Stay ordered in a rush

Today’s post will remain delightedly short – for once – as I would just like to update readers on the currently hot topic of “biological patents” (this expression being a shortcut of course). 

At the end of a recent post co-penned with Lionel Vial, I briefly mentioned a notice by the European Commission regarding the so-called biotech Directive 98/44/EC. The Commission took the view in this notice that the EU legislator’s intention in the Directive was to exclude from patentability products (plants/animals and plant/animal parts) that are obtained by means of essentially biological processes.

This view by the Commission is contrary to the position recently taken by the Enlarged Board of Appeal in decisions G 2/12 and G 2/13 of the Tomato and Broccoli sagas. The final words in the post were that patentability of biological materials in Europe is currently on moving grounds, and that more episodes of this developing story were to be expected.

No, this is not an illustration of a EU commissioner. I was just wondering whether this creature was obtained through an essentially biological process.
No, this is not a picture of a EU commissioner. I was just wondering whether this creature was obtained through an essentially biological process.

However, what Lionel and I did not expect is that the new developments would be so quick.

According to a notice from the EPO dated November 24, 2016 (but actually published only on December 12), “follow-up measures” further to the Commission’s notice are under discussion with representatives of the member states of the European Patent Organisation.

In the meantime, the president of the EPO has decided that all proceedings before examining and opposition divisions in which the decision depends entirely on the patentability of a plant or animal obtained by an essentially biological process will be stayed ex officio.

This notice from the EPO does come as a surprise.

Clearly, the notice from the European Commission has no binding effect on the EPO. The EPC is a non-EU international agreement. Rule 26 EPC specifies that the biotech Directive shall be used “as a supplementary means of interpretation” when it comes to European patent applications and patents concerning biotechnological inventions. But there is no organic link between EU institutions and the EPO. Thus, the EPO or the Enlarged Board of Appeal may very well have a different interpretation of the biotech directive than the EU institutions.

On the other hand, since the majority of the EPC contracting states are members of the EU (and this is supposed to remain the case in the future, Brexit notwithstanding), some consistency between the approaches taken by the various institutions involved would be highly desirable.

Gossip has it that the president of the EPO is looking for any opportunity to throw tomatoes (or broccoli) at the Enlarged Board of Appeal – things between them being what they are. Now, gossip is seldom reliable; but is it conceivable that the EPO management might currently show less deference to the Enlarged Board’s views on a number of topics than in the past?

What will happen next is anyone’s guess – though of course the stay of proceedings does not bode well for biological product patents or applications.

  • Will the EPO align its practice on the Commission’s notice? If so, how? Will an amendment of the Implementing Regulations be proposed?
  • Shouldn’t the EPO wait first for the Court of justice of the EU to have its say on the matter, one way or another? After all the Luxembourg judges may not necessarily share the same interpretation of the Directive as the Commission.

The bottom-line is that the fate of products obtained by essentially biological products is becoming again very much a matter of public policy.

In this respect, it is quite interesting to note that France, sometimes mocked by its neighbors for its handling of patent matters, was first to act before the Commission’s notice, as reported in the earlier post.

Finally, as explained by Lionel in the post, most interesting is the definition of which processes are essentially biological and which processes are not. Various stakeholders have vastly different views in this respect. Is it possible that, on this issue as well, the Boards of Appeal’s position could at some point of time be at odds with that of member states or EU institutions?

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.

Open Sesame! (part 2)

This is the second part of Aujain Eghbali’s walk-through post on the Sesame decision on business methods.

In the first part, Aujain demonstrated that the Paris Cour d’appel confirmed the refusal of Sesame’s application by applying the same general principles as those relied upon by the EPO.

As he is a man of paradox, he will now show us that the French judges did in fact not use an EPO-compliant approach in their ruling.

Here is to him.

First, a few words on the EPO-compliant approach.

The EPO nowadays almost systematically rejects business method software claims on the ground of a lack of inventive step.

