Biotechnology continues to be a highly innovative industry, and biotechnology inventions are prevalent in many fields of technology. Biotechnology patenting is particularly important for ensuring investment in continuing innovation in the industry. However, biotechnology patenting suffers from a number of unique issues which do not apply to other technological fields, particularly in relation to ethics and morals. As a result, over the years, there have been many developments in biotechnology patent law which have resulted in significant changes to the way patent protection can be sought for biotechnology inventions.

For European patent applications, the European Patent Office (EPO) follows the legal provisions of the European Patent Convention 2000 (EPC). Over the years, many biotechnology patent applications in Europe have tested how the EPC should be applied and interpreted to biotechnology inventions in general.

Here we highlight five patent cases that have had a marked effect on the patentability of biotechnology inventions at the EPO.

1. Patenting plants obtained by “essentially biological processes”

Tomatoes and broccoli cases

The EPC sets out inventions which are excluded from patentability; a number of which relate to biotechnology inventions. One of these exceptions includes inventions relating to “plant or animal varieties” and “essentially biological processes for the production of plants or animals”. Two key cases concerning this exception are commonly known as Tomatoes and Broccoli and involve patents relating to biotechnologically enhanced breeding methods of tomatoes and broccoli, respectively.

There have been several decisions of the European Boards of Appeal (BoA) regarding these cases. In earlier decisions (G1/08 Tomatoes I, G2/07 Broccoli I), the BoA defined which processes for the production of plants are excluded from patentability (e.g. methods involving asexual crossing and selection) and which processes for the production of plants are patentable (e.g. methods involving genetic modification). Subsequent decisions (G2/12 Tomatoes II, G2/13 Broccoli II) assessed how this exclusion is to be applied to products involving plants and plant material. The BoA decided that the exclusion of “essentially biological processes for the production of plants” does not also exclude products involving plants or plant material, even if the only method available for generating the product is an “essentially biological process for the production of plants”. Consequently, plants and animals obtained by “essentially biological processes” are patentable.

This decision caused controversy as the decision did not align with other European legislation (European Biotech Directive 98/44/EC), nor did it align with the national patent laws of some European countries. Moreover, the decision did not appear to consider ethical, social, or economic issues. After further consideration, the relevant provisions of the EPC were amended to better align with other legislation in Europe. However, the newly amended provisions contradicted the earlier decision of G2/12 Tomatoes II and G2/13 Broccoli II. Thus, legal uncertainty was cast over whether plants and animals obtained by “essentially biological processes” would remain patentable under the new rules.

The most recent decision relating to the Tomatoes and Broccoli cases (G3/19) sought to address this uncertainty. The BoA concluded that the that their interpretation of the exclusion to patentability set out in the earlier decisions (G2/12 Tomatoes II, G2/13 Broccoli II) should no longer be applied, and as a result, plants and animals “exclusively obtained by essentially biological processes” are not patentable after all.

This decision may not be welcomed by innovators in the field. However, while plants or animals “exclusively obtained by essentially biological process” are no longer patentable, not all plant or animal related inventions are unpatentable, for example, transgenic plants and animals should remain patentable.

2. Patenting transgenic plants and animals

Harvard Oncomouse case

The patentability of transgenic plants and animals has been confirmed in decisions of the BoA. Here we discuss the patentability of transgenic animals, but please see G1/98 for a key decision in relation to the patentability of transgenic plants.

One of the first transgenic animals to be produced was the Harvard Oncomouse by researchers at Harvard Medical School in the 1980s. The Oncomouse was genetically engineered for its increased susceptibility to cancer and was intended to be used in cancer research. Harvard sought patent protection at the EPO for the Oncomouse which raised several moral and ethical issues, as well as patentability issues.

With regards to patentability issues, the case considered two aspects of EPC law. As already mentioned, the EPC sets out which inventions are excluded from patentability. Two of these exclusions are relevant to this case, (i) inventions in which the “publication or exploitation of which would be contrary to ordre public or morality”, and (ii) inventions claiming “plant or animal varieties” or “essentially biological processes for the production of plants or animals”.

Firstly, when considering the exclusion relating to inventions claiming “plant or animal varieties”, the BoA decided (in decision T315/03) that the exclusion should not be interpreted as animals being non-patentable per se. The BoA decided that the Oncomouse was not an “animal variety” and so did not fall within the exclusion.

When considering the exclusion relating to inventions that are “contrary to ordre public or morality”, the BoA compared the potential benefits of granting a patent for the Oncomouse against the negatives. Applying this approach, the BoA decided that the positives (i.e. the medical benefits afforded to humans) outweighed the negatives (i.e. the suffering/welfare of the Oncomice). The BoA also considered that it was unlikely that the public would disapprove of the use of mice in cancer research. As such, the BoA concluded that the Oncomouse (i.e. a transgenic animal) did not fall under the exclusion and so was indeed patentable.

This case demonstrates the ‘balancing approach’ that the EPO apply when considering the patentability of transgenic animals (or plants), an approach which has been subsequently applied to other cases with differing outcomes (Upjohn Mouse, T0791/96).

3. Patentability of human embryonic stem cells

Brüstle case

The patentability of inventions relating to human embryonic stem cells is a complex topic and has been debated for many years. Human embryonic stems cells are capable of specialising into any type of cell in the body and may be used in applications such as the regeneration or repair of diseased tissues/organs. However, the use of human embryonic stem cells is controversial as it may involve the destruction of human embryos.
As discussed above, the EPC excludes from patentability inventions which are considered “contrary to ordre public or morality”, and under this exclusion falls the “uses of human embryos for industrial or commercial purposes”.

