Plants and Animals Exclusively Obtained by Biological Processes Not Patentable at EPO

By James Nurton
May 18, 2020

“The EPO Enlarged Board of Appeal said the exclusion in Rule 28(2) is ‘not incompatible with the wording of Article 53(b)’ and the exception in Article 53(b) ‘is to be understood and applied as extending to products exclusively obtained by means of an essentially biological process or if the claimed process feature defines an essentially biological process.’”

https://depositphotos.com/86141172/stock-photo-european-patent-office.htmlThe Enlarged Board of Appeal (EBA) of the European Patent Office published opinion G 3/19 “Pepper” on Thursday, May 14, holding that plants and animals exclusively obtained by means of an essentially biological process are excluded from patentability. The opinion, which arose via a referral from the EPO President, also set out principles regarding the interpretation of the European Patent Convention (EPC) that could apply in other technical fields.

This is the sixth case in which the EBA has considered questions regarding the exceptions to patentability in Article 53(b) of the EPC, which states that European patents shall not be granted in respect of “plant or animal varieties or essentially biological processes for the production of plants or animals.”

The particular questions in this case arose from Rule 28(2), a new paragraph introduced into the Implementing Regulations by the EPO’s Administrative Council, which came into force on July 1, 2017. Rule 28(2) was supported by 35 of the 38 EPO Contracting States, with just one voting against, and states: “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” (emphasis added). Rule 28(2) was adopted to align the EPC with the EU Biotech Directive.

The Pepper case arose from a European patent application filed by Syngenta Participations AG for “New pepper plants and fruits with improved nutritional value.” In December 2018, the Technical Board of Appeal (Case T 1063/18) found that Rule 28(2) was in conflict with Article 53(b) as interpreted by two earlier EBA decisions (G 2/12 “Tomatoes II” and G 2/13 “Broccoli II”). These two decisions, which pre-dated the introduction of Rule 28(2), found that the non-patentability of essentially biological processes for the production of plants or animals did not extend to products exclusively obtained by means of an essentially biological process.

Plant or animal products obtained by essentially biological processes are excluded from patentability in 10 of the 38 EPO Contracting States, and similar exclusions are planned in some other states.

Dynamic Interpretation

The Technical Board’s decision prompted the President to refer two questions to the EBA in April 2019. As the referral came from the President, the patent applicant was not a party before the Board and there were no oral proceedings. However, the Board did take account of 41 amicus curiae briefs from a wide range of companies, law firms and organizations.

The two questions addressed essentially: (1) the scope of the Administrative Council’s power to adopt/amend Rules that give a different interpretation of the EPC compared to earlier EBA decisions; and (2) the proper interpretation of Article 53(b) following the adoption of Rule 28(2).

In its opinion, the seven-member Enlarged Board re-phrased and combined the two questions, as it found them “too general and unspecific.” Instead, it asked whether the exception in Article 53(b) could “have a negative effect on the allowability of product claims or product-by-process claims directed to plants, plant material or animals, if the claimed product is exclusively obtained by means of an essentially biological process or if the claimed process feature define an essentially biological process.”

The EBA concluded that the issues underlying the referral concern a point of law of fundamental importance which requires a uniform application, and that the question whether an amendment to the Implementing Regulations can have an impact on the interpretation of an Article of the EPC is one on which two Boards of Appeal have given different decisions.

Turning to the substance, the EBA said that neither a grammatical, systematic or teleological reading of Article 53(b) was satisfactory. Rather, it favoured a “dynamic interpretation” of the EPC, thereby rejecting the notion that decision G 2/12 had settled the Article 53(b) issue “once and for all.” The Enlarged Board said the Technical Board’s notion that G2 2/12 represented a definitive interpretation was “too strict” and added: “A particular interpretation which has been given to a legal provision can never be taken as carved in stone, because the meaning of the provisions may change or evolve over time.”

The Enlarged Board said it cannot now ignore the decision to introduce paragraph 2 into Rule 28 when interpreting Article 53(b), and it rejected arguments in certain amicus submissions that it could disregard the adoption of Rule 28(2).

As a result, the Enlarged Board endorsed the conclusions in the G 2/12 case but noted that Rule 28(2) meant that “the legal and factual situation underlying decision G 2/12 has substantially changed.” The exclusion in Rule 28(2) is “not incompatible with the wording of Article 53(b)” and the exception in Article 53(b) “is to be understood and applied as extending to products exclusively obtained by means of an essentially biological process or if the claimed process feature defines an essentially biological process.”

