Report of the Committee on Biotechnological Inventions

A. De Clercq (BE), Chair

The Committee on Biotechnological Inventions met on 11 September 2018.

1.1. Patentability of antibodies

Ms Carine Crepin and Ms Brigitte Taravella gave a presentation after formation of a working group composed of different representatives from the pharmaceutical industry working in the field of therapeutic antibodies. Its' aim is to be better armed vis-à-vis the challenges faced with broad functional claims, and to build a partnership with the EPO in order to address the patentability requirements of antibodies. Several examples were shown on granted patents with broad claims such as "binding to an amino acid of an epitope", "compete for binding with a reference antibody" as well as broad use claims, all aimed at illustrating the current practice of the EPO, including problems resulting from inconsistent examination from one Examiner to another. The working group is aiming at partnering with the EPO to find a balance between too broad and too narrow claims, to understand and propose patentability requirements for the claims, to advance innovation and increase business certainty in this highly competitive field. A better predictability of the examination outcome and an increase in the quality of the examination will lead to strong and enforceable patents. A further point that was mentioned was the need to have greater transparency in the way these types of claims are examined, and ultimately to get access to the EPO Guidelines on patentability of antibodies as they are at the moment for internal use only. A discussion followed on the best way to find a balance between narrow and broad claims.

1.2. Patentability of plants and animals - amendments to EPC and GL

There was a report on a case by Syngenta Seeds Inc.: EP 12756468 - T1063/18-3.3.04 (New Pepper Plants And Fruits With Improved Nutritional Value) where the new EPO Rules and Guidelines would apply. The Applicant refused to insert disclaimers as required by current R. 28 EPC and the TBA summoned for oral proceedings. The oral proceedings are set forth for 5 December 2018. Several other applications in the plant field are following[1].

The Working Group for Guidelines in EPPC will meet end of September[2] to comment on proposed amendments, especially asking for further clarification on disclaimers in relation to R. 28 EPC with the EPO.

1.3. Guidelines

It was decided to set up, by means of the forum, a small ad hoc working group to review the EPO Guidelines for Examination. This working group shall liaise with EPPC.

2. 5 Nov 2018 EC Expert Group on Industrial Property Policy meeting - Brussels

On 5 November 2018, Ann De Clercq (Chair Biotech) was invited to a Meeting at the EC in Brussels of the Expert Group on Industrial Property Policy in the presence of outside experts to discuss the application of the Biotech Directive in the field of plants. Different stakeholders were present at this meeting and Francis Leyder (President epi) also attended. The following topics were discussed:

(1) Implementation of the Commission notice: Overview of the recent practices of the EPO and the Member States.
(2) Patentability of plants obtained by New Breeding Techniques of native traits
(3) Scope of protection of patents on native traits and products obtained by NBTs
(4) Access to genetic resources/developments of new varieties/farmers privileges

The questions for the panel 2 discussion on "Patentability of plants obtained by new breeding techniques and of native traits" were formulated by the Rapporteur of the panel as follows:

1) Rule 28(2) EPC says: "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." Assuming for a moment that this Rule is in conformity with what is said in Art. 53(b) EPC as interpreted by the Enlarged Board of Appeal, does this provision not guarantee adequately that only a very clearly defined category of plants obtained by specific processes are excluded from patentability?

2) One of the issues seems to be that in a growing number of circumstances it is impossible to distinguish and/or discern whether a plant has been obtained by an essentially biological process or a technical process. Do you think that the current legal framework tackles this issue sufficiently and why (not)? Please illustrate your views with examples.

3) Can patents obtained by technical processes be enforced against infringers under a scenario as per 2), and why (not)?

4) Do you have any suggestions as per 2) and/or 3)?

Ann De Clercq presented slides in the panel 2 discussion and defended a position which is in line with what is presented under point 5 below. It is not clear at this moment whether the EC will draft a report on this meeting or not.

