The National IPR (Intellectual Property Rights) policy was released on May 11. This 38-page document will give directions to the government to promote ‘creative and innovative India’. Questions have been raised in some quarters about the need for a new policy now, as extensive legislation has been passed amending patent, copyright, trademark and design laws. Was the report released because of the Prime Minister’s US trip? Will it play into the pharmaceutical lobby?
Justice Prabha, who chaired the six-member team of the IPR think tank, is a retired justice of the Madras High Court (between 2000 and 2010). She was chairperson of the Intellectual Property Appellate Board of India (2011-13). One of her landmark judgments was in determining the constitutionality of section 3(d) of the Indian Patents Act, in the now famous Novartis litigation. Justice Prabha was named one of the 50 ‘most influential people in the IP World’ by the Managing IP magazine for two years in succession (2012 and 2013). I arrange to meet her to discuss various IPR issues.
We decide to have lunch at Isha Yoga’s Mahamudra restaurant, a vegetarian hotspot in the heart of Chennai, with comfortable parking space. We ask for Sanjeevini, their mixed fruit drink. To have uninterrupted conversation, we decide to have executive rice platter which gives us small portions of a couple of variety of rice, vegetables, raita, papad and wild rice payasam.
The think tank was set up in October 2014, after the NDA formed the government. The mandate was to draw an IPR policy. The report was released in May 2016. Justice Prabha is puzzled at some of the criticisms, but does not want to get drawn into discussing them. She tells me, “This is a report on intellectual property rights and not intellectual property. We wrote to academics and various stakeholders. Many responded and we took their inputs. There cannot be a perfect policy. The draft cannot spell out everything that can be done. It gives directions and the government has to execute them.”
I ask her why an IPR policy is necessary now. “What is the right time for an IPR policy? We have an IP Act, but have never had a spelt-out policy. Historically, our country has not had intellectual property rights. Lyrics of Papanasam Sivan or Kabir had no copyright. Musical composers and lyricists never got their due. Poet, lyricist and scriptwriter Javed Akhtar spearheaded the move to correct this wrong, which led to the passing of an amendment to the copyright laws to give music directors and lyricists a share of the profits earned on their work.”
Justice Prabha shows me an excerpt from the overview of the policy, which says that an all-encompassing IPR policy will promote a holistic and conducive ecosystem to catalyse the full potential of intellectual property for India’s economic growth and sociocultural development, while protecting public interest. Such a policy will nurture IP culture, guiding and enabling all creators and inventors to realise their potential for generating, protecting and utilising IPRs, which would contribute to wealth creation, employment opportunities and business development.
“We have to review IP laws to remove anomalies and inconsistencies, and update them in consultation with the stakeholders,” she says. “Rights are not anti-people. Creation and innovation too have monetary values. We have to re-look at the way we view knowledge.” I ask her whether traditional knowledge (TK) should be viewed differently. “We have said we will protect TK. The think tank has not equated TK to other IPRs. Local communities must be respected as custodians of their knowledge.”
There are different methods to nurture TK, like giving GI (Geographical Indication) registration to TK. GI is a sign used on goods that have a specific geographical origin and possess qualities, reputation or characteristics that are essentially attributable to that place of origin. It has many success stories, such as the remarkable work done on Muga silk in Northeast India.
What is her take on fears about pharmaceutical patents and Indian drugs becoming too expensive for the common man? “The government will not do anything to make medicines more expensive. India’s strength as a leading generic drug manufacturer has been well-acknowledged and must be leveraged.” I ask her about her famous Novartis judgment of 2007. “Innovation and invention have grown at a breakneck speed over the last few decades. India has committed itself to the obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Therefore, it was necessary for the country to look at its patent laws again. In 2005, the Indian Patents Act was amended—section 3(d) being one of the amendments. It was the basis of the Novartis case.”
TRIPS recognises that members have the right to adopt measures to protect public health so long as they are consistent with TRIPS. The Doha Declaration is an affirmation of the right to use the flexibilities in TRIPS, especially by developing and less-developed countries, regarding access to medicine. The language of the Doha Declaration emphasises the importance of implementing and interpreting TRIPS in a way that supports public health.
Any person who pursues commercial interests in another country must submit himself or herself to the laws of the country. Novartis claimed a patent for Gleevec (Imatinib), a cancer drug, which was refused. Novartis then appealed to the Supreme Court, which said that Novartis had attempted to get a patent for a drug which would otherwise not be permissible under our laws. “Filtering doubtful patents is the strength of our law and not its weakness. The Novartis judgment was not about price, but about patentability.”
She explains the concept of compulsory licence (CL), talking about the Bayer versus Natco case. “The mechanism of CL is essentially about balancing patent rights with access to medicine. Essentially, a CL is granted subject to three conditions—one of them is about price. The reasonable requirement of the public with regard to the invention should be satisfied. The price at which it is made available should be reasonably affordable. It should be worked in India. In fact, a CL may be granted if the answer is a ‘no’ to any of the three conditions,” she says.
The grant of CL to Natco for anti-cancer drug Sorafenib tosylate and the litigation around it was the first of its kind in India. Sorafenib tosylate is a crucial drug for patients suffering from kidney and liver cancer. Bayer was selling the product under the brand name Nexavar for Rs 2.84 lakh per patient per month, which is unaffordable for most people in India. In 2012, the Patent Controller granted a CL to Natco Pharma to market a more affordable generic version of Nexavar at Rs 8,800 per person per month. Bayer unsuccessfully challenged the order before the Intellectual Property Appellate Board (IPAB) and later in the Bombay High Court. The Supreme Court refused to entertain Bayer’s appeal to set aside the CL on Nexavar in 2014.
As we finish lunch with Mahamudra’s signature drink—chukku coffee (dry ginger with jaggery)—Justice Prabha tells me, “You cannot have a one-size-fits-all IPR policy.”