However, to ensure legal certainty, this new interpretation has no effect on European patents granted before July 1, 2017 or pending applications filed before that date.

Greater Legal Certainty?

EPO President António Campinos said in a statement: “I strongly welcome the opinion of the Enlarged Board of Appeal. It will bring greater legal certainty for patent applicants, and the general public, on what is a sensitive and complex issue that has legal, societal and economic implications.” The Office will implement the opinion’s guidance in examination practice, and proceedings that were stayed while the referral was pending will be resumed.

According to the opinion, there are 18 appeals pending against decisions based on Rule 28(2) at the EPO, as well as about 250 examination and seven opposition cases in which its application could be decisive.

The opinion was welcomed by No Patents on Seeds!, which represents charities and campaign groups. Martha Mertens of Friends of the Earth Germany said: “For more than ten years we have been fighting against patents such as those on broccoli, tomatoes, peppers, melons and cereals. Therefore, we welcome this verdict in the name of the European public, gardeners, farmers and consumers. Knowledge of methods of breeding plants and animals continues to evolve as a common good from the activities of farmers and breeders over centuries, it is not invented by industry. In future, conventionally bred plants and animals have to be kept available for further breeding.”

Sygnenta was invited to comment for this article but did not immediately respond.

Comments on social media highlighted the fact that the opinion brings the EPO into line with the EU Biotech Directive, and also raised concerns about the possibility of the Administrative Council making clarifications to other Articles of the EPC in future:

Image Source: Deposit Photos
Copyright: Joeppoulssen
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The Author

James Nurton

James Nurton is a freelance journalist and editor, based in London, United Kingdom. He was previously editor of Managing Intellectual Property magazine and has worked on publications and events for AIPPI, AIPLA, INTA, WIPO, the EPO and EUIPO. He is editorial consultant to MARQUES and a partner of Lextel, which provides editorial and thought leadership services to law firms.

For more information or to contact James, visit his Firm Profile Page.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author as of the time of publication and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 9 Comments comments.

  1. Anon May 18, 2020 10:46 am

    exclusively.. essentially… smacks simply of very poor writing.

    When one thinks of ‘exclusively’ in the sense of its use here, one does not permit wiggle room – which is exactly what ‘essentially’ provides.

    Are genetic modifications, which ONLY take effect through the natural course of nature’s actions (think Monsanto genetically modified plants which pass on the herbicide resistance entirely through nature’s actions of seed generation) now NOT covered?

    What part of the natural process of planting a seed, growing a plant and then using that plant’s own seeds as a next generation of plantings fall outside of ‘essentially’ for the natural mechanics of how the seed is generated?

    Let’s not mistake the fact the desired attribute allows application (by man or machine) of poisons that destroy OTHER undesirable plants in the vicinity of the plant being grown. The actual mechanics of the genetic trait being carried forward is SOLELY an act of nature.

  2. MaxDrei May 19, 2020 5:56 am

    The controversial aspect of all of this is, who is Europe’s supreme authority on eligibility/patentability. It’s a “separation of powers” issue isn’t it, James?

    There is no court of appeal sitting on top of the EPO’s Enlarged Board of Appeal, that was created by the 1973 European Patent Convention, to decide the meaning of the provisions of the EPC. So you would think that the EBA interpretation of the EPC would be final.

    But now we are told that its interpretations are instead “dynamic”. How did that happen then?

    The EPC is not an EU Convention. There are many more EPC States than EU Member States. Turkey, for example. The EPO’s Administrative Council (on which all EPC Member States sit), its AC, has already amended the EPC Implementing Regulations though, to fit better with the EU Biotech Directive.

    And now, one stage further along, the EPO’s EBA has taken it upon itself to tweak what the European Patent Convention itself declares, in order to align with those AC-tweaked administrative regulations. Is the AC then, de facto, the legislative branch, in effect writing new legislation which the judicial branch (the EBA) then has to adjudicate?

    If you want to change the EPC, the Convention itself declares, you have to have a conference of all the EPC Member States. It is above the EBA’s “pay grade” itself to change the EPC.

    But, these days, it is hard to organise inter-Governmental Conferences that revise Treaty provisions. Other means have to be devised, eh James?

  3. Anon May 19, 2020 8:46 am

    MaxDrei,

    It seems like the “you are banal” comment hit home, and you are attempting to channel your response into the mode that I use when I talk about the actual Separation of Powers issue in US patent law.

