The Coronavirus pandemic requires an adjustment of all organizational processes in the field of intellectual property rights and patenting. In this regard, the pandemic had a considerable, however not purely negative impact on patenting in the life science and pharmaceutical industries. Three aspects will be briefly discussed below from my personal professional perspective as a patent attorney working in these technical fields.
1) Changes in the interaction with relevant patent offices during the pandemic
The first reaction of the European Patent Office to the spread of the SARS-CoV-2 virus in the jurisdiction of the European Patent Convention was a temporary suspension of ongoing proceedings and applicable deadlines from March 15, 2020 until June 2, 2020. During and after this suspension, some changes were implemented for an improved handling of the pandemic situation.
For example, fortunately, oral proceedings could now be efficiently conducted by video to avoid travel and real-life contacts in enclosed hearing rooms. However, the European Patent Office further implemented the current practice of making video-conferencing the general standard for oral proceedings. This could entail that even after the pandemic may have subsided, conduct of proceedings will be made mandatory as videoconferencing without consultation and, possibly, even against the explicit will of the parties involved.
This approach is controversial among many patent attorneys acting as European representatives as well as among European and international companies actively filing and prosecuting European patents and patent applications for their inventions. Within the community, there is no agreement that proceedings held in person could be adequately replaced by proceedings via video conference. This conflict has been taken up before the highest judicial instance of the European Patent Office, the Enlarged Board of Appeal, in case G 1/21, “Oral proceedings by videoconference”. Any further developments in this case will undoubtedly be closely monitored.
In my personal experience, especially in negotiations with two or more parties or including participants from other time zones, substantial difficulties may arise in oral proceedings by video conference. It will be the responsibility of the legal authorities as well as us as European patent attorneys to ensure that these difficulties do not lead to disadvantages for the parties involved.
2) Need for faster effective legal protection for applicants and owners of industrial property rights due to the substantially shorter marketing cycle
In contrast to the normal development and marketing cycle of an active pharmaceutical ingredient, the pandemic entails its own (market) rules: There is an extremely high market potential in the short term, which, however, may collapse again just as quickly (< 5 years) once the pandemic has been contained or stopped. According to current expectation, such a short cycle and requirements associated therewith can also be assumed for SARS-CoV-2.
This schedule implies that, on the one hand, marketing approval is sought as quickly as possible through accelerated clinical trials and rapid market entry for the pharmaceutical products. At the same time, equally rapid and effective legal protection for these products should be made available, for example through patents or utility models. One negative example in this context was observed in relation to the 2012 outbreak of Middle East respiratory syndrome (MERS) when effective legal protection through granted patents was not obtained until 2020, when the originally high marketing potential for this disease and therapeutics against it was no longer present.
In the current pandemic situation, which remains a global challenge, it is therefore all the more important to obtain effective legal protection against imitators in all potential markets as promptly as possible. This can be achieved, for example, through quick registration of utility models in different countries, early publication of European and international patent applications, and other means that can be employed in close consultation between the rights holders and a skilled and experienced patent attorney.
It is evident that in view of the gigantic economic potential of successful COVID-19 therapeutics or diagnostics, an optimal IP strategy and early effective legal protection can make the difference between success and failure. The need for legal advice in this segment is thus noticeably high at the moment in my personal experience.
3) Investment focus on products and processes related to SARS-CoV-2
A positive side aspect that could be observed in the past year is the availability of significantly increased funding in the pharmaceutical sector. Apart from the great successes in vaccine development by BioNTech, Moderna, and the like, development and availability of efficient therapeutics remain an unmet need to this day.
Major pharmaceutical companies in particular have devoted a great deal of energy and financial resources to the strategy of repurposing their own drugs. This strategy involves testing their proprietary compounds, which have already been approved and are in their production pipeline, for efficacy against SARS-CoV-2 and COVID-19.
In most patent jurisdictions, such repurposing can be effectively protected as part of a so-called “second medical use”. Prominent examples of repurposing approaches of approved drugs include remdesivir (originally developed by Gilead Sciences for the treatment of Ebola), dexamethasone (previously used for its anti-inflammatory effect in various clinical diseases) and the IL-6 inhibitor tocilizumab (originally developed by Hoffmann-La Roche for the treatment of rheumatoid arthritis).
Overall, however, there has been substantial frustration with regard to results of drug repurposing in the therapy of SARS-CoV-2 infections.
Examples for novel therapeutic approaches developed in Germany:
As appears to be the case all over the world, German researchers and pharmaceutical companies have been industrious developing therapeutics against COVID-19. Among other promising approaches, an antibody drug is currently being tested for neutralization of SARS-CoV-2 in a Phase 1/2a clinical trial by the pharmaceutical company Boehringer Ingelheim in collaboration with researchers from the University of Cologne, the University of Marburg and the German Center for Infection Research (DZIF) led by Professor Florian Klein. The next few months will show whether excellent neutralization of the virus by this drug which had already been observed preclinically can also be reproduced in patients.
As part of my work as European patent attorney representing research institutes, start-ups and innovative biotech companies, I regularly see promising data and developments with novel therapeutic strategies. However, despite the immense funding made available in this field in general, there are great projects struggling to obtain sufficient funding and investment to be able to translate from the scientific invention to a commercial use in patients despite the current investment climate.
One example in this context is a nucleic acid therapeutic agent from the startup company “Berlin Cures” that can exert therapeutic effects against the SARS-CoV-2 virus in various ways, including highly specific binding to different epitopes of the virus, antithrombotic effects as well as efficacy against the increasingly important post-COVID syndrome or “Long COVID”.
Pharmacological tolerability and safety of this aptamer at effective doses has already been confirmed in clinical trials. Nevertheless, despite excellent perspectives for patent protection and marketability of the “second medical use” in the context of SARS-CoV-2, further development and clinical trials are delayed due to hesitations to invest in the further development of this therapeutic approach.
Generally speaking, in the context of the Corona pandemic, a separate article may be warranted to discuss the relevance, purpose and usefulness of the patent system in the field of pharmacological inventions. Forcing invalidation or waiving of intellectual property rights such as patents by compulsory licenses or the like can neither be in the interest of the right holders nor in the interest of the public. Overall, it certainly seems imperative for all stakeholders to act responsibly during the pandemic situation to counteract any erosion of the patent system and maintain confidence therein.
About the author:
Dr. Christoph Klöckner practices as a German and European patent attorney in Munich at the patent law firm Isenbruck Bösl Hörschler PartG mbB and advises and represents numerous research institutes, start-ups and investors in the field of pharmaceuticals and life sciences.
This article was originally published in German as part of issue 1/2021 of Plattform LifeSciences