Access to Medicines in the Developing World: No to Evergreening in Novartis Case and No to Patent Linkage in Patricia Asero Case

As part of the World IP Day 2013 activities in Kenya, CIPIT will host a special intellectual property (IP) debate organised by the Aids Law Project (ALP) between students drawn from the local universities. The topic of this debate is: how the Novartis and Patricia Asero court decisions affect public health in developing countries. Although this blogger will not be able to attend the debate in person, what follows are a few ruminations on this debate topic.
The Supreme Court of India judgment in the Novartis case and the High Court of Kenya judgment in the Patricia Asero case seem to have one common consequence: making pharmaceutical companies very unhappy. Both these cases have placed the spotlight on the generic drugs industry. In the developing world, where few people can afford original patented medicines, many opt for generic versions of the same drugs that are sold for as little as 1/10th of the price of the original product. Therefore, what generics companies do essentially is to replicate drugs that are no longer protected by patents. This leaves the pharmaceutical companies with two main issues to deal with: Firstly how do they “extend” patent protection for their well-known drugs? Secondly how do they ensure strict IP enforcement in respect to their patented drugs? The first issue is illustrated in the Novartis case and the second issue appears in the Patricia Asero case.
As many may know, the Indian Supreme Court made worldwide news at the start of this month by upholding the decision of the Intellectual Property Appellate Board to reject a patent application filed by pharmaceutical company Novartis in respect of an improved version of its patented cancer drug, “Glivec”, after a seven-year legal challenge. As mentioned above, the generics industry poses a major challenge to pharmaceutical companies with the latter seeking ways and means of extending the life of their patented drugs. One common practice by pharmaceutical companies is called ‘evergreening’, whereby these companies apply for patents on modifications or improvements to their patented drug(s), and thereby extend the 20-year protection granted by the original patent(s). However the judgment in the Novartis case (available in full here) provides a binding interpretation of the Indian Patent Act aimed at curbing ‘evergreening’ by preventing the grant of a patent for new forms of known substances, unless the applicant can establish the new form demonstrates an increased efficacy. Therefore in the Novartis case, the court ruled that the new patent did not satisfy the requirement of novelty, being no more than an amended version of a known compound, namely that of the original Glivec.
The Patricia Asero case was filed by three petitioners living positively with HIV accompanied by a number of non-governmental organisations (NGOs) including AIDS Law Project (ALP). The gist of the petition was to challenge the implementation of the Anti-Counterfeit Act (ACA) of 2008 with regards to generic medicines. It was argued that the effect of this law is that it applies civil and criminal penalties to generic medicine manufacturers. Therefore, enforcing this Act will limit the petitioners’ access to generic HIV medicines bearing in mind that many HIV-positive citizens rely on generic anti-retrovirals because they are cheap and affordable. As a result, the petitioners’ rights to health, life and dignity as protected in the Constitution were in jeopardy as a result of the implementation of the Act. In a landmark decision, the court upheld the right to life of the petitioners as protected by Article 26 (1), the right to human dignity guaranteed under Article 28 and the right to the highest attainable standard of health guaranteed under Article 43 (1). Therefore the Act was held to be unconstitutional in as far as it purported to limit access to essential medicines. From a public health perspective, the Anti-Counterfeit Act’s definition of what constitutes a “counterfeit” product is considered to be vague, and likely to be used to block the import and local manufacture of generic drugs. This is because the definition of ‘intellectual property rights’ includes the ‘Industrial Property Act’ which in effect would mean that generic medicines are a subject matter under the Act therefore they are subject to detention or confiscation as part of policing and enforcement measures by the Anti-Counterfeit Agency. This patent linkage ensures that patent rights of the pharmaceutical companies are protected by all local law enforcement agencies thereby jeopardising access to life-saving medicines. It follows that pharmaceutical companies would have a key vested interest to ensure that patent linkage provisions remain in our IP laws, particularly our anti-counterfeiting legislation. Patent linkage is therefore one way of protecting their patents and achieving more profits from the sale of medicines worldwide including Kenya.
In sum: the judgments in the Indian and Kenyan cases on generics are significant in that they strike a fundamental balance between the rights of patent owners and the interests of the users. The Novartis case acts as a major deterrent to other pharmaceutical companies intending to use “evergreening” as means of extending the life of their patents thereby depriving many from access to medicines. The Patricia Asero case is an affirmation of constitutional supremacy therefore patent linkage provisions in the Anti Counterfeit Act may not be used to unjustifiably limit the rights or fundamental freedoms of any Kenyan, particularly the right to life and the right to health.

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