CIPLA WON THE LANDMARK ROCHE V CIPLA LITIGATION

Indian Generic manufacturer Cipla has won the landmark Roche v. Cipla Patent Infringement case in the Delhi High Court over Ciplas Generic version of Anti-cancer Drug Erlotinib. The case is the first Patent Litigation in India post Indias 2005 Product Patent Regime which included public interest and pricing issues in addition to Indias Section 3d that prevents evergreening. The case was followed by Pharma Giants worldwide. Justice Manmohan Singh has passed the judgement in favour of Cipla stating that Cipla did not infringe Roches Indian patent IN 196774. According to the Judge, it was scientifically proven that Ciplas Generic Drug is the Polymorphic Form B which is not Roches patented Drug. The complete judgement is not yet available. Roche sued Cipla in 2008 before Delhi High Court claiming that Ciplas generic product Erlocip violates formers Indian 774 patent claiming Erlotinib Hydrocloride. The trial Judge rejected Roches appeal to grant interim injunction restraining Cipla from selling generic version of Tarceva on the grounds of public interest and the fact that there was an ongoing patent revocation proceedings against 774 patent. Ciplas generic version costs about 1/3rd of Roches patented drug. Roches subsequent appeal to Division Bench also failed when not only did the bench uphold the findings of Trial Judge but also imposed costs on Roche for suppression of material patent information about Roches later filed application in India (IN/PCT/2002/00507/DEL). This was the Patent Application which was actually on Polymorph Form B of Erlotinib Hydrocloride but was rejected in 2008 following the opposition filed by Cipla primarily on Section 3d. Cipla argued that Tarceva corresponds to Polymorphic Form B (which is not a product of 774 patent but a 507 rejected application) and that it is Form B which is more stable and suitable for solid oral dosage form than the compound disclosed in 774 patent comprising a mixture of Forms A and B. Roches subsequent appeal before the Supreme Court (SC) challenging the order passed by the division bench got dismissed due to the ongoing trial at the Delhi High Court.

TATA CHEMICALS WINS PATENT REVOCATION BATTLE AGAINST HULS WATER PURIFIER PATENT BEFORE IPAB
In a recent order, dated 12 June, 2012 (available over here), the Intellectual Property Appellate Board (IPAB), acting on a petition filed by Tata Chemicals, has revoked Indian Patent No. 195937 granted to Hindustan Unilever Ltd. (HUL) on the 26th of August, 2005 for the invention of a filter cartridge that is used in HULs Pureit brand of waterfiltration devices.

While Tata Chemicals was represented Senior Advocate P.S. Raman who was briefed by Essenese Obhan, Managing Partner of the promising young patent law firm Obhan & Associates; HUL was represented by veteran patent litigator - S. Majumdar of Majumdar & Co. The judgment, penned by Justice Prabha Sridevan, is very interesting and covers somenew ground with respect to disclosure requirements under Section 8 of the Patents Act, 1970 and also the role of expert witnesses in Indian patent litigation. For those of you curious about the face behind Mints excellent reporting on IP, please do click here to view a video of C. H. Unnikrishnan explaining the significance of the IPABs decision. A. The invention Patent No. 195937: The claimed invention is constructed in such a manner that it forces the water introduced in it to climb in an upward direction through the filter media before exiting the invention as a purified water. The claimed advantage of such a mechanism was an increased rate of flow of water through the filter cartridge when compared to traditional water filters which forced water through the filter cartridge in a downward mechanism. The reason for this increased rate of flow of water was because water moving in an upward direction does not face the problems of airlocks and channelling of water which are common problems faced by water moving in a downward direction through a filter media. Of course, this is an over-simplified version of the actual patent specification and although the claimed invention may seem simple, the IPAB makes it very clear that simplicity was not its main ground for revoking the patent.

B. The anticipation & obviousness challenge: Tata Chemicals challenged the patent as being anticipated and lacking an inventive step when compared to prior art. The IPAB examines the prior art in considerable detail and appears to have found several prior art documents anticipating and rendering obvious the present invention.

