SpicyIP | De-Coding Indian Intellectual Property Law
Founded in 2005 by Prof. Shamnad Basheer, an IP academic and consultant. SpicyIP is one of India’s leading blogs/repositories on intellectual property (IP) and innovation law/policy. Through its independent reporting/analysis, SpicyIP is committed to fostering transparency within the Indian IP ecosystem.
In the latest development in the Patent Working PIL filed by Prof. Basheer, the Delhi High Court has directed the Government to file an affidavit stating a reasonable timeline within which it will complete its ongoing consultation with the stakeholders on the patent working issues, examine the comments it receives and effectuate the necessary amendments under the Patents Act. In a laudable move, the Court has also ordered the Government to immediately publish all the comments received by it on the website in order to enable all stakeholders to participate effectively.
The relevant paragraphs of the Court’s order (dated 15th March) read as follows:
“We direct the respondent no.1 to place before this Court a reasonable time line within which the consultation would be completed, suggestions received examined and such amendments as may be deemed necessary would be effected under the Patents Act 1970. Such affidavit shall be filed within one week of 21st March, 2018, when the stakeholders meeting is proposed to be convened.
For enabling effective participation, let the comments received be immediately posted on the website.”
As we had informed our readers here, the Patent Office, in pursuance of the Court’s order dated 7th February, had issued a circular on 1st March inviting the stakeholders to submit their comments on issues relating to patent working provisions and proposing a consultation meeting with them. The comments were to be submitted by March 16 initially but the deadline was later extended to 23rd March (i.e. today). So, if any of you are still interested in sending your comments, please do so by today. The meeting is now rescheduled for 6th April.
After the issuance of this circular, Government had filed an affidavit (as per the Court’s directions vide order dated 7th March which we had covered here) before the Court on 13th March, wherein it had stated that it may take around 12 months for it to consider the stakeholders’ comments and effectuate the necessary amendments to the Patents Rules. When Prof. Basheer’s counsel, Mr. Sai Vinod, brought the Court’s attention to this, the Government responded saying that the affidavit was actually drawn up last month before the issuance of the circular. It is in light of this that the Court has now directed the Government to submit an affidavit stating a reasonable timeline for completion of this consultation and amendment process.
This scheme replaces the earlier scheme run by the Ministry of HRD, which was called the Central Scheme of Intellectual Property Education, Research and Public Outreach. The earlier scheme was fairly successful in the field of IP education in the sense that some of these chairs conducted fairly popular distance education programs on IP. However, there was some disquiet regarding the quality of research being generated under the scheme. From what I hear, several of these chairs were also quite dysfunctional in the sense that they had become parking space for some candidates.
The government had constituted a committee of three members to examine the working of the scheme and acting on the recommendations of the committee the DIPP has decided to rework the scheme going forward. The entire scheme can be read here.
To the credit of the DIPP, the new scheme democratizes the entire process by throwing open the process to all universities recognized by the University Grants Commission or the AICTE and institutions affiliated to recognized universities in the area of IPRs. The earlier scheme had instituted chairs only in national law universities or IITs.
The new scheme also dilutes some of the qualification criteria for being appointed as Chair Professors. The earlier criteria made it very difficult for universities to appoint professors. The new qualification criteria basically allows for any academic/scholar of outstanding track record in the designated areas of studies, retired officials from the Intellectual Property Office (IPO) or an outstanding professional with established reputation in the field of IPR. The pay for these Chair Professors will be Rs. 1 lakh. Universities also have an option to give the Chair to their existing faculty, as an additional charge but these faculty will be paid only an honorarium of Rs. 25,000. The Scheme also allows for hiring of research assistants and funds for purchasing books, secretarial assistance etc. The budget for organization of workshop conferences, seminar is surprisingly at a paltry Rs. 1 lakh!! How is anybody going to organize a conference in 2018 on a budget of Rs. 1 lakh?
While this new scheme looks better than the previous version, I think we would have been better if the DIPP simply launched a research fund for IP research on lines of the scheme being run by the Law Ministry for research into judicial and legal reforms. The Law Ministry scheme basically invites research proposals which are evaluated by an expert panel and then funds are sanctioned for the proposals selected by the panel. Since there is a fixed deliverable in the nature of a report, this scheme has helped generate some research which is made available on the law ministry website. Schemes like this are far easier to administer than the DIPP’s scheme for Chair Professors.
In any event, I do hope this new scheme leads to some good research on Indian IP that is subsequently made publicly available – a lot of the research from these Chairs isn’t published, which should not be the case with publicly funded research.
In a rather rambling blog post on Monday, Mr Amitabh Bachchan, Bollywood’s angry young man turned angry-preacher-from-the-social-media-pulpit, let loose a diatribe against the seeming injustice done to him by the Indian Copyright Act – specifically, the concept of copyright terms – which temporally limit rights in original copyrighted work, beyond which the works is included in the public domain. The motivation for the post seems to be the realisation that the copyright in Harivansh Rai Bachchan’s poetry, currently with his estate, is not eternal. In India, the term after which copyright protection in a literary work ceases to exist is 60 years from the death of its author(s), which indicates that Mr. Bachchan’s grouse relates to a (catastrophic) event taking place after the year 2063. (Mr. Harivansh Rai Bachchan died in 2003).
While the post is somewhat incomprehensible (albeit entertaining for its use of inflection), the crux of Mr Bachchan’s argument can be broken down in three arguments:
Copyright is individual property, and should rightfully belong to the designated heirs of an author, similar to physical property.
“my and mine of family will and shall and must have its creative consent before its usage and exploitation after .. that is my inherited right .. it shall prevail ..
who built this Law .. who prescribed the time years of 60 .. why did they do so .. how can individual property become public property .. NO .. that is not .. !!”
Copyright vests naturally in all creations and the Copyright Act, by virtue of establishing rights, limits this natural right.
“you never made them aware of copyright protection .. and because you did not, how have you reached a conclusion that they would have agreed ..
just because they were unaware of the assumed Law, you have taken advantage of situation and given their works to them that have no right authority by the rightful presence of genes ..
why was not William ‘Bill’ Shakespeare made aware of copyright ; why not Mr Beethoven or Messrs Chopin and Tchaikovsky, or closer home Gurudev Rabindra Nath Tagore ‘Thakur’ .. had they known or made to know, they may never have wished for any other, but their progeny of generations to come … and because no record has been kept of such .. there is a LOSS OF OPPORTUNITY for them that were rightful heirs of them .. !!”
Allowing the use of a creative work without permission (i.e. putting it in the public domain) diminishes the worth of the work.
“so what gets left as natural heir by Father Dr Harivansh Rai Bachchan, after his passing passed 60 years, belongs no longer to his domain or possessive copyright as willed .. but becomes for the entire Universe to tread, scratch, mutilate, use in commercial consideration on their own creative discretion .. ???”
In this post, I would like, to put it in Mr. Bachchan’s own words to “OPPOSE, DISAGREE, LAMENT, DISPUTE, BE IN VARIANCE OF, IN VEHEMENT LOUD SCREAMS OF VOICE .. EVER” (sic), with his arguments.
The False Equivalence Between “Real” and “Intellectual” Property
Property rights denote the allocation of a bundle of rights in a manner so as to make the most efficient use of that property. In the case of real (physical) property, the use of a physical good by one person diminishes the quantity of that good available for someone else, and therefore the most (economically) efficient allocation of the good is by limiting its availability and use. On the other hand, ‘intellectual goods’ are ‘non-rivalrous’ – they are not limited in quantity and can be freely reproduced and used by anyone without losing their inherent value.
