SpicyIP Weekly Review (June 2013, Week 5)

In a historic development, the negotiators at the WIPO Diplomatic Conference at Marrakesh last week concluded the 'Treaty to Facilitate Access to Published Works by Visually Impaired Persons and Persons with Print Disabilities'. The draft text of the treaty is available here. Several civil society organizations who have relentlessly fought for the treaty since 2008 were in boundless joy with the news. The negotiations were intense and faced huge roadblocks from publishing lobby in US and EU. Readers can soon expect a detailed analysis on the treaty. 

Pfizer's testimony leads the way as US pressure on India increases (Part I & Part II)

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In an excellent two part post (here and here), Swaraj exposes the lies, misrepresentations and disingenuous claims against Indian's IP policy from governmental and industry groups in the US. Leading the pack is Pfizer's Chief IP Counsel, Roy Waldron, who recently in his testimony before US House of Representative accused India of violating TRIPS obligations and harming innovation by granting compulsory licenses. Waldron noted that the provision 'effectively nullified the contributions of the whole discipline of pharmaceutical sciences'. In Part I, Swaraj dwells into fallacious allegations of TRIPS violations by India and demonstrates how this is nothing but a case of double standards by US. Subsequently, more than 150 members of the US Congress wrote to President Obama criticizing India's patent regime and suggested action before WTO dispute settlement body. In Part II, Swaraj looks into several other reports emanating from US on India's IP regime. 

IPO publishes all ‘Statements of Working’ for 2012

Section 146 of the Patents Act, 1970 requires patentees to submit information relating to working of the patent to the Controller General every year. Finally, the Patent Office for the first time has uploaded the ‘Statements of Working’ filed by patentees for last year (i.e. 2012) on its website (here). One had to file an RTI application in order to obtain the information previously. As Prashant rightly states, this information is critical for evaluating the performance of patent system in India. 

Delhi High Court grants ex-parte injunction against Aprica Pharma

The Delhi High Court granted yet another ex parte injunction in patent infringement suit against Aprica Pharmaceuticals on June 17, 2013. The injunction prevents Aprica from launching generic versions Merck's Sitagliptin sold under brand names, Januvia and Janumet. Madhulika notes that the 'vaguely' worded order  neither discusses the patent claims nor finds infringement in any specific product. Incidentally, the High Court denied interim relief to Merck against Glenmark for the same drug, a fact which doesn't find any mention in the latest order against Aprica. 

Online censorship continues

Anubha brought to our attention the recent order of the Department of Telecom (DoT) which directed ISPs to block 39 websites for hosting pornographic material. Yet again, the DoT passed the order callously without specifying any reasons for blocking the site. Incidentally, the Supreme Court has asked the IT Ministry and the Home Ministry to respond to a recent PIL seeking a ban on pornographic content on the internet and also criminalizing viewing as a non-bailable offense. 

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In a similar but unrelated incident, Moutshut.com filed a PIL earlier this year before the Supreme Court seeking orders to quash the abusive IT Rules (Intermediary Guidelines), 2011 and declaring them as violative of Articles 14, 19 and 21 of the Constitution. Mouthshut.com is a popular platform to review consumer products and services. Unfortunately, it had to face the brunt of the Bombay High Court recently after a complaint filed by Sharda University for alleged objectionable comments against them on the site.

Legality of 'reverse payments' in EU

UK based Solicitor and Head of EIP Legal, Gary Moss, analyses the recent decision of the European Commission (EC) to impose a whopping 160 million euro fine on Lundbeck and four generic manufacturers for entering into 'reverse payment' agreements. Ranbaxy is one of the four generic manufacturers slapped with 10.3 million euros for agreeing to delay generic version of Lundbeck's blockbuster antidepressant, Citalopram in 2002. Lundbeck strongly disagreed with the Commissions' decision and stated that: 'Patent settlement agreements are efficiency enhancing and legitimate when there are bona fide grounds for dispute'. Ranbaxy too, expressed its disappointment and announced its intention to appeal before General Court of the European Union. The exact nature of violation of anti-trust law is unclear at this point. Moss concludes with raising pertinent questions on parameters the Commission would have employed to scrutinize settlement agreements against infringement suits. 

MPP succeeds in licensing key HIV medicines

Gopika reported a recent success recorded by the Medicines Patent Pool (MPP) in assisting patent licensing negotiations between Gilead Sciences and Karnataka-based Shilpa Medicare. The UN backed MPP has been created to improve access to HIV/AIDS medicines in developing and under-developed countries by assisting in licensing negotiations between patent holders and generic drug manufacturers. This latest license agreement between Gilead and Shipla extends to manufacture and sale of five key HIV/AIDS patented medicines in over 100 countries. The royalty rate hovers between 3-5 percent on the market price.

'Om Shanti Om' copyright infringement dispute (Update)

Aparajita blogged on the copyright infringement dispute pending before the Bombay High Court pertaining to Sharukh Khan's home production, Om Shanti Om. Prior to the movie release in 2007, a certain scriptwriter by the name Ajay Monga, alleged that the movie infringes his script titled 'The Silent Movie'. Before moving to the Bombay High Court in 2008, Monga agitated the matter before the Film Writers Association which went in vain. The High Court, however, refused to grant an interim relief in 2008 as there was a considerable delay in filing the suit from the date when legal notice was served. In March this year, the Court framed the issues and asked Monga to submit evidence in support of his claim by 2nd of April. Subsequently, the High Court on April 18, 2013 dismissed the suit. However, the High Court restored the suit on June 18, 2013 after allowing a notice of motion from the Plaintiff's lawyer with directions to pay a total of Rs. 20,000/- as cost to Defendants.  

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Kerala’s Endosulfan Ban –The science that never got discussed 

This guest post from award-winning journalist, Priyanka Pulla, explores the ban on use of endosulfan by the Kerala government. Many have attributed the tragedy in Kasargod, Kerala to the aerial spraying of pesticide, endosulfan (organochlorine class) which has been declared as persistent organic pollutant (POP). In a piece published in Open magazine, Ms. Pulla argued that there is no epidemiological evidence to establish any causal relationship between use of enodsulfan and diseases in Kasargod. In this guest post, Ms. Pulla explores if the Kerala government was correct in banning endosulfan by invoking the precautionary principle.

As per the Stockholm Convention, only a chemical which has a half-life of more than 6 months in soil (persistence) can be classified as POP in addition to three other factors. In a research paper authored by Ivan Kennedy of University of Sydney demonstrated that endosulfan has a half-life greater than 6 months when tested in a laboratory or in arctic regions. On the other hand, the half-life period is much lower than 6 months in tropical climates. Ms. Pulla queried three of scientists, whose works are believed to have been instrumental in listing endosulfan as POP, about Kennedy’s findings. Interestingly, two of studies were conducted in a laboratory and the other did not measure half-life at all. Furthermore, Crispin Halsall of Lancaster Environment Centre who supports the classification agreed with Kennedy’s arguments on half-life. 

What about alternatives to endosulfan? Ms. Pulla states that there is no data on safety of other alternatives to endosulfan proposed by the Stockholm Convention. Furthermore, cashew growers in Kasargod who switched to organic farming were apparently hit by tea-mosquito bugs.