In one such instance the IPAB states It is not the simplicity of the invention that makes us hold it is not patentable It is not patentable because it is not new as seen from US 260, and it is obvious as seen from US 402 which provides for the vertical upward flow through the absorbent cartridge which was also addressed to remove the tendency of water to flow in channels leaving portion of absorbent untouched because air remains in the cartridge. The problems of air bubbles, channelling and non-uniform flow are all mentioned here. We are unable to see either novelty or inventive step in the invention.

C. Section 8 challenge: Section 8 of the Patents Act, 1970 requires Indian patent applicants to disclose all details of corresponding foreign patent applications. While the Section 8 argument has been used previously in context of patent prosecution in foreign countries, the issue that cropped up in this present case was whether Section 8 could be extended to patent prosecutions before international non-governmental organizations under international treaties the context in the present case being the International Preliminary Examination Report (IPER) issued by WIPO under the PCT.

The HUL patent application had been issued an extremely adverse IPER by WIPO and the same had not been disclosed before the Indian Patent Office. The most significant piece of prior art cited in the IPER, was reportedly an EP-1106578. Coincidentally this same EP patent was also cited by the Indian Patent Office during its examination and HUL managed to overcome the objections. HUL therefore argued that the nondisclosure of the IPER was inconsequential, since the prior art cited in the report, was duly considered by the Indian Patent Office. The IPAB however considered the suppression vital enough to constitute a separate ground for revocation of the patent. In pertinent part the IPAB states, after a detailed discussion into Section 8,

106. The respondent cannot be heard to say that since European Patent No.1106578, the prior art was anyway considered by the Controller and no prejudice was caused by not disclosing the ISR or IPER. It is not enough that the Examiner knew that this prior art was there, the respondent ought to have disclosed the results of the IPER. The IPER rejected the claims 1 to 3 on both the grounds of novelty and inventive step. It is not for us to conjecture what effect this might have had on the examiner here if he had the benefit of the IPER. This is the object and purpose of enacting Section 8. The Report says that this information would be of great use for a proper examination of the application. It is no answer to say anyway the office looked at EP578. The Patent Office did not see the IPER. The learned counsel for the respondent submitted that this lapse is of a de-minimis nature, we do not think that honestly furnishing the information or particulars allows a de-minimis qualification.

Moral of the story: Start filing your IPERs and ISRs with the Indian Patent Office.

D. The role of expert witnesses: This judgment is probably one of the first to discuss the roles of expert witnesses in a patent revocation petition. Some of the important observations are as follows:

(i) An expert is a witness of fact and his evidence is in the nature of an advice. It is not his opinion but the reasoning with which he supports his opinion, that is the principal contribution of the expert;

(ii) We find as a rule the experts called upon by the parties before us file affidavits. These affidavits are naturally drafted by the respective advocates. So they read almost like the statement of case or counter statement depending on who has called the witness. Instead it may be better to just get their opinion in the form of an affidavit. This opinion will deal with the prior art, the common general knowledge, this invention and why the expert is of the opinion that it is anticipated or not, it is obvious or not. Even when the affidavit has to counter the opinion of the other side expert, it is better merely to say that the expert disagrees with the opinion and for what reason.

Posted by Prashant Reddy at 11:34 PM

Labels: Indian patent litigation, Patent, Patent act

8 comments:

Anonymous said...

It is very nice of you to have covered this case. My personal opinion is that IPAB is wrong with respect to its judgment on Sec. 8 more particularly when the said prior art was in any case considered by the Indian Patent Office. In this connection it may be pointed out that recently we had meting with CG who was informed about the unnecessary requirement of filing of certain documents which are in any was available on the website of WIPO with respect to the PCT applications, then why are we required to file the copies in Indian Patent office and that too in duplicate. The CG has now issued PUBLIC NOTICE on filing of PCT National Phase Applications in India being CGI Public Notice1P0/2012/15 Dated:02.07 .20 12. The relevant portion is as follows:

Indian Patent Office (lPO) continuously endeavors to improve its efficiency so

as to render better services to the public. In an effort to simplify the process of filing of a PCT National Phase Application, the IPO has, in coordination with the International Bureau (lB) of the World Intellectual Property Organization (WIPO), acquired online access to the PCT International Applications and related documents available with the lB. The benefits of this coordination will be passed on to the stakeholders as redundant processes will be eliminated. An Applicant will no more be required to file multiple copies of documents already available with lB, as IPO will be able to utilize such documents accessed electronically from lB. This would also result in more efficient usage of the valuable resources of IPO and reduce errors in data entry, thereby obviating the need for corrections in many cases.

