CRISPR is considered to be "the biggest biotech discovery of the century” and was the subject of the Nobel Prize in Chemistry 2020. The technology has quickly become an indispensable tool for gene editing and has countless applications in various fields of research. It is no surprise that demand for licenses is high. By contrast, obtaining a license is often difficult. The article illustrates some of the questions and challenges associated with licensing CRISPR technology.
Different researchers contributed to the CRISPR gene editing variations that exist today, including Jennifer Doudna and Emmanuelle Charpentier (who jointly received the Nobel Prize in Chemistry in 2020), as well Feng Zhang and George Church, among others. Owing to the diversity of contributors, important patents for CRISPR gene editing are held by different entities, including CRISPR Therapeutics, Intellia Therapeutics, ERS Genomics and Caribou Biosciences. Most of these entities were founded by the universities involved for the specific purpose of commercializing their CRIPSR patent portfolios. For an insightful overview and discussion of the different patent holders, see the article “Licensing the unlicensable”.
There are now more than 11’000 patent families on CRISPR and numerous legal disputes regarding rightful ownership of some of the early and broad patents are currently ongoing. Although the US Patent and Trademark Office has recently ruled in favor of the Broad Institute, the legal battle is likely to continue over the next few year.
Whether or not a license is needed obviously depends on the specifics of a given case. However, for most applications, especially mainstream applications where CRISPR is used as a tool for gene editing, the answer is probably yes – in fact, multiple licenses may well be needed. The reason for this is that many applications fall under multiple patent rights, which means that a license is required in respect of all these patent rights. As an example, a state-of-the-art CRISPR gene editing application may fall under one or more of the broad early patents on CRISPR in general, as well as more recent patents relating, for example, to a specifically optimized version of the Cas protein.
Much to the dissatisfaction of prospective licensees, no comprehensive licensing pool exists for CRISPR gene editing which would include the major patent holders. This means that the patent portfolios of the different patent holders will have to be carefully analyzed to establish whether a given application falls under one of their patents.
One exception to the general obligation to obtain a license for a patent protected technology is provided by the broad Swiss research privilege. Similar exemptions do not necessarily exist in other countries, and if they exist, their extent may differ. In essence, the research privilege exempts research on the patented invention, including its potential uses, from the effect of a patent. As an example, no license may be required for investigations into the exact mechanism how the Cas9 protein effects double strand scissions. Perhaps commercially more relevant, the Swiss research privilege also extends to investigating potential uses of the patented invention. The extent and limitations of the research privilege is discussed in further detail in our article “Challenges and Opportunities in Licensing Biotechnological Research Tools” in “Life Science Recht”.
The daunting reality for many prospective users of CRISPR gene editing technology is that they will have to wade through its complex licensing landscape in order to identify relevant patent rights, and then probably have to enter into licensing negotiations with different patent holders. This is particularly challenging for startup companies and SME’s for which the effort required is disproportionately high and, sometimes, prohibitively high. As such, it is worth considering national measures, such as the research privilege, which may significantly facilitate access to a patented technology like CRISPR gene editing under certain circumstances. For a more detailed analysis of the CRISPR licensing landscape and the legal measures available, see our article in “Life Science Recht”.
We gladly assist you in assessing the licensing needs for your specific application.
On 25 March 2022 the European Commission announced, that the EU and the US reached an agreement in principle for a new Trans-Atlantic Data Privacy Framework. The new framework would be a replacement for the the old EU-US Privacy Shield and the even older Safe Harbor framework, both of which had been declared invalid by ECJ rulings. The conclusion of a new agreement would again allow European companies to transfer personal data to the USA without having to deal with the restrictions in art. 45–49 GDPR.
The original two agreements between the EU and the US were declared invalid by the ECJ because US intelligence agencies may access data without EU data subjects having a legal remedy against this access. According to the information now available, the US government has agreed to limit access to data by US intelligence authorities to what is necessary and proportionate to protect national security. There is a risk that the ECJ will not consider these limitations to be sufficient, and that a new agreement will only lead to yet another Schrems decision (Schrems III?). However, this question will remain unanswered for some time until the ECJ issues a subsequent ruling. Until then, the future agreement – if it is definitely concluded – should bring significant relief for European companies in their dealings with US service providers. It is quite conceivable that Switzerland will conclude an analogous agreement with the US, as was already the case with the Swiss-US Privacy Shield. This would also allow Swiss companies to use US service providers relatively freely.
