The ongoing patent battle between COVID-19 vaccine giants, Pfizer-BioNTech and Moderna, has seen a new development when the European Patent Office (EPO) invalidated one of Moderna’s patents related to “respiratory virus vaccines.” BioNTech, in collaboration with Pfizer and Sanofi, opposed the patent, leading to its invalidation. The European patent process is complex but essential. As competition around biotech innovation continues to increase in Europe, how can you ensure the validity of your patent will be maintained?
How important are patents in the biotech industry?
Patents are guardians of groundbreaking research and development (R&D). Biotech firms rely heavily on patents for several reasons.
Firstly, these patents safeguard the immense investment poured into research, as biotech companies dedicate a significant portion of their revenues toward R&D. The R&D budgets of major actors such as Roche, Merck or Novartis represent more than 20% of their total investments. Without patent protection, the risk of competitors replicating these innovations at a fraction of the cost looms.
Secondly, patents facilitate collaboration and investment, particularly for smaller biotech entities. Licensing patented innovations to larger firms secures funding and resources for these innovators, creating a pathway for their breakthroughs to reach the market.
By disclosing intricate details about technologies, they not only safeguard inventions but also inspire new ideas and further advancements. This cycle of innovation drives the biotech industry forward, benefiting society as a whole.
Navigating patent systems in Europe
The EPO is the official patent institution in Europe. It centralizes the European patent application process for the 39 member states. This saves the cost and the trouble of filing individual national patents for innovators. However, these patents must be maintained individually, which entails significant costs, especially for smaller entities.
In June 2023, the EPO deployed the unitary patent. This legal measure has been adopted by 17 states so far through ratification of the agreement in a Unified Patent Court. This is open to every European Union member state so, in the coming years, the Unitary Patent could be applicable in 25 states. However, this is uncertain. After the European patent is granted, the applicant can simply request unitary effect, and the patent will benefit from equal protection in the 17 states.
A patent gives you a negative right, as it prevents actions from competitors rather than granting you any specific positive rights. The choice of the patent you apply for, be it a European patent, an American patent, or any other, depends on a variety of factors, including the market you want to position yourself in. A patent generally grants intellectual property protection for 20 years from the filing date.
Starting from the date of the initial filing application, the applicant will benefit from a one-year window to file for the same patent application in other jurisdictions. Courtesy of a notion called ‘priority,’ the applications filed in other jurisdictions will be afforded the same effective date as the first application. This priority is provided by the Patent Cooperation Treaty and applies to the 157 states where the treaty is in force.
How can you ensure patent validity for your biotech innovation in Europe?
To answer our questions about patent validity in Europe in the field of biotech, we reached out to the EPO, who told us the most important advice they could give to a potential applicant was to contact a European patent attorney.
That’s what we did!
Here’s what Harry Bedford, U.K. and European Patent attorney at Caldwell told us: “Patents can be a very useful tool for a technology company, in the traditional sense of protecting innovation, but also as assets in themselves, generating value for the company. At a high level, a patent carves out a piece of the market for the applicant, and value comes from the ability to control or influence access to that piece of the market.”
Investors recognise this. A joint study between the EPO and the European Union Intellectual Property Office (EUIPO) found that “European startups applying for patents and trademarks during their initial seed or early growth stages are up to 10.2 times more likely to secure funding from investors.”
While the intellectual property (IP) knowledge varies from one applicant to another, Harry Bedford said it was useful to put together an IP strategy as early as possible, especially for smaller companies and start-ups that might not have the same resources as more established entities. Registered IP provides start-ups with the means to come to the table with investors and bigger players in the industry, to discuss funding, licensing, joint ventures, and mergers and acquisitions (M&A) opportunities.
However, Harry noted that “there is no guarantee you can avoid an invalid patent at any level because you can never be certain what has already been published or otherwise disclosed by third parties that relate to your invention, but there are ways of reducing the risks.”
The patent application process can be costly and time-consuming. The EPO gives an average estimate of 6,325 euros to take the patent application through the grant stage. However, costs and time vary from one case to another.