I se no reason for the applicant to file a document which is available in the website of WIPO. Had the Indian Patent Office not considered the prior art citation, it was understandable, but not in the given circumstances as in the present case.

ENERCON PATENT LITIGATION

On a petition by Enercon (India) Ltd, the Intellectual Property Appellate Board (the Board) revoked twelve (12) out of the nineteen (19) patents registered by Enercon in India. Enercon was one of the first wind turbine manufacturers to develop the Indian market. The subsidiary Enercon (India) Ltd. (EIL) was set up at Mumbai in 1994 as a joint venture between Yogesh Mehra and the Enercon founder Dr. Aloys Wobben. The dispute over strategic differences in business strategy arising in 2005 led to conferring of general powers on Yogesh Mehra in 2007 by the EIL Board for all business activities. Apparently due to this development Enercon terminated the license agreement with EIL at the end of 2008 citing serious breaches of contract. Yogesh Mehra intensified the conflict in 2009 by having EIL initiate patent revocation proceedings before the IPAB in Chennai. In addition to the decision on revocation petitions, the litigation maze has in its fold a decision of Madras High Court and Delhi High Court.

Revocation The Board's decisions are important from the point of view of determination on some principal concepts of patent law, which till now were indistinct such as the standard of 'obviousness' or 'lack of inventive step' significant from the aspect of patent prosecution. Inventive Step - One of the grounds for revocation of a patent is that if the invention claimed through the claims in the complete specification is obvious or does not involve any inventive step having regard to what was publicly known or used in India OR what was published in India or elsewhere before the priority date of the claim (S 64(1)(f)). Under the Indian patent regime 'inventive step' means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art (S 2(1)(ja)). The Board on this core issue referred to Halsbury Laws of England to ascertain the test of 'inventive step'. The test is to ask the question that 'was it for practical purposes obvious to the skilled worker, in the field concerned, in the state of knowledge existing at the date of the patent to be found in the literature then available to him, that he should or would make the invention the subject of the claim concerned'. This may be reworded as would a non-inventive mind have thought of the alleged invention? If the answer is 'no' then the invention is non-obvious and patentable but then the test is incomplete without the determination of the state of existing knowledge or common general knowledge and the notional person skilled in the art, as both would give substratum to the test of inventive step thereby determining obviousness or lack of inventive step. Common General Knowledge - The Board's approach on the question - whether a common knowledge on the date of the patentee's claim would amount to anticipation by way of public knowledge affecting the inventive step - began with the understanding that the Common General Knowledge (CGK) is the background of technical knowledge or common knowledge available to all in a particular trade for further research by those engaged in the art. The Board thus concluded that CGK is the information, which at the date of the impugned patent is known and accepted without question by those who are engaged in the art to which the alleged invention relates. The Board also viewed that CGK on the subject may not be available or found in a prior document, but may be available in the country for a long time which every skilled worker in that field is expected to know and that such knowledge is sufficient to invalidate a patent. Person Skilled in the Art - The interconnected inquiry into who is the 'notional person skilled in the art' makes known that persons with practical knowledge and experience of the kind of work in which the invention is to be used, is the notional person skilled in the relevant art and such person reads the specification with the common general knowledge of the same. He is unimaginative and has no inventive capacity. The Board also, importantly, said that a 'notional person skilled in the art' is essentially a legal