Art. 52 EPC provides:

(1) European patents shall be granted for any inventions, in all fields of technology, provided that they are new, involve an inventive step and are susceptible of industrial application.

(2) The following in particular shall not be regarded as inventions within the meaning of paragraph 1:(…)(c) schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers;(…).

(3) Paragraph 2 shall exclude the patentability of the subject-matter or activities referred to therein only to the extent to which a European patent application or European patent relates to such subject-matter or activities as such.

The Boards of appeal wanted to clear all debates on the interpretation of the expression “as such” in the Convention. Furthermore, they departed from the so-called “contribution approach”, and came to consider that the exclusion of subject-matter under Art. 52(2) EPC had to be determined without any knowledge of the prior art. As a result, the established case law is now that any tangible element or tangible action in a claim qualifies as a technical feature and allows the claimed subject-matter to pass the hurdle of Art. 52(2) EPC.

Any patentability issues related to the non-technical aspects of a claimed subject-matter are then addressed within the assessment of inventive step.

This is explained in landmark decision T 258/03 (Auction method/HITACHI):

4.6. The Board is aware that its comparatively broad interpretation of the term “invention” in Article 52(1) EPC will include activities which are so familiar that their technical character tends to be overlooked, such as the act of writing using pen and paper. Needless to say, however, this does not imply that all methods involving the use of technical means are patentable. They still have to be new, represent a non-obvious technical solution to a technical problem, and be susceptible of industrial application.

Another landmark decision T 641/00 (Two identities/COMVIK) established the framework for assessing inventive step of a claimed subject-matter consisting of a mixture of technical and non-technical features (“mixed-type claims”): all features which contribute to said technical character should be taken into account, whereas features making no such contribution cannot support the presence of an inventive step.

The reasoning is basically a three-step process:

a. What is the technical character?

b. Which features contribute to the technical character?

c. Do these features (and these features only) form a non-obvious technical solution to a technical problem with respect to the prior art?

When the EPO believes that a claim relates to a mere automation of a business method, as the Cour d’appel considered in Sesame, the answers to these three questions are the following:

a. Automation of human and business activities (in this case related to haulage).

b. A system with hardware and data structuring and communication capabilities.

c. No, because the hardware and the data structuring and communication capabilities are conventional. (This last assertion can possibly be held merely on the basis of common knowledge.)

Thus, the reasoning leads to a finding of lack of inventive step for business method software claims.

It seems that French judges do not want to bother with such theoretical and complex legal reasoning. For instance, as already reported on this blog, the Paris Tribunal de grande instance recently held that a claim directed to a “storage medium storing [a computer program]” fell under the exclusion of computer programs as such – although the EPO would have given weight to the presence of the “storage medium” feature in the claim.

The Cour d’appel de Paris confirmed this stance in Sesame. It was held that, although a computer system is recited in the claims, the subject-matter was excluded from the scope of patentability under Art. L.611-10-2° of the Code de la propriété intellectuelle (that is, the equivalent of Art. 52(2) EPC). Said the Court:

The legislator was not concerned with the phrasing of the claims.

The spirit of the statutes is to exclude patentability of solutions that are not at a technical level but at a business level.

The director of the INPI should thus appreciate the existence of an invention without being bound by the wording used in the claims.

By proceeding in this way, he did not alienate the claims. 

It even seems that the judges did not consider the different invalidity grounds to be exclusive from one another. Indeed, the court additionally found that the claims were manifestly not novel:

It obviously results from [the fact that the invention is directed to a mere automation of a business method] that the claims do not call for any search as they manifestly lack novelty.

Sesame is also the name of a famous street.

Sesame is also the name of a famous street.

But there is certainly another (procedural) reason for the Court’s approach in the present case.

Under French law, the INPI does not assess inventive step in examination proceedings. The grounds under which the director of the INPI may refuse a patent application are listed in Art. L. 612-12 and lack of inventive step is not one of them. Lack of inventive step is only a ground for patent invalidation in an inter partes trial.