Biotech patent validity in Europe: the importance of R&D confidentiality
The first setback a company can get from not taking IP into consideration is disclosing their potential patentable innovation themselves. One of the first criteria for an invention to be patentable in Europe is that it hasn’t been publicly disclosed. In this way, marketing a product or showcasing it for investment-seeking purposes can prevent you from obtaining a patent. Thus, It is important to keep R&D confidential where possible, and to avoid discussing your technology in detail at least until a patent application is on file.
Harry Bedford explains that “keeping your innovations confidential before filing a patent application is important.”
“One of the most common things I see, particularly amongst start-ups, is an over-eagerness to tell others of the intricate workings of their technology. Of course, it is important to bring the technology to market and generate interest, but a lot of would-be applicants do not know that to patent their tech, their tech must be ‘new,’ meaning it hasn’t been disclosed in the public domain before.”
Sometimes, several potential patents can be extracted from a company’s R&D. Patent professionals can help identify these different options and suggest the most protective IP strategy.
An invention should be new and inventive
This refers to two key criteria for an invention to qualify for a patent and to maintain validity in Europe: the biotech innovation must be ‘novel’ and ‘inventive.’
The criterion of novelty means the invention must not be disclosed in ‘prior art’ (anything disclosed publicly before the filing of the application). Novelty generally takes into consideration an isolated disclosure, meaning a document such as an academic paper or marketing material. A document such as this, which discloses the entire invention which the patent has been filed for would invalidate the patent.
The second criterion, the inventive step, requires that the invention is not obvious in consideration of the prior art. This is slightly different from novelty, as a combination of documents can invalidate the patent if the conjecture of knowledge leads to rendering the innovation obvious.
“One way applicants can try to mitigate the risk of running into problems regarding novelty and inventive step is to perform some searching for prior art prior to filing patent applications.”
It is useful to identify documentation and publications in the field of the innovation before deciding to start the European patent process, as this can inform prospective applicants not only of potential prior art, but also of other players in the industry. This can help inform the prospective applicant’s wider IP strategy.
This research can be done by intellectual property experts and specialist searching firms but can be anticipated by the applicant. The patent process can be expensive and time-consuming, but applying due diligence in researching prior disclosures that could invalidate the patent before filing, can streamline the process and reduce the potential for surprises later down the line.
Identifying the right keywords to do the prior art research is decisive. The most obvious keywords can be of no help if they provide too many results since publications potentially invalidating your patent might be hidden in plain sight.
A patent application should describe your invention in detail
Finding the right timing to file a patent application can be tricky. For well-established companies finding the budget for IP might not be an issue but it is not as easy for smaller entities. However, bypassing the patent process might prevent a company from moving forward as it should.
The moment you have a fully developed product or solution that you believe is eligible for a patent is the right time to engage in the process. This responds to the criteria of “sufficiency of disclosure.” This criterion is completed when the invention is described in enough detail that a skilled person in the industry could put it into application.
This is the bigger picture of the utility of patents. In exchange for giving access to the industry’s community and the full disclosure of your findings, patent holders are granted a twenty-year term of protection. This allows R&D to progress and fosters collaborations, instead of promoting absolute confidentiality of each company’s progress.
Applying too early in the development cycle of new technology can jeopardize the application’s chances of patent approval. The more detail you provide in the description of your application, the larger the pool of information and features you have at your disposal to prosecute the patent application at the respective patent office.
Harry Bedford said: “Choosing when to file and what to include in your first few patent applications can be a balancing act of sorts. However, generally speaking, making sure you have proof of concept, and can discuss the technical details of your innovation with your patent attorney allows the patent attorney to draft a more useful specification for your patent application, that hopefully meets the sufficiency of disclosure requirements but that also aims to cover the broad definition of your innovation as well as further useful/optional technical features.”
The European patent process is complicated and very specific and requires expertise. The advice we were given was for young companies such as start-ups to obtain at least a high-level understanding of IP, its value, and how it can help their businesses. Start-ups can get this education in several ways, by consulting a patent attorney, or at an early stage by utilizing IP mentorship opportunities at incubators and accelerators. Innovators should consider seeking the help of IP specialists to put together their wider IP strategy.
The European patent process must be seen as an investment. Once the application is filed, the applicant can freely disclose and market the object of the potential patent. As mentioned earlier, start-ups which have registered trademarks and patents are more likely to attract investors, according to the EPO and the EUIPO.