Roche Vs CIPLA: The Rhetoric of Patent Busting: Monday, April 21, 2008
Roche Vs CIPLA: The Rhetoric of Patent Busting: Monday, April 21, 2008
Roche Vs CIPLA: The Rhetoric of Patent Busting: Monday, April 21, 2008
Roche, a multinational pharma company and CIPLA, a generic manufacturer from India. CIPLA brazenly
defied Roche's patent over an anticancer drug, Tarceva and went ahead and introduced a generic version at 1/3rd
the price. It claimed that the patent ought not have been granted in the first place. CIPLA's counsel, Arun Jaitley
argued very persuasively in court that Roche's drug did not meet the requirements of section 3(d), a unique
section introduced into India's patent regime in 2005 to prevent a phenomenon widely known as "evergreening".
Under section 3(d), derivatives of existing pharmaceutical substances would not merit patent protection, unless
such derivative was more "efficacious" than the earlier existing pharma substance. The section was challenged
by Novartis as being violative of TRIPS and of the Indian constitution
CIPLA also stressed that since the price differential between the patented drug and the generic version sold by
CIPLA was extremely high, "public interest" demanded that no injunction be granted in favour of Roche. In a
remarkably sophisticated and well researched judgment, Justice S Ravindra Bhat of the Delhi High Court ruled
in favour of CIPLA.
The matter is now under appeal. Unless Roche is able to demonstrate empirically that CIPLA's lower prices for
Tarceva (the lung cancer drug in issue) does not really translate to increased access to poor patients, it is
difficult to see how Justice Bhat's order will be overturned in appeal.
The verdict on one of the most keenly watched patent litigations was finally out last month. In a carefully
nuanced and remarkably well-researched judgment, Justice S. Ravindra Bhat of the Delhi High Court refused to
injunct Cipla from selling generic versions of a patented anti-cancer drug belonging to Roche. The judgment has
received mixed reviews, while innovative pharmaceutical companies see this as “patent busting” of the worst
order, public health activists are ecstatic at this clear preference for patients over patents.
The judgment appears to strike the right balance between private patent rights and public health imperatives.
First, Cipla’s drug, Erlocib was being sold at one-third the price of Roche’s patented anti-cancer drug, Tarceva.
Second, Roche was not manufacturing the drug in India, but importing it — causing the judge to worry about
the prospects of long term supplies from a multinational corporation operating within India.
Third, Cipla raised very serious doubts about the validity of the patent.
Fourth, Roche’s attorneys were ill prepared and committed a number of lapses. Besides this, as the judge he
points out in his judgment — they failed to raise the issue of “irreparable hardship”, a critical component of the
three step injunction test in India.
The crux of his judgment is: At this “interim” stage, one cannot conclusively determine whether or not Roche’s
patent is valid. In the light of this uncertainty, the critical factor for consideration is “public interest” — whether
or not the grant of an injunction will cause “irreparable hardship” to critically ill lung cancer patients, who may
not be able to afford Roche’s monopoly prices. And if the court finally finds in favour of Roche that the patent
is a valid one, then Cipla can be made to compensate Roche for all the losses up to that stage. To this extent, the
court asked Cipla to maintain a clear account of moneys made from the sales of its drugs.
To conclude, one is not certain at this stage if the Roche patent over Tarceva is a valid one or not. Prior to a final
decision on this count, deploying adjectives such as “patent busting” or “patent breaking” to describe the Delhi
High Court order smacks of ignorance. If at all anything has been “busted”, it is the notion that patents are
sacrosanct monopolies that cannot be derogated from. Most patent scholars today readily agree that patents are
nothing more than a statutorily granted right by the state in exchange for the useful disclosure of scientific
information. As with other statutory rights, they can be derogated from, when “public interest” so demands.
Sophisticated patent policy requires a careful balancing of innovation imperatives through patents against other
competing and perhaps more important interests, such as the right to health. And it is this delicate balance that
Justice Bhat strives for and achieves in his judgment — a judgment that will no doubt go down in the annals of
history as representing a milestone in Indian patent jurisprudence."
Patents vs. Patients: Cipla’s victory and the evolution of new “Compulsory Licensing” Norms
In a major victory for public health advocates the world over, Justice Ravinder Bhat of the Delhi High Court
recently ruled that CIPLA could continue producing generic versions of Roche’s patented anticancer drug,
Tarceva (Erlotinib). Ignoring Roche’s statutorily granted right and ruling unequivocally in favour of the rights
of cancer patients to access cheap medications, this could be India’s most path breaking patent decision till date.