A quick look at Venus & PPL’s challenge to copyright amendments

As reported earlier, Venus Worldwide Entertainment Pvt. Ltd. and Phonographics Performance Limited (PPL) have jointly filed a writ petition challenging the constitutionality of Sections 31(1)(b), 31D and 33A(2) and their corresponding rules under the Copyright Rules, 2013. The petition is more or less similar to Super Cassettes Industries Ltd. (T-Series) challenge to compulsory licensing and statutory licensing scheme affecting music companies. This petition additionally challenges the right to appeal against tariff scheme prescribed by copyright societies under Section 33A(2). The role of Copyright Board in determining royalty rates and removing ‘unreasonable’ elements in prescribed tariff scheme is seen as unwarranted and unreasonable interference to freedom of contract. Furthermore, it argues that there is no public utility in the favourable treatment meted out to radio broadcasters who operate on purely commercial basis. Consequently, the provisions are challenged as violation of Articles 14, 19(1)(c), 19(1)(g), 21 and 300A. The contentions against Sections 31(1)(b) and 31D are similar to the ones raised by T-Series.

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SpicyIP Tidbit: Update on Om Shanti Om Copyright Dispute

We would like to thank our readers who brought to our notice certain updates with regard to the Om Shanti Om copyright case (here). As informed, the case has been restored as of June 18, 2013. The High Court order restoring the same is available here. Reportedly, the cause for delay in filing evidence and documents was due to certain personal difficulties Monga's lawyer was facing. The case has been placed for 'directions' on July 17, 2013.

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Guest Post: The legality of 'reverse payments' in the E.U.

The issue of reverse payments, appears to be a rather hot topic this year, with both the U.S. and the E.U. cracking down on this practice, where an innovator pharmaceutical company, which owns a patent, pays off a generic competitor to not enter the market. Last week we had a guest post by George Yu, on the U.S. Supreme Court's decision in the Acatavis case. Today we have for our readers a guest post by Gary Moss, a U.K. solicitor, specialising in patent litigation and the Head of EIP Legal, London.  

The legality of 'reverse payments' in the E.U.

by

Gary Moss

Gary Moss

Competition authorities around the world are taking considerable interest in how pharma companies are using their patents to maintain their positions in the market, and in particular, whether they are using them in a way which breaches anti-trust laws.  One item which appears to have particularly exercised them is the so called “reverse payment” where the pharma company / patent holder pays a sum of money to a “generic” in return, ostensibly, for the generic agreeing to drop its challenge to the pharma company’s patent and to stay off the market for a given time. 

 Spicy IP recently published herethe report on recent case on this topic which came up before the United States Supreme Court and which had been instigated by the Federal Trade Commission.

 The latest salvo was fired last week by the European Commission when it fined Lundbeck of Denmark and four other generic companies (Merck KGaA / Generics UK,, Arrow (now part of Activis), Alphapharma (now part of Zoetis) and Ranbaxy) a total of €146 Million.  The largest fine (€93.8 Million was levied on Lundbeck.  Rambaxy was fined €10.3 Million.

 According to the press release which was issued by the Commission (the full text of which can be found here)

 In 2002, Lundbeck agreed with each of these companies to delay the market entry of cheaper generic versions of Lundbeck's branded citalopram, a blockbuster antidepressant. These agreements violated EU antitrust rules that prohibit anticompetitive agreements (Article 101 of the Treaty on the Functioning of the European Union – TFEU)……..

Citalopram is a blockbuster antidepressant medicine and was Lundbeck's best-selling product at the time. After Lundbeck's basic patent for the citalopram molecule had expired, it only held a number of related process patents which provided a more limited protection. Producers of cheaper, generic versions of citalopram therefore had the possibility to enter the market. Indeed, one of them had actually started selling its own generic version of citalopram and several other producers had made serious preparations to do so.

Experience shows that effective generic competition drives prices down significantly, reducing dramatically the profits of the producer of the branded product and bringing large benefits to patients. For example, prices of generic citalopram dropped on average by 90% in the UK compared to Lundbeck's previous price level once wide-spread generic market entry took place following the discontinuation of the agreements.

But instead of competing, the generic producers agreed with Lundbeck in 2002 not to enter the market in return for substantial payments and other inducements from Lundbeck amounting to tens of millions of euros. Internal documents refer to a "club" being formed and "a pile of $$$" to be shared among the participants. Lundbeck paid significant lump sums, purchased generics' stock for the sole purpose of destroying it, and offered guaranteed profits in a distribution agreement. The agreements gave Lundbeck the certainty that the generics producers would stay out of the market for the duration of the agreements without giving the generic producers any guarantee of market entry thereafter. These agreements are very different from other settlements of patent disputes where generic companies are not simply paid off to stay out of the market.

 Unfortunately the Commission decision is not currently publicly available, nor is the Statement of Objections which was served on the various entities and which specifies the exact nature of the objectionable behaviour.  What is clear is that underlying this was some form of settlement agreement relating to patent litigation over citalopram.  To quote from Lundbeck’s press release (the full text of which can be found here)

Lundbeck strongly disagrees with the Commission's decision. It asserts that any settlement agreements involving a transfer of value from an originator to a generic company is a restriction of competition and the value transfer reflects an understanding that the patent is invalid or weak.  This approach is erroneous. There is no question about the validity of Lundbeck's process patents at issue.  Patent settlement agreements are efficiency enhancing and legitimate when there are bona fide grounds for dispute.

The agreements did not restrict competition in the market beyond the protection already offered by society via the patent rights Lundbeck already held and as has been confirmed by the European Patent Office (EPO). Over 600 meticulous analyses of the generic citalopram demonstrated that they were all produced with infringing processes. Furthermore, in many concurrent documents the generic companies acknowledged that their products violated Lundbeck's patents.

Lundbeck welcomes competition between companies. Lundbeck also strongly believes in and advocates for a level-playing field, which includes that intellectual property rights should not be  ignored and infringed by third parties, since this seriously damages innovators' investments and reduce their incentives to innovate.

The company acted transparently and in good faith in trying to protect our patents.

Ranbaxy has been similarly vitriolic in its condemnation of the decision.  It issued the following statement:

 "Ranbaxy is disappointed with the decision by the European Commission to rule its patent settlement agreement with Lundbeck, covering the molecule Citalopram, anti-competitive, and intends to appeal the decision in the General Court of the European Union…….These events took place over 10 years ago, and the company considers that the Commission has misunderstood the facts and misapplied the law.  It believes it has strong grounds of appeal.” 

An appeal against the Commission’s decision will lie to the General Court of the EU, with the possibility of a further appeal to the Court of Justice of the EU.  At that stage hopefully there will be provided greater transparency as to what exactly the Commission found so heinous.

This decision needs to be viewed in context.  In 2008 the Commission conducted an investigation into the pharmaceutical industry with particular reference as to how the industry (allegedly) used its patent in order to restrict competition.  Although the Commission made something of a song and dance about the outcome, identifying that generic entry into the market was delayed by a period on average of 7 months following patent expiration (EU Commissioner Neelie Kroes was quoted as saying “Overall it is indeed a conclusion that there is something rotten in the state”), to many commentators eyes the outcome was something of a damp squib.  The press release issued by the Commission at the end of this Inquiry can be found here. (For those people who are interested the writer recommends reviewing Robin Jacob’s (formerly Lord Justice Jacob) masterly presentation to the inquiry the text of which can be found here In its press release following the inquiry the Commission stated:

 To reduce the risk that settlements between originator and generic companies are concluded at the expense of consumers, the Commission undertakes to carry out further focused monitoring of settlements that limit or delay the market entry of generic drugs.

