The Covid-19 pandemic has set off a veritable explosion of biomedical research, as innovators all around the world rush to answer the urgent calls of health care systems and governments in crisis. As a result, it is more important than ever before for innovators in the biomedical sciences to have a sensible approach to balancing the need to protect their intellectual property rights in key markets while sharing information with other researchers. This article provides a brief review of the basic principles for obtaining patent protection in the key markets of the United Kingdom, Europe and Canada.
What kind of COVID-related technology can be protected by a patent?
The law on what constitutes patentable technology in the biomedical sciences varies substantially between countries. An erroneous belief about what is protectable may lead to loss of protection and revenue in certain countries.
For Covid-related inventions in the UK, Europe and Canada, it is not possible to patent methods of treatment of the human or animal body. Examples of inventions which can be patented in the UK, Europe and Canada include:
- Substances/drugs for use in treating Covid-19, including new uses and effects of known drugs
- Processes for manufacturing substances/drugs for use in treating Covid-19
- Gene sequences with a technical effect, including genes used in making proteins such as antibodies
- Diagnostic devices, including for rapid PCR testing and antibody detection
There are differences regarding patentability of other categories of invention between these jurisdictions based on local jurisprudence. For example, genetic sequences isolated from the human body may not be patentable in the UK or Europe, but appear to be patentable under current practice in Canada. Similarly, in the UK and Europe a diagnostic method performed on a patient sample may be patentable, but if performed on the human body is not patentable; such a method may be patentable in Canada. Of note, the Canadian Patent Office is currently reviewing its practices in view of a recent Federal Court decision which found fault with the Patent Office’s “problem-solution” approach to analysing claims which was used to reject applications directed to diagnostic methods. Inventions directed to dosage regimens, i.e., where the drug X is known for treating condition Y, and the invention lies in the dosage regimen (dosage amount and/or timing) are somewhat difficult to patent in Canada. However, in many cases, an appropriate claim strategy that will provide commercially important protection can be developed. A discussion on commercial packages for dosage regimens can be found here.
We recommend speaking with an IP specialist to determine what aspects of an invention may be patentable in the UK, Europe or Canada.
Why file for patent protection in the UK, Europe and Canada?
Given the worldwide reach of the pandemic, the market for inventions related to diagnosing and treating Covid-19 is global. The UK, EU and Canada are all important commercial markets for Covid-related inventions in terms of the money spent by the respective governments on universal health care and population size. According to one study, Canada in particular has pre-ordered more Covid-19 vaccine per capita than any other country from potential suppliers. The UK, Europe and Canada are important trading partners for the USA and Asia, so they are correspondingly an important part of a global strategy.
In the UK, Europe and Canada, multiple aspects of the invention can be claimed in a single application (e.g., a novel drug, compositions comprising it, methods of making it, and uses thereof) because unity of invention in these jurisdictions is treated similarly. As a result, it is often possible to obtain patent protection for most or all commercial interests in a single patent in each country, a benefit not available in some other jurisdictions.
How can patent strategy be coordinated once patent applications have been filed?
A patentee will usually want to align the patent applications filed in various jurisdictions as part of a global patent strategy. In many cases, very similar claims can be presented in both the UK and Canada, with only minor changes (if any) in accordance with local practice.
The timing of prosecution of patent applications in these jurisdictions can be coordinated. In particular, prosecution of an application can be delayed in one jurisdiction while another application is actively prosecuted in other more commercially important jurisdictions.
One of the ways this may be achieved is by deferring examination. In Canada, the filing of a new application does not automatically trigger examination. The request for examination may be delayed for up to four years from the filing date, which allows the patentee to develop their patent strategy in the other jurisdictions in the meantime, then use that experience to facilitate prosecution in Canada. A more detailed discussion on coordinating prosecution in Canada with global strategy may be found here.
Is it possible to obtain patent protection once an invention has been disclosed?
One of the primary goals of the patent law is to encourage innovators to provide the public with an enabling description of their technology so that others can build on it. However, it is strongly recommended to file a patent application for an invention before sharing the details of the invention with the public, as one of the fundamental requirements for patentability is novelty – that is, the invention must be new in the sense that it is not previously known or available to the public. Thus, public disclosure of an invention prior to filing an application at a patent office can be an absolute bar to patent protection in all but a few jurisdictions.
The marketing and sale of an invention before a patent application is filed may well be found to be such a public disclosure barring patent protection. In addition, published articles disclosing the invention will likely also be a bar to obtaining a patent, but even other kinds of disclosures such as abstracts, presentations, and research proposals can be problematic.
Canada is one the few countries that offers a grace period that permits disclosures by the inventor provided a patent application is filed within 12 months of that disclosure. However, such provisions do not exist at all in the UK and Europe, or most other jurisdictions.
It is recommended to speak with an IP specialist ahead of engaging in any activities that may be considered a public disclosure of an invention. An IP specialist will also be helpful for drafting appropriate non-disclosure and confidentiality agreements in situations where disclosure of the invention to specific third parties is necessary.
When is the best time to file a patent application?
The UK, EU and Canada all operate on first-to-file patent systems. This means that when a Patent Office finds that two applicants have filed similar patent applications such that the claims of the applications overlap, the applicant who has the earliest claim date is entitled to a patent. With the sudden flood of Covid-related research, it is possible that we will soon see patent applications directed to very similar Covid-related inventions that were filed within days of each other. Consequently, it is good practice to file a patent application as early as possible.
However, the importance of early filing a patent application should be carefully balanced with the requirement that the patent application describe the invention in sufficient detail so as to enable a person skilled in the relevant art to practice it, in order to be granted a valid patent. In the case of substances/drugs for treating Covid-19, it may be possible to file a patent application when early laboratory research shows promising results, before extensive clinical results demonstrating the utility of the substance/drug.
It is best to have a discussion with an IP specialist at an early stage of research, as they can assess the invention and advise whether it has developed to a point that is suitable for filing a patent application. IP advisers can also discuss the scope of the invention with you and whether additional experiments may provide a better scope of protection and increase the value of the patent. As an inventor, it is also important to consider an invention in a broad sense, namely how the invention can be applied to different fields and alternative embodiments of the invention, since limiting the invention to use in Covid-19 may be unnecessary. IP specialists can assist in that process.
Why seek patent protection during a pandemic?
Patents provide their owners with a legal right against third parties who use their patented invention without permission. With collaboration and knowledge exchange key to ending the pandemic, Moderna and Gilead have recently joined a growing list of biopharmaceutical companies pledging that they will allow open access to their coronavirus-related patents without threatening lawsuits and will create licencing opportunities when the pandemic is over. Such a move is unprecedented in the bio field and builds on Tesla’s 2014 decision to “open-source” their patents relating to electric cars. Importantly, these companies have not stopped filing patent applications – recognising that patent protection will likely outlive Covid-19 and that having a claim over certain technologies means being able to control the use of the invention in the future. Intellectual property rights are valuable assets and having this control will support businesses, in particular small and medium-sized enterprises, through the financial difficulties that Covid-19 will bring.
However, having a patent may not prevent government use of an invention. Canada has recently implemented measures to make patented inventions accessible to the government without authorisation from the patent owner in the event of a national emergency, with compensation to be decided by the Commissioner of Patents. A similar, but rarely used, provision also exists in the UK and a number of European countries provide for compulsory licensing. In the UK, compensation may be payable to a patent owner when this provision is used. This is an interesting development and shows how IP systems may not be able to resist the change that Covid-19 brings.