As a direct consequence, the INPI cannot, from a legal standpoint, follow the Comvik approach to refuse an application directed to a business method, when the claims incorporate tangible features. Such an application can only be refused under Art. L. 612-12 if:

  • it relates to subject-matter which can manifestly not be considered as an invention (exclusion from the scope of patentability), or
  • it has not been amended, after an invitation to do so, although the lack of novelty manifestly results from the search report.

In the Sesame case, the INPI retained the first solution and did not even conduct a prior art search, declaring that no relevant comparison with the prior art could be performed, as no technical features were claimed except for a very conventional computing system.

The Court not only approved but also considered that the explanations of the director of the INPI regarding the impossibility to establish a search report were “unnecessary”, as the actual ground for refusing the application was not the lack of novelty but the exclusion from the scope of patentability.

So, it is true that the INPI reached the same conclusion that the EPO probably would have reached, i.e. the invalidity of the haulage platform claims. But by relying on the ground of ineligibility, the INPI totally discarded the raison d’être of the Comvik approach.

In fact, the patentability assessment of mixed-type claims is often a complex question. This is probably why the EPO established the sophisticated Comvik approach.

This Comvik approach starts by determining the claim’s technical character and those features that contribute to said technical character. But the EPO is well-aware that these first steps of the reasoning are not always easy to conduct (see T 1749/06).

Therefore, one often has to perform the first steps with some knowledge of the prior art. The Comvik approach provides exactly for that, because non-technical aspects are assessed within the inventive step analysis.

This is explained in the EPO Guidelines for examination (G-VII, 5.1):

Determination of the features contributing to the technical character of the invention should be performed for all claim features in step (i) (T172/03, T154/04). However, in practice, due to the complexity of this task, the examiner can normally perform the determination in step (i) on a prima facie basis only and perform the analysis at the beginning of step (iii) in a more detailed manner. In step (iii), the technical effects achieved by the differences over the selected closest prior art are determined. The extent to which the differences contribute to the technical character of the invention is analysed in relation to these technical effects. This analysis, limited to the differences, can be performed in a more detailed manner and on a more concrete basis than the one performed at step (i). It may therefore reveal that some features considered in step (i) prima facie as not contributing to the technical character of the invention do, on closer inspection, make such a contribution. The reverse situation is also possible. In such cases, the selection of the closest prior art in step (ii) might need to be revised.

When performing the analysis in steps (i) and (iii) above, care should be taken to avoid missing any features that might contribute to the technical character of the claimed subject-matter, in particular if the examiner reproduces his understanding of the subject-matter of the claim in his own words during the analysis (T 756/06).

For that reason, EPO examiners nowadays often conduct a prior art search anyway, even when they are to refuse the application for a lack of any other technical contribution than a mere automation of a non-technical method. This is however not how the EPO examiner who was in charge of conducting the search on behalf of the INPI behaved in Sesame. Indeed, the EPO examiner did not issue a search report but rather declared that no meaningful search could be performed.

By allowing the INPI not to conduct any prior art search in such a case, the Sesame decision could be broadly construed as authorizing examiners to directly refuse applications when they are faced with mixed-type claims, based on their sole interpretation of the application.

Examiners could do so even in cases in which it is not so clear which features contribute to a technical character and which ones do not.

In the present case, the Cour d’appel held that both the absence of an invention and the lack of novelty were clear. However, looking at the decision in detail, it seems that a significant reasoning actually had to be conducted in order to reach such a conclusion.

Why is the INPI not entitled to refuse an application on the ground of lack of inventive step but only on the ground of the manifest absence of an invention or a manifest lack of novelty? One explanation is that the INPI is not supposed to rely on a subjective analysis to refuse an application. The law reserves the exercice of such subjectivity to litigation.

But the question of whether a business method software invention only relates to mere automation or implies further technical considerations is usually not an easy one which can be answered without any subjectivity. Even experts in that field cannot give an answer in a straightforward manner.

