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7 May 2021PatentsAlex Baldwin

US backs COVID IP waiver - Industry reacts

After months of open letters and petitions from various sources, the US government has decided to throw its support behind waiving IP rights for COVID-19 vaccines.

Countries, charities and even the majority of Democrats in the US House of Representatives have been asking the US to back India and South Africa’s proposal for a temporary Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) waiver to help struggling nations tackle the pandemic.

The announcement by US trade representative Katherine Tai came in on Wednesday, just a day prior to the World Trade Organization’s (WTO) latest meeting regarding the waiver yesterday.

Whilst some consider this a simple issue of providing more equitable access to vaccines, voices in the legal and pharmaceutical industry have highlighted the potential problems in removing IP protections from the vaccines.

WIPR asked legal experts, pharmaceutical representatives, industry bodies and academics their opinion on the US decision and whether it will ultimately help vaccinate more people.

Sally Shorthose, partner in the life sciences at Bird & Bird

“The urgent need to cure the vaccine scarcity problem has led to calls for a ‘waiver of patent rights’.  This appears to be a different proposition to the granting of compulsory patent licences during a pandemic (a process that is permitted under the TRIPS Agreement).   What the final proposal will involve will only emerge after significant negotiations at the WTO. It is not clear at this stage why compulsory licences could not achieve the desired goal.

“However, the problem to be solved (quickly creating enough cheap vaccines for the world) is likely to be more complicated than just waiving patent rights that relate to the vaccines.  There is no guarantee that the information contained in the relevant patents will be sufficient for a third party to effectively manufacture a vaccine.  A lot of the vaccines that we are now reliant upon are a new technology and the necessary know-how on how to manufacture bulk quantities to a high standard is likely to be known to only a few at this time.

“Also, with the requirement of unanimity at the WTO supporting a waiver looking unlikely to be achieved in the short term (the UK and the EU are reported as stopping short of backing the proposed waiver), it is not clear if this will actually be the way that the politicians and manufacturers seek to maximise supply.”

Yaël Ossowski, deputy director of the global consumer advocacy group Consumer Choice Center

"By backing the seizing of intellectual property around innovative vaccines, the Biden administration is actively harming future innovation and certainty for biotechnology firms that use patents to fund their research and development.

"If the US wants to help vaccinate low and middle-income countries suffering because of the pandemic, they should release all doses of AstraZeneca vaccine sitting in American warehouses, which the FDA has not yet approved, and begin exporting our vaccine surplus to the most hard-hit countries.

“Bad actors will have an easier time pushing black market products on the market. Fake vaccines will not just undermine the global vaccine drive but also put lives at risk and reduce trust in vaccines.”

Adam Stoten, COO of Oxford University Innovation

“I would worry that, if the waiver is implemented, it would at best be a double-edged sword. Waiving IP rights inherent in patents is but one part of the equation when producing a vaccine subject to such rights.

“The amount of unpublished know-how relevant to process development and manufacturing is significant and difficult to replicate. Given that with biologics such as vaccines the process is effectively the product, we might see different variations on ostensibly the same vaccine.

“If such variations have implications in terms of side effects then they could adversely affect the original products on which they are based; we have already seen the incredible sensitivity regarding such side effects from the current approved vaccines.”

Stephen Ubl, president and CEO of Pharmaceutical Research and Manufacturers of America (PhRMA)

“In the midst of a deadly pandemic, the Biden administration has taken an unprecedented  step that will undermine our global response to the pandemic and compromise safety. This decision will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines.

“This change in longstanding American policy will not save lives. It also flies in the face of President Biden’s stated policy of building up American infrastructure and creating jobs by handing over American innovations to countries looking to undermine our leadership in biomedical discovery. This decision does nothing to address the real challenges to getting more shots in arms, including last-mile distribution and limited availability of raw materials. These are the real challenges we face that this empty promise ignores.