Patent searches are used to identify information about patents and help to discover technical innovations. The objective of searching for patents is to provide an overview of existing inventions and to discover the state of the art as well as to identify third party intellectual property rights. This is important in order to assess the chances of getting a patent for an invention granted. Another type of search, a so called freedom to operate (FTO) search, is used to check whether a product or process infringes third party patents. Furthermore, patent searches give an insight into the technical progress of a competitor and may serve as inspiration for future developments. For these reasons, there are different types of searches for patents with different objectives:
Patentability searches can be carried out by professional search service providers. A cost-effective alternative for startups is the so-called Assisted Patent Search offered by the Swiss Federal Institute of Intellectual Property (IPI) to Swiss startups, Swiss SMEs, individual inventors from Switzerland and to Swiss public research institutes. During the Assisted Patent Search, a patent search is carried out at the IPI together with the inventor. The APS provides an initial overview of the state of the art in the technology sector of interest in order to assess whether the invention is new and worthy of applying for a patent. In addition, the Assisted Patent Search provides information on the patent system, shows various patent application procedures and will teach the inventor what to pay attention to once the patent has been granted.
Novelty and inventive step are two essential requirements for a patent to be granted. As outlined in an earlier blog [LINK], we often recommend startups to file the first patent application in Switzerland as the official filing fees are low. Once the Swiss application has been filed, the applicant may request one of two searches to be performed on the basis of his application: a national search or an international-type search.
In a national patent search, the IPI conducts a search in patent and scientific technical databases. Relevant hits are documents which are prejudicial to novelty or which render an invention obvious. On a side note, it is a virtually universally accepted principle that it is irrelevant for the assessment of patentability if the inventor was actually aware of a given piece of prior art or not. Based on the results, the chance of getting a patent granted may be estimated. This allows to decide the further steps: i) whether the application should be maintained and the application should also be filed abroad, or ii) the patent claims have to be amended or iii) the patent application should be withdrawn. For the Swiss National Search, a search report will be drawn up, which contains all relevant documents found and information on patent family members. A categorization according to international standards shows the importance of the documents for evaluating the invention. The Swiss National Search is a very cost-effective search performed by the IPI and certainly worthwhile for startup companies (CHF 500.00 inclusive up to 10 claims; as of 12/2021).
The International-Type-Search has the same purpose as the Swiss National Search. However, this patent search is carried out by the European Patent Office (EPO) and is more expensive. If the applicant later decides to file a European patent application claiming the priority of the first Swiss patent application, it may be advisable to request an International-Type-Search report, since the search fee will be at least partially refunded during the later proceedings before the EPO.
Freedom-to-Operate (FTO) searches are fundamentally different from prior art searches: Rather than starting with an own invention and asking whether it is patentable, you start with a commercial product or process and ask whether it infringes third party patents. An FTO analysis is used to identify technical IP rights of third-parties which can block the commercial use of a technical product or process. An FTO search provides market-relevant documents, a detailed evaluation and an assessment of the relevance of the documents. In contrast to patentability searches, FTO-related searches may be restricted to those countries for which the commercial use of the technical product or process is planned. However, international and regional patent applications are also taken into account, as national IP rights can also arise from these applications. Furthermore, in the context of an FTO search, only IP rights are relevant which are either still pending or have already been granted and are still active, because only these rights can be infringed. An FTO search is only a snapshot of relevant IP rights, however it can be very cost-intensive and always contains a certain residual risk due to the fact that even an extensive search can never fully exclude the possibility that a relevant patent is simply not found. Additionally, since patent applications are typically published after 18 months from filing, unpublished applications cannot be found and a certain degree of uncertainty will always remain.