Another distinguishing aspect between intellectual and real goods is the relative difficultly in excluding the use of the former as compared to the latter. While (most) real goods can be excluded from others by physically preventing them from using it, intellectual goods can be replicated and used with much more ease. The difficulty in exclusion makes such creative goods easier to copy and use. This, in turn, leads to the problem of free-loading of resources – the use of a resource for self gain, while diminishing (or at least, not contributing to) the value of that good. Copyright piracy, for example, is often used as an example of the use of creative goods without making any compensation to the creators of such work.
Such free-loading of creative goods is often viewed as reducing incentives for their creation, because it is assumed that creators do not have any incentive to create new goods when they get no direct benefit from its creation (counterview here). Therefore, a common rationale for intellectual property rights is to prevent freeloading by allocating property rights through legal fictions, in order to incentivise the creation of such goods by securing economic incentives for such works.
This system of exclusion is, however, economically inefficient, as the scarcity introduced by preventing the use of intellectual goods is artificial, and excludes uses of such goods which do not diminish its value. Moreover, the primary rationale for the law remains that of increasing the availability of scientific and cultural goods in society, not merely of securing rights of creators or authors. This is why we have exceptions and limitations to copyrights, such as fair dealing or fair use, for example under Section 52 of the Copyright Act, which are also recognized in international treaties like the TRIPS agreement and the Berne Convention.
To conflate two ideas of real and intellectual ‘property’, as Mr. Bachchan has done, is therefore disingenuous and ignores the significant differences between rivalrous and non-rivalrous goods and the nature of intellectual property laws.
Similarly, Mr. Bachchan assumes that the rights granted to authors are ‘natural rights’. As per this argument, the limitation of the natural rights of authors like ‘Will’ Shakespeare or Rabindranath Tagore are frauds played on authors when they were not aware of any such limitations in their natural rights, and if they were aware of such limitations, they may not have consented to the use of their creations.
However, this argument is ontologically incorrect, and, in my opinion philosophically flawed (counterview here). In fact, the history of copyright law, and its subsequent evolution shows that copyright is a relatively recent concept. Copyright was a extremely limited privilege granted to authors – the first such statute enacted in India only granted copyright for the author’s life plus seven years, and in no case exceeding a total of 42 years. Further development through the ages, and international harmonisation of copyright regimes has only extended such terms (the Berne convention, for example, mandates a minimum term of 50 years). Therefore, whether for ‘Bill’, Tagore or Harivansh Rai Bachchan, copyright terms for their works have only increased – which also indicates that longer copyright terms may not necessarily provided greater incentives for creative or scientific production.
Whether creative works should be seen as a natural right of the creator has been a much debated topic since the inception of the concept of intellectual property rights. Suffice to say, there is a long way to go for this debate to be settled in India, let alone in the annals of philosophy. My personal opinion, however, can be summed up by this quote from the Delhi High Court’s DU Photocopy Case judgement –
“Copyright, [e]specially in literary works, is thus not an inevitable, divine, or natural right that confers on authors the absolute ownership of their creations. It is designed rather to stimulate activity and progress in the arts for the intellectual enrichment of the public. Copyright is intended to increase and not to impede the harvest of knowledge. It is intended to motivate the creative activity of authors and inventors in order to benefit the public.”
In Defence of the Public Domain and Narrow Copyright Terms
Copyright terms, similarly, were seen as necessary in order to strike a balance between creating adequate incentives for the production of intellectual goods, and contributing to a robust public domain – that sphere which ensures the availability of the public to intellectual goods, free of encumbrances of copyright, after the expiry of a certain period of time, or under certain other conditions.
The public domain plays a crucial role in society. The removal of barriers to the access of cultural and scientific intellectual goods enriches society in a myriad ways – greater access to cultural and scientific goods allows the creation of new knowledge which builds on existing information; it allows incremental innovation from such goods; increases individual’s attainment of happiness and a good life, and decreases the costs of obtaining information by making such ‘borrowing’ permission-less.
In many cases, longer copyright terms directly correlate to reduced utility of the information once in the public domain. Copyright terms must therefore be set in a manner where the eventual lapse of intellectual goods into the public domain can continue to be relevant and valuable.
Mr. Bachchan’s view of the public domain is needlessly pessimistic. This is not, in fact, the first time that Mr. Bachchan has been wary of the use of his father’s work without his permission. In 2017, he sent a legal notice to poet-turned-politician Kumar Vishwas over a public recital (and subsequent video) of one of his father’s poems. It truly baffles the mind as to why one of Bollywood’s richest men would want to prevent the enjoyment and access to his father’s poetry, which is regarded as a pinnacle of hindi romantic poetry.
The reuse, remix and reworking of Harivansh Rai Bachchan’s works can be transformative and innovative; it can provide the inspiration for greater feats of creativity; and most importantly, it can allow the general public to access such great poetry, which, surely, must have been the intendment of Mr. Harivansh Rai Bachchan himself. In his own words –
“Kabhi phulo ki tarah mat jina, jis din khiloge tutkar bikhar jaoge, jeena hai toh pattar ki tarah jio, ek din taraashe gaye to, bhagwan ban jaoge.”
The couplet means – ‘don’t live like a flower, which will crumble after blossoming. If you live, live like a stone – once carved, you become a god.’ It’s an apt metaphor for allowing his poems to be free from the shackles of copyright.
This is a case of ex parte proceeding concerning trademark dilution. We had dealt with identical legal issues earlier. Therefore, this post is more of a revision for lawyers. [For Prof. Dev Ganjee’s thoughts on trademark dilution, click here.]
The plaintiff sought a decree of permanent injunction and damages with respect to infringement of the plaintiffs’ registered trademark, passing off and unfair competition. The Plaintiff wanted the Defendants to be refrained inter alia from “manufacturing or authorizing the manufacture, selling or offering for sale, marketing, advertising, promoting, displaying or in any other manner whatsoever using the impugned mark KINLEY and/or any other mark which is deceptively or confusingly similar to the registered trademark KINLEY of Plaintiff No. 1 as a trade mark or part of a trade mark, trade name or part of trade name or as a domain name or part of a domain name or in any other manner whatsoever so as to infringe the Plaintiff No. 1’s registered trade mark or pass off its goods as those of the Plaintiffs”. Further, inter alia, the Plaintiff wanted the Defendants to be directed by a decree of mandatory injunction “to transfer the domain name “kinley.in” and “kinleyro.com” and/or any other domain name which is similar to the Plaintiff No. 1’s registered trade mark KINLEY to the Plaintiff No. 1”. The Delhi High Court, vide order dated 29th April, 2013, granted an ex-parte ad interim injunction in favour of the plaintiffs and against the defendants. The Court proceeded against the Defendants ex-parte and decreed against the Defendants.
As the plaintiffs’ evidence had gone unrebutted, the evidence adduced by the Petitioner was accepted as true and correct. The Supreme Court in Ramesh Chand Ardawatiya Vs. Anil Panjwani, (AIR 2003 SC 2508), held as follows:
“33. ………In the absence of denial of plaint averments the burden of proof on the plaintiff is not very heavy. A prima facie proof of the relevant facts constituting the cause of action would suffice and the court would grant the plaintiff such relief as to which he may in law be found entitled. In a case which has proceeded ex parte the court is not bound to frame issues under Order 14 and deliver the judgment on every issue as required by Order 20 Rule 5. Yet the trial court should scrutinize the available pleadings and documents, consider the evidence adduced, and would do well to frame the “points for determination” and proceed to construct the ex parte judgment dealing with the points at issue one by one. Merely because the defendant is absent the court shall not admit evidence the admissibility whereof is excluded by law nor permit its decision being influenced by irrelevant or inadmissible evidence.”