According to early case law, the EPO takes the view that products which, at the date of filing, could only be prepared by a method that necessarily involved destruction of human embryos are excluded from patentability. This is the case even if the destructive method was not part of the claims. This view has been clarified further by subsequent decisions at the EPO and the Court of Justice of the European Union (CJEU).

One key case on this topic, the Brüstle case put before the CJEU (C-34/10), clarified the effect of the above exclusion on downstream products and processes of embryonic stem cells. The decision of the Brüstle case concluded that inventions relating to embryonic stem cells are patentable only if, at the date of filing, there was available at least one method for providing the embryonic stem cells which did not necessitate the destruction of an embryo. This view has also been demonstrated by the EPO BoA. The EPO consider that methods for providing human embryonic stem cells without the destruction of an embryo were first published on 5 June 2003, and so if a patent application has an effective date after 5 June 2003 (and providing the invention can make use of such methods), then the exclusion to patentability does not apply.

The Brüstle case was also important for defining that the term human “embryo” should include all stages of human development after fertilization, as well as cells that are capable of developing into a human being.

Subsequent to this decision, the CJEU was asked to consider the issues again in relation to parthenogenetically activated human oocytes. In light of technical advances in the field, the CJEU (C-364/13) held that a parthenote does not constitute an embryo if it does not have the inherent capacity of developing into a human being. Accordingly, it was considered that parthenotes are not necessarily human embryos and so inventions relating to the use of human embryonic stem cells derived from parthenotes are not necessarily excluded from patentability.

The EPO have published further guidelines on this topic, please see here for more detail.

4. Patenting human genes

Relaxin case

Another key challenge concerning biotechnology patenting revolves around the moral issue of “patenting life”. Debates around this topic have been prevalent for many years, particularly when patents began being filed on human genes in the 1980s.

The Howard Florey/Relaxin case provides an overview of points raised in debates around this topic. In summary, the case concerns a European patent related to relaxin, a hormone which relaxes the uterus during childbirth. The Howard Florey Institute isolated the relaxin hormone from human tissue samples and determined its chemical structure. Their research uncovered a form of human relaxin which was not expected. The structure of the hormone was found to differ from other species such that only human relaxin could be used for the medical purposes envisaged. As a result, in order to use human relaxin therapeutically, the Howard Florey Institute produced synthetic relaxin from the isolated gene using novel gene cloning methods involving recombinant DNA techniques. The patent application claimed the gene encoding the unexpected form of human relaxin, as well as the synthetic form of human relaxin produced using novel cloning methods.

The first point that this case raises is that the “mere discovery” of a substance found freely in nature is not considered an invention under the EPC. In this case, the BoA considered that it was not a “mere discovery” to isolate and characterise a substance for the first time. Further, the invention provided a solution to a technical problem (i.e. creating relaxin for therapeutic use), and so the BoA decided that the invention was not solely a “mere discovery” and was indeed patentable.

Secondly, the opponent argued that the patent was not novel as the gene encoding relaxin had always been present in the human body. In response, the BoA decided that if a naturally occurring substance is isolated for the first time and does not previously exist in its isolated form, then such substance is patentable. The opponent further argued that the invention was obvious as conventional methods were used to isolate the gene. The BoA held that the very existence of the substance in the form disclosed was a surprise and unexpected. The method used to obtain the isolated gene is not significant in assessing obviousness.

Several morality issues were also addressed in this case. One issue in particular related to the fact that the relaxin gene was isolated from human tissue samples obtained from pregnant women. The opponent argued that this was an offence to human dignity. However, the BoA were not in favor of this argument as the tissue samples were donated with consent and many life-saving substances were isolated in such way, patented, and welcomed by the public.

Finally, turning to address whether patenting genes is the same as “patenting human life”, which would be contrary to morality. The BoA decided that “the patenting of a single human gene has nothing to do with the patenting of human life. Even if every gene in the human genome were cloned it would be impossible to reconstitute a human being from the sum of its genes”. No moral distinction was seen between the patenting of genes and other important human substances.

5. Patentability of second medical uses

Dosage Regime Case

Inventions concerning methods for the treatment of the human or animal body are not patentable at the EPO. However, the use of a substance/composition for the treatment of a disease (i.e. first medical use) is patentable. Furthermore, the use of a substance/composition which is already known for treating a disease is also considered patentable when claiming the substance/composition for any specific new use (i.e. a second medical use).

What constitutes a “second medical use” was developed further in the decision G2/08, Dosage Regime case. Notably, the decision confirmed that “any specific new use” of a second medical use claim should be interpreted broadly, and does not have to be limited to the treatment of a new disease. For example, a substance/composition that is known for treating a particular disease can be patented for the same disease but using a new therapeutic method. A new therapeutic method may include novel and inventive dosage regimes.
Patents for dosage regimes may be useful to patentees when the lifetime of their patent is coming to an end but the patentee still seeks to prevent generic products from entering the market. In such cases, filing a new patent directed to a dosage regime may allow for an extension of time in which the patentee has control over the market. However, in reality, the grant of patent applications for dosage regimes is not simple, as the hurdle of inventive step must also be overcome. Recent case law suggests that that the barrier for inventive step is set relatively high at the EPO.

Final comments

As advances in the biotechnology field continue and new challenges arise, it can be expected that patent law will continue to evolve in order to address such challenges and ensure that there remains appropriate protection for biotechnology inventions in Europe.

If you need any advice on biotechnology patenting in Europe (or the UK), please get in touch to speak to one of our attorneys.