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European developments surrounding the patentability of plants and animals have become rather political, but there are ways for patentees to mitigate the effects of political influence over the patenting process, writes Jane Wainwright of Potter Clarkson.
Followers of the changing life sciences patenting landscape will be well aware of the extended saga at the European Patent Office (EPO) regarding two cases heard together and known as Broccoli and Tomatoes. In these cases the Enlarged Board of Appeal of the EPO decided that, while essentially biological processes of producing plants or animals (such as crossing of plants or sexual reproduction of animals) are excluded from patentability, new products derived from such processes are not excluded from patentability simply because they resulted from such an essentially biological process.
For the past 18 months, this decision from the highest legal authority at the EPO has clarified the position for the biotechnology industry on what was theoretically patentable at the EPO in relation to production of plants and animals. However, things began to look less clear on November 8, 2016 when the European Commission issued a notice following a year-long investigation into the patenting of biotechnological inventions deriving from essentially biological processes.
As part of its investigations, the commission considered opinions from numerous stakeholders in the patenting, biotechnology and plant/animal breeding areas. The organisation felt that, for plants, protection is already provided through plant variety legislation.
Furthermore, the commission believed that the original intention of the EU biotech directive, which is implemented into national law in EU member states and was voluntarily included in the implementing regulations of the European Patent Convention (EPC), was not to cover animals and plants produced by essentially biological processes. It turned to preparatory work undertaken in drafting the biotech directive in order to justify this position.
The preparatory note does indeed suggest that exclusion of products of essentially biological processes may be desirable, but the biotech directive in its final issued form states that plants and animals are patentable, providing the technical features are not limited to one plant or animal variety. As a result, it is difficult to know with certainty what was intended by those drafting the biotech directive in the first place.
The EPO suspension
In light of the commission notice, the EPO announced on November 24, 2016 the indefinite suspension of all proceedings at the EPO (examination, opposition and appeals relating to both) in which the decision would depend on the patentability of plants or animals obtained by essentially biological processes.
The president of the EPO has implemented the suspension to allow discussion between the EPO and the EPC contracting states in order to determine what, if any, follow-up measures are needed by the EPO in light of the commission notice. Such discussions are ongoing and the European Council recently urged EU members to advocate as part of those discussions that EPO law and practice are updated to align with the commission’s guidance notice.
The suspension is rather unusual because, despite the majority of EPO contracting states being EU members, the EPO itself is not an EU institution and so is not formally bound by EU law. Not only is that the case, but the commission notice itself states that it is merely an opinion and intended only as guidance. The notice goes on to say that only the Court of Justice of the European Union (CJEU) is competent to interpret EU law. Therefore, the commission notice is not binding on any of the EU member states, let alone the EPO.
“Alternative ways of producing the plant or animal should be explored, as well as investigating all of the downstream products and uses for the plants and animals.”
Until such time that the law itself is changed or a question is referred to the CJEU regarding patentability of plants and animals derived from essentially biological processes, current EU law and related case law continues to apply which, in theory, allows such plants and animals to be patentable. For the EPO, the Enlarged Board decisions in the Broccoli and Tomatoes cases can only be overturned by the president of the EPO if the EPC and/or implementing regulations are amended to include the exclusion.
A further point of note regarding the EPO suspension is that within the EPC itself there is only a mechanism for suspending proceedings generally when a particular issue is being determined by the Enlarged Board and the suspended cases will all be decided based on that issue.
There is no legal mechanism within the EPC for a broad suspension of proceedings based on other factors, and hence there is a serious question of whether the suspension is even allowable. The suspension cannot be appealed to the Board of Appeal at the EPO, and as the EPO lies outside of EU and national court jurisdiction, there is no mechanism for the suspension to be appealed elsewhere.
It is also interesting to note that, at the time of writing, key patenting jurisdictions within Europe that normally conduct an in-depth examination of national patent filings (for example, the UK and Germany) have not suspended national proceedings relating to such plant and animal technologies and have made no comment on either the commission notice or the EPO suspension.
Mitigating the effects
Irrespective of the rights and wrongs of the suspension, it has been put in place by the EPO and eventually a decision on possible law changes will be taken by the EU and its member states (and ultimately also by the EPO). The question therefore follows, ‘what should patent applicants be doing right now to mitigate the effects of the suspension and future-proof their patent portfolio against a potential change in law in due course?’. There are a number of actions that could potentially be taken depending on what stage the portfolio has reached.
Where a patent application undergoing examination has been suspended by the EPO, then if other subject matter can potentially be covered by the claims, applicants may wish to consider filing divisional applications in order to pursue subject matter not solely relating to the plant/animal deriving from the essentially biological processes.
Such subject matter may include downstream products deriving from the plant/animal (for example, a mixture of an extract from such a plant and other components) or technical uses of the plant/animal being derived from an essentially biological process. This approach would increase costs due to the additional fees payable for the divisional application, but would mean that there is a hope of obtaining some commercially useful patent protection while awaiting the currently indefinite suspension to be lifted by the EPO.
In the case where a patent application has yet to be drafted, then care should be taken not to focus the application on, for Europe at least, protecting the plant or animal as derived from an essentially biological process per se. Depending on the technology, alternative ways of producing the plant or animal should be explored, as well as investigating all of the downstream products and uses for the plants and animals and all, including the essentially biological processes, should be described in detail and as far as possible exemplified in the application as filed.
These alternative production methods as well as the downstream products and uses provide basis and exemplification for the future in case the law is changed to explicitly exclude the animals and plants produced by essentially biological processes.
The actions of the commission and EPO have resulted in a significant amount of uncertainty for those involved in production of plants and animals by essentially biological processes, but there are routes around this in order to try to ensure that useful patent protection can be obtained.
Jane Wainwright is a partner at Potter Clarkson. She can be contacted at: email@example.com
Jane Wainwright, Potter Clarkson, European Patent Office, patent, biotechnology, EPO, European Commission, European Patent Convention, plant variety, CJEU,