This latest action by the Commission needs to be seen in that light.

What is of interest to commentators is how the Commission intends to prove that the agreements under scrutiny did not constitute genuine attempts by the parties to settle their ongoing patent dispute?  Are they going to effectively attempt to retry the patent dispute which was settled to show that one or other of the parties was bound to win and thus had no legitimate interest in settling?  And are the parties going to be forced to prove exactly the opposite of what they would have been intending to prove had those cases not been settled – i.e. will Lundbeck be required to establish that the generic companies could have succeeded and shown that the patents relied upon were invalid?  Conversely will the generic companies need to show that their cases were not so strong that they could be certain of winning?  If so it will indeed make for an interesting spectacle.

 For the time being, however, in the absence of further detail that is all speculation. 

In the meantime the Commission has two other investigations on the go.  One relates to perindopril in which Servier, Teva, Mylan and several others are in the Commission’s sights, and the other relates to fentanyl, where Johnson & Johnson and Novartis / Sandoz are involved.  The former investigation relates to settlement of patent disputes, the latter involves a co-promotion agreement.  Interesting times - watch this space!

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Internet Censorship: Is Blocking Porn Possible?

Reportedly in yet another order, the Department of Telecom (DoT) has ordered a few ISPs to block 39 websites. The list has not been disclosed; however mostly consists of file sharing websites- especially ones which allegedly facilitate sharing of pornographic content. The reasons for blocking have not been specified, keeping in trend with DoT’s previous orders lacking in transparency. The order merely says, "It has been decided to immediately block the access to the following URLs... you are accordingly directed to immediately block the access to above URLs."

The IT Act, 2000 and the Indian Penal Code do not decriminalize watching pornography, only production and transmission is illegal. The government can order removal of content only if the website is hosted in India. Most of these websites are hosted in the US (and legal in the US), thus this move by the DoT to block access to these pages is seriously over-reaching. It must be noted that the Intermediary Guidelines, 2011 ask intermediaries like ISPs to "inform users of computer resources not to host, display, upload, modify, publish, and transmit any information that is obscene and pornographic". The government clearly wants to control what Indians can watch over the web.

In 2001, a PIL was filed in the Bombay High Court requesting blocking of porn sites as porn is illegal in India, thus it is the duty of the government to devise a mechanism to block the same. The Court commissioned a study with advocates and technical members and concluded in its judgment that it was not feasible to employ unscientific filtering technology which would actually constitute an act of censorship. In April 2013, the Supreme Court sought response from the government on a PIL to block and ban porn sites and making viewing porn a non-bailable offence. Industry experts have suggested that the mechanism  would  involve triggering of an alert the moment a blacklisted website is accessed. However, to ban porn and track viewers the government will also have to ban perfectly legitimate softwares such as Virtual Private Networks(VPN) and proxy servers (which help in circumventing the servers and allow access to blocked content). Now, blocking VPN and proxy servers would be a draconian move; yet if the government seeks to accomplish a ban on viewership of porn, it is a necessary step. Users are already complaining about sweeping blocking orders by the DoT, which has led to some legitimate software being rendered inaccessible. 

Further, any blanket ban would be ineffective because everyday new software tools crop up to defy censorship. Anyway, instances show that it is futile to block these URLs because the sites simply change URLs and continue to operate. Removal of content is only possible when the servers hosting porn lie within the court’s jurisdiction. Thus, even a comprehensive anti- pornography legislation banning online viewership doesn't stand to make much improvement to the existing situation. It will just be another miserable example of the Indian government desperately trying to censor the cyberspace.

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Delhi High court grants ex-parte injunction order against Aprica Pharma

On 17th June, in a patent infringement suit initiated by Merck, the Delhi High Court passed an ex parte injunction order, preventing Aprica pharmaceuticals from launching generic versions of Januvia and Janumet. The high court order can be accessed here.

Merck’s counsel argued that the drug (sitagliptin) has been patented in over 102 countries. Merck’s counsels also contended that the invention entailed huge investment and the sales of the medicine in India alone exceeded several crores and in case the defendants (Aprica) are able to launch their product, irreparable loss and injury would be caused to them.

Justice Sanjeev Sachdeva opined “The plaintiff has established a prima facie case on merits and I am of the view that in case ex parte injunction is not granted to the plaintiff and defendant is able to launch the product, irreparable loss and injury would be caused to the plaintiff, which cannot be compensated in terms of money. Balance of convenience is in favour of the plaintiff.”

Vague order?

The order employs standard language and does not seem to address the general principles issued by Supreme Court in such cases. (Not that I am complaining about the outcome itself!). Prashant, in his previous posts has discussed the general principles laid down by the Supreme Court precedents.Although not explicitly stated in the order, the fact that the patent had been granted in other major jurisdictions worldwide seemed to have worked in Merck’s favour.

The order does not discuss the patent claims and there was no finding of infringement of any specific product. The order restrains the defendant from dealing with any product that infringes subject matter of the patent (talk about vague!).Also what’s more, there is no reference to the previous order where the court refused to grant interim relief to Merck, for the very same drug. Readers may recall that we had covered the previous order denying interim relief to Merck over here.

What was different in the previous order? Well, Glenmark argued that their product comprises three components (sitagliptin, a dihydrogenphosphate and a crystalline form). Glenmark also argued that Merck had filed separate patents for sitagliptin, a dihydrogenphosphate salt form considering the salt form to be a new invention worthy of a separate patent. The patent to the dihydrogenphosphate salt form was abandoned. Merck failed to satisfactorily plead the circumstances for obtaining a separate patent application and the court denied interim relief to Merck.

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Mad rush for sitagliptin? 

As Prashant points out, The Form 27 working statement filed by Merck for the year 2012, reveals that the sales of Januvia and Janumet put together exceeds 180 crore (whopping amount)! The sales of its closest rivals Novartis’s (Vildagliptin) i.e. Galvus and Galvus-met is around 165 crores for the year 2012!!

Also,the health ministry in India recently banned pioglitazone belonging to the thiazolidinedione class of anti-diabetic drugs because of reports of increased risk of bladder cancer associated with its use. Another anti-diabetic drug Rosiglitazone belonging to the thiazolidinedione class was banned a few years ago following reports of the drug causing cardiac problems. So apart from metformin and sulphonylureas, the only alternative left for Type-II diabetics amongst oral hypoglycemic drugs are gliptin class of molecules. No wonder everybody seems to want to have a piece of the sitagliptin pie!

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Negotiating licenses between patent holders and generic producers: the Medicines Patent Pool

The Medicines Patent Pool (MPP), backed by the United Nations, is a mechanism that has been formed with the intention of increasing access to HIV medicines in the developing world by increasing their affordability. The MPP negotiates licenses between patent holders and generic producers to make and sell HIV medicines at affordable prices to those who need it. An analysis of the concept of patent pools can be found here and here.  

