Biological patents: an endangered species

Last August, while most of the patent profession was enjoying well-earned holidays, the Code de la propriété intellectuelle (CPI) was amended in a way that may significantly alter the fate of patents on biological materials.

So much so that my colleague Lionel Vial wonders whether France may become a safe haven for copies of patented plants.

Here are his thoughts on the subject.

The so-called law for the recovery of biodiversity, nature and landscape dated August 8, 2016, which entered into force on August 9, 2016, has introduced two amendments into the Code de la propriété intellectuelle (CPI).

The first amendment is the addition of a new paragraph in article L. 611-19 CPI:

I – The following shall be unpatentable:

1° Animal varieties;

2° Plant varieties as defined in Article 5 of Regulation (EC) No. 873/2004 […];

3° Essentially biological processes for the production of plants and animals. A process that consists entirely of natural phenomena such as crossing or selection shall be regarded as such;

3° bis Products entirely obtained by the essentially biological processes defined in 3°, including the elements constituting these products and the genetic information they contain;

4° Processes for modifying the genetic identity of animals which are likely to cause them suffering without substantial medical benefit to man or animal, as well as animals resulting from such processes.

II – Notwithstanding the provisions of (I), inventions which concern plants or animals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety.

III – The provisions of I (3°) shall be without prejudice to the patentability of inventions which concern a technical process, in particular a microbiological one, or a product obtained by means of such a process; any process involving or resulting in or performed upon a microbiological material shall be regarded as a microbiological process.

According to parliamentary discussions during the lawmaking process, this amendment was essentially triggered by decisions G 2/12 (Tomatoes II) and G 2/13 (Broccoli II) of the Enlarged board of appeal of the EPO. As a reminder, these two decisions provided that the exclusion of essentially biological processes for the production of plants from patentability in article 53(b) EPC does not extend to product claims directed to plants or plant materials such as plant parts.

The idea was also to push for a modification of European Union law, in particular of Directive 98/44/EC, after similar amendments were made in German and Dutch national laws (see Patentabilty of Plants in epi information 4/15:156-168).

However, the French version of this new exclusion from patentability is broader than a prohibition of patents on products entirely obtained by essentially biological processes, like in Germany and the Netherlands. Indeed, the exclusion also encompasses elements constituting these products and the genetic information they contain.

According to statements made by members of parliament promoting this amendment, the aim was to further prevent native traits of plants from being patented.

As a consequence, the exact scope of this new exclusion from patentability is not simple to delimit. Indeed, from a teleological point of view, it appears that elements from plants previously occurring in nature are also intended to be excluded from patentability by this provision. In contrast, based on a literal approach, only elements from plants entirely obtained by essentially biological processes, and thus obtained by human action, should be excluded from patentability. This would also be consistent with article 3.2. of Directive 98/44/EC per which

Biological material which is isolated from its natural environment may be the subject of an invention even if it previously occurred in nature.

The impact of the amendment of article L. 611-19 CPI should nevertheless be relatively limited, as it applies only to French patents. Besides, the INPI (French patent and trademark office) had already decided, before the entry into force of the new law, that it would not apply G 2/12 and G 2/13 and that it would refuse to grant French patents pertaining to biological material obtained by essentially biological processes.

But lawmakers also added a third paragraph in article L. 613-2-3 CPI which defines the protection conferred by a patent on biological material and which applies both to European and French patents (possibly including those already granted before the entry into force of the new law):

The protection conferred by a patent on a biological material having specific characteristics as a result of the invention shall extend to any biological material derived from that biological material through propagation or multiplication and having the same characteristics.

The protection conferred by a patent on a process for producing a biological material having specific characteristics as a result of the invention shall extend to biological material directly obtained through that process and to any other biological material, derived therefrom, by reproduction or multiplication and having the same characteristics.

The protection conferred by a patent relating to a biological material having specific characteristics as a result of the invention does not extend to biological materials having these specific characteristics, obtained independently from the patented biological material and by an essentially biological process, nor to biological materials obtained therefrom, by reproduction or multiplication.

Our readers may have difficulties determining the exact scope of this exclusion from patent protection. If so, we would be inclined to think that this is not entirely due to the translation, as the French text itself is quite cryptic.

Let’s try to get things straight.

The aim of this amendment is mainly to prevent seed makers who use essentially biological processes to generate genetic diversity when producing new seeds from being prohibited to use or sell the new seeds thus obtained because of existing patent rights.

An enlightening example for understanding the motives of the lawmakers in this regard relates to the aphid-resistant lettuce case which was referred to by several members of parliament during the debates.

