Pankhuri Malik is an IPilogue Writer, IP Innovation Clinic Fellow, and an LLM Candidate at Osgoode Hall Law School.

On , the Delhi High Court protected the title of the iconic Bollywood movie “Sholay” from trademark infringement and passing-off by a U.S. based company, as well as its Indian affiliates and founders.

The lawsuit was filed in 2001 when the defendants were found to have registered the domain name ‘www.sholay.com’ for its website. Additionally, the defendants were also found to be publishing a magazine with the same name and offering for sale various merchandise using content from the movie, including its title, in the same logo script. Through its website, the defendants were found to be offering various electronic services, such as web-chat, e-greetings, horoscopes, classifieds, and Bollywood news.

About “Sholay”

The iconic film “Sholay” was released in India in 1975 and became the biggest record-breaking film in the history of Indian cinema. The movie ran in fully packed theatres until 5 years after its release and made history on numerous occasions., The High Court of Delhi has previously the widespread popularity of Sholay and rights in its’ title and content.

Defences raised

The defendants did not deny their use of the impugned marks. The defendants however contended, in their written response, that:

1. Film titles are not entitled to IP protection;
2. There is no probability of confusion between the defendants’ business and the plaintiffs’ movie;
3. “Sholay” is a dictionary word (translation: embers)

These defences were considered by the court separately. Regarding confusion, the court held that the internet has created an additional market for “Sholay”. The popularity of the film, along with its widespread availability on the internet, would lead individuals to consider the defendants’ goods and services to be “off-shoots” from the film. The court also held that since the defendants’ website is popular within the Indian community in the U.S., the final demographic of the website is yet unclear. This, in addition to the use of an identical logo and marks by the defendant, creates a “”.

 Can movie titles be protected as trademarks in India?

It is settled law in India (and Canada) that titles of movies, books, songs etc. are not eligible for copyright protection. However, Indian courts have trademark protection to from passing off where:

1. The title has acquired a secondary meaning; and
2. There is likelihood of confusion of source, affiliation, sponsorship or connection of potential buyers/audience/viewers.

Accordingly, the court that Sholay has acquired such a reputation over the past (almost) 50 years that the word Sholay connotes only that film and none other.

In accordance with the above findings, the High Court imposed an injunction restraining the defendants from using the mark Sholay and any images from the film for its business.

What about Canada?

As stated above, Canadian copyright law also does not  protect titles of works. However, unlike India, Canadian courts also trademark protection to titles. The Federal Court of Canada last addressed this issue in where protection of a book title as a trademark was refused.

Canadian courts have not addressed this issue in the past decade. It will be interesting to see if the Courts’ stance has changed, given the increasing prevalence of the internet and streaming of content, and sale of artwork etc. in recent years.

The post Rights in Titles: Delhi High Court Affirms Rights in the Title of Iconic Bollywood Film appeared first on IPOsgoode.

Photo Credit: Jon Tyson on Unsplash

Ryan Erdman is an��IPilogue��Writer and a 2L JD Candidate at��Osgoode��Hall Law School.��

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In a truly monumental achievement in scientific innovation, there are now authorized COVID-19 vaccines around the globe. However, present inequities in global distribution plague the achievement and ultimate success of these vaccines in ending the pandemic. show that 87% of the over 1 billon doses administered worldwide have been in high-income countries, compared to only 0.2%��of doses administered in low-income countries. As world case numbers continue to rise, the presence and likelihood of variant strains only prolong the immediate harms and long-term impacts. If current trends persist, COVID-19 will continue to devastate countries with less developed and more permeable borders long after developed countries reach majority levels of immunization. At the current pace, it is some low-income countries will not see significant percentages of the population vaccinated until 2023.

The trends in inequitable global access to new medicines are not novel and have long been tied to the intellectual property (IP) rights granted to drug manufacturers in return for taking on the “risk” of research and development (R&D). In general, by awarding a period of limited exclusive rights during which the developer can set non-competitive prices, IP protections inherently and negatively impact affordability. At the beginning of the pandemic, costs and public sector investment affected the ability of high-and upper-middle-income countries to around 6 billion doses through advanced purchase agreements. In October, South Africa and India submitted a to the World Trade Organization (WTO) calling to temporarily waive the Trade-Related Aspects of the Intellectual Property Rights (TRIPS) Agreement provisions relevant to COVID-19 related technology, citing historical and present barriers in affordable and timely access to new medicines created by IP rights. Specifically, they call for a waiver of sections outlining the rights and obligations in the areas of copyright, industrial designs, patents, and the protection of trade secrets relating to “the preventing and treatment of COVID-19.”

The breadth of the original proposal is important in light of the Biden Administration’s recent supporting a waiver of IP rights. The announcement, however, does not directly support the waiver initially proposed 7 months ago. The scope of the initial waiver proposal was purposefully broad, looking to eliminate barriers created by IP protections related to accessibility of not just vaccines, but also other necessary technology in the areas of diagnostics, P.P.E., and other therapeutic drugs. The scope and duration of a waiver comprise many key issues that will need to be agreed to and countries have shown a to come to the negotiating table in light of the US announcement. Canada has that it will not block a waiver, and that the government is committed to work towards a “consensus-based” solution.

