An Introduction to the recent Frontline issue on Indian Patent Law

Frontline, in a series of articles its recent issue, discussed the recent developments in Indian Patent Law and its reverberations in the pharmaceutical industry and public health [ ‘Patent to plunder’ by Amit Sengupta, ‘A big step forward’ by C.P. Chandrasekhar, ‘Patents and the law’ by V. Venkatesan, ‘A welcome first’ by T.K. Rajalakshmi, ‘Western warnings’ by R. Ramachandran, ‘Question of efficacy’ by Leena Menghaney, ‘The current patent system is deeply flawed’, interview with Prof. Shamnad Basheer and ‘Drug and duplicity’ by Brook K. Baker]. In this post, I intend to introduce you all to some of the issues highlighted in the issue. If time permits, I shall analyse all or some of the articles in the later posts.

The articles inter alia examined the Novartis patent dispute and the recent grant of first Compulsory Licence (“CL”). The articles traced the Novartis patent dispute touching upon the patent office decision, IPAB decision, the Madras High Court judgment and the pending SLP before SC. [The patent dispute is discussed in several posts.]

The article ‘Patent to plunder’ compared the prices of Glivec and generic version viz., INR 1,20,000 and INR 8,000 respectively and tried to undermine the claims of altruism of Novartis. The article also examined the ramifications of dilution of threshold in Section 3(d).  V. Venkatesan in ‘Patents and the law’ contended that Section 3(d) had been critical in filtering out frivolous patent claims. Leena Menghaney, in ‘Question of efficacy’, pointed out that  a high threshold for “efficacy” test under Section 3(d) and the inventive step, was crucial for ensuring access to generic medicines. 

In the context of his written submission to the Supreme Court in the Novartis case, Prof. Shamnad Basheer, in his interview, opined that the Madras High Court was correct in interpreting “efficacy” to mean therapeutic efficacy even though its reasoning could have been stronger. Relying on Section 3(d) and parliamentary history, he stated that he presented stronger grounds before the Supreme Court for reliance on therapeutic efficacy as the appropriate standard.

Venkatesan in ‘Patents and the law’ pointed out that the opposition mechanisms under the Patent Act, 1970 were underutilized. Prof. Basheer agreed with the aforesaid view and opined in his interview that a vibrant opposition mechanism could ensure adherence to the high standards under the Patents Act, 1970.

The articles discussed the first Compulsory Licence (CL) issued by the Indian patent office to the Indian generic drug company Natco Pharma Ltd for Bayer's anti-cancer drug sorafenib. [The issue of first CL is discussed here.] It was noted that the Bayer's version of the drug which costed INR 2,80,000 for a patient a month could be made available at INR 8,800 a month. 

C.P. Chandrasekhar, in ‘A big step forward’ noted that the grounds on which the Controller of Patents accepted Natco's application and rejected Bayer's opposition were path-breaking. Referring to the fact that some of the developed countries had in the past resorted to CL, he contended that the ideology and international pressure delayed the use of CL provision in India.

‘Western warnings’ by R. Ramachandran examined the external reactions particularly that of Pharmaceutical Research and Manufacturers of America (“PhRMA”) to the recent issue of CL. It refuted PhRMA's criticisms on the recent issue of CL and noted that the decision was in full compliance with the Doha “Declaration on the TRIPS Agreement and Public Health” of November 2001 and Article 31 of TRIPS.

T.K. Rajalakshmi, in ‘A welcome first’, examined voluntary licensing which was suggested as an alternative to CL. Referring to those who have expertise in this area, it was argued that the compliance level on voluntary licensing was abysmal. The article, on the other hand, cited the anthrax scare in the U.S., where the government threatened to issue CL and thereby, ensured a reduced price. It also refuted PhRMA’s contention by citing the discretion enjoyed by a country in treating price as a determinant factor for issue of CL. 

Prof.Basheer, in his interview, opined that there was no empirical work demonstrating any adverse effect on innovation by CLs. On the other hand, there were a few studies such as study conducted by Colleen Chien which indicated that licences did not have any significant demonstrable effect on the rate and pace of innovation. Prof.Basheer, further, noted that some of the successful extant innovators benefited from the lax IP regimes in the past. 

Prof. Basheer reminded that a CL was not an evisceration of the patent.  The patentee, who continued to hold the patent, was entitled to a reasonable royalty from every new player entering the market. A CL might permit an innovator to profit from newer, untapped markets with generic entrants to such markets. He believed that the extant law on CL was unsatisfactory as it gave scope for patentees to strategically delay the proceedings and frustrate the applications. 

Leena Menghaney, in ‘Question of efficacy’, highlighted the possibility of a new patent model that routinely allowed low-cost alternatives in lieu of royalty payments which helped the originators to recoup their development costs and at the same time ensured access to medicines for the people in the developing world.

Brook K. Baker, in ‘Drug and duplicity’, criticised Novartis on its position on CL and Section 3(d). According to him, even though it issued pious statements in the past about its benign intentions with respect to the use of lawful TRIPS flexibilities, it sought to strengthen and lengthen patent monopolies and preclude India from using TRIPS flexibilities to its advantage.

