Civil society sounds the war cry for affordable Herceptin – Roche’s worst nightmare comes true

A coalition of NGOs, breast-cancer-survivors and academics have shot off a letter to the Prime Minister of India demanding measures to ensure that Herceptin, the breast cancer drug sold by Roche is made more affordable for Indian women. The letter dated 5^th of November, 2012 can be foundhere and does not appear to have been picked up by the mainstream media as of yet. You can join the Facebook group over here.

The letter provides the Prime Minister with details about breast cancer, Herceptin and the cost of treatment with Herceptin in India. Readers may remember that we had previously described the cost of Herceptin in an earlier post available over here. In my opinion, this letter to the PM is actually quite kind to Roche and for reasons unknown it eschews the rhetoric that is common in such letters.

Most of you may already know that Herceptin, is a breakthrough cancer drug, which was taken to the market by Genentech Inc., a company later taken over by Hoffman La’ Roche. Herceptin can be used to treat only a particular kind of breast cancer known as the HER2+ mutation. I had blogged about it over here. Although this kind of cancer is quite aggressive, Herceptin is known to be particularly effective against it. What makes Herceptin all the more attractive (for the lack of a better word) to cancer patients is the fact that it has virtually no side-effects save for a runny nose. Conventional chemotherapy can be quite painful to the patient, since it is associated with hair-loss, vomiting amongst other severe side-effects. Not to mention that it is also relatively ineffective.

In India, Herceptin was originally priced at Rs. 1,10,000 per vial. This was later reduced to Rs. 75,000 per vial when Roche entered into a marketing arrangement with the Pune based Emcure Pharmaceuticals Ltd. Although the letter to the PM mentions that the price is now Rs. 72,000 and that the number of doses is limited to 12 doses over a year, I have information, on good authority, that the revised price is actually Rs. 75,000 and the required number of doses, if administered at a three week interval are between 18-20 doses. This would mean that at the original cost of Rs. 1,10,000 an entire cycle of treatment with Herceptin would have cost close to Rs. 20,00,000 (Rs. 20 lakhs). With the reduced cost of Rs. 75,000 per dose, the entire cycle of treatment now costs Rs 13,50,000 (Rs. 13.5 lakhs). Does it make Herceptin more affordable? Hardly! Like I had stated before most middle class Indians cannot afford this drug even if they have insurance. We are talking about a country with an annual per capita income of about US $ 1000.

To give you some perspective on the issue let me give you an example: An Indian Supreme Court judge earns a salary of Rs. 90,000 per month. Even a judge of the highest court in the country will not be able to afford Herceptin on his or her salary. It is a different matter that government employees and judges are covered under a very generous government insurance scheme but the example is illustrative of the obnoxious pricing strategy followed by Roche in India.

Like I discussed earlier with respect to Pegasys, the Hepatitis C drug sold by Roche, at around Rs. 4.5 lakhs for the entire cycle – it was selling the drug to a mere 0.01% of its target market. Clearly there are no takers for even life-saving medicine if it is priced at such a high price. Drugs like Herceptin have a huge market and companies like Roche can make a ton of money even if they slash the prices further. For example, the letter mentions that 100,000 Indian women are diagnosed with cancer every year – I think the numbers are higher. Given that Herceptin is slowly being approved for other kinds of cancer too it is possible that its market will only increase.  

Commenting on the price cuts by Roche the letter states that the cuts “are defensive and pre-emptive measures to preserve its monopoly in India against the issuance of compulsory licensing and price control measures by the Indian government.” The letter also alleged that “The agreement between Roche and Emcure does not involve any transfer of technology or create any possibility for the entry of other players into the market - Roche will continue to produce the drug at its plants in the US, Singapore and Germany and ship vials to Emcure for packaging.”

The unique aspect of Herceptin in the Indian market is the fact that despite not being patented as of yet (I think!), there is not a single generic manufacturer in the country. This is all poised to change. According to various sources like Vikas Dandekar & Joshua Berlin of Elsevier and Divya Rajagopal of the ET, the Indian company – Biocon has a biosimilar of Herceptin in Stage III clinical trials and is looking to enter the market by next year. I wouldn’t be surprised if other Indian companies forayed into this area.

Just a few years ago, Dr. Reddy’s forayed into the bio-similar space with its version of another Roche drug called MabThera. The generic version marketed by Dr. Reddy is called Reditux and it was targeted at non-Hodgkin’s lymphoma. Despite Dr. Reddy entering the market at almost half the price as Roche’s drug, the latter did not slash prices for MabThera till 5 years later. For a more detailed analysis of the market dynamics of these products I would recommend reading the story by Dandekar and Berlin.

Since there are not yet any generic manufacturers in the market, the letter to the PM requests measures to ensure quick entry of generics in the market to ensure competition with Roche’s product.

While generic competition is always welcome, it will be interesting to see whether Herceptin can be put under price control. If anything this would be the perfect test case. So far the litigation before the Supreme Court between health activists and the government has been limited to 348 essential drugs – as far as I know, none of them pertain to cancer. Why is cancer medication not contained in this list? According to Lancet, India lost a total of 556 400 national cancer deaths in India in 2010 and the Health Ministry has not even made cancer a ‘notifiable disease’. Read this excellent piece in the Hindu by Dr. V. Shanta.

It would be interesting to see a PIL before the Supreme Court, informing them that a cancer drug costing almost Rs. 14 lakhs, is not even mentioned on the list essential drugs – how would the Supreme Court react to this petition?

Parliament and price control: Traditionally, the Central Government has kept patented drugs outside the purview of patented drugs. This may change. In one of its report earlier this year, the Parliamentary Standing Committee virtually roasted the Health Ministry for keeping patented drugs out of price control. The report can be accessed over here. In pertinent part, the Committee stated “The Committee notes that as of now there is no mechanism in place to regulate the prices of new patented drugs which are imported in the country and sold at supernormal profits, whereas prices of the same medicines are considerably lower in other countries. The Committee does not accept the submission made by the Secretary (Pharmaceuticals) that there is no price control of a patented drug for open market. The Committee would like to observe that India as a sovereign country has every right to decide the prices of a drugs which are sold in the open market. The Committee therefore recommends to evolve an effective mechanism to control prices of imported patented drugs being sold in Indian Market.”