But where time is at a premium, the complexity and length of negotiations is an obvious cause of concern. Given the likelihood of COVID-19 becoming , including the persistent threat of variants, any waiver may significantly affect future innovation in COVID-19 “booster shots” and other vaccine technology. This is part of why Big Pharma has met the Biden Administration’s announcement with continuous and skepticism for the efficacy of any waiver in meeting the objective of timely increases in global production. The most prominent of these criticisms doubts that a waiver will effectively address the true bottlenecks, which is to be the scarcity of raw materials and ingredients and the lack of technical know-how.

This is particularly important in determining the scope of the waiver, as a vaccine “patent waiver”, as the media consistently calls it, is simply underinclusive of the knowledge transfer necessary. While a vaccine patent waiver could help alleviate obstacles around technology fragmentation, where different parties own multiple patents related to one vaccine, scaling up production in developing countries also requires the transfer of technical processes. This would involve numerous types of IP and requires technical expertise to build and implement. Some this is why, even though Moderna has long not to enforce certain COVID-19 patent rights during the pandemic, there has been “no flourishing of factories pumping out “generic” messenger-RNA vaccines.” New manufacturers would also need to generate a novel and comprehensive “”, as they cannot rely on the safety and efficacy clinical trial data of originators like with small molecule drugs. The original waiver addressed both copyright and trade secrets, but there are clear that any waiver is certainly going to be narrower than that originally proposed. Any “consensus-based solution”, if at all, will take months and not include the time for new producers to build production capacity and meet regulatory hurdles. WTO Director-General Ngozi Okonjo-Iweala recently expressed “hope” that a waiver could be agreed upon by .

Nonetheless, while accepting that a waiver may not be a “silver bullet” solution, the announcement has certainly reflected optimism for a critical shift in the status-quo, with the head of the WHO calling it a “monumental moment in the fight against COVID-19.” We could look back on this as the moment where high-income nations finally move-away from strong notions of “vaccine nationalism.” Timely access requires a unified effort and immediate, continued support from developed nations for global initiatives like the UN-backed , which plans to deliver billions of vaccines to low-income countries. Members on both sides of the waiver debate advocated for vaccine-producing nations increasing production and reducing restrictions on the export of vaccines (and materials). Interestingly, some that the threat of a waiver could also be a tactic to push companies into greater licensing strategies and persuade them to exhaust production capacity and sell extra supplies to poor countries. The perceived threat of compulsory licensing has pushed companies to make broader global pledges in the .

Where a pandemic is truly a “” every second matters, yet there are many reasons to believe that we will not feel the effects of any negotiations for a long time. Waiver discussions are sure to intensify ahead of the WTO’s next formal meeting in early June.

The post Biden Support for Covid-19 Intellectual Property Waiver: A Step Below Progress? appeared first on IPOsgoode.

While health activists, generic manufacturers and several academics lauded the decision, the multinational pharmaceutical industry was up in arms.

The facts of the case are thus:

In August 2011, Natco, an Indian generic manufactured applied for a compulsory licence in respect of Bayer’s patent covering an anticancer drug, Sorefanib Tosylate, meant for patients with advanced kidney and liver cancer.

Underlying the Indian Patents Act is the philosophy that if an intellectual property owner abuses her statutorily granted monopoly by engaging in prohibitive pricing (where a patented drug is priced out of the reach of the average consumer) or by failing to supply adequate quantities of the IP good to the public, a compulsory licence will issue (after three years from the date of grant of the patent).

Constituting what many regard as a for compulsory licensing, the Controller General of Patents, PH Kurian found that all the grounds prescribed in section 84 of the Indian Patents Act for the issuance of a compulsory licence had been met, namely:

1. Bayer supplied the drug to hardly 2% of the total patient population of approximately 8000 patients that required the drug. Therefore, the reasonable requirements of the public with respect to the patented drug (Nexavar) were clearly not met.

2. Bayer’s pricing of the drug was excessive and did not constitute a "reasonably affordable" price. It charged Rs 2.8 lakhs for a months' supply of the drug, whereas Natco was willing to supply the same quantity at Rs 8800 per month.

3. Since Bayer did not manufacture reasonable quantities of the drug in India, but merely imported it, it could not be said to have complied with the “working” requirement under the Indian Patents Act. The Controller held in pertinent part that “'worked in the territory of India" under section 84 meant manufactured to a reasonable extent in India."

The Controller then proceeded to issue the licence, stating that Natco ought to pay 6% of its net sales to Bayer as royalty.

Local Working:

The Controllers decision on “local working” is likely to prove controversial, since almost 90% of MNC drugs are not manufactured in India, and therefore susceptible to compulsory licences. However, a close reading of the decision suggests that it is backed by cogent reasons and tenable under the law.

For one, Section 83 of the Act makes clear that patents are not granted only for the purpose of “importation” of the patented product. Secondly, the Indian Patents Act uses the terms "working" and "importation" quite distinctly throughout the Act, making it evident that "working" as used in the Act cannot include "importation".