IPAB releases Annual Report on World IP day

In a welcome first, the Intellectual Property Appellate Board has published its Annual Report on its website on April 26th which is recognized as World IP day. It also gives us an important wrap-up of the milestones in the last year. I don’t think the IPAB has ever come out with such a report in the past. The report can be accessed over here. (Image: Logo of the IPAB)  Some of the important milestones, as extracted from the report, are as follows: 

Intellectual Property Appellate Board has been witnessing a steady increase in the number of cases before it. The year 2011 was no exception. 353 new cases – both Trademark and Patent included – were filed during 2011. The winds of change saw several new appointments being made at different levels. Smt. Justice Prabha Sridevan was appointed as the Hon’ble Chairman of the Board on 09/05/2011. Smt. Justice Prabha Sridevan served as the Judge of High Court of Madras for more than ten years from March, 2000 to August, 2010 prior to assuming charge in IPAB. Mr. D.P.S. Parmar, formerly Deputy Controller of Patents, assumed charge as Technical Member (Patents) in IPAB on 04/05/2011. The Head of the Registry of the Board is headed by the Deputy Registrar. Mr. N. Anbazhagan, Assistant Registrar of Madras High Court, took over the reins of the Registry on 05/12/2011 after Mr. G.Vijayaraghavan, the erstwhile Deputy Registrar, demitted office on 01/08/2011. Mr.V.Ravi, formerly Senior Joint Registrar of Trade Marks was appointed as Technical Member (Trade Marks) on 13.12.2011 (He assumed charge on 2.1.2012). 

The term speedy disposal – an avowed purpose for creation of the Board – acquired a distinctive meaning as the number of disposed cases catapulted from 166 for the year 2010 to 274 during the year 2011. The achievement will be better appreciated keeping in mind that the Trademark and Patent Benches could not be constituted for four months and five months respectively due to absence of incumbents. Hence, the disposal figure of 274 is the output of just about 7 to 8 months. Further, it is pertinent to mention here that the speedy disposal has been achieved despite the problems ranging from poor inadequate infrastructure to paucity of manpower. 

In 2011, Circuit Bench Sittings became more frequent, resulting in the increase in disposal of cases. 

Important orders such as, Yahoo Case, Infosys case, Anandabhavan case, Brooke Bond Tea case, etc. were among the orders pronounced during 2011 and other orders pertaining to procedural aspects regarding leave of court under Section 124, granting of time under IPAB Rules, were also passed. 

The problems that continue to afflict the Board were highlighted before the Hon’ble First Bench of the High Court of Madras in a PIL filed by a professor in Intellectual Property Rights, West Bengal National University of Juridical Sciences, Kolkata (W.P.No.1256 of 2011). The Hon’ble High Court has, by way of interim order, directed the Central Government to make available good infrastructure to the Board to ensure proper functioning. The Central Government has indicated its willingness to allow IPAB to hire a bigger accommodation till a regular infrastructure is available. The Board is in the process of finalizing a suitable accommodation. The PIL is still pending.

Guest Post: The story behind Ranbaxy's new drug

Pursuant to my last post on Ranbaxy’s new anti-malarial drug, I received a few comments indicating a certain level of confusion about the exact nature of Ranbaxy’s invention. I therefore requested Akshat Rathi, a doctoral student in chemistry at the University of Oxford, to write us a guest post tracing the evolution and nature of Ranbaxy’s invention. Akshat also writes at the Allotrope, a blog focussed on the impact of science on society. 

The story behind Ranbaxy’s new drug 

By, 

Akshat Rathi 

From Prashant’s recent post about Ranbaxy’s new anti-malarial drug, we know that Synriam is a fixed-dose combination of two known molecules, arterolane maleate and piperquine phosphate. The highlight of the media coverage has been to call this India’s first new drug, which isn’t entirely correct. What makes Synriam special, though, is that it is the first ever drug based on arterolane, a cheaper and better alternative to what is currently available. 

Before we look at arterolane, let’s take a quick look at malaria and anti-malarial drugs. According to a World Health Organization (WHO) report, every year 250 million new cases of malaria are reported and it causes 800,000 deaths. It is the biggest killer among the diseases that affect children less than 5-years of age. Anti-malarial drugs have existed for over 300 years, but it is only in the last century that there has been a rise in drug-resistance among the parasites responsible for the disease. This spurred research into developing new drugs and therapies. 

One key finding from the increased attention that malaria received was the role of combination therapy. It was found that a judicious combination of drugs could help delay the development of resistance to drugs. To ensure that the new drugs that have been developed do not develop resistance, according to WHO guidelines, the artemisinin class of drugs must always be used in combination with other drugs. Arterolane falls in that class. 

Funded by a Swiss non-profit, Medicines for Malaria Venture (MMV), arterolane (codenamed OZ277) was revealed in 2004 in a paper published in Nature. It was developed as part of a collaborative drug discovery project that consisted of researchers in the US, the UK, Switzerland and Australia. The aim of the project was to discover a new chemical entity (NCE) that could overcome the limitations of artemisinin, a widely-used antimalarial drug. 

