No (cross) product liability

I am not sure I have ever seen a bioinformatics patent lawsuit in France before the case reported on today: this may well be a first.

It is therefore particularly interesting to see how our judges grappled with such an exciting and complex topic. And the short answer is: pretty well it would seem!

The Codexis group is a leader in the field of biocatalysts. In particular, Codexis Mayflower Holdings LLC owns European patent No. EP 1761879, filed in June 2005 and claiming a priority of June 2004. The patent was granted in August 2013 and was not opposed.

Claim 1 of the patent is the following (the wording which will be important for the discussion below has been emphasized):

A computer-implemented method for identifying amino acid residues for variation in a protein variant library in order to affect a desired activity, said method comprising:
(a) receiving data characterizing a training set of a protein variant library, wherein the data provides activity and sequence information for each protein variant in the training set;
(b) from the data, developing a sequence-activity model that predicts activity as a function of amino acid residue type and corresponding position in a protein sequence,
wherein the sequence-activity model includes one or more non-linear terms, each representing an interaction between two or more amino acid residues in the protein sequence,
and wherein the sequence-activity model can distinguish amino acid residues that have a significant impact on the desired activity from those that do not; and
(c) using the sequence-activity model to identify one or more amino acid residues at specific positions that are predicted to impact the desired activity for variation to impact the desired activity,
(d) wherein at least one of the non-linear terms is a cross-product term comprising a product of one variable representing the presence of one interacting residue and another variable representing the presence of another interacting residue, and
(e) wherein developing said sequence-activity model comprises selecting one or more cross-product terms from a group of potential cross-product terms, wherein the selected cross-product terms are those cross-product terms representing true structural interactions that have a significant impact on activity.

Unusually, the main defendant is an individual, and even more unusually, a university Professor, Mr. O.

Mr. O happens to teach biochemistry, molecular biology and bioinformatics in Nantes; he was blamed by Codexis for his personal website offering a tool for predicting protein sequences, called ProSAR. Furthermore, Mr. O is a vice-president of the company Peaccel, which provides services to biotech and pharma companies, and which uses the ProSAR software.

The issue, as you have probably guessed, is that Codexis deemed that the ProSAR software infringes its EP’879 patent.

In 2015, Codexis had an internet bailiff’s report, and then an infringement seizure at the professor’s home (!) carried out. The source code for ProSAR was seized and placed under seal. Codexis then formally initiated infringement proceedings against Mr. O and his company. The defendants filed a nullity counterclaim.

In 2016, an expert was appointed by the judge in charge of case management to analyze the source code and provide a comparison with the patent claims. The expertise was concluded in a matter of months.

In 2018, the Paris TGI issued its decision on the merits, rejecting both the nullity counterclaim and the infringement main claim.

Codexis appealed, Mr. O and Peaccel counter-appealed, which now leads us to the judgment rendered by the Paris Cour d’appel on January 15, 2021. This second judgment fully confirmed the first instance decision.

Starting with the validity discussion, one first item of contention was whether the priority claim was valid.

Indeed, Codexis’ inventors had originally filed a U.S. provisional application in 2002, followed by three successive continuation-in-part applications CIP1, CIP2 and CIP3 in 2003 and 2004. The EP’879 claims priority to the third one, CIP3.

Whenever patent attorneys see “continuation-in-part” and “European priority claim” in a same sentence, they smell blood in the water.

And indeed, the infringement defendants argued that CIP3 is not the first application for the claimed invention, as the first application is rather CIP2. As a result, they said, the priority is invalid, since only a “first application” can give rise to a priority right under article 87 EPC.

This argumentation must sound perfectly clear to EQE candidates, but it may not be an easy objection to deal with for a court of law. However, in this case, the court nicely set out the test to be applied:

It must therefore be first determined whether the subject-matter of the main claim 1 of the EP’879 patent and of dependent claims 2, 3, 7, 10 and 12 can be directly and unambiguously derived by the skilled person from the teaching of application CIP2, or from only the parts of application CIP3 not present in application CIP2. 