The report further states “The Committee also takes note of the submissions of the Secretary (Pharmaceuticals) to the effect that the issue of price regulation of imported molecules being sold in the country at high prices will be taken care of in the New Pharmaceutical Policy which is currently under finalization. The Committee feels that the issue at hand is too urgent to be left open-ended and, therefore, recommends that Department of Pharmaceuticals resolve this issue within a period of six months. The Committee would also like the Department to put in place an effective mechanism to enable the use of international price benchmarks in such cases and limit the price of an imported drug by comparison with the price of the same drug in other countries and thus check windfall profits made by importers on selling imported molecules at exorbitant prices in the country.”

Is price control alien to Western pharmaceutical companies? Not at all – they experience pricing pressures from insurance companies and in some instances like the U.K. even the government, since the National Health Service drives a strong bargain before approving the purchase of any drug. All of this serves as de-facto price controls. Collective actions by insurers and governments are the only way to keep patent monopolies in check. It is only in India that cancer patients are left literally at the mercy of pharmaceutical companies.

Conclusion: Will Roche drop the prices of Herceptin in response to this petition? Not likely. It can still make money but in all likelihood they will not want to be ‘seen’ as caving into pressure. Western pharmaceutical companies tend to react poorly under pressure. They get combative and more likely than not trip over their egos into a PR disaster. The market dynamics will eventually play out and sooner rather than later generic companies will displace Roche from the market.

Personally, and this is only my opinion, I have been relatively sympathetic to the cause of pharmaceutical patents. I believe in innovation and the wonders of modern science which have resulted in life-saving inventions like Herceptin. So much so, that I walked into a scholarship interview this year trying to defend the cause of pharmaceutical patents. No prizes for guessing who is staring down the wrong side of a pretty expensive education loan. The pricing debate however is distinct from the patenting debate. This particular case of pricing in the Herceptin case just strikes me as utterly obnoxious if not downright stupid. When Ranjit Shahni and Novartis were trying to make their case, at the height of the Novartis litigation, for patenting Glivec they argued that the newly prosperous middle class in India could afford patented drugs with their insurance policies. That may be true for Glivec but the average insurance policy in India will not cover the entire cost of Herceptin and I say this from reliable first-hand sources.

In such a case what is the ordinary Indian supposed to do? Beg and grovel at the feet of Roche?

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SpicyIP Weekly Review (November Week 4)

Another relatively quiet week in the IP world has passed us as we go deeper into holiday season. Having said that though, there have been a few very notable developments in this last week.

Starting off, in what is definitely the highlight this last week, is the 5-6 hour hearing that Prof Shamnad Basheer received as an academic intervenor over a 2 day period in the much highlighted Novartis case presently before the Supreme Court. As Prashant writes, 'His arguments (as expected) were logical, uncluttered, and with a delightful sprinkling of anecdotes and examples.' The submissions can be found here (Part 1) and here (Part 2); and the summary can be found here. 

Prashant then took us through the dangers that granting ex-parte interim injunction may entail by pointing out flaws and questions in the granting of certain patents in the case of Issar Pharmaceuticals v. Vinod Dua. After noting that details of 2 of the 3 patents involved are not even accessible on the  patent office website, he proceeds to point out some serious doubts as to the reasons for granting the 3rd patent in the first place. Prima facie, it appears that this patent is not valid, yet, an interim injunction against the accused has already been granted. 

Kruttika then takes us through a very well analysed judgement in Star India v. Piyush Agarwal, wherein the Delhi High Court looks into the question of whether the Copyright Act prevents the defendants from updating their users on the score and fall of wickets through text messages even though exclusive 72 hour media rights are given to the plaintiffs. The court says that information from the broadcast falls within the public domain and is not protected by the Copyright Act, thus allowing of communication of this information to the public. In what Kruttika refers to as the "Maggi rule", it also determined that the prescribed "period... by which the information can be no longer be said to be part of or so intimately associated to/with the first right of the broadcast of the plaintiff" is 2 minutes from the time of broadcast. 

On other news, Bangalore based Environmental Support Group (ESG) has finally decided to take action against the Union of India, the National Bio-diversity Authority, the Ministry of Environment and Forests, and others, by filing a public interest litigation for the non-prosecution of Monsanto's Indian subsidiary, Mahyco. 

Prashant has covered the issues that ESG seeks to prosecute on as well as his thoughts on their their likelihood of success. He also notes in a follow up post that some 'press-release journalism' has been happening over at Times of India. As he says, "I was amazed to notice that the entire news report in the Times of India, on ESG’s PIL, was a word for word reproduction of the press release put out by ESG, save for the last two and a half paragraphs of the press release which were not reproduced in the ToI report. The ToI report can be read over here and the ESG press release can be read over here." 

Following this came the big news that Ms Prathiba Singh, founder of Singh & Singh, has been recognized as the foremost female IP lawyer by the Asia Women in Business Law Awards, celebrated by the Euromoney Legal Media Group, which also publishes Managing IP. The entire list can be accessed over here. We congratulate Ms Prathiba Singh on this terrific achievement. 

Prashant then brings our attention to a recent Madras High Court decision in a case brought by copyright owners in 'Dhammu' and '3' against 15 ISPs regarding the issue of whether the ISPs would be protected under the 'safe harbour' provisions in S.79 of the IT Act, from having to comply with the John Doe orders. Justice Chandru shot down this argument, as well as arguments against the legality of 'qua timet' actions, the non-joinder of essential parties, and the legality of John Doe orders. Thus giving a victory to copyright holders. 

Finally, in another cricket based issue, Shouvik discusses the BCCI's attempts at closing out photo press coverage of the on-going India-England test series. International News Agencies have risen up together against this move and have threatened to boycott their coverage of the series. It seems to me to be a ridiculous move by the BCCI and a clear attack on the freedom of media to report on such sporting events. Even the high profiled International Olympic Committee, notorious for being extra stringent with it's IP rights, have condemned the move by BCCI. 

International Developments

On the international front, World Health Organization members have gotten together at WHO's headquarters this week to look past the current patent system and conduct an open ended meeting to analyse the feasibility of new models for financing research and development for diseases lacking sufficient market incentives and public policies.