construct and not a mere lowest common order of all the persons engaged in the art at a particular time. Obviousness - IPAB relied heavily on foreign precedents to judge the obviousness of the inventions in this patent dispute. It assessed obviousness as deducted in Windsurfing versus Tabur Marine and in Pozzoli versus BDMO. In the context of revocation of patent granted to Aloy Wobbens, the Board took the following steps: [1] "Who is the notional person skilled in the art in this field of wind power installation technology?" [2] "Identify the inventive concept of the claim in question" [3] "Identify, if any, the differences existing between the matters cited as forming state of the art and the inventive concept of the claim or the claim as construed". [4] "Ask whether, when viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?" In the face of cited foreign patents forming common general knowledge, the Board held that a person skilled in the art could arrive at the inventions as claimed in the claims of the impugned patents, hence the invention cannot be said to have any inventive step Thus the Board's analysis and the findings based on the assertion as above made clear of the lack of inventive step as claimed in the impugned patent and that the invention claimed is obvious to any skilled person in the art. Madras High Court Aloy Wobben (petitioner) invoked the writ jurisdiction of the Court for issuance of a writ of Certiorari (Judicial Review) quashing the orders passed by Intellectual Property Appellate Board (the Board) in petitioner's various miscellaneous petitions (MP) filed in all the Original Revocation Applications (ORA) by Enercon (India) Ltd (respondent). The Board had disposed all the MPs directing the registry to list the ORAs on a day-to-day basis. The miscellaneous petitions challenged the maintainability of the ORAs on the ground that the respondent lacks competence to file revocation petitions. The petitioner, relying on specific Articles from the Articles of Association had contended that the Board resolution does not authorize Yogesh Mehra to do so. Moreover, a proceeding before Company Law Board (CLB) alleging oppression and mismanagement is pending with an interim order by CLB to maintain status quo with respect to all issues. The respondent countered, stressing that Yogesh Mehra has been duly authorized to defend and institute suits and proceedings on behalf of the company and has the requisite locus standi to file and institute the revocation proceedings on behalf of the respondent. The Board finally disposed the MPs after a discussing the factual and legal position and

observing ways in which the matter could be disposed of. The Board finally decided to hear the revocation applications against which the petitioner went to High Court with a writ. The petitioner argued on the perversity of the Board's decision taking a three-pronged approach (1) the Board has mixed the concepts of locus standi and the person interested (2) No urgency to hear the respondent's ORAs when such applications filed in 2006 are still pending before the Board, and (3) The proceeding before CLB is separate and will not affect the Board's proceeding. Respondent's counter inter alia relied on apex court's decision in M/s Fomento Resorts and Hotels Ltd Vs Gustavo Ranato Da Cruz Pinto & Ors [1985 2 SCC 152] to contend that the question of locus standi could be discussed as one among the several issues when there is a possibility of appeal rather than disposing the case on only one issue. The Court upheld the decision the Board taking into account the cited Apex Court's decision and concluded, while dismissing the writ petition, that there is no ground for interference. The Intellectual Property Appellate Board while hearing the revocation petition took the Company's Board Resolution authorizing Yogesh Mehra to sign the pleadings fully empowered to do so. It declined to look into the validity, legality and propriety of the same citing absence of any judgment or an order of a competent court. Delhi High Court Dr. Aloy Wobben (Plaintiff) filed a suit complaining infringement of his patents by Yogesh Mehra (Defendant) and preferred an interlocutory application to restrain the defendant from pressing his application for revocation of plaintiff's patents [Dr Aloys Wobben Vs Shri Yogesh Mehra & Ors IA No. 12638/2010 in CS (OS) No 1963/2009; Delhi High Court]. The defendant sought cancellation of the patent as a counter-claim in the Written Statement to the Plaint besides already petitioning for revocation of the plaintiff's patent before Intellectual Property Appellate Board (IPAB). The plaintiff argued that the defendant's approach in pursuing parallel and concurrent remedies is in defiance of the Doctrine of Election as he has already availed his statutory right of invoking revocation of the patent before IPAB i.e. elected his remedy and cannot urge the same as a defence in the infringement suit. The plaintiff argued further that it is imperative to direct the defendant to either withdraw the revocation applications or not pursue them during the pendency of the suit as the proceeding before IPAB would unnecessarily hamper progress of the suit. To this, the defendant contended that directions of the nature as raised by the plaintiff is not within the purview of the jurisdiction of this Court and that the canon cannot oust statutory remedies which can only be waived consciously. The Court said that the patent law, in commensurate with the absence of presumption of validity, allows patents to be challenged at various stages. The cancellation or