The latest is the license negotiated by the MPP between the patent holder, Gilead Sciences and given to Shilpa Medicare, a Karnataka based generic producer to produce five key HIV medicines for sale in over 100 countries. The five HIV medicines for which the license is given are tenofovir, emtricitabine, cobicistat, elvitegravir and a combination of the four known as “the Quad”. 

Although, the purpose of the license is to provide these medicines to the needy at affordable prices, MPP makes no commitment about the price and the sale price of the drugs is as set by the market. From the market price of these medicines, a royalty of 3-5 per cent will be paid by Shilpa Medicare to the patent holder, Gilead Sciences depending on the medicine. It is interesting to note that Gilead Sciences was the first company to enter into an agreement with the MPP. Swaraj's post on the same is available here.

Shilpa Medicare is the sixth license holder of drug patents held by Gilead Sciences, through an agreement negotiated via MPP. The five other generic producers who tapped into the MPP to obtain licenses of Gilead Sciences are Aurobindo, Shasun, Laurus, Hetero and Emcure. Aurobindo, additionally holds another set of license of  pediatric HIV medicine, which was licensed to MPP by ViiV Healthcare. (ViiV Healthcare's colloboration with MPP is covered here.) This enables Aurobindo, a generic producer to produce medicines patented by Gilead Sciences and ViiV Healthcare, enabling greater access to needy people at affordable prices. This also provides Aurobindo an opportunity to produce combination drugs using the drugs patented by Gilead Sciences and ViiV Healthcare, which is generally impossible as the patents are owned by different companies. Such combination techniques, facilitated by MPP are an important and much more effective part of HIV treatment, as patients find it easier to take one pill that combines different drugs as opposed to the same drugs separately. This opinion finds support within the medical community, including organisations such as Doctors Without Borders.

The MPP acts as an intermediary between the patent holders and the generic producers. The participation of the patent holders in MPP's pool is voluntary and is mainly composed of large drug makers. Generic producers who express an interest to tap into the patent pool are assessed on various criteria including quality. The generic producers are usually required to obtain approval from regulatory authorities such as the US FDA or the WHO pre-qualification programme to tap into the patent pool. There is also a license management process which ensures through mechanisms such as quarterly reviews that the MPP licenses actually result in impact. However, questions have been raised about the licensing agreement, an excellent analysis of which is available here.

This is a welcome measure for the people of the developing world who are, many a time, denied access to life saving HIV medicine mainly because of its expense. As MPP works through a platform of voluntary participation, there has rightly been a call for increased participation by companies that hold patents for HIV drugs through MPP, not only because this leads to increased access through greater affordability but also provides for effective treatment by making the possibility of combination therapy between drugs patented by different companies possible.

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Om Shanti Om: Copyright Dispute



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A suit for copyright infringement, filed by scriptwriter Ajay Monga, in relation to the blockbuster movie ‘Om Shanti Om’ was recently dismissed. For all orders in relation to Ajay Monga v Red Chilli Entertainment Ltd. see here.

The plaintiff (Ajay Monga) alleged infringement of his copyright over the script ‘The Silent Movie’. He argued that upon completion of his script he had distributed it to various producers, including the defendants. Subsequently, the defendants released the film Om Shanti Om (2007) and it was claimed that the movie was based on the plaintiff’s script. Thereafter, the plaintiff approached the Film Writers Association in vain.

In 2008, he responded to a public notice that was issued (7/4/2008) with regard to objections pertaining to telecasting of the film. In his response he stated that the said film infringed his copyright and insisted that the film should not be telecast. This response was sent to Mutli Screen Media Pvt. Ltd.

After this, on 5/8/2008 the plaintiff filed a suit for infringement under S. 13 and 14 of the Copyright Act, before the Bombay High Court. The plaintiff had prayed for an interim injunction to stop the defendants from, directly or indirectly, exploiting the film ‘Om Shanti Om’ by any mode or medium. The Single Judge of the Bombay High Court, however, refused to grant the interim injunction on the grounds of gross delay of filing the suit (4 months delay). The court observed that though, a legal notice was sent by the plaintiff on 7/4/2008, no steps were taken by him to immediately file the suit and seek ad interim reliefs. Moreover, the plaintiff gave no explanation for the delay. Thereafter in November 2008, the plaintiff sought time to file an affidavit in rejoinder.

In March 2013, the Bombay High Court framed the issues – which included questions such as – whether the suit was bad for non-joinder of Mutli Screen Media Pvt. Ltd.? Whether the plaintiff can prove that he is the owner of the script? Whether, by broadcasting the film, there has been infringement of the plaintiff’ copyright? Whether the plaintiff is precluded from filing the suit on account of an undertaking given by him to the Film Writers Association? The court also asked the parties to file their documents of evidence and other documents by April 2, 2013.

On April 18, 2013, the Bombay High Court dismissed the suit. As the judge recorded, this decision came after the plaintiff had failed to submit evidence and relevant documents despite frequent reminders.

It would have been interesting to read the judgment that would have come out of this case, had it traveled through. However, one wonders why the plaintiff could not produce evidence and documents on time given  that he had initiated this case 5 years back. Should the court have provided more time? Are script-writers just trying their luck? Or is there is something else going on? These questions will hopefully find answers in the months to come.

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A quick look at Venus & PPL’s challenge to copyright amendments

As reported earlier, Venus Worldwide Entertainment Pvt. Ltd. and Phonographics Performance Limited (PPL) have jointly filed a writ petition challenging the constitutionality of Sections 31(1)(b), 31D and 33A(2) and their corresponding rules under the Copyright Rules, 2013. The petitioners initially filed this petition before the Supreme Court (W.P.(C) No. 122 of 2013), however, withdrew the challenge with leave to approach the High Court. The petition is more or less similar to Super Cassettes Industries Ltd. (T-Series) challenge to compulsory licensing and statutory licensing scheme affecting music companies. With PPL joining the fight, this petition also challenges the right to appeal against tariff scheme prescribed by copyright societies under Section 33A(2). Our guest blogger, Chaitanya, has analyzed the substantive grounds of challenge to Sections 31(1)(b) and 31D raised by T-Series here. 

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Needless to say, the common underscore to both petitions are claims of high risk in content creation, huge production costs and soaring piracy. The role of Copyright Board in determining royalty rates and removing ‘unreasonable’ elements in prescribed tariff scheme is seen as unwarranted and unreasonable interference to freedom of contract. It denies any public utility in the favourable treatment meted out to radio broadcasters who operate on purely commercial basis. Consequently, the provisions are challenged as violation of Articles 14, 19(1)(c), 19(1)(g), 21 and 300A. The contentions against Sections 31(1)(b) and 31D are similar to the ones raised by T-Series. Below is the gist of arguments raised in the petition: 

Section 31(1)(b): As per the provision, the Board can grant a compulsory license over sound recordings for refusal to communicate works to the public after hearing the copyright owner. The latest amendments grant powers to the Board to extend the license not only to the complainant but also to such ‘other persons’ who in their opinion are qualified to obtain the license. Venus points out the absence of right to be heard against ‘other persons’ and thereby violating principles of natural justice. Furthermore, it contends that the lack of any guidance fixing ‘reasonable’ royalty rate gives the Board unbridled and arbitrary powers. It fears that the provision encourages licensees to abandon contractual agreements with music companies despite not applying for any license under Section 31(1)(b). 