“In the past few days alone, we’ve seen more American vaccine exports, increased production targets from manufacturers, new commitments to COVAX and unprecedented aid for India during its devastating COVID-19 surge. Biopharmaceutical manufacturers are fully committed to providing global access to COVID-19 vaccines, and they are collaborating at a scale that was previously unimaginable, including more than 200 manufacturing and other partnerships to date. The biopharmaceutical industry shares the goal to get as many people vaccinated as quickly as possible, and we hope we can all re-focus on that shared objective.”

David Silverstein, partner in Axinn’s Intellectual Property Practice Group

“Because waiving patent rights requires unanimous approval by all member countries, and in light of strong opposition by Germany and others, it seems unlikely that the WTO will ultimately require waivers of coronavirus vaccine patent rights.

“Even if coronavirus vaccine patent rights are waived, such a move likely won’t have a positive impact on vaccine availability because there are much bigger barriers to manufacture than patents. For example, coronavirus vaccines are far more complex products than small-molecule drugs—especially with respect to how they are made.

“As a result, they aren’t capable of being reverse engineered without the originator’s assistance. This is best illustrated by the fact that, despite Moderna’s pledge over a year ago not to enforce its IP rights during the pandemic, not a single generic version of Moderna’s vaccine is commercially available today.

“Far beyond the controversial waiver of patent rights, full-blown tech transfer of vaccine technology is what is required to increase the manufacturing capacity of these vaccines to meet worldwide demand.  But tech transfer, which necessarily implicates trade-secreted know-how and a host of other information not found in patents, is beyond the scope of what is being discussed at the WTO and is clearly unthinkable as far as vaccine originators are concerned.”

Dr. Axel B. Berger, Patent attorney, Bardehle Pagenberg

“The aim of the Biden-Harris administration to get as many safe and effective vaccines to as many people as fast as possible in the present COVID-19 pandemic, is absolutely understandable and I guess everybody would agree that nothing should stand in the way to achieve this goal.

“The question is whether waiving IP protection for COVID-19 vaccines is actually needed and helpful in this context or whether, to the contrary, the downsides of such a general waiver actually speak against such initiative.

“Specifically, we see enormous difficulties in describing the limits to any COVID-19 vaccine waiver. Be it regarding the subject-matter of the IP rights – i.e. is this only about the actual vaccines, what about the required facilities, vials, syringes, and other materials? –, be it regarding the limitation in time – i.e. when is the pandemic over, what happens to the established technology at third parties when the waiver no longer applies?

“Also, and probably even more important to the general public at this stage, having the right to practice an invention does not mean that a third party has the knowledge and the possibilities to produce or even mass produce any of the vaccines, and in particular the novel mRNA vaccines. Knowhow transfer and support is crucial along the full supply chain, from building the facilities, producing the vaccines, quality control, regulatory aspects (i.e. obtaining and maintaining marketing authorizations), delivering the vaccines to the patients, etc.

“On the other hand, the implications of introducing a general IP rights waiver – IP rights after all being state-granted monopoly rights that their owners can rightfully rely on and which cost a lot in investment – would have far reaching consequences. Many national patent systems, including the one in Germany, provide for compulsory licenses, if there is a public interest that justifies the use of an otherwise protected invention.

“The conditions under which a compulsory license is granted are well-defined and the owner receives a royalty. A general IP right waiver would undermine the industries’ trust in the well-established system of disclosing an invention for a time-limited monopoly – this would be jeopardized, and an effective incentive for industry to invest in innovation would be severely impacted. This may already have consequences for the further development of the present COVID-19 vaccines, but it will certainly have an impact on innovation in general far beyond the present pandemic.

“The much faster and, in our view, much better option is to encourage all patent and IP right holders to enter into collaboration agreements with partners that are interested and willing to support the common fight of the pandemic. If there were still reservations in some companies about working together for the common good, the present discussions about an IP waiver should be a clear message.”

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