellate bench consisting of Justice AP Shah and Justice S. Muralidhar. The key arguments advanced were:
1. That the patent in suit (covering Erlotinib) was invalid
2. That the patent, even if valid, was not infringed
The "public interest" and "pricing" argument was altogether avoided by Cipla’s counsels. It appears that they may have strategically decided to downplay the “public interest” argument. (Or perhaps they make take it up at the next hearing). Recall that in an earlier post, we noted that Justice Shah's query to Jaitley went unanswered:
"Interestingly, Judge Shah asked Jaitley point blank: if the Roche patent was finally held valid, could the court still deny an injunction to Roche on the ground that the patented price is higher than the generic version? In other words, ought the court to establish an automatic judicially created compulsory licensing ground? Jaitley cleverly ducked this issue, stating that he would address it later. Clearly, this will be a major point on which the appellate court ruling is likely to hinge."
I, for one, am a fan of such automatic compulsory licensing norms in the context of pharma patents (which some scholars prefer to label as "liability rules"). I think its high time that IP regimes such as ours experimented with such "liability rules". But whether the appellate court would necessarily endorse such norms remains to be seen. Particularly when there already allegedly exists a compulsory licensing authroty and a price control authority. I hope to explore this issue in further detail in an article that we are doing for EIPR titled "Roche vs Cipla: The "Price" of a Patent Injunction in India". I look forward to sharing a draft of this paper with our readers when this is done (hopefully in the next week or so).
Interestingly, Cipla’s counsel, Arun Jaitley was joined by S Majumdar of Majumdar and Co. Majumdar was the counsel for Natco in the pre-grant opposition before the patent office.
The patent invalidity argument ran along the same lines of what had been advanced before Justice Bhat.
i) That Erlotinib was “obvious” from an earlier patent covering a "known" substance, Gefatinib.
ii) That Erlotinib did not show any increased efficacy over and above Gefatinib. And therefore contravened section 3.d of the Indian Patents Act.
iii) That the patent office finding in favour of Roche (during the course of the pre grant oppn hearing) ought to be disregarded by the court. Counsels for Cipla advanced rather cogent and powerful arguments for why they thought the patent office ruling was suspect (on similar lines as that advanced in the trial court before Bhat J):
a. For one, the order in favour of Roche was passed by the patent office within a span of a mere 7 days, when the norm for most opposition decisions was 6 to 8 months.
b. Secondly, the date of grant of the patent in suit was unclear. As we noted in a previous post:
"Apparently, there was some problem with determining the exact date of the grant/issue of patent. The register of patents notes the date as 6th July 2007. However, the patent certificate states the date to be 23rd February 2007.
This date has direct relevance for determining the dates of the opposition proceedings. Natco filed an opposition on 10th April 2007. If the Feb 2007 date is taken to be the date of grant, then NATCO's opposition is a post-grant one. However, if the 6th July 2007 date is taken, then Natco's opposition qualifies as a "pre-grant" one.
c. Most importantly, perhaps, Cipla’s counsels argued vehemently that the controller merely addressed arguments on “novelty” and did not even consider arguments on non obviousness, when the case effectively hinged on non obviousness.
d. Counsels decried the ruling of the patent office on 3 (d) observation as garbled and totally incoherent.
While this attack by counsel on the patent office decision appears persuasive, this does not automatically mean that the court will conclude that the patent is invalid. Rather, defendants will have to independently demonstrate that this is the case, since the patent is a granted one and remains in force, till invalidated. However, given this persuasive attack, the court may not defer too much to the patent office determination that the patent was indeed valid.
On the issue of section 3(d), I’m not too sure which way the court is likely to hold. The key issue here is likely to be: Is Erlotinib a derivative of Gefatinib? As noted in a previous post:
"Now, in Roche vs CIPLA, the earlier known substance is Gefatinib. Roche then claims a structurally similar compound, Erlotinib. The question essentially is: is Erlotinib a derivative of Gefatinib? If it is a "derivative", then under the explanation to section 3(d), unless such
derivative demonstrates "a significant difference in property with regard to efficacy", it will be construed as the "same substance" as Gefatinib.