The Plaintiff No. 1 is the registered proprietor of the arbitrary mark KINLEY in class 32, which is primarily used by the plaintiffs in relation to drinking water. The plaintiffs stated that they came across the use of the mark “KINLEY” by the defendants, in relation to water purification systems using reverse osmosis, where the defendants falsely claimed to have launched their water system in collaboration with the Plaintiff no.1’s Indian subsidiary, the Coca Cola India Pvt. Ltd., whereas, in fact, no such collaboration existed. Further, the investigations conducted by the plaintiffs revealed that the defendant no.1 was openly advertising its product, and that the mark KINLEY was displayed prominently on its advertising and promotional material. Also, a search of the trademark register was conducted by the plaintiffs and the same revealed that the defendant no.1 had also applied for registration of the mark KINLEY bearing Application No. 2329491 in Class 11 for the specifications “water purifier, water supply and sanitary purpose” claiming use since 1st April, 2011.
A registered trademark is infringed by a person who not being a registered Proprietor or a person using by way of permitted use, uses in the course of trade, a mark which-
(a) is identical with or similar to the registered trade mark and
(b) is used in relation to goods or services which are not similar to those for which the trade mark is registered : and
(c) the registered trade mark has a reputation in India and the use of the mark without due cause takes unfair advantage of or is detrimental to, the distinctive character or repute of the registered trade mark.
The provision derives its inspiration from Section 10(3) of the UK’s Trade Marks Act, 1994.]
It is pertinent to refer to Anubha’s excellent post on trademark dilution. As she rightly pointed out, the Delhi High Court judgment in Bloomberg Finance LP v Prafull Saklecha widened the scope of anti dilution protection of trademarks in India, thus lending more clarity to the concept. Section 29(4) of the Indian Trade marks Act, 1999 embodies the concept of Trademark Dilution. A trademark is diluted when its uniqueness is lost owing to its unauthorised use in relation to products that are not identical or similar to the product of the trademark owner. In relation to lesser known yet identifiable brands, the test of likelihood of confusion applies as laid down by the Supreme Court in T.V Venugopal v. Ushodaya Enterprises. Dilution of trademark essentially happens in relation to a ‘mark with reputation’ as per section 29(4) of the Indian Trademarks Act. Prior to the Bloomberg judgment, there was ambiguity surrounding the meaning of the term ‘mark with a reputation’ as against a well known trademark. Going by the Delhi HC judgment, marks which do not qualify as well known trademarks do also enjoy anti-dilution protection.
Prescribed Deadline for Filing Patent Examination Requests
Section 11B of the Patents Act, 1970 r/w Rule 24B of the Patents Rules, 2003 stipulates that a request for examination of a patent application must be made within 48 months from date of priority or the date of filing of the application (whichever is earlier); otherwise the application will be not examined and treated as withdrawn by the applicant.
Facts and Arguments
In the present case, the petitioner Sphaera Pharma had attempted to file a request for examination of their patent application (No. 3584/DELNP/2015) within the prescribed time of 48 months from the date of the application, but the request did not get uploaded due to some technical reasons. Its patent application was consequently treated as abandoned under Section 11B, leading it to request the Patent Office for review of its application status. The review request was not considered by the Patent Office, prompting the petitioner to file a writ petition before the Delhi High Court for restoration of the application. Although the petitioner conceded that the request was not made within the prescribed period, it argued that under Rule 138 of the Patent Rules, the Controller of Patents retained the power to extend the prescribed time for a period of one month in certain cases.
The Court, firstly, held that from a plain reading of Section 11B r/w Rule 24B it is clear that there is no scope for consideration of a request for patent examination which is filed beyond the prescribed period of 48 months from the date of filing of the application.
Secondly, it rejected the petitioner’s contention based on Rule 138, noting that a plain reading of sub-rule (1) of the said rule clearly indicates that the power of extension conferred on the Controller under this provision does not extend to the time prescribed under Rule 24B as its application to sub-rules (1), (5) and (6) of Rule 24B is expressly excluded. It further observed that even otherwise, the petitioner could not take recourse to Rule 138 because as per sub-rule (2) of the rule, it applies only to requests for extension made before the expiry of the prescribed time and the petitioner had not made any such request within the period of 48 months from the date of filing the patent application.
The court concluded by reproducing the following observation made by it in the Nippon Steel case on the same issue, where it clarified that the time-limit prescribed under the Act for filing a patent examination request is not directory but mandatory and it cannot be relaxed in any event:
“Here is a logic to the time limits set out under the Act. The scheme of the Act and the Rules require time-bound steps to be taken by applicants for grant of patent at various stages. The provisions of the Act and the Rules have to expressly reflect the legislative intent to permit relaxation of time limits, absent which such relaxation cannot be read into the provisions by a High Court exercising powers under Article 226 of the Constitution. In other words, it is not possible for this Court to accept the submission of the learned Senior counsel for the Petitioner that the time-limits under Section 11-B(1) of the Act read with Rule 24-B of the Rules, notwithstanding Section 11- B (4) of the Act, are merely directory and not mandatory. In fact, the wording of Section 11-B (4) of the Act underscores the mandatory nature of the time limit for filing an RFE in terms of Section 11-B (1) of the Act read with Rule 24-B of the Rules.”
So, the lesson is, file the requests for examination of your patent applications well within the prescribed time limit of 48 months from the date of priority or the date of application. Because if you aren’t able to do so, whether due to a technical reason or an error in entering the priority date (as was the case in the Nippon Steel case) or any other reason, your application will be deemed to have been withdrawn and will not be examined under any circumstances whatsoever. In short, stick to the deadline no matter what as there’s no way out of it!
Domain names constitute the signposts for the world wide web, making it possible to navigate the immensity of the internet. Given the transnational nature of the internet and the domain name registration system in particular, it was realized early on in its development that a suitable system must be developed to protect the rights of trademark holders in domain names, to prevent the misuse of brands and secure better consumer protection. Therefore, the ICANN, the apex body responsible for administering the domain name system, designed a mandatory dispute resolution policy to apply to all registrars and domain name holders.
The Uniform Domain Name Dispute Resolution Policy (UDRP) is the outcome of this process, and it applies to all generic top-level domain names (.com, .org, .net, etc.) administered by the ICANN as well as certain country-code level domain names, which voluntarily adopt it. Other registries have adopted their own dispute resolution policies, such as the INDRP administered by the IN Registry (handling .in domain names)
The manner in which the UDRP and similar policies are interpreted and administered can have important implications for many critical issues, including consumer protection and freedom of speech on the Internet. Following the UDRP is an interesting exercise in seeing how international cross-jurisdictional IP disputes can be handled in an alternative to the judicial system. We have covered such issues in the past on this blog, here.
In this post, I cover an interesting trend in UDRP administration which brings in a much needed balance between the rights and interests of trademark holders and domain name registrants.
Domain Names and the UDRP
The Uniform Domain Name Policy (UDRP) is the standard procedure to be followed in the case that a dispute arises between trademark holders and domain name registrants. Any such dispute must be referred to an approved arbitration panel, as per whose directions domain-name registrars would cancel, transfer or change the domain name.