Then, the court noted that the patentee did not dispute that features (a) to (d) were directly and unambiguously derivable from CIP2. On the other hand, they did not believe that feature (e) could be derived from the passages cited by the defendants. As a result, CIP3 was acknowledged as the first application for the invention, and the priority was found valid. Too bad for the defendants, as the application CIP2 itself was published between the priority date and filing date of the patent.

Mr. O and Peaccel further raised objections of lack of novelty based on two articles published in 2001.

The first article, “W et al.“, apparently disclosed a method similar to that of claim 1, but applied to peptides, and not proteins as required by the claim.

Let’s take a step back to molecular biology 101: peptides and proteins (also referred to as polypeptides) both designate polymers comprising amino acid residues. But the term “peptide” generally refers to a short polymer, whereas a “protein” is a long polymer. Paragraph [0024] of the patent mentions a “typical” minimum number of amino acid residues of 30, 50 or 100 in a protein. In W et al., only three amino acids were present in the analyzed peptides.

The defendants insisted that the allegedly infringing software ProSAR works on both peptides and proteins, and that the internet bailiff’s report and expertise proceedings were actually conducted based on a test peptide of only ten amino acid residues, but this was considered irrelevant to the issue of novelty by the court.

From a peptide to a protein… to a living organism? Would the modelling still work then?

As to the defendants’ argumentation based on the second article , “L. et al.“, it was found to be so lacking that the court did not even bother to address it in detail:

The object of this publication differs from that of the EP’879 patent since it does not disclose a computer-implemented method to identify amino acid residues for variation in a protein variant library in order to affect a desired activity, but a method for rationally designing a medicament, […] as not contradicted by the very partial translation of the L et al. article filed [by the defendants]. [They] unsuccessfully attempted to combine various excerpts from incomplete sentences […] [so that] it is not necessary to reply in detail to this technical argumentation. 

Next, inventive step.

Starting from the first article W et al. as the closest prior art, Mr. O argued that the disclosed process was obvious to adapt from short peptides to actual proteins. The court was not convinced, as the proposed secondary reference related to a different process of protein engineering without features d) and e) of claim 1.

A second inventive step challenge also starting from a document directed to peptide engineering failed for similar reasons.

The patent was thus upheld. Let’s now turn to the issue of infringement.

Mr. O first argued that the analysis of the software relied upon by the plaintiff was based on a ten-amino acid test peptide – and thus not a protein. However, the court rejected the argument, since the software clearly works similarly with peptides and proteins. Squeeze-type arguments do not always work, and in this case the peptide/protein squeeze raised by the defendants left the judges unimpressed.

But another defense hit the mark, both in first instance and on appeal. Features d) and e) of claim 1 make reference to “a cross-product term comprising a product of one variable representing the presence of one interacting residue and another variable representing the presence of another interacting residue”In the ProSAR tool, a different calculation is performed, based on quadratic, term-to-term products.

Codexis’ technical expert acknowledged that there is a well-accepted mathematical definition of “cross-product” (“produit vectoriel” in French) but then submitted that a broader interpretation of this expression should be adopted in view of the description of the patent, which would cover any non-linear term expressing the interaction of two residues in the polypeptide. The court did not agree that a definition of cross-product different from the conventional one could be found in the patent.

The identification of this difference between ProSAR and claim 1 of the patent was not offset by other contextual arguments, such as allegedly incriminating statements made by Mr. O that he had been inspired by articles published by Codexis. The identified difference was sufficient to conclude that there was no literal infringement.

Codexis had another shot, based on the doctrine of equivalents. They claimed that the quadratic terms in the ProSAR software are equivalent to the cross product of EP’879.

Again, the court was unsympathetic to this view:

[…] Therefore, the equation of step 6 of the expert report and the one of paragraph [0101] of the description of the patent are neither identical, nor mathematically equivalent, and it can thus not be stated […] that the ProSAR tool is identical to the cross-product of the patent in terms of function and effect. 