3. 16 Nov 2018 User Life Science Groups - Liaison meeting at Boards of Appeal - Haar

On 16 November 2018, Ann De Clercq (Chair Biotech) was invited to a "User Life Science Groups - Liaison Meeting with the Boards of Appeal of the EPO - 2018" by Mr Carl Josefsson, President of the Boards of Appeal of the EPO. CIPA Life Science Committee and the UNION Lifescience Group have also been invited to participate in this common meeting with all chairs of the boards dealing with "life science", i.e. 3.3.01 (chair: Albert Lindner), 3.3.04 (chair: Gabriele Alt) and 3.3.08. (chair: Beat Stolz). Epi Biotech was represented at this meeting by Ann De Clercq (Chair Biotech), Chris Mercer (Chair EPPC) and Heike Vogelsang-Wenke (Vice-President).

4. 5 Dec 2018 User Consultation Conference on the Rules of Procedure of the Boards of Appeal - Munich

On 5 December 2018, Ann De Clercq (Chair Biotech) will attend the User consultation conference on the Rules of Procedure of the Boards of Appeal.

5. Comments Biotech Committee on draft Guidelines for Examination on R. 28 (2) EPC

The Biotech Committee has also provided its comments to the draft Guidelines for Examination on Biotech matters. Amongst these comments there was a comment to the Rule 28(2) EPC disclaimer:

5.1. Comments on the "Rule 28(2) disclaimer"

The following comments refer to the proposed amendments to the Guidelines for Examination in the EPO compared to the previous version as of November 2017. Many changes in the proposed guidelines relate to the need to introduce a disclaimer when claims are directed to plants characterized by a technical feature that may be the result either from a technical intervention or from an essentially biological process (EBP). The need for such a disclaimer seems to originate from the change to Rule 28(2) which now reads as follows:

Rule 28 - Exceptions to Patentability
...
(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.

The comments below are generally with regard to the disclaimer issue.

5.1.1. The legal basis for a Rule 28(2) disclaimer should be clarified first

Discussions about the need of a disclaimer seem to have started on the change to new Rule 28(2).

However, it should be noted that the legality of that rule change is currently being challenged before the Technical Board of Appeal of the EPO in T1063/18 with requests to refer several questions to the Enlarged Board of Appeal (EBA). Third party observations addressing concerns with regard to the rule change were filed in that case[3]. It is therefore requested not to introduce changes in the guidelines during the pendency of T1063/18 and any potential referral to the EBA[4],or in the alternative to clarify in the guidelines that the requirement for removing subject matter pursuant to Rule 28 (2) - by disclaimer or otherwise - is contingent upon the applicability of Rule 28(2) as it currently exists.

5.1.2. There is no absolute requirement for a disclaimer

Even if the current Rule 28 (2) remains applicable this does not necessarily "mandate" or "require" a disclaimer. The proposed guidelines use wording like "a disclaimer is necessary to delimit the claimed subject matter..." and "A disclaimer is required in all cases and, in particular, even if the description only mentions a technical method of production and is silent on the use of an essentially biological process.". In fact there does not seem to be a legal basis for doing so and the passages in the proposed guidelines that relate to the mandatory introduction of a disclaimer do not provide any legal authority by reference to standing case law of the EPO.

The EPC gives no basis for requiring introducing a disclaimer into any claim. To the contrary, it is standing case law of the Appeal Boards that the Applicant is solely responsible for wording of an application, including claims. Introducing the strict requirement of a disclaimer having no basis in the EPC in particular into claims of a specific technical field, drawn to a specific product by way of internal instructions is not in line with the provisions of the EPC[5]. Although nobody is legally bound by the Guidelines, the Examining and Opposition Divisions of the EPO are bound to comply with the Guidelines based on internal instructions. Examining and Opposition Divisions will therefore have no choice but to impose a disclaimer to applicants. The appeal boards of the EPO however are strictly and only bound by the EPC (Art 23 (3) EPC). Thus, introducing a disclaimer requirement for plants into the Guidelines will oblige Examination and Opposition Divisions bound to the Guidelines by EPO internal instructions to only propose that single unarguable solution, which applicants will have no choice but to appeal. Constantly having to appeal such decisions contradicts the principle of efficiency of proceedings and equity and good faith an applicant can rely on in a constitutional system.