Among the many limitations of artemisinin is its price. It is produced from a plant-based source, making it an expensive solution to a poor man’s disease. Arterolane, on the other hand, can be synthesised from commercial chemicals and more cheaply (As a side, arterolane also has one of the funkiest chemical structures among drug molecules). With this molecule, MMV had achieved its goals of finding an NCE with desired qualities, but without further development through clinical trials, it would not have become a marketable drug. That is when Ranbaxy entered the scene. MMV tied up with Ranbaxy in 2003 and supported the development of the drug up until 2007. 

According to LiveMint, MMV decided to stop funding the project after it reviewed preliminary data and other portfolio priorities. According to results that were presented at a conference in 2006, MMV found that results of Ranbaxy’s trials were not very satisfactory compared to other drug candidates available in the agency’s many collaborative projects. By this time, Ranbaxy had spent about $16 million. Despite losing MMV’s support, it planned to continue the development of the drug. 

The IP-related issues surrounding arterolane remain unclear. In a conversation with Jonathan Vennerstrom, who led the study that was published in Nature, I was told that MMV owns the patent for arterolane (see here and here). By 2007, given that MMV had lost interest in arterolane might mean that it licensed the molecule to Ranbaxy at a low price. 

Looking at the lack of confidence that MMV showed in the drug, in 2007, Ranbaxy was taking a risk by continuing research because there was no guarantee that the final clinical trials would be successful. It deserves credit to have been brave enough to plough in a further $15 million (of which $1 million came from the Department of Science Technology) to bring Synriam to the market. Whether they did that to avoid losses or because they truly believed that Synriam was going to be successful, I am not sure. 

The drug is claimed to be more effective than any other drug currently available. The recommended dosage is one pill a day for three days, which is less than other for other drugs. Ranbaxy has also ensured that the price remains low at Rs. 130 for the three-day treatment. It is interesting to note that this is much cheaper than Cipla’s Mefliam Plus, which is priced at Rs. 300. Ranbaxy gets more points also because Mefliam Plus is a combination of artesunate and mefloquine, both of which are known molecules that have been used in different fixed-dose combinations previously. 

Although Synriam does not qualify as ‘India’s first new drug’ (because none of its active ingredients were wholly developed in India), Ranbaxy deserves credit for being the first Indian pharmaceutical company to launch an NCE before it was launched anywhere else in the world.

Akshat Rathi is a science writer and a doctoral student in chemistry at the University of Oxford. He blogs at the Allotrope.

Ranbaxy’s new anti-malarial drug: A first for India?

The last few days have witnessed at least a dozen news reports on the launch of Ranbaxy’s new anti-malarial drug – Synriam. Several of the news reports such as the one over here and here give the impression that this drug launch is the first of its kind in India. The Business Line report in particular claims that Ranbaxy has spent invested $30 million to develop this drug. A part of this claim can be traced to Ranbaxy’s press-release which claims that Synriam is India’s ‘first new drug’. Image from here.

However several other papers have reported that Ranbaxy’s ‘Synriam’ is not a brand new molecule but a fixed-dose combination (FDC) of two existing drugs. In particular, the DNA report by Priyanka Golikeri reports that the drug is arterolane maleate +piperaquine phosphate. She also reports that Cipla has also has launched another anti-malarial FDC drug which is also a combination of two existing drugs: artesunate + mefloquine. The DNA news report appears to be corroborated by a quote in the Ranbaxy press-release itself: “The new drug, which will be marketed first in India, is developed as a fixed dose combination consisting of arterolane maleate 150 mg and piperaquine phosphate 750 mg drug, in line with WHO recommendations.” 

While this achievement in creating a new FDC is commendable, it is certainly not the first time that an Indian company has developed a FDC, as is being projected in some of the news reports. Cipla and Ranbaxy and in fact most of the Indian drug industry has been extremely adept at developing FDCs. In fact Cipla is credited with pioneering FDCs in the battle against AIDs/HIV. One of its first such FDCs was Triomune, a FDC of three anti-retroviral (ARVs): Lamivudine, stavudine and Nevirapine. The FDC was credited with greatly increasing compliance amongst the HIV patient community since it did away with the need to take the three drugs independently. 

It is interesting to note that both the Ranbaxy and Cipla FDCs to combat malaria, where done in combination with the Department of Science & Technology (DST) and the Drugs for Neglected Diseases Initiative (DNDi), respectively. The Business Line reports that the DST primarily funded Ranbaxy’s phase III clinical trials for the new drug in South Asia, South-East Asia and Africa. The amount released for the clinical trials, according to the Business Line was Rs. 5 crores (i.e. roughly one million US dollars). Before the DST, Ranbaxy was reportedly working with the Medicine for Malaria Venture (MMV). The partnership with MMV was broken off a few years ago. 

Although details are unavailable on the exact nature of the agreement between DNDi and Cipla, I’m guessing it is more of a marketing arrangement because as per the Wikipedia page for DNDi, the artesunate + mefloquine FDC was developed in the year 2008 itself and already being manufactured by a Brazilian government owned pharmaceutical company. 

