The extent to which follow-on pharmaceutical innovations should be protectable by patents is hotly debated amongst the public health and IP community in Geneva. But are fears that follow-on patents simply extend indefinitely, or “evergreening”, medicine patents justified?
Drawing on global experiences and real-world evidence, this working lunch examined what exactly is follow-on pharmaceutical innovation, how it impacts public health, and whether national patent laws should treat it differently to other forms of medical innovation.
The common theme amongst participants that “evergreening” is a problematic concept, and that follow-on innovations have produced real benefits for patients, and the ability to secure patents has been a critical incentive to underpin R&D in these areas.
Participants included representatives from the diplomatic community, multilateral organisations, academia and the private sector.
Prof Timo Minssen of the University of Copenhagen presented the findings of his recent joint paper Patentability Standards for Follow-On Pharmaceutical Innovation. He cited numerous examples from jurisdictions around the world in which patent offices and courts have applied the well-recognized requirements of patentability, including patent eligibility, novelty, inventive step and industrial application, to follow-on pharmaceutical inventions, and in so doing have advanced innovation in public health and ultimately the lives of patients.
He also put into perspective the concept of “evergreening”, pointing out that – unless there is a clear misuse of the regulatory system – a patent on an improved formulation, for example, is limited to that improvement and does not extend patent protection for the original formulation – and nor does it impede generic entry for the original version.
Of course, this assumes a reasonably well-functioning pharmaceutical market and competition. If that market breaks down in a manner that forces patients to pay higher prices for a patented new version of a drug that provides little real improvement over the original formulation, then it is the deficiency in the market or the regulatory system which should be addressed, rather than the patent system itself.
Finally, he emphasised the role of competition law in countering abuses of the patent system, and the mitigating effects of correctly and coherently applied patentability criteria. If the traditional patentability criteria are applied, there are no need for new ones.
Prof Prabuddha Ganguli of the Rajiv Gandhi School of Intellectual Property Law gave his perspective as an IP practitioner who has drafted and defended dozens of patents within the Indian patent regime. He explained the importance of follow-on innovation within medicine and discussed the details of section 3d of the Indian Patent Act and how that has forced innovators in India to change and adapt their approach to R&D and patent drafting. The ability to patent follow-on innovations has been particularly critical to help generic companies boost their innovative capacity and take their first steps into de novo drug R&D – critical for the long-term future of the Indian pharmaceutical industry.
Peter Thomsen of Novartis outlined the importance of patents to support investment in R&D into follow-on innovations, giving several examples of important follow-on medicines and formulations that have depended on patent protection. In his view, it would be a mistake to discriminate against these kinds of technologies within the patent system given their importance to innovation and advances in medical technology.
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Digital services hold enormous potential for improving healthcare delivery around the world, according to a panel convened by Geneva Network and the Information Technology and Innovation Foundation at this year’s WTO Public Forum. However, governance and trade issues need to be resolved to ensure the best management and cross-border flow of data.
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For countries like Chile looking to reduce dependence on the export of natural resources, innovation will be key. Knowledge-based industries from life sciences to film form the basis of economic growth in most OECD countries, their growth and investment encouraged by a strong framework of intellectual property rights.
Latin American countries such as Chile hold much promise due to their biodiversity, good science base and entrepreneurial citizens. Yet there is scepticism in policymaking circles in Chile and elsewhere in Latin America about the potential of innovation, and role of intellectual property rights, in particular in debates about public health. This most recently has manifested itself in attempts to by the legislature undermine intellectual property rights by making it easier to issue a compulsory license for medicines.
Latin America will need to prioritise innovation if it is to meet its social, demographic and economic challenges.
In an era of globalization in which knowledge-based industries form the bedrock of the most successful economies, intellectual property rights (IPRs) must be considered as fundamental market institutions, alongside physical property rights and the rule of law. By contrast, government attempts to co-opt IPRs through for example compulsory licenses create enormous uncertainty for domestic and international investors.
Strengthening domestic intellectual property rights is often viewed as a “cost” of trading with wealthier countries, to be resisted or watered-down. It is, in fact, necessary to meaningfully participate in an increasingly knowledge-based global economy.
As knowledge-based goods and services are an increasingly important component of global trade, policymakers should look to the trading system to create a level playing field and high standards of protection.
Clearly, enormous challenges remain if Latin American countries are to become more innovative and participate more meaningfully in global value chains and international innovation networks. But the opportunity is there: it is up to the current generation of policymakers to seize it.
https://geneva-network.com/wp-content/uploads/2019/04/IMG_0282.jpg24483264gnadmhttps://geneva-network.com/wp-content/uploads/2017/10/geneva-logou.svggnadm2019-04-25 10:09:312019-07-04 15:25:39Making the case for strong intellectual property rights in Chile and Latin America