It is thus questionable that the INPI should suddenly be entitled to do so. The only explanation would be that granting a patent which is invalid because it merely relates to a business method is somehow worse than granting a patent which is invalid because it relates to a solution made obvious by a combination of two prior art teachings – for example from the standpoint of legal certainty. But the decision does not provide any hint in this respect.

We thus have to wait and see how INPI examiners will behave. It will notably be interesting to monitor if they rely on Sesame to refuse mixed-type claims on a regular basis. Also, it will be interesting to see how they behave in case the EPO conducts the search (instead of declaring it meaningless) and accompanies the search report with a written opinion where the ground of invalidity is… a lack of inventive step. Will the INPI bypass the reasoning of the EPO examiner and merely refer to Sesame?

Many thanks, Aujain. So, we are left with the question of whether Sesame has planted a seed at the INPI. If readers have any intel on this, comments are welcome as usual.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, February 26, 2016, Sesame Active System v. Directeur général de l’INPI, RG No. 15/01962.

Open Sesame! (part 1)

I have always thought of case law decisions as well as experts’ commentaries on the patentability (or rather the unpatentability) of business methods as a tough read.

Fortunately for many bloggers and authors around the world, the name of one of the most significant recent U.S. decisions in this respect, namely Alice Corp. v. CLS Bank International, has elicited a mass of enjoyable headings and extended metaphors (most of them involving Wonderland one way or another) making the read somewhat more fun.

We in France did have a relatively significant recent decision on this topic as well.

And fortunately for us French bloggers and authors, the decision’s designation, Sesame Active System v. Directeur général de l’INPI, also makes a number of (bad) puns possible.

Even more fortunately for me, my partner and friend Aujain Eghbali agreed to comment on the case, in a two-part post. He does the hard work, I make the bad puns, teamwork at its best.

So thanks to Aujain, the Sesame ruling will now open up for us.

In the case at hand, Sesame Active System filed a patent application before the INPI (French patent and trademark office) in 2012 to protect a communication platform dedicated to light commercial vehicle goods transportation or haulage. The platform receives and compares information related to charterers’ offers and carriers’ capacities and constraints, so as to send most relevant offers to carriers who can thereby optimize their load. The platform has a specific architecture and specific software, and it processes data concrete and specific to vehicle loading. The platform optimizes such vehicle loading and thereby offers many advantages including global traffic reduction.

In 2013, the INPI sent a communication declaring that no search report could be established and that a rejection was to be expected, as the application related to subject-matter excluded from the scope of patentability. As far as we can tell based on the facts set forth in the judgment, it seems that this communication was sent to the applicant after the INPI itself received a similar declaration from the EPO. Indeed, French patent applications which do not claim a foreign priority are sent to the EPO which is in charge of establishing the search report, owing to an agreement between the two offices.

A few letters were exchanged between the patent office and Sesame’s representative, who attempted to resolve the situation with claim amendments and arguments.

But finally, the director of the INPI refused the application on the ground that it was directed to subject-matter excluded from the scope of patentability (in other words, to ineligible subject-matter), as it related to a method for performing mental acts or doing business as such, and the mere fact that it was automated owing to generic computing means was not sufficient to change its nature.

In addition, the director of the INPI considered that no search report could be issued: the only technical elements of the claim were those of a very generic and well-known computing system which was manifestly not novel, without a need to perform any prior art search; and no relevant comparison with the state of the art could be made as there were no technical features.

In 2015, the applicant lodged an appeal before the Cour d’appel de Paris, which led to the decision at stake.

Unsurprisingly for European practitioners familiar with this field of innovation, the Cour d’appel de Paris confirmed that the claimed system may not be patented. The court relied on general principles similar to those usually relied on by the EPO in similar cases; but on the other hand, the court also departed from the EPO’s well-established methodology set in particular by the famous Comvik decision T 641/00.

The key to the Sesame ruling.
The key to the Sesame ruling.