Some argue that a “local working” provision contravenes the mandate under Article 27 to not “discriminate” between locally produced and imported patented products. Given the fact that in the WTO Canada case, the panel stated that discrimination meant “unjustified differentiation”, one could argue that “local working” is a “justified” differentiation. For one, the Paris Convention clearly stated that “importation” would not amount to working of ��a patent, and that if a patent wasn’t worked, this could be treated as an ��“abuse”. Secondly, TRIPS is premised on the promise of technology transfer to developing countries. And a local working provision is geared towards encouraging such technology transfer. By forcing patentees to “work” their patents in India, the regime encourages local use/transfer of the said technology. A similar provision on “local working” in Brazil’s regime was��challenged by the US—however, the case was later withdrawn and there was no ruling.

This decision of the Indian Patent Office is particularly important since it is not a “government” licence stricto sensu, where the government itself issues and works the licence (sometimes referred to as “government use”), as was the case in Brazil and Thailand. Rather this licence was triggered by the application of a private party (Natco) and the government issued this licence in its capacity as a quasi-judicial authority. In other words, the licence was not issued at the “discretion” of the government, but upon the satisfaction of certain pre-requisites, which when fulfilled, entitled a third party such as Natco to demand a licence.

It bears noting that the licence is very legal in nature and scope and helps temper the excesses of a patent monopoly to achieve public health ends. It is also perfectly compatible with TRIPS, notwithstanding the U.S. Commerce Secretary John Bryson’s that this licence amounted to a “dilution of the international patent regime”

Compulsory Licences and Incentives to�� Innovate

The key question now is: Would such licences decrease incentives to innovate? Thus far, there is no empirical work demonstrating that licences stultify the rate of innovation. The few studies available indicate that licences do not have any significant demonstrable effects on the rate and pace of innovation. Illustratively, empirically tests the rates of patenting and other measures of inventive activity before and after six compulsory licences over drug patents issued in the 1980s and 1990s. She observed no uniform decline in innovation by companies affected by compulsory licences and found very little evidence of a negative impact.

More importantly, one needs to ask whether all countries in the world need to contribute equally to Bayer’s R&D efforts. Or whether countries such as India with significant numbers of poor patients can devise policies to induce lower priced drugs in the market, without worrying excessively about Bayers’ incentives to innovate, given that such incentives are more than adequately provided by western markets such as the US and EU. After all, some of the biggest innovators today benefitted from lax IP regimes in the past. Illustratively, Switzerland, which houses some of the world’s leading refused to introduce product patents till 1977 and it was only after considerable pressure and bullying from Germany that it finally yielded.�� (See Dominique S. Ritter, y, 14 Fordham Intell. Prop. Media & Ent. L.J.��463 (2004).

Lastly, it must be borne in mind that a compulsory licence is not an evisceration of the patent, as is sometimes made out to be in media reports. Rather, it embodies what in their seminal piece describe as a “liability” rule, where the patentee continues to hold the patent and is entitled to a reasonable royalty from every new player entering the market. This advantage (in terms of compensation through royalties) cannot be understated, particularly in a market like India, where the consumer market is highly differentiated in terms of purchasing power. Drug originators typically cater to very high-income consumers, while generics are able to tap into middle and low-income consumer segments as well. Consequently, the possibility of a new generic entrant entering a market segment hitherto untapped by the originator, rather than simply displacing the patentee’s existing customer base is high. To this extent, a compulsory licence may permit an innovator to profit from newer untapped markets.

Shamnad Basheer is the Ministry of HRD Professor of IP Law at the National University of Juridical Sciences (NUJS), Kolkata and founder of Indian IP blog, SpicyIP. He has written on this licensing order at and in an editorial for the . His earlier writings on this theme (including a) were relied on by the Controller General in his order.��

The post India’s First Compulsory Licence: Patents vs Public Health? appeared first on IPOsgoode.

Google a that aims to curtail music piracy in India. By teaming up with three digital music providers who represent a large portion of Indian performers, Google’s services to free yet legitimate content for streaming. While there has always been a demand for music in India, “piracy, in the form of knock-off CDs and dozens of websites peddling illegal downloads, has stunted the Indian market, analysts say. Total Indian music industry revenue was about $165 million in 2009, a fraction of the $26.4 billion spent on recorded music globally," according to a report by PricewaterhouseCoopers.

This attempt to end music piracy comes initially paired with “a bevy of music services [like] imeem, Lala, MySpace’s recently-acquired iLike, Pandora and Rhapsody” to create Google’s music service in the United States. This , which allows users to hear an entire track for free once through one of the music service providers, is being used in India to divert users from pirated music in an attempt to boost their ailing entertainment industry. Despite piracy, “India's domestic music market is expected to grow to $590 million by 2014” and Google’s music service may increase this growth if successfully implemented. However, Google’s endeavors through the Music India service has a that must be addressed in order to effectively curb online music piracy in the future.

The post Google Aims to Curtail Indian Music Piracy appeared first on IPOsgoode.