revocation of patents under section 117G of the Patents Act is one such independent remedy to the Board. In addition, in the event of a suit, the defendant can, besides contending non-infringement, also counter claim and seek revocation under section 107. The Court reasoned the rejection of the application saying that the relief cannot be granted because the remedies though seemingly overlapping may not be necessarily availed simultaneously. For instance a third party sued for infringement may prefer an application before the Board for cancellation or revocation. If his application before the Board is held to be not maintainable, or alternatively, he is asked not to raise the ground of cancellation in his written statement, his defence would be seriously prejudiced and therefore it would be contrary to statute and also against public policy to hold that there cannot be a pursuance of an independent statutory remedy. Appeal against Revocation Dr Aloy Wobben (petitioner) appealed against patent revocation orders of the Intellectual Property Appellate Board at Madras High Court and Delhi High Court. The Delhi High Court was petitioned against three patent revocation orders of the Board by invoking the writ jurisdiction but later the petitioner sought to withdraw the writ petitions on issues of maintainability. The Court granted the petitioner's prayer to withdraw the writ petition with liberty to proceed in a court of competent jurisdiction but not without imposing heavy costs on account of valuable judicial time being wasted in hearing the matter. The appeal in Madras High Court is currently pending. In the past the Indian patent litigation scene was rife with pharmaceutical patent disputes over section 3(d) of the Act, however this patent dispute traversing forums does show considerably on the Indian patent law.

THE TARCEVA PATENT CASE (ROCHE VS CIPLA)

Roche vs. Cipla marks the end of the first phase of a key battle between big pharma and the Indian generic industry. The infringement action brought by Roche against Cipla and Cipla's counterclaim for Roche's patent invalidity was both dismissed. Roche was granted Indian Patent No. IN '774 in February 2007, under which per Claim 1, they had patent rights over the Erlotinib Hydrochloride (EH) molecule (which has demonstrated breakthrough capabilities as an Epidermal Growth Factor Receptor (EGFR) inhibitor which spiked survival benefit in non-small cell lung cancer (NSLC) patients). Based on media reports declaring Cipla's intention to launch a generic version of Roche's drug in January 2008, Roche moved the Delhi High Court seeking to injunct Cipla from marketing Erlocip. Cipla counterclaimed, arguing that Roche's patent was invalid. The judgment deals with two key issues: [1] Whether the manufacture of Erlocip infringes Roche's IN '774 patent and

[2] Whether Roche's IN '774 patent ought to be revoked as being invalid. The court concluded that 1. The manufacture, marketing and sale of Cipla's generic version of the Roche's patented product do not infringe Roche's Indian Patent 196774. 2. Roche's Indian Patent 196774 is valid against the grounds raised by Cipla in its written statement and counter-claim. 3. A permanent injunction is denied to Roche. 4. The counter-claim proves that Roche's subsequent US Patent 6900221 is directed at the compound of claim No.1 of the suit patent is a mixture of the two, Polymorph A and B Compound and need to be separated to perform and get the claimed compound for acceptable efficacy. The Infringement question: The relief claimed, however, was for infringement of rights in the drug Tarceva as well as an injunction restraining the manufacturing and marketing Erlocip. Cipla's defence to Roche's infringement claim was that IN '774 is for an admixture of Polymorphs A and B of EH but Tarceva is the stable form of Polymorph B, which corresponds to US '221 (and the rejected IN '507) and that the same was not covered by 'IN 774, and hence there can be no infringement. Roche argued that Cipla's drug was also EH and manufacture of Polymorph B by Cipla was sufficient to trigger infringement of Claim 1 of IN '774 on the premise that any process involved in making Polymorph B would first involve the preparation of a combination of Polymorph A and B. This led the court to construe Claim 1 of IN '774 to examine whether it subsumes Polymorph B of Erlotinib Hydrochloride, which is admittedly Erlocip. The court while placing reliance on expert testimony adduced by Cipla, went on for a purposive claim interpretation as an aid which advocates giving effect to 'the real purpose for which the product was invented'. Lastly, on the basis of US '221 specification which attest Polymorph B as the sole efficacious expression of Erlotinib Hydrochloride and by the fact that Roche's application for IN '507 cuts through IN '774, the court held that: "In [the] absence of the explanation of the said role either as a major or minor reactants coupled with the fact that both in India as well as in [the] US, the [P]laintiffs have applied for the patent for the said process and product separately than the underlying compound, the purposive construction of the claim and the specification of IN '774 clearly indicates that the said [P]laintiffs did not intend to include the Polymorphic version B in the suit patent IN '774". This makes it clear, according to the court that Tarceva did not correspond with that of the patent and therefore there was no infringement of the legal rights of Roche. The Validity question