As a colleague of mine who wishes to remain anonymous and whom I deeply respect for his knowledge on both the Indian pharmaceutical industry and patent law writes and tells me:
"Structurally, they both have the common 4-quinazolinamine nucleus but the substitution patterns are quite different. They both are derivatives of 4-quinazolinamine, but are not really derivatives of each other (though it could be tenuously argued that any two compounds that have even the slightest of similarities could be interconverted.)
Such an argument could then be reduced ad absurdum to say that only one compound in any series of compounds having some structural similarity and acting by the same mechansim whould e patentable. That'll truly be absurd."
Non Infringement:
The non infringement argument is a rather interesting one and goes something like this:
The patent in suit (IN196774) effectively claims a combination of Polymorph A and B. However, Tarceva (and Cipla’s generic Erlocip) consists of only Polymorph B. Therefore, Erlocip which is an exact cophy of Tarceva does not infringe. From a brief perusal of the claims. I’m not entirely sure that the ’74 patent can be limited to a combination of polymorphs, as suggested by Cipla. Surprisingly during the course of arguments, the claims were never referred to even once.
The above non infringement argument had been seriously advanced before Justice Bhat as well, but he did not give it much weightage. As to whether an appellate court is likely to buy this argument remains to be seen. In relation to the hearings before the trial court (Bhat J), we noted in a previous post that:
"Most interestingly perhaps, Jaitley sprung a total surprise when he alleged that the patent in issue was very different than what was being argued in the case for more than 3 days!! To understand his argument better, let's go back to our previous post, where we listed particulars of the alleged patent under dispute:
1. Details of Roche patent involved in Litigation:
Granted patent: IN196774 ('774)
Grant Date: 23 Feb 2007 or 6 July 2007 (we're not sure)
Application Number: 537/DEL/1996
Corresponding US patent: US 5747498 ('498)
2. Second Patent Application for Erlotinib: A later patent application for Erlotinib was filed in India (IN/PCT/2002/00507/DEL). This corresponds with US patent 6900221 (the '221 patent).
Jaitley argued that CIPLA’s product implicates the latter patent by Roche (US patent '221) and not the patent in dispute (US patent '498 and Indian patent '774)!! Now if this is true, then there can be no "infringement", as the US patent '221 is still not issued in India. It is pending as Application No IN/PCT/2002/00507/DEL.
I am not entirely clear on the exact nature of arguments here, but perhaps we’ll have more light shed on this when we get the final ruling from the court. Till then, I remain as much intrigued by this as you….."
To get a sense of how tenable this argument is, we’ll wait to hear more from counsels on this at the next hearing.
If I were to bet on the outcome of this case….
The case is likely to hinge on two factors, namely:
i) Invalidity:
Whether or not the patent is invalid? If a clear and convincing case of invalidity is made out, then the appellate court will have to necessarily hold that Roche had not established the existence of a prima facie case. This is not a simple case of one piece of prior art that clearly anticipates the patent in suit. Rather, the validity of the patent in suit will hinge on complex issues of non obviousness.
Recall that Justice Bhat, though somewhat skeptical of the patent's validity had held in favour of Roche on the "prima facie" count. I’m therefore not entirely sure that the appellate court will disturb the findings of Bhat J in this regard. Particularly when the prima facie assessment is more of a factual assessment and an appellate court is likely to defer more to the trial court on this count (as opposed to a pure queston of law, on which a de novo review is possible). The appellate judges already seem to be quite perplexed with the range of technical issues thrown up; therefore, the likelihood of deferring to Bhat J on the prima facie count is a strong one.
ii) Pricing and Public Interest:
As mentioned earlier, counsels now seem to be downplaying the "public interest" part of Bhat J's judgment. I’m not entirely sure which way the court will go on this. Unless we have more arguments from counsels on the merits or otherwise of importing the public interest and pricing factor into India's injunction jurisprudence (Singhvi is likely resurrect this during this rebuttal), it is difficult to gauge which way the courts might turn on this.