The major cost in developing FDCs, is the clinical trials, especially for drugs aiming for the WHO pre-qualification regulatory approvals. A seal of approval from WHO would mean that the drug will be bought in bulk by the several international aid agencies that carry out anti-malarial programs in Africa and Southeast/South Asia where malaria is rampant. Once the cost of clinical trials is covered by the DST, it is unlikely that Ranbaxy would have had to invest any significant sum in the development of the drug. Public private partnerships such as this negate the need for monopoly IP measures such as patents or data exclusivity, since the public sector is in effect subsidizing the private sector in drug development. It is also not the first time that somebody proposed this model of developed. Jerome Reichman, for instance has long called for a ‘public goods’ approach clinical trials where the cost is borne by the government in a bid to reduce demands for monopoly IP protections by pharmaceutical companies. You can read his paper over here. (Image from here)

Returning to the issue at hand, although, both Ranbaxy and Cipla claim that their drugs are a part of their corporate social responsibility agenda, I’m guessing that they stand to make killer profits from these drugs simply through economies of scale. Both drugs appeared to be priced quite cheaply, the Ranbaxy drug for instance is just Rs. 130, but the number of new malaria cases in the world every year is estimated to be at around 250 million. You do the math! This is not to say that profits are bad but instead point out how the profit motive is always effective in delivering results. In case you are wondering as to why both companies launched their drugs in tandem, it was most probably because April 25th is World Malaria day.

Statutory licensing for radio stations to be dropped from Copyright Amendment Bill, 2010?

The Times of India & the Economic Times have both reported that radio stations are opposed to any move by the HRD Ministry to do away with the proposed ‘statutory licensing’ provision in the Copyright (Amendment) Bill, 2010. It is not even clear whether the Ministry has actually proposed such a move. Image from here.

As per Section 31 of the Copyright Act, 1957 a compulsory licence for broadcast could be issued by the Copyright Board only if the works in question had been withheld from the public. This provision had been interpreted in many different ways during the arguments before the Supreme Court in the case of ENIL v. SCIL. The music companies tried to argue that since they were licensing their repertoire to the government broadcaster, All India Radio (AIR), there was no question of the works being withheld from the public and thus the private radio stations were not entitled to any relief under the compulsory licencing provisions. The Supreme Court however proceeded to give the provision a purposive interpretation in light of the changing economic scenario. As a result of the Supreme Court’s purposive interpretation of Section 31, multiple radio stations could now apply for compulsory licences. 

The Copyright (Amendment) Bill, 2010 aimed at codifying the Supreme Court judgment, by replacing the earlier section with a new provision (Clause 31D) which gave all broadcasters a right to apply for a licence at a rate fixed by the Copyright Board. Then in August, 2011 the Ministry moved an amendment to the pending amendment bill seeking to limit the scope of Clause 31(D) to only radio broadcasters and not television broadcasters. This led to very vocal protests from the television broadcasting industry. Their concerns were voiced in Parliament by members of the Opposition who had stalled the Bill due to a range of concerns. 

The reports in the ToI and ET now indicate that the Government is contemplating dropping the provision entirely. The Association of Radio Operators (AROI) has reportedly written to the I&B Industry asking them to take up cudgels on their behalf and convince the Ministry of HRD to not drop the provision in its entirety. 

The original amendment was blessed even by the Parliamentary Standing Committee and the government will be required to have a good reason to drop this amendment. On a separate note it will be interesting to see how the press covers this particular issue since several of the popular radio stations in India are in fact owned by media conglomerates which also own other media establishments. For example Radio Mirchi is owned by the Times Group which also owns Times of India and Economic Times. Similarly HT Media which owns Radio Fever also owns the Hindustan Times and Mint. The Dainik Jagran Group which own Radio Mantra also publishes several newspapers in Hindi, English and other regional languages. A few years ago the Government had proposed a law to curb such extensive cross-holdings in the media. However after an outcry from the media, the government seems to have dropped any attempt to push for such a law.

Spicy IP Tidbit: ‘Bold strategies for Indian Science’ by Prof. Gautam Desiraju

One of the recent issues of the international weekly journal of science, Nature, carried an interesting and witty article on the state of Indian science. The article titled ‘Bold strategies for Indian Science’ by Gautam Desiraju, a Professor of Chemistry, at the prestigious Indian Institute for Science (IISc.), Bangalore. The article can be read over here. (Image from here)

In this article, Prof. Desiraju laments at the slow progress of Indian science; on how India has not produced a single Nobel laureate since C. V. Raman, on how there have been no radical breakthroughs to ‘rival the telephone’ and how India lacks any postdoctoral system worth its name. He reasons that lack of funding is only one of the problems and definitely not the core problem facing Indian science. The core problems according to Prof. Desiraju are a feudal mindset, lack of dissent and lack of institutional autonomy. 

In pertinent part Prof. Desiraju states “Our cultural value system, backed by Hindu scriptural authority, has created a strongly feudal mindset among Indians. Centuries of servitude, right up until 1947, have made the average Indian docile, obedient and sycophantic. 'Behave yourself and be rewarded', is the pragmatic mantra. I believe this feudal–colonial mentality has had far-reaching and debilitating consequences for research.” 

“The first is our lack of the ability to question and dissent that is so essential to science.” 