Thus, it is not demonstrated by Codexis that the selection of quadratic terms implemented in the ProSAR tool fulfils the same function as the selection of terms of the cross-product in the patented method, namely the identification of interactions between acid amino residues which have an impact on activity, in order to achieve a same result, namely predicting the activity of new variants. The expert report does not confirm […] that the sole purpose of the genetic algorithm implemented in the ProSAR tool is to allow an efficient selection of non linear terms. 

It is slightly unfortunate that the judgment does not contain a more detailed discussion on this last aspect. Assessing infringement by equivalence in France requires determining what the function of the allegedly equivalent means is, but this determination is seldom straightforward. In the present case, based on the judgment itself, it is not easy to understand what the exact respective roles of the term-to-term product and the cross-product are in the process – and why.

Other than that, the quality of this ruling seems quite remarkable, given the high complexity of the technical field.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, January 15, 2021, Codexis Mayflower Holdings LLC & Codexis Inc. v. Bernard O. & SASU Peaccel, RG No. 18/15295.

The flip side of the coin

Pharma-savvy readers are probably well aware of the pan-European pemetrexed litigation.

Eli Lilly’s patent No.EP1313508 is probably one of the most litigated patents in Europe. A nice summary, which is a little bit more than one year old, can be found here but there have been more recent developments, in particular in the Netherlands and in Germany.

In this context, France was late in the game, but here we are, with a remarkable judgment by the Paris TJ (tribunal judiciaire) issued a few days ago. Many thanks to Loïc Lemercier at Clifford Chance for providing a copy!

The French decision seems to be overall aligned with the rulings issued in most other jurisdictions: in a nutshell, it is a (big) win for Eli Lilly.

The patent was upheld as valid and infringed. A permanent injunction was ordered against the defendant, Fresenius, and provisional damages amounting to 28 million euros were awarded – pending final determination.

There are certainly several noteworthy aspects in this decision, but the most interesting one is probably the interpretation of the claims and the infringement finding.

Claim 1 of EP’508 is a Swiss-type claim, which is drafted as follow:

Use of pemetrexed disodium in the manufacture of a medicament for use in combination therapy for inhibiting tumor growth in mammals wherein said medicament is to be administered in combination with vitamin B12 or a pharmaceutical derivative thereof, said pharmaceutical derivative of vitamin B12 being hydroxocobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-chlorocobalamin perchlorate, azidocobalamin, chlorocobalamin or cobalamin.

The claimed invention thus relates to a cancer combination therapy based on the administration of pemetrexed disodium, the main active substance, in association with vitamin B12 (or the like).

As summarized by the court in the judgment, pemetrexed disodium is a known anticancer agent marketed by Eli Lilly under the trade name Alimta®. This agent is toxic and has significant side effects. According to the patent, these undesirable side effects may be reduced owing to the co-administration of vitamin B12, which lowers the level of methylmalonic acid (a predictor of toxic events in patients) without impairing the efficacy of pemetrexed. The two substances may be administered as a single composition or separately.

Fresenius obtained a marketing authorization for a generic of Alimta®, called Pemetrexed Fresenius Kabi®, in 2016, and has been marketing this generic in France.

According to the summary of product characteristics of Pemetrexed Fresenius Kabi® (NB: for some reason, you have to use another navigator than Google Chrome to open this link), there is a mandatory pre-medication regimen: “patients must also receive an intramuscular injection of vitamin B12 (1000 micrograms) in the week preceding the first dose of pemetrexed and once every three cycles thereafter“.

In other terms, Pemetrexed Fresenius Kabi® is intended for the combination therapy recited in EP’508.

But there is a hitch: the active substance in Pemetrexed Fresenius Kabi® is not in the same saline form as Amlita®. The generic drug contains pemetrexed diacid, whereas the originator’s contains pemetrexed disodium. And, most importantly, claim 1 of EP’508 refers to pemetrexed disodium. Fresenius’ non-infringement defense was based on this difference.