The hearings were meant to resume today--but since one of the judges was not feeling well, they did not take up the matter. The matter will be heard again after a week on the 19th of September. (next Tuesday).
1. That the patent in suit (covering Erlotinib) was invalid
2. That the patent, even if valid, was not infringed
The "public interest" and "pricing" argument was altogether avoided by Cipla’s counsels. It appears that they may have strategically decided to downplay the “public interest” argument. (Or perhaps they make take it up at the next hearing). Recall that in an earlier post, we noted that Justice Shah's query to Jaitley went unanswered:
"Interestingly, Judge Shah asked Jaitley point blank: if the Roche patent was finally held valid, could the court still deny an injunction to Roche on the ground that the patented price is higher than the generic version? In other words, ought the court to establish an automatic judicially created compulsory licensing ground? Jaitley cleverly ducked this issue, stating that he would address it later. Clearly, this will be a major point on which the appellate court ruling is likely to hinge."
I, for one, am a fan of such automatic compulsory licensing norms in the context of pharma patents (which some scholars prefer to label as "liability rules"). I think its high time that IP regimes such as ours experimented with such "liability rules". But whether the appellate court would necessarily endorse such norms remains to be seen. Particularly when there already allegedly exists a compulsory licensing authroty and a price control authority. I hope to explore this issue in further detail in an article that we are doing for EIPR titled "Roche vs Cipla: The "Price" of a Patent Injunction in India". I look forward to sharing a draft of this paper with our readers when this is done (hopefully in the next week or so).
Interestingly, Cipla’s counsel, Arun Jaitley was joined by S Majumdar of Majumdar and Co. Majumdar was the counsel for Natco in the pre-grant opposition before the patent office.
The patent invalidity argument ran along the same lines of what had been advanced before Justice Bhat.
i) That Erlotinib was “obvious” from an earlier patent covering a "known" substance, Gefatinib.
ii) That Erlotinib did not show any increased efficacy over and above Gefatinib. And therefore contravened section 3.d of the Indian Patents Act.
iii) That the patent office finding in favour of Roche (during the course of the pre grant oppn hearing) ought to be disregarded by the court. Counsels for Cipla advanced rather cogent and powerful arguments for why they thought the patent office ruling was suspect (on similar lines as that advanced in the trial court before Bhat J):
a. For one, the order in favour of Roche was passed by the patent office within a span of a mere 7 days, when the norm for most opposition decisions was 6 to 8 months.
b. Secondly, the date of grant of the patent in suit was unclear. As we noted in a previous post:
"Apparently, there was some problem with determining the exact date of the grant/issue of patent. The register of patents notes the date as 6th July 2007. However, the patent certificate states the date to be 23rd February 2007.
This date has direct relevance for determining the dates of the opposition proceedings. Natco filed an opposition on 10th April 2007. If the Feb 2007 date is taken to be the date of grant, then NATCO's opposition is a post-grant one. However, if the 6th July 2007 date is taken, then Natco's opposition qualifies as a "pre-grant" one.
c. Most importantly, perhaps, Cipla’s counsels argued vehemently that the controller merely addressed arguments on “novelty” and did not even consider arguments on non obviousness, when the case effectively hinged on non obviousness.
d. Counsels decried the ruling of the patent office on 3 (d) observation as garbled and totally incoherent.
While this attack by counsel on the patent office decision appears persuasive, this does not automatically mean that the court will conclude that the patent is invalid. Rather, defendants will have to independently demonstrate that this is the case, since the patent is a granted one and remains in force, till invalidated. However, given this persuasive attack, the court may not defer too much to the patent office determination that the patent was indeed valid.
On the issue of section 3(d), I’m not too sure which way the court is likely to hold. The key issue here is likely to be: Is Erlotinib a derivative of Gefatinib? As noted in a previous post:
"Now, in Roche vs CIPLA, the earlier known substance is Gefatinib. Roche then claims a structurally similar compound, Erlotinib. The question essentially is: is Erlotinib a derivative of Gefatinib? If it is a "derivative", then under the explanation to section 3(d), unless such
derivative demonstrates "a significant difference in property with regard to efficacy", it will be construed as the "same substance" as Gefatinib.