Section 31D: The newly inserted statutory licensing scheme allows broadcasting organization to communicate literary, musical works or sound recordings by merely giving a notice of broadcast to copyright owners in the manner prescribed in Rule 29. The Board will fix the royalty rate as per the procedure laid down in Rule 31. Similar to arguments raised against Section 31(1)(b), it contests the fixing of royalty rate as arbitrary. The petition denies any intelligible criteria in excluding other classes of works (namely, artistic, dramatic and cinematographic works) from the licensing scheme. Furthermore, it alleges discrimination in restricting the statutory licensing provisions to only one of the seven exclusive rights the copyright entails, i.e. public performance or communication to the public. Venus also points out the ambiguity in application of Sections 31(1)(b) and 31D as both provide for licenses to communication of sound recordings.

Section 33A(2): Section 33A(2) allows users to appeal against tariff scheme prescribed by copyright societies before the Copyright Board. The Board in turn has powers to remove any ‘unreasonable’ element in the prescribed tariff scheme. Again, the petition questions the competence and qualifications of the Board in determining ‘reasonableness’ in tariff scheme without legislative guidance. PPL argues that this provision causes prejudice to members of copyright society vis-à-vis music labels not part of any copyright society. Furthermore, it fears that it would discourage music labels from becoming part of copyright societies as the provision unfairly interferes with freedom to negotiate licensing terms. The petition also contends that Rule 56(3), (4) & (5) and Rule 57(3) & (4) as not only unconstitutional but also exceeds the scope of Section 33A. Rule 56 and 57 deals with the procedure for publication of tariff scheme and appeals to the Board, respectively. 

In a nutshell, the petition argues that the above provisions confer arbitrary powers to the Copyright Board in determining ‘reasonableness’ in fixing of royalty rate and hence violates Article 14. The petition also raises alarm on the qualifications of Board members and their track record in adjudicating matters. However, does not raise any challenges to either Sections 11 and 12 or Rule 3. Furthermore, their claims on violation of Article 19(1)(g), 21 and 300A are based on the justifiability of favourable treatment to radio broadcasters in licensing sound recordings. It questions the public utility in licensing of works to commercial driven entities. Lastly, it argues that the provisions discourage music labels to join copyright societies and thereby violating fundamental right to form associations. Readers can soon expect a detailed analysis of the petition soon.

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Internet Censorship: Gagging Mouthshut.com

While Facebook and Youtube routinely get several requests to delete offensive content, Mouthshut.com recently has been at the receiving end of several legal actions for facilitating consumers to post negative reviews. Mouthshut is a popular site which provides consumers a platform to post their reviews of products and services. It was launched in 2000 and is regarded as a reliable source of information. In April, the Bombay High Court ordered Mouthshut to delete reviews critical of Sharda University. Another case filed by a certain Pune based Kumar builders claiming damages for 2000 crores is pending too. Mouthshut has a strict policy which does not let users delete the review unless specifically requested by the user. It states that they will delete a review only if the original author requests or if there is a court order asking it to remove a review.

Indian cyberspace is largely governed by Information Technology Act, 2000. Insertion of section 66A in the Information Technology Act, 2000 penalised dissemination of ‘any information that is grossly offensive or has menacing character...’. A negative comment can easily be held illegal under this. The provisions leave ample room for sweeping interpretation of comments, thereby burying the principles of free speech. Further, the Information Technology Rules 2011 place responsibility on the website owner to remove ‘offensive comments’, failing which they could face legal prosecution. This report demonstrates how ISPs have started removing any dissenting comment complained as ‘offensive’, without actually going into the merits of the takedown request. The vagueness of these laws has been discussed on this blog (here and here).

As a consequence of increasing legal threats and actions, in April 2013, Mouthshut filed a filed a writ petition in the Supreme Court for quashing the IT Rules, 2011 on the grounds that the rules are violative of articles 14, 19 and 21. Eminent lawyer Harish Salve appeared on behalf of Mouthshut. The petition pleads that the Rules curtail free speech, and are vague and rather uncertain regarding the criteria for removal of allegedly offensive content. 

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Part II: Pfizer's testimony leads the way as US pressure on India increases

Part I of this looked into some of the claims that Pfizer has made. This part looks into what that testimony has led to.

170 Members of US Congress write to Obama criticizing India's IP regime

The effects of Waldron's testimony, no doubt combined with other lobbying efforts, have led to 170 US Members of Congress writing to President Obama, urging him to ensure 'these issues are raised at the highest levels of the Indian Government and that they are a top priority at the upcoming US-India Strategic dialogue and other bilateral and multilateral meetings.' KEI has made the letter available here.

The letter specifically mentions the Nexavar Compulsory license but without giving reasons other than  it's a "stage three liver and kidney cancer drug". Presumably, the letter is referring to the same reasons that Pfizer's Waldron used in his testimony - ie, the local working requirement. Presumably, they've also skipped over the main reasons for the Nexavar CL (ie, that the medicine was made available to only 2% of the patients and that it was very unreasonably priced at Rs 2.8 lakhs/month).
Regarding the local working requirement - this certainly is controversial. However, there are strong arguments (for eg: 'justified differential treatment' + technology transfer goals of TRIPs) that say it does not fall afoul of Art 27 of TRIPs.
(A similar provision present in Brazilian law was challenged by the US at the WTO, but US withdrew the complaint before any ruling could be given on the matter. Brazil assured US that they would consult with US in case it chose to use that provision to issue a CL).
Though this time they may actually have an argument (as opposed to their claims discussed in part I), once again their confident 'imposition' of this unilateral conclusion on the matter seems disingenuous to me. This opinion is informed by surrounding circumstances as mentioned below.
[On a side note, the Indian Patent Office's latest move of publishing all Statements of Working, is bound to be making a few companies very uncomfortable. Readers can look forward to more from SpicyIP on that front] 

As KEI also points out, "the letter cites the USPTO's statistics claiming that 30 percent of the American work force are employed by intellectual property intensive industries. As noted by KEI previously, however, that USPTO report contained misleading data and more than eighty-three percent of those "IP-intensive" jobs were actually employed by those industries considered to be "trademark intensive"; grocery stores were listed as the top IP-intensive industry."

In any case, this letter is not the only thing that's going around about India's IP regime. A few more IP Reports coming out from US are listed below:

1. Special 301 Report: The latest edition put India on the Priority Watchlist. It too focused on Novartis, Nexaver and data protection. We've covered it before in some detail here,

2. GIPC IP Index: The "Global Intellectual Property Center", run by the US Chamber of Commerce, ranked India last in their inaugural index. They also only ranked 11 countries, of which India was (one of?) the only lower middle income countries. Incidentally, this was also the report that Waldron cited in his testimony before the House of Representatives. The GIPC website issued a statement when India's first Compulsory License was issued (March 2012) saying they were disappointed and that a reliance on compulsory licenses was bad for innovation and didn't go into any other reasons. A 'reliance on CLs' when it was the first ever CL granted that they were talking about? They also issued a statement when the Novartis judgment came out showing their disappointment without giving any reasons other than to state that nearly 40 other countries had given the patent to Novartis. And referring to the Supreme Court as the high court, didn't do anything to boost my confidence in their unsubstantiated opinions either.