When analyzing the scope of the patent, the court made reference to article 69 EPC (the claims must be interpreted in the light of the description and drawings) and its protocol on interpretation. As a reminder, according to this protocol, claim interpretation must stay away from the extremes of an excessively literal interpretation and an excessively extensive interpretation. Besides, any element equivalent to an element specified in the claims must be taken into account.

A claim is like an iceberg: there is more to it than you can see.

Interestingly, the court cited the file history as an additional source of interpretation:

The scope of the claims is determined in the light of the description and drawings, and also if appropriate by taking into account elements from the file wrapper of examination proceedings, such as the amendments and arguments made by the patentee, which are factual elements, to be considered among others. 

The court turned to the description of the patent and noted that it makes reference to the general class of antifolate drugs, of which pemetrexed disodium is an example. This seems to be because, in the application as filed, an antifolate was originally claimed, which was later restricted to pemetrexed disodium.

The court then noted that the crux of the invention is the combination of pemetrexed with vitamin B12, and that the disodium form of the active is inconsequential:

The skilled person knows that the active part of the pemetrexed active substance is the anion (which causes the therapeutic effects as well as the unwanted side effects) combined with vitamin B12 […] and understands, without focusing on the literal wording of the claims, that the invention resides in the combined administration of the active agent, whatever its form, with the other substances claimed in the patent. 

The court added that the existence of other patents owned by the same company and claiming an active in more general terms (with the notion of “pharmaceutically acceptable salts“) is irrelevant.

The court also added that the file wrapper, in the present case, did not need to be taken into account. Anyway, it merely showed that the restriction to the disodium salt form was not necessary to distinguish the invention from the prior art. It was necessary because there was no support in the application as filed for pemetrexed in general, therefore omitting the disodium feature would have resulted in an extension of subject-matter by intermediate generalization:

[…] The examination procedure in front of the office [provides] a simple optional tool of interpretation, it has no effect on the scope of the patent, and is not binding on the court or the patent proprietor. The behavior of the patent proprietor, who accepted a modification requested by the examiner, cannot be interpreted as an admission which is binding on the court and it has no consequence on the scope of the claim. […] Especially so in the present case, as Lilly meant to designate a preferred embodiment, without intending to modify the scope of its right, even if they did not object to the examiner’s argumentation. In fact, this modification due to added matter under article 123(2) EPC was not meant to overcome a prior art prejudicing the validity of the patent, and was only made for purely formal reasons. The modification due to added matter may not prevent the patent proprietor from relying on infringement by equivalence, since it is a formal condition relating to the substance of the inventive contribution and the literal content of the specification, prohibiting the patentee from adding any element which cannot be directly and unambiguously derived from the patent [sic]. It does absolutely not alter the base on which the interpretation must be performed, and it has no bearing on the extent of protection which is conferred. 

On the contrary, with respect to assessing the scope of the patent, article 69 EPC […] demands that equivalents be taken into account. Therefore, adding matter during examination proceedings is not a bar to relying on infringement by equivalence, provided that the specifically claimed means or combination of means (here, the combined used of vitamin B12 […] with the active substance) have a novel function (namely the reduction of toxic effects without impairing therapeutic efficacy) […]. 

The technical problem to be solved consists in reducing the toxicity of the pemetrexed antifolate, without impairing therapeutic efficacy. The solution recommended in the patent, despite the restrictive formulation of the claims, is the combined administration of the pemetrexed anion and the other substances mentioned in the patent, the form in which this antifolate is administered being irrelevant. The scope of the patent thus extends to all forms of pharmaceutically acceptable forms of pemetrexed (salt or others) employed in combination with the […] other substances

There is a lot to digest here.

First, although the file history was generally presented as a source of interpretation, it is rated as a secondary, “optional” one.

My take is that file history is duly taken into account when it confirms the interpretation that the court wants to adopt, but it is disregarded when it does not fit the court’s reasoning.

Second, a primary reason for accepting that the patent covers more than pemetrexed disodium is the fact that the description of the patent generally refers to an antifolate drug.

