Trade policy response to COVID-19 examined in Committee report – News from Parliament – UK Parliament

“[The unanimously adopted report from the International Trade Committee] also recommends the Government consider adjusting intellectual property provisions to allow for compulsory licensing of therapeutic drugs or vaccines against COVID-19, as a means of ensuring they can be made available as quickly, widely and cheaply as possible..”

Countries Are Adapting Intellectual Property Laws to Prioritise Health During COVID-19

“Intellectual property (IP) rights can potentially impede mass production of existing health products, as well as innovation and research and development of new products. IP rights can be exercised by their owners to grant or withhold from licensing the technology required for manufacturing or further developing a product. If a license is denied, the technology will not be available for other firms to manufacture or supply.

Usually, a bundle of several IP rights can exist around a particular technology. It is very common patenting strategy in the pharmaceutical industry to take separate patents on the main compound of a drug and a large number of secondary patents on different formulations and combinations, dosage, as well as other possible therapeutic use of a drug. This can make it difficult for follow on innovators to invent around the thicket of IP rights….

Through a resolution of the World Health Assembly on COVID-19, member states of the WHO have recognised the possible need for countries to adopt measures to ensure that IP rights do not constrain global equitable access to health technologies for COVID-19 through the full use of the flexibilities of the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) as well as voluntary pooling of patented technologies, data and know-how….

A number of flexibilities available under the TRIPS Agreement can be applied by governments to ensure that IP rights do not constrain innovation and availability of health technologies required for responding to COVID-19….

It is time for developing countries to review the extent to which such measures can be adopted, or what changes, if any, need to be introduced into their legal regimes so as to be able to act effectively and timely to address the devastating effects of the COVID-19 pandemic….”

Intellectual Property Conservancies

Abstract:  Conservancies, which hold real property in trust for public purposes or administer easements restricting future uses of private property, are a successful means of securing public benefits within the system of private property ownership. They have been widely encouraged by governments, through tax regulations. Most of us are generally familiar with the idea that property owners may deed rights or donate easements limiting future development or exploitation to a non-profit organization, while continuing to live on their land or in their historic property. With the increased attention that businesses and individuals are paying to the value of knowledge assets, it should be no surprise the conservancy metaphor is now being extended to intellectual property (IP).

Intellectual Property Conservancies (IPCs) are being conceived as a means to provide public benefits by making digital content donated, or licensed to them, freely available and by ensuring its long-term preservation. As such, they would offer free public access to intellectual property as a way of ‘leveling the playing field’ for rich and poor individuals, and rich and poor countries. The Knowledge Conservancy (http://www.knowledgeconservancy.org) is a non-profit IPC incorporated in August 2000; here, the author, who was involved in its planning, explores the issues any such organization will face.

IPCs are digital libraries and therefore have all the problems associated with digital libraries. In addition, IPCs face a large number of challenges that most digital libraries do not confront. These include:

Obtaining content donations (persuading IP owners of the benefits of giving, possibly without any tax advantage)
Obtaining financial contributions (persuading philanthropists and the general public of the value of free public access)
Obtaining usable digital assets
Creating metadata to support discovery, rights management and preservation
Providing access to potential readers worldwide
Providing long-term, or even ‘perpetual’, access.

EIFL endorses Open COVID Pledge | EIFL

“EIFL has pledged its support for the Open COVID Pledge that seeks to remove barriers to the use of intellectual property (IP) to help end and mitigate the effects of the COVID-19 pandemic. 

The Pledge was developed by the Open COVID Coalition, an international coalition of legal experts, engineers and scientists who are calling on companies, universities and other organizations to make their patents and copyrights temporarily available free of charge to accelerate the rapid development and deployment of diagnostics, vaccines, therapeutics, medical equipment and software solutions in this urgent public health crisis….”

The NIH claims joint ownership of Moderna’s coronavirus vaccine – Axios

“The National Institutes of Health may own intellectual property that undergirds a leading coronavirus vaccine being developed by Moderna, according to documents obtained by Axios and an analysis from Public Citizen.

