… for affordable medicines, or not? According to some press coverage, this week’s rejection by India’s Supreme Court of the appeal of a patent application denial by Novartis, a multinational pharma company (MNC), on its cancer drug, Gleevec, was a triumph for the poor of India who can’t afford the high price of the drug and for India’s generic drug companies who supply affordable medicines to the developing world. Not surprising, the story is more complicated and, for me anyway, the case’s resolution is of minor importance in creating a competitive world market for drugs.
Gleevec is one of Novartis’s most profitable drugs with worldwide sales of $4.7 billion in 2012 (FiercePharma article), in part because it works well against its molecular target and in part because Novartis has worked diligently to expand its approved uses for a bunch of relatively rare cancers. Invented by Novartis (then Ciba-Geigy) in the 1990s and based on 30 years of academic research, Gleevec was approved in 2001 by the FDA for the treatment of a rare white blood cell cancer, chronic myelogenous leukemia, for which it increased the 5-year survival rate from 30 to 90% (Scitable article). It is now used to treat a dozen cancers and proliferative diseases. The patent case in India as along history, too, as I learned from Derek Lowe’s post (In the Pipeline ) and a summary by the Lawyers Collective HIV/AIDS Unit (2009 Summary). Novartis got around to filing a patent on Gleevec in India in 1998 before the country was granting composition-of-matter patents, and, for a reason obscure to me, the application was for a purer “beta-crystalline” form of the drug. In 2005, the patent office rejected the application because Novartis had not shown that this form was sufficiently more effective that the original Gleevec under a section of the patent law designed to prevent companies from extending a drug’s patent life by filing patents on inconsequential changes to it. After appeals, rulings, and changes of venue, the case came before the Supreme Court in 2009 and was decided against Novartis this week (the wheels of justice grind slowly but also finely).
Given Novartis’s dogged pursuit of the case, one would presume it stood to lose a lucrative market for Gleevec in India but not so. The company gives the drug away to needy patients, currently to 31,000 in 80 countries, including 16,000 or 95% of all patients in India (and 5,000 in the US) (Novartis Gleevec case FAQ). Was it to prevent India’s generics companies from flooding the world with low-priced Gleevec look-a-likes? Not likely, since the knock-offs are out there already at a tenth of list price (PharmacyChecker.com, PharmacyChecker.com), and the drug goes off patent anyway in 2015*. Was it because, as a spokesperson for Médecins Sans Frontières (MSF) implied, Novartis and other MNCs are attacking Indian patent law to maximize profit and minimize access to essential medicines (WSJ article)? While I acknowledge that companies need to maximize profit to stay in business, I’m glad that Novartis is profitable enough to have a essential medicines access program and to develop Coratem (a combination drug for malaria) and sell more than 400 million doses at cost to public-sector agencies, including MSF, since 2001, contributing to saving 1 million lives in Africa (Novartis access program). As for attacking, it seems the Indian patent office and courts are attacking the MNCs’ patents, including by favoring the granting of compulsory licenses because a patented drug was being sold a too high a price (not one of the criteria under the WTO of which India is a member; see my post, “Dueling Sitars”).
I think Novartis pushed the case under a policy of defending its patents universally and know first-hand that corporate legal departments are combative. Novartis may have wanted a ruling to set legal precedent in advance of other patent disputes it may have in India, although I haven’t seen any reports of pending cases. As for an effect of the ruling on access to affordable medicines, I don’t see much of one. For the Indian generic drug companies, they may be able to copy and sell more of the MNC drugs that fall within this narrow category of drugs that received patents on minor modifications. But they should be concentrating on the many non-patented but essential medicines in short supply in India and elsewhere by improving their manufacturing and distribution systems. As for the MNCs, they will continue to participate in a number of donation/at-cost programs to gain access and experience in emerging markets (see the Access to Medicines Foundation’s recent Index for a rating of companies’ performance).
More importantly, the MNCs seem to be serious about competing on price in the developing world markets. Several years ago, Gilead licensed a number of its HIV drugs with technology transfer to Indian and South African generics companies that lowered prices on the licensed drugs and put price pressure on competing, non-licensed versions. As announced in 2009, Glaxo-SmithKline has priced its drugs at 25-30% of list in developing world markets. In 2010, the CEO of Sanofi stated the company’s emerging markets strategy included competing with generics companies on price and increasing local manufacture (see my post, “Patent Non Grata?”). The company recently announced it was starting up four new manufacturing plants in China (for a total of ten) and starting to build a third plant in Vietnam at a cost of $75 million (FiercePharmaManufacturing article). As I have posted previously (e.g., “Knickers in a Twist”), patents and patent cases are less important in providing access to affordable medicines than companies seeking market share and to the extent that governments and NGOs can help create markets, for example, by building functional health care systems and transparent regulatory and approval regimes, the better. A “victory” in improving world-wide access to medicines will require much more than court rulings.
*I noted that Novartis anticipated loss of patent coverage on Gleevec and declining profit and invented a more potent drug, Tasigna, that was approved in the US in 2007 (Bloomberg article).