In fact when looking at the notice on introduction of Rule 28 (2) (CA56/17 point 41) seems, when faced with claims including both natural and artificial mutant plants, to direct the practice in the opposite directions:

Some forms of mutagenesis occur in nature (usually called spontaneous mutagenesis). However, whether a specific mutation indeed would occur as the result of spontaneous mutagenesis is entirely speculative. Application of an exception to patentability cannot depend on hypothetical considerations and on whether specific process elements are traceable in the claimed product, in particular when taking into account the considerable developments in the technical field of plant Nbreeding in the past and the unpredictable nature of future developments. (emphasis added)

Furthermore in notice CA56/17 there is an entire section about use of disclaimers but this only generally points to the case law of disclaimers. Nowhere is there any suggestion that any disclaimer should be mandatory. Even in the proposed guidelines Part H, the use of a disclaimer and its form is left completely at the discretion of the applicant.

5.1.3. There is no need for a disclaimer - other options are available

If at all, applicants should be able to remove any subject matter from the claims by other means. In factat least one example of permitted claim language in the proposed guidelines seems to make this possible without the need for a disclaimer.

A mutant of a plant carrying a heritable exchange in a nucleotide sequence effected by technical means, e.g. UV mutagenesis or CRISPR/Cas

If Rule 28(2) remains applicable, it should be clarified that there are multiple ways in which the claims can comply with it and that the applicant is free to choose the wording of the claims.

In this case, other guidance with regard to acceptable claim language should be included. For instance, it is suggested - in the spirit of the above-cited example - to clarify that a claim reciting "a mutated gene" (rather than "a mutant gene") implies an active mutation step so that the requirements of Rule 28(2) are implicitly complied with. Other suggested alternative to comply with Rule 28 (2) could be "human created mutant gene", "manufactured" or "artificially induced mutant gene" or similar wording. In this respect, it may even be provided that the adjectives "mutated", "human created" or "artificially induced" would not necessarily have to find support in the specification to allow compliance with both R. 28(2) and Art. 123(2) EPC.

5.1.4. Introduction of "Rule 28(2) disclaimers" provides legal uncertainty

The proposed guidelines indicate that the disclaimer is required to exclude subject matter that is not patentable pursuant to Rule 28 (2) and seem to suggest that the disclaimer should be in the form of

" A plant ... provided that the plant is not exclusively produced by means of an essentially biological process".

In fact, in many applications applicants will have no choice but to use such wording because they have no support for other claim language that would effectively exclude subject matter that is not patentable pursuant to Rule 28 (2) and would run into restrictions with regard to the use of undisclosed disclaimers (as set forth in proposed guidelines Part H).

However it is submitted that a disclaimer in the form specified above is unclear and would introduce legal uncertainty both for applicants and third parties as it would be based on unclear terms (see below).

The term "essentially biological processes"

Rule 28(2) refers to processes by which the claimed plant product is obtained (i.e. essentially-biological processes). However the definition of essentially biological processes is not at all clear.

Rule 26(5) provides that:

A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection.[6]

This definition was taken over from the Biotech Patent Directive EC 98/44/EC and was necessarily the one used by the European commission in drafting their Commission Notice on certain articles of Directive 98/44/EC of the European Parliament and of the Council on the legal protection of biotechnological inventions (the "Commission Notice"). Indeed, the Commission Notice took the view that "the EU legislator's intention when adopting Directive 98/44/EC was to exclude from patentability products (plants animals and plant/animal parts) that are obtained by means of essentially biological processes". In addition the Commission Notice links the technical character of the invention to reproducibility.

However the EPO, in G2/07 deviated from the principle of alignment with 98/44/EC in adopting a
broader definition of an EBP and furthermore defines processes comprising steps of crossing and
selection as non-technical, irrespective of their reproducibility and technical character. This definition is reflected in the Guidelines Part G 5.4 and is used also for purposes of Rule 28(2) :

"Thus the exclusion extends to plants and animals exclusively obtained by means of an
essentially biological process where no direct technical intervention in the genome of the plants or animals takes place, as the relevant parental plants or animals are merely crossed and the desired offspring is selected for. This is the case even if technical means are provided serving to enable or assist the performance of the essentially biological steps. In contrast, plants or animals produced by a technical process which modifies the genetic characteristics of the plant or animal are patentable."

