Licensing

Policy discussions and actions related to the COVID-19 pandemic

Below we’ve provided a round-up of recent developments related to the COVID-19 pandemic. Policymakers are working to identify and execute the best policies for pandemic preparedness and healthcare delivery, against a difficult backdrop. Innovators and other actors must step forward to provide their insights and experiences on the ground, whether in relation to IP, trade, regulatory or other types of policies.

African Union backs call to waive IP rights on COVID-19 drugs

The African Union is backing calls for drugmakers to waive some intellectual property rights on COVID-19 medicines and vaccines to speed up their rollout to poor countries.

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Senator calls on Biden to reject COVID IP waiver

Thom Tillis, ranking member of the senate IP subcommittee, has urged US president Joe Biden to oppose ‘harmful’ proposals to waive rights related to COVID-19 vaccines currently in discussions at the World Trade Organisation (WTO).

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U.S. Chamber opposes WTO waiver of vaccine intellectual property rights

The U.S. Chamber of Commerce said it opposed calls for the World Trade Organization to back a temporary waiver of intellectual property rights to speed coronavirus vaccine production in poor countries, calling them “misguided”.

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U.S. Extends Tariff Exclusion on China Virus Supplies 6 Months

The U.S. is extending exclusions on tariffs for face masks, cleaning supplies and other personal protective equipment from China for six months, providing protection against higher costs as the nation fights the Covid-19 pandemic.

The move affects 99 different products, according to a draft of the notice by the U.S. Trade Representative seen by Bloomberg News. The exclusions, extended in December, will now run through the end of September 2021.

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UNCTAD Paper Examines Linkages Between Non-Tariff Measures and SDGs

According to this paper, of all the NTMs adopted in response to the pandemic, almost 60 per cent were put in place to ensure adequate and affordable domestic supplies of medical goods and other essential items to combat the virus.

To minimize potential adverse impacts on trade and sustainability, the paper recommends policymakers first consider whether an NTM is needed or whether there are alternatives, then design high-quality NTMs where they are needed and implement them strategically with full transparency to inform other countries and the private sector of the measure.

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EU-UK Trade and Cooperation Agreement: Implications for Life Sciences Companies

The widely anticipated EU-UK Trade and Cooperation Agreement (the Agreement) came into effect on 1 January 2021 after several difficult months of negotiations. The Agreement aims to ease trade barriers resulting from the UK leaving the EU and includes positive developments for life sciences companies. However, according to this article, the Agreement does not address all of the concerns raised by the life sciences industry, and significant gaps and areas for further discussion remain between the EU and the UK as the Agreement is implemented. This Client Alert from 03 March 2021 sets out key aspects of the Agreement for life sciences companies.

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Swiss Financiers: IP Securities Corporation Receives NASDAQ Ticker, Announces Intent To List Via IPO

Intellectual Property Securities Corporation (IPSE) just received its NASDAQ ticker and announces their intent to list through a traditional IPO in 2021, according to Swiss Financiers. IPSE, a novel kind of security called an Intellectual Property Security, allows Intellectual Property owners to sell current and future authoring and neighbouring royalties on the stock market.

With this listing, IPSE will be able to start offering its Intellectual Property Securitisation solutions to issuers. IPSE intends to create a new market segment in full partnership with the NASDAQ, that will be solely dedicated to the listing and trading of IPS instruments.

The target valuation of IPSE will be above the $1 billion mark reflecting the high-quality of the innovative solution and the size of the total addressable market.

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Why intellectual property rights matter for COVID-19

Ending the COVID-19 pandemic requires innovation. IP is part of the solution and drives competition. IP licensing allows the innovator to control which partners manufacture the product, ensuring high quality supplies, and to maximise low-cost access for low and middle-income countries. Philip Stevens and Mark Schultz show that the reality is different from what calls for the suspension of IPRs suggest in order to keep prices low and address supply shortages. A highly competitive market in COVID-19 vaccines is unfolding right now. There is no evidence that abolishing IPRs will achieve anything more than the licensing agreements currently in place between innovators and big-name vaccine manufacturers in countries like India and Brazil; and the emergence of procurement mechanisms like COVAX. The authors demonstrate how the IP system has put us in a position to end the pandemic and why we should allow it to continue doing its job.

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A review of SDO IPR Policies: Do they require component level licensing?

This paper by Richard Vary (Bird & Bird) sets out a detailed analysis of the intellectual property rights policies (IPR policies) of standard development organizations (SDOs) in the mobile technology sector. SDOs’ IPR policies enable innovators to contribute their best technologies to standardization processes, in the knowledge they will achieve a fair return on their R&D investments through licensing at the end product level.

The result is a virtuous cycle of innovation whereby earnings from licensing standardized technology are re-invested in R&D, contributing to evolution of the technology. He shows that none of the IPR policies requires the IPR holder to offer licenses of its essential IPR to component makers.

All of the policies would appear to permit holders of essential IPR to adopt a policy of licensing to the end-user product manufacturer. Many of the policies contain wording that could only be relevant or applicable when licensing to parties who buy in components from component makers, such as end-user product manufacturers.

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ISO standards diluted by WiFi negative LOAs

This article discusses a partnership between IEEE and ISO to fast-track some IEEE standards through ISO. Certain IEEE standards relating to Wi-Fi technologies are getting fast-tracked even though they have not gotten positive Letters of Assurance, despite this being a necessary prerequisite for ISO approval.

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Webinar: Ensuring leadership on 5G

Looking ahead to 2021 and beyond, this webinar explores the future of technological leadership, with a focus on 5G and other emerging technologies. Panelists discuss the roles that business and government will play in building the next generation of technologies.

Topics include:

  • What is 5G?
  • 5g use cases: examples from the U.S. and Germany
  • Challenges to using 5G
  • How we can engender innovation related to 5G
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Recent Trends in the WHO’s Essential Medicines List

While the number of patented medicines on the EML has increased in recent editions, the portion of the list currently under patent remains a small portion of all drugs on the EML, currently about 10%. A deeper dive into the data shows that many drugs are only patented in a fraction of lower income countries. Thus, 80% of lower income countries have 50 or fewer active patent filings on that ten percent. Moreover, many of these patented drugs are subject to institutionalized programs to provide access at lower cost. This paper provides an update to previous efforts to understand the nature of the EML, while expanding previous information thanks in part to the existence of new freely accessible online databases showing patent status and participation in programs to provide access.

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Collaboration to enhance availability of COVID-19 therapeutics

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.
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Collaborations to accelerate COVID-19 vaccine development and distribution

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 BioSolutionsBioKangtai (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.
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