He further states “Another consequence of this feudal mindset is our unquestioning acceptance — bordering on subservience — to older people. In this part of the world, age is blindly equated with wisdom, and youth with immaturity. This facilitates the continuance of the status quo.” 

The second problem according to Prof. Desiraju is the method of appointments followed by state universities. In his words: “In the more influential central institutions, appointments are often made incestuously, with students of a few senior researchers filling a disproportionately large number of vacancies, or with plain academic 'inbreeding'. A good dose of regional parochialism completes the picture.” 

He concludes the article with a prescription for the future. The solution according to him, apart from changing mind-sets, lies in focussed funding for projects of national importance such as energy, water and public health and ensuring high accountability of such projects. 

In my opinion Prof. Desiraju’s analysis is applicable across the board – the feudal mind-set and the subservience to older people is not a problem of just Indian science. It extends to even law and lawyers. As he notes it’s a probably a hangover of our past.

His analysis may just explain how brilliant Indian scientists are being intellectually suffocated in India. 

World IP Day: A Natural Take

SpicyIP wishes all of its readers a very imaginative IP day. Each year, we've commemorated this occasion with a short note, and also offered up a new SpicyIP product (a database/website etc) for public consumption.

This year, we bring to you an exclusive IP writing competition titled Pondering IP (PIP). This competition is organised under the aegis of the Ministry of HRD Chair at WB NUJS, but in collaboration with IPTLS (a student run IP society at NUJS) and SpicyIP. 

Sai Vinod carried an earlier post, highlighting this competition; further details can be found here. The competition is open to law students throughout the world and we offer a modest prize for the best three essays. So please help spread the word.

We've been very fortunate to line up an incredible array of judges representing a multitude of jurisdictions including the UK, US, New Zealand, Canada, Australia and Scotland. In case you're wondering how the multi-jurisdictional numbers add up, you have to dig a bit into the backgrounds of this stellar panel.  
 

Professor David Vaver, perhaps the most cited IP scholar in Canada is originally from New Zealand. He moved to Canada, then to the UK (where he served as the Director of the Oxford IP Research Center for a good number of years and helped it gain international recognition through several innovative initiatives) and back again to Canada where the folks at Osgoode refuse to let him retire--after all, with him around, its Osgoode as it gets. 

Professor Lionel Bently, one of Europe's leading IP scholars and author of several books and articles including a classic treatise on intellectual property law (which is now the standard IP text book in many jurisdictions, including India) is of Australian vintage. 

Professor Graeme Dinwoodie is of Scottish heritage and spent a large part of his career teaching in the United States, where, among other things he ran a very reputed IP programe out of Chicago Kent law school, wrote a stream of high impact scholarly pieces on various facets of intellectual property law and was conferred with one of the highest teaching awards (the Pattishall Medal for Teaching Excellence) before he moved to the UK to take over as the Director of the Oxford IP Research Centre (OIPRC).

As for Judge Rader, although he has not switched borders yet, his reputation is by all accounts very "trans-border" in scope. Many would agree that he qualifies as a well known mark in several jurisdictions, where he routinely visits and speaks, leaving one to ponder the source of his indefatigable energy, good cheer and occasional creative outpourings on the non IP side, which have rightly earned him the sobriquet, the Rock Star of IP.

And now, its time for our short World IP day note. As always, let me fall back on the inspiring theme conceptualised by WIPO this year to mark this momentous day, namely that celebrating our visionary innovators and creators.

I had a tough time tossing up between several innovators who've left lasting impressions on me. I travelled back in time to experience the creative vision of Sushruta as he dug deep into a pair of eyes to perform what might rank as the first cataract operation ever, the courage of Aryabhata in theorising that the earth rotated on its own axis and the other-wordliness of Patanjali who effectively engineered the path to salvation by crafting the Yoga Sutras (a transcendental series of postures and breathing techniques). And more recently, the humane touch of Jagdish Chandra Bose who abandoned a very lucrative area of research (radio waves) and jaunted off to demonstrate that plants have feelings too! 

All of them were exceptionally brilliant in their own way, and it was well nigh impossible to come up with a rank list of sorts. It then struck me that there was one creator who stood head and shoulders above the rest. And her name was mother nature....a mother who embodies the highest form of creativity and innovation ever known to mankind and whose offerings represent the best of functionality and design. 

And so I end this note by paying homage to her, with the hope that she continues to inspire each day, helping us unleash our imagination to the hilt. Have a wonderfully stimulating IP Day! 

ps: image from here

Kenyan Court holds Anti-Counterfeit Act unconstitutional

UNAIDS Executive Director welcoming the decision

A couple of years ago we had blogged about the controversial Kenyan Anti-Counterfeit Act that had been passed in 2008. At that time, I had written that its broad definition of counterfeits would include generics and would be severely problematic:

"The problematic part of the legislation is that it recognises intellectual property rights of pharmaceutical products registered in any part of the world and not just in the country of export or import....  The legislation claims that copies or generic versions of all products having protection in Kenya or anywhere else will be considered 'counterfeit'... By the year 2012, the global pharmaceutical market will see approximately $123 billion worth of products lose their patents. Given that the expiry time line for drug patents differs across countries, it’s really problematic that the Kenyan legislation protects the intellectual property rights of drugs that are registered even outside Kenya. This gives good reason to believe that the Kenyan legislation has been influenced by vested interests.