Meanwhile, IP Watch also brings us the good news of WIPO's close approach to the adoption of a treaty for providing copyright exceptions to the visually impaired. This has taken about 2 years of negotiation so far. Though the developed countries have expressed satisfaction with the terms so far, the developing countries seem to have mixed reactions to the progress, though they have said that countries have come to the table with good faith and have shown flexibility. 

Over at the USPTO, some lingering rumours have proven to be true when a source inside the PTO confirmed that USPTO Director David Kappos will be stepping down from office in January 2013. I can't claim to know much about the workings of the USPTO, but IP professionals across US have expressed regret over his parting from the USPTO. According to Dennis Crouch, Deputy Director Teresa Stanek Rea will likely be nominated into more permanently position after Kappos leaves. 

A topic often relevant but not discussed in detail has been written about by Neil Wilkof in his post on Patent Valuation over at the IP Finanace blog. He looks into some questions that I've pondered over myself - regarding how companies, especially those at the brink of bankruptcy (think Kodak), can value their assets as high as ~$2.6 billion dollars. It's an interesting read and I would personally like to see more discussion around IP Valuation. 

And that seems to wrap up a rather quiet week on the international front! Let us know if we've missed something. We look forward to receiving comments about any of our posts and/or the international highlights.

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SpicyIP Tidbit: Bayer makes an attempt to nix NATCO’s CL for Nexavar

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Bayer Corporation, which earlier this year lost its bid to oppose NATCO’s application for a compulsory license (CL) for its Nexavar patent, is now attempting to terminate the CL on the grounds that NATCO has violated the terms and conditions of the CL by exporting its generic version of Nexavar to Pakistan and China. The Controller General’s order was very clear that NATCO was licensed to market the drug only within the territory of India. 

Bayer had raised this ground even in its appeal to the IPAB, against the grant of the CL by the Patent Office. The IPAB had refused to rule on this aspect on the grounds that the issue required factual determinations which were best made by the Controller. This order of the IPAB was dated the 14th of September, 2012. Prior to this order of the IPAB, Bayer had already made an application to the Controller General of the Patent Office, on the 21st of August, under Section 94 of the Patent Act to have the CL cancelled on grounds that NATCO had violated the same by exporting the generic versions authorized by the CL to Pakistan and China. 

For its part NATCO sought an extension of one month on the 18th of September, 2012 to file a reply to Bayer’s application, on the grounds that the evidence was being collected and that it was of a ‘complicated technical nature’. The reply by NATCO was finally filed only on the 29th of October, 2012 wherein it claims that “the products obtained by the Appellant are suspect and orchestrated” and that it had no distributor in Pakistan or China. Natco once again reiterates that “these are possible orchestrated instances for filing present petition”. Further, NATCO also seeks to wash its hands off the entire matter by claiming that once it sells it product in India, its rights are exhausted in the same. 

While denying that its products were available at the pharmacies in Pakistan, NATCO also produces affidavits of its managers, explaining that some of the distributors and online pharmacies buy NATCO products from distributors to whom NATCO sell its products. 

Although NATCO does not spell it out in as many words, it appears to be implying that its products were most probably sold by the distributors, not under its control and that NATCO itself cannot be held liable for the same. 

That answer is simply untenable in the law since NATCO received a CL only on the grounds that it would sell the product in India. In such a case, NATCO would be under an obligation to control the chains of distribution and at the very least it should have included a covenant in its agreement with its distributors restraining them from exporting the impugned product. If NATCO has not included such a covenant in its distribution agreements, it has not complied with the terms of the CL. 

I’m not sure whether the Controller General has passed an order on Bayer’s applications. Any tips would be appreciated.

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BCCI blocks Photo Agencies in India-England Test Series: International News Agencies say "It's not Cricket!"

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Well, the cricket enthusiasts among the readers of Spicy IP are no doubt glued to the daily reports of the India-England ongoing test series, with the series poised on 1-1 in a tantalizing manner. The traditionalists would undoubtedly swear by the attractions of a well-crafted test match news report (with stalwarts like Neville Cardus having created not a few rare gems in that field). However, it is not the fate of the entire global populace to savour the writings of the modern day successors of Cardus, at least as far as the ongoing series is concerned. This is because most of the prominent international news agencies’ earlier decision to boycott the series as a protest against the restrictions imposed by the Board of Cricket Control of India on selected photo agencies covering the tour.

Getty Images, Action Images and two other Indian photo agencies have been prevented by the BCCI to engage in their regular practice of distributing many images as part of their editorial coverage. This practice was apparently widely appreciated by the news agencies, the fans and hence by the sponsors too by proxy. However, this time BCCI had said that it would provide its own photographs and withheld the accreditation of the photo agencies to stop them from such practice. To protest such high-handed action that many are perceiving as a curb on media freedom, international print media giants like Thomson Reuters, Agence France-Presse and Associated Press have decided to suspend pictorial as well as text coverage of the tour that was initially being perceived as the Indian team’s shot at ‘brownwashing’ their British peers.

The News Media Coalition has condemned this move by the BCCI, saying that it would deprive cricket enthusiasts the world over in enjoying the high quality pictorial coverage usually provided by those agencies. Even the International Olympic Committee has supported such condemnation of what it says to be a "direct attack on the freedom of the media to report from sporting events," that "shows contempt for the sporting public around the world who would otherwise like to follow these important matches." BCCI was not even forthcoming with a reasonable explanation of its move, which have angered the media even further. On the contrary, it has stated that the said agencies has not met its accreditation standards on the ground that their primary businesses involved the commercial sale and licensing of images rather than the supply of images to news publications for bona fide editorial purposes.

The readers may remember a recent coverage of a set of restricting principles that the Delhi High Court had laid down in the matter of TV channels displaying footages from cricket broadcasts. While that was a matter in which broadcast and commercial broadcast had been firmly distinguished between by the court, this seems like yet another ostensible attempt to do the same, if the BCCI’s explanation is accepted, that is. One may wonder the extent to which the distinction can be extended, given there isn’t likely to be a lot agents these days, whether belonging to print or visual media, who don’t have commercial motives involved in their activities. Given that such agents are likely to attract the best quality artists by way of incentives, it is perhaps the audience at the end who’re going to suffer if the former are to be stifled by way of media freedom being curbed.

