biotech

A top U.S. official on Tuesday dismissed calls for countries to waive intellectual property protections on vaccines and other products to fight the coronavirus pandemic.

“Before any drastic measures are taken with respect to IP rights, evidence must be brought to bear that such measures are actually needed,” Andrei Iancu, director of the U.S. Patent and Trademark Office, said during a discussion hosted by the U.S. Chamber of Commerce. “This has not happened.”

“To the contrary, the evidence to date shows that there is an unprecedented level of cooperation in industry, and that IP has facilitated this worldwide cooperation,” Iancu added.

Read full story [has subscriber paywall].

As of November 2020, at least 44 manufacturing and production deals for COVID-19 therapeutics around the globe were made public. A number of these deals were intended to expand access to therapeutics to low and middle-income countries. In relation to all of them, licensing, enabled by a well well-functioning intellectual property system, has been a key enabler.

• Eli Lilly and Company and the Bill & Melinda Gates Foundation, as part of the COVID-19 Therapeutics Accelerator, have entered into an agreement to facilitate access to future Lilly therapeutic antibodies under development for the prevention and treatment of COVID-19, to benefit low- and middle-income countries. Lilly’s collaborators have agreed to waive their royalties on the Lilly therapeutic antibodies distributed in low- and middle-income countries as part of this initiative.
• Gilead has entered into voluntary licensing agreements with nine generics manufacturers to further expand supply of remdesivir to 127 countries that represent nearly all low-income and lower-middle income countries. Gilead has completed technology transfers with these companies, and they are beginning the manufacturing process.
• Merck, IAVI, and Serum Institute of India are collaborating to develop a neutralizing monoclonal antibody treatment for COVID-19. If successful, Merck will lead commercialization in developed countries and the Serum Institute will lead global manufacturing as well as commercialization in low- and middle-low-income countries, including India.

The need for the rapid development and global distribution of a vaccine to prevent COVID-19 infection has spurred a number of novel collaborations between the pharmaceutical companies, research entities, and other stakeholders. These collaborations aim to ensure broad access to new health technologies to address the pandemic.

• One example is the University of Oxford Jenner Institute vaccine candidate, developed with AstraZeneca, that included collaborations with Catalent Biologics (Italy), Symbiosis Pharmaceutical Services (UK), Oxford Biomedica (UK), Emergent BioSolutions, BioKangtai (China), and R-Pharm (Russia). Through the WHO’s Access to COVID-19 Tools Accelerator, AstraZeneca signed an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi, the Vaccine Alliance, on vaccine development, manufacturing, and procurement, ensuring 300 million doses of the vaccine for low- and middle-income countries. Separately, AstraZeneca also signed a license agreement with the Serum Institute of India (SII) to supply 1 billion doses of vaccine to low- and middle-income countries.
• Another example involves Sanofi and GSK, which signed a Statement of Intent with Gavi, to make available 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine, if approved by regulatory authorities.
• A third example focuses on Johnson & Johnson.  The company has committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use and anticipates the first batches of a COVID-19 vaccine to be available for emergency use authorization in early 2021.

This article examines the context in which the Oxford COVID vaccine was developed – such as the slow response to the Ebola outbreak – and new technological breakthroughs at Oxford’s Jenner Institute that enabled researchers to cut 10 years of vaccine work down to 10 months.

This article explores the mixed reactions to a new art exhibit commenting on lab-grown meat. The installation of steak grown from human cells at the Design Museum in London was intended to criticize the meat industry’s rising use of living cells from animals. It ended up triggering a roiling debate about bioethics and the pitfalls of artistic critique.

Singapore’s Food Agency has approved for sale a lab-grown meat product, a global first. Read more.

In this article, Professor Erika Leitzen argues that critics of so-called “evergreening” of healthcare patents have an ulterior motive: to deny drug innovators the right to enjoy the exclusivity, and the resulting pricing advantages, their patents afford them. She says understanding this requires unpacking the regulatory landscape and market more carefully, and paying closer attention to word choice.

Around the world, multiple vaccines against COVID-19 are on track for regulatory approval. Arriving at safe, efficacious vaccines of consistent quality will be a major scientific achievement. No less a feat will be manufacturing and delivering COVID-19 vaccines globally – a challenge of unparalleled scale, reach, and complexity. This checklist from the WTO breaks down the regulatory, IP-related, and trade-related concerns that must be considered at each step, from development to distribution. This accompanying infographic illustrates these steps visually.