Why it matters: Because the federal government has an actual stake in this vaccine, it could try to make the vaccine a free or low-cost public good with wide distribution, if the product turns out to be safe and effective.

The big picture: The NIH mostly funds outside research, but it also often invents basic scientific technologies that are later licensed out and incorporated into drugs that are sold at massive profits. The agency rarely claims ownership stakes or pursues patent rights, but that appears to be different with this coronavirus vaccine….”

Big Pharma Attacks Coronavirus Price Controls

“On April 15, Rep. Jan Schakowsky, D-Ill., along with Reps. Peter DeFazio, D-Ore., Rosa DeLauro, D-Conn., and Lloyd Doggett, D-Texas, laid out basic principles for the development and pricing of coronavirus therapies and vaccines. Their demands were simple: Pharmaceutical companies should have to set reasonable prices for their drugs and vaccines used to treat or prevent Covid-19. They should be required to make the costs of research and manufacturing of these products public. During the pandemic, the legislators said, companies should not be able to profit exclusively from these potentially lifesaving drugs.

“Exclusivity determines who has access, who can manufacture, and how we scale up production to meet the need,” the members of Congress noted in a press release at the time….

Few have spoken out against the protections that were designed to ensure equitable access to lifesaving medicines — at least publicly. But privately, a coalition of conservative groups attacked the proposed patient protections as “dangerous, disruptive, and unacceptable.” In a May 7 letter, representatives of 31 groups, including Hudson Institute, the Council for Citizens Against Government Waste, and Consumer Action for a Strong Economy, called on Congress to reject the drug pricing guidelines and defended patents and the exclusive right to profit from drugs as “America’s great assets.” …

Perhaps most galling to the Democratic lawmakers is the fact that the vast majority (if not all) of the drugs they seek to protect from exorbitant pricing have been developed at least in part with taxpayer dollars. Between 2010 and 2016, every drug approved by the Food and Drug Administration benefited from science funded with federal research through the National Institutes of Health, according to the advocacy group Patients for Affordable Drugs. During that time, taxpayers spent more than $100 billion on that research.

Although American taxpayers are the “angel investors” of pharmaceuticals, as Doggett put it, many cannot afford the treatments they’ve bankrolled….

On Friday, the World Health Organization unveiled a global effort to pool intellectual property, data, and research related to Covid-19. While 36 countries have already announced their support for the project, the U.S. was not among them. Just as WHO was detailing its plan to broadly share the benefits of scientific advancement, President Donald Trump was announcing his plan to withdraw from the global organization.”

New Report – How COVID-19 is Changing Research Culture – Digital Science

“The report key findings include: 

As of 1 June 2020, there have been upwards of 42,700 scholarly articles on COVID-19 published, 3,100 clinical trials, 420 datasets, 270 patents, 750 policy documents, and 150 grants.

Preprints have rapidly established as a mainstream research output and a key part of COVID-19 research efforts. They started at relatively low levels in early January 2020 and accounted for around one quarter of research output by the beginning of May 2020.

To date, more than 8,300 organisations have been involved in supporting COVID-19 research, with over 71,800 individual researchers identified as working on COVID-19 research.

The highest intensity of research into COVID-19 began in China and gradually migrated west mirroring the movement of the virus itself.

While the US and EU have both now published more than China in journals such as The Lancet, New England Journal of Medicine and JAMA, China continues to benefit from an early mover advantage and continues to enjoy the lionshare of the citations. While research in the field is clearly moving quickly, it currently remains anchored to China’s early publications.

A density map of global COVID-19 paper production shows there are three to four major centres of research: an extended area in China composed of several cities—Wuhan, where the virus is alleged to have started, Beijing and Shanghai; Europe, specifically Italy and the UK, two of the harder hit countries; the US’s east coast research corridor including Boston and New York; and finally, a lighter focus from the Californian institutions on the West coast.

The top producing institution of COVID-19 research (since the beginning of 2020) is in China, Huazhong University of Science and Technology, followed by Harvard University and the University of Oxford.

The top healthcare producers of COVID-19 research (since the beginning of 2020) are Zhongnan Hospital of Wuhan University, then Renmin Hospital of Wuhan University, and Massachusetts General Hospital.