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University of New Hampshire School of Law seeks Executive Director for the Franklin Pierce Center for IP

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IP Job Opening: Some of the readers of Spicy IP may be interested to know of a new promising career position that has just opened with the University of New Hampshire (UNH) School of Law (formerly Franklin Pierce Law Center). UNH is currently looking for an accomplished IP professional with administrative experience and expertise to serve as the Executive Director for the Franklin Pierce Center for Intellectual Property.

Profile of Employer Institution: For the rare few who are unaware of the Center’s impressive reputation, it seeks to promote global economic development by facilitating research and training in the protection and use of IP for technological innovation. In pursuit of such goals, it has already garnered a stellar repute for educating global IP leaders and providing pioneering IP programming. At present, the Center hosts one of the largest IP faculty strength in the US as well as the only dedicated exclusive IP library in the country. It encourages the students, faculty, and researchers to collaborate with peers and partners from governments, industry and academia on a global scale on research projects, conferences, and strategic fronts.

Duties and Responsibilities: The responsibilities of the Executive Director will include administering the Center’s internal and external operations, including all major programs, conferences, and events. The major programs that the Center has at present up and running include the International Technology Transfer Institute, the Intellectual Property Valuation Institute, and summer law programs that address a wide range of IP issues. In collaboration with administrative leadership, IP faculty, IP alumni, and other relevant stakeholders, the Executive Director will be required to assist the development and execution of new strategic initiatives, including collaborative partnerships with national IP offices, major educational institutions, and international organizations. Additional duties will include facilitation of the law school’s integration with UNH through the development and administration of multi-disciplinary programs and student-centered learning opportunities in coordination with other law school departments and IP faculty.

The Executive Director position is an administrative appointment with potential for associated teaching and research activities. The incumbent will report to the Associate Dean for Academic Affairs.

Required Qualification: Applicants for the position must possess a Juris Doctor, Ph.D. or comparable academic credentials and must have at least five years of experience in IP teaching, scholarship, leadership, policymaking, practice, or industry. They must also have a proven ability to communicate effectively in writing and verbally with numerous diverse stakeholders, such as academics, government officials, practitioners, students and the public, both nationally and internationally. A collaborative, efficient, and professional management style and a strong commitment to working in a diverse, multi­cultural environment are also preferred.

Contact Details and Deadline: Interested applicants should submit a cover letter and resume to humanresources@law.unh.edu no later than December 15, 2012.

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Madras High Court rules against ‘safe-harbour’ for ISPs – a victory for copyright owners

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The Hinduand Medianama, have both recently reported on a judgment of the Madras High Court in the copyright infringement lawsuits filed by the copyright owners of ‘Dhammu’ & ‘3’ against 15 Internet Service Providers (ISPs). These are the lawsuits which led to the entire blocking of file-sharing websites on the suspicion that these websites were being used to distribute pirated copies of the newly released movies. Outraged internet users had responded to these orders by hacking the websites of the Madras High Court and several other institutions. Some ISPs like Airtel were fined by consumer courts for interrupting services to their customers.

The Madras High Court, acting on a subsequent petition by the ISPs, modified its initial ex-parte order to allow ISPs to block only specific links and not entire file-sharing websites. We have blogged about these orders of the Madras High Court over hereand here. The present judgment of the Madras High Court can be accessed over here.

The present judgment was the result of a plea by the ISPs to dismiss both lawsuits or alternatively to vacate both interim injunctions in their entirety. Justice Chandru of the Madras High Court declined to grant any of these prayers by the ISPs and the lawsuits and the interim injunction stand as of now. The judgment is very interesting since it is one of the first Indian lawsuits to discuss the legality of John Doe orders, their ‘qua timet’ nature and most importantly it is the first judgement on the applicability of the ‘safe-harbour’ provisions in Section 79 of the Information Technology Act, 2001 to ‘Internet Service Providers’ in the case of copyright infringement. Justice Manmohan Singh of the Delhi High Court had delivered last year the first judgment on the applicability of the Section 79 ‘safe harbour’ to online content providers like MySpace. (Amlan has discussed the MySpace judgment over here)

Also interesting in the present case was the fact that the Plaintiffs were represented by Advocate Arun Mohan who appears to have argued the case by himself against a battery of Senior Advocates who were representing the ISPs. It is rare to see young lawyers like Arun, who is about 28 years, to take on Senior Advocates in the High Court and it is even rarer to see them win.

Getting down to the main issues in the present case:

(i) Section 79 of the Information Technology Act, 2001: The crux of this case was whether or not the ISPs would be covered under the ‘safe-harbour’ provided in Section 79 for network service providers. ISPs like the BSNL and Bharti-Airtel also argued that they were bound by the terms of their licence to provide uninterrupted internet access to all their service providers and that they could not exercise any editorial control over what their users did or did not access.

Justice Chandru of the Madras High Court shot down this argument on the grounds that it was bound to give a literal interpretation to the law and if it were to extend the ‘safe-harbour’ provision in Section 79 of the IT Act to ISPs for copyright infringement it would render null and void the ‘proviso’ to Section 81 which was inserted via an amendment to the Act in 2008. The ‘proviso’ reads as follows “Provided that nothing contained in this Act shall restrict any person from exercising any right conferred under the Copyright Act, 1957 or the Patents Act, 1970.”

Further, Justice Chandru appears to have been significantly influenced by Justice Manmohan Singh’s order in the Myspace case since he has cited Jusitce Singh’s order liberally.

The final conclusion of the Court was as follows “In view of the above discussion, I find that there is no impact of provisions of Section 79 of IT Act (as amended on 2009) on the copyright infringements relating to internet wrongs where intermediaries are involved and the said provision cannot curtail the rights of the copyright owner by operation of proviso of Section 81 which carves out an exception cases relating to copyright or patent infringement.”

(ii) The legality of qua timet actions: A ‘qua timet’ action, is one where a lawsuit is filed in anticipation of an alleged wrong. Normally a lawsuit can be filed only after an alleged wrong has taken place and not in anticipation of a wrong. Once again, Justice Chandru liberally quotes from Justice Manmohan Singh’s judgement in the MySpace case to rebut the ISPs.