The key issue before the court was whether or not the patentee, Roche was entitled to a temporary injunction
restraining CIPLA from selling its version of Erlotinib, under the brand Erlocip.
Echoing the findings in an old British case, American Cyanamid Co vs Ethicon Ltd, the court held that a
temporary injunction would issue in favour of Roche, only if it proved the following:
i) That it had a prima facie case
ii) That the “balance of convenience” was in its favour
iii) That it would suffer “irreparable injury”, if CIPLA was not injuncted
On the first condition, the court held that Roche had demonstrated the existent of a prima facie case of
infringement, since it held a valid patent that was infringed by CIPLA. However, the court also noted that
CIPLA had raised a plausible doubt that the patent was invalid, as it was “obvious” and it did not comply with
section 3(d)—a unique section introduced in India’s patent regime to weed out frivolous pharmaceutical patents.
Owing to the fact that this was only an interlocutory petition, the court did not delve too deep into the merits of
this contention.
The court then looked to the second factor, namely “balance of convenience”. In other words, would the non-
grant of an injunction inconvenience Roche more or would its grant inconvenience CIPLA (and the patients)
more? Closely related to this analysis is whether or not Roche would suffer irreparable hardship if it did not
obtain the injunction.
The court held that Roche would not suffer irreparable hardship from the non grant of an injunction. If Roche’s
patent was to be found to be valid at the final stage, it could easily be compensated at that stage for all the losses
accruing to it from the non-grant of a temporary injunction. To this extent, the court asked CIPLA to maintain
accounts of sales etc.
In supporting CIPLA and holding against Roche, the court revealed a clear preference for patients over patents.
It noted in pertinent part that CIPLA’s drug was 3 times cheaper than the Roche version. From this, the court
concluded that more patients would be able access the CIPLA version, Erlocib.
Importantly, the court was also very concerned with the fact that Roche was not manufacturing the drug in
India. Perhaps the pre 1970 position, where India was literally at the mercy of MNC’s (which more or less
controlled drug supplies) might have played out in the mind of the judge.
In what must surely be music to the ears of patients and public health activists, the court elevated the right of a
patient to access cheap drugs as a fundamental right to health under Article 21 of the Constitution.
Another major implication of the courts judgment is the introduction of new compulsory licensing norms. Thus
far, we’ve known of only “statutorily” created compulsory norms in Chapter VII of the Patents Act. This
chapter contains a number of provisions whereby a patentee could be forced by an applicant to license his/her
invention on reasonable royalty terms.
Unfortunately, most grounds for compulsory licensing under this chapter kick in only after 3 years have elapsed
since the date of grant of patent. For a drug like Tarceva patented only in 2007, CIPLA would have to wait till
2010 before approaching the patent office for a license. Under the Delhi High courts ruling however, CIPLA
could cleverly achieve what the statute states without waiting for the 3 year period. All it has to do is to
introduce generic versions of a patented drug and then wait to be sued!!
Although this is only a temporary ruling and we still await the final decision (after trial), the logic of Justice
Bhat could be transposed to a final decision on the merits. In other words, if the patented drug is priced more
than the generic (which is almost always the case) and is not manufactured in India (about 90% of MNC drugs
qualify under this), the patentee will not be entitled to an injunction. Rather, damages will be taken as sufficient
compensation for the losses to the patentee from infringement by a generic which sells its own cheap version of
the generic.
In short, the Delhi High Court has effectively created another stream of “judge made” compulsory licensing.
And to this extent, India has once again shown that it will strike a different chord from the rest of the world and
evolve new “patient” friendly patent norms, when the situation so demands.
Supreme Court bench ordered that the ongoing trial at the Delhi High Court be expedited.
The Indian Supreme Court dismissed the special leave petition filed by Roche on a generic version of its
erlotinib (Tarceva) from Cipla, challenging the order passed by a the division bench of the Delhi High Court in
April 2009.
The key reason for dismissing Roche’s special leave petition appears to be that the final trial in generic erlotinib
case is also underway. Retired judge SM Chopra is appointed as a court commissioner to hear evidence in the
patent infringement dispute. Supreme Court’s intervention in this dispute at this point of time could only further
delay the final trial.