3. The IP Commission Report: The Report of the Commission on the Theft of American Intellectual Property : Signed by some current and former governmental higher-ups, this report gives some bizarre recommendations even within US law - like giving IP owners the power to remotely lock up your computer if you try to access their files, and requiring law enforcement to unlock it. With respect to India, it just vaguely mentions how terrible India's IP regime is. Some of their referrals include mention of weak criminal enforcement mechanisms for IP violations, some quotes from USTR's 2013 Special 301 Report, incentivizing provincial and municipal leaders in India to create business environments that protect IP, and a few references to the local working requirement. Techdirt has a bit to say about this report.

4. 2013 National Trade Estimate Report on Foreign Trade Barriers. Issued by the office of US Trade Representative. As per this article, the US government has accused India of lacking “effective protection against unfair commercial use of undisclosed test and other data generated to obtain marketing approval for pharmaceutical and agrochemical products”. It has also stated that India has “weak protection and enforcement of intellectual property rights” and that recent patent-related happenings have only “heightened concerns.”

5. 2013 Joint Strategic Plan on Intellectual Property Enforcement: Prepared by the US IP Enforcement Co-ordinator, this report seemed more well prepared than the first three. Regarding India, it discusses actions taken by the USPTO IP attache in India. While it did voice concerns about IP in India, it seemed a lot more balanced and matter of fact - skipping the alarmist attitude that were present in some of the other reports.


Curiously enough, despite all this, the US-India joint statement issued on the recently concluded US-India Strategic Dialogue makes no mention of patents or pharma or even intellectual property! Meanwhile, Indian Ambassador to US, Nirupama Rao, asserted that the Indian patent regime was not discriminatory against foreign companies and offered to discuss the issue with concerned law makers.

Despite my clear lack of faith in much of these reports and my belief that nearly all of Big Pharma (+ associated lobbyists) efforts are more self serving than anything else, I do believe that India needs to wake up to its healthcare concerns. Given our poverty levels, even if innovation continues to come from the west (despite current drying pipelines), India's not going to be in a position to ensure access to medicines as Big Pharma is hardly likely to deal with developing country diseases and that too at developing country prices. And despite all their claims, patient assistance programs are hardly sufficient even when present. And in any case, charity is hardly a business model for India to rely on.

At the same time, I don't see how promoting stronger patent rights are going to address this concern either. Are programs like OSDD extendable? Private Public Partnerships? Patent pools? Prize systems? Health Impact Fund? Workable theories are out there and solutions need to be worked on. And in the mean time, India needs to ensure it maintains its balance in this innovation versus access debate. 

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Part I: Pfizer's testimony leads the way as US pressure on India increases

Readers may remember our recent coverage of Pfizer's Chief IP Counsel, Roy Waldron's testimony before a hearing of the US House of Representatives and the heated exchange that followed between Waldron and the Indian Pharmaceutical Alliance (IPA) thereafter. Waldron's main allegations were that the Indian Pharmaceutical patent regime flouted international trade rules and abused the compulsory license system and recommended that the US government use all means at its disposal to get India in line. IPA responded with a strong letter of their own rebutting Pfizer's main points. Since the time of that post, I've also received a copy of Pfizer's response to IPA, dated 23 May 2013 (available here). 

There are a couple of things which stood out to me about Pfizer's statement. Due to the effect that their lobbying is evidently having I will address these in Part I.  Part II will look at the larger context of international pressure that US is trying to create towards establishing a stronger pharma patent regime in India. (Warning: Both posts are fairly long)

Pictured above: Image too humorously relevant to not include
Source

I. Pfizer's response: 

Let me start off by stating that I think India has a long way to go to better the innovation climate for pharmaceutical products. Having said that, aside from Pfizer's growing revenues coinciding with their growing complaints, there are some essential parts of Pfizer's statement where I can't help but think that they are shamelessly engaging in intellectual dishonesty. And this is having dangerous repercussions as will be discussed in part II later. 

Waldron says that India's patent regime has failed to reach standards required by TRIPs due to S.3(d) which allegedly "effectively nullified the contributions of the whole discipline of pharmaceutical sciences". He then points to the Glivec (Novartis) case as an example to prove his point, stating that bioavailability is the holy grail for pharmacists and by any definition is a more therapeutically effective drug. He goes on to state that India's reason and rationale for not complying with the full extent of its TRIPS obligations is 'related to preserving its domestic industry's export markets'. 

Firstly, the Glivec case is a ridiculous example to take, simply because Novartis did not submit data to back up any claim of increased therapeutic efficacy over the former 'known substance' imatinib mesylate. Contrary to what Waldron seems to indicate, the Court had in fact stated that increased bioavailability "can" be linked to therapeutic efficacy. However, as the judgement holds in para 189 “In this case, there is absolutely nothing on this score apart from the adroit submissions of the counsel. No material has been offered to indicate that the beta crystalline form of Imatinib Mesylate will produce an enhanced or superior efficacy (therapeutic) on molecular basis than what could be achieved with Imatinib free base in vivo animal model.” 

To state that a Court should grant a decision in Novartis' favour when they fail to submit evidence to back up a claim is disingenuous. 

Further, Pfizer's claims as to what consists of evergreening should've taken into account their own experience in Pfizer v Apotex, when a US Fed Cir Court ruled that their claimed advantage of increased solubility and stability were not sufficient 'since it found the claimed advantage (better solubility and stability) to be fairly ordinary and the result of mere routine experimentation.' Simply put - trivial changes cannot be passed off as incremental innovation. 

Secondly, for all their declarations of India not fulfilling their WTO TRIPs obligations, Pfizer's submission was clear that they did not want this to go to the WTO dispute settlement body. They do however want US to use 'every available bilateral and multilateral fora to push their message - apparently this doesn't include the WTO forum itself. My opinion is very simply that they know a decision on this issue would likely go in India's favour . This would a) encourage other countries to follow India's role on encouraging only therapeutically innovative pharmaceutical patents, and b) would remove leverage for pushing for (unnecessarily) stronger patent rights. 

Very briefly, the reasons why India's S. 3(d) would likely be held as TRIPs compliant: 

The WTO DSU (Art 3.2) mandates that the existing provisions of the covered agreements are to be clarified in accordance with 'customary rules of interpretation of public international law.' This takes us to the Vienna Convention on the Law of Treaties, 1969 (VCLT), which holds that provisions of a treaty must be interpreted in accordance with the ordinary meaning to be given to the terms of the treaty, “in their context” and “in the light of its object and purpose”. For the object and principles, we turn to Art 7 and 8 of the TRIPS Agreement.

Art 7 (Objectives) emphasizes a balance being struck between technological advancement and social and economic welfare, to the mutual benefit of producers and consumers of technological knowledge.

Art 8 (Principles) also sets forth some of the basic principles of the Agreement, providing that “Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health ... provided such measures are consistent with the provisions of this Agreement.”

And of course the Doha Declaration on TRIPs and Public Health unequivocally affirmed that TRIPS "can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all."

Allowing the grant of insufficiently inventive or trivial patents or otherwise lax standards, can result in blocked legitimate competition, discouraging further innovation, market distortions and distort trade and harm for public welfare.  A provision like S.3(d) prevents these harms, and due to its applicability in the pharmaceutical sector, encourages therapeutically beneficial innovation rather than minor changes to known compounds which do not increase health benefits and yet allow monopolistic costs. 