The legislation also lacks a differentiation between the definitions of spurious goods and counterfeit goods. While one implies a sub-standard product - a public health issue, and the other merely refers to alleged IPR violations and do not necessarily compromise on quality of the product and this is not reflected in the legislation." 

A few days ago, in a landmark decision, the High Court of Nairobi held the relevant three provisions of this Anti-Counterfeit Act, 2008 as unconstitutional - Section 2 (definition of counterfeiting), section 32 (offences) and Section 34 (Powers of the Commissioner to seize suspected counterfeit Goods). The Court held that the definition of counterfeits could unfairly include generic medicines and that this would violate the right to life, dignity and health. The conflagration of generics and counterfeits during in-transit seizures was also mentioned as the type of consequence that could occur by allowing this type of provision. In fact, the Court also said that in a legal regime that respects Intellectual Property Rights, "the danger that such generic drugs can be seized under section 32 and 34 of the Act is therefore manifest." 

Importantly, the Court also discussed that even though counterfeiting is a current issue and requires addressing and even though it is important to protect IPR rights - this cannot be done at the cost of fundamental rights to life, dignity and health. Even though this may seem obvious to the casual observer, people who have been following IP trends of today will realise the unfortunate truth that it is becoming increasingly important to state this up front (see the end of my last post mentioning the rhetoric of IP 'rights'). 

Finally, the Court pointed out that the intentions of the Act are clearly not to safeguard consumers from counterfeits, but rather just to protect IP rights of individuals - "It would be in violation of the state’s obligations to the petitioners with respect to their right to life and health  to  have included in legislation ambiguous provisions subject to the interpretation of intellectual property holders and customs  officials when such provisions relate to access to medicines essential for the petitioners’ survival."

The implications of this decision are potentially quite large for Indian generics. Other countries in Africa which are contemplated / have already implemented legislation similar to the Anti-Counterfeiting Act will be taking note of this landmark judgement from Kenya - and India exported an estimated $1.58 billion worth of pharmaceutical products to Africa in 2010-2011, up from $1.19 billion in 2009-2010 (according to the HBL). 

Takeaways:

There is one important take away from this whole incident which Indian generics should take note of - and that is that substandard/spurious drugs are becoming an issue which may no longer be one that can be ignored. Earlier on the blog, Suchita had mentioned that batches of drugs in various African countries labelled "made in India" were found to be fakes coming from China. 

As drugs worth billions of dollars start going off patent, more and more generics are produced to penetrate those markets, resulting in millions of patients suddenly being able to afford drugs that they earlier weren't able to. As generic companies are increasing access to these markets (and patients are more able to access drugs), it is important to maintain good quality in order to not further inflate the misconception that 'counterfeits' (which has a legal and hence slightly flexible definition) and substandard / bad quality drugs. 

As to the other important takeaway - it pertains how other countries react to the Kenyan decision. It would shock nobody if USTR's next 301 report mentions their 'disappointment' in Kenya's attitude towards IP rights. Hopefully other African countries though, view it through a more pragmatic lens - regarding the effect that such legislation can have on their people. Countries which produce generic drugs will of course hail the decision. And thus, the debate regarding the strength of IPRs regarding pharmaceutical products goes on. In the meantime though, no doubt, this decision will affect many many lives in Kenya quite positively, and hopefully also brings us closer to recognising our normative balance of priorities.  

Don'tTradeAwayOurLives provides the text of the judgement here for those interested. 

The review petition: Will Dr. Kardam stop the IPO from slipping back into the dark ages?

 

Continuing from our last post on the latest RTI fiasco before the Intellectual Property Office (IPO), we have now prepared a ‘review’ petition which we will mail to the IPO by tomorrow.

The ball is now in Dr. Kardam’s court – if he accepts the contentions in the review petition he will have to necessarily accept that the RTI Act, 2005 overrules the existing procedures under various IP laws to request information from different IP offices. If he rejects the review petition, he will bear the sole responsibility for sending the Trade Marks Registry, the Patents Office and the G.I. Registry back to the dark ages when there was no RTI Act. The existing procedures may help in procuring information from the IP offices but it is no secret that those rules were largely ineffectual since they did not give citizens any rights, as is the case under the RTI Act. This is precisely why the RTI Act was such a powerful weapon which shone so much light on the opaque workings of the IPO. 

In any case, I have full confidence that Dr. Kardam will do justice to this review petition. If not, we'll just have to appeal his order. 

The petition is as follows:

Dr. K. S. Kardam,
Patent Office,
Intellectual Property Office,
Plot No. 32, Sector – 14,
Dwarka,
New Delhi – 110075.

Dear Dr. Kardam, 

Sub: Application for review of your order No. POD/RTI/Appeal/2/4/2012 

1. You are requested to please consider this as an application requesting you to review your order No. POD/RTI/Appeal/2/4/2012 dated April 18th, 2012 in the case of Sumathi Chandrashekaran v. G.L. Verma, CPIO, GIR, Chennai. 