What if the description had been more thoroughly adapted to the amended set of claims during prosecution, and if all generic mentions of the antifolate class had been removed? Would the court have reached a different conclusion, or would it have made it harder for the court to reach this conclusion? If so, this is a red flag for patent attorneys: do not underestimate the importance of this sometimes boring phase of examination proceedings at the EPO, namely the adaptation of the description.

Third, the court draws a clear distinction between two types of amendments made during prosecution: amendments introduced to distinguish the claimed invention from the art and amendments which are not necessary to distinguish the invention from the art.

Only the former type of amendment affects the actual scope of the patent.

Let’s now turn to the assessment of infringement:

Fresenius’ generic drug is composed of the same active substance pemetrexed, and its administration must be combined, as recommended in the EP’508 patent, with vitamin B12 […]. It is therefore irrelevant whether the [incriminated] compound uses a diacid solution so as to enable its administration, since this does not have any specific technical effect. It should be added that it has been admitted that a formulation specialist is able to offer a number of possible counter-ions other than sodium, to form a free acid or a number of well-known pharmaceutically acceptable salts. The selection of the salt form is thus irrelevant. Only the therapeutic effect of the pemetrexed anion combined with the other substances matters. The defendants claimed that it was not obvious to use this particular salt, which ranks 10th among frequently used salts. This is a criterion for the validity of an invention, not for the assessment of infringement. Fresenius obtained patents […] on this form of salt. But all of this is immaterial. 

The variant directed to the use of a different salt is totally incidental. Pemetrexed Fresenius Kabi® is administered according to the use provided in the invention. It is meant to treat the same cancer conditions, with the same technical effect. It was authorized as a generic drug of the originator’s drug. 

Infringement by reproduction is established. 

Since infringement by reproduction is established, in view of the scope of the patent as determined above, infringement by equivalence does not need to be decided upon. 

This latter part is a bit confusing. By “infringement by reproduction” is probably meant “literal infringement“. So the court seems to say that there is literal infringement when the claims are properly interpreted in the light of the description, so that “pemetrexed disodium” is understood to actually mean “pemetrexed“.

On the other hand, the court did cite the French equivalence test (different means, same function, function must be novel) when determining the scope of the patent (see the passages quoted above). This wavering is mostly inconsequential, though.

I personally think it would be much cleaner to consider that there is no literal infringement because the wording of the claims is crystal-clear, but that there may be infringement by equivalence when considering that the claims could have been drafted in a broader manner in view of the inventive concept. That said, literal infringement and infringement by equivalence both mean infringement, and it does not make any difference in terms of outcome or legal consequences.

To finish this post, I would like to go back to the rosuvastatin case commented on this blog a couple of years ago. In this case, the main claim was directed to the active compound rosuvastatin in the form of an acid or a non-toxic pharmaceutically acceptable salt thereof. The alleged infringement was a zinc salt of rosuvastatin. The court decided that there was no infringement because the claim, when properly interpreted in the light of the description, only covered salts in which the cation is an alkaline metal ion, an alkaline earth metal ion or an ammonium ion – and therefore excluded the zinc salt.

Rosuvastatin and pemetrexed are two sides of the same puzzling coin. On the one hand, an embodiment literally covered by the wording of the claims is found to be excluded from the patent’s scope. And on the other hand, an embodiment explicitly excluded from the claims during prosecution is found to still be covered.

I am not questioning that the outcome in both cases might be the right or “fair” one. But frankly, this is a nightmare for legal certainty.

One can also wonder whether the gap between patent prosecution and patent litigation has not become too deep. In front of the patent office, you have to argue based on the claims, the whole claims and nothing but the claims. In front of a French court, you might as well forget about the wording of the claims: it is all about what the description teaches.


CASE REFERENCE: Tribunal judiciaire de Paris, 3ème chambre 3ème section, September 11, 2020, Eli Lilly and Company & Lilly France v. Fresenius Kabi France & Fresenius Kabi Groupe France, RG No. 17/10421.

Patentee schussing down

Are you getting tired of automotive equipment technology and anti-hypercholesterolemic drugs?

This would be understandable. Cheer up, as today I give you a seasonal alternative, with this ruling which involves a patent directed to a “method of securing, monitoring and management of the ski area of wintersportplaces“.