While dismissing Roche’s appeal, the two-judge — Justice Dalvir Bhandari and Justice MK Sharma —
Supreme Court bench ordered that the ongoing trial at the Delhi High Court be expedited. They also stated that
nothing in the Delhi Division bench order would bind the trial court judge, who is expected to decide the case on
final merits.
Erlotinib or Tarceva, a lung cancer drug originally invented by Swiss pharma firm Hoffman La Roche Ltd, was
granted a patent in India in September 2007.
Despite this, Cipla Ltd of Mumbai launched a generic version of erlotinib branded Erlocip last year.
While launching the drug, Cipla was quoted as saying that they intended to launch their own version of the drug
at a lesser price – Rs 1,600 ($41) a tablet. Roche’ selling price was Rs 4,800 ($122) per a Tarceva tablet.
Following this, Roche sued Cipla for patent infringement in the Delhi High Court and applied for a temporary
injunction. During hearings, Cipla maintained that the patent was invalid and should be revoked. Cipla claimed
that erlotinib (Tarceva) is a derivative of an earlier substance called gefatinib, and therefore should not have
been granted a patent, unless increased efficacy can be proved.
The trial judge refused to grant an interim injunction on the ground that since Cipla was selling the drug at 1/3rd
of the price of Roche, an injunction would mean impeding affordable access for a large number of cancer
patients in India. Therefore, “public interest” demanded that no injunction (restraining order) be granted.
However, a High Court bench vacated its interim order by which Cipla was restrained from exporting the drug
to other countries in which La Roche has patent rights.
The Delhi High Court dismissed the plea of the Swiss company saying that the Indian company should be
restrained from manufacturing and selling the generic drug till the issue of patent rights was decided through
litigation.
The Swiss company had approached the Division Bench of the High Court after a single Bench had dismissed
its plea to restrain Cipla.
The Court also imposed a cost of Rs five lakh (US $ 10,000) on Roche.
The litigation concerned Indian patent number 196774, which was issued against a mailbox application dated
March 1996. In March 1999 the Indian government amended its patent law to allow companies to file mailbox
pharmaceutical patent applications prior to the launch of India’s product patent regime. The law applied
retrospectively from January 1 1995 and the Patent Office began to examine them in 2005, after the law was
changed to allow product patents to be issued for pharmaceuticals.
India’s patent law allows companies to oppose patents both before and after grant. Natco, another Indian drug
maker, filed an unsuccessful pre-grant opposition against Roche’s application for erlotinib.
Another Swiss drug maker Novartis AG also challenged the contentious Section 3(d) of India’s Patent Act, last
year, Section 3(d) restricts what can be patented. In particular, the section states that salts and other derivatives
of known substances “shall be considered to be the same substance, unless they differ significantly in properties
with regard to efficacy”.
Heated arguments between Arun Jaitley (representing CIPLA) and Abhishek Singhvi (representing Roche)
yesterday. The key issue was the validity of the patent. Jaitley cited a number of case law etc to establish that
since this is a new patent, the validity attack should be taken seriously. He also argued that the Indian Patent Act
does not grant a presumption of validity.
Jaitley was more persuasive and it could well be that his advocacy skills could see CIPLA win. However,
CIPLA's initially flawed strategy of going to press and openly declaring that they will infringe may swing the
matter in favour of Roche. CIPLA never bothered to participate in the pre-grant opposition or file a post grant
opposition challenging the patent---and yet goes ahead and develops a product based on Roche's molecule and
gains regulatory approval. This fact may again tilt the case in favour of Roche.
Perhaps the judge may temporarily injunct CIPLA and stay the proceedings till such time as the post grant
opposition mechanism is pursued and exhausted.
These are two separate issues and it is important that we keep them distinct. If Roche's patent is an otherwise
valid one (it meets all the patentability criteria under the Indian patent regime), one cannot simply knock it off
on the ground that the patent is used to charge high prices.
Patents are not ‘bad’ per se, as most of these statements make them out to be. Rather, as with most other things
in life, they are susceptible to abuse. In this regard, it is important to strike a distinction between the grant of a
patent and the regulation of its ‘use’. Assuming that the Novartis patent issues, there are plenty of built-in
safeguards in India’s patent regime to ensure that the prices remain in check.