More than mere compliance, I'd go as far as to say that S 3(d) in fact protects the regime that TRIPs sets up.  

As for the question of discrimination in field of technology:

Aside from mandating the three requirements for patentable subject matter (new, inventive step, and capable of industrial application), Art 27.1 mandates that “…patents shall be available for any inventions, whether products or processes, in all fields of technology… ” and “…without discrimination as to … the field of technology…”. It does not however define these requirements, leaving room for interpretation. Art 7 and Art 8 already suggest that Art 27.1 requirements can be crafted to suit member country needs. 

In Canada - Patent Protection of Pharmaceutical Products, the panel described 'discrimination' as "results of the unjustified imposition of differentially disadvantageous treatment." The panel also stated that Art 27 does not prohibit bona fide exceptions to deal with problems that exist only in certain areas. While there is 'differential' treatment, S.3(d) is not 'differentially disadvantaging' in its application. It recognizes that a unique problem exists with chemical entities - i.e., the possibility of 'evergreening' - and puts forward a condition which ensures that these trivial changes cannot be patented. Indian patent law still requires patentable subject matter to be new, involve an inventive step, and be capable of industrial application. On top of this, it is recognizing that ignoring this problem could lead to high public health consequences, and puts forth S.3(d) to handle that situation. Thus is it 'unjustified imposition of differentially disadvantageous treatment'? No. It is simply justified imposition of differential treatment. And it is hopefully something that other countries aren't scared / politically pressured against incorporating in their own patent regimes. The fact that Pfizer/US specifically want to avoid going through the rightful dispute settlement mechanism to decide this, to me, is indication enough that they are well aware of the actual 'strength' of their claims and fear that a panel ruling on this will delegitimize their claims. 

Amongst his other statements, Waldron also claims that India is violating its TRIPs obligations due to its 'local working' requirement for Compulsory licenses, and due to the lack of a provision providing protection for proprietary data. 

There are certainly arguable - to - definitive counters that can be made to most (but not all) of his points. (For eg: See part 3 here, and any of the posts here) I am not going into them for now. I simply wanted to point out that while certain central claims of his statement are plain wrong and others are certainly arguable, this has been portrayed as a real and present 'danger' to the US House of Representatives. This sort of laced rhetoric is not only dangerous for the millions that rely on the low priced drugs that India enables but also because it contributes to the simple minded "Stronger IP = more innovation" rhetoric. It removes focus from the necessity of keeping in mind all the various factors that are required to be considered while formulating pharmaceutical innovation and access to medicine policy. 

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Agreement reached on Treaty for the Visually Impaired!

Some great news came out of Marrakesh last night as negotiators and civil society took to social media to celebrate consensus finally being reached on the Treaty for the Visually. KEI also put out a short clip of the reactions and congratulations going around just after the agreement was reached - available here. Mr Raghavender, Registrar of Copyrights and part of India's delegation, is at 2:15 and he notes that "it's a great day in the history of Copyright law today". Jamie Love of KEI's tweeted, "WIPO reaches historic agreement on treaty for blind... blind and civil NGO extremely happy."

This agreement had a long and hard journey but despite opposition where there should've been none, it seems to have finally come to a fruitful conclusion - one that finally puts in place a legal regime that allows print disabled people to get access to print material that everyone else can take for granted. 

The draft has been made available by IP-Watch here. We should be able to cover the treaty in more detail on the blog soon. As per Mr Raghavender, "Only ritual of official adoption will take place in Marakesh Diplomatic Conference in a couple of days." More reactions from people who've been working hard towards this are available here. A big congratulations to all those who worked so hard over the last 5 years to get to this result! And lest we forget one of the strongest proponents for this treaty - hopefully this final outcome is one that Rahul Cherian would've appreciated as well. 

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Guest Post: Kerala's Endosulfan Ban - The science that never got discussed

We have for our readers today, a post by an award-winning journalist, Priyanka Pulla who has previously blogged for us over here on Ayurvedic medicines. She was recently awarded the first prize in the Science and Innovation category of the RedInk Awards for Journalism, 2013 for this story on Flock Theory and the Synchronies of Nature, published in Open, over here. One of her more recent stories in Open Magazine, available over here, was on the Endosulfan tragedy where she boldly questions whether the tragedy even occurred? In this post, Priyanka questions the science behind the ban on Endosulfan in India. While this is not a conventional post for a blog like SpicyIP - it does raise important questions of regulation of science in the country and if history has taught us one thing, it is the link between regulation and innovation: the degree of regulation can often set the pace of innovation. Priyanka's post, is a convincing reminder of why India needs a better system of regulating science. Priyanka's post is very well researched and a must read for those of you even remotely interested in how science is regulated in India. For those of you interested in following Priyanka's writing in greater detail, you can follow her on here blog: http://layscientist.blogspot.com

Kerala’s Endosulfan Ban---The science that never got discussed

by Priyanka Pulla

While researching my article in Open on ‘Kerala’s endosulfan tragedy---Did it really happen?’, I came across several controversial points of view among the scientists I interviewed. These views have never really been debated in India, and probably never will, given the politicization of the events in Kerala. But in an ideal situation, they should have.

Increasingly (not just in India, but the world over), there is a tendency to conflate several issues surrounding a subject. In the case of GM foods, environmentalists conflate health effects, farmer suicides, super-weeds, contamination by transgenes, and Monsanto’s monopolistic practices, in their argument against GM foods. But these are five distinct issues, with five different sets of arguments. Here is an excellent article in Nature that separately addresses three controversial GM-related subjects and summarizes the state of evidence in each of them.

Similarly, in the case of the endosulfan ban, there were two separate questions---a) Were the diseases in Kerala caused by endosulfan? b) If they weren’t, should India have banned endosulfan, invoking the precautionary principle?

Image from here.

My story, which can be accessed here, argued that there was no credible epidemiological evidence that the diseases in Kasargod were caused by the aerial spraying of endosulfan.

But I did not address the other part of the debate. Should India have banned endosulfan?  

My research made me realize how divided scientists are on this issue. Interestingly, the differences are mostly about the policy decision to ban endosulfan, and not about the scientific ‘facts’ this decision was based on. There was broad consensus on the properties of endosulfan. And one thing I can say for sure is that contrary to what environmentalists claim with so much confidence, it is not a ‘well-known fact’ that endosulfan is bio-accumulative and harmful to humans.  

To understand the ‘facts’ of the issue, one needs to understand the criteria the Stockholm Convention uses to label a chemical as a persistent organic pollutant or POP. A POP is defined as a chemical that has four properties. First, it is persistent in the environment and does not degrade for long periods of time. The Stockholm Convention says chemicals with a half-life of more than 6 months in soil are POPs.  Second, the chemical should be capable of accumulating in living creatures---i.e, the rate at which an organism absorbs it should be greater than the rate at which it excretes it. Third, the chemical should be capable of long-range transport. And last, the chemical should impact human health adversely.

Let’s begin with persistence.

According to Ivan Kennedy, a professor of environmental chemistry from the University of Sydney with  numerous published papers on the behavior of endosulfan,  the data cited by the Stockholm Convention’s POP review committee to prove that endosulfan has a half-life greater than 6 months was either laboratory data or data from arctic regions. Both tend to be extreme values. Average values should have been used, considering that in warm, tropical climates, where 95% of the world’s endosulfan usage occurred till recently, endosulfan’s half-life in soil is much lower than six months.