Article 4(a) of the UDRP provides the conditions under which a panel may award the cancellation, transfer or change of a domain name. These conditions are that:
(i) The domain name registered by the respondent is identical, or confusingly similar, to a trademark
or service mark in which the complainant has rights;
(ii) The respondent has no rights or legitimate interests in respect of the domain name; and
(iii) The domain name has been registered and is being used in bad faith.
The third requirement of bad faith itself is fairly expansive, and has been explained under Article 4(b), which provides the following illustrations of ‘bad faith’ under the UDRP –
(i) Circumstances indicating that the domain name was registered or acquired primarily for the purpose of selling, renting, or otherwise transferring the domain name registration to the complainant who is the owner of the trademark or service mark or to a competitor of that complainant, for valuable consideration in excess of the domain name registrant’s out-of-pocket costs directly related to the domain name; or
(ii) The domain name was registered in order to prevent the owner of the trademark or service mark from reflecting the mark in a corresponding domain name, provided that the domain name registrant has engaged in a pattern of such conduct; or
(iii) The domain name was registered primarily for the purpose of disrupting the business of a competitor; or
(iv) By using the domain name, the domain name registrant intentionally attempted to attract for financial gain, Internet users to the registrant’s website or other on-line location, by creating a likelihood of confusion with the complainant’s mark as to the source, sponsorship, affiliation, or endorsement of the registrant’s website or location or of a product or service on the registrant’s website or location.
The limitation of the scope of the UDRP only to bad faith registrations was, as the WIPO report indicates, a deliberate attempt to find a balance between the legitimate rights of trademark owners and the protection of good faith domain registrants from being forced into mandatory litigious procedures. The UDRP, therefore, was meant to only apply to “egregious examples of deliberate violation of well-established rights ”
Retroactive Bad Faith Opens the Doors to Reverse Domain Name Hijacking
Despite the clear requirement that only ‘egregious’ bad faith cases of domain name conflicts should come under the mandatory UDRP, there have been frequent accusations that the policy, and its application, have been biased towards trademark holders. One example of this bias manifested in the theory of ‘retroactive bad faith’ registration.
Article 4(a)(iii) of the UDRP, on a plain reading, clearly requires that the domain name challenged must have been registered and currently be used in bad faith. The language of Article 4(a)(iii) presupposes that the domain registrant must have had knowledge of the trademark rights of the complainant at the time of the domain registration. An overview of panel decisions by the WIPO confirms that the consensus view of panels has been that:
“when a domain name is registered by the respondent before the complainant’s relied-upon trademark right is shown to have been first established (whether on a registered or unregistered basis), the registration of the domain name would not have been in bad faith because the registrant could not have contemplated the complainant’s then non-existent right.” (Emphasis Added
Domain name registrants are required to make representations and warranties, which, inter alia, state that the registrant “will not knowingly use the domain name in violation of any applicable laws or regulations. It is your responsibility to determine whether your domain name infringes or violates someone else’s rights.”
According to the Octogen cases, the language of the representations requires a continuing obligation of registrants to ensure that there is no use of the domain name in violation of trademark or copyright laws. This implies that the use of a domain name in a manner which violates the representations, would date back to, and be considered a breach of, conditions at the time of registration, and therefore would be viewed as bad faith at the time of registration.
Octogen came to be widely cited in favour of trademark holders hoping to wrest domain names from good faith domain name registrants, without going through the strictly legal route within their jurisdiction – a practice known as Reverse Domain Name Hijacking (RDNH) – where trademark owners attempt to arm-twist domain name registrants into giving up their domains with the threat of a legal dispute. As this website notes, the newly evolved theory of ‘retroactive bad faith’ provided a lot of ammo for trademark holders to engage in bad faith complaints, causing many difficulties to legitimate good faith registrants of domain names, who must either engage in costly and time consuming litigation or compromise with the abusive complainant.
RDNH findings are generally made when the panel believes the complaint has been brought in bad faith and is abusive. Going against the literal interpretation of the policy and claiming bad faith registration against a domain registrant, prior to the registration of the complainant’s own trademark, would generally have returned a clear RDNH finding.
However, the growth of the retroactive bad faith theory was difficult to stem, given the strong weight that the UDRP process places on precedent – while prior decision of panels may not be binding, they are ‘strongly persuasive’. This also led to its inclusion as a ‘non-consensus’ view on the application of bad faith registration in the WIPO Overview 2.0, largely considered authoritative, thus legitimizing the wayward theory.
The legitimation of retroactive bad faith led to a spate of abusive complaints – an analysis shows that up to 65% of UDRP complaints filed in 2015 relied upon the newly constructed theory of retroactive bad faith. Consequently, fewer RDNH findings were returned, as bad faith was difficult to establish since there was clearer precedent for the complainant to rely on.
The Slow Decline of Retroactive Bad Faith
Initially, panels were reluctant to out rightly reject the outlier view on retroactive bad faith. More recently, however, panels direct in their consideration and rejection of the theory –in Coolside Limited v. Get On The Web Limited, WIPO Case No. D2016-0335 (TRTL.COM), the panel found that relying on this reasoning constituted abuse of the policy and rendered a finding of RDNH. In March 2017, a three member of panel soundly rejected the reasoning of the Octogen cases, holding that:
“the overwhelming approach of UDRP panels since then has been to affirm the literal meaning of paragraph 4(a)(iii) of the Policy and to require bad faith at the time of registration or acquisition of the disputed domain name.”
This panel too came to hold that the dispute was brought in bad faith, and made a finding of RDNH against the complainant.
Subsequently, there has been a reassertion of the necessity to prove bad faith at the time of registration, following the literal interpretation of the UDRP. This has similarly resulted in more findings of RDNH against those seeking to rely on retroactive bad faith.
The decline of retroactive bad faith, will not, unfortunately, allow registrants to reclaim the domain names taken from them by complainants relying on that theory. However, a strong reversal of the same, and the recent findings of RDHN against complainants relying upon this, may bring in a much required balance between the competing rights of trademark holders and domain name registrants.
The ICANN itself, however, should view the saga of retroactive bad faith as an imperative to make the UDRP a clearer, more easily administered policy which does not allow for misuse. Hopefully, the ICANN working group on Rights Protection Mechanisms would take into account the ambiguity in panel decisions and the application of misleading precedent under UDRP cases in its review of the UDRP, which is expected to come out this year.
In October 2017, I posted a brief report on the Global Innovation Index (GII) 2017 (10th edition). Over the course of the ensuing write-up, I have attempted to provide a more general review of the GII, albeit basing most viewpoints on recent reports (including the 2017 report). The objective is to acquire a better understanding of (a) the process behind such indices, (b) the inherent subjectivity and also, (c) take note of a few limitations of the GII.
The GII provides data that enables academicians to understand innovation across the world, governments to reconsider policy changes and businesses to decide upon the most suitable economies to make R&D investments in. Further, please note that all data provided is absolute and therefore, can be utilized for various purposes by relevant actors. Only the rankings, obviously, are relative.
The latest report has been jointly-published by Institut Européen d’Administration des Affaires (INSEAD), Cornell University and the World Intellectual Property Organization (WIPO). The first report, published in 2007, was INSEAD and World Business’ initiative. INSEAD has been publishing reports annually ever since, while WIPO and Cornell have been associated with the report since 2012 and 2013 respectively. Further, knowledge partners, such as the Confederation of Indian Industry, assist in the report making.
