India: Roche Cipla Appeal: Upheld In Favour Of Cipla

Last Updated: 12 May 2009

An appeal was filed by F. Hoffmann-La Roche Ltd. (`Roche') and OSI Pharmaceuticals Inc. (`OSI') against the earlier judgment of the learned Single Judge of the High Court of Delhi (dismissing I.A. No. 642/2008 in suit CS (OS) No.89/2008) 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 (duly authenticated by CAs including tax returns) so as to assess damages accruing to Roche in the event of the suit being decreed.

Roche in the plaint filed in the suit CS (OS) No. 89 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 a 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) (ta) 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 under O VII R 11 CPC 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 (i.e. patent No.196774 corresponding to U.S.'498) 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 n 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

In the absence of this issue having been raised before the Single Judge, the present Court took note of the same. They noted that by the time the Ld. Single Judge took up for consideration I.A. No. 642/2008 filed by Roche seeking the ad interim injunction, Cipla had proceeded to file I.A. No. 1272/2008 under Order 7 Rule 11 CPC. Cipla at both fora raised the plea that the suit patent pertained to Polymorph A + B whereas Tarceva was Polymorph B. The Court noted that the plea concerning Polymorph B was noticed by the learned single Judge in the passing, but had no occasion to consider whether this was a relevant factor for determining if Roche had made out a prima facie case for grant of injunction in their favour.

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 (and their statements in the corresponding patent U.S.'221) 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 germane or 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.

© Lex Orbis 2009

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

 
In association with
Related Topics
 
Related Articles
 
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions