The Indian government is being taken to court.
After the country’s patent office rejected a patent application filed for imatinib mesylate, branded Gleevec or Glivec, the drug company Novartis filed for legal action against the government of India over the country’s strict patentability criteria as outlined in Section 3d of the patent act, which states that new patents should not be given for routine improvements of existing medicines[i]. When considering Novartis’ Gleevec application, India ruled that imatinib mesylate is simply a salt form of the already existing compound imatinib, and thus lacked inventive step and did not provide enhanced therapeutic efficacy, as required by Indian law. By ensuring that all patent applications are locally examined and by insisting that a stricter test of inventive step be applied by patent examiners to claims on new use or new forms of known medicines, India’s law blocks superfluous patents that could impede access to medicine[ii]. Novartis is taking India to court specifically over Section 3d, a critical public health safeguard built in to the country’s patent law that requires its examiners to apply a stricter test for inventive step by insisting on demonstration of therapeutic efficacy on derivative forms of known medicines. The case is now meant to be heard before the Indian Supreme Court on August 22.
Imatinib mesylate isn’t the only medicine to see its patent rejected under Section 3d. Fixed-dose combinations (FDCs) and paediatric formulations of existing drugs are also not given patents in India, because simply putting separate medicines together in one pill, or making a new formulation of an old medicine (for example, a syrup version of a pill) is not considered inventive under Indian law. Because of this, a child friendly formulation of Nevirapine —used for treatment of HIV in babies—was never given a patent in India, despite an attempt by the pharmaceutical company Boehringer Ingelheim to do so[iii]. Fixed-dose combinations of HIV medicines that are used widely in South Africa and internationally, such as tenofovir/emtricitabine , was also not granted a patent because combining medicines together is not considered inventive by Indian patentability standards.
Because India did not grant pharmaceutical product patents until 2005[iv], and then subsequently practically limited patenting to medicines that are truly new and inventive, the country has developed a thriving generic medicines industry and is considered the “pharmacy of the developing world.” The majority of anti-retrovirals (ARVs) used in developing countries are Indian generics[v].
A win for Novartis in their case against the Indian government could turn all of this around. If Section 3d is weakened, patents could be granted far more broadly in India, blocking the competition among multiple producers that drives prices down. Generic competition in India has been key to the cost of first-line ARVs dropping from over $10,000 per patient per year[vi] in 2000 to approximately $150 per patient per year today[vii]. Perhaps most egregiously, companies have applied for routine improved formulations on drugs that were never eligible for patents in the first place—since India did not have a product patent regime for pharmaceutical products until 2005, many early ARVs, for example, were never given a patent in the country. But drug companies could now apply for new formulations of old medicines and receive new patent monopolies, despite these drugs being on the market for years. In the area of AIDS treatment it would also mean that pharmaceutical companies who have pending patent applications on important HIV medicines will easily be able to push for patents on new forms and fixed dose combinations of HIV medicines, blocking access to more affordable generic versions across India and the developing world.
It may seem unusual for a government to be taken to court by a drug company for trying to protect patients’ lives, but South Africans know that we’ve actually been here before: in 2001, the Pharmaceutical Manufacturers Association (PMA) took legal action against the South African government for changing its law to promote access to cheaper medicines, despite the proposed legislation being compliant with international law. The South African government, with the help of civil society in South Africa and globally, fought back and won, allowing the Medicines and Related Substances Amendment Act of 1997 to be passed[viii]. The Indian government, again with the support of activists, academics, and lawyers across the world, is now also fighting to preserve its right to balance public health and intellectual property protection as allowed under international law.
Yet despite similar histories in battling for access to life-saving medicines, South Africa’s patent law still lags far behind India’s law when it comes to protecting the right to health. South Africa’s patentability criteria is less strict than India’s, and as such, South Africa routinely grants so-called “new use” and “new formulation” patents, or patents given for routine changes on existing medicines. By allowing for new patents to be routinely granted on old medicines, pharmaceutical companies are able to get monopoly after monopoly in South Africa, essentially ensuring that they have market exclusivity beyond the 20 years required under international law (so-called “evergreening”)[ix].
South Africa’s weak patentability criteria is compounded by the fact that the country does not have a patent examination system—the patent office simply does not examine whether patents meet the country’s patentability criteria, as outlined in South Africa’s patents act, but instead issues patents as long as administrative requirements are met. India, by contrast, has a patent office that examines patents and, far from costing the state money, is actually a significant source of revenue, through collection of fees on various activities related to filing and grant and maintenance of patents.[x].
South Africa’s weak patent standards, coupled with the absence of an examination system, results in a very high number of patents being granted annually: in 2008 alone, 2,442 pharmaceutical patents were given in South Africa[xi].
This long list includes patents for imatinib mesylate, or Gleevec itself. Because of South Africa’s weak patent standards, at least ten patents have been granted on imatinib[xii]. Because it is patent protected, Gleevec is available in South Africa’s private sector at a whopping R862.5 per 400 mg tab; in India, the generic company Cipla offers a 400 mg tab version for just R86. South Africa also routinely grants patents on FDCs and paediatric formulations that were rejected in India[xiii].
A Novartis victory will not only stymie access to life-saving generics across southern Africa, but will also result in a negative precedent for countries facing a high burden of disease like South Africa. South Africa should consider examining patent applications independently and strengthening its patentability criteria to ensure that only truly new medicines are granted patents.
[i] The basic molecule imatinib was first patented in the US (US 5521184) in 1993; it was not eligible for patenting in India as the country did not have a product patent regime. In 1998, Novartis filed an application 1602/MAS/1998 on the mesylate salt of Imatinib, which was subsequently rejected. At least ten patents relating to imatinib have been granted in South Africa.
[ii] Section 3d reads as follows: “The following are not inventions within the meaning of the Act – The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a know substance … Explanation. – For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of [a] known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.”
[iii] In addition to India’s stringent patentability criteria, patent oppositions have also been important to the rejection of new use and new formulation patents, such as those on Nevirapine. In 2008, the pharmaceutical company Boehringer Ingelheim filed for a patent on an extended release version of Nevirapine. A patent opposition has been filed.
[iv] India patent law is compliant with the Trade Related Aspects of Intellectual Property (TRIPS) Agreement. TRIPs does not define inventive step and leaves it to the countries to develop their own inventive step standards. India was not required to introduce a pharmaceutical product patenting regime until 2005.
[v] Waning, B. “A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries.” Journal of the International AIDS Society. 2010; 13: 35.
[vi] d4t-based regimen
[vii] TDF-based regimen
[viii] This allowed for substituting generic medicines for off-patent branded medicines; transparent pricing mechanisms; and importation of cheaper branded medicines from other countries.
[ix] According to the Agreement on Trade-Related Aspects of Intellectual Property.
[x] During 2009-2010, the patent office generated a revenue of approximately R208,966,862 while its expenditure amounted to approximately only R30,903,550.
[xi] Correa, C. “Pharmaceutical Innovation, Incremental Patenting and Compulsory Licensing.” The South Centre. September 2011.
[xii] According to a search done on July 9 2012 through the Online Patent Register, Companies and Intellectual Property Commission. http://patentsearch.cipc.co.za/patents/patentsearch.aspx.
[xiii] Examples include, among others, tenofovir/emtricitabine and darunavir/ritonavir FDCs.