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

Brook Baker

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.[1]  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.          

See also: Debunking Pharma’s Cant Against the Novartis Judgment:  Myth and Fact

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.[2]  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.[3]  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.

Technical Analysis of the Opinion

The Novartis judgment is a long one.  It combines a meticulous examination of the legislative context within which India passed its amended Patents Act in 2005 and a painstaking analysis of the claims and disclosures in the original patent application on Glivec’s base ingredient, imatinib, the details of its regulatory filing when it first sought product registration in the US and in India, and its subsequent application on the beta crystalline form of imatinib mesylate.  It also clarifies the interrelationship between standards for invention found in section 2(1)(j) and (ja) of the Act and section 3(d) addressing the patentability of previously known substances including medicines.

In terms of the successive patent applications, the Supreme Court held that the original patent application, filed in the United States in 1994 before the effective date of India’s amended Patents Act (the so-called Zimmerman patent), had claimed and had covered the imatinib mesylate as well as imatinib (paragraphs 133, 157).  It held further that the second application, filed in India’s “patent mailbox” in 1998, on the beta crystalline form was a rough cut and paste version of the original patent (paragraph 164).  It found that Novartis’s application for approval of Glivec/Gleevec in the United States had claimed that the active pharmaceutical ingredient was imatinib mesylate rather than only the beta crystalline form thereof (paragraphs 116-120), that Novartis’ exclusive marketing rights application in India had been based on imatinib mesylate as well (paragraph 193), and that all of the pharmaceutical properties of the beta crystalline form were equally possessed by imatinib in free base form or its salt (paragraph 163).  In terms of properties, the Court found that the beta crystalline form had better flow properties, was more termodynamically stable, and was less hygroscopic (paragraph 172), but none of these characteristics were relevant to the section 3(d) analysis which focuses on increased efficacy in term of treatment (paragraph 187).  It found that there was no evidence that the beta crystalline form had better bioavailability than the imatinib mesylate itself, the relevant comparison (paragraph 170).

It terms of its legal ruling, the Supreme Court clarified several important points.  First, by examining the legislative context and history, the Court confirmed that India’s amended Patents Act was intended to prevent evergreening patents (paragraphs 75-86).  Second, it confirmed that India had incorporated strict standards of patentability, especially with respect to medicines, and that section 3(d) encapsulated that intent and was a clarification of basic standards of invention  and inventive step found in section 2(1)(j) and (ja) of the Act (paragraph 104).  Third, it held that Novartis’ attempt to differentiate the “coverage” of a patent from what is “disclosed” in patent claims and specifications was unacceptable and that there should be no significant gap between the two (paragraphs 136-156).  Finally, it confirmed an interpretation of section 3(d) that focuses on the therapeutic impact of modifications rather than simply physical properties such as solubility, flow, or stability (paragraphs 158-187).  It rejected an interpretation that section 3(d) requires that the full therapeutic efficacy of the original compound be known and demonstrated at the time of filing and stated further that evidence of increased bioavailability alone would not necessarily show increased therapeutic efficacy (paragraph 188-189).  The Court declined to further specify the exact meaning of increased efficacy even while acknowledging divergent opinion offered by counsel (paragraphs 182-186).

At the end, the Court summarized the legal standard that should be applied in assessing secondary patent applications:

Section 2(1)(j) defines “invention” to mean, “a new product or …”, but the new product in chemicals and especially pharmaceuticals may not necessarily mean something altogether new or completely unfamiliar or strange or not existing before. It may mean something “different from a recent previous” or “one regarded as better than what went before” or “in addition to another or others of the same kind”. However, in case of chemicals and especially pharmaceuticals if the product for which patent protection is claimed is a new form of a known substance with known efficacy, then the subject product must pass, in addition to clauses (j) and (ja) of section 2(1), the test of enhanced efficacy as provided in section 3(d) read with its explanation.  (Paragraph 192.)

The Court was quite patient with the “creative” arguments advanced by Novartis’ high priced lawyers.  But in the end, it found the case incredibly easy to decide:  the beta crystalline form failed both tests of invention found in section 2(1)(j) and (ja) and standards of patentability further set forth in section 3(d) (paragraph 195).  The Court further stated that “the case of the appellant [Novartis] appears in a rather poor light and the claim for a patent for the 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.”  (Paragraph 194.)