As if this technical field weren’t unconventional enough, the ruling is also unusual in that it was issued by the Lyon Cour d’appel.

The Paris courts have had exclusive jurisdiction over patent matters for a number of years now, so it is increasingly infrequent to come across a judgment issued in another forum. Who knows, this could actually be the very last one.

Mr. Costa, who lives in the Rhône département, owns European patent No. EP 1048789, filed in 2000 and which claims a French priority. The patent was licensed to a local company, Construction Moulage Fabrication Polyester (CMFP).

The patent was granted in 2003. Shortly thereafter, the patentee and the licensee initiated infringement proceedings against Perception and Guidance Embedded Systems (now Perguisys), Kässbohrer Engins au Service de l’Environnement as well as SA Aménagement Touristique de l’Alpe d’Huez et des Grandes Rousses. Already from the name of the third defendant, it can be inferred that the alleged infringement takes place in the Alps area.

As this was 15 years ago, the complaint was filed with the Lyon Tribunal de grande instance (TGI), which had jurisdiction at that time.

Two oppositions were filed at the EPO, one by Sabatier SA and a joint one by the defendants Perguisys and Kässbohrer. This led the Lyon TGI to stay proceedings pending the outcome of the opposition. Hence the extraordinary length of the proceedings.

The oppositions were rejected by the opposition division in 2006 and the rejection of the oppositions was confirmed by the Board of appeal in 2009. Only then were the infringement proceedings resumed. But it took 6 more years for the Lyon TGI to issue its judgment, in 2015. This is amazingly long but (1) we don’t know all the details, and it is possible that all parties did their best to delay the proceedings; and (2) now that patent litigation is centralized in Paris, my understanding is that there are no longer cases that drag on forever to this extent – except when the Cour de cassation successively sets aside appeal judgments four times, like in the Nergeco case discussed last week.

In the first instance judgment, the infringement claim was dismissed, and so was the defendants’ nullity counterclaim. The plaintiffs appealed, which now brings us to the appeal judgment.

Here is claim 1 of the patent at stake, again, not a conventional one, as you will see:

Method for protecting, following up maintenance and managing the field intended for skiing in a winter sports resort using mobile protection, control and maintenance means equipped with means for marking the position and guiding vehicles from a satellite network or from fixed markers, using fixed devices which need to be controlled and maintained, using a digitized cartography, as well as radio or remote transmission cables for transmitting digital data between at least one computer situated in a central station and computer terminals situated in intervention services or on mobile means fully or partially associated with automatic or manual coding means, characterized in that the computer system situated in the central station is able to divide the site of the winter sports resort into homogeneous zones with respect to at least one criterion from a series of coherent criteria zones stored in said computer system connected by remote transmission means to the mobile means and the intervention services so that when a mobile element is positioned in an homogeneous zone of the skiing field, the computer system of the central station is able to immediately be aware of the criteria applied to this homogeneous zone so as to deduce from this task orders, observations or action to be taken by the central unit and/or by the mobile element and/or by the intervention or maintenance services.

Peter Rabbit managing the ski area.

The validity discussion is extremely short in the decision.

Apparently, the defendants raised the same arguments of lack of novelty and lack of inventive step that they had already raised in first instance. The appeal judges thus simply stated that they agreed with the first instance judges and had nothing to add.

The infringement discussion is more interesting. The plaintiffs alleged that there was infringement by equivalence.

According to the court, the patented method comprises numerically mapping a ski resort site in the form of points according to coordinates, and then storing the information in a computer of a central station so as to provide a virtual grid in the form of planar polygones (cf. the claimed “digitized cartography“).

Fixed and mobile devices are deployed in the ski area and supply positional information to the central station using transmission means.

Still according to the court, the alleged infringement does not make use of virtual mapping and of a central station. Thus, the court held:

[…] Even though the [allegedly infringing] system uses GPS technical means, it does not achieve the sophistication of the patented system, in that it does not make it possible to provide a division of the area into homogeneous zones in real time on the screen, based on predefined and modifiable criteria.  Contrary to what the appelants state, this sophistication […] prevents infringement by equivalence from being acknowledged, as the Snow Sat system is of a lesser quality and lesser efficiency. 