2. In this particular case I had filed a RTI Application with the CPIO, Geographical Indications (G.I.) Registry requesting for a photocopy of the file pertaining to the ‘Darjeeling Tea’ G.I. The CPIO had agreed to provide the information that I had requested for, but at the cost of Rs. 10 per page of photocopying. Since this amount was five times the cost prescribed by the Central Government, I filed an appeal requesting you to direct the G.I. Registrar to charge a fee of only Rs. 2 per page as per the relevant Govt. of India rules. 

3. In your decision, you dismissed the appeal on the grounds that the RTI Act was inapplicable to those categories of information which could be requested for under the G.I. Act & Rules. 

4. Your latest decision is entirely contradictory to what you have held earlier in the case of Sai Vinod v. CPIO, Patent Office, Chennai (No.POD/RTI/Appeal/7/12/2011). In that case, you had rightly depended on the judgment of the CIC in the case of Mr. R.S. Misra v. CPIO, Supreme Court of India (Decision No. CIC/SM/A/2011/000237/SG/12351). 

5. In the case of my appeal, you have denied me information under the RTI Act, 2005 on the basis of a later decision of the CIC in the case of V.K.Malik v. Tis Hazari. 

6. I would however like to point out to you that the CIC decision in the V.K.Malik v. Tis Hazari would be applicable only if I had requested for certified copies. In contrast, my RTI application is very clear that in its request for only photocopies, and not certified copies. You will appreciate that there is a distinction between a ‘certified copy’ and a mere photocopy. The term certified copy is defined in Section 76 of the Evidence Act, 1872 in the following manner: 

76. Certified copies of Public Documents - Every public officer having the custody of a public document, which any person has a right to inspect, shall give that person on demand a copy of it on payment of the legal fees therefor together with a certificate written at the foot of such copy that it is a true copy of such document or part thereof, as the case may be, and such certificate shall be dated and subscribed by such officers with his name and his official title, and shall be sealed whenever such officer is authorized by law to make use of a seal, and such copies so certified shall be called certified copies. 

7. A certified copy of a document, in context of the G.I registry, would be given under the seal of the G.I. Registry with a certificate that the document thus provided is a true copy, and has been so verified by the Officer in charge. Such documents can be submitted as evidence in a court of a law. 

8. On the other hand, a photocopy is a mere copy of a document, which does not carry a certificate from the Officer in charge stating that the information sought for is a true copy of the actual information. A simple photocopy is not the equivalent of a certified copy. 

9. The CIC decision cited by you clearly applies only to certified copies and not simple photocopies. 

You are therefore requested to review your order in my appeal and grant me the original relief that I had applied for. 

Thanking you, 

Yours sincerely, 

Sumathi Chandrashekaran

Patent issues on date of decision of grant

A division bench of the Delhi High Court has brought a definite end to the practice of mischievous serial pre-grant oppositions and affirmed the single judge ruling in the matter of Dr. Snehlata Gupte and Others V. Union of India.  Shamnad had, in a previous post while discussing the single judge order had said that more Indian party specific cases would lead to greater objectivity in the patent system.  It is now certain that all inventors, whether Indian or non-Indian, now stand at an equal footing after this decision-at least in respect of patent opposition cases.  

Quotable quote: "We ......reiterate that the date on which the patent is granted cannot be the date of issuance of certificate but has to be the date on which orders are passed by the Controller."

The appellants, represented by Mr. Sudhir Chandra, Senior Advocate, and others referred to the definition of a patentee (Sections 2(p)), 21, and 25(1)) and Rules 14, 31 to discuss that the date of a patent would be the date it is formally entered into the register.  Great emphasis was laid at the fact that the Controller had while dismissing the patent opposition filed by one of the appellants had included the words ..."With the following conditions........" after ordering the patent to be granted.    

The respondents, represented by Mr. Maninder Singh, Senior Advocate, for the patent office (Union of India), and Ms.  Pratibha Singh, for respondent 5, countered this assertion (grant coupled with conditions) by discussing the process an application filed at the patent goes through to become a patent.

"[A]n application is filed under Section 5 of the Act and after 18 months, there is a publication of patent application under Section 11A of the Act and it takes 48 months to examine the request under Section 17B of the Act. Examination takes place as per Section 12(1) of the Act.  It is thereafter stage of filing of application takes place in terms of Section 25(1) of the Act. Thus, by that time, opposition is received, Controller has examined the feasibility of grant of the application at that level and the same is found to be in order. Otherwise, the Controller could reject the application at that stage also. Once the opposition is filed, hearing on the said opposition is in terms of Rule 55 of the Rules. Therefore, the moment the pre-grant opposition is rejected, the Controller is empowered to pass the order of grant of patent which in fact, happened in the present case. It was not a conditional order as contended by the appellant."

The judgment discusses the relevant provisions including the sections and the applicable rules in greater detail to conclude that the important date is the day an order of grant is issued.  

The Bench also agreed with the single judge decision as regards capability of misuse re filing serial oppositions through aliases and stated: "We command the Patent Office to issue directions/instructions in terms of Paras 55 to 58 of the order of the learned Single Judge;"  and imposed costs to the tune of Rs. 25000/ per appeal (~approximately USD 500 per appeal).