In this case, the French seed maker Gautier Semences, a family business, was allegedly forced into a license agreement with Rijk Zwaan in respect of European patent EP 0921720, to be able to continue to market the aphid-resistant lettuce seeds it had been selling before the patent was filed.

As a side note, claim 1 of the patent as maintained in amended form after opposition proceedings reads as follows:

Lettuce plants of the species Latuca sativa L. which are resistant to the aphid Nasonovia ribisnigri due to presence in the genome of the Nr resistance gene, characterized in that the genetic information responsible for the CRA phenotype is absent from the genome of the plant at least to such an extent that in the presence of the Nr gene in homozygous condition the CRA phenotype is not expressed.

But how on earth could this patent be enforced against Gautier Semences, as they should benefit from prior user rights? In addition, shouldn’t there be a serious novelty issue in view of the seeds marketed by Gautier Semences?

The response is that in theory Gautier Semences should indeed have been immunized against the effects of Rijk Zwaan’s patent. However, evidence of prior user rights or of public prior use may be difficult to provide, especially for an SME.

The new provision should therefore facilitate the defense of those marketing biological materials covered by a patent, when the materials were obtained by an essentially biological process. However, it will probably still be necessary for those wishing to take advantage of this provision to prove the latter fact.

Besides, it should be noted that the new provision goes beyond simply addressing situations such as the above aphid-resistant lettuce case, as it applies to any biological material obtained by an essentially biological process, irrespective of whether it was obtained before or after the patent was filed.

Now that we have a better view of the aim of the new provision, let’s examine two interesting consequences.

The first one is in relation to the meaning of the expression “essentially biological processes”.

At least we can tell that this plant material was not obtained by an essentially biological process.
At least we can tell that this plant material was not obtained by an essentially biological process.

This expression is not defined as such in the rest of the statute. Reference is made to “essentially biological processes for the production of plants and animals” in Article L. 611-19 3° CPI. The same article also provides that “processes that consist entirely of natural phenomena such as crossing or selection shall be regarded as [biological processes]”.

Accordingly, it is possible that the expression “essentially biological processes” in Article L. 631-2-3 CPI could be construed as not being limited to processes entirely consisting of natural phenomena such as crossing or selection.

This may be apparent from the parliamentary history of the new provision which, until the last round of amendments and vote (out of 7!) still recited:

The protection defined in the first paragraph of the present article does not extend to the biological materials entirely obtained by the essentially processes defined in the third paragraph of part I of article L. 611-19 CPI.

The result of this last minute amendment, the justification of which was to protect the French seed industry, was to cancel any explicit reference to a process that entirely consists of natural phenomena such as crossing or selection being regarded as a biological process.

A consequence could therefore be that plants obtained by a process involving, among steps of a biological nature such as crossing or selection, a step of random mutagenesis, and having properties similar to a plant covered by a patent, could be considered as being obtained by an essentially biological process and would thus be excluded from patent protection.

Indeed, the French union of seed makers (Union Française des Semenciers) for instance considers that random mutagenesis, e.g. by the use of chemical agents or ionizing radiations, yields native traits, i.e. traits that could be obtained through natural processes

It will be interesting to see how case law will develop in this regard, especially in view of new mutagenesis techniques, such as the superstar CRISPR/Cas9 technique for which Monsanto has just secured a non-exclusive license.

Another consequence of this last minute amendment, which might be seen as a huge side effect, is that the exclusion from patent protection set by the new provision in article L. 613-2-3 CPI is not confined to plants and animals but now encompasses all biological materials and potentially microorganisms.

Again, it remains to be seen how patents pertaining to isolated microorganisms endowed having specific characteristics, e.g. food transformation or health properties, will be enforced against microorganisms having these characteristics but which were isolated independently from the patented microorganisms.

At present, there is no way for patentees to escape the new provision. However, there might be one in the future owing to the Agreement on a Unified Patent Court. Indeed, the limitations of the effects of a non-opted out European patent will be defined by Article 27 of the Agreement… and not by the French statute. That is, if the agreement ever enters into force…

Many thanks, Lionel. Struggling to figure out what a new legal provision exactly means, and guessing about unintended fallout are probably the perks of every single patent law reform.

Conformity of the new provisions to the biotech directive 98/44/EC could also be an interesting and tricky question. All the more so that the European Commission released a notice which was published in the Official Journal of the European Union a few days ago.

The notice addresses a number of aspects of the biotech directive. It is in particular stated that:

The Commission takes 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.

The Commission’s view is thus contrary to the position taken by the Enlarged Board of Appeal and on the face of it consistent with at least part of the recent amendment of French law.

Clearly, patentability of biological materials in Europe is on moving grounds right now. I would not be surprised if there were more episodes of a tomato, brocoli or lettuce saga coming up in the near future.