The GII 2017’s press release notes that the report covered 127 countries, using hard data, surveys and composite indicators (discussed later), with 90% confidence intervals (the probability of the data being accurate is 90%). Further the Joint Research Centre of The European Commission has conducted a statistical audit of the report (Annex 3 ; Pg. 59).
BASIC FUNCTIONING (Input and Output)
Let us briefly understand the process behind compiling the GII. (Annex I; Pg. 47)
Two kinds of data were taken into account: Input related and Output related.
Input (“Innovation Input Sub-Index”):
The data used to arrive at this figure involves variables that affect innovation, as opposed to those that measure innovation itself.
The broad areas examined were:
Human Capital and Research
One might question the necessity of considering Inputs at all, when Output data is available to measure the actual innovation. Input data is relevant because measuring innovation holistically on Output data alone is complex and could possibly be inaccurate. To explicate further, where there exists a dearth of standards for determining the degree of innovativeness ascribed to an economy’s products, Input data could serve to fill the void.
Output (“Innovation Output Sub-Index”):
The “Innovation Output Sub-Index” was arrived at by using data that measures results of innovation (e.g. number of patent filings), rather than the factors that cause it.
The broad areas considered were:
Knowledge And Technology Outputs
Moving on, the GII rankings are based on a final figure arrived at by calculating the average of the “Innovation Input Sub-Index” and the “Innovation Output Sub-Index”.
The “Innovation Efficiency Ratio” is the ratio of the Input and Output Sub-indices. Essentially, it is a measure of the output generated with respect to the input. While assessing an economy’s performance on the basis of the IER, we need to take note of the Output index as economies may have a favourable ratio merely due to a lack of inputs, rather than actual outputs.
CLASSIFICATION ON THE BASIS OF THE DATA’ S NATURE (Hard, Composite, Survey)
For arriving at the Input and Output Sub-Indices, 81 more specific indicators were considered (Indicator explanations at Appendix 3; Pg. 403) . The indicators can be classified into “composite indicators“, “surveys” and “hard data“. Let us have a look at each and attempt to identify the elements of human subjectivity.
“Hard data” refers to objective, quantitative data. It needs to be contrasted with “surveys” (qualitative, subjective data; “soft data“). Also, both hard data and soft data cannot be split into further components, unlike “composite indicators“, which are an average of other base indicators (soft, hard or a combination thereof). (Refer to Appendix IV; Pg. 419)
Hard Data (57 of 81 indicators)
Hard data is objective, quantitative data, that isn’t derived from opinion. Examples include “Gross Expenditure on R&D (% of GDP)” and “Government Expenditure On Education Per Pupil, Secondary (% of GDP per capita)“.
We needn’t delve too deep into hard data, as it is largely uncontentious. While there exist considerations related to scaling to account for differences in population, purchasing power parity and GDP amongst economies, there is little for the legal analyst to note here.
Composite Indicators (19 of 81 indicators)
As stated above, such indicators are the result of combining multiple base indicators (could include both soft and hard data). In other words, they are an “index within an index“. Composite indicators are a slightly contentious kind of indicator, as including them could lead to the duplication of variables. The same variable might feature in multiple composite indicators, or even independently, and thus, unsettle the balance. The report’s “Technical Notes” section underplays the problem by stating that very few such indicators (19) were used and the inclusion of expert opinion counteracts the detrimental effects of composite indicators. Examples of composite indicators in the GII include “Political Stability and Safety“, “Government Effectiveness Index” and “Environmental Performance Index“.
If you are wondering about the means behind incorporating subjective expert opinion into a quantitative analysis, hold onto that thought as we will discuss it shortly.
Soft Data (5 of 81 indicators)
As stated earlier, soft data involves surveys and quantification of subjective opinion. The quantification is carried out by ascribing a numeral to a particular opinion. By way of illustration, “intensity of local competition” was arrived at by averaging expert ratings of an economy’s state of competition between 1 (“Not intense at all“) to 7 (“Extremely Intense“). Other examples of such data include “ICTs and Business Model Creation” and “ICTs and Organizational Model Creation”.
Further, it is pertinent to note that certain factors, such as “Regulatory quality” and “Rule of law“, have been given lesser weightage (1/2) than others. This isn’t problematic by itself, but it is significant to note, as it further highlights the elements of subjectivity and compromises in accuracy that such indices inevitably entail. For instance, one could argue that dividing factors, by weightage, into a bipartite classification overlooks the various degrees of significance that different factors could have. In other words, a particular factor might deserve 1/4 the weightage, while another might deserve 3/4 weightage. Yet, such factors, in the current model, are approximated to be slotted into either category (full weightage or half-weightage), thereby detrimentally affecting the Index’s accuracy.
The definition of “innovation” followed by the GII is that of the European Communities and the Organisation for Economic Co-operation and Development’s Oslo Manual:
“An innovation is the implementation of a new or significantly improved product (good or service), a new process, a new marketing method, or a new organizational method in business practices, workplace organization, or external relations.“
The 2017 report notes the development of the concept of innovation from being perceived solely as a result of developing radical, breakthrough technologies through industry based R&D, to also being understood as a result of incremental innovation and “innovation without research” through actors outside the industry as well. By “innovation without research” the report is referring to an economy’s capability to capitalize on combinations of existing technologies, as opposed to innovation due to breakthrough developments. The report accounts for such innovations by incorporating factors that are indicative of an ecosystem suitable for innovation of the incremental kind, rather than focusing excessively on factors that indicate traditional markers of innovation (patent filing, et cetera).
The criticisms of the GII’s adopted definition of “innovation” pick on the report’s excessive emphasis on the element of “new(ness)” in innovations, instead of giving due consideration to innovation’s benefit to society. In other words, critics argue that innovation should be judged by its beneficial impact on society, rather than focusing on the novelty aspect.
The definition notwithstanding, I submit that the GII, effectively, hasn’t overemphasized the element of novelty and in fact, has attempted to arrive at a rather holistic analysis through the methodology involving Input and Output factors outlined above.
Moving on, one of the stronger criticisms I have come across is regarding the excessive significance attributed to factors that aren’t integral to innovation. For instance, “Ease of Paying Taxes“, “Electricity Output“(half-weightage) and “Ease of Protecting Minority Investors” are factors alongside “Ease of Getting Credit” and “Venture Capital Deals“. Hence, an argument could be made to reduce the scope of indicators to isolate the most relevant indicators of innovation.
While it’s true that quite a few indicators used in the GII share an arguably tenuous relationship with innovation, analysts, policy-makers and other stakeholders would be better served through a comprehensive trove of data, rather than a narrow analysis. Of course, the perceived loss of accuracy in an economy’s represented innovativeness could be viewed as a limitation. However, I feel that the benefit of data dissemination is a sufficiently countervailing value. Therefore, analysts should take the rankings with the proverbial “pinch of salt“.
Lastly, the official press-conferences (accessible here, here, here and here), also highlight a few more limitations. Innovation in the defence sector isn’t factored in directly, though their downstream applications in other sectors is factored into. Also, a few jurisdictions allow for “secret patents“, which haven’t been accounted for.
The write-up aims to help readers understand the elements of human subjectivity and inaccuracies that are inherent to indices in general and GII specifically. Now that we have understood the limitations, we can better appreciate and utilize the data provided in such indices.
Limitations notwithstanding, the GII continues to serve as a valuable source of data for all sorts of actors to base their decisions on. Be it policy-makers attempting to identify good practices, or an academic seeking reliable data for research.