Canadian telecommunications giant Research in Motion (RIM), which manufacturers the popular BlackBerry, has reportedly offered information and tools to assist India’s government in monitoring encrypted emails and messaging services ().����India, which had threatened to shut down the BlackBerry service, is the latest country to pursue access to user communications from RIM.�� Recently the governments of Saudi Arabia and the United Arab Emirates have also threatened to ban BlackBerry services unless RIM provides access to user data ().

The threat by foreign governments to ban BlackBerry services poses a serious danger to RIM.�� Competitors in North America continue to eat away at RIM’s once dominating grasp on the smart-phone market, and RIM wishes to expand in the global marketplace to further develop its customer base.�� The reported that during the last fiscal year, 37 per cent of RIM's $15 billion in revenue came from outside North America, up from 23 per cent about five years ago.�� The demand for security concessions from countries such as India may threaten to erode RIM’s customer base as smart-phone manufacturers Nokia and Apple have already lined up to move into this market.��

RIM, unlike rivals Nokia and Apple, controls its own networks, which handle encrypted messages through centres in Canada and the UK.�� Should BlackBerry service be restricted in India, Nokia and Apple would easily snatch up RIM’s market share. This is because Nokia and Apple rely on local telecommunications infrastructure to transmit their data allowing easy government oversight.�� As a result Nokia and Apple would not be subject to a similar ban, as proposed by the Indian government against RIM.��

India has suffered deadly attacks, by both home grown and foreign militants, with some regularity for years. Mohammed Ajmal Kasab, the lone surviving gunman in the 2008 Mumbai attack, told an Indian court that he and his comrades all had Nokia mobile phones ().�� India and other foreign governments are seeking access to encrypted Blackberry communication that could be used to coordinate national security threats.���� ��

In response, RIM has assured its customers ‘that it genuinely tries to be as cooperative as possible with governments in the spirit of supporting legal and national security requirements’ ().�� ��RIM stated that a foreign government’s access to BlackBerry communications should not be boundless, and ‘lawful’ access be limited by four principles.�� First, that access be restricted to the context of national security requirements as governed by the country's judicial oversight and rules of law.�� Second, government access to BlackBerry services should be no greater than regulators already impose on RIM’s competitors and other similar communications technology companies.�� Third, no changes will be made to the BlackBerry’s security architecture and finally that RIM will maintain a consistent global standard for lawful access requirements that does not include special deals for specific countries.

RIM and other companies will likely continue to work with foreign lawmakers in their respective countries to resolve national security concerns.�� However, in doing so RIM risks damaging an important aspect of its business, its reputation.

BlackBerry Messenger users have long enjoyed the secure end-to-end encryption methods used by RIM to scramble information sent from one RIM phone to another.�� However, as reported by the , RIM may have agreed to place a BlackBerry server inside Saudi Arabia and more recent reports indicate RIM may hand over the “codes” to all local BlackBerrys to the Saudi government.��Providing such information has drawn RIM into the ongoing debate of the morality and ethics of allowing foreign government access to communications that can be used to quell political dissent and imprison human rights advocates.�� The reported the comments of Ron Deibert, director of the Citizen Lab at the University of Toronto’s Munk School of Global Affairs: “These can be ruthless nasty regimes where political opposition or human rights advocates are imprisoned or worse. In colluding with them, [RIM is] assisting in that abrogation of human rights.”

Canada and the United States (U.S.) have aligned behind RIM against access to Blackberry communication, citing the need to defend consumer privacy and internet freedom ().�� The economic interests of Canada and U.S. are also at stake, which may have instigated the strong response by these countries against the proposed BlackBerry bans.�� Patrick Leblond, an expert on international economic integration and government-business relations at the University of Ottawa summarized Canada’s position “It is good business for the Canadian government to stand up for RIM, since this is one of the world's leading technological companies, and ‘what is good for RIM is good for Canada.’”������

RIM’s struggles with foreign governments to maintain its security systems and preserve its market share will likely expand to other forms of communication.�� Any concessions made by RIM may set a precedent for future negotiations between foreign governments and other communications companies.�� As reported by the , the Indian government is already considering a crackdown on Google and Skype to gain access to the information transmitted by these services. Moving forward, it will be interesting to observe the impact that RIM’s security negotiations will have on other communications based companies.

The post RIM’s Battle for Information Privacy, Market Share, and its Reputation appeared first on IPOsgoode.

I have finally returned home to Toronto after spending three difficult months in India. I have travelled to India before but never during the summer. Unfortunately, there was a drought during my stay in Delhi, with temperatures hovering around fifty degrees celsius on a daily basis. Despite the heat and other obstacles I encountered, the experience was still memorable. During my tenure at the Human Rights Law Network (HRLN), I experienced firsthand the meaning of fighting a legal battle at a grassroots level. The lawyers' efforts were inspiring and I will forever be grateful for how they helped me grow both personally and professionally. The most important lesson I learned during my term at HRLN is that if you maintain commitment and passion during your work, you can achieve great legal feats.

