“Inventing” in COVID-19 Environment and Key Local/ International Developments
The COVID-19 pandemic has driven mankind to question sufficiency and sustainability of business models, social and moral norms, and Law-practices, which cannot be separated from society and its needs. Due to the ongoing pandemic basic need of survival and the need to access the means such as ventilation machines, masks, goggles and most importantly pharmaceuticals, is at its climax, as well as the need for an invention is at its most.
Everyone agrees that an invention will save us from this disaster. Indeed, there have been numerous patent applications filed before Turkish Patent and Trademark Office and European Patent Office, to protect inventions related to COVID-19, so far. Likewise, patent applications or already granted patents for ventilation machines and their parts, diagnostic kits and pharmaceuticals also gained great importance during this period. According to the World Economic Forum currently there are more than 70 vaccine candidates in development around the world.
Having said that the measures taken by many governments do not seem encouraging inventing acts. However the first action taken by most governments was to introduce compulsory licensing provisions or to strength the existing ones.
Israel, was the first Country granted a compulsory license during the COVID-19 pandemic for the importation of generic version of Abbvie’s patent protected Kaletra product including lopinavir/ritonavir active ingredients from India, where the patent protection is terminated. With this decision Israel implemented the Article 104 of its Patent Act, which does not confers with patentee before issuing such license and also does not confer a right to appeal the decision of the government.
Germany, strengthened its compulsory license provisions by enacting a new legislation on March 28, 2020 titled “Act to Prevent and Control Infectious Diseases in Humans” with which Federal Ministry of Health is authorized to issue an administrative order for use of a patent as per section 13(1) of the German Patent Act, which was at the authority of the federal government. In addition to that, the requirements of such administrative order has also be simplified.
Canada, on the other hand, enacted “Bill C-13, the COVID-19 Emergency Response Act” on March 25, 2020 changed the Canadian compulsory licensing scheme and regulated an easier route to compulsory license. The Part 12 of the Act amends the Patent Act to provide that the Commissioner must, on the application of the Minister of Health, authorize the Government of Canada and any person specified in the application to make, construct, use and sell a patented invention to the extent necessary to respond to a public health emergency that is a matter of national concern. However, the new legislation which requires the federal government to provide notice and pay royalties to the patent owner, does not require the government to engage in any notification with the patent owner.
France enacted an act numbered 2020-290 on March 23, 2020. With this act an amendment is introduced to Public Health Code Article L.3131-15 which gives French Prime Minister broad powers including a swift compulsory license route and the power for requisition of goods and services necessary for the fight against the sanitary disaster as well as any person necessary for the operation of these services or the use of these goods.
Different from others, UK has not introduced a new law to amend or to strengthen the existing compulsory licensing laws but pointed out “Crown Use Defense” can be used in case of infringement of IP rights due to products such as masks and ventilators, which the local firms were requested to produce in large quantities for use in combating the COVID-19 pandemic. Additionally it was announced that the UK firms manufacturing ventilators for use in combating the COVID-19 pandemic will be protected by the government from the financial impact of potential legal claims arising over intellectual property infringements.
The USA already had legal regulations to work compulsory licensing mechanisms. Particularly the famous Bayh-Dole Act enables compulsory license for the use of a patented technology that was developed with the help of federal funding for health and safety reasons. Given the role of the federal government in funding several candidate COVID-19 medicines, it can be said that the legal ground for issuance of a compulsory license for the medicines is ready.
Turkey is one of the countries that did not take additional cautions like amending or strengthening compulsory license provisions, yet directed the COVID-19 situation so far so good. However, the current results concerning pandemic shows that Turkey has been one of the best-performing countries in terms of mortality rates and burden on health care system. On the other hand it should be noted that existing compulsory licensing provisions of Turkey is broad and strong enough to suspend or overcome any patent rights in case of “public interest” emergency situation. Article 132 of the IP Code governs that the President of Turkey can decide on compulsory license upon proposal from the relevant ministry in cases where the commencement of patent use, or the extension or generalization of its current use are in the interest of public health or national security. The compulsory licensing due to “public interest” reasons is free from negotiations with patent holder or any pre-procedure before Courts or Turkish Competition Authority.
While governments are mostly counting on compulsory licensing, innovator companies found the solution in participation to the Covid-19 Therapeutics Accelerator and the Innovative Medicines Initiative Covid-19 partnership. Besides most of the innovator companies generously gave up on related IP rights, publicly shared product specifications, made patents available on a royalty-free basis for covid-19 tests or pledged not to assert patents against activities to stop the spread of covid-19. Only a few of innovators tried to take measures to protect monopoly over their IP rights; however
The question is whether creating a strategy depending on “compulsory license” really appropriate when we need the motivation and encouragement to make an invention most? Especially thinking that any invention requires huge investment which cannot be compensated without IP and the COVID-19 will most probably not be the last pandemic and we will need inventive acts soon again.
More inspiring and sustainable ideas other than compulsory licensing measure also sparked during these times. For example on March 31, 2020, United Nations-backed Medicines Patent Pool (“MPP”) which normally aims to improve access to HIV, Hepatitis C and tuberculosis, temporarily expanded its mandate to include any health technology that could contribute to the global response to COVID-19 and where licensing could facilitate innovation and access.
Medicines Patent Pool system seems to offer a more equitable and foreseeable solution, where a voluntary license is taken from the patentee and the product is manufactured by the generic pharmaceutical companies.
Indeed, on May 19, 2020 Seventy-Third World Health Assembly adapted a Resolution that calls international organizations and stake holders to work collaboratively at all levels to develop, test, and scale-up production of safe, effective, quality, affordable diagnostics, therapeutics, medicines and vaccines for the COVID-19 response, including, existing mechanisms for voluntary pooling and licensing of patents in order to facilitate timely, equitable and affordable access to them, consistent with the provisions of relevant international treaties, including the provisions of the TRIPS Agreement and the flexibilities within the Doha Declaration on the TRIPS Agreement and Public Health.
Considering the highlight to “existing mechanisms for voluntary pooling and licensing of patents”, MPP has published a declaration on May 20, 2020, stating that, as the only existing patent pooling mechanism in the public health field, MPP looks forward to playing that role. MPP also highlighted that Licensing under public health-oriented terms and patent pooling, which are at the heart of MPP’s work, are proven mechanisms for making patented health technologies rapidly available at affordable prices for all those in need.
Compulsory Licensing seems to be the first thing to come to mind when the need for an invention arises. However, this instrument should be handled carefully and it should not be ignored that patent protection is the main incentive of the innovator companies that will hopefully result in an invention. Implementing the compulsory license tool as if a sword of Damocles hanging upon the innovator companies, will have a negative effect on the realization of the invention that is desperately awaited.
A system like the Medicines Patent Pool system, which does not force pharmaceutical companies to compulsory licenses, yet provides an environment where the system will negotiate for public-health driven licenses with the patentees and sublicense those drugs to pharmaceutical companies, seems like the most sustainable offer, protecting all parties’ interests.