By way of a special report that I highly recommend to our readers, Prashant & Balaji brought us this week’s topical highlight. The report draws on a recent coverage by The Hindu reporting limited access to Bedaquiline, which has been touted to be the most promising drug for the treatment of multi-drug resistant tuberculosis (MDR-TB) and is patented by US based company, Janssen. Subsequently diverging from the Hindu report, Prashant and Balaji take us through their own research on the subject and reveal notable aspects flanking the issue. These include deeper investigations into the reason behind the low access rates to the drug, which is revealed to be the approval of the drug without the conduct of any Phase III clinical trials. This observation is then supplemented by speculation on the possibility of the Indian government essentially conducting “de-facto” clinical trials on behalf of Janssen, the foreseeable dangers of such a practice and the true nature of clinical trial data exchanged between the Indian government and Jansen.
Prashant and Balaji also wrote an update to the report summarised above. This was based on the correspondence between Janssen and the Ministry of Health, obtained by way of an RTI application. They highlight key aspects of this correspondence between the two parties, including interalia the exact nature of the data sharing arrangement between the two parties, the conditional access programme limiting access to the drug, as proposed by Janssen and the differences in this conditional access as functional in jurisdictions such as the US & UK and of that in India.
The thematic highlight is Rahul’s post reporting on a recent Delhi High Court judgment on patent infringement comprising three patents over insecticides and herbicides. Rahul outlines the factual matrix of the case, noting that the three patents in question relate to a herbicidal composition of two compounds – known to effectively tackle two different types of weeds together. He notes that the plaintiff sued for infringement primarily on the ground that the defendant participated in a tender for the supply of a composition consisting of the same compounds, roughly in the same proportion. On the whole, Rahul agrees with the court’s decision on the matter, which confirmed infringement on grounds including interalia – lack of anticipation by prior art, and substantial similarities between the two compositions.
Prashant also reported on another recent coverage by The Hindu on the recent “expression of interest” (EoI) published by the World Health Organisation (WHO) inviting pharmaceutical companies to pre-qualify their products for procurement programs administered by WHO. Highlighting the misreportage by the paper on the subject, Prashant notes that the report gives the impression that the inclusion of bedaquiline and delaminid, in the WHO’s EoI is going to lead to the drugs being more affordable. Among a few other observations on the subject, he argues that the reality of the situation is that this inclusion cannot change the patent status of the drugs. They will continue to be manufactured by the respective patentees, and unless they decide to lower the prices in India, these drugs will remain unaffordable.
Among other news and announcements breaking on the blog:
Pankhuri and Prof. Basheer reported that the IPO has issued a public notice seeking feedback from stakeholders on Form 27 filings, or specifically, “on the issues relating to working of Patents i.e. Section 146 of the Patents Act 1970 (as amended) read with Rule 131 of Patent Rules 2003 including Form 27, and penal provisions provided in Section 122…” This feedback is to be submitted by March 16th, 2018 and sent to Dr. W.M. Dhumane at firstname.lastname@example.org Dr. Usha Rao email@example.com. Subsequently, selected stakeholders will be invited for a consultation meeting to be held on March 21, 2018. This is noteworthy in the context of our Patent Working PIL, during the course of which, the Delhi High Court asked the Government to submit an affidavit outlining the proposed framework and timeline for enforcing the patent working disclosure mandate and also to consider reviewing/revising the Form 27 format.
Pankhuri announced that The World Trade Institute of the University of Bern, Switzerland and the Centre for WTO Studies, Indian Institute of Foreign Trade, India will be conducting the 5th WTI – CWS Joint Academy on International Trade Law and Policy (“Joint Academy”), from June 4 to June 29, 2018 in New Delhi. The last date for submission of applications is March 30, 2018.
The suit was filed for permanent injunction and related reliefs against the infringement of the plaintiff’s mark, KINLEY. The court had granted an ex parte interim injunction against the defendants. However the defendants did not appear despite service. Therefore the averrments in the plaint and the plaintiff’s evidence went unrebutted, it was deemed to be true. The court decreed the suit accordingly.
M/S.Lyca Productions v. J.Manimaran — Madras High Court [February 22, 2018]
Suit was filed for permanent injunction and related reliefs against the copyright infringement of the plaintiff’s film KARU, for which it had Guild Registration. The Appeal Court in this order, while reviewing an order granting interim injunction found that the lower court’s decision was per incuriam and that the plaintiff has been unable to make out a prima facie case. The Court hence dismissed the appeal.
This order of the Court gave effect to a memo of compromise arrived at between parties to a suit for permanent injunction and related reliefs against infringement of the plaintiff’s mark, label and trade dress XXX.
Suit was filed for permanent injunction and related reliefs against the infringement of the plaintiff’s design of a jug. The defendant claimed that the Court did not have jurisdiction. The Court, relying on Proviso to Section 22(2) of the Designs Act, found that a design infringement suit can be instituted no lower than the District Court, and that ‘any person’ can instituted the suit. The Court further noted that the alleged acts arose in Jodhpur, and hence the Court had territorial jurisdiction to entertain the suit (under Section 20 of the CPC.
Suit was filed for permanent injunction and related reliefs against the infringement and passing off of the plaintiff’s mark, WOODS in the incense market. The court found that the offending mark was deceptively similar to the plaintiffs, and the product and mode of conducting trade is the same. Moreover, the infringement had been going on for a long period of time. Hence, the Court granted the plaintiff’s prayers and held that he would be entitled to damages and costs of the suit.
Suit was filed for permanent injunction and related reliefs against the infringement and passing off of the plaintiff’s mark, KALANJIYAM. The plaintiff was able to establish prior use and registration, and the sole defendant undertook to change the name of his business to RATHI TEXTILES, and hence the suit was decreed accordingly.
Suit was filed for permanent injunction and related reliefs against the infringement and passing off of the plaintiff’s mark, THALAPPAKATTI. The plaintiff withdrew the suit.
M/S.Justickets Pvt. Ltd vs Orbgen Technologies Pvt. Ltd. Madras High Court [February 5, 2018]
Suit was filed for permanent injunction and related reliefs against the infringement and passing off of the plaintiff’s mark, TICKETDADA as a domain name, or on any other web form. However, neither of the parties were present in the court on several occasions that it was listed on the board. The Court dismissed the suit.
M/S.Unisept Nourishments v. M/S KTC Ventures — Madras High Court [February 5, 2018]
This order of the Court gave effect to a memo of compromise arrived at between parties to a suit for permanent injunction and related reliefs against infringement of the plaintiff’s mark, label and trade dress LASSI HOUSE.
The petitioner approached the Court under Article 226 to delineate the ICAI from the IOCAI, and use the same as trademarks to represent the two institutions. The Court held that this was not the appropriate forum for the relief sought, and directed the petitioner to approach the Court under the Trademarks Act, 1999.
Star India Private Limited v. Department Of Industrial Policy and Promotion & Ors. — Madras High Court [March 2, 2018]
The petitioner challenged a TRAI tariff order on grounds of copyright. The Court however, could not arrive at a unanimous decision, and referred the decision to the third judge.
Preethi Kitchen Appliances Pvt. Ltd. v. Baghyaa Home Appliances & Anr. — Madras High Court [March 1, 2018]
Suit was filed for permanent injunction and related reliefs against the infringement of a registered design in respect of tripod shaped base unit for mixer grinder and passing off. The Court compared the two products and found similarities between the two designs, and also noted that the defendant was a late entrant in the market and registrant of the design. Hence, it held in favour of the plaintiff.