(iii) The non-joinder of essential parties: The ISPs had also sought dismissal of the lawsuits on the grounds that the plaintiffs had not impleaded the actual websites which were hosting the infringing content. Once again, Justice Chandru liberally quotes from Justice Manmohan Singh’s judgement in the MySpace case to rebut the ISPs.

(iv) The legality of ‘John Doe’ orders: In his judgment, Justice Chandru upholds the legality of the concept of John Doe orders on the basis of a Delhi High Court order in the case of ESPN Software India Private Ltd. Vs. Tudu Enterprise and others in C.S.(OS)No.384 of 2011. The Plaintiff had cited this case and also argued that the requirements of naming the defendants under the Code of Civil Procedure be waived. In pertinent part the Plaintiffs argued “The CPC provides that under Order 7 Rule 1, the plaint shall contain the name, description and place of residence of the defendants so far as they can be ascertained. In this case, the violators are many in number, the plaintiffs could not identify each and every one.”

My problem with this aspect of the order is that the ESPN order by the Delhi High Court was an ex-parte order – it was passed on the first day without hearing any of the defendants. Such orders have zero precedential value and at the very least the Madras High Court should have provided a much more detailed reasoning to uphold the concept of John Doe order instead of placing reliance on the ESPN order.

An update on the MySpace appeal before the Delhi High Court: Justice Manmohan Singh’s judgment in the MySpace case was appealed last year by MySpace. The hearing of the appeal was adjourned on several occasions since MySpace and Super Cassettes were interested in settling the matter. This is not all so surprising since Super Cassettes appears to have licensed its music to Youtube and clearly there is a right price for Super Cassettes. In any case, in an order dated 12^th September, 2012 the Delhi High Court records that all efforts at a compromise have failed and that the appeal against the denial of the interim injunction will be heard in January, 2013. At the same the Delhi High Court has also ordered that the main trial be expedited.

Interestingly, the order (available over here) also records that a third party, represented by Advocates Shewtasree Majumdar & Eashan Ghosh, is seeking to intervene in the appeal. The identity of the third party is not revealed in the order.  

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SpicyIP Tidbit: Prathiba Singh wins award for being the foremost female IP lawyer in the Asia region

We’ve recently been informed that seasoned IP litigator and founder of Singh & Singh, Ms. Prathiba Singh has been recognized as the foremost female IP lawyer by the Asia Women in Business Law Awards celebrated by the Euromoney Legal Media Group, which also publishes Managing IP. The entire list can be accessed over here.

For those of your familiar with Prathiba Singh, you must know that she has participated in some of the most high-value IP litigation in the country including pharmaceutical patent litigation, trademark litigation and copyright litigation. 

Litigation in India, is a crazy profession – it can be highly competitive and extremely frustrating. More so if you are a woman in Delhi, especially since litigation continues to be a pre-dominantly male bastion. So, for Prathiba Singh, to climb up the hard way and be recognized as a leading IP lawyer in the Asian region is certainly a commendable achievement. 

Knowing the ultra-competitive nature of litigation and litigators in Delhi, I’m expecting several barbs from our readers accusing us of 'advertising' for Prathiba Singh, 'paid news' and god knows what else. My advice to you – relax – we have quite the track record of reporting objectively on her important cases, defeats included and we will continue to do so.

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Off-topic: Press Release Journalism by the Times of India in the ESG-Monsanto case

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Earlier this year, on the 10 of May, 2010 one of India’ national newspapers, Hindu carried a first of its kind story alleging that its rival competitor and the largest selling English newspaper in the world, the Times of India was publishing advertisements for Monsanto’s Bt cotton crop as ‘news’ without informing its readers that the same was an advertisement – a phenomenon known as ‘paid news’ in India. I won’t get into the accuracy of Hindu’s reporting but you can read that report by P. Sainath over here. 

I don't know whether this is worse or better but while writing the post on the PIL by the Environmental Support Group (ESG), which I just blogged about over here, I was amazed to notice that the entire news report in the Times of India, on ESG’s PIL, was a word for word reproduction of the press release put out by ESG, save for the last two and a half paragraphs of the press release which were not reproduced in the ToI report. 

The ToI report can be read over here and the ESG press release can be read over here. 

Reproducing press releases, in their entirety, as news reports, is bad journalism but what makes it worse is when the news report does not even state that it is quoting from a press release or in this case just reproducing the entire press release. Not once does the ToI news report state that the facts were being reproduced from a press release put out by the petitioner and the fact that the report ran with the byline of a ToI reporter – Saswati Mukherjee, makes the normal reader assume that the report was independently researched by the journalist in question. Why even run a byline on such a report which is a complete reproduction from a press release? 

ESG’s press release gave only its version of the story and while ESG is completely entitled to do so, it is up to journalists like the ones at ToI to investigate and authenticate the story instead of borrowing each and every adjective and pejorative used by ESG in its press release. There is also the question of non-attribution of the source of the lifted text i.e. the press-release in this case. Non-attribution almost cost Fareed Zakaria his job and the poor chap had just lifted a few words here and there. 

I’m surprised that the ToI has dealt with this story in this manner – I’ve seen them in action before when Shamnad had filed the PIL against the IPAB and in that instance the journalists from the ToI grilled him thoroughly before publishing a story on the PIL. 

According to this Guardian story available over here - the practice of reproducing press releases as news is quite a rampant problem in the U.K. Be that as it may, stories like the present one involving Monsanto, ESG and the High Court of Karnataka should be researched thoroughly before being reported on. This is just too important an story to be treated in such a cavalier manner and certainly the Times of India can do better than this. 

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SpicyIP Tidbit: ESG sues the Govt. of India & NBA for non-prosecution of Monsanto’s Indian subsidiary

Well, it finally happened. After crying itself hoarse for more than a year over the non-prosecution of Monsanto’s subsidiary Mahyco for alleged bio-piracy of biological resources related to Brinjal, the Bangalore based NGO – Environmental Support Group (ESG) has filed a Public Interest Litigation (PIL) before the Karnataka High Court. In this petition ESG has sued the National Biodiversity Authority, the Union of India, the Ministry of Environment & Forests, the State of Karnataka & the Karnataka State Biodiversity Board. The NGO has also challenged certain provisions of the Biological Diversity Act, 2002 as being unconstitutional and ultra vires the Constitution of India. Reportedly, the Karnataka High Court has issued notice on the petition. 

