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.
IP protection
Why intellectual property rights are a key, not a curse, for COVID-19 vaccines
The whole world is waiting for the distribution of vaccines against COVID-19 and should be distributed to all adults globally over the next 18 months. Calls are getting louder that intellectual property rights (IPR) should be suspended to allow unfettered vaccine manufacture will mean faster access for developing countries. The head of the World Health Organization, Tedros Adhanom Ghebreyesus, gave tacit support this week, warning of a “catastrophic moral failure” caused by unequal access to COVID vaccines. However, IP has played a vital role in every step of vaccine research, manufacturing and distribution. The Pfizer/BioNtech partnership behind the first vaccine to be authorised in the US would not have taken place without strong IP rights.
In a competitive market, no single company will monopolise COVID vaccines or succeed in “profiteering”. A zero IP world would be a backward step and discourage companies from making urgently needed refinements to existing vaccines to combat new COVID-19 variants.
Artificial Intelligence in the Life Sciences Industry — Strategies for IP Protection
AI technologies including machine learning, deep learning, and natural language processing can be harnessed to process vast data sets to identify new drug candidates, optimize drug dosing, match patients with drug trials and diagnose diseases. Recognizing this potential, global biopharma companies have invested heavily in AI technology—the AI in life sciences market was valued at USD 1092.44 million in 2019 and is expected to reach USD 3445.60 million by 2025. But what happens to the IPRs? Can AI be an IPR holder?
This article provides answers to important questions about (future) IP ownership:
- Life science companies utilizing AI can mitigate potential IP ownership issues by defining ownership of AI-related IP rights in employment, licensing, or purchase agreements.
- Aside from general contractual protections of IP, life sciences companies should consider what type of IP protection is appropriate for their AI-related inventions.
- If patent protection is more appropriate (e.g., where the requirement of secrecy for trade secret protection is hard or impossible to meet), the companies should adopt an “AI-Patent Playbook” as follows to obtain patent protection for AI-related inventions.
The strategies described in the article could be adopted to minimize the risks while still harnessing the powerful potential of AI technology.
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.
The rise and fall of the first American patent thicket: The sewing machine war of the 1850s
The patent war of the 1850s may have been a long time ago, but it is still relevant. Adam Mossoff shows how the invention and incredible commercial success of the sewing machine is a powerful display of early American technological, commercial and legal ingenuity that heralds important empirical lessons for understanding and applying patent thievery theory today.
The Sewing Machine War demonstrated all these phenomena, including the effects of patent trolls, and proves that this is an age-old problem in patent law. The untangling of this patent thicket in the sewing machine combination of 1856, led to the first privately established patent pool. This also challenges the conventional wisdom that patent thickets are best resolved by public law rules limiting ownership of patents.
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.
Webinar: Promoting Diversity in U.S. Innovation
When the American patent system becomes more diverse, America’s innovation economy becomes stronger and more successful. Inventors who hold patents consistently earn higher incomes than non-inventors, and businesses with patents—especially small businesses and startups owned by women and people of color—are better able to access capital, attract customers and licensees, and create jobs than businesses without IP. Inventors, academics, industry leaders, advocacy leaders, policymakers, and other stakeholders must work together to close the patent gaps for women, people of color, and low-income individuals to help close wage and wealth gaps, strengthen the U.S. economy, and develop new and different inventions. This webinar discusses how policymakers, educators, and the private sector are working to ensure that everyone has the opportunity to invent and patent.
U.S. patent chief warns against ‘drastic’ actions in light of COVID
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.
Vaccine manufacturing and distribution: WTO perspectives
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.