In the current COVID-19 situation, many researchers and pharmaceutical companies are rushing to find both treatment and vaccines. The pandemic is still continuing and the financial uncertainty related to Covid-19 will undoubtedly impact the business's choices and prioritizes. Intellectual Property may be an estimated low priority at this moment where businesses will face many other challenges, but there must be a balance between IP rights and public access and interest.
The coronavirus pandemic may accelerate new thinking about patent issues and IP balance. Many owners of relevant patents face the risk of criticism for asserting their patent in this situation. Is there any company that wants to be known as stopping the cure for the coronavirus pandemic?
There are a few pieces of evidence that show a patent holder could refuse to license its patents; For instance, in 2001, the United States faced a likely threat of an anthrax outbreak, and Bayer as a patent holder 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.
During this pandemic, there is a public objection over patents related to COVID-19, and such reaction will likely grow in intensity if an effective treatment is seen as being hindered by patents.
Recently, some companies came under public scrutiny after their coronavirus-related actions. One of them was a disgraced medical testing company, Theranos, that sparked an outcry with its acquired patent after it sued a company developing COVID-19 tests. The public pressure resulted in this company pledge to offer royalty-free licenses for pandemic-related uses.
Later, Gilead Sciences abandoned its bid for "orphan drug" status for an experimental COVID-19 treatment, which could have provided it with seven years of exclusivity on sales and tax credits, after critics accused it of trying to profit off the pandemic.
Another example is Pharmaceutical company Roche, that initially refused to release in the Netherlands the recipe for a solution, a lysis buffer, which is needed for the Covid-19 diagnosis tests. This measure of the company could have hampered laboratories to quickly produce their own solution, ramping up their testing capabilities.
The above-mentioned actions taken against pharmaceutical companies have raised concerns for companies who having IP for developing equipment or treatments, about what the public perception would be if they enforce it to limit potential liability.
With the COVID-19 response, the world wants products to come out as quickly as possible, and some propose it's probably better IP rights take a backseat to the manufacture and distribution of essential equipment (ventilators, masks, valves, and…) for helping out society.
Although most companies think differently right now than before the pandemic and there would definitely be hesitancy around pursuing an infringement case these days. With this regard, in contrast to the above-mentioned companies which hamper public access to medical devices or medicine using their IP rights, some pharmaceutical companies, such as AbbVie, waived their patent rights, thus removing the barrier for a new therapeutic, combined use of two known and commercially available antivirals, lopinavir and ritonavir (marketed under the trade name Kaletra), which thus may be manufactured everywhere by qualified producers.
A medical device company, Medtronic, similarly, shared its design specifications for rapid manufacturing, even for companies with limited or no prior experience, of a simplified ventilator model (PB 560). It’s worth noting that Medtronic isn’t open-sourcing the PB 560’s design exactly: it’s merely issuing a special “permissive license” specifically for the purposes of addressing this global coronavirus pandemic.
However, while patent holders might be reluctant to pursue infringement suits during the pandemic, it doesn't mean companies ignore patents?
Is Pandemic Resulted in Undermining IP?
IP rights are considered an incentive for innovation in the long run in a normal circumstance.
New pharmaceutical products are time-consuming and expensive to develop, and large pharmaceutical companies such as Pfizer, MSD, GSK, Sanofi, and Johnson & Johnson, typically rely on their IP rights, to compensate for the significant investment (billions of dollars) associated with developing new product development. But in the middle of the COVID-19 pandemic, the traditional procedure, has faced some changes.
The pandemic has created uncertainty around pharma companies’ activities that have taken risks on huge investments to repurpose medicines for Covid-19 treatment and scale-up manufacturing. Patents, and IP more generally, are the main reason that proves there is such a strong innovation base to work from to find solutions.
Today there are more than 1,000 clinical trials ongoing, over 150 treatments being tested, and more than 120 vaccine projects. There is no guarantee of success as few treatments and even fewer vaccines may prove to be safe and effective. This level of risk-taking would be impossible without a high-performing innovation ecosystem built on strong IP incentives.
Although according to Francis Gurry, director-general of the World Intellectual Property Organization (WIPO), there is not any evidence that shows IP is a barrier to access to vital medical preventive measures, such as vaccines, or to treatments or cures, but it should be noted that for pharma industry as a high-level risk-taking industry, a flourishing innovation space must be built based on strong IP incentives and in balance with public access.