Within my , I outlined my objective of composing a booklet that will inform HRLN lawyers on how to fill pre-grant patent oppositions. I am still working on this large undertaking. For those who are unfamiliar with this legal avenue, it provides NGO’s and those alike the opportunity to oppose patent applications. This legal avenue was made available through TRIPS (Trade Related Aspects of Intellectual Property Rights), an international agreement formed by the WTO (World Trade Organization.) This is ideal since Patent Law has changed in India, which could potentially allow many multinationals to patent existing drugs. During my first month in India, it was always perplexing why lawyers hardly utilized this option. During my project it became apparently clear. This option may seem simple but the reality is that the process is quite difficult. Despite India ratifying TRIPS, many have not conformed to its provisions. This has resulted in many lawyers experiencing crossroads between the old and new patent law. There is a steep learning curve being experienced due to patent law amendments and beyond the availability of pre-grant oppositions, many lawyers are not familiar with the options available due to ratifying TRIPS. Once knowledge is actually attained, there are still other obstacles such as individuals with political power, deep pockets and who are corrupt. To delve into these factors could easily take pages but rest assured, they exist. However, knowledge is a step in the right direction.

My focus resided primarily on patents which could limit the availability of ARV medications for HIV/AIDS patients. This focus spawned from , who recently lost a pivotal case regarding patenting their drug Glivec. If they had won, resulting in their case becoming precedent, pharmaceutical companies would have been able to make mild modifications to existing ARV medicine and then attain patentability. The majority of companies who usually apply for these patents are multinationals. Their objectives are often profit driven. This goal would likely prompt them to charge high prices for ARV medications, limiting access to those from impoverished regions or groups. What is concerning is that children compose large portions of these groups. By having patent protection, pharmaceutical companies could monopolize the market, resulting in not only increased prices but also the inability of Generic Pharmaceuticals (GP’s) to produce drugs. I visited child care and treatment centers for those with HIV/AIDS. It was obvious from first sight and confirmed through conversations, that many patients could hardly afford their medications. It was enough that they mustered the courage to visit the center, since a strong negative stigma still exists regarding the virus. I certainly do not oppose patents, considering my law background but it was evident that a system needs to be in place ensuring the right companies were provided protection and accessibility at a low cost was maintained.

The counter argument which has been provided, arguing in favor of Novartis,is utilizing a provision within TRIPS. It allows for the issuance of a compulsory licence. If the country feels a national emergency is at hand and the health of its population is compromised, the government can order the issuance of compulsory licences. The issuances of these licences entail a small royalty towards the patent holder. This technically allows a government to break a patent if there is a severe health issue. This argument which was provided by Novartis, maintains little weight since countries such as Brazil have threatened the use of compulsory licences to no avail. Prices of the drugs have simply fluctuated when there has been a threat of issuing compulsory licences, resulting in the drugs still being overpriced. Novartis has lost its legal case and as of now, does not intend to file an appeal regarding the decision made by the courts. Compulsory licences seem like a viable option but as mentioned before, I have learned that a grassroots approach in India is much more effective. It would be better to tackle this problem from the time of patent considerations. The secretary general of the Indian Pharmaceutical Alliance (IPA), DG Shah, has also voiced opposition regarding the issuance of compulsory licensing. He believes that the inclusion of this licensing provision within TRIPS was commercially and monetarily motivated, rather then being human rights based.

The importance of the Novartis judgement is illuminated in knowing there are approximately 120 outstanding patent applications encompassing ARV’s. They would all attract the attention of s.3(d) of the Patent Act, which outlines the need to satisfy the efficacy standard.�� What is important to note is that these applications are for both first and second line ARV medications. Establishing a high threshold to attain patentability is a step in the right direction but every case cannot be settled through court. Filing a pre-grant patent opposition is a cheaper and more expeditious option for lawyers within India to consider.

Immunity Against Patent Infringement - s.11

There is some recourse offered to generic manufacturers when it comes to the amendments made to the Patent Act. Within s.11(a) of the Patent Act, a GP is provided protection under enumerated circumstances. It states, "provided also that after a patent is granted in respect of applications made under sub-section (2) of section 5, the patent-holder shall only be entitled to receive reasonable royalty from such enterprises which have made significant investment and were producing and marketing the concerned product prior to the 1st day of January, 2005 and which continue to manufacture the product covered by the patent on the date of grant of the patent and no infringement proceedings shall be instituted against such enterprises." The implications of this provision are enormous. This means that if a GP was producing and marketing a drug before January 1, 2005 and had also made substantial investments in it, they were afforded protection against those who receive patentability for the same product after the Patent Act amendments. The patent holder would only be entitled to a royalty and will not be able to undertake any infringement proceedings against the GP. However, a potential problem is wording within the provision which states a “reasonable royalty.” There are no clear guidelines of what constitutes being reasonable and without precedent, patent holders could charge excessive prices. This would cause GP’s to incur higher costs, resulting in drugs being more expensive and hinder access for those who are impoverished. Another problem is that this provision is mainly applicable to first line ARV’s and not those which are second line. After 2005, many second line treatments have been developed since the HIV virus has been mutating. This results in NGO’s having to recourse to pre-grant opposition within s.25 rather than relying on s.11. There will come a time when many first line treatments will be ineffective and patented second line treatments will be needed.

