Tiêu đề Personal statement - Harvard Law School.pdf ✅

Aditya Gupta PERSONAL STATEMENT PART (A) Through an amendment in its patent statute in the year 1970, India excluded the grant of product patents to pharmaceuticals leading to a massive turnaround for India’s generic pharmaceutical industry. From being a heavy importer of pharmaceuticals, India became one of the largest exporters of pharmaceuticals. In this background, India reluctantly entered into the TRIPS Agreement after several rounds of negotiations. Pursuant to the Agreement, India amended its statute ushering in a pharmaceutical product patent regime in the year 2005 amidst intense debates in Parliament regarding the anticipated rise in prices of pharmaceuticals following the amendments. The affordability of patented pharmaceuticals has since been at the forefront of the patent debate in India. The comparative price of patented drugs and their generic counterparts has factored in decisions relating to patentability1, infringement2 and compulsory licensing3. Innovator companies argue that patents are essential for incentivizing innovation particularly in the pharmaceutical sector, and that the price of their drug is a function of the research and development costs underlying innovation. However, one view is that unless the patented product is affordable, public interest in incentivizing innovation is significantly diminished and the unaffordability of a patented invention renders it an “illusion” 4 for the Indian populace. Generic companies that sell the same drug at a fraction of the innovator’s price are perceived as messiahs of public health, even though they declare millions of dollars in profit each year. The lack of a robust health insurance system is further fuelling public opinion against pharmaceutical patenting. With less than 5% of the population being covered by health insurance5, out-of-pocket expenditure forms a major component (about 75%6 ) of private expenditure on healthcare. In this backdrop, the high cost of patented pharmaceuticals severely undermines the patient’s ability to afford 1 Novartis AG v. Union of India and Others, MIPR 0345 (IPAB 2009) 2 F. Hoffmann La Roche v. Cipla Ltd., 37 PTC 71 (Del. 2008) 3 NATCO Pharma Ltd. v Bayer AG, 50 PTC 244 (P.O. Mum. 2012) 4 Remark by Justice Aftab Alam, Judge, Supreme Court of India, during the hearing on September 12, 2012 in Novartis AG v. Union of India and Others, Special Leave Petition No. 20539 – 25049 of 2009 5 International Institute for Population Sciences (IIPS) and Macro International, National Family Health Survey (NFHS-3), 2005-06, India: Key Findings, Mumbai: IIPS, (2007) 6 World Health Organization, The World Health Report, 2006 – working together for health, (2006)
Aditya Gupta treatment, to the extent that poor patients choose to forego treatment even for life– threatening indications. This pricing debate has been widely commented on by the media building a strong public sentiment in favor of the generic industry and against patenting of pharmaceuticals. In my view, this public sentiment has resonated in decisions relating to grant of patents to pharmaceuticals. For instance, India has denied patents to pharmaceutical inventions that are considered patentable by most Patent Offices across the world. The Indian Patent Office recently revoked the patent over Pfizer’s SUNITINIB molecule that enjoys a patent in over 90 countries, even though no new prior art was cited before the Indian Patent Office. The Government and the judiciary justify these decisions on the basis that while the TRIPS Agreement lays down basic patentability criteria, member countries have the flexibility to interpret and apply these criteria in a manner that is consistent with their indigenous public health needs and the state of their respective economies. The developments in India are being closely watched the world over for two reasons – firstly, Indian generic companies have large market shares in many developing and least developed countries and thus patentability of drugs in India potentially has an effect on several markets; secondly, India is taking the lead in setting stricter patentability standards with other developing nations following suit. For instance, the Philippines has introduced a provision identical to India’s unique and highly controversial ‘Section 3(d)’ that was enacted to restrict patentability of chemical inventions. Thus, the critical issue in the Indian context is this: Where does the balance lie between ensuring accessibility to affordable drugs and providing adequate patent protection to incentivize innovation? It is critical that innovator companies adopt differential pricing models consonant with India’s unique economic realities. Currently, companies offer patient assistance programs that are perceived as complex and opaque. Companies should consider voluntary licensing arrangements with local companies that will not only help reduce manufacturing and marketing costs but can help counter the bias against multinational companies that litigate with the local generic companies. Alternatively, innovator companies may consider unilaterally lowering price by reducing profit margins. By eliminating the price factor, the focus in patentability and infringement decisions will rightly return to the merits of the invention and the scope of patent claims. While the reduction in price may lead to lower profits from sales in India, the successful grant and enforcement of patents in India will help
Aditya Gupta innovator companies capture market share not only in India but also in other developing or least developed countries where Indian generic companies enjoy a sizable market share. Further, to inculcate a patent – friendly culture in India and to counter the rhetoric by generic companies, innovator companies must reach out to the public and spread awareness of the value of innovation (as opposed to the need for patents) through extensive public relations exercises. It is equally important for India to adopt a less pedantic approach towards patenting of pharmaceuticals and not lose sight of the contribution of innovation in a nation’s development. Since its patent law is at a nascent, though highly effervescent stage, India has the opportunity to develop patent law standards that incentivize genuine innovation. India must realize that while its ingenious pharmaceutical industry is currently predominantly generic, a balanced patent law will encourage innovation within the country. It is such ‘in - house’ innovation that will best serve India’s public interest as it will be targeted towards serving its indigenous public health needs especially since treatments for indications more prevalent in less patent – friendly jurisdictions are often neglected. PART (B) Innovation and creativity are, in my view, the two most awe–inspiring facets of human life. While intellectual property litigation may appear to be a battle between large corporations it is, at its heart, about protection of the innovative/ creative genius of an individual. That intellectual property law endeavors to foster this genius has fuelled my passion for the subject and I am determined to actively partake in the progress of this field of law in India. Professor Banerji, the Director of Intellectual Property Studies at the National Law University, introduced me to the subject of intellectual property law and shed light on the integration of patent law and technology. I was instantly intrigued by the interdisciplinary nature of the subject and elected for an integrated course in science and law at the University, especially since I had earlier pursued science in high school. In order to appreciate the practical nuances of intellectual property, I opted for internships at firms with a special focus on intellectual property litigation. My growing love for the subject led me to pursue an honors course in intellectual property law at the University that entailed studying eight courses on various aspects of intellectual property affording me an opportunity to read extensively on the subject.