On World Intellectual Property (IP) Day 2021, the innovative biopharmaceutical industry came together to launch a new initiative foregrounding the benefits to patients and to society at large of a robust IP framework. Under the INTERPAT umbrella, 25 industry members and associations launched the ‘IP Principles for Advancing Cures and Therapies (IP PACT)’, which frames IP as the “cornerstone” for the creation of new diagnostics, treatments, and vaccines.
“It is important to us that patients and society understand the way we use IP and why it matters for what we do,” said Andrew Jenner, INTERPAT’s director-general, ahead of the IP Pact’s launch. “The IP PACT is an industry-wide unified commitment to the IP system and to using it in a way that brings value to patients and society. We want to communicate the key principles to which we adhere to and guide our companies’ use of IP to advance the goals of improving and extending patients’ lives.”
Jenner also noted that IP had been “the oil in the machine of collaboration during this pandemic that has seen unprecedented cooperation and sharing of know-how,” as private companies as well as public sector actors banded together to solve the challenges thrown up over recent months. “We hope that the IP PACT will create a platform for further informed dialogue and how we use it to address the health challenges of today and tomorrow for all patients worldwide,” he added.
Corey Salsberg, global head of IP affairs and VP at Swiss giant Novartis agreed, telling the launch that “several of the principles pertain specifically to themes that are on full display in the COVID context, such as the important role that IP plays in enabling collaborations and partnerships, driving innovation, and bringing together the expertise and capacity needed to achieve things like manufacturing breakthrough technologies on a global scale. But these are principles for all times, and the statements and commitments we make here should be read in that broader context.”
“[IP has been] the oil in the machine of collaboration during this pandemic that has seen unprecedented cooperation and sharing of know-how”
Andrew Jenner, INTERPAT
Although not mentioned explicitly, the shadow of COVID-19 vaccine access looms large over the document. Indeed, the IP Pact is being published amidst growing calls – primarily from developing countries – for the WTO to waive IP rights on products related to COVID-19 for the duration of the pandemic.
A waiver of the WTO’s Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS) was first proposed by South Africa and India in October 2020 and is still under discussion. However, the TRIPS waiver has met with fierce resistance from wealthy nations and from the pharmaceutical industry which argues that such a move would not be a cure-all for current gaps in vaccine production and would even be harmful for innovation and the quality of finished products.
With pharmaceutical IP now headline news and receiving a barrage of criticism, the industry has taken it upon itself to reassert its attitude to IP and explain – in ten straightforward points – its benefits (see below).
On the issue of IP waivers in developing countries, the IP PACT’s Principle Ten outlines how far the innovative industry is willing to bend. “We support a time-based transition period for Least Developed Countries (LDCs) to meet the TRIPS standards while they focus on overcoming … structural challenges and work towards implementing the necessary framework to protect and enforce IP,” states the document. “We will also continue to engage in approaches to IP in LDCs that take into account their unique challenges. These may include voluntary licensing, non-assert policies or selective approaches to filing, in addition to supporting capacity-building initiatives which can foster a dynamic local innovation ecosystem.”
It also tackles generics, with the document having met with a lukewarm initial response from the off-patent industry. “We believe that generic and biosimilar medicines play an important role in the sustainability of health systems and the promotion of a healthy innovation lifecycle,” notes Principle Seven. “To that purpose, we commit to continue supporting appropriate exemptions from patent infringement for activities related to seeking regulatory approval, that facilitate efficient approval while preserving the integrity and function of the patent and regulatory review systems.”
While debates over IP waivers for COVID-19 vaccines will continue to swirl in the coming weeks and months, through the IP PACT the innovative industry has set out its stall and is sending out “an important signal” in the words of IFPMA Director General Thomas Cueni. “Innovative biopharmaceutical companies are eager to show that the way they use the IP system can bring value to patients and society,” he concludes.