Fifty AIDS activists, students, and community group members protested at Novartis’s Institute for BioMedical Research in Cambridge, Massachusetts, on February 22, the eve of the Swiss pharmaceutical company’s annual shareholders meeting in Berne Switzerland.  The protest was part of two days of global  action drawing attention to the pharmaceutical giant’s pending lawsuit against cancer patients and the government of India, aiming to reinterpret India’s strict patent standards.

Novartis is seeking to establish a binding court precedent that will make it much easier to obtain overlapping and successive patents on minor variations to existing medicines ­ a precedent that will increase the number of patents on medicines and extend the length of patent monopolies thereby limiting and delaying generic competition.  In the absence of generic competition, Novartis and other Big Pharma companies will be able to set price affordable to elites, but unaffordable to the broad mass of poor people in India.  Because India is the “pharmacy of the developing world,” Novartis’s case threatens future access to affordable generics in all categories of life-saving and health-enhancing medicines .

Background of the Novartis Case

This court case is part of a long series of legal actions by Novartis designed to eviscerate India’s lawful efforts to restrict the widespread practice of “evergreening” by pharmaceutical companies whereby they seek new or additional 20-year patent monopolies for minor changes to existing chemical entities and for medicines based on those changes.  They are part of an even broader spectrum to IP-strengthening and price-protection lawsuits that Novartis has brought against developing countries including South Africa (1998), Argentina (2010), and S. Korea (2009).

Concerning the present case, scientists had invented a basic compound imatinib, which was first patented globally, but not in India, in 1993.

Thereafter, researchers at Novartis tweaked the basic compound to first produce a mesylate salt form and then a beta-crytalline form of that salt.

This routine discovery resulted in slightly enhanced bioavailability or absorption of the compound into the body (30% improvement).  This revised active pharmaceutical ingredient became the basis of a powerful anti-cancer medicine called Gleevec in the U.S. and Glivec in India.  In 1998, Novartis filed a patent application on the revised in the India Patents Office and in many other countries.

[Coincidentally, because of exclusive marketing rights it gained under TRIPS for pending patent applications, it enjoined production of generic Glivec by six India generics in 2004.  Those companies were permitted to resume manufacturing in 2005 because of special rules in India’s Amended Patent Act.]

Although the Gleevec/Glivec patent was granted in 40-plus countries that had relatively weak patent standards, the patent was denied in India for three simple reasons.

  • First, prior to 2005, India, like many countries before it, did not grant patents on medicines at all. Although the 1994 World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) forced India to start granting patents on medicines in 2005, TRIPS did not require India toretroactively grant patents on medicines invented before 1995 (medicines invented between 1995 and 2005 were kept in a “mailbox” to be evaluated in 2005 when India was required to become fully compliant with TRIPS.)
  • Second, India enacted Section 3(d) of its patent law, a so-called exclusion that does not ordinarily allow patenting of variations, new uses, new combinations, and new formulations of preexisting chemical entities.  Because the beta crystalline mesylate salt of imatinib was a variation of the preexisting imatinib, Novartis was “grandfathered out” of being eligible for a patent.
  • Third, India incorporated a narrow exception to the no-patent-for-variations rule if, but only if, a patent applicant could demonstrate that changes to an existing substance actually showed significantly increased efficacy.  The Indian courts and Patents Office have interpreted this efficacy standard to mean efficacy in treating human disease or illness and not to include changes inbioavailability, stability, shelf-life, etc.  Applying this narrow exception ­ no true therapeutic gain, no patent ­ the India Patents Office denied Novartis’s patent application on Glivec because Novartis only showed a minor gain in bioavailability but did not otherwise show that its tweaks to the basic compound had improved Glivec¹s efficacy in treating cancer.

Disappointed with this outcome, Novartis filed a court challenge seeking to overturn Section 3(d) and to reverse the Patent Office’s denial of its patent application.  Novartis initially attempted to get Section 3(d) declared unconstitutional under India law and/or to be held invalid under the TRIPS Agreement.  Novartis argued that the provision was unconstitutionally arbitrary and irrational, that it was internally inconsistent with other provisions of the India Patent Act, and that it defeated Novartis’s established expectations.  It also argued that Section 3(d) was inconsistent with TRIPS and it must therefore be reinterpreted or invalidated.  The Madras High Court rejected both of these challenges.

With respect to the challenge of the denial of its patent application, the Court ordered that Novartis pursue an administrative appeal before coming back to court.  It did so after various procedures twists and turns, but it lost its administrative appeal before the Intellectual Property Appeal Board.  After losing administratively, Novartis appealed again, this time to the Indian Supreme Court where it is trying to change the interpretation of Section 3(d). In essence, Novartis wants section 3(d) to be reinterpreted to allow routine ³evergreening² of minor modifications to existing medicines based on a minimal showing of any positive effect, including bioavailability.

Global Protests

Demonstrators in Cambridge tried to deliver a Silver Urn (for the ashes of people who would die if Novartis’s court challenge is successful) to Novartis officials, but they were barred from the building and ordered off the premises by Cambridge police.  Demonstrators in Washington D.C. delivered an “indictment” against Novartis’s CEO and other protesters in New York City also occupied Novartis offices.  These protestors organized by Health GAP, Student Global AIDS Campaign, Occupy Boston Health Justice Group, and others were joined by a larger group of protestors at the annual meeting in Basel.  There, activists from Act Up Paris, Act Up Basel, MSF, Oxfam, the Berne Declaration and others showed videos and interacted with shareholders, many of whom were sympathetic to the campaigners¹ protests against Novartis’s lawsuit.

Novartis’s reaction to the protests is to claim that:

“We believe that working through the judicial system is the legitimate and appropriate approach to gaining clarity on the unique aspects of India’s patent law.  We disagree with assertions that access to medicines is threatened by our case. The basis of this argument is false and very misleading. Currently available generic drugs launched in India before 2005 ­ including HIV/AIDS medicines and generic versions of Glivec ­ will continue to be available under a grandfather clause in the Indian patent law regardless of the legal outcome of our case. All pharmaceutical products, including HIV/AIDS medications, have been patentable in India under the existing patent law since 2005, and some have been patented.”

This defense is patently evasive – ­ the part-truth that tells a lie.  Yes, there is some degree of grandfathering, even for Glivec; yes, India does patent some medicines since 2005.  However, India has tried to limit patent monopolies, to address public health needs, and to ensure access to medicines within the bounds of the TRIPS Agreement.  Novartis’s statement ignores that is trying to erase those legislative efforts, hiding behind the fig leaf of seeking “clarity.”

Indian generic companies manufacture 80% of the antiretrovirals used to treat people living with HIV/AIDS around the world.  Although manufacture of existing AIDS and other medicines is not threatened by the court case and although the court case will not shut down the six generic companies in India that are selling generics equivalents of Glivec at 1/12 the cost, the threat with respect to newer and future medicines is very real.  With more frequent and longer patent monopolies, poor people and poor governments will be priced out of access for many, many years.  This is the true cost of Novartis’s power-grabbing lawsuit.