This paper was originally submitted to the American Intellectual Property Law Association (AIPLA) ahead of its 2021 Annual Meeting and was the subject of a presentation at a plenary session there on 28 October 2021. The author, Andrew Bentham, is a partner in the Biotechnology and Life Sciences group of J A Kemp LLP (Cambridge, UK).
This paper is in two sections. The first relates to current topics, issues and developments in European patent practice in that may be relevant for innovators in the life sciences. As far as possible, this first part tracks the issues discussed from a US perspective in the paper submitted by my co-panellist Courtenay Brinckerhoff of Foley & Lardner LLP, in the hope that US-based readers can better compare the situation in the US with that in Europe. The second part, focussing on differences between US and European practice and how to avoid these differences becoming pitfalls for US applicants, is more timeless - as in general these issues change relatively little over time, and yet they remain problems if they remain unfamiliar. For completeness, both sections include some information on issues that are general to all applicants but equally or especially relevant to those in the life sciences.
I. Current patenting issues in Europe facing Life Science innovators
Patent-eligibility has of course been a very significant issue in US practice in the near-decade since the US Supreme Court decided the Prometheus case and opened up many questions that are still being worked out through follow-on case law today. Patent-eligibility has also been a significant issue in Europe since the European Patent Convention (EPC) first came into force in 1978. In part because of the drafting of the EPC and in part because of the rapid changes in life science technology since it was implemented, much of this debate has tended to focus on the metes and bounds of various exceptions to patentability in the life sciences.
However, the contours of these issues are at present very different. This may be because, while US law on eligibility is generally judge-made case law, the EPC has a hardwired black-letter framework of exceptions to patentability1. In the life sciences, these include prohibitions on patenting, for example, methods of medical treatment (Art 53(c) EPC) and plant varieties (Art 53(b)), which do not arise in US law. Similarly, the EPC's "morality" exclusion (Art 53(a)) has in practice been a life science issue as questions came to be asked about patenting subject matter such as human genes, transgenic plants and human embryonic stem cells.
This highlights an issue. The EPC came into force in the 1970s but the thinking underlying it goes back even further, to a time when much of what we today call biotechnology was at best science fiction. The Articles of the EPC, which can only be changed via agreement of all the (now 38) member states have been amended hardly at all since then and only fairly limited codification2 via rules amendments has been possible. The EPC is therefore by its nature somewhat inflexible on patent-eligibility. This contrasts with the situation in the USA where 35 USC §101 is very general and case law fills the gaps. The US Supreme Court has therefore at various times taken what are in effect policy decisions on the eligibility of certain subject matter.
This is not to say that case law has not played a critical role in development of practice on patent-eligibility in Europe too. Every one of the exceptions in the EPC has been the subject of case law developed as applicants tried to maximise what they could claim notwithstanding the exceptions, and much of what we know about how to interpret them originates from decisions of the EPO's Enlarged Board of Appeal (EBA)3, but even the EBA always has to operate within the more defined framework defined by the legislation. Sweeping changes such as those that began with Prometheus are therefore much harder to envisage.
Whether this is an advantage or a disadvantage for life science innovators may depend on exactly what field of life science one is concerned with. For example:-
- The EPC does exclude diagnostic methods from patent-eligibility but only those practised on the human or animal body, so methods performed on samples taken from patients are patent-eligible even without the specific technique steps that it sometimes helps to add in the USA.
- Under Rule 29(2) EPC, isolated genes are specifically stated to be patent-eligible even if their sequence is the same as a naturally occurring one; this also applies equally to human genes.
- Isolated microbial strains have always been patentable when claimed narrowly and supported by a biological deposit under the Budapest Treaty (see below) and are not especially encountering increased issues now.
In addition, there are areas where the EPC is prima facie unfavourable but in practice the exclusions have been mitigated by practice developments. The most important of these is of course methods of therapy, where inventions that relate to pharmaceuticals are little if any less protectable in Europe than in the USA. New active ingredients can be claimed as compounds per se (possibly more easily in some biopharma situations as antibodies, gene/ therapy vectors, cell therapies, microbial strains, products extracted from natural sources and so on would in practice face no scrutiny on eligibility grounds) and medical use claims4 take care of many of the situations where methods of treatment would be claimed in the USA5.
On the other hand, some inventions are clearly patent-eligible in the USA and clearly patent-ineligible in Europe. An invention that is literally a method of treatment defined entirely by steps carried out by a physician on a patient will not be patent-eligible, and nor will a plant or animal variety6 or breeding method (or, following recent EBA case law, the product of such a method7).
For most of the EPC's existence, US patent law has been more flexible and liberal on life science patent-eligibility; whereas currently the picture in Europe is relatively stable, and in some (but not all) ways more favourable. Put another way, patent-eligibility in life science has many times been a major issue in Europe but, right now, it is reassuringly more of a major non-issue compared to the USA.
1. See Articles 52 and 53 EPC
Article 52- Patentable inventions
(1) European patents shall be granted for any inventions, in all fields of technology, provided that they are new, involve an inventive step and are susceptible of industrial application.
(2) The following in particular shall not be regarded as inventions within the meaning of paragraph 1:
(a) discoveries, scientific theories and mathematical methods; (b) aesthetic creations; (c) schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers; (d) presentations of information.
(3) Paragraph 2 shall exclude the patentability of the subject-matter or activities referred to therein only to the extent to which a European patent application or European patent relates to such subject-matter or activities as such.
Article 53 - Exceptions to patentability
European patents shall not be granted in respect of:
(a) inventions the commercial exploitation of which would be contrary to "ordre public" or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States;
(b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof;
(c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.
2. See Rules 28 and 29 EPC
Rule 28 - Exceptions to patentability
(1) Under Article 53(a), European patents shall not be granted in respect of biotechnological inventions which, in particular, concern the following:
(a) processes for cloning human beings; (b) processes for modifying the germ line genetic identity of human beings; (c) uses of human embryos for industrial or commercial purposes; (d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.
(2) Under Article 53(b), European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process.
Rule 29 - The human body and its elements
(1) The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions.
(2) An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.
(3) The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application.
3. Which, within the more limited context of patent law under the EPC, has a function somewhat similar to the US Supreme Court in that fundamental questions of law that arise are referred up to it and it returns answers to those questions that the regular Technical Boards use to decide the cases in front of them and that then exist as precedential case law for the future.
4. Typically in the form "Compound X for use in the treatment of disease Y".
5. Increasingly including finer details such as dosage regimens and sometimes patient groups, so these claim types now have a lot of power and flexibility.
6. Though it will likely be possible to obtain a plant variety right, similar to PVP in the USA.
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