Power Soaps Ltd. v. M/S. C M Detergent — Madras High Court [February 20, 2018]
Suit was filed for permanent injunction and related reliefs against the infringement of the plaintiff’s marks POWER and DK. However, since the plaintiff stopped using the mark DK, it wished to withdraw the suit, and the Court permitted the same.
Today Merchandise Private Ltd. v. Www.Indiatodays.Com — Delhi High Court [March 5, 2018]
Suit was filed for permanent injunction and related reliefs against the infringement of the plaintiff’s trademark and domain name. The Court opined that the defendants had no real prospect of defending the allegations, and have not even entered appearances despite service. Since the averments and evidence of the plaintiff unrebutted, it was deemed true and correct, and the suit was decreed accordingly.
Apollo Hospitals Enterprise Ltd v. Sri Sai Apollo Pharmacy — Madras High Court [March 1, 2018]
Suit was filed for permanent injunction and related reliefs against the infringement of the plaintiff’s mark, APOLLO. Based on facts, the Court noted that this was a clear case of infringement, and the defendant’s mark was deceptively similar to the plaintiff’s which could cause confusion in the minds of the consumer. Hence, the Court granted the plaintiff’s prayers.
M/S.Ultra Tile Pvt. Ltd v. Shri Ganesh Tiles & Granites — Madras High Court [March 1, 2018]
Suit was filed for permanent injunction and related reliefs against the infringement of the plaintiff’s mark, ULTRA in the tiles market. The Court found that the defendant had infringed on the plaintiff’s mark and that the product is same as is the channel of trade. Hence, the Court granted the plaintiff’s prayers.
M/S.Nexmoo Solutions (India) Pvt. Ltd. v. M/S.Nexmo Inc. — Madras High Court [March 1, 2018]
Suit was filed for permanent injunction and related reliefs against the infringement of the plaintiff’s trademark and domain name, NEXMOO. The Court presided over an application for an interim injunction by the plaintiff. The Court found that the test for an injunction was satisfied by the plaintiff, and hence granted the injunction.
M/S.Classik Cooling Towers v. M/S.Classic Equipments — Madras High Court [February 23, 2018]
Suit was filed for permanent injunction and related reliefs against the infringement of the plaintiff’s trademark, CLASSIK COOLING TOWERS. The plaintiff withdrew the suit for want of jurisdiction.
The Hindu published yet another story in today’s edition on the issue of access to the new TB drugs like bedaquiline and delaminid. We’ve been tracking The Hindu’s coverage of this issue on the blog over here, here and here. Unlike the earlier reportage, The Hindu has finally acknowledged some of the issues that we have flagged relating to safety and efficacy of both drugs, given pending clinical trials. Today’s report notes that both drugs “are yet to pass large-scale safety and efficacy tests, or phase III of clinical trials, which are necessary for India’s drug regul
ator approval.” (The report however is quiet on the fact that the DCGI has approved this drug without mandatory phase III clinical trials.)
There are however several factual issues in the article, which I will flag first before tackling the larger issue raised by the article.
The perils of calling the new TB drugs magic bullets
To begin with, I think it is very problematic when a newspaper like The Hindu decides to classify bedaquiline and delaminid, as “magic bullets”. TB experts like Dr. Madhukar Pai have cautioned the media against using phrases like “miracle drugs” to describe bedaquiline. The following is a quote from an Indian Express report:
“I have already seen media reports from India which call Bedaquiline a ‘miracle drug’. This worries me – terms like ‘miracle drug’ should not be used lightly as it can raise expectations and also encourage abuse. More evidence is needed on how Bedaquiline fits in with existing and other new drug regimens. It is not intended to be used alone,” Pai explained.
With regard to delaminid, as we have pointed out earlier The Hindu (a different reporter) has earlier reported on how the drug’s performance was disappointing in recently concluded Phase III trials. I extract the relevant portion of that earlier report below:
“Delamanid drug, approved for use in multidrug-resistant tuberculosis (MDR-TB) patients by the World Health Organisation in October 2014, did not show any statistically significant difference in successfully curing the disease or reducing the mortality rates compared with a dummy in a Phase III human clinical trial, WHO’s position statement issued on January 15 says.”
So why call them “magic bullets” and give false hope to patients?
The number of patients suffering from MDR-TB – where are the sources?
The second factual issue pertains to the statistics put out in the news report. The report states the following:
“The World Health Organisation says that 423,000 Indians die each year of tuberculosis (TB), which is about 1,159 people a day. As standard TB-drug treatments are ineffective for nearly 1,30,000 of the 2.8 million TB patients in India, two relatively-new and powerful drugs, bedaquiline and delamanid, could benefit such patients with drug-resistant (DR) TB. With a success rate of approximately 70%, these drugs are now being called ‘magic bullets’. The Indian government says that nearly 13,000-20,000 patients qualify for treatment with these drugs.”
“But as of today there are 1,000 patients on bedaquiline and another 81 on delamanid in India’s national programme, which has received these drugs as a donation from the innovator pharmaceutical companies.”
The first rule of citing statistics when reporting is to also cite the source of the statistics. The Hindu report fails to do so. In our earlier post, we had relied on a government report that put the figure of MDR-TB patients at 79,000. The Hindu puts the figure at 1.3 lakhs. It then claims that only 13,000-20,000 patients qualify for the drug i.e. not all MDR-TB patients qualify for these drugs. Thankfully, The Hindu has finally acknowledged this aspect, albeit implicitly. It would have been nice if The Hindu also acknowledged that its reporting a few days ago was erroneous because it gave the impression that all 1.3 lakh DR-TB patients require the new drugs. I quote from its earlier report:
“India has nearly 1.3 lakh DR-TB patients, the most in the world, but the Health Ministry gets only 10,000 doses of Bedaquiline and 400 doses of Delaminid.”
The Hindu needs to get these statistics correct and provide authoritative sources as citations.
The Lancet study that claimed a 74% cure rate
The Hindu’s report today cites a study published in The Lancet Infectious Diseases journal by MSF to claim that 74% of the patient cohort converted to negative within 6 months and that MSF has recommended scaling up the use of the drug. I am not a medical expert and far be it from me to question a study published by the MSF but I did have a look at the report. It appears to be an observational study on 28 patients at 3 different locations: 7 in Armenia, 7 in India and 14 in South Africa. That is hardly a statistically significant figure given that drugs like bedaquiline are usually tested on over 1,000 patients. Moreover, the MSF study only recommends, as The Hindu rightly notes, the use of bedaquiline and delaminid in combination for only those patients with few treatment options. It does not recommend rolling out the drug for the entire population of MDR-TB patients or XDR patients. Exactly how many patients qualify for the combination therapy in India is not clear.
Dr. Jennifer Furin and her continuing tirade against the Indian Government
After citing the MSF study, The Hindu reports that the MSF’s conclusion is backed by “Independent medical experts” and proceeds to quote Dr. Jennifer Furin. The Hindu fails to mention that Dr. Furin was part of the MSF study published in the Lancet Infectious Diseases journal. How can a newspaper cite the author of a study as an independent medical expert?
Further, Dr. Furin is quoted as saying the following:
“Less than 10% of India’s TB patients, who qualify for these drugs are on them. Contrast this with Swaziland, where 90% of patients who needed new drugs received them. Rather than offer them the best possible therapy, TB patients in India are offered old drugs which have terrible side-effects. The newer agents are being ‘protected’ in case other people need them in the future. The older regimen has a 50% success rate and side-effects include permanent hearing loss in a significant proportion of patients (more than 25% in some settings).”