The main documents can be accessed on the ESG website over here. I’ve also provided the links below: 

(i) The Press Release; 

(ii) The PIL filed before the High Court. 

On the point of prosecution of Monsanto’s Indian subsidiary (Mahyco), I’ve already covered the main issues involved and my past posts on the topic can be accessed over here, here and here. Like I’ve said before, I don’t think ESG has any case over here. From the evidence on the record it is quite obvious that Mahyco’s involvement in the Bt Brinjal case happened with the blessings of the Department of Biotechnology, Ministry of Science & Technology, Government of India. I don't think Mahyco needed to take any further permissions when it was amply clear that the Government of India was aware of its research project. Further, like I stated in a previous post, if ESG is serious about prosecuting Mahyco it should, in the interests of being fair, also seek to prosecute the Department of Biotechnology, Cornell University and the United States Agency for International Development (USAID). The reason for this is the simple fact that Mahyco’s research into the development of Bt Brinjal happened under the auspices of the Knowledge Initiative on Agriculture (KIA) which is a bilateral treaty between the Government of India and the U.S. signed during former President George Bush’s visit to India. 

On the remaining issues in its petition, ESG appears to be on firmer ground, especially the non-notification by the NBA of the guidelines to access biological resources under Section 18. 

The constitutional challenge against Section 40 of the Biological Diversity Act, 2000 on the grounds that it delegates un-canalized and arbitrary power to the executive is going to be an uphill climb given the high standards set by High Courts in such constitutional challenges. In any case, this PIL should hopefully force open a much needed debate on the Biological Diversity Act and its draconian provisions.

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Del HC hits a sixer: The Boundaries of Copyright and Cricket

Our friends at Medianama have pointed us in the direction of one of the most superbly analysed IP judgments that I have read in a long time - Star India v. Piyush Agarwal (and other connected matters)

The facts of the case are simple. Star India broadcasts matches organized by the Board of Control for Cricket in India (BCCI). The defendants update their subscribers with the score and fall of wickets through text messages (SMSes).  The Plaintiffs claim they have the exclusive right to provide such value added services to the public based on their agreement with the BCCI (dated 10.08.2012) which grants them a 72 hour monopoly over the media rights i.e the right to all information emanating from the event. To bolster this argument, the Plaintiff states that the Copyright Act is not exhaustive of the rights emanating from a live event/performance.

The Delhi High Court through Justice Mehta decided this case (in a 56 page decision) on 8 November 2012 by analysing this issue in various stages:

Is the Copyright Act exhaustive in delineating the rights emanating from a live event or performance?

The Court holds that in light of the specific bar contained in Section 16 of the Copyright Act, there is no other right held in any copyrighted work other than that specified by the Act (with the exception of cases where there is a breach of trust or confidence).

So, what are the rights of the Plaintiff as the broadcaster of the cricket match?

Analyzing Sections 2(q), 2(qq), 2(y), 13, 14, 38 and 38A (phew!), the Court holds that there are only specific entitlements that go along with the "performance" of the cricket match as recorded in a visual recording and/or the sound recording. These are stated exhaustively in Section 38A of the Copyright Act which deals with the exclusive rights of performers.

Since this is the position of the law, Justice Mehta goes on to elaborate the limits of this right by stating that the reproduction or communication of the exact sound and/or the visual recording without/in violation of a license/permission being obtained from the owner of such recording amounts to infringement of the copyright under the Act except when use of copyright material is made permissible under certain provisions of the Act such as Sections 39 and 52.

(This I believe is stating the obvious, but as we know, dear readers, where the obvious is not stated, frivolous litigation and absurd conclusions always emerge.)

Can the agreement between the Plaintiff and the BCCI trump the provisions of the Copyright Act?

The Court first states that after the broadcast of the match, it is impossible for any party to claim that this information conveyed by the performance is not in the public domain. According to the Judge, once the "first broadcast" of the performance has been made, the information that underlies the performance is in the public domain. 

Therefore (as stated above) while the performance and visual/sound recordings of the said performance are protected by copyright, the facts from the broadcast were not. This subtle distinction is hugely important is the crux of the whole decision. 

The Court also goes on to state that despite the Plaintiff's contentions, no agreement could expand the scope of the rights as provided under the statute. Therefore, the 72 hour media right monopoly as agreed upon between the plaintiff and the BCCI is meaningless since copyright law does not protect information in the public domain.

What is the appropriate time gap allowing the persons such as the defendants to publish information about the matches broadcast by the plaintiff?

In what I will be christening the Maggi rule (!), the Court held that since the information in the performance was itself not copyrightable after  the "first broadcast", it was necessary to determine what is length of "the period... by which the information can be no longer be said to be part of or so intimately associated to/with the first right of the broadcast of the plaintiff."

The Court in its discretion determined that for cricket matches this could be approximated approximated to two minutes. After two minutes, information such as regular updates fall into the public domain and can no longer be claimed as the exclusive monopoly of the plaintiff.

The Court also importantly states that where there is an important event, such as the fall of wickets or cricketing milestones (such as runs scored etc.), there need not be any delay in the dissemination of the information. This is based on the doctrine of reporting of current events and affairs and the logic that stale news is no news.

Blogger observations:
I am not one of those people who follows cricket regularly. However, even I regularly hit the refresh button on CricInfo or similar sites when there is an exciting match going on. To not do so is well...unpatriotic. I do not have a TV and find online minute-by-minute coverage of sports an easy way to follow the game. So as a lawyer, blogger and possible target audience to the services of the plaintiff and the defendant, I think the judgment is extremely well-reasoned.

I know the defendant won. However, I still found two things odd:

(a) There is no mention of the "Hot News Doctrine". There have been cases litigated in India and abroad, and they fit perfectly into this scenario for the Defendant. (Especially the case of NBA v. Motorola);

(b) I'm also not sure if the defendant brought this up (because there is no mention in the judgment) but in this particular fact situation, it is perfectly reasonable to think that the defendant could have got this information from places other than the broadcast i.e. by watching the match live in the stadium and then relaying the information to its subscribers.