To elaborate further:
At the grant stage, one merely looks to whether or not the claimed invention is a good one to protect via patents
i.e. whether it is a technical advancement of some sort that furthers the cause of science and technology in some
way. The patent may then issue and the patentee may either use the patent in a good way or can abuse it (by
charging excessive prices etc).
If the patentee abuses the patent right by charging excessively, then there are various mechanisms within the
Indian Patent Act itself that can be deployed to address the situation. Notably, there is a compulsory licensing
provision that clearly states that a CL will issue if the patented product is sold at an unreasonably high price.
Lastly, Roche itself may voluntarily bring down the prices or have differential pricing schemes to have drugs at
cheaper prices to those with lower income levels.
In short, the key issue is whether or not, Roche's Erlotinib is a valid patent under the Indian Patent Act i.e. is it
"new", "non obvious", useful and does it demonstrate increased efficacy over and above an earlier known
substance. If it is valid, then we ought to respect it and CIPLA ought to be injuncted. If the patentee (Roche)
uses the patent to charge high prices for its drug (Tarceva), then the price controller should step in and ask them
to reduce prices.
Application: 537/DEL/1996
US expiry: 30/Mar/2015
A later patent application for Erlotinib was filed in India (IN/PCT/2002/00507/DEL). This corresponds with US
patent 6900221 (the '221 patent).
In a ruling that could encourage more generic, or off-patent, drug makers here to challenge patents held my
multinational pharma firms, the Delhi high court dismissed a patent infringement suit filed by Swiss pharma
company Hoffman-La Roche Ltd for its lung cancer drug Tarceva (generic erlotinib), thereby allowing Indian
drug maker Cipla Ltd to continue marketing the generic version of the drug.
A bench of the court, headed by chief justice A.P. Shah, also imposed a cost of Rs5 lakh on Roche for
suppressing material facts and not making full disclosure to the court.
“The court has dismissed the appeal with a Rs5 lakh cost,” said Cipla’s counsel Pratibha Singh.
However, Cipla said that Roche may appeal in the Supreme Court (SC)..
Another lawyer familiar with the case, who did not want to be identified, told Mint that the court has come to the
conclusion that there is “serious doubt on the validity of Roche’s patent. In view that it is in public interest, we
don’t grant this injunction”.
Cipla had launched its generic version of Tarceva, ‘Erlocip’, in December 2007 at a price of Rs1,600 per tablet.
The Roche price in the Indian market is Rs4,800 per tablet. However Tarceva “costs Rs3,200 and that’s because
they only give out the drug through their company distributor outlets. They have not sold a single strip for
Rs4,500 or Rs4,800 as being quoted in the media. Moreover, the Rs3,200 tag includes 32% customs duty. If you
remove this duty and then look at the cost, it is only 15% more than that of the generic version”.
In January 2008, Roche filed an infringement suit in the Delhi high court and asked for an injunction that would
prevent Cipla from selling Erlocip. Cipla submitted to the court that no injunction should be granted till its post-
grant opposition filed in the Delhi patent office was heard and decided upon.
The high court decided the matter on 19 March 2008 in favour of Cipla.
However, Roche re-appealed to a division bench comprising chief justice Shah and justice S. Muralidhar, which
completed hearing the case on 15 September.
The validity of Roche’s patent itself would now appear to be in doubt, said Basheer.
In view of the existence of gefatinib, an earlier known molecule, the court appears to suggest that erlotinib,
Roche’s patented molecule, may not be inventive. Secondly, there is a serious doubt about whether or not Cipla
infringes the Roche patent at all. Since the court ruled that Roche had not even established a prima facie case, it
did not have to go into detail into other factors, such as the pricing of the drug and the public interest factor,
something that the trial judge, justice S. Ravindra Bhat had based his judgement on,” he added.
Roche had filed for two patents in India, one for gefatinib (polymorph A+B) and another for erlotinib
(polymorph B). In its patent for erlotinib, it had said that gefatinib had an ingredient that was unstable for tablet
form. The patent office had granted it a patent for gefatinib.
the court is conscious that the defendant (Cipla) has been able to demonstrate prima facie that the plaintiffs
(Roche) do not hold a patent yet for Tarceva, which is the polymorph B form of the substance for which they
hold a patent. Secondly, the defendant has raised a credible challenge to the validity of the patent held by the
plaintiffs. In such circumstances, the public interest in greater public access to a life-saving drug will have to
outweigh the public interest in granting an injunction to the patent holder.
