In our series on future food, we have explored the exciting innovations in areas such as cultured meat, controlled environment agriculture, alternative proteins and plant based meat analogues. These technologies continue to develop at rapid pace. As with any innovative field, obtaining robust patent protection is vital for attracting investment, securing a market position, and blocking competitors from launch. Whilst we have stressed the importance of a strong IP position for innovators in this field, we have not explored in detail how such protection can be secured.
Our experience with future food has revealed some particular quirks when it comes to patent protection in this field. Many applicants, even those with considerable experience of the patent process, will be unfamiliar with the technology. The same is true of courts and examiners – it appears that many will have backgrounds in conventional agriculture, food technology, or biomedical cell culture, and may lack an intimate knowledge of the unique challenges in future food. Even with such uncertainty, several drafting issues stand out that could ensnare the unwary, and result in refusal or weak patent portfolios.
1. Over-reliance on “product by process” language
Many cellular agriculture inventions can be summed up as “meat (or another animal product) obtained through cell culture”. However claims this format, also known as “product-by-process” claims, are unlikely to be allowable in many national offices.
In most countries, a claim to a “known” product that is indistinguishable from those known in the prior art cannot be rendered novel through a new method of manufacture of the product. There are however some limited circumstances when a product-by-process format is permitted. In the US, for example, a product-by-process claim is only allowable if the product is in and of itself novel and inventive over the prior art. The burden of proof in this lies on the applicant, and it can be difficult to convince the examiner on these points. As the “holy grail” of cellular agriculture is a product that is indistinguishable from conventional meat, these claims will become increasingly difficult over time as more patents emerge as prior art in this space.
The practice in Europe is even stricter, as applicants must additionally show that the product cannot be described based on physical characteristics in a clear and concise manner. In other words, product-by-process claims are only allowed if it is the “best” way of drafting the claim. This is usually a difficult barrier to overcome, as pointing to novel features can lead the examiner to question why these aren’t used to define the product instead of a product-by-process claim. Moreover, there is an increasing trend (at least at the EPO) to apply this practice to functionally-defined features within claims. Therefore, claims reciting “cultured meat” or “cells grown in vitro” as part of a broader product or process are likely to rejected as unclear products-by-process, or interpreted as not distinguished from “meat” or “cells” in general.
Product-by-process claims do have their uses, especially in countries like Japan and Israel where these are more likely to be allowed. Where particular countries are vital for commercialisation, consultation with local attorneys as to national practice is likely to be valuable. Regardless, applicants can improve their position by additionally claiming their products as defined by physical characteristics such as cell surface markers, morphology, or through additional components. Even though these may be narrower in scope, they have a higher probability of proceeding to grant.
2. Using awkward definitions
Patent drafting is, first and foremost, an exercise in definition. Being able to craft succinct and clear definitions is the hallmark of a skilled drafting attorney, and defining features in and of themselves, based on clearly inherent properties and without referencing knowledge outside the claims, is the gold standard. However, in the field of future foods, where products are often defined by what they are not (conventional meat) and how they are made (cell culture), this is a significant challenge.
Many umbrella terms common in discussions of cultured meat are likely to draw the ire of patent examiners. For example, “meat animal” could be viewed as unclear, as all animals produce “meat” (albeit not all of it palatable). Similarly, examiners may interpret “farm animal” as including any animal resident on a farm, including human farmers. The breadth of these terms can lead examiners to unfavourable prior art in human or murine cells. Conversely, terms like “slaughter-free meat” may be difficult to define – does this include carrion, living animals, or plant-based meat analogues? – and conventional terminology for cuts of meat, such as chops or steaks, may lose meaning when the tissue is grown ex vivo.
Indeed, the word “meat” itself lacks a universally acknowledged definition – in some cultures, fish and shellfish are not viewed as meat in common usage, whilst others draw a distinction between meat and offal. Given this ambiguity, can we say with confidence that a cell culture derived product, or plant-based analogue, would even be accepted as “meat”?