Despite all this minor nitpicking, Justice Mehta's judgment stands on firm footing in the Copyright Act. As an IP lawyer, I appreciated the judge's clear discussion of the various rights involved, the interplay of various provisions of the Copyright Act and the limits of those rights. Specifically, I thought that the Court makes an important distinction very clear -  that the non-infringement is restricted to the information that is underlying the broadcast and not the reproduction of the broadcast itself.

Hat tip to our friends at Medianama once again.

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Dangers of ex-parte interim injunctions, in full display, in patent litigation between Issar Pharmaceuticals and Ind-Swift

Image from here

Time and again, we have on this blog highlighted the dangers of ex-parte interim injunctions in cases of pharmaceutical patent litigation. For its part the Delhi High Court has been relatively restrained in granting such ex-parte injunction in pharmaceutical patent litigation. However, there have been occasions on which some judges of the High Court do grant such orders, with little adherence to Supreme Court precedents on the point. 

In the present case of Issar Pharmaceuticals v. Vinod Dua (According to LinkedIN he is a Director at Ind-Swift, a generic pharmaceutical company), the Plaintiff sued for the infringement of three of its patents: 186437, 185703 & 185613. Ind-Swfit’s product, MELSWIFT, was allegedly infringing all three patents. 

Justice Manmohan Singh who was at the time hearing this case, granted an ex-parte interim injunction on the very first day hearing of the case. The order can be accessed here. To be fair to Justice Singh, the plaintiffs had also alleged copyright & trademark infringement along with trade-secret misappropriation by the Defendants and some of these aspects may have warranted an interim injunction but the extension of the injunction to even potential violation of the patents in questions, was absolutely unwarranted. 

For reasons I just cannot understand, some of the judges in the Delhi High Court do not understand that the process in the patent office has always been quite flawed, save for the drastic improvements that we have seen in the last few years. All of this just means that the patents issued, especially the old ones, are usually flawed for a number of reasons, both substantial and procedural. The Delhi High Court has itself dealt with several such cases of irregularities in the patent office and therefore it is even more disappointing when you see judges from the very same court granting ex-parte interim injunctions in such cases. 

Getting down to the details of this present case of the three patents, for some reason best known to the patent office, I cannot even access, on the patent office website, details of two of the patents: 185703 & 185613. 

The third patent, 186437, however is accessible and the file-wrapper prima faice raises several questions as to how and why the patent was even granted. 

As per the Form 1 (available over here), the application (537/DEL/1997) was a divisional from another patent application (1051/DEL96), which was filed on 20th May, 1996. 

The patent specification for the ‘537 patent (available over here) should be able to bag an award for being the shortest ever specification in the history of pharmaceutical patents – stretching a little over a grand total of 3 pages. There is no description in the specification of any prior art and how the impugned patent was smarter than anything known in prior art. The invention claimed in this patent, and described in the specification was a pharmaceutical composition, which could be used as a ‘vehicle for active agents for use in applications other than tanning of a skin surface’. 

Since this patent application was filed prior to 2005, the patent office appears to have objected in the FER under the erstwhile Section 5 of the Patent Act which denied product patents for food, medicines and chemicals. This prohibition was done away with only in 2005 when the Indian patent legislation was amended for compliance with TRIPs. However, in reply to the FER (available over here) issued by the Patent Office, the patentee’s agent informs the patent office that the claimed invention “cannot be used as a drug by itself” and that “the product of this invention is used for the administering of the drug to the patient”. Concluding the argument, the patent agents state “Therefore we submit that the vehicle/product of this invention does not fall within the scope of Section 5(a) of the Patent Act.” 

To me, the above arguments should have been rejected outright by the patent office as the definition of ‘food & medicine’ in the erstwhile legislation would have easily covered the impugned invention, which according to the Patentee, was supposed to be used in a pharmaceutical product. Further, Section 5 is quite clear that it prohibits all patents for chemical products and the impugned invention should have been barred outright under that provision. However, the patent office, in a letter dated 23rd January, 2001 (available over here) informed the applicant that the application had been accepted by the patent office and that the same would be advertised and notified as was necessary under the pre-2005 law. The patent certificate was issued on 10th June, 2002, 

There is a very little probability of the IPAB or the High Court sustaining this patent after a determined trial for its revocation. Yet our judges, go ahead and grant ex-parte interim injunctions in such cases. 

Things go further downhill from here. Usually, after the patent certificate was issued the patent is considered issued. However according to the patent office website the patent application was published under Section 11A on 12th September, 2008 and then the grant of patent was published on 11th March, 2011. If the patent certificate was issued in 2002, why were Section 11A and Section 43(2) publications taking place 6 and 9 years later? 

The problems with this patent do not end with the above issues. The ‘e-register’ of the patent application indicates that the patent had lapsed and that the patentee had filed a application to restore it on 4th December, 2008, which application was allowed on the 20th April, 2010 – the final order of the Controller however is unavailable on the patent office website. In my experience, these restoration applications are usually nefarious affairs and any final conclusion on the legitimacy of the restoration will depend on the order of the Controller. 

Therefore, when it is amply clear that at least one patent is not prima facie valid, why would a judge grant an ex-parte interim injunction and shut down a legitimate business? What’s the hurry? Why not wait for a trial and evidence?

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A successful academic intervention before the Supreme Court in the Novartis - Glivec patent case

Image from here

As the arguments in the now epic Novartis case draw to a close before the Supreme Court of India, I’m glad to report that the bench, consisting of Justice Alam & Justice Desai, gave Shamnad a patient and receptive hearing in his role, as an amicus curiae or ‘academic intervener’ in Supreme Court parlance. 

As our readers may remember, Shamnad had filed an intervention application before the Supreme Court last year in order to provide academic assistance to the Court in what is probably the most important IP case to be decided by the Supreme Court in its history. This was a relatively unconventional move as academics in India do not usually file such interventions and from what I’ve been told Shamnad’s intervention was the first of its kind. His arguments before the Supreme Court continued over two days and one lawyer who witnessed the arguments wrote to me saying “Court 5 is expected to be packed on account of this unconventional academic approach. His arguments (as expected) were logical, uncluttered, and with a delightful sprinkling of anecdotes and examples. Including quoting Ogden Nash.” The same lawyer also informs me that “This is a first of its kind academic intervention in over 60 years, and one that has had such impact. Honestly, with so little knowledge among us counsel on specific areas of law (IP, IT, GI, Competition) such steps must be encouraged.” 