"Determining whether a plant or animal is obtained by exclusively n biological means entails
examining whether there is a change in a heritable characteristic of the claimed organism which is the result of a technical process exceeding mere crossing and selection, i.e. not merely serving to enable or assist the performance of the essentially biological process steps."

Therefore it remains unclear what is actually disclaimed with a disclaimer in the form set forth above since the scope of the disclaimer will depend on the definition of EBP that is adopted. It will be up to the Boards of Appeal of the EPO and/or the National courts to determine which definition is appropriate in the context of Rule 28(2).

This fundamental question is also raised in T1063/18 where one of the questions requested for referral to the ELBA is :

"What is the applicable definition for an essentially biological process in the context of Rule 28(2) EPC?"

Consequently, in line with the definition in the commission notice, the term essentially biological
processes should be clarified first before any disclaimer requirement based on such term should be considered to be introduced.

The scope of removal of Rule 28(2) subject matter (by disclaimer or otherwise)

The Guidelines in Section F IV 4.24 provide that:

"Claims defining plants or animals produced by a method including a technical step which imparts of technical feature to a product constitute an exception in so far as the requirements of Art 53 (b) are concerned"

This provision is not based on any precedent and is not binding on the Boards of Appeal of the EPO or on National Courts. It is however contrary to existing product-by-process EPO case law which consistently equates "obtained" as meaning "obtainable". It is therefore not certain how this would be decided in the end. Nevertheless, the outcome of such interpretation is especially important with regard to claims in the form "a plant obtained by a technical process" (which is a form of claim explicitly endorsed in the guidelines (see examples in Part G II 5.4.2.1) as well as to claims with a disclaimer which amount to "plants not obtained (exclusively) by an essentially biological process".

The term "exclusively obtained"

In principle offspring of a mutated plant that carry the mutation would be obtained by processes that involve only crossing and selection and could be regarded as plants exclusively produced by EBP. Although the guidelines provide that

"When looking at the offspring of transgenic organisms or mutants, if the mutation or transgene is present in said offspring it is not produced exclusively by an essentially biological method and is thus patentable"

it remains to be seen how the disclaimer would be interpreted with regard to offspring, especially in the case of potential infringers who have developed varieties based (unknowingly perhaps) on the basis of plants originally produced by a technical process. Such potential infringers may argue, that since "plants obtained exclusively by an essentially-biological process" have been disclaimed from the patent scope, offspring of the claimed plants, which are obtained only by crossing and selection, are part of the disclaimed subject matter and are therefore not infringing the patent, even though such claimed plants and their offspring originate from a process having created or modified a trait in their genome. Although this may not have been the intent of the legislator having created Rule 28(2), the consequence may well be for patentees that their technically-obtained plant inventions become so easily copied that applicants may consider not to file such applications any more this solely because of having been forced to introduce a disclaimer.

5.1.5. The introduction of a disclaimer aggravates undesired consequences of Rule 28(2)

As discussed above in section 4) the use of the disclaimer in the form set forth there results in legal uncertainty. It is simply not clear what subject matter is covered by a claim that has such a disclaimer. This is true from the perspective of both patentee and for the potential infringer[7].

An undesired effect of the new Rule 28 (2) seems to be that it allows that use is made of the information provided by a published patent application disclosing a trait that is introduced into a plant by technical means, to "copy" the invention by using "essentially biological processes". Indeed, the fact that it was technically created means that it is likely to be genetically characterized at DNA level in the patent application. As soon as the application is published the disclosed genetic information can be used in combination with current technologies to screen large plant populations to identify plants with the similar genetic change (which would then have occurred naturally). Plants obtained in such way would however then not necessarily be covered by claims of the patent under Rule 28 (2). Apparently, this seems to create a loophole for potential infringers to benefit from the teaching of a patent application and create products that would be non-infringing[8].

From a patentee's position the generation of such product obtained by EBP using the technical
information of a patent should be equivalent with having made such product by technical means and should therefore not fall under any disclaimed subject matter. Obviously the presence of a disclaimer in the form set forth above makes this problem even more visible.

