In a decision that is likely to impact the pharma stock market (albeit slightly), the Bombay High Court restrained Cipla from using the mark "Valcept" or any mark that was confusingly similar to Roche's trademark "Valcyte". Roche sued Cipla in September this year alleging both patent infringement and trademark infringement, in respect of an anti infective, "Valgancyclovir", sold as "Valcyte" by Cipla and 'Valcept" by Cipla.
Read the stories here at the Mint, DNA, Business Standard and Economic Times.
It is to be noted that this is not a final order but only a temporary injunction. In other words, it is quite possible that after a full fledged trial, the court may find that “Valcept” does not infringe trademark rights over “Valcyte”. Further, Cipla has been given 3 weeks to comply with this ruling. It is very likely that it will appeal this order to the Supreme Court during that window. In an earlier post, I had noted, that given the trend of pharma trademark cases in India, Cipla is likely to prevail. Clearly, I was wrong! (unless the Supreme Court (or the final trial) ends up vindicating my stand).
In any case, the trademark issue, though significant, is not likely to damage Cipla severely. At worst, Cipla has to rebrand all the drugs that were stocked up and ready to roll. I'm given to understand that the Bombay High Court order does not in any way impact the drugs that have already been distributed/sold by Cipla (but I could be wrong--and if any of you have information to the contrary, plase let me know).
This being the case, the trademark issue and its impact on either party is not half as important as the patent issue, where the stakes are much higher. A ruling against Cipla on this count could translate to colossal losses, as it cannot then merely rebrand the drug, but has to stop selling it altogether.
The Bombay High Court however, skirted the "patent" issue, by adjourning the case for eight weeks. This "skirting" may have stemmed from the recent Madras High Court order setting aside Roche's patent covering Valcyte on grounds of procedural irregularity. The court directed the patent office to grant a hearing to the "pre-grant" opposers, consider the matter afresh in the light of such hearings and take a call on whether or not the patent ought to be granted. And all this has to be done prior to Jan 31st 2009. In particular, the court chided the assistant controller, (Madhusudhanan?) who blatantly disregarded the request to be heard by the pre-grant opposers (patients groups, represented by Lawyers Collective) and directed that the matter be heard and considered afresh by another Controller.
The Mint reports that this order of the Madras High Court has now been challenged by Roche through an SLP (special leave petition) filed before the Supreme Court of India. The Bombay High Court may have therefore thought it prudent to wait for an outcome in this regard before ruling on the patent law suit filed against Cipla.
Rather than skirting the "patent" issue, ought the Bombay High Court to have dismissed the patent suit on the ground that, in view of the Madras High Court ruling, there is no valid patent in force? To answer this issue, consider two potential outcomes:
(i) After the pre-grant opposers have been heard by the patent office, the office finds that there is merit in their contention that the patent application is not "new" or "inventive" and decided to not grant the patent.
(ii) Despite the "hearing", the patent office reaffirms its earlier decision to grant the patent to Roche.
Outcome (i) is non problematic, in so far as the Bombay High Court is concerned. There is no "patent" cause of action in favour of Roche.
However, assuming that the patent office decides to grant the patent (outcome (ii)), Roche is likely to bring a case again before the Bombay High Court (or another court) praying that Cipla be injuncted. Rather than wasting resources and time etc through a second filing, the Bombay High court might have thought it far more optimal to stay the proceedings (an "adjournment "here has the same effect as a "stay"), till such time as the pre-grant opposition is resolved at the patent office.
Some press reports, most notably the Times of India have wrongly used the term "revocation" to describe the "setting aside" of the patent office order granting the patent in favour of Roche. “Revocation” is a term that normally connotes the cancellation of a granted patent once and for all. In the Valcyte case, the court has only set aside the initial grant (owing to a procedural irregularity) and asked the patent office to hear the “opposing” party and consider the application in the light of this hearing. In other words, if the patent office, after a hearing, concludes that the patent ought to be granted, it may do so. Contrast this with a traditional understanding of “revocation”, under which the patent is struck off once and for all.
