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.

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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Upon arriving, I attended the HIV/AIDS Conference, initiated and organized by HRLN. My involvement in the conference sparked anger, passion and hunger, emotional elements advocated during teachings to initiate change. It was strikingly apparent that access to ARV medication for treatment of HIV/AIDS is a prevalent field pertaining to human rights and patent law. It is a field in desperate need of activist support within India. What was even more surprising was the immense role patent law is playing in limiting access to these life saving drugs. During group discussions conducted by Colin Gonsalves, founder of HRLN, it was saddening to become aware there is a lack of action being undertaken to spark Public Interest Litigation (PIL.) It became crystal clear to me during these discussions what I would like to achieve during my tenure at HRLN. I have been recently granted permission to compose a circulatory booklet, that would distill complex knowledge regarding Indian patent law and spark action for increasing access to ARV medication for the treatment of HIV/AIDS. My hope is that after reading this booklet, HRLN employees will undertake litigation due to being informed. By maintaining a comprehensive understanding of patent law, they may file pre-grant oppositions against patent applications for ARV medications. Patent applications for ARV medications, since India ratified TRIPS are often simple modifications or combinations of existing drugs. Terrains that will be investigated comprise of adequacy of current patent law, suggested reform, and possible international benchmarks which could be incorporated, while taking into consideration cultural and modern norms. To attain these goals, extensive field work and research will have to be undertaken.

Some Background Information

Review and reform of the 1970 Patent Act became an extensive undertaking within India from the beginning of 1995. Amendments were made to become compliant with standards maintained by the WTO and ratifying TRIPS. The most significant difference due to amendments is that both drug processes and products can now be patented in India. Utilizing the 1970 Patent Act, only pharmaceutical drug processes could be patented, which allowed generic manufacturers to simply reverse engineer drugs. They would provide these drugs to both domestic and international markets for substantially lower prices. The ability to mass produce generic pharmaceuticals, due to the non-existence of pharmaceutical product patentability, helped create the current generic industry which is renowned internationally. However, by becoming TRIPS compliant and allow product patents, many fear the ramifications towards the industry will be significant.

These changes also resulted in the current form of s.3(d) within the Patent Act. This section has been deemed the “efficacy standard.” Based on recent case law, this provision disallows the granting of patentability towards mild modifications or combinations of existing patented drugs. This was demonstrated in the denied patent application for Glivec by Novartis. The initial establishment of this high threshold limits the ability of pharmaceutical manufacturers to undertake simple modifications or combinations of drugs and then then attain patentability. There have been PIL’s introduced in India courts by multinational pharmaceuticals regarding the constitutionality of this provision. However, the outcomes have yet to lower the threshold. Despite these recent positive outcomes, there is still fear that a case may eventually lower the standard. Another prevalent problem is the lack of a definition for the “efficacy” standard, which would allow the establishment of a bright line for threshold purposes. Right now, there is a “therapeutic” standard being maintained to decipher the definition. This means there must be a more beneficial outcome for the new drug in comparison to the older one. Despite the therapeutic standard, it is quite obvious that more clarity is needed. The lack of flexibility and clarity within this provision could result in ramifications on the generic pharmaceutical industry not only for India but on a global scale as well.

We are well aware that India, through its recent ratification of the TRIPS agreement, which stands for Trade Related Intellectual Property Rights, is now participating in a globalized legal pluralist landscape. Initial impressions resulted in governing bodies in India thinking acceptance was necessitated for economic prosperity and protection. However this may not be the case. India, who was once deemed a leading manufacturer of generic pharmaceutical drugs, is now restricted by patent law and can no longer simply reverse engineer drugs. This will disallow provision of low cost drugs to developing countries, including itself. The 1970 Patent Act was providing positive results towards access and even economic prosperity prompting one to question the substantial changes. Case law is still lacking regarding s.3 of the Patent Act which outlines patentability guidelines and many still fear mild modifications and combinations could still achieve patent protection during coming years. This will further impact the generic industry, since they cannot produce drugs which receive patent protection. Another issue I intend to cover, which is within TRIPS, is the granting of compulsory licenses as a possible solution.

Overall, the amendments can be deemed a double edged sword. Product and process patentability for pharmaceuticals, disallow generic manufacturers to simple reverse engineer drugs. However, based on recent case law, it disallows pharmaceuticals companies from attaining patents on simple modifications or combinations. Overall, changes and clarity still needs to be achieved. I will write again soon to provide you with some of my findings from field research undertaken and experiences.

The post Impact of TRIPS on Generic Pharmaceuticals in India - A Research Endeavor in Delhi appeared first on IPOsgoode.

It’s debatable but many stipulate current financial ramifications, spawned by free downloading, is due to lack of vigilance and excessively high prices charged by music titans such as Warner. Lack of initiative to streamline high cost productions and lower inflated profit margins equated towards . On the opposite side of the spectrum, users have not morally abided to copyright stipulations, resulting in infringements. By downloading and initiating unmerited distribution, they have �����Ի�  for authors of music. The copyright regime exists to assure authors that creative work is rewarded justly. It is fair to say both sides are at fault!

Initially, I perceived the practicability of attaining music label collaboration as difficult. This was supplemented knowing this proposition endorses and finally succumbs to free downloading, an outcome avoided by music labels. However, initial steps have already been taken. Imeem, a social utility tool, allows listening and sharing of ! Major labels, including Warner, have provided a blank license and royalties are attained through a percentage of advertising revenue. Inadvertently, Warner became a collecting agency itself by accordingly taking the royalties and distributing them to the artists. By digitally monitoring the number of downloads and accordingly distributing profits to labels, would eradicate the need to utilize third party governmental agencies such as SOCAN, to distribute royalties. Expanding the scope of royalty distribution to record companies and artists, has been advocated by proposed amendments in Bill C-32 and the Copyright Act. These outcomes substantiate the fluid possibility of Griffin’s proposal being achieved. 

Despite this transitional proposition being minimally frictional, the germane question is whether the general public will accept it? Griffin suggests downloaders voluntarily pay established fees for unlimited song accessibility from collecting societies. Taking human nature into consideration, despite vast pools of music being available through the collection society, would this option actually hinder taking opportunities to download music for free? Personally, I would opt for the free option. Unless ISP providers mandate the incorporation of a progressive fee into their monthly charges for all users, varied based on demographical statistical sampling, internet surfers will likely look for cheaper options. This seems plausible since royalties from the mandatory fees can be distributed to collective agencies, free downloading hindered, and music .

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