It should first be noted that the grounds on which the INPI can refuse a patent application are listed in Art. L. 612-12 of the Code de la propriété intellectuelle, which notably provides:

Any patent application will, wholly or partly, be refused: (…) 5° If its subject-matter can manifestly not be considered as an invention in the meaning of Article L.611-10, second paragraph;

Art. L. 611-10 which is referred to recites almost exactly the same provisions as Art. 52 EPC, and its second paragraph thus excludes from the scope of patentability methods for performing mental acts or doing business, and programs for computers.

Now, relying on these statutory provisions, the Cour d’appel de Paris held the following:

Even though this exclusion relates to “methods”, it does not follow that the mere definition of the claims with the terms “system” and “process” necessarily leads to patentability […].

The legislator was not concerned with the phrasing of the claims.

The spirit of the statute is to exclude patentability of solutions that are not at a technical level but at a business level.

The Court thus followed the general principle that, in order to get a valid patent, there needs to be a solution of a technical nature (rather than of a business nature) to a technical problem. As such, this is in line with well-established EPO case law: refusal of applications directed to business schemes is regularly approved by the boards of appeal, regardless of the incorporation of the schemes into claims involving computer hardware – such as a computer system claim or a computer-implemented method claim.

After having recalled this general principle, the Cour d’appel de Paris then held that it was not met by the invention at stake:

The claimed “system” is thus characterized by the fact that it comprises sets and subsets of data of a business nature related to deliveries to be performed for charterers (type, delivery place and date) and to haulage offers (capacity and positioning of the vehicle) as well as a CPU which compares this data.

The data “registers” are not characterized on a technical level (format, compression, etc) but only by the type (business-related) of data they contain.

The mere fact that this data is grouped into three sets (type of loading/time/space) of two subsets (charterers/carriers) relates to a mere information organization which does not bring about any technical character as such.

No technical indication is provided on the CPU, which is only characterized by the fact that it performs comparisons, that is, operations of an intellectual nature that consist in putting data in relation one with another.

Therefore, similarly to the EPO in T 172/03 (Order management/RICOH) and T 696/06 (Freight exchange/ELGRABLY), the French judges did not see any technical considerations in the data structures and data processes involved in the method of claim 1, as they were of a business and intellectual nature.

By way of comparison, T 172/03 was concerned with “an improved office system suitable to select, out of a plurality of suppliers, a supplier of expendable supplies of items needed by a section of the office“, while T 696/06 was directed to “a data processing system (x) adapted to confront an offer (o) and a demand (d) in the field of transporting travelers or goods“.

The Court further established that the automation of such data processing of a non-technical nature did not remedy the above deficiencies:

The solution thus relies on a computer system that allows its automation.

Such a system is commonly used in human activities and notably business and thus does not bring about any specific configuration.

It is not characterized at a technical level and is only defined by reference to data gathering and comparison operations that it allows to perform.

This is also in line with EPO case law which consistently holds that the mere automation of a non-technical process cannot be awarded a patent, when conventional systems are at use. See the above-cited decision T 172/03 (Order management/RICOH) and also landmark decision T 258/03 (Auction method/Hitachi).

More surprisingly, although the reasoning would have appeared sufficient with the above considerations, the French judges went a step further by adding the following subsidiary statement:

In addition, the problem raised is not solved by this data processing since the carrier is then only put in front of possible choices that could optimize his profitability.

Although very succinct and arguably not necessary for the court’s demonstration, this consideration is quite something of its own.

It clearly reminds us of the so-called “broken technical chain fallacy” concept laid out by the boards of appeal in T 1741/08 (GUI layout/SAP) and T 1670/07 (Shopping with mobile device/NOKIA). According to this concept, the need for the intervention of a user to solve an alleged technical problem breaks the technical chain and makes the whole chain non-technical.

In summary, the Sesame decision shows that, when the EPO does not grant patents for software for implementing business or administrative methods, applicants probably do not have much more to expect from French courts.