On another note, readers may recollect Prashant's interesting post critiquing the Madras High Court ruling. While his analysis is rigorous, I beg to differ with him on a few issues and will post on this separately. As some of you may have guessed, my dissent with his analysis stems primarily from an overzealous (and perhaps misplaced) desire to induct more transparency into the patent grant system. Therefore, I view the Madras High Court decision as an extremely useful and potent precedent that pushes the patent office and the patent grant process towards greater openness and transparency.
Read the stories here at the Mint, DNA, Business Standard and Economic Times.
It is to be noted that this is not a final order but only a temporary injunction. In other words, it is quite possible that after a full fledged trial, the court may find that “Valcept” does not infringe trademark rights over “Valcyte”. Further, Cipla has been given 3 weeks to comply with this ruling. It is very likely that it will appeal this order to the Supreme Court during that window. In an earlier post, I had noted, that given the trend of pharma trademark cases in India, Cipla is likely to prevail. Clearly, I was wrong! (unless the Supreme Court (or the final trial) ends up vindicating my stand).
In any case, the trademark issue, though significant, is not likely to damage Cipla severely. At worst, Cipla has to rebrand all the drugs that were stocked up and ready to roll. I'm given to understand that the Bombay High Court order does not in any way impact the drugs that have already been distributed/sold by Cipla (but I could be wrong--and if any of you have information to the contrary, plase let me know).
This being the case, the trademark issue and its impact on either party is not half as important as the patent issue, where the stakes are much higher. A ruling against Cipla on this count could translate to colossal losses, as it cannot then merely rebrand the drug, but has to stop selling it altogether.
The Bombay High Court however, skirted the "patent" issue, by adjourning the case for eight weeks. This "skirting" may have stemmed from the recent Madras High Court order setting aside Roche's patent covering Valcyte on grounds of procedural irregularity. The court directed the patent office to grant a hearing to the "pre-grant" opposers, consider the matter afresh in the light of such hearings and take a call on whether or not the patent ought to be granted. And all this has to be done prior to Jan 31st 2009. In particular, the court chided the assistant controller, (Madhusudhanan?) who blatantly disregarded the request to be heard by the pre-grant opposers (patients groups, represented by Lawyers Collective) and directed that the matter be heard and considered afresh by another Controller.
The Mint reports that this order of the Madras High Court has now been challenged by Roche through an SLP (special leave petition) filed before the Supreme Court of India. The Bombay High Court may have therefore thought it prudent to wait for an outcome in this regard before ruling on the patent law suit filed against Cipla.
Rather than skirting the "patent" issue, ought the Bombay High Court to have dismissed the patent suit on the ground that, in view of the Madras High Court ruling, there is no valid patent in force? To answer this issue, consider two potential outcomes:
(i) After the pre-grant opposers have been heard by the patent office, the office finds that there is merit in their contention that the patent application is not "new" or "inventive" and decided to not grant the patent.
(ii) Despite the "hearing", the patent office reaffirms its earlier decision to grant the patent to Roche.
Outcome (i) is non problematic, in so far as the Bombay High Court is concerned. There is no "patent" cause of action in favour of Roche.
However, assuming that the patent office decides to grant the patent (outcome (ii)), Roche is likely to bring a case again before the Bombay High Court (or another court) praying that Cipla be injuncted. Rather than wasting resources and time etc through a second filing, the Bombay High court might have thought it far more optimal to stay the proceedings (an "adjournment "here has the same effect as a "stay"), till such time as the pre-grant opposition is resolved at the patent office.
Some press reports, most notably the Times of India have wrongly used the term "revocation" to describe the "setting aside" of the patent office order granting the patent in favour of Roche. “Revocation” is a term that normally connotes the cancellation of a granted patent once and for all. In the Valcyte case, the court has only set aside the initial grant (owing to a procedural irregularity) and asked the patent office to hear the “opposing” party and consider the application in the light of this hearing. In other words, if the patent office, after a hearing, concludes that the patent ought to be granted, it may do so. Contrast this with a traditional understanding of “revocation”, under which the patent is struck off once and for all.