Protecting IP: Providing a Balance
Before potential treatments could yield results in trials, relevant stakeholders quickly made their respective and expected positions relating to the balance between IP rights and public access. Pharmaceutical companies will be reluctant to take the brunt of those uncertainties on their own, but the adoption of alternative approaches to funding, and collaborative research across the private and public sector, and academia, allow the risks associated with those complexities to be shared more effectively.
Some alternative approached proposed or accomplished for balancing IP rights and public access in current condition are as follow:
- Sharing Data and IP Open Sources
In the pandemic situation, some companies and researchers are looking for partners to help drive innovation at an accelerated pace. Such collaboration among players of various stages of the development of innovation can be accomplished by transactional licensing or other forms of open-source collaborations.
Many life sciences innovators changed their normal business models to match the COVID-19 pandemic conditions; they are sharing data and granting royalty-free licenses to their protected innovations. For example, Gilead despite what you read in the above paragraphs about its IP enforcement has recently entered into non-exclusive agreements with five generic companies to increase supplies of remdesivir for distribution in 127 lower-income countries.
- COVID-19 IP Pool
World Health Organization (WHO) has launched recently a platform intended to pool IP rights, data, and know-how relating to COVID-19 healthcare products. The platform was first suggested on 23rd March by the government of Costa Rica to the WHO proposing a voluntary mechanism for the sharing of patent, regulatory data, and other useful information relating to technologies that would be useful in the fight against the effects of the novel coronavirus. The intention of this proposal was to ensure affordable access for people around the world, including low- and middle-income countries.
In early April, Tedrios Adhanom Ghebreyesus, WHO director-general supported the idea, and the platform launched on May 29th. The COVID-19 patent pool will apparently be built off of the Medicines Patent Pool(MPP), a pool funded by Unitaid, that pools patents for a variety of treatments and then license the patents to generics.
However, it seems industry support for the new COVID-19 pool is not likely to happen as predicted at this stage. In spite of the initial acceptance of this proposal, the International Federation of Pharmaceutical Companies and Associations, (IFPMA)’s director-general recently declared that the existing MPP is sufficient and the creation of yet another ‘patent pool’ would be a waste of time and resources.
Moreover, the virtual World Health Assembly (WHA), with regards to the IP pool, adopted a landmark resolution which its a few paragraphs pushed the United States to release an Explanation of Position dissociating itself from a number of the IP POOL provisions. The US objected to paragraphs 4, 8.2, and 9.8, and claim the language there does not adequately capture the carefully negotiated, and balanced, language according to the TRIPS and the Doha Declaration of 2001. US implies that those sections in the WHA resolution purportedly present an “unbalanced and incomplete picture of that language at a time where all actors need to come together to produce vaccines and other critical health products.”
A concern stated by the pharma industry relating to the Covid_19 IP POOL is the inability of companies to control which organizations they license their rights to is. IP plays an important role in this regard by limiting partners to those who are going to create quality products.
- Purchasing Related Patents by Governments or International Organization
One another option was given by the Prime Minister of Greece, Kyriakos Mitsotakis, who proposed recently that the EU should buy patents for innovative COVID-19 tests and medicines in order to ensure that they can be supplied quickly in all member states.
This proposal was welcomed by some scholars, who believe If European governments could reward vaccine manufacturers by buying their patents at reasonable costs, thereby achieving a balance between maintaining incentives for innovation and providing fair access to treatments at an affordable price. However, due to the general economic shock, the COVID-19 pandemic has caused for many governments, this option has become an even more pressing issue because of the and the huge spending commitments that have been made to mitigate the damage.
The epidemic is still ongoing and the financial uncertainty related to Covid-19 will undoubtedly impact business choices, bringing to prioritization of the economical and legal choices. Among many challenges, IP may an estimated low priority in a moment where businesses will face many other challenges, but IP portfolios need attention to not be undermined as IP protection is a key incentive to innovation.
The great amount of know-how shared provided during the pandemic able to keep the necessary resources for inventors and innovators looking at what they can build today, revealing how times of emergency can produce new and innovative ideas.
Moreover, companies with an acknowledged reputation in IP rights and patent filing should continue to innovate for fostering continuous and total innovation policies, defending the reliable tradition of their products from new competitors, protecting their inventions.
With regard to the IP pools launched so far, the challenging terms can be negotiated to encourage disclosure, to bring together parties that have different expertise required to get medicine or vaccine through clinical trials and out to patients as quickly as possible, while still providing incentives and reasonable.
 The Doha Declaration encouraged countries to let TRIPS get in the way of protecting public health.