I second those views. Academics in India are usually cloistered in their classrooms and conference rooms. I hope we have several more of such interventions, especially since we now have a breed of brilliant young academics in India and for its part the Supreme Court appears to be very receptive to the idea. 

The arguments made during the intervention

I’ve posted below the links to the summary and written submissions made by Shamnad to the Supreme Court. I’m not going to get into describing the arguments, lest I lose some in translation but it should suffice to say that Novartis is not going to be too happy with some of the conclusions that Shamnad has drawn in this case, especially the conclusion that “Therefore, under the present set of facts and the evidence filed, the new form does not cross the section 3(d) hurdle.” To translate that into simple English – given the evidence on record, Novartis should not be granted a patent for Glivec. 

At the same time the activist community & generic drugs industry are going to be less than happy with Shamnad’s emphatic conclusion that excessive pricing cannot be a ground to revoke a patent on the grounds that it offends Section 3(b) of the Patents Act, 1970 which in itself bars certain patents on the grounds of public order or morality. In pertinent part, Shamnad’s summary states “Does the claimed new form violate section 3(b), owing to the high price of patented drug? No, section 3(b) only applies when the commercial exploitation of the invention itself is barred by public order or morality.” 

Well, I think it is safe to say that Shamnad is not going to win a popularity contest conducted amongst the litigants in this case but as an academic it is a privilege and honor to lose such popularity contests. 

The ‘summary’ and the ‘written submissions’ are available below: 

(i) Summary; 

(ii) Written Submissions (Part I); 

(iii) Written Submissions (Part II).

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SpicyIP Weekly Review (November Week 3)

With the country celebrating Diwali on 13 November, there have been a spate of public and Court holidays and as a result a much quieter week on the IP front.

Prashant started us off by doing this very interesting analytical post on the treatment of patients with Hepatitis C with Pegasys. Questioning the small percentage of patients who actually could afford the high price of the drug, Prashant suggests that the business model of innovator companies may need to be reassessed to suit the Indian market.

Rajiv then gave us data of the 97 decisions by the Controller at the Indian Patent Office in October 2012 highlighting a couple he thinks may interest our readers. This is usually my favourite post to read every month since Rajiv reproduces all this data which gives us an insight into emerging trends at the Patent Office.

Prashant also brought us the breaking news in the new big ticket pharma litigation between Cipla and Pfizer over the Sunitinib patent. In an SLP filed by Cipla in the Supreme Court, the Supreme Court has stayed the order of the Delhi High Court which restrained Cipla from selling a generic version of the Sunitinib patent. In what appears to be a huge procedural gaffe - no notice of the SLP was provided to Pfizer despite being on caveat. This promises to be an exciting battle and one that we will continue to track on the blog.

The highlight this week I think is Mathew's post discussing the recent IPAB decision on the geographical indication application for the Payyanur ring. As our readers have undoubtedly already seen, the IPAB decision discusses the standing of parties filing as "producers" under the Geographical Indications Act. GI holders and applicants should definitely examine the decision in case they haven't already.

Shamnad closes out the week by inviting our readers to what promises to be an outstanding conference to be held on November 27 & 28, 2012. The conference focuses on a very relevant topic 'The Copyright Amendments, 2012: A fair balance?'. For more details, do look at Shamnad's post here, and Sai's earlier post about the event here.

International Developments

Globally, IP has been in the news for several reasons. But Google has a big role to play in the first three highlights.

IP licensing just got a lot more interesting. The RAND licensing cases have exploded and are all over the news. The case Apple v. Motorola concerns fixing of royalty for Motorola's patents that are licensed under RAND terms which Apple believes are unreasonably high. A week ago, the solution-oriented Judge in the Apple v. Motorola case cancelled the trial "with prejudice" once it became apparent (much to her frustration) that Apple would not abide by the decision if they believed that the royalty fixed by the Court was too high. Now it appears that the parties are exploring alternative resolution methods such as negotiation and arbitration. This article rather ambitiously believes that if successful, this will end all licensing disputes. A tall claim especially since the Microsoft v. Motorola trial litigating similar licensing terms just got underway in front of a packed courtroom.

In a strange twist of fate, karma seems to be catching up with publishing houses. Usually the defendants in litigation with freelance authors about re-publication rights, publishing authors are lobbying to have Google pay for the reproduction of news articles in the face of steeply declining sales. Like the other wrangles that Google has managed to get itself into (and out of) over the years, this will definitely be an interesting spat to watch out for.

Google remaining in the news: The bi-annual publication of the Google Transparency Report is out. Apart from data on removal of copyrighted data in accordance with DMCA take-down provisions, the Report also published very interesting data about requests from governments seeking user data. With cloud services already converging with privacy and security concerns, it may interest our readers to know that USA and India (in that order) have made the most requests of this nature.

There has been a repeat of a curious decision in the US Fed. Circuit Courts (2d Circuit). After a remand of the Transocean v. Maeserk in 2010, Transocean II has come out with a stunning case stating that in some cases secondary indicia of obviousness may weigh greater than primary indicia. The decision has come out a few days ago, but this blogger shamefully admits that she has not had a chance to analyse it yet. Our friends at Patently-O however, have a handy analysis that you may want to read.

One of our nerdier bloggers has kindly pointed me in the direction of what is being dubbed "The Patent Prom" i.e. the Santa Clara University Software Patent Conference which had the who's who of the patent world in the USA discuss issues and possible solutions to the problem of software patents. A short recapitulation can be found here. 

Last but definitely by no means the least (pun intended), Least Developed member Countries  of the WTO (led by Haiti) are seeking an indefinite extension from becoming TRIPS compliant. Going by the limbo India is currently stuck in, it will be interesting to see how this proceeds.

That's the roundup for this week. Let us know if we've missed something. We look forward to receiving comments about any of our posts and/or the international highlights.

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