Final Thoughts
HRLN is renowned for being proactive and my undertaking was no different. The amendments made to s.3(d) in the Patent Act do not apply to any drugs patented before 1995 since this is when India ratified the TRIPS agreement. However, HIV/AIDS is known as being a mutating virus resulting in most first line ARV treatments likely becoming ineffective in the near future. New forms of ARV medications will have to be developed. It is important to file pre-grant patent oppositions for second line treatments now rather than deem compulsory licensing or other legal tools useful. Some postulate that inventive pharmaceutical companies will not develop drugs if they are not afforded patent protection. My suggestion is to allow GP’s to produce the new developed drugs and sell them on a licensing basis, paying royalties based on sales. This ensures drugs are produced at a low cost and pharmaceuticals are given monetary payments for the development of the drug and incentive to continually research. For pharmaceuticals who deem this option unattractive, they can be fought by continually filing pre-grant oppositions. It may take me a while to complete my educational book. However, I consistently wonder if it would be helpful considering there are still so many obstacles despite lawyers being educated. After seeing how bad conditions can be for those who have the virus and are impoverished, you have to hold onto hope!

The post India's Pre-Grant Patent Oppositions - A True Remedy? appeared first on IPOsgoode.

Currently, India’s domestic seed market is being overshadowed by the growing stature of Multinational corporations (MNCs), mainly due to their access to international germaplasm. Despite the dominant presence of MNCs, there is still huge potential for the expansion of the hybrid seed market in India. MNCs tend to focus on the expansion of the market itself rather than advertising a particular brand of seed. They attempt to convince farmers to invest in the hybrid seed market by commissioning numerous field workers in which open-pollinated varieties predominate. These field workers organize demonstrations and field-days, which are invitations to farmers to a local farmer’s field exhibiting extraordinarily high yields of crop. Cargill, for example, employs this advocacy strategy. Other companies, such as ITC Zeneca, screen a touring short film that dramatizes competitions between villages for the best crop.

The private sector market consists of three main types of companies: those that develop, produce, and market their own hybrid varieties; companies that produce and market public sector varieties; and companies that concentrate strictly on marketing hybrid seeds. The former category is where the most growth in the private sector is occurring, and there are several legislative changes that have facilitated this, mainly the New Seed Policy (1988), which liberalized seed imports and encouraged foreign investment in the seed market, and legislation that loosened limitations on foreign equity participation, allowing foreign companies to hold controlling stakes in industrial enterprises.

Two laws were proposed in 2004, which has been seen as a threat to biodiversity and farmers rights. Traditionally seeds were saved by farmers, year after year, allowing the farmer to adapt his crop to the changing conditions. These indigenous varieties were traded between farmers, and allowed for a healthy biodiversity. Currently eighty percent of all seeds in India are still saved by farmers. There are thousands of evolved varieties of pulses, millets, oilseeds, rice, wheat, and vegetables. The Seed Act requires that any planted variety of seed be licenced. This pushes farmers into dependency on corporate monopolies of patented seed, which was made possible by the Patent Amendment Acts which introduced seed patents.

The Indian Patent Act (1970) excluded agricultural techniques and plants from patentability. Two recent amendments, however, has allowed for the patenting of GM seeds. One removed ‘plants’ from a section of the Act, allowing a method or process modification of a plant to count as an invention and thus be subject to patentability. The other amendment prevents the patentability of “essentially biological” plant varieties. GM plants, however, are not technically considered “essentially biological”, which allows for Multinational corporations to assert their patents through this ‘loophole’.

In effect, India has been adopting a MNC-friendly and patent-liberal posture that is not only compelling farmers to engage in the private seed sector thereby rapidly destroying the public sector, it is damaging the farmer’s right to openly develop and maintain varieties in a way that his family has done just a generation ago.

Primary Source: Seeds of Suicide, The Ecological and Human Costs of Seed Monopolies and Globalisation of Agriculture, by Dr. Vandana Shiva and Kunwar Jalees, 2006.

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I have been researching at Human Rights Law Network for over a month now and my findings are quite concerning. In terms of patent law, a skeleton based on international standards is in place but clarity is lacking. As mentioned in my , there were numerous amendments made to the 1970 Patent Act to become compliant with TRIPS and WTO standards. One outcome is the inability to simply reverse engineer drug products and provide generic versions at cheaper prices. Another outcome, as of now, is the higher threshold that needs to be satisfied to achieve patentability. This disallows simple modifications or combinations of existing drugs. However, many NGO's fear this threshold will not remain stagnant and will likely lower since many pharmaceutical multinationals oppose it. With their resources and legal teams, they will likely explore all options to lower this standard. To understand the "efficacy standard" that was inserted into the reformed Patent Act and its implications, it is vital to decompose s.3(d). Precedents established dealing with this provision will ascertain the patentability threshold for future applications. For the remainder of my tenure at HRLN, case law primarily encompassing s.3(d) will definitely be incorporated into my research.