As a colleague of mine who wishes to remain anonymous and whom I deeply respect for his knowledge on both the Indian pharmaceutical industry and patent law writes and tells me:
"Structurally, they both have the common 4-quinazolinamine nucleus but the substitution patterns are quite different. They both are derivatives of 4-quinazolinamine, but are not really derivatives of each other (though it could be tenuously argued that any two compounds that have even the slightest of similarities could be interconverted.)
Such an argument could then be reduced ad absurdum to say that only one compound in any series of compounds having some structural similarity and acting by the same mechansim whould e patentable. That'll truly be absurd."
Non Infringement:
The non infringement argument is a rather interesting one and goes something like this:
The patent in suit (IN196774) effectively claims a combination of Polymorph A and B. However, Tarceva (and Cipla’s generic Erlocip) consists of only Polymorph B. Therefore, Erlocip which is an exact cophy of Tarceva does not infringe. From a brief perusal of the claims. I’m not entirely sure that the ’74 patent can be limited to a combination of polymorphs, as suggested by Cipla. Surprisingly during the course of arguments, the claims were never referred to even once.
The above non infringement argument had been seriously advanced before Justice Bhat as well, but he did not give it much weightage. As to whether an appellate court is likely to buy this argument remains to be seen. In relation to the hearings before the trial court (Bhat J), we noted in a previous post that:
"Most interestingly perhaps, Jaitley sprung a total surprise when he alleged that the patent in issue was very different than what was being argued in the case for more than 3 days!! To understand his argument better, let's go back to our previous post, where we listed particulars of the alleged patent under dispute:
1. Details of Roche patent involved in Litigation:
Granted patent: IN196774 ('774)
Grant Date: 23 Feb 2007 or 6 July 2007 (we're not sure)
Application Number: 537/DEL/1996
Corresponding US patent: US 5747498 ('498)
2. Second Patent Application for Erlotinib: A later patent application for Erlotinib was filed in India (IN/PCT/2002/00507/DEL). This corresponds with US patent 6900221 (the '221 patent).
Jaitley argued that CIPLA’s product implicates the latter patent by Roche (US patent '221) and not the patent in dispute (US patent '498 and Indian patent '774)!! Now if this is true, then there can be no "infringement", as the US patent '221 is still not issued in India. It is pending as Application No IN/PCT/2002/00507/DEL.
I am not entirely clear on the exact nature of arguments here, but perhaps we’ll have more light shed on this when we get the final ruling from the court. Till then, I remain as much intrigued by this as you….."
To get a sense of how tenable this argument is, we’ll wait to hear more from counsels on this at the next hearing.
If I were to bet on the outcome of this case….
The case is likely to hinge on two factors, namely:
i) Invalidity:
Whether or not the patent is invalid? If a clear and convincing case of invalidity is made out, then the appellate court will have to necessarily hold that Roche had not established the existence of a prima facie case. This is not a simple case of one piece of prior art that clearly anticipates the patent in suit. Rather, the validity of the patent in suit will hinge on complex issues of non obviousness.
Recall that Justice Bhat, though somewhat skeptical of the patent's validity had held in favour of Roche on the "prima facie" count. I’m therefore not entirely sure that the appellate court will disturb the findings of Bhat J in this regard. Particularly when the prima facie assessment is more of a factual assessment and an appellate court is likely to defer more to the trial court on this count (as opposed to a pure queston of law, on which a de novo review is possible). The appellate judges already seem to be quite perplexed with the range of technical issues thrown up; therefore, the likelihood of deferring to Bhat J on the prima facie count is a strong one.
ii) Pricing and Public Interest:
As mentioned earlier, counsels now seem to be downplaying the "public interest" part of Bhat J's judgment. I’m not entirely sure which way the court will go on this. Unless we have more arguments from counsels on the merits or otherwise of importing the public interest and pricing factor into India's injunction jurisprudence (Singhvi is likely resurrect this during this rebuttal), it is difficult to gauge which way the courts might turn on this.
The hearings were meant to resume today--but since one of the judges was not feeling well, they did not take up the matter. The matter will be heard again after a week on the 19th of September. (next Tuesday).