Patent monitoring is a valuable and relatively cost-efficient tool for startup companies to keep an up-to-date overview of the IP rights of their competitors. Patent monitoring involves patent searches at regular intervals in order to monitor desired fields of technology, competitors in the market as well as legal and procedural status of already known property rights. This may allow an early detection of potentially problematic patent applications of competitors, may prevent cost-intensive duplicate-developments and may better protect the own patent rights.
Securing the IP rights of a startup company is crucial in order to secure funding and the long-term benefits from research and development activities. For this reason, it is important to know the relevant technological fields as well as the competitors in the relevant markets to avoid cost-intensive duplicate developments and to achieve market exclusivity. Various patent searches help to achieve these goals. Rentsch Partner AG offers free initial consultation sessions and specific consulting modules tailored to the needs for startup companies to help finding the right search strategy to secure new inventions in order to achieve market exclusivity.
There is a plethora of blogs and articles about questions startup entrepreneurs typically ask about IP (including our earlier blog post about patenting tips for Swiss Startups). In contrast to these frequently asked questions, this blog will focus on a selection of questions startup entrepreneurs should ask (or should not ask).
The patent system is based on a simple deal: protection in the form of a limited monopoly is granted in return for full disclosure of the invention. This basic principle seems to contrast with a common prejudice many people have regarding patents: that they are written in an overly cryptic way that actually leaves the core of the invention ill-defined and vague rather than fully disclosing it. Many inventors are therefore wondering if they can “hide” their invention in the shadows of complicated and, perhaps, even deliberately misleading language. However, this is a dangerous strategy which often leads down a slippery slope of increasing legal uncertainty and risk. In fact, a sufficient disclosure of the invention is required to receive patent protection for the invention.
Leaving the exact nature of the invention unclear will likely cause severe problems during prosecution, if not inhibit it altogether. It is a general and necessary requirement in most, if not all jurisdictions in the world that the invention to be protected has to be fully disclosed such that a person skilled in the art can carry it out. This requirement is taken very seriously and interpreted strictly during examination. During and even after examination, many jurisdictions offer mechanisms to attack patents that do not fulfill this criterion, including so called third party observations and opposition proceedings. It should also be noted that it is not possible to leave out crucial information in the patent application at first and then hand them in later upon request by the examiner. The reason for this is the equally important and general concept that you cannot add subject-matter that goes beyond the scope of what was originally disclosed in the application as filed.
Additionally, leaving out essential features of your invention poses a difficult-to-estimate, if not unpredictable future risk regarding enforceability. Having a patent just for the sake of it may be great and may convince customers and investors alike of the value of your technology. However, like a bicycle helmet that should not just look good but also protect your brain in an accident, a patent should also be strong enough to be enforceable: This includes being specific enough to clearly identify cases of infringement but also being able to resist the rigorous cross-fire during a fierce nullity suit. Once again, leaving out crucial technical information about the invention renders the patent vulnerable towards attack, which may eventually lead to its revocation.
Taken together, you should be aware that getting a patent comes at the cost of public disclosure of your technology. In other words, this is another ‘no free lunch’ situation. That being said, while the lunch may not be entirely free, certain discount options may be available: depending on your invention, it is not required to meticulously list every single bit of detail about all different aspects of it. Rather, it is can be sufficient to disclose the concept or the essential features of the technology in order to protect it and to prevent competitors from using it. Additionally, you can strategically decide to only patent and disclose certain aspects of your technology while keeping other aspects a trade secret. Striking this delicate balance of disclosing as much as required but as little as possible at the same time is not easy and usually requires years of experience, preferably in prosecution as well as litigation.
Choosing a patent law firm can be a daunting prospect for entrepreneurs who may view patents as a necessary evil rather than a valuable asset. However, there are a few questions to consider when choosing a law firm:
It should be noted that there is a big difference between obtaining a patent in the first place and actually enforcing it in the case of patent infringement. Additionally, many patents are actually infringed unknowingly by third parties and it is frequently up to the patent owner to actively identify cases of infringement and take legal action against them. Accordingly, if you are seeking to potentially enforce your patent as well, it may be advisable to choose a law firm that has experience in patent prosecution as well as enforcing patents and, ultimately, patent litigation. An additional benefit associated with this is that experience in litigation typically enhances the process of drafting a patent: practitioners experienced in both areas tend to draft patents that strike the balance between meeting the patent office’s stringent requirements of examination and enabling the unequivocal identification of cases of infringement.
