India's Pre-Grant Patent Oppositions - A True Remedy?

Nigel D’Souza is a JD Candidate at Osgoode Hall Law School.

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 first blog, 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 learning about Novartis, 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!

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