While the proportion of internationally co-authored work is steady, the vast majority of research on COVID to date has been unusually authored within countries.

At the time of writing, 156 grants totalling at least 20.8m USD have been awarded to COVID-themed researchers in public institutions.

Much of the clinical trial initiation activity in January and February is sponsored by China and this then begins to fall off in March, April and May. We see a similar wave for Europe and the US, but shifted back by two months, beginning in March….”

Pharma CEOs and IFPMA comment on WHO proposal for COVID 19 technology pool. – YouTube

“At a May 28 press briefing organized by the international Federation of Pharmaceutical Manufacturers & Associations (IFPMA), Pharma CEOs and the IFPMA DG comment on WHO proposal for global pool for rights in technologies for the diagnosis, prevention and treatment of COVID-19. Pascale Soriot, the CEO of AstaZeneca, a company receiving a reported $1.2 billion in funding from the US agency BARDA, claims he was “not aware” of the WHO proposal. Pfizer CEO Albert Bourla is the most negative, calling the proposal, dangerous. At 2:30 on this clip, Thomas Cueni of IFPMA claims that a focus on vaccine patents is misplaced since know-how is the larger issue, and he claims that there has never been a compulsory license on a vaccine patent.

There have been, of course, many disputes over patent rights for vaccines, and know-how, data and even access to cell lines, is actually part of the Costa Rica/WHO proposal for a COVID-19 technology pool, which, Thomas Cueni, a former journalist, certainly understands. The full IFPMA briefing is here: https://www.youtube.com/watch?v=0wMMwDshed0 …”

Pharma CEOs and IFPMA comment on WHO proposal for COVID 19 technology pool. – YouTube

“At a May 28 press briefing organized by the international Federation of Pharmaceutical Manufacturers & Associations (IFPMA), Pharma CEOs and the IFPMA DG comment on WHO proposal for global pool for rights in technologies for the diagnosis, prevention and treatment of COVID-19. Pascale Soriot, the CEO of AstaZeneca, a company receiving a reported $1.2 billion in funding from the US agency BARDA, claims he was “not aware” of the WHO proposal. Pfizer CEO Albert Bourla is the most negative, calling the proposal, dangerous. At 2:30 on this clip, Thomas Cueni of IFPMA claims that a focus on vaccine patents is misplaced since know-how is the larger issue, and he claims that there has never been a compulsory license on a vaccine patent.

There have been, of course, many disputes over patent rights for vaccines, and know-how, data and even access to cell lines, is actually part of the Costa Rica/WHO proposal for a COVID-19 technology pool, which, Thomas Cueni, a former journalist, certainly understands. The full IFPMA briefing is here: https://www.youtube.com/watch?v=0wMMwDshed0 …”

Could a patent get in between you and a Covid-19 test? Yes | Opinion | The Guardian

“Imagine if one company held a patent covering all methods of testing for Covid-19 antibodies. The company could charge monopoly prices for its tests and prohibit competitors – including non-profit and university labs – from manufacturing or administering their own. If the company made itself the country’s sole supplier, it would struggle to meet demand. The company would profit, but Americans would face waiting lists, confusion and inequitable access – and the virus would keep spreading.

Would a patent holder ever exploit an outbreak of life-threatening infectious disease in this way? Yes. In 2001, the United States faced a credible threat of an anthrax outbreak, yet Bayer refused to license its patents on ciprofloxacin (Cipro), the most effective antibiotic treatment for anthrax, to competitors, even as Bayer itself struggled to supply the nation’s antibiotic stockpile.

It may seem outlandish to imagine one patent creating a wide-ranging monopoly on diagnostic testing, but it happened. In the 1990s and 2000s, biotech companies obtained and enforced broad patents on medical diagnostics that gave them near-total control of testing for particular conditions. One company obtained patents on methods of diagnosing people at high risk of developing breast cancer and “attempted to eliminate … testing at competing laboratories by sending cease-and-desist letters”; another became “the sole provider of genetic testing for many neurological and endocrine conditions”, including muscular dystrophy and Alzheimer’s disease….”