On another note, readers may recollect Prashant's interesting post critiquing the Madras High Court ruling. While his analysis is rigorous, I beg to differ with him on a few issues and will post on this separately. As some of you may have guessed, my dissent with his analysis stems primarily from an overzealous (and perhaps misplaced) desire to induct more transparency into the patent grant system. Therefore, I view the Madras High Court decision as an extremely useful and potent precedent that pushes the patent office and the patent grant process towards greater openness and transparency.
SB,
ReplyDeleteI think you gave clear views in your interview with one of the newspapers'.
But what got my goat was the ET article... the reporter completely missed the TM angle and was mixing it up with the patent angle...
In any case, if I remember correctly, this wont be the first time that an Indian company has been hit with a TM injunction for a marketed product... a few years ago, Ajanta faced similar order for its version of Lilly's Cialis.
I think Ajanta too had a very similar mark [for the same active drug] and Lilly could at least get a TM order...
But as you mentioned, this may not impact Cipla too much... they have ways and means to change the brand :-)
Regards,
Frequently Anon.
Dear FA,
ReplyDeleteYou're absolutely right. Quite clearly,we're failing in our mission to make our press a little more "IP" aware. At the very least, the conflation between separate IP categories ought to stop!
A well wisher of SpicyIP and a reputed IP practitioner writes:
ReplyDelete"Hi - In your earlier post, you were of the view (and I quote)- "The term "Val" derives from the chemical name of the active ingredient, "Valgancyclovir". Since "Val" is not a proprietary term but one that is derived from a chemical name, the courts may hold that Cipla's "Valcept" does not infringe."
Although I am also unaware of the particular facts of the case, I wonder whether any fragment like just V, or Va or Val of an INN like Valgancicolovir (note - the chemical name is a longer scientific name, different from the international non proprietory name, and does not feature Val) can always and automatically also be considered non-proprietory.
What if Valcyte is a registered trademark and/or a mark-in-prior-use and Val (or V or Va as may be) is an essential feature (basic ideal etc.) of Valcyte? Some examples of valid trademarks include Imipram [not found to be a 'legal equivalent of' INN Imipramine], Cortrophin [not found to be 'descriptive of' Corticotrophin, being 'merely suggestive of' not being adequate] and Prantel [not a 'mere trivial modification of' (- draft Indian TM Manual) Pyrantel Pamoate].
To be non-proprietory, should not a prefix fragment like Val denote the concerned chemical substance - Valganciclovir or the pharmacological group of Valganciclovir viz. be 'publici juris therefor and generic thereof' ? Is this at all possible if Val is not an INN Stem [there is an INN Stem in Valganciclovir incidentally and that is vir]? Now, although Val is a prefix of 2 other INN's [Valaciclovir and Valomaciclovir] belonging to the same pharmacological group as Valganciclovir, is Val even potentially capable of denoting Valganciclovir or its pharmacological group (or being notified as an INN Stem therefor in the future) given that it is also already a prefix of several other INN's belonging to other diverse pharmacological groups such as - Valopicitabine, Valtorcitabine; Valategrast; Valconazole; Valdecoxib; Valrubicin; and Valsartan? For Val to be non-proprietary for Valganciclovir brands, should not Val "point unequivocally viz. only to" Valganciclovir or/and its pharmacological group? Even if there were not all these other INN's to which Val points, if at all, as much as to INN Valganciclovir; should not the test be whether in the relevant channel of the trade (prescribing doctors, chemists, patients, attendants etc.), Val is taken to denote Valganciclovir (for which these persons should be led by Val to make the connection with Valgancicolovir without their attention also being otherwise drawn to valganciclovir)? If so, should not the onus of proving this lie on Valcept (Cipla) as it would be Valcept that so asserts in its defence viz. that Val is "publici juris for/ generic of" Valganciclovir? If Valcept were able to show that Val is an INN Stem and is used thus in Valganciclovir, that might shift the onus of proof as would also perhaps strong evidence from Valcept of uncontested longstanding extensive and significant proliferation of Valganciclovir brands beginning with Val in the marketplace; but failing this would not the onus of proof by testimonials etc. be on Valcept to discharge to sustain its defence?