Patent Act (2005) - The Efficacy Standard

A prime example of this standard being used is in a recent case dealing with the drug Nevirapine, an ARV medication for the treatment of HIV/AIDS. The patent applicant was able to produce the drug in liquid form allowing it to be administered in a pediatric capacity. One would initially assume this could be ideal since many children lack the capacity to swallow pills. However, they were denied patentability and production of this drug since it was not a substantial modification in a therapeutic capacity. This denial was prompted by action undertaken by many NGO's since they feared the granting of a patent would provide them the opportunity to monopolize this form of medication. This would result in the medication being expensive and limit access to young couples who often have children in need of the medication. This case reflects the need for reform towards patent law to allow accessibility for impoverished groups but also induce further research by providing patent protection.

It is vital to know the exact wording of s.3(d), which states a patent will be denied if there is a "mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant." To further elaborate this provision, an explanation is also provided to outline what is not considered a new efficacy. Within the Patent Act of 2005, it states that "for the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy." (Patent Act 2005) This provision lacks clarity if benchmarked against reputable international patent law.

Pre-Grant Patent Opposition

One of the primary purposes of the booklet I will be composing at HRLN will be to inform lawyers on how to file a pre-grant opposition. As mentioned in my previous post, through attendance at conferences and field research, it was becoming apparent that filing public interest litigation cases is not achieving desired goals. A benefit of the 2005 amendments is the inclusion of s.25 within the Patent Act. This provision allows outside organizations, including NGO's, the opportunity to file pre-grant oppositions. This gives them the chance to review a patent application before patentability is granted. If they find problems with the application, they are provided the ability to bring it to the attention of the patent office of India. This will likely delay the patent process and may result in the denial of patentability. This is a useful legal avenue to undertake but many lawyers within India are not knowledgeable on how to utilize it. Within my booklet, I will provide background knowledge regarding patent law. Once this foundation is established, it will be easier for lawyers to abide with the necessary steps to file the pre-grant oppositions, which will also be outlined in the booklet.

Pre-Grant Opposition Cases

Through their recent ruling, it was demonstrated that the Madras High Court strongly supports pre-grant opposition procedures undertaken by the patent office. The patent for the drug Valganciclovir was given without due consideration to pre-grant oppositions which was filed by civil society organizations. The high court in Madras ruled that improper consideration given to these oppositions should result in the annulment of the granted patent. To truly obtain patentability, the office must hear the oppositions and then make a ruling whether to grant a patent. The reason why this ruling is significant becomes apparent when prices are investigated. If Roche had attained patentability, they would likely charge $10000US for a four month treatment. On the other hand, MSF approached Roche in 2006 to discuss a price to offer the drug to less developed countries and they agreed to sell the drug for $1900US. There is a substantial price difference between the cost quoted to MSF and the one given for the general public. Reducing the cost of drugs is a factor that should be kept at the forefront (along with effects on the incentives to innovate) during considerations involving life saving drugs.

Novartis Case: One of the First Patent Applications and Refined Efficacy Standard

Once the Patent Act amendments came into force in 2005, the drug Glivec produced by Novartis, was one of the first considered for patentability. The patent application by Novartis was rejected since it was considered a simple modification of an existing drug. This was deemed an important rejection, setting a vital precedent since it was the one of the first drugs considered following the WTO compliant amendments. This prompted Novartis to initiate a legal case where they argue that the 2005 amendments to patent law actually do not comply with TRIPS. They are calling into question the "inventive step" which is required by patent law. This definition was amended and inserted into section 2, provision JA within the Patent Act. The filing of this case sparked numerous protests, outrage and concern. Many NGO's were concerned of the resulting implications if Novartis were to win the case. Since their patent was the initial rejection within the Patent Office, the outcome of their case within the court system would likely establish a leading precedent. If they had succeeded in court, it would have lowered the patentability threshold in India and possibly allowed simple modifications to existing drugs to achieve patentability. These mild modifications to existing drugs and the ability to attain a patent would disallow established GP's from producing low cost drugs and decrease access to those who are impoverished. The ramifications would be both domestic and international. Novartis did not not win their case, which resulted in many NGO's applauding the courts. However, one must remain cognizant that this was a precedent establishing case and the ruling is not law. This results in the allowance of variances from one case to the next. Another important implication is that the case does not eliminate evergreening. If a company were able to provide a combination or modification which maintains a higher level in terms of efficacy, then they could achieve patentability. This reflects the need for government to establish law which is clear and then guided by precedents.

I am looking forward to researching more, conducting interviews and reviewing steps involved in filing a pre-grant opposition. I will keep you all updated.

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The Human Rights Law Network (where I am summer interning) utilizes public interest litigation (PIL) as their primary weapon to fight for human rights. The People's Patent Group, under the umbrella of HRLN, is not a priority, however, as HRLN seems to have their hands full at the moment with securing maternal rights, rights for HIV/AIDS positive people, dalit rights, and right to food and healthcare, to name a few initiatives. As a result, issues involving GM seeds are not actively fought. As a matter of fact, I have not met a single person working for the People’s Patent Group, aside from Nigel D’Souza, my colleague-intern from Osgoode. HRLN therefore expects the interns to devise their own research proposal and submit a deliverable that will (hopefully) be useful to HRLN in furthering a PIL.