A public health lawyer, who has been following the case, closely welcomed the decision. “This judgement will
play a key role in the future in similar cases. Its legal precedence is of great importance in the pharmaceutical
sector. The most important part of this judgement is that you cannot grant injunctions against the marketing of
generics because it effects patients.
Story so far
12 April 2008 Roche appeals against copycat versions of patented cancer drug
20 March 2008 Cipla gets HC breather to sell copycat version of Roche drug
09 February 2008 Roche-Cipla row test case for balancing health issues, patents
This was yet another momentous day in the big ticket Roche vs Cipla litigation. Abhishek Manu Singhvi,
counsel for Roche (along with Parag Tripathi) closed arguments on behalf of Roche. And immediately
thereafter, Arun Jaitley opened arguments on behalf of Cipla.
In the first instance, a single judge of the Delhi High Court, Justice S Ravindra Bhat denied an injunction to
Roche in relation to its anticancer drug "Tarceva" and permitted Cipla to continue manufacturing generic
versions. Thereafter an appeal was filed by Cipla before a division bench of the Delhi High Court, consisting of
the Chief Justice, AP Shah and Justice S Muralidhar.
Roche Arguments:
Roche’s counsels (Abhishek Manu Singhvi, assisted by Parag Tripathi) closed their arguments after good 5-6
hearings. And it was believed the last hearing went on for a good 5 hours. Their main thrust seemed to be that
“public interest” and “pricing” ought to not form part of India’s injunction jurisprudence. Particularly since the
Patents Act already provided for extensive compulsory licensing provisions. Therefore, Singhvi contended that
the court should not operate as a defacto compulsory licensing authority.
The "public interest" and "pricing" logic of Justice Bhat could be transposed to the final stage, --i.e. even if the
patent were held valid, a judge could deny an injunction to Roche since its drug was more expensive than
Cipla's. Since in most pharma patent cases, this would always be the case, no patentee would ever get an
injunction. In short, such a ruling would amount to a de facto judge made automatic compulsory licensing rule.
Roche's counsels also argued that Justice Bhat ought not to have second-guessed the patent office ruling in
favour of Roche. Particularly when the patent office possesses more expertise to assess technical issues when
compared with Justice Bhat, who was merely examining the matter at a peripheral “interim” level.
In other words, although it was seemed suitably impressed by the validity attack by Cipla's counsel, he was
careful enough to ensure that this did not impact his finding that Roche had established the existence of a “prima
facie” case in its favour. As we noted earlier in several posts, the traditional three step test for the grant of a
temporary injunction demands that the plaintiff demonstrate that:
While Justice Bhat held in favour of Roche on the first ground (prima facie case), held against them on the other
two. And most controversially perhaps, he imported "public interest" as a factor to be considered while
assessing the third ground, namely "balance of convenience".
By holding in favour of Roche on the first ground, Justice Bhat appeared to suggest that he was wary of second
guessing a more thorough assessment of “validity” by the patent office. Had he second guessed the patent office
and held against the existence of a “prima facie” case, his ruling might have come under attack.
Cipla Arguments:
Jaitley attempted to rebut most of the arguments advanced by Singhvi and team. In short, some of the arguments
that he raised were as below:
1. He reiterated his argument before the lower court that there is no statutory presumption of validity in favour
of a patent (unlike the trademarks act, which presumes a registered trademark to be valid). One wonders as to
what effect this argument would have at the appellate level, given that the trial court had already held in favour
of a "prima facie' case, despite casting aspersions on the validity of the patent. Given that an appellate court only
reviews questions of law de novo, it is doubtful if it will overturn Bhat's ruling that a prima facie case had been
established. In fact, if anythying at all, Justice Shah seemed to be concerned that Justice Bhat had even ventured
to cast aspersions on the patent office (oppn) ruling, without the benefit of more evidence and hearing on the
point.
2. Jaitley appeared to suggest that there were two Roche patents in issue here. While the first patent was a
granted one, the second one was merely a pending application. And that Cipla's product, Erlocip merely
implicated the second patent application. Since the second application was still pending and not yet granted,
there could be no "infringement". From the facts of the case, I doubt very much if this argument is likely to fly.
In the lower court, Bhat J does not seem to have given much weightage to this argument. In fact, if this
argument were a strong one and a finding of "non infringement" were likely, Justice Bhat would not have found
in favour of a "prima facie" case at all.