5.1.6. Conclusions

The following comments should be taken into account when revising the proposed Guidelines:

The introduction of the need to remove subject matter in accordance with Rule 28 (2) - by
disclaimer or otherwise - should await resolution of cases such as T1063/18.
There is no overall need to remove subject matter - by disclaimer or otherwise solely on the ground of Rule 28 (2). It is well accepted that claims can cover subject matter that is not
patentable on its own (G1/98).
The introduction of a disclaimer would introduce legal uncertainty for all involved parties. If Rule 28(2) remains applicable in its current form, guidance should rather be provided on various other ways of claim construction, including by way of examples.

6. Remaining matters

In view of items 4 and 5 above, the epi Biotech Committee is updating its overview of the patent ability of plants in the Members States based on input of its members.

Ann De Clercq has requested to become an associate member of the epi Guidelines sub-committee

The Biotech Committee will also be involved in any other topics that come up for discussion related to Biotech or referred to it by EPPC or other channels.

The Biotech committee welcomes any epi member wishing to become an associate member who has a solid background in biotech and wishes to contribute to ongoing discussions in biotech patent matters. An email can be sent to the Chair of Biotech or the epi secretariat for applications.

The next meeting date of our committee is still to be scheduled in 2019. A meeting with the EPO Biotech Directors will also be scheduled for next year. The meeting with the Biotech EPO Directors may in the future be jointly organized with the meeting with the PAOC EPO Directors and EPPC.

T2734/18 (EP2825024) is a more recent other example
This has in meanwhile happened
These can be accessed at the EPO register under the documents with respect to European Patent Application EP 12756468. Observations by e.g. Prof. Kirchberg concluded that: The amendment/supplementation of Rule 28 ...contradicts the primacy of the Convention over the Implementing Regulations (Art. 164 para. 2 EPC). It also infringes the legitimate expectations based on the existing legal and judicial practice as a generally accepted procedural principle in the EPC contracting states (Art. 125 EPC). This is because of the retrospective application of the amended Rules which has been ordered. Finally, it also unjustifiably intervenes with the proprietary right to the European patent under Art. 60 EPC guaranteed by Art. 1 of the Additional Protocol I of the ECHR.
Before the change to Rule 28 (2) was introduced complaints were raised that claims directed to plants being issued in the plant breeding area might lack clarity and would somehow affect the freedom to operate of breeders. It should be pointed out that rather than applying the Rule 28(2), another option would be to ensure that claims to plants carrying a novel characteristic could only be granted when the genetic basis for such characteristic is clearly and unambiguously and reproducibly described in the specification. This would allow breeders to unequivocally determine whether any material in their possession would be infringing any such claim.
Further, it would give legal certainty to all involved parties what is patentable subject matter or not. Any still remaining freedom to operate concerns could be addressed by other legal means such as by a breeder's exemption, or by the prior use exemption or by (to some extend already existing) facilitated licensing offerings. Raising the clarity requirements for plant based inventions is actually already an ongoing process as is shown by developing case law (T0967/10, T1988/12).
There is precedent for not requiring a disclaimer even though the claims may encompass embodiments excluded from patentability (G1/98). Indeed plant varieties are clearly not patentable under Art 53 (b) EPC but there is no requirement for applicants to disclaim plant varieties from claims directed to plants. In this regard it may be important to note that Art 53 (b) and Rule 28(2) in defining exceptions to patentability use similar wording:
"European patents shall not be granted in respect of...". Furthermore, in a comparable situation, the European Patent Office now routinely grants claims directed to (human) stem cells without requiring a disclaimer to exclude stem cells obtained by a method which involves destruction of a human embryo although such methods excluded from patentability under Art 53(a) and Rule 28(1) (see e.g. EP 2455452, EP 2548950 or EP 2611910).
The Administrative Council when introducing the amendments to Rule 28 did not amend Rule 26(5), which consequently stays in place.
In this respect it should not be forgotten that, since the guidelines are not binding on the boards of appeal of the EPO and on national courts, neither party will necessarily be able to rely on the guidelines for interpretation of a disclaimer.
In this regard - as discussed above - the discussion resulting in the new Rule 28(2) seemed to have been primarily arising from the concern of breeders that they may be prevented from using traits that are subject of patents but that they had independently developed prior to patent publication. However, if Rule 28(2) remained applicable in its current form, breeders could also independently develop patented traits after patent publication even making use of the teaching of the patent.