My area of interest was GM seed patents and the social, economic, and legal issues created by such patents. To focus on a project that would be useful to HRLN, I began by reading and analyzing a PIL on the biosafety of GMOs that was filed in the Supreme Court of India in 2005. Several issues came to light in this petition. Firstly, I noticed that very little scientific background was provided. As the name implies, GMOs are genetically altered organisms that are engineered to enhance a certain genetic trait (or to suppress a trait). For thousands of years, traditional farmers have been ‘genetically manipulating’ their seeds without actually knowing it, by planting certain seeds and discarding others. The process of freely trading and planting seeds with other farmers has allowed for a genetic diversity that provides the farmer with the benefit of a strong crop.

Today, companies like Monsanto are able to modify the genes of seed varieties in a way that is much less subtle than the traditional farmers freely trading and planting seeds over generations. Without any scientific explanation, the PIL stated that these GM seeds are deemed hazardous to the environment and to people by scientists across the board (neither does the PIL source their information or name scientists...). Furthermore, the PIL seemed to confuse or blur the issue by stating that the GM safety standards, although good, are not properly applied and many GM products that would otherwise fail are deemed safe to eat (this argument seems to imply that if GM safety standards are applied adequately, then GM seeds would be safe to eat?).

Thus, my experience at HRLN in my first few weeks made me aware of the following: First, that the PPG is virtually nonexistent at the moment and that my research needs to be useful to the PPG in initiating a future PIL; and secondly, that any information in a PIL needs to be sourced; and third, that it is important to separate and compartmentalize the legal issues for simplicity sake. After discussing with Colin Gonsalves, the head advocate at HRLN, I decided that my goal with the PPG will be to produce a short internal document that will serve to educate the lawyers (briefly) on the issues surrounding GMOs as well as emphasizing the need to adequately source and provide the legal issues at hand when filing a PIL. The hope from my end is that my work here will be useful, if even in a small way, in creating a PIL in the near future.

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I'm very excited to announce the collaboration between IP Osgoode and the International Legal Partnership (ILP) that will see the placement of Research Fellows with the People's Patent Group (PPG) in Delhi, India. From June to August 2009, two Osgoode students-Nigel D'Souza and Jasdeep Singh-will work with the PPG on a variety of issues that intersect between Intellectual Property Law and Human Rights Law. Nigel and Jasdeep will be blogging about their research and travel in India, and I look forward to reading about their experiences here on IPilogue. In a way, doing so will allow me to reminisce about my time working with the PPG.

Last summer, I was fortunate enough to be granted an opportunity to be an ILP Research Fellow with the PPG. During my three months with the PPG, I was able to conduct legal research on two major intellectual property related issues that India, as a rapidly industrializing country, is facing: the state and transition of the country's generic manufacturing industry, and the introduction of agricultural biotechnology. In addition to economic, environmental and health concerns, these two issues also have a significant interrelationship with human rights.

As part of my research with the PPG, I wrote a chapter for a book that the organization was publishing on access to anti-retroviral (ARV) treatment in India. My chapter was based on India's generic manufacturing industry, which is facing a transition period of sorts with India's adoption of the Trade-Related Intellectual Property Rights (TRIPs) Agreement. Prior to the adoption of TRIPs, India's generic manufacturing industry -the largest in the world- was able to provide an adequate supply of ARV treatment to most of the developing world. Now, with the trade liberalization of IP rights, many of India's generic manufacturing companies cannot simply reverse engineer drugs, but must focus on finding new ways to compete, primarily through process-driven innovation. The issue facing India's generic manufacturing industry is finding a way to provide access to inexpensive treatment for people living with HIV/AIDS (PLHAs), while at the same finding a new role in a new global IP regime.

The other facet of my research focused on the introduction of agricultural biotechnology-most notably Genetically Modified Organisms (GMOs)-into a primarily-agricultural country such as India. As more Indian states are allowing BT crops to be planted on their soil, the country must be prepared to deal with the effects of such crops, such as increased water consumption, and possible health and environmental risks. Traditional agricultural practices such as seed exchange are no longer possible, as Indian farmers increasingly must rely on the purchase of genetically modified seeds every season. In my research, I also examined how India is extremely rich and diverse in terms of "genetic wealth".�� The country must find new ways to protect its genetic resources, Geographical Indications (GIs) and traditional/indigenous knowledge from the threat of bio-piracy.

My experience with the PPG was immensely rewarding on both a personal and professional level. In my role as a Project Director for ILP this year, I sought to renew our partnership with the PPG in the hopes that future Research Fellows could benefit from the same experience that I had.�� I certainly hope that Nigel and Jasdeep can continue much of the work that we started last summer. I invite you all to read about their journey this summer.

For more information on the global legal education, research opportunities and international placements available through ILP, please visit:

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