A view on 20 years of Biotech patenting in Europe

A. De Clercq, PhD, ex-Chair epi Biotech CommitteeA. De Clercq, PhD, ex-Chair Biotech Committee

As a (now) ex-chairSince 19 July 2023 Mr. Simon Wright succeeded Ms. De Clercq as chair of the epi Biotech committee of the epi Biotech Committee and for many years a practitioner in this field, it is a privilege to report on the last two decades of biotech patenting at the EPO and in general in Europe. Some major changes and developments have occurred in this field. In the early days of biotech patenting in Europe it was debated whether living organisms and certain types of biotechnological inventions could be patented. In 1998, the European Union adopted the Biotechnology Directive (Directive 98/44/EC), which aimed to harmonize patent laws in the EU member states concerning biotechnological inventions.

Over the past 20 years, several landmark biotech patent cases have been decided by the EPO. In the field of animal patenting, Technical Board of Appeal decision T315/03 (Harvard Oncomouse) was issued, relating to morality under Art. 53(a) EPC and R. 23d(d) EPC. For many years we debated a lot on patents on stem cells. An Amicus Curiae brief was filed by epi in 2006 in the Enlarged Board of Appeal (EBA) case G2/06 (WARF). In 2011, the EPO’s policy was that the morality exclusion could be overcome if one can refer to a public human embryonic stem cells (hESC) cell line deposited after May 2003. In 2012, the EPO examiners followed the instructions given in the Guidelines which came into force in June 2013.

In 2012, EPO had a new policy on stem cell patenting. The EPO had, to a significant extent, followed the CJEU Brüstle decision. The previous policy of there being a threshold in 2003, depending on whether stem cells were deposited or not, had been scrapped as a new threshold date, 10/01/2008, concerning the publication of the single blastomere biopsy process (SBB) came into the picture. The interpretation of the CJEU Brüstle decision by the German Federal Court of Justice (BGH) is different than the EPO interpretation. The epi filed Third Party Observations in 2012 in the Brüstle EP patent opposition case requesting the Opposition Division to consider also the Brüstle decision of the BGH relating to the equivalent German Brüstle patent. In summary, stem cell patenting has undergone many changes and reviews.

In 2010 the ECJ Monsanto Decision relating to a product (the DNA sequence) which forms part of a material (soy meal) and does not perform its function came out. This mainly concerned infringement, and the scope of downstream product claims. It was not well reasoned and so there remains a question mark over whether this decision will exclude all situations where the gene is inactive from infringement. Other national decisions in the Biotech field were also often a centre of debate, such as the UK HGS v Lilly case.

The epi also has filed amicus briefs in US cases such as in 2013 in the US Myriad case before the US Supreme Court supporting a previous declaration of Prof. Strauss filed in this case and supporting the patentability of human genes. The epi filed a Third-Party Observations in 2012 in the Brüstle EP patent opposition case requesting the Opposition Division to consider also the Brüstle decision of the BGH relating to the equivalent German Brüstle patent.

In 2013, the US Supreme Court issued the “Myriad” decision concerning the patent eligibility of human genes in the United States. The Myriad and the Mayo vs. Prometheus decisions from the US are very controversial and caused a lot of discussion in the US. The EPO did not follow the same lines of thought and sticks to its long-lasting practice of dealing with the patentability of gene and diagnostic method inventions. The EU Biotech Directive has an advising role on the EPO’s practice.

Plant biotech patent law was (and is) also heavily debated in Europe. According to the current version of the EPC, plant varieties and essentially biological processes to produce plants, and the products exclusively obtained therefrom, are not patentable. However, it is essential to note that there was a period of uncertainty regarding this exclusion and over the years plant patentability changed a lot.