SpicyIP Announcements: The First PIP (Promoting Intellectual Property) Competition 2012

The First Annual NUJS IP Essay Competition 2012 announced last month has now been renamed as the PIP (Pondering Intellectual Property) Competition, 2012. We are pleased to announce that SpicyIP will co-host the first edition the competition along with the MHRD IP Chair at the National University of Juridical Sciences (NUJS) and the Intellectual Property and Technology Law Society (IPTLS).

All students currently enrolled in full-time graduate program anywhere in the world can participate in the competition by submitting essays on the topic below:

Should the process of creating an invention or work determine its protectability as an intellectual property?  

The entries will be judged by a 5 member panel of renowned international experts in intellectual property. The panel comprises: 

Professor David Vaver, Professor of IP Law, Osgoode Hall Law School 

Professor Lionel Bently, Director of the Centre for IP Law, University of Cambridge 

Judge Randall R. Rader, Chief Judge of the United States Court of Appeals for the Federal Circuit 

Professor Graeme Dinwoodie, Director of the Oxford Intellectual Property Research Center, University of Oxford 

Professor Shamnad Basheer, MHRD Chair Professor in IP Law at the National University of Juridical Sciences 

Word Limit: The submissions should not exceed more than 5,000 words inclusive of footnotes and references. Entries exceeding the word limit would be automatically disqualified. 

Awards: The winning entry will receive Rs. 25,000 and will be eligible for publication at the NUJS Law Review. The runner up will receive Rs. 12,500 and the third best entry will receive Rs. 7,500.

Deadline: The last date for submission is July 14th, 2012. 

The terms and conditions of the competition are available here. For more details about the competition, feel free to email us at iptls@nujs.edu.

Moral Rights for Moral Wrongs - Dismantling of the Bhilai 'Flight of Steel' sculpture

If you are an artist or sculptor or just someone who just appreciates good art, the recent episode concerning the destruction and dumping of the sculpture 'The Flight of Steel', an iconic sculpture (which was later renamed 'Murga Chowk') in Bhilai, is sure to irk you to an uncomfortable degree. 

This is a curious case of a seventy year old artists being humiliated after being commissioned by Bhilai Steel Plant to construct a steel sculpture in a designated area covering about 30 square feet. Jatin Das, an eminent artist and sculptor was informed by the guards present during the demolition, that the sculpture was being 'taken away' to a zoo known as Maitri Garden. However, to Jatin Das' dismay, when he visited the zoo premises, he found only bits of his sculpture strewn around, without any apparent indication that the sculpture was to be installed there. In fact, he found different bits of the sculpture in different places, indicating a haphazard and unorganised plan to reinstall the sculpture at a different location - if indeed that was the intention of the officials.

The reason being advanced by BSP officials for such an inexplicable act is that an expansion project is underway and that “one of the flyovers being constructed in the township is passing over the intersection which housed the artifacts”. They have even gone to the extent of claiming that the artifact was 'carefully removed', with a view towards reinstallation at a later point in time. However, the images below suggest a completely different picture - the dismantling was done hurriedly and the zoo premises has more rubble than warranted in a carefully executed relocation procedure. 

While the dismay and anger being expressed by Jatin Das is understandable, particularly since he was not even informed of such plans, there does appear to be a violation of a definite legal right of Jatin Das, giving way to a cause of action in court if he so desires. Our readers will remember the landmark decision in Amar Nath Sehgal vs Union of India [2005 (30) PTC 253] which was the first Indian case to not only recognise the moral rights of an author of a copyrightable work, but also awarded damages to the claimant. 

The facts of the present case relating to 'The Flight of Steel', is remarkably similar to the situation that arose in Amar Nath Sehgal as well. There, the renowned artist and sculptor Amar Nath Sehgal was commissioned by the Ministry of Works, Housing and Supplies of the Central Government in 1959 to design and construct a mural. The mural was to be placed around a central arch of the Vigyan Bhawan - a well-known convention centre in New Delhi, where the government hosts and organises several events. The construction, which then Prime Minister Jawahar Lal Nehru personally approved, was completed in 1962. However, in the course of renovation in the year 1979, the mural was removed and only bits and pieces remained of the iconic sculpture that attracted large gatherings and earned widespread acclaim. 

Amar Nath Sehgal, understandably dismayed, brought a suit against the government and argued that the dismantling and dismemberment of his works constituted 'mutilation' (as provided under Section 57 of the Indian Copyright Act) and further that his honour and reputation as an artist was compromised and lastly, that his authorship rights were at stake since no sculpture remained and his name on the work was obliterated. The defence revolved around issues such as assignment, ownership and dispute resolution mechanisms under the deed of assignment - effectively conceding that the officials did in fact authorise the removal of Sehgal's mural. The judge awarded damages amounting to Rs. 5,00,000 to Amar Nath Sehgal, relying on the statutory protection afforded to artists under the above mentioned section relating to moral rights.

It seems that a similar claim may be raised by Jatin Das, and if in fact it is proved that the sculpture has been damaged beyond repair, it is very likely that he will be awarded damages as well. For now, we request our readers to spread the word about this incident and pass along this protest note that Mr. Jatin Das sent me this morning to your friends and colleagues.