Shamnad,
ReplyDeleteIs it possible that since the public access/ affordability aspect has been hammered/ advertised in the media, Cipla wants to not talk too much on the same in Courts?
That way, they get more time to argue that Erlotinib is only a derivative of Geftinib.. possibly try to 'educate' the Judge[s] more...
So to really appreciate your argument, let me take the case of Manu Sharma (accused of killing Jessica Lal) represented by leading criminal lawyer, Ram Jethmalani:
ReplyDeleteSince Manu Sharma was "accused" by the media of the heinous crime, Ram Jethmalani should not bother arguing in court that he is innocent?
Dear Blogger
ReplyDeleteI have a question regarding date of patent of accused patent. As per your blog the date of patent in the register of patent is July 06, 2007 wherein the patent certificates states that the grant date is Feb 23, 2007. I have one more question if you consult the official journal of 2007 the alleged patent has been published U/S 43(2) is July 13, 2007.
Please clarify this issue ? Inthat case you have one year from the date of this notification means July 13,2008 to file post grant opposition.
Shamnad,
ReplyDeleteYou are taking my comment the other way round.
What I should have said was that for Cipla, its strategically more sensible to 'educate' the Judge on the [non] patentability of the drug or its [non] infringement... since the public access part has been, in a sense, 'pre-argued' by the media.
Possibly, [more likely] that Cipla does not have a clear answer on the Judge's query of injunction in case of a granted patent and hence they do not want to talk on public access as a point in favour of no injunction?
i think they will argue it in the end. it would be interesting if the Judge asked them to justify their products price.
ReplyDeletebut the court should hear public interest as a separate argument and not one argued under balance of convenience.
i think they will argue it in the end. it would be interesting if the Judge asked them to justify their products price.
ReplyDeletebut the court should hear public interest as a separate argument and not one argued under balance of convenience.
@Anon re: public interest argument: MOre than the media coverage, as you rightly hint at the end, it may be more of a strategic effort to avoid answering the "de facto" compulsory licensing regime question. Personally I am a fan of such a regime. But the question is: should the court do this or should parliament amend statute to attain this result (i.e knock off the 3 year rule in section 84 and have section 11A automatic license apply across the board and not just to stuff that was manufactured pre '95).
ReplyDeleteGauging from the reaction of the appellate court so far, the court may have problems expressly endorsing such a proposition (de facto CL regime) and becoming a parallel authority ihn this regard to the CL authorities and the price control authorities.
@anon: I think your point about public interest being read as a separate leg is an interesting one. no case has expressly stated it as a separate factor till date. I guess since Bhat was already rocking the boat in terms of denying an injunction in terms of pricing, he may have wanted to hew as close as possible to existing jurisprudence and may have therefore fitted this in within the balance of convenience limb.
ReplyDeleteSorry for repeating my comment in two consecutive posts..I wasn't sure if it got noticed in the last post.abt what u said..eBay laid down four factors for interim injuction and public interest is the fourth. Balance of convenience is based on balance of hardships that would be suffered by each party in case of grant or refusal of an interim injunction.american cynamide,also referred to by J.Bhat,explains BOC in detail.If the Judge had analysed the four separately or the plaintiffs counsel cd have had - prima facie case,irreparable injury and balance of convenience- argued in their favour in addition to CIPLA's statements in the press disregrading d patent..it might have helped this appeal!
ReplyDeleteBest regards
Dear fellow anonymous,
ReplyDeleteSection 43 is confusing for sure as regards what dates have significance. If u read 43(1) and (2) the order is - patent is granted, patent is entered in the register and publication of the fact that patent is granted. Hence, Feb 23,July 6 and July 13. Nw the problem is date of grant is significant only to the patentee since it is only after this date that he can institute an infringement action. But for purposes of the public to be able to file a post grant opposition, the date of publication in the journal is significant. Don't know why we need the date on which the patent is entered into the register OR what significance does it have.
Sir, would like to know if u agree with me.
Best regards
it makes me so sad to see a discussion come to a halt!
ReplyDelete