Actually, the accuracy with which the Cour d’appel applied principles also in use at the EPO in this field is remarkable. It is sometimes believed that courts in France tend to set out a “loose” reasoning. But the decision at hand shows that, even in the complex field of business method software patentability, the Cour d’appel de Paris can reach the same general conclusion as the EPO in a precise and well-reasoned manner.

That said, the Cour d’appel de Paris did not follow the exact same approach as the EPO.

Specifically, under European case law, the application should probably have been refused on the ground of lack of inventive step; whereas the Cour d’appel approved the director of the INPI for refusing the application on the ground that it was directed to subject-matter excluded from patentability. Discrepancies of this kind are not a surprise for French practitioners. Usually, such discrepancies between French practice and European practice are apparent at the litigation stage only. But in the present case, there could be consequences on prosecution before the INPI as well.

Thank you Aujain for the detailed account as well as the final cliffhanger. I am looking forward for the second part.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, February 26, 2016, Sesame Active System v. Directeur général de l’INPI, RG No. 15/01962.

A makeshift win

I am happy to introduce another contribution by Lionel Vial to this blog, for a new update on the war waged by French courts on second medical use claims. Today, Lionel tells us about one such claim which bravely survived a first instance judgment, only to be later butchered on the appeal battlefield:

It is often tempting to rule out of hand seemingly makeshift arguments but the decision we discuss today is a reminder of why it is always a bad idea to do so. It is also yet another reminder that it is not easy to be Swiss in France nowadays.

The decision in question was rendered by the Cour d’appel de Paris on November 3, 2015 (Ethypharm SA v. Alkermes Pharma Ireland Ltd.). It notably dealt with the appeal of Ethypharm against the decision of the Tribunal de Grande Instance (TGI) de Paris of December 21, 2012 to uphold claim 9 of European patent EP 0644755 (the ‘755 patent), which Ethypharm was found to infringe.

The ‘755 patent was filed on June 1, 1993 and was granted on March 19, 1997, i.e. well before the entry into force of EPC 2000. Accordingly, claim 9 is under the form of a so-called Swiss-type claim (i.e.use of a substance or composition X for the manufacture of a medicament for therapeutic application Y”). It reads as follows:

The use of particles consisting essentially of a drug substance having a surface modifier adsorbed on the surface thereon in an amount sufficient to maintain an average particle size of less than 400 nm or a pharmaceutical composition thereof for the preparation of a medicament for hastening the onset of action after administration to a mammal, with the proviso that the drug substance is other than naproxen or indomethacin.

It can be seen that the scope of the claim is rather extensive as it basically covers any process of manufacture of a medicament with particles of a drug substance (different from naproxen or indomethacin) having an average size of less than 400 nm, thanks to the use of a surface modifier which adsorbs onto the drug substance, for increasing the speed with which the substance will exert its activity upon administration.

While all the arguments set forth against the validity of the claim had failed in the first instance, in the course of the second instance Ethypharm found a new motive to be opposed to the validity of claim 9, namely that the claim would cover a method of treatment of the human or animal body and that it would be therefore excluded from patentability.

According to Ethypharm, this would be because claim 9 does not relate to a specified substance or composition but relates to all existing active substances without specifying their therapeutic use, since it covers the use of nanoparticles of any medicament for treating any disease, any patient, by any administration route and with any dosage.

The patentee, Alkermes, made the mistake of not offering any counter argumentation.

In this regard the Court first notes, somehow ironically, that Alkermes apparently intended to respond to the argument, in view of the following statement in their written submissions:

To conclude, we will say a word on the argument of “revocation of claim 9 because it relates to a method of treatment” a last resort makeshift which replaced the equally exotic argument of “nullity of the further medical use claim”.

However, nothing of the sort could be found by the Court in the rest of these written submissions.