In a document titled “Invalid basis for listing endosulfan as a POP: A critique with strong evidence that the Stockholm Convention is exceeding its mandate, ” Kennedy systematically questions the relevance of each bit of data cited by the Stockholm Convention’s POP Review Committee as evidence that endosulfan is a POP. He says these data and papers were cherry picked and did not reflect field conditions in tropical climates. Further, the process of listing endosulfan as a POP did not include peer-review, and therefore, could easily have been hijacked by political motivations.

I reached out to three of the scientists whose papers Kennedy said were cherry picked. In essence, Kennedy said that while the studies by these scientists were of good quality, they do not show that endosufan is persistent in the field, because they are lab studies. The scientists I contacted were N Sethunathan (author of ‘Persistence of Endosulfan and Endosulfan Sulfate in Soil as Affected by Moisture Regime and Organic Matter Addition’, Bulletin Environmental Contamination and Toxicology, 2002 ), Volker Laabs (author of ‘Fate of Pesticides in Tropical Soils of Brazil under Field Conditions’, J. Environ. Qual,2002), and N Vasudevan (author of ‘Effect of Tween 80 added to soil on the degradation of endosulfan by Pseudomonas aeruginosa’, International Journal of Environmental Science and Technology, 2007).

Their responses were fascinating.

N Sethunathan believes endosulfan is persistent. But he agrees that his study was a lab study, as Kennedy alleges, and not a field study.

N Vasudevan said his study did not measure ‘persistence’ and half-life at all. They were only measuring prevalence of the pesticide and distribution in soil.

Volker Laabs agreed that his study was a lab study, but believes it is still relevant to the Convention’s decision. But he also agreed that endosulfan is unlikely to be persistent in tropical climates such as India.

All in all, I’d say Kennedy’s arguments bear out.

Next, I spoke to another UK-based environmental chemist, Crispin Halsall, of the Lancaster Environment Centre. His 2010 paper “Endosulfan, a global pesticide: A review of its fate in the environment and occurrence in the Arctic” in the journal Science of the Total Environment is also cited by the POP Review Committee. Further, Halsall advised the Committee and believes the decision to classify endosulfan as a POP was correct.

When I ran Kennedy’s arguments past him, however, Halsall seemed to agree with them broadly. He agreed that endosulfan is not persistent or bioaccumulative in tropical climates, but argued that even POPs like DDT behaved differently in different climates. However, he agreed that evidence of harm to human beings was not conclusive.

But his main point really was that even if there is inconclusive evidence about the health effects of endosulfan, it is enough to invoke the precautionary principle. According to him, classifying chemicals such as DDT as POPs was easy, because they were such obvious POPs. But with chemicals such as endosulfan, the evidence is weaker. Increasingly in the future, he feels, there will be more debate as chemicals such as endosulfan, which are ‘on the cusp’, come up for inclusion among POPs.

The first twelve chemicals to be classified as POPs by the convention were known as the Dirty Dozen. These included DDT, chlordane and dieldrin. These are “true POPs”---chemicals whose properties make them very obviously toxic. These chemicals easily meet the Stockholm Convention’s criteria. This means their half lives in soil are clearly higher than six months; they are clearly bioaccumulative; they travel long ranges; and they clearly effect human health.

But endosulfan is on the cusp. It may have some properties similar to true POPs, but in other ways, it behaves very differently.

Given all this, Keith Solomon, a professor of environmental science at Canada’s University of Guelph, feels the precautionary principle is just being used as a political tool in the endosulfan case. In a paper published this year in the Journal of Agricultural and Food Chemistry, Solomon authored a section on endosulfan, broadly making the same points Kennedy did in his criticism of the Convention’s decision. Solomon believes the use of precautions is enough, given the evidence on endosulfan, and that classification as a POP was an overkill.

Image from here

What makes this debate more interesting is that Solomon is a co-author of the Science of the Total Environment paper, together with Crispin Halsall. Basically, two co-authors of the same paper disagree on the subject they are summarizing.

Given this background, let’s cut back to India.  First, why does India need endosulfan?

I quote from my story in Mint in 2011. “India is the supplier of 70% of the world’s endosulfan needs—a market valued at $300 million (Rs 1,340 crore). Out of the 9,000 tonnes India produces every year, half is bought by the country’s 75 million farmers, making it the world’s largest consumer of endosulfan. Much of it is used by farmers with small and marginal holdings, because endosulfan is cheap—Rs 286 per kg—and has a broad spectrum of effects. Alternatives such as flubendiamine and imidacloprid cost Rs 13,800 and Rs 2,229 per kg, respectively. Endosulfan is sprayed on all major crops such as vegetables, cotton, pulses and rice to combat pests such as whitefly, leafhoppers, aphids and cabbage worms, without harming insects such as bees, which help in pollination. “This is one of the safest insecticides for pollinators,” said A.K. Chakravarthy, entomology department head at Bangalore’s University of Agricultural Sciences (UAS).”

So, clearly, banning endosulfan would have a very significant impact on farmers’ livelihoods.

Let me add that being friendly to pollinators such as bees is no small deal.  Among the alternatives to endosulfan that were proposed by the Stockholm Convention, Imidacloripid is already being implicated in bee colony collapse disorder. Also, endosulfan has been used for so many years that there is enough data on how to use it safely. The same cannot be said about newer pesticides such as Flubendiamide. All pesticides, by nature, are toxic. Should we, then, prefer a pesticide that we have more data about, or switch to a newer, less-tested one, driven by fear?

Another alternative to endosulfan that the Stockholm Convention suggested was organic farming. I tried very hard to determine the impacts of organic farming in Kasargod after the ban on pesticides. C Jayakumar, an environmentalist with Thanal, an NGO which was a major campaigner against endosulfan, told me in an email that organic farming was working out fantastic for Kasargod.

But, as always, there was another side to the story.  

K M Sreekumar, the entomologist I quoted in my article, gave me the example of a rice farmer whose 400 acre crop was destroyed by an attack of leafhoppers, because endosulfan had been banned, and no suitable organic alternative was available yet.

Unfortunately, the Plantation Corporation of Kerala does not release data on cashew yields. So there is no way of knowing if overall yield in its cashew estates was affected due to abrupt shift to organic farming. But when I spoke to the managing director of PCK, he agreed that there had been an initial loss of productivity due to the increased attack of tea-mosquito bugs.

This is to be expected. Any shift to organic farming takes time, because a farm system must stabilize and adjust to the new interventions. During this time, pesticides should be made available for use as a last resort. But this didn’t happen in Kasargod. Research has shown that in cashew plantations, any shift to organic farming immediately causes a loss of yield of up to 50 percent before the system recovers. Clearly organic farming, for all its benefits, is no cakewalk.

To sum it up---there was a lot more to the endosulfan issue than what was reported by the Indian and global media. In taking its decisions, India was driven by fear and possibly misled by the political motivations behind the Stockholm Convention’s decision. What it should have done instead was carry out a high-quality epidemiological study of its own, evaluate the scientific evidence, and then taken a suitable decision. It could have been the same decision as it is today, but a more meaningful one. 

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