3. In reply to Singhvi's contention that there was already a compulsory licensing scheme to address pricing and
public health issues, Jaitley argued that such a scheme would come into effect only 3 years after the date of the
grant of a patent. While this is true in the case of section 84 (which is a ground to be invoked by private parties
such as Cipla), it is not true in the case of Cl grounds invocable by the government (there is no minimum time
period for this).
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.
5. Jaitley also pointed to section 92A of the Indian patents act as endorsing public health concerns. And
mentioned that "epidemic" as used in this section would include even "cancer" .Jaitley will continue his
arguments on Monday.
Conclusion:
At the appellate stage, the case will likely hinge on whether or not pricing and public interest can be part of the
“interim injunction” calculus. And whether or not "judge made compulsory licensing norms" can form part of
Indian patent jurisprudence. We'll bring you more updates as this case proceeds.
Cipla to sell copycat version of Roche drug
Cipla claims it will launch a version of a lung cancer drug at one-third the price that its licence holder, Roche
Scientific Co. (India) Ltd, sells it for in India
In a legally risky move, India’s second largest drug maker by sales, Cipla Ltd, which started a new drug
markets a few years ago by offering generic versions at one-tenth of prevailing branded drug prices, is adopting
a similar business strategy in India for cancer.
Cipla claims it will launch a version of a cancer drug at one-third the price that its licence holder, Roche
Scientific Co. (India) Ltd, sells it for in India.
Roche has an India patent on the drug, called Tarceva, and the drug whose chemical name is erlotinib, was
jointly invented by Pfizer Inc. and OSI Pharmaceuticals Inc. It was licensed to F Hoffmann-La Roche Ltd,
which launched Tarceva in India in 2006, after securing a product patent here.
Roche sells Tarceva for about Rs4, 800 per tablet, to be taken once a day. It usually means Rs1.4 lakh for a
month’s treatment in India.
The generic version of the drug at about Rs1,600 in the domestic market and will be export it to other markets at
an affordable price as claimed by the Cipla executive.
Roche got a patent for Tarceva overcoming a pre-grant opposition petition from Hyderabad-based cancer
speciality company Natco Pharma Ltd.
According to a report by the Indian Council of Medical Research, at least 90,000 men and 79,000 women are
diagnosed each year in India with cancer of the lungs and bronchitis. Bhopal has the highest incidence of lung
cancer at 14.5 per 100,000 men, followed by Mumbai at 14.3 and Delhi at 13.2.
Tarceva’s clinical trial data shows that it has demonstrated a striking survival benefit (42.5%) in advanced non-
small cell lung cancer, the most common form of the disease.
The drug was approved in the US in 2004 and a year later in the European Union.
Case result
An appeal was filed by F. Hoffmann-La Roche Ltd. and OSI Pharmaceuticals Inc. against the earlier judgment
of the learned Single Judge of the High Court of Delhi wherein their prayer for the grant of an interim injunction
to restrain Cipla Ltd. from manufacturing, offering for sale, selling and exporting the drug Erlotinib was
declined. The impugned judgment had however directed Cipla to maintain accounts of sale and file in Court
every quarter accounts so as to assess damages accruing to Roche in the event of the suit being decreed.
Roche in the plaint filed in the suit of 2008, had stated that its co-plaintiff OSI jointly owned a patent with Pfizer
Products Inc. in respect of a drug molecule, claimed to be a major breakthrough and innovation in the treatment
of cancer. According to Roche, the drug has depicted an increase in the survival benefit and is administered in
the form of a tablet under the trademark and commercial name of 'Tarceva' which is registered in the name of
Roche. The drug formulation was also claimed to have acquired approval from the USFDA (United States Food
& Drug Administration). OSI along with Pfizer had moved to the Controller General of Patents, New Delhi who
granted them a patent in respect of the drug. Subsequently, Roche entered into development collaboration and
licensing agreement with OSI whereby Roche was granted licence to use and sell and offer for sale the licensed
products of the former including Erlotinib. Roche was further licensed and authorized to cause enforcement of
any infringement of property rights of any of the products of OSI. Roche claimed to have introduced Tarceva in
India around April 2006 with wide publicity by the media owing to its importance in cancer treatment.
