June 13, 2021

Volume XI, Number 164

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Waiver Of Intellectual Property Protections For COVID-19 Vaccine Unlikely To Have Meaningful Impact In Short Term

On Wednesday, May 7, 2021, the United States officially endorsed waiving intellectual property protections for COVID-19 vaccines. While the United States has taken the opposite position in recent months, the administration asserts that its departure is guided, at least in part, by the goal “to get as many safe and effective vaccines to as many people as fast as possible.”[1] That goal, however, is unlikely to be affected by such a waiver in the short term due to uncertainty in World Trade Organization (“WTO”) politics, ongoing shortages on raw materials and equipment, and lag-time in retrofitting potential manufacturers.

It’s not clear when, or if, the WTO, currently comprising 164 members, will unanimously approve the waiver from certain provisions of the TRIPS agreement for the prevention, containment, and treatment of COVID-19. While there is indeed overwhelming support for waiver, some countries without facilities appropriately outfitted to manufacture vaccine (e.g., Brazil) are reticent to join the endorsement, sharing concerns that such waiver could interfere with their efforts to buy vaccine, thereby leaving them in the lurch. Whereas some other countries appear to oppose the waiver (e.g., Germany), warning that intellectual property rights must remain protected.

Even if the WTO approves the waiver, however, which could take months, increases in vaccine production capacity are unlikely in the short term. As a primary concern, tech transfers will not alleviate the ongoing shortages on raw materials and equipment used to make the vaccines (e.g., glass vials, bioreactor bags, cell culture media, and filters). Additionally, many manufacturers that could potentially make use of the waiver don’t have the requisite facilities and personnel appropriately equipped to reliably and consistently prepare generic versions of the COVID-19 vaccines, which involve hundreds of process steps, thousands of quality and assurance checks, and require highly skilled expertise. Indeed, and perhaps most tellingly, there are no generic versions of the Moderna vaccine, despite Moderna’s promise not to pursue patent infringement during the pandemic.

In conclusion, because of ongoing shortages of raw materials and equipment, and because manufacturers are not poised to immediately begin making generic vaccines, international waiver of intellectual property protections for COVID-19 vaccines, if passed, is unlikely to have any meaningful effect in the short term.


FOOTNOTES

[1] Press Release, Executive Office Of The President, Statement From Ambassador Katherine Tai On The Covid-19 Trips Waiver (May 5, 2021), https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/may/statement-ambassador-katherine-tai-covid-19-trips-waiver.

Copyright © 2021, Sheppard Mullin Richter & Hampton LLP.National Law Review, Volume XI, Number 130
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About this Author

Lorna L. Tanner, Sheppard Mullin, Life Sciences Lawyer, Intellectual property Litigation Attorney
Partner

Lorna Tanner is a partner in the Intellectual Property Practice Group in the firm’s Silicon Valley and San Francisco offices and also serves as the Co-Team Leader of the firm’s Life Sciences team.

Lorna counsels biopharmaceutical and medical device clients on strategic issues relating to the development and management of their global patent portfolios.  Her practice focuses on preparing and prosecuting patents with a key objective of ensuring that her clients’ business objectives are met.  She performs due diligence analyses on patent portfolios...

650.815.2658
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