    To tell you the truth, I fear that I do not know enough to be able to say whether or not ANY type of Separation of Powers meme would apply to the difference between the EU and the EPC, and how you are trying to fit the different pieces of the various political entities together.

    I do know this though: your grasp of law and even patent law is woefully inadequate and you attempt to continuously try to fit the Ends that you want to be an answer, even when it is painfully obvious that such is not the answer.

  4. Anon May 19, 2020 10:39 am

    Legal certainty…?

    For whom? (Emphasis added)

    However, to ensure legal certainty, this new interpretation has no effect on European patents granted before July 1, 2017 or pending applications filed before that date.

    Since “pending” opens a substantial window of time, what this does is create a certain level of UNcertainty into the future.

    I would posit then that the better implementation would be that the change in law is set at the date it is set, and that any item going forward in order to earn patent rights simply — and uniformly — must adhere to the law in order to be granted.

    I “get” the “no ex post facto” aspect, and would apply that to items already granted, but not to items still in the process of being vetted to the law.

  5. James Nurton May 21, 2020 12:02 pm

    MaxDrei – I think you raise some interesting points. Clearly making any change to the EPC is very difficult, particularly now the EPO has 38 Contracting States (and remember how long it took to do EPC2000!). It seems like the EBA has identified this issue as a particularly challenging one (hence six cases in the past few years) and tried to make its ruling correspondingly narrow.

    But time will tell if it is applied more widely. It’s difficult to think of other areas where the EU/EPO tension is as clear (especially since the failure of the Software Directive). Only 11 of the EPO Contracting States are not EU Member States, but these include economically important countries such as Switzerland, Norway, Turkey and of course now the UK, and it’s possible more countries may join the EPO. If the EU decides in future to legislate on topics that touch patent law (eg software, AI or cleantech) then this decision might set a challenging precedent. The European Commission has also mooted the EPO playing a role in assessing essentiality of FRAND patents (although I sense some resistance to that idea) so that may be another source of tension?

  6. MaxDrei May 21, 2020 4:06 pm

    Thanks James. FRAND eh? It’s OK if the EBA looks at eligibility/patentability, but ruling on the scope of rights given by registration strikes me as ultra vires.

    On the Kluwer blog is a parallel 27 comment thread. Link below. My comment is the last before the thread closed. Here it is:

    “Each of the seats on the AC is occupied by a representative of a national government that has a working majority in the Parliament of a sovereign State that is ruled as a representative democracy. If these States wish to set up a multi-national, supra-national agency for granting patents, what’s to stop them? So long as that agency does nothing more than filter what gets through to grant, all it is doing is confining within limits what can be patented.

    Patents are a restraint of trade. Some say that the patent system has had its day and that patents should be abolished. Not me. But public acceptance (and my acceptance) requires that any “creep” of patent rights into areas where the harm they do outweighs the good work they do (in promoting the progress of technology) should be blocked.

    Worse things can happen, than that the EPO acts to hold patent rights within limits. It is not as if the current President of the EPO is, on this particular occasion, abusing any basic human rights (for example, those of::::::::::::::::

    http://patentblog.kluweriplaw.com/2020/05/15/enlarged-board-of-appeal-plants-and-animals-cannot-be-patented-after-all/?doing_wp_cron=1590091214.4760301113128662109375

  7. Anon May 21, 2020 8:35 pm

    any “creep” of patent rights into areas where the harm they do outweighs the good work they do (in promoting the progress of technology) should be blocked.

    And just who is to decide that notion of ‘outweigh’ ? How is that decision to be made? Based on what?

  8. MaxDrei May 22, 2020 3:03 am

    Who is to decide: the supreme court. How is it to decide? By enquiring into what, as of today, “the useful arts” of the patents clause of the US Constitution.

    Or, outside the USA, what GATT-TRIPS means by a “field of technology”.

    Based on what? Philology.

  9. Anon May 22, 2020 3:44 am

    So, “outside of the Useful Arts” is synonymous with “harm outweigh the good?”

    You are wrong in more than one way.

    “Exceptions” are things otherwise within a category (claims in Alice were stipulated by both sides TO BE to machines, Step 1 of the Alice/Mayo test routinely satisfies the statutory category test, and yet are tossed.

    You do realize that this decision is NOT within the power of the US Supreme Court, right? This is a writing of patent law — statutory law — and in our Sovereign, this power was provided ONLY to one particular branch of the government.

    Maybe you should restrain yourself in discussing things you understand so little about…