It was further stated that Cipla Ltd. launched the generic version of Tarceva (Erlotinib) in India, around January,
2008 and through news daily learnt of Cipla's plans to infringe and violate their rights. Roche claimed that
Tarceva had been developed after enormous investment in R &D and that owing to legal rights in the same
Cipla could not violate their rights vested therein. The suit was said to have been valued at Rs. 20 Lakhs and
damages were tentatively valued at Rs. 1 Crore.
Cipla in response had filed a counter-claim along with a prayer for the revocation of the patent granted to
Roche. They averred Roche' patent to be "completely invalid". Section 3(d) of the Patent Act was brought to
light and the drug in question was said to be a derivative of a known patent "Quinazoline", and the two
displaying the exact chemical structure as found except for one substitution which is "obvious to any person
skilled in the art". Cipla also claimed that Roche had failed to prove "any improved efficacy of the said drug"
and that no invention or inventive step in the patent could be attributed.
Bringing to fore the pre-conditions for a recently granted patent claim to be protected was that it ought to be
"worked fully and commercially". It was pointed out that though Roche acquired approval to import and sell the
drug in December 2005, yet as on date the product was neither easily available nor affordable due to its high
pricing. Cipla in its written statement had also pleaded the ground of public interest, in view of Roche' drug
Tarceva costing Rs.4, 800/- per tablet while Cipla's Erlocip was priced at Rs.1, 600/-; the latter being cheaper
and more affordable.
Cipla in its counter-claim filed contended Section 2 (1) of the Patents Act 1970, defining the expression
'pharmaceutical substance' as "any new entity involving one or more inventive steps" and under Section 2 (1) (l)
describing a "new invention". They stated that a special scrutiny in the light of these provisions was called for.
Further, Cipla averred that relevant data to portray enhanced activity over the closest compound of the prior art
had not been adduced as also data to demonstrate the claimed compound had a higher therapeutic efficacy.
A reference was made to U.S.'221 which clearly stated that the compound Erlotinib Hydrochloride was a
mixture of two polymorphs A&B and that one needed to separate and purify the B polymorph so as to get to the
claimed compound for acceptable efficacy. It was stated that subsequent patent clearly defeated the inventive
step of the alleged invention.
Cipla had filed an application before the learned Single Judge seeking dismissal of the suit. Cipla had also
discovered that Roche had made two further applications for grant of patent in respect of the same chemical
compound for a different crystal form which was termed by Roche as B polymorph. The Single Judge on taking
due consideration of all factors ruled in favour of Cipla and denied an injunction to Roche, giving due
importance to pricing and the public interest factor.
This court while admitting the appeal did not stay the operation of the impugned judgment. However, it
restrained Cipla from exporting Erlocip to countries where Roche had a patent during the pendency of the
appeal.
While addressing the appeal, one of the significant issues posed by Cipla, which had a bearing upon whether
Roche having made out a prima facie case for grant of injunction, is that the specification for the suit patent
showed that it was in respect of Erlotinib Hydrochloride Polymorphs A+B which was on their own showing an
unstable form which could not be administered as such. It was contended that the case of Roche was that it was
Polymorph B which was the more stable form of the compound which could be administered in the tablet form.
The x-ray diffraction pattern of the tablet Tarceva showed that it corresponded to Polymorph B for which the
plaintiff of Polymorphs A and B. Roche averred that a separate application for grant of patent in respect of
Polymorph B had been made. As regards non-mention of these facts before the learned Single Judge they
submitted that the application for Polymorph B was independent of the patent validly granted to the plaintiffs in
respect of Polymorphs A and B.s did not yet hold a patent. Roche' application for the grant of patent for
Polymorph B was pending consideration. It was further submitted that even a prima facie case was made out by
Roche since they were seeking an injunction against Cipla in respect of a drug for which they did not yet hold a
patent. This fact had not been revealed by Roche before the Controller of Patents as well as in the suit.
The Court opined that ground was sufficient to refuse an injunction. Further it was averred that Polymorph B
form of Erlotinib Hydrochloride (marketed as Tarceva) was not known to Roche at the time they applied for a
patent for Erlotinib Hydrochloride as a combination of Polymorphs A and B. Therefore it was averred that
Polymorph B could not be said to be subsumed in the compound of a combination
Roche had clarified in a letter to the Controller of Patents that while in the U.S.A "it is perfectly possible and
routinely done to patent incremental inventions e.g. Polymorph B of the main compound in addition to the
main/dominating/umbrella compound", in India this is possible only subject to the conditions specified in
Section 3 (d) of the Patents Act 1970 being satisfied. They also asserted that Polymorph B was
thermodynamically more stable and provide improved oral dosage.