There is obviously no right or wrong answer regarding the size of the law firm. You may simply like the family atmosphere of working with a small law firm. However, larger law firms are frequently able to offer distinct advantages by virtue of their size. As an example, larger law firms typically employ attorneys in different technical areas who can quickly exchange expert opinions and provide insights into their respective fields. These synergies may be particularly advantageous if your invention relates to the interface of different technical areas. Additionally, many larger law firms are able to provide a broad scope of different legal services relating to IP without relying on outside expertise. Having a single law firm covering all aspects of IP is not only convenient for many clients, but frequently also translates into cost-efficiency.
Even if you may primarily seek assistance in the technical drafting of patents, it is important to note that many questions relating to patents and, more broadly, intellectual property do not exclusively fall under the realm of patent attorneys but also require the expertise of attorneys-at-law. As an example, such issues may range from standard contracts such as NDA’s and License Agreements to more complex questions about indemnity clauses or the legal caveats of different jurisdictions. Accordingly, it may save you time and effort to choose a law firm that is able to draw on the expertise of attorneys-at-law and patent attorneys and is thus able to provide a holistic solution to all different aspects of intellectual property.
For startups striking the right balance between short-term success like getting your product ready for the market or launching its new generation and the long-term strategy can be difficult. Having an IP strategy definitely falls into the realm of the long-term strategy. However, it can hardly be overstated how important it is to have at least a rough outline of an IP strategy even as a startup company. This is particularly true if your company depends on a small number of technologies, or even a single technology. A basic IP strategy should include defining the core technological areas and their respective importance for the company as well as a thorough analysis of external IP rights to establish the company’s freedom-to-operate (FTO). The latter is particularly crucial for startups because even the possibility of facing a costly infringement suit is not just dangerous but often fatal.
It should be noted that “developing an IP strategy” does not necessarily have to involve seeking patent protection. Alternative strategies to secure IP such as trade secrets are available and have their own pros and cons, as discussed in detail in several other blogs. Regardless what your IP strategy may look like, having a clear and unified view of it ensures that you consistently apply effective measures to protect one of your key assets, namely your technology.
Beyond protection of your core technologies, a clear IP strategy also enables you to make informed strategic decisions about the future development of your technologies. To fulfill this function, it is important that your IP strategy is aligned with your overall business strategy. This becomes even more apparent when you consider how many business implications intellectual property has at different levels across the company, including licensing opportunities, royalties and potential tax deductions on expenses relating to research and development (Patentbox). Consequently, developing an IP strategy early on will not just provide a useful tool for managing already existing IP but will also enable you to proactively guide your research and development such that it will serve your overall business objectives.
Finally, a patent on your core technology will significantly enhance your chances of attracting funding. In fact, many investors increasingly require startups to have at least a pending patent application to be eligible for venture capital, particularly if large sums of money are at stake. This means that the cost of a patent should not be viewed as mere expenditure but rather as an investment.
The word patent is frequently associated with groundbreaking achievements such as the development of light bulbs or cars. Awestruck by the genius of Thomas Edison, Carl Benz or Nikola Tesla, many people may not consider their ideas to be worthy of a patent. However, it is a widespread misconception that patents are only available for groundbreaking inventions. In fact, the crucial criterion of “obviousness” or “involvement of an inventive step” is purely qualitative rather than quantitative in many jurisdictions. In other words, even small improvements of the prior art may be eligible for a patent.
By contrast, there are other criteria an invention has to fulfill in order to be patentable. Some of these criteria, such as the requirement for novelty or susceptibility of industrial application, can be found in one form or another in most jurisdictions. Other criteria, such as what is often referred to as ‘technicity’, are less universal and can be difficult to evaluate. In this respect, questions relating to the patentability of computer-implemented inventions are particularly tricky. Different articles describing the various exceptions to patentability are available, including our blog post on how to protect your AI innovations.
