Patients Overturn First Ever Product Patent On Medicine In India



By Shobha Shukla, CNS
November 5, 2012
The author is the Managing Editor of Citizen News Service (CNS). She is a J2J Fellow of National Press Foundation (NPF) USA. She received her editing training in Singapore, has worked earlier with State Planning Institute, UP and taught physics at India's prestigious Loreto Convent. She also authored a book on childhood TB (2012), co-authored a book (translated in three languages) "Voices from the field on childhood pneumonia" and a report on Hepatitis C and HIV treatment access issues in 2011. Email: shobha@citizen-news.org, website: http://www.citizen-news.org

(CNS): The growing trend by Asian countries to allow local production of cheap generic drugs got another feather in its cap recently in India. In a landmark victory for patients’ groups fighting against patents to ensure access to medicines, the Intellectual Property Appellate Board (IPAB), while holding that a patients’ group can challenge the validity of granted patents, has revoked a patent granted in India to Roche for pegylated interferon alfa-2a (a medicine used to treat Hepatitis C). This patent, granted to Roche in 2006, was the first product patent on a medicine in India under the new TRIPS-mandated product patent regime for medicines, as part of the country’s obligations under World Trade Organization's (WTO) international trade rules.

Sankalp Rehabilitation Trust, an organisation that provides treatment and rehabilitation support for injecting drug users—filed a post-grant opposition challenging the grant of the patent with technical and legal aid from Lawyers Collective HIV/AIDS Unit. Sankalp filed its appeal before the IPAB, challenging an earlier 2009 decision of the Patent Office that upheld the validity of Roche’s patent. Roche argued that because Sankalp was not a business competitor or a researcher in the sector, it could not have challenged its patent at all. Sankalp argued that it represented a community of drug users who are particularly at risk to Hepatitis C and also that its members were directly affected by Hepatitis C.

Setting aside the patent, the IPAB held that Roche’s pegylated interferon was obvious to a person skilled in the art and that Roche has not provided any evidence, in the specification or even otherwise, to prove that pegylated interferon has enhanced efficacy. The IPAB observed that “public interest is a persistent presence in intellectual property law” and also held that it was against public interest to “allow unworthy patents to be on the Register”. Holding that “the appellant who works for the community which needs the medicine, is definitely ‘a person interested’”, the IPAB noted that a successful challenge would “break the monopoly” and “bring the drug within reach of the community for whom it works, not only by reduction in cost, but also because of increase in supply”.

This judgement is indeed a people’s victory and gives new hope to an estimated 10–12 million people in India, including 50% of IDUs nationally and 90% of IDUs in the northeast, who are infected with the Hepatitis C virus (HCV). Hepatitis C treatment, which entails a six month course of pegylated interferon and ribavirin, is currently unavailable in the public healthcare system. So patients with chronic Hepatitis C are expected to purchase Roche’s pegylated interferon alfa-2a at an exorbitant cost of approximately INR 4, 36,000 (available at a discounted price of INR 3, 14,496) and spend another 47,160 on ribavirin, entailing a total expenditure of nearly INR 5, 00,000, making it unaffordable to most of them.

Mr. Eldred Tellis, Director of Sankalp Rehabilitation Trust, who had challenged the patent, said to Citizen News Service (CNS): “We hope that the absence of patent barrier will spur generic competition to bring down the price of this much-needed drug for those suffering from Hepatitis C. We also hope that the Government will now take concrete steps to start providing access to this medicine. It is unacceptable that people are dying due to Hepatitis C because they cannot afford to buy the medicine.”

Mr Anand Grover, senior counsel and Director of Lawyers Collective HIV/AIDS Unit, who appeared for Sankalp in this matter, said, “We are happy that the IPAB has recognised the element of public interest in setting aside undeserving patents and held that patients’ groups, who are directly impacted by patents on medicines, can challenge granted patents. Concerned patients’ groups will now have better clarity in challenging patents on medicines for HIV, cancer and other diseases.”

Earlier this year (2012) in March, the Indian government, in its first-ever case of compulsory licencing approval, had allowed a domestic company, Natco Pharma, to manufacture and sell a generic version of Bayer's patented anti-cancer drug, Nexavar (used to treat kidney and liver cancer), bringing down its price from INR 2.8 lakh to INR 8,880 for a 120-capsule pack for a month's therapy—a reduction of 97%. Natco will pay a 6% royalty on net sales every quarter to Bayer and is also committed to donating free supplies of the medicines to 600 patients each year. The licence will be valid till such time the drug's patent is valid, i.e. 2020.

Then again, very recently in October, Novartis appeared to suffer a setback in the Supreme Court of India in its attempt to obtain a patent for its anti-leukemia medicine imatinib mesylate, which the company markets under the brand name of Glivec in many countries. Imatinib mesylate (Glivec) is the salt form (mesylate) of an older medicine, imatinib. The plea of Novartis for the patent (to sell the drug at higher prices in India) was rejected by the Indian patent office in 2006 on the grounds that the medicine was merely a new form of an old medicine, and therefore was not patentable under Indian patent law. Novartis challenged this decision in the Supreme Court. But the two judge Supreme Court Bench expressed skepticism over the company's claims that the two drugs were substantially different, saying that, "A plain reading of the two patent applications shows that there is no difference in the two substances."

Seemingly inspired by India’s bold decision on compulsory licensing of the cancer drug, the Indonesian government too has taken steps to over-ride patents on a range of HIV drugs. President Susilo Bambang Yudhoyono quietly issued a decree in September 2012 authorizing government use of patents for seven HIV/AIDS and hepatitis B medicines held by the likes of Merck and Co, Glaxo Smith Kline, Bristol-Myers Squibb, Abbott and Gilead.

China has also overhauled parts of its intellectual property laws in June 2012, to allow local production of patented medicines. The amended patent law allows Beijing to issue compulsory licenses to eligible companies to produce generic versions of patented drugs during state emergencies, or unusual circumstances, or in the interests of the public.

We must not forget that Thailand had issued 3 compulsory licenses way back in 2006/2007, for the heart disease drug clopidogrel (patent holder: Sanofi-Aventis’ Plavix), HIV/AIDS drug, lopinavir/ritonavir (patent holder: Abbott’s Kaletra), and HIV/AIDS medicine, efavirenz (patent holder: Merck Sharp and Dohme’s Stocrin).

These welcome winds of change highlight a growing trend by Asian countries to allow local production of cheap but quality generic drugs with a view to make them accessible to those who need them most. Loon Gangte, of the Delhi Network of Positive People rightly believes that, "When drugs are patented, and pharmaceutical companies fail to fulfill their obligation to make patented medicines available and affordable to patients, the only way to bring prices down is through examining the validity of the patent granted or compulsory licensing which allows generic production of more affordable versions."

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Posted on: November 05, 2012 09:28 AM IST