The Court opined that from Roche' own showing it would not have been possible for the Controller to have
granted a patent in their favour both in respect of Polymorphs A+B as well as Polymorph B. The Court noted
that in the light of Section 3 (d) demonstration of enhanced efficacy of the product. Although it was urged by the
plaintiffs that stability of a product is not the same thing as its efficacy, it would have to be demonstrated by the
Plaintiffs, particularly in light of their statements in the application for grant of a patent in respect of Polymorph
B that a compound of Polymorphs A and B (and not A alone or B alone) could be orally administered as a drug.
The Court opined that it was impossible to imagine that the therapeutic efficacy of a pharmaceutical product
could be tested without it even being able to be administered to a sample population. Further, they noted that it
was for the Controller to consider the application for the grant of the suit patent, for which he would have had to
address the issue whether it was the combination of Polymorphs A and B or Polymorph B alone which satisfied
all the patentability tests vis-à-vis Section 3 (d).
The Court noted that the failure of Roche to bring the relevant facts to the notice of the Controller of Patents at
the time of consideration of the application for patent for the compound of a combination of Polymorphs A and
B was inconsistent with the requirement of a full disclosure. Considering the effect of nondisclosure by Roche,
they stated that a sufficient ground had been made out to hold that Roche in fact failed to demonstrate before the
learned Single Judge and even before this Court that notwithstanding the pending applications in respect of
Polymorph B which wholly corresponded to the tablet Tarceva, they had a prima facie case.
The Court noted that when Roche proceeded to file their suit, they were fully aware of the fact that Polymorph B
was the more stable form of Erlotinib Hydrochloride and that the tablet form, was more suited to its marketing.
The Court expressed that they were intrigued that Roche chose not to be candid in making a full disclosure in
view of the facts in its plaint.
Cipla founded its argument in the proviso to Section 11 A (7) of the Patents Act 1970. As an off shoot, they
averred that Roche had admittedly not commercially exploited the patent granted in their favour for a compound
which is a mixture of Polymorphs A and B, since the tablet form corresponds to Polymorph B of the said
compound Erlotinib Hydrochloride. The Court was also of the view that Cipla in this regard had raised a serious
doubt whether Roche in fact held a patent for the product sold in the tablet form as Tarceva. In this regard, the
establishment of a prima facie case to favour the grant of an order restraining Cipla from marketing Erlocip was
said to have been defeated.
The Court further noted the facts of the application in respect of Polymorph B which had been rejected by the
Controller of Patents and the ruling there under was noted, however refrained from commenting on the Order.
The order of the Controller was stated to have no bearing upon the failure of Roche to make out a prima facie
case before the learned Single Judge. In this respect the Court stated that they ought to have been refused an
interim injunction.
The Principles governing the grant of an injunction in an infringement suit were also looked into in view of the
facts of the case, submissions made and precedents cited. The Court opined that at the present stage of
considering the grant of an interim injunction, Cipla has to show that the patent that has been granted is
vulnerable to challenge. Consequently, this Court rejects the contentions of the plaintiffs on this issue and
affirms the impugned judgment of the learned Single Judge.
The discussion on the validity of the patent was concluded by concurring with the Single Judge that, assuming
that Roche held a patent for the product which was the subject matter of the suit for infringement, Cipla raised a
credible challenge to the validity of the patent by raising a serious triable and substantial question that renders it
vulnerable to challenge.
Revisiting the Public Interest argument, the Bench opined that the issues of public interest and pricing were not
relevant in the context of patent law and that public interest was significant in protecting a validly granted
patent. Roche had contended that if the rights of a patentee are not respected then it would be contrary to the
public interest of encouraging further research. They also contended that generics having relatively low research
and development costs, hence its pricing was lower. However, taking note of the fact that Roche imported the
life-saving drugs into India and did not manufacture the same in the country, noted that the demand was fulfilled
by relying on an international transport system. The Court noted that in the event of a grant of interim injunction
the manufacturing and marketing network established by Cipla would get dismantled. In the event of the drug
being unavailable in the required quantity in India, would prove disastrous for the patients.
In consideration of the factors alluded, the appeal was dismissed with costs quantified at Rs. 5 Lakhs to be paid
by Roche to Cipla within a period of four weeks.