Analysis: India’s Supreme Court Upholds Strict Patent Standards and Patients’ Right to Access to Affordable Medicines; Court dismisses unmeritorious court challenge by drug giant Novartis,[1]

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By Professor Brook Baker, Health GAP

April 1, 2013.  In a stunning victory for poor patients throughout the developing world, the Indian Supreme Court today ruled against a Novartis challenge of a denial of a patent on its cancer medicine Glivec.  The Court upheld strict standards in the India Patents Act thereby limiting pharmaceutical monopolies and speeding access to more affordable generic medicines.  The Indian generic industry, the pharmacy of poor in the Global South that supplies over 80% of AIDS medicines for the 8 million people in low- and middle-income countries, will not have to delay introduction of medicines year after year as Big Pharma evergreens its patent monopolies by seeking new 20 year patents on minor variations to existing medicines.

Novartis, the Swiss pharmaceutical giant that challenged section 3(d) of the Indian Patents Act, had one goal in mind – to expand its pharmaceutical empire and price impunity in India and the countries that imports Indian generic medicines.  Novartis said that it was appealing an adverse decision on the patentability of Glivec as a matter of principle – and that principle was to maximize profits and to pave the way for a flood of easy-to-get patents on medicines.  Novartis tried every legal trick in the book.  It first challenged the constitutionality of India’s strict prohibitions against unwarranted patents and its compliance with the WTO TRIPS Agreement that establishes baseline global standards for intellectual property protections.  That case was thrown out by the Madras High Court in 2007.  For five additional years, Novartis pursued a second challenge in appeals at the Indian Patents Office and in the courts of India asking that the challenged provision be reinterpreted to allow successive patents on minor tweaks to existing medicines.

But the Supreme Court of India held firm, ruling that the Indian Patents Act was clear on its face and in its intentions.  Indian parliamentarians wanted to allow new patents only in special circumstances where a revised medicine offered significant enhancements to the treatment or prevention of human illness but not for routine changes such as those that extend shelf life, improve solubility, extend or shorten uptake in the body, or the like.  Taking cognizance of India’s duty to protect the health and wellbeing of its citizens and recognizing the pivotal role India plays in supplying other countries as well, the India Supreme Court found the Novartis challenge not only unmeritorious, but bordering on frivolous.[1]  Specifically, the Court held that Novartis’ application satisfied neither the requirements defining inventions (with respect to inventive step) nor the requirements of section 3(d) of the Act.

This ruling is important not just because it augers well for the continued enforcement of strict standards of patentability in India, but also because it shows that courts can and should stand up to attempts to extend transnational corporate power and monopolies on medicines.  It is a cottage industry for Big Pharma drug companies to sue developing countries to try to change legal rules that thwart their quest for profits.  There are several such cases still pending in India, including a Bayer case challenging the issuance of a compulsory license on a cancer medicine and a Pfizer case challenging the denial of one of its patent applications.  The Novartis ruling is also important because several countries have followed India’s lead and adopted comparable strict patenting standards as a key flexibility under international law.

Novartis, in response to the adverse ruling, has threatened to take its marbles and go home.  Paul Herrling, Novartis’ former head of research and development, is on record saying that Novartis may no longer bring its new medicines to the market in India.[2]  This is a hollow threat.  Big Pharma continues to file patents on all of its truly new medicines in India because Indian law allows such patents and there’s plenty of money to be made off of India’s growing middle class.  As proof, hundreds of patents on medicine have been granted in India since its patent law was revised to become compliant with international standards in 2005.  What Novartis and other companies can’t do, is file for new patents on revised version of older medicines, which comprise 90-plus percent of Pharma filings globally.

Although India, its generic industry, and patients around the world have won a key victory in the fight for affordable access to life-saving medicines, Big Pharma and its supporter in US and EU trade offices will not stop pressuring and threatening India and other countries to allow longer, stronger, and broader patent and data monopolies on medicines.  Indian policy makers, health advocates, and courts must continue to remain vigilant in trade negotiations and elsewhere to resist intellectual property proposals that encroach on fulfillment of the right to health. 

[1] The text of the Supreme Court’s decision is available at http://judis.nic.in/supremecourt/imgs1.aspx?filename=40212.

[2] Paragraph 194:  “[T]he case of the appellant appears in rather poor light and the claim for patent for beta crystalline form of Imatinib Mesylate would only appear as an attempt to obtain patent for Imatinib Mesylate, which would otherwise not be permissible in this country.”

[3] Novartis warns India over drug patent, Financial Times (March 31, 2013), available at http://www.ft.com/intl/cms/s/0/c377e20a-99eb-11e2-83ca-00144feabdc0.html#axzz2PCguK9ie    the case of the appellant appears in rather poor light and the claim for patent for beta crystalline form of Imatinib Mesylate would only appear as an attempt to obtain patent for Imatinib Mesylate, which would otherwise not be permissible in this country.