EBA decisions G2/07 and G2/08 (Tomatoes and Broccoli) relating to Art. 53(b) EPC, effectively said that the breeding methods for plants that involve sexual selection are excluded. On these cases a second referral was done to the EBA: decisions G2/12 and G2/13 (Tomatoes II and Broccoli II) afterwards clarified that product claims or product-by-process claims directed to plants or plant material other than a plant variety are not excluded from patentability under Art. 53 (b) EPC and are allowable if they fulfill the formal and substantive requirements of the EPC. These decisions confirmed that exclusions to patentability must be construed narrowly. The EPO Guidelines were amended in this way. On 3 November 2016, the EC issued a notice on certain articles of the Biotech Directive 98/44/EC suggesting that the Biotech Directive should be interpreted to exclude plant products. On 24 November 2016, the EPO issued a notice informing that they would stay the proceedings of certain cases due to the Commission Notice of 3 November 2016. Such a stay was unprecedented at the EPO. As of 1 July 2017, Rules 27 and 28 EPC were amended and apply since then to European patent applications filed on or after this date, as well as to European patent applications and European patents pending at that time. In T1063/18, the Board had found the new R. 28(2) EPC, excluding plants or animals exclusively obtained by means of an essentially biological process from patentability, to contradict Art. 53(b) EPC and its interpretation thereof by the EBA in cases G2/12 and G2/13. This was very much welcomed by the plant industry professionals. A referral was made to the EBA again now by the President of the EPO. G3/19 issued on 14 May 2020 and this opinion (so not a decision) explicitly abandoned earlier EBA decisions G2/12 (Tomatoes II) and G2/13 (Broccoli II), as it now held that plants and animal products exclusively obtained by essentially biological processes are not patentable. The EBA considered in G 3/19, the referral admissible and advanced a new interpretation of Art. 53(b) EPC in line with the amended R. 28(2) EPC and related developments. Applying a dynamic method of interpretation, having regard to the wording of the new R. 28(2) EPC and the travaux préparatoires for that Rule, the EBA accepted that it was the EPC legislator’s intention to establish a particular interpretation of Art. 53(b) EPC, which is that plants or animals exclusively obtained by means of an essentially biological process are excluded from patentability. The epi had suggested in their amicus curiae brief to establish transitional measures to protect the legitimate expectations established by the EBA’s earlier decisions. The EBA noted that its new interpretation of Art. 53(b) EPC has no retroactive effect on European patents containing such claims which were granted before 1 July 2017, when R. 28(2) EPC entered into force, or on pending European patent applications seeking protection for such claims which were filed (or have a priority filing date) before that date. This opinion is still controversial and was commented on by many practitioners as being very much influenced by political inspiration.

EBA decisions G2/07 and G2/08 (Tomatoes and Broccoli) relating to Art. 53(b) EPC, effectively said that the breeding methods for plants that involve sexual selection are excluded.

The Biotech Committee also followed the national developments and updated overviews of the patentability of plants in the member states based on reactions of the members in each country(see https://patentepi.org/r/patentability-of-plants).

Plant patent specialists are mainly concerned about the need for plant disclaimers according to the Guidelines. G3/19 does not say anything about the need for disclaimers. At the SACEPO WP Guidelines meetings, epi biotech practitioners yearly reiterate to the EPO their concerns about the current need for plant disclaimers for which epi holds there is no legal basis. We regret at this moment no changes are being considered in the Guidelines. We may also expect future Technical Board of Appeal cases on this topic. epi would like already for many years to understand where the basis is in R. 28 (2) for a disclaimer requirement. A disclaimer would appear to introduce legal uncertainty for applicants, because the scope of what is disclaimed, and how national courts or the UPC will interpret the coverage of the remainder of the claim remain to be seen, particularly in the light of various definitions of “essentially biological processes” or “exclusively obtained by essentially biological processes”. The EPO confirmed disclaimers are not needed for genetically modified transformed plants and gene edited plants (created by CRISPR technology), provided the latter can be distinguished from natural variation and are not needed for offspring and propagatable parts of said plants. EPO explained that it is up to the applicant to show that it does not relate to a plant produced by an essentially biological process. EPO explained they consider what kind of exchanges are known for the plant in question and depending on the plant make an objection or not. Recent discussions are regularly reported on in epi information by the epi Biotech Committee.

Antibodies have also been a field of heavy debate, changes and high importance in the field of biotech. Years of discussions between epi and EPO and amongst practitioners have happened and the most recent evolutions were reported on in our recent committee reports in epi information. The Guidelines need to be very carefully drafted and reflect the Case Law as they are also being referred to in national court cases. It is desired to have more interaction with the epi practitioners when draft Guidelines are made (also in the other Biotech areas). The antibody patenting Guidelines were a long time not public but have been inserted into the Guidelines now since 2020.

In general, the EPO Guidelines are updated yearly. Antibodies, G3/19 and plant disclaimers as well as exclusions for stem cells parts were added and amended, and new paragraphs added also as well as a new part on homology, similarity, identity of genes and protein sequences, all in 2020. The biotech aspects of the Guidelines are from then also under yearly review after the SACEPO WP GL meetings. Maintaining high quality Guidelines is essential.

For more than a decade, the Biotech Committee has been also very involved in all discussions on Sequence listings, and we went from the incorporation of ST.25 to ST.26 WIPO Standard for Sequence Listings which came into force on the big bang date of 1 July 2022See discussion in the recent reports of the epi Biotech Committee on the recent developments of this topic. This raises a lot of questions which are reported on in epi information by the epi Biotech Committee regularly.

Several landmark biotech patent court cases in Europe have also had a significant impact on the interpretation and application of patent law in the field of biotechnology in Europe. Other topics than the above-mentioned ones that we have been dealing with in the last 20 years from the biotech angle are for instance sequence alignments, deposits of biological materials, pharmacogenomics, medical use claims, non-unity, post-published data, functions of genes, credible or plausible gene or protein function requirements, added matter, gene-editing technology, genomic sequencing and personalized medicine, T-cell receptor patenting and the Nagoya Protocol.

It is expected that biotech patenting will continue as a changing and challenging field and hopefully it can keep on flourishing for applicants and inventors and have commensurate protection possibilities.