Cipla's counterclaim contended that IN '774 contains no inventive step and is not novel for two reasons first, IN '774 specification is silent on how is it an advancement over the closest prior art which is Example 51 of EP '226; and second, the difference between IN '774 and Example 51 of EP '226 with respect to the substitution of a methyl group with ethynyl at the third meta (3') position is obvious to a person skilled in the art on account of at least five prior art teachings which suggest that methyl and ethynyl can be used interchangeably with no categorical loss of efficacy. In response, Roche argued that comparative efficacy in this case had been mapped according to inhibitory concentration (which term can be loosely understood as the concentration of a substance that causes a defined inhibition of a system), in which respect IN '774 is closest to a prior art reference EP '851 and is also inventive over it. Consequently, they saw no reason why EP '226 (and Example 51 specifically, which does not display an inhibitory concentration value within even the top five such values of compounds disclosed by EP '226) should be treated as the point of departure in the inventive step analysis. Indeed, EP '226 teaches a methyl/ethynyl substitution at the 6, 7- position and not at the 3' position and there are several demonstrable differences in bond angle, bond length and bond strength and the type of reaction with EGFR kinase between methyl and ethynyl group that make the substitution ostensibly inventive. The court, in addition to the absence of any positive evidence by Cipla in establishing obviousness, procedurally disregarded the five patent specifications cited by Cipla to show that methyl/ethyl substitution was well known in prior art because they were filed after framing of issues and did not meet the requirement that they could not be filed on account of being outside Cipla's knowledge or resources. Cipla's challenge to the validity of the impugned patent on it being attracted by section 3(d) did not find favour with the court on account of Cipla failing to meet the positive evidence onus to sustain that challenge. The court observed that Cipla had to prove that IN '774 is the 'new form of an old substance' (the 'old substance' being EP '226) and that Example 51 of EP '226, through further reaction, can result in IN '774 is insufficient to establish 'new form of an old substance' unless proven to be contrary, which none of their witnesses deposed. On an overall consideration of factors, the court held that Cipla was unable to meet even a balance of probabilities to establish revocation. Lastly, The Roche v Cipla judgment on Section 8 of the Patents Act 1970 which lays down disclosure requirements as to all corresponding foreign patent applications and pursuant to a decision in Chemtura Corporation v Union of India,which laid down a strict threshold of disclosure and also warned that inadequacy of disclosure would be a ground to seek revocation of a patent, does not refer to Chemtura but categorically does not revoke IN '774 despite holding on facts that "...the plaintiffs as patentee has not disclosed the information as required by the controller as per Section 8 of the Act which is evident upon from the examination report dated 22.8.2006 and the responses thereto which do not record the subsequent patent in US'221 which ought to have been

disclosed. Thus the ground of revocation under Section 64 (1) (m) is made out". Despite holding that the ground under Section 64 (1) (m) is made out the court chooses to exercise positive discretion in the plaintiff's favour to not revoke the patent by inferring the existence of such discretion from the presence of the word "may" in the Section. This observation will undoubtedly afford a respite to patentees who have been find it challenging to meet with Section 8 obligations and thus being faced with revocation of substantively valid patents on account of inadequacy of disclosures under Section 8. 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.