Needless to say, I have no idea how much of this is "in" the High Court's order or even in the cases advanced by the parties before the High Court. But since the High Court has granted an injunction, it will be interesting to see how it has proceeded in the matter. "
My response to the well wisher:
ReplyDeleteYou’re right about the fact that we may need to look at this from the perspective of INN and stems as well.
However, the fact that a trademark is based on the root of a “generic”/INN is sufficient for a court to conclude that there cannot be any monopoly on the portion of the name so taken. Why should it matter that the portion taken qualifies separately as a “stem”?
In other words, even if not a stem, the fact that the brand has drawn from the first bit of an INN ought to be sufficient for a court to deny protection to that portion used alone—unless of course, that portion has acquired substantial distinctiveness through long periods of use.
I think the trickier issue is not so much whether or not an abbreviated part of an INN is capable of trademark protection by itself, but whether the addenda (portion added such as “cyte”) can confer trademarkability. And what ought to be the standards of judging infringement when it is this addenda that is changed by the alleged infringer. I.e “cyte” vs “cept”. (Note that “cyte” may be derived from “Cytomegalovirus” (CMV retinus) as well.)
Here as to whether or not the words are confusingly similar ought to be judged in terms of the words themselves (phonetics etc) and in terms of the customers that buy them. I’m not entirely sure which way the judges are likely to go in terms of determining whether or not “Valcept” is visually/phonetically similar to “Valcyte” and I suspect judges would lean toward holding them to be “similar”. However, I’m not entirely sure that they would hold them to be “confusingly similar”. These are prescription and very high end drugs—and customers are typically educated doctors, who are more sensitive to the various innovator vs generic differences, particularly in the light of the high price differential. Would they be confused in this case? I think not—but mine is at best an intuition. Lets see what kind of evidence crops up in court during trial. Also, see Badar Durez J’s judgment in Schering vs Alkem:
“Comparing the plaintiffs' trademark 'TEMODAL' and 'TEMODAR' with the defendant's trademark 'TEMOKEM', it is apparent that the marks are not identical. There is also no phonetic or visual similarity between the marks. I have already noted above that the term 'TEMO' cannot be exclusively used by the plaintiffs in view of the fact that it is publici Jurisdiction being a clipped abbreviation of the generic word Temozolomide. There is no doubt in my mind, at this prima facie stage, that the suffix 'KEM' is entirely different and distinct from the suffixes 'DAL' and 'DAR' of the plaintiffs' trademarks. There is also no doubt that there is no phonetic or visual similarity between the defendant's mark and the plaintiffs' marks taken as a whole as would be prone to deceive consumers. It is also relevant to point out that Temozolomide is a Schedule 'H' drug which can only be sold in retail on the prescription of a registered medical practioner. While this condition is not by itself sufficient to establish a case of 'no deception', it is an important factor particularly when the pharmaceutical product is a highly specialized drug and is used for the specific treatment of a type of brain cancer. The warning indicated in the packaging of the defendant is also relevant. The warning reads:
To be supplied against demand from cancer hospitals, institutions and against the prescription of a cancer specialist only.
It is obvious that the defendant's product is not an off-the-shelf product which any person can go and purchase. The product is to be supplied only against demand from cancer hospitals / institutions and that too against the prescription of a cancer specialist only. This warning greatly reduces the possibility of deception. The cancer specialist would be aware of the therapeutic values of the defendant's product as also of the plaintiffs' products. Apart from this, a significant consideration is the vast difference in the prices of the products. It has already been noted above that the plaintiffs' products are approximately six times more expensive than the defendant's product. When the difference in the price structure is so vast, the likelihood of deception is virtually nil.”
Lets continue the debate.