Where these terms are refused by examiners, it can be difficult to find a suitable alternatives that are broader than the specific examples and most preferred embodiments. To prepare for this eventuality, applicants should think not only of broad category terms, but useful intermediates between them and the specific (e.g. cell type) embodiments in their examples. At the same time, this may mean being prepared to surrender some scope in exchange for allowable claims, and applicants should seriously consider what embodiments are likely to be commercially valuable and which are not when drafting patent applications.
3. Refusing to accept that product claims are likely to be narrow
Astute readers may have noticed that the issues outlined above primarily affect product claims, and may wonder whether broad product claims can be obtained in cultured meat? The answer is likely no.
Product claims are often treated as the crown jewel of a patent portfolio. However, in future food at least, it is unlikely that broad product claims can be obtained due to the vast quantity of prior art describing cultured meat and similar technologies at the conceptual level.
Applicants should therefore consider focussing their product claims on narrower aspects of their technology. Instead of describing cultured meat at the high conceptual level, claims capturing the measures needed to overcome specific challenges are more likely to succeed. For example, claiming features of cell lines required for effective conversion into meat may be one approach. Similarly, focussing on relatively narrow sets of features in the finished product, such as presence or absence of certain nutrients, could overcome these obstacles.
Through claiming different overlapping aspects in their own narrower claims, a broad canopy of protection can be obtained.
4. Failure to make use of all available categories of claims
Whilst “product-by-process” claims may be difficult to obtain, these are not the only prizes on offer. Method claims describing the producing a foodstuff may be more readily allowable. Whilst there is a (largely unwarranted) belief that method claims are more difficult to enforce, this may be offset by their broader allowable scope in this field. Furthermore, as claims to methods also provide protection for the direct products, these claims can be used to stop importation and sale as well as manufacture.
Relatedly, claims to intermediates – cell lines, culture media, raw products, and bioreactors – should be considered alongside more immediately obvious claims to finished “on the shelf” products. Many intermediates are necessary for production at scale, and some may even be present in finished products.
Whilst the strategy proposed may appear more complex than simply drafting broad claims covering the finished products, it is more likely to result in useful protection. A mosaic of partially overlapping claims to products, intermediates, and methods, even if they are themselves quite narrow, can provide a wide-reaching umbrella of robust protection. Not only does this provides a strong position when bringing litigation, but may have a chilling effect on third parties who would rather seek a licence or avoid the field entirely than navigate the complex landscape.
5. Tell a story
When prosecuting a patent, applicants will have higher chances of success if they can tell a compelling story about why their product or technology is innovative. For example, the development of plant-based meat analogues is broadly motivated by the desire to reduce meat consumption (whether for dietary, ethical or environmental reasons), and this is not unique to any particular product. However, a specific analogue may include a particular ingredient to improve texture or flavour, or may employ a novel processing method which improves production efficiency. Explaining these motivations in the application can support patentability arguments that might result in broader, stronger claims.
Good stories require an improvement of one or more qualities over the art. In food technology, many qualities are subjective – especially organoleptic properties such as mouthfeel, richness, or flavour. Applications that include detailed metrics by which seemingly subjective properties may be defined and quantified, as well as evidence that these properties are improved by the invention, will have an improved probability of success. Examiners and courts are more likely to follow lines of argument when they can draw support from the application as-filed, rather than solely based on attorney submissions.
Applicants can be surprisingly modest when describing the improvements provided by their inventions. In future food at least, a more bullish outlook could be highly rewarding.
Summary
Future food is an emerging field, where the consensus around best practice is yet to settle. However, this provides significant opportunities for applicants who know how to draft realistic patents with valuable claim language in reserve. Fortunately, the obstacles identified above can be avoided with a little preparation at the drafting stage, and enlisting the help of a skilled attorney during the process can be the difference between success and failure.
This blog was originally written by Andrew Tindall.
