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Intellectual Property (IP) rights are an important asset to the life sciences sectors. Many life science companies typically apply biology to develop products –therapeutic agents, nutritional products, biotech crops, bioplastics and biofuels. Successful products are the intellectual property of their creators. They often represent cutting-edge scientific solutions with enormous promise to provide the most effective means to solve a multitude of problems.
The major organisations within the life sciences focus on developing drugs, therapies and health technologies – a high stakes venture. Some inventions will turn out effective and improve the lives of potentially millions of individuals. In contrast, others will never make it to market. It is a business model filled with enormous uncertainty.
IP and the Life Sciences
IP systems tend to be highly neutral, establishing comprehensive concepts that are then adapted and applied in practice as scientific advancements progress. Yet PI rights within the life sciences are a distinctive area of technology that require special treatment.
Some of the factors that distinguish life sciences technologies include:
- The essential human matters at risk: health, food, the environment
- The demand for distinctive regulative tools for certain life sciences technologies, such as drugs and genetically modified organisms, to make sure of safety, efficiency and also biosafety
- The economic and social effect of agricultural as well as clinical industries
- Use of genetic resources – human, agricultural, marine and terrestrial biodiversity – raising questions of ownership and control of resources, benefit-sharing.
Life Science Healthcare Innovations
These factors justify the specific interventions for life sciences technology in the patent system.
Product development costs within life science are still immense, with estimated figures for developing a new drug reaching as high as £2 billion per drug (Wouters et al., 2020). When research and development (R&D) expenses are so high, any life science company would certainly anticipate outsize chunks of overall revenues to come from a handful of triumphant R&D efforts. IP protection aids companies in recouping their expenditures through the creations that do make it to market. However, there are no defences against the losses arrive at through the inevitable failings. As such, for most typical life sciences companies, IP is a most valuable asset—it propels growth, drives success and sets owners apart from competitors. But IP is also a most vulnerable asset.
In the life sciences sector, licensors consistently profit from licensing to a competitor, even for small technological leads (Lee et al., 2018). Smaller biotech firms will often rely on out-licensing revenue, while large corporations manage large patent portfolios to monetise their intellectual property. Indeed, the market for licensing patents in the life sciences sector has expanded in modern times.
IP and the Impact of COVID-19
At the dawn of the covid 19 pandemic and associated health crises, various factions have increased pressure on life science companies to scale back patent protection and open up IP for public benefit.
A few weeks ago, the new director-general of the World Health Organisation called for relinquishing IP rights to guarantee more equitable access to COVID-19 vaccines. Rising economies like India and South Africa have long led a bid, back by more than 100 other countries, urging the World Trade Organisation (WTO) to waive IP for COVID-19 treatments to combat the disease. In the UK this month (March 2021), pressure has been mounting on the government, led by business leaders, academics, economists and trade unions, to back a proposed IP waiver related to COVID-19 treatments before the WTO.
Over the last year, the American pharmaceutical company Gilead Sciences rescinded its description of the potential COVID-19 treatment, remdesivir as an orphan drug, after pressure associated with the extended exclusivity duration and tax incentives accompanied its new classification. Popular opinion criticising Gilead Sciences for profiting from the pandemic may have played a part in this decision.
COVID-9 has also introduced innovation such as compulsory generic licensing to better combat coronavirus. In this model, a relevant patent office or health ministry grants licenses to third parties to promote generics production, with a reasonable cost to the license holder as settlement.
These developments push for substantive changes to the way IP is handled. As modifications are made in response to the COVID-19 emergency, the necessary groundwork should also be laid to ensure that the licensing systems work as intended for all stakeholders. Surrendering IP would remove inducement for innovation. R&D overheads for companies are a considerable expenditure, and it may be challenging to rebuild previous market dynamics after the coronavirus pandemic has ended. If IP is not adequately secured now, future drug and product development could be restricted and more limited in scope. IP provides a transparent mechanism for the dissemination and accessible publication of innovative products and the practical, fair availability of the fruits of innovation.
Regardless of just how much innovation is currently originating from life sciences firms, it seems that the extraordinary pressures of COVID-19 will certainly quicken changes to the way IP is handled. Determining a solution that works for all involved, over the long term, past the present pandemic might be difficult. Life science organisations must carry on demonstrating the value they contribute to the health ecosystem for their voice to be heard.
Final Thoughts
In the end, an equilibrium would have to be reached between profiting from investments in innovation and open access for the public good. It will boil down to how to find the optimal balance between these two goals. On the one hand, at the level of principle, in terms of how various legitimate life science business interests are accommodated in national laws and international treaties; and on the other hand, at the level of practice, calculated in terms of public welfare outcomes.
As an organisation, we specialise in a range of activities responsible for advancing creative intellectual activity and facilitating the development and transfer of life science technologies. How life science organisations commercialise their IP innovations and gain regulatory compliance is crucial for the success of their businesses. This article aims only to help shed light and clarify the current issues on IP rights, the life sciences and public health without seeking to make assessments in these multiple areas of debate and policy analysis. Our in-depth understanding, awareness and responsibilities regarding the preceding issues guide our work.
About The Author: Optymum SS is a networked, international pipeline-organisation of chartered scientists and certified laboratories. UK Chartered Scientists represent the best professional scientists working in the UK and abroad. We utilise our innovative business model to support the provision of the best, most cost-effective solutions to challenges within the broad life sciences –advancing well-being and quality of life. For more information about working with us or joining our partnership, please get in touch.
References
Lee, J. H., Kim, E., Sung, T. E., & Shin, K. (2018). Factors affecting pricing in patent licensing contracts in the biopharmaceutical industry. Sustainability (Switzerland), 10(9).
The Wouters, O. J., McKee, M., & Luyten, J. (2020). Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018. In JAMA – Journal of the American Medical Association (Vol. 323, Issue 9, pp. 844–853). American Medical Association.