Although this is less of an exotic question, it is nevertheless definitely one you should ask. It can’t be stated too often that you should not publicly disclose any details of your idea until a patent application is filed or it was consciously decided not to seek patent protection for it. Even after filing, it is best to keep your invention secret for as long as possible in order to keep the option of filing further applications on improvements of your technology.
If you still have to disclose parts of or even the entire technology, this should be done only after having every recipient of the information sign a specific non-disclosure agreement (NDA). It should be stressed at this point that the use of a generic NDA available online can be risky, as discussed in more detail in this blog post. Additionally, it is advisable to keep a clean documentation record of your disclosures, which may serve as invaluable evidence in potential future disputes regarding the date of disclosure or even ownership. Specifically, we recommend documenting all internal and external communication, e.g. by keeping and distributing meeting minutes.
Patents are national rights that grant the right to exclude others from using the patented invention. In general, a Swiss patent grants the patent holder the exclusive right to prevent others from using the claimed invention in Switzerland. More specifically, if your patent relates to a product, the patent comprises the right to prevent third parties from producing, storing, offering, selling, importing or exporting the relevant product.
To obtain similar protection for your invention abroad, you will need to file patent applications in other jurisdictions. There are several ways and strategies to do this, and in this blog post we will introduce a common strategy for obtaining patent protection abroad which works well for many of our clients.
For many of our clients we suggest filing the first patent application in Switzerland as the official filing fees are low and the patent application can be filed in English, German, French or Italian. We often recommend requesting an international-type patent search at the same time. This patent search is carried out on behalf of the Swiss Federal Institute of Intellectual Property by the European Patent Office (EPO) and lists those prior art documents deemed relevant for the patentability of your invention. The international-type search report is usually received within 4-10 months of the filing date and allows you to re-evaluate your patent application in light of the prior art.
The 12-month period following the filing of the first application is called the priority period, in which you can file other applications in other jurisdictions for the same invention. You can also, and this is what we normally recommend, file a PCT application. The PCT application is an international application which effectively postpones the time point at which you need to decide in which countries you will ultimately seek patent protection.
We recommend filing the PCT application with the EPO. The EPO will provide a written opinion on the patentability of your invention. This gives you another good opportunity to re-evaluate your patent application.
After 18 months, the international patent application is published, along with the results from the international search and the Patent Office’s written opinion on the search report. Up until this point, your application has been subject to strict confidentiality on the part of the patent offices.
Only 30 months after the filing date are you required to make a final decision as to which jurisdictions you wish to continue in with your patent application. For example, you could file for a European patent at the European Patent Office (EPO), file for a US patent at the USPTO, etc.
As outlined above, one of the major advantages of the “Swiss Classic” is that it allows you to postpone the costly and strategically invaluable decision as to which countries you seek protection in to a later point in time. However, it should be noted that the PCT application does not result in a PCT patent: the PCT application eventually diverts into a number of national and/or regional applications. Therefore, the PCT application should be drafted to be highly compatible with different patent systems. Though the patent systems in different jurisdictions are broadly similar, there are formal as well as substantive differences which invariably impact the way both the priority founding patent application, as well as the international patent application are drafted. For example, the European requirements relating to claiming priority and amended subject matter are stringent, whereas the US patent system is more permissible in this regard. Another example relates to the requirement of sufficient experimental basis to support broad claims in life science patent applications, which tends to be particularly strict in several Asian countries. A patent attorney with a working knowledge of different patent systems is ideal, both for drafting the patent application as well as guiding the patent application through prosecution to grant.
Normally you would need to decide which countries you want to obtain patent protection in within 12 months of your first filing. By filing a PCT application you can push this out to 30 months. This has the following benefits:
This patent strategy works well for many of our clients that are active in different international markets. While popular and widely applicable, this strategy is obviously not a one-size-fits-all solution and other patenting strategies may be more suitable for your specific needs. Please reach out to us to discuss your specific needs in more detail with one of our specialists.
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