This proved to be fatal in the present case, because the argument surfed on the French courts’ supercilious approach to claims liable to cover methods of treatment (see our previous posts here and there) and was thus found to be persuasive by the Court:

[…] In application of that text [i.e. EPC 1973] a European patent can be granted for any further medical use of a known substance or composition, provided the claim is drafted under the so-called “Swiss-type” form, of the use of a product for obtaining a medicament used in a novel therapeutic application;

[…] It is thus necessary that a determined specific substance has a new therapeutic use which is distinct from the state of the art, since a simple claim to a method relating to a therapeutic treatment is not patentable;

[…] In the present case claim 9 of the patent at stake relates to any drug substance, with the only exceptions of naproxen and indomethacin, already taught in the state of the art, with the sole aim of hastening the onset of its action upon its administration to a mammal;

[…] When reading the claim, it appears that it relates to no known determined substance or composition with the view of obtaining a medicament for a novel and determined therapeutic use;

[…] Indeed the claimed hastening of the onset of the action of the medicament is only a mode of action of a medicament, which is by the way undefined, and cannot be considered as a therapeutic use of this medicament;

[…] Accordingly claim 9 only teaches a hastened mode of therapeutic treatment applying to any drug substance (naproxen and indomethacin being excluded) for treating any disease and applying to any patient, whatever the mode of administration of the drug and its dosage;

[…] As a consequence the claim will be revoked […].

The Court thus considered that although it was in the form of a Swiss-type claim, the fact that neither (i) the drug substance nor (ii) the therapeutic use were specified meant that claim 9 was to be considered as covering a method of treatment.

However, with this reasoning it appears that the Court merely assimilates Swiss-type claims to further medical use claims according to Article 54(5) EPC 2000, thereby casting aside the literal sense of Swiss-type claims, which is to cover a process for the manufacture of a medicament. As a reminder, in decision G 5/83, the Enlarged Board of Appeal of the EPO ruled that it is legitimate in principle to allow claims directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application, even in a case in which the process of manufacture as such does not differ from known processes using the same active ingredient.

Should Swiss army knives also be considered as excluded from patentability?
Should Swiss army knives also be considered as excluded from patentability?

Accordingly, the sanction for a Swiss-type claim which is found not to benefit from the special approach of novelty defined in decision G 5/83, for instance because the claim does not relate to a specified therapeutic application, should rather be to consider that the intended therapeutic use is not limiting. This approach is notably illustrated by decision T 1758/07 (see paragraph 3.4.3).

Applied to the present case, the finding of the Court according to which the hastening of the onset of the action of the medicament cannot be considered as a therapeutic use could thus have led to reformulating claim 9 as the use of particles consisting essentially of a drug substance having a surface modifier adsorbed on the surface thereon in an amount sufficient to maintain an average particle size of less than 400 nm or a pharmaceutical composition thereof for the preparation of a medicament suitable for hastening the onset of action after administration to a mammal, with the proviso that the drug substance is other than naproxen or indomethacin.

Incidentally, this would also have had the valuable advantage of doing without the rather confusing notion that a claim found not to relate to a therapeutic use could be considered at the same time to cover a method of treatment.

Thank you Lionel for this report. As already mentioned in last week’s post, the TGI and the Cour d’appel are quite strictly bound by the (written) submissions of the parties. So, not every surprising ruling can be blamed on the courts themselves.

As a postscript I would also like to bring the first instance decision to readers’ attention.

One issue that was discussed in this decision was the admissibility of the disclaimerwith the proviso that the drug substance is other than naproxen or indomethacin” in claim 9. This “undisclosed disclaimer” was introduced to distinguish the claimed invention from a prior art under Art.54(3) EPC. The TGI applied the test set out in decisions G 1/03 and G 2/03 of the Enlarged Board of Appeal (without quoting those) and held that the disclaimer passed the test and was allowable. This issue is not addressed again in the appeal ruling since the claim was found invalid on another ground.

I thought that some readers irritated by the marked deviation of French case law from EPO case law on the topic of patent eligibility might find solace in this remarkable illustration of consistency.


CASE REFERENCE: Cour d’appel de Paris, pôle 5, 1ère chambre, November 3, 2015, Ethypharm SA v. Alkermes Pharma Ireland Ltd., RG No. 2012/23743.