Dr. Furin is once again under the impression that the Indian government isn’t making the new TB drug available to a wider population because it is “protecting” or “saving” them for future use. I am not sure where she is getting this information from because from the information that Balaji and I managed to get from the government, including a sworn affidavit, the Indian government is not making this drug widely available because Phase III clinical trials have not yet been completed. That is a completely reasonable proposition. So why is Dr. Furin repeatedly peddling falsehoods about the government denying access to the drugs because it is saving up the drug for future use? I am all for bashing the Indian government on issues pertaining to health but it is not okay to make up facts.
The claim that 70% to 90% of drugs that enter phase III successfully complete Phase III
One of the arguments used by The Hindu to justify calling for the scaling up of the new TB drugs (on the lines suggested by MSF) is its claim that “70% and 90% of drugs that enter this stage successfully complete phase III.” Once again, The Hindu refuses to mention the source of this claim. I have always been under the impression that a majority of drugs that enter phase III fail to clear that stage, which is why pharmaceutical companies justify outrageous prices for new medicines. Anyway, since The Hindu made such a claim I did some research. There appears to be at least one industry sponsored study, reported on in the Reuters, that makes a similar claim that at least 80% of drugs that enter Phase III trials are finally approved. However it is important to qualify that study with another study published by the United States Food & Drug Regulatory Authority (USFDA) which documents at least 22 cases where drugs that showed promise in Phase II trials failed to clear Phase III trials. The study highlights why phase III trials are important. I don’t think we will ever get an accurate figure on how many drugs actually clear Phase III because as per the USFDA study quoted earlier only “9 in 10 drugs/biologics that are tested in humans are never submitted to FDA for approval”.
Apart from the USFDA study, I would like to point readers towards this blog post by Dr. Anupam Singh, a TB survivor and a Doctor of Internal Medicine, who has explained his various reasons for disagreeing with The Hindu’s reportage and the importance of Phase III clinical trials. I think he makes convincing arguments.
Framing the issue of access to experimental therapy as a “human rights” issues
A new aspect in today’s report in The Hindu is its attempt to frame the lack of access to bedaquiline and delaminid as a “human rights violation”. The report cites a patient activist, Nandita Venkateshan as saying the following:
“I am deaf. I did not have access to these medicines and my life crumbled to pieces. People don’t know that TB treatment is as toxic as cancer treatment. How is it morally or economically justifiable to deny care to patients? We don’t refuse or ration treatment to cancer patients even though there isn’t a perfect cure. HIV treatment was experimental when patients started getting it because of the gravity of the epidemic,”
“It is a human rights violation to use just enough TB patients as laboratory rats while withholding treatment from the rest of the patients who either die or go deaf,”.
Ms. Venkateshan raises a valid issue that has no perfect answers. How should we as a society decide on the issue of access to experimental drugs whose safety and efficacy has not yet been established? I can’t even imagine what must be going through the mind of a XDR-TB patient reading reportage about these new “magic bullets” against TB and then being told that access to such drugs is curtailed on the grounds that the safety and efficacy of the drug has not yet been conclusively established despite promising results. This is an old debate in the US where patient groups and pharmaceutical companies have teamed up to lobby for greater access to experimental drugs for diseases that demonstrate high mortality rates. The uncomfortable logic that backs these arguments is that the patients in question are anyway going to die so why not just give them access to new experimental drugs? The uncomfortable answer to that uncomfortable question, is that the patients in question may die quicker and perhaps more painful deaths precisely because we don’t know how the drugs work. With bedaquiline, the fear is that the Phase II trial showed higher mortality than the other arms of the study. It is also important to not forget the Thalidomide babies – the reason that we follow stringent 3 stage clinical trial program.
So how do we as a society make that call?
The answer is not in black and white as made out by The Hindu. It is a hazardous grey and one that we need to debate in more detail.
In the meanwhile, if we are worried about the “human rights” of TB patients, we should also question why the government is making Indian patients sign consent forms that force them to waive their right to compensation and worse, not even informing them of the high mortality rates associated with the drug? Informed consent is a human right. Telling patients that their data is going to be transmitted to a private company is a part of their right to informational privacy. Not informing them of the same is violation of their human rights. Why is nobody raising these issues despite Balaji and me raising them in our previous posts? If you don’t want to acknowledge us as the source of the information that’s fine with us but at least raise the goddamn issue!
Over the last week, The Hindu has been reporting on the issue of access to two new TB drugs called bedaquiline and delaminid. As Balaji and I have pointed out in our last two posts on SpicyIP, there are serious issues with both stories that The Hindu published on March 3, 2018 and March 4, 2018. A third story published in today’s edition of the paper, titled “WHO launches plan for cheaper TB drugs” is with regard to a recent “expression of interest” published by the World Health Organisation (WHO) inviting pharmaceutical companies to pre-qualify their products for procurement programs administered by WHO. These prequalification programs involve an evaluation of manufacturing facilities and product portfolios of pharmaceutical companies, on the basis of which their products may be procured by WHO.
The Hindu’s report, starting with its title, gives the impression that the mere inclusion of bedaquiline and delaminid, in the WHO’s EoI is going to lead to the drugs being more affordable. The report quotes a MSF representative saying the following:
Inclusion of the two new drugs, Bedaquiline and Delaminid, in the pre-qualification call is being interpreted by aid agency Médecins Sans Frontières (MSF) as WHO’s backing for generics.
Christophe Perrin, pharmacist at MSF said, “It is clear from the EoI that WHO considers the two drugs key compounds to address challenges of drug-resistant TB. It also means that they want to encourage generic competition to start finding ways to make these medicines available in countries where they are not yet registered. The EoI allows generics manufacturers interested in producing these two drugs, and currently facing technical challenges, to address their questions to WHO’s pre-qualification team.
But the mere inclusion of two drugs in a WHO EoI does not change the patent status of the drugs. As of now, both drugs are patented in India and elsewhere in the world. The WHO cannot alter the status of the patents protecting these drugs in India and across the world. This basically means that only Janssen and Otsuka can manufacture bedaquiline and delaminid and supply it to WHO. As a result, the price of the drugs is likely to remain high unless both companies decide to lower the price of the drug in India.
It will be difficult to replicate the success of low cost HIV/AIDS generic drugs manufactured by the Indian industry at the height of the AIDS epidemic because as The Hindu rightly notes, India did not have a products patent regime at the time. This meant that Indian manufacturers could manufacture generics that could not be manufactured in countries where patents were in force. The situation in 2018 is very different. Indian generics can’t enter the field without procuring licenses from the patentees. There has been loose talk about compulsory licenses but let’s not forget the fact that one of the reason new TB drugs are so rare is because it is a disease that afflicts poor countries and hence is not financially lucrative. If India, with the largest TB affected population in the world issues compulsory licences for these two drugs, it is likely to affect future investments in TB research. Unlike other drugs which are in any case invented for developed country markets, TB is a disease of the developing world. If the developing world does not provide incentives, why is private investment going to come into TB research?
The bigger elephant in the room, however, is the issue of safety and efficacy of both drugs. As The Hindu itself has reported in January, 2018 Phase III clinical trials of delaminid were disappointing. And as the government has explained to the Delhi High Court Janssen’s bedaquiline is yet to complete Phase III clinical trials.
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