Okay. This is kind of frustrating as it is very far from being a clear and complete infringement reasoning. But again, you probably cannot expect too much from a court that may not have seen any other patent case in a number of years.

But there is possibly one interesting take-away message though.

The established standard for assessing infringement by equivalence under French law is the following: two means are equivalent when, although they are of a different form, they perform a same function for a result of a same nature, if not of the same degree.

Lyon’s position is that, since the defendants’ method is not as efficient as the patented one, it does not infringe.

This is clearly confirmed by the court’s following statement:

[…] A means is not equivalent when its different implementation leads to a result of a same nature but of a different quality or efficiency. 

This is not a common aspect of equivalence discussions. But it is not unheard of. In fact, in a previous post, I reported on a similar analysis by the Paris Cour d’appel.

Thus, if anything, today’s judgment confirms that assessing infringement by equivalence is tricky. You cannot just look at the function of the means at stake – and at whether the function was known from the prior art. You also have to look at how effective the means is and what the quality of the end result is.


CASE REFERENCE: Cour d’appel de Lyon, 1ère chambre civile A, September 20, 2018, Antoine Costa et al. v. Perguisys et al. (RG No. 2015/06635).

A dented infringement case

It seems that whatever patent-related news breaks in the UK often sets the tone for discussions throughout Europe – it remains to be seen if the Brexit will make any difference.

Take for example the doctrine of equivalents: this topic has become trendy again since the issuance of the Eli Lilly decision of the UK Supreme Court a few months ago. The excitement brought about by the decision is in fact quite understandable as the Supreme Court offered a new test for the appraisal of equivalents.

In France, on the other hand, much less is new under the sun in this respect.

The standard for assessing equivalents has been confirmed many times by the Cour de cassation, and all recent decisions dealing with this issue consistently rely on this standard (see notably here, here and there).

However, a recent ruling by the Paris Cour d’appel seems to have shed a new light on the nuts and bolts of the doctrine. 

French medical company Produits Dentaires Pierre Rolland (PDPR) owns French patent No. FR 2983398 on a “canula and adapter for a multifunction syringe“. In October 2013, PDPR initiated infringement proceedings against Itena Clinical, claiming that the marketing of the canula known as “Aireo Universel” infringed the patent (claims 1 and 6).

In April 2015, the Paris Tribunal de grande instance (TGI) confirmed that claims 1 and 6 of the patent are valid, and found Itena guilty of infringement. Itena appealed, which led to a second ruling issued in June 2017.

The validity part of the first instance judgment was upheld, but the appeal judges overturned the infringement part and found in favor of the defendant.

Here is claim 1 of the patent: 

A canula for a multifunction dental syringe, the canula comprising a fastener bushing that is defined by a circular opening, an end wall, and a side wall comprising a circular cylinder, the canula also including at least two channels enabling fluids to be conveyed separately or together from said end wall to fluid projection orifices, the two channels beginning in said end wall beside each other, the canula being characterized in that the circular cylinder presents a cutout in the thickness of its wall, which cutout comprises, going from the opening: at least one segment extending in a direction other than the axial direction of the cylinder; followed by a longitudinal segment extending towards the end wall.

Am I the only one to be horrified by this dental toy set?

The Cour d’appel first recalled the standard for appraising infringement, taking into account equivalents. As mentioned above, this standard was defined a long time ago:

The scope of the patent extends from the technique which is expressly claimed to any variant combining in the same manner different means performing the same function. The function of a means in an application is defined as the first technical effect achieved by the implementation of this means, making it possible to obtain the result. And two means are equivalent when, although they are of a different form, they perform a same function for a result of a same nature, if not of the same degree.

In this case, the court found that all the features of claim 1 were literally reproduced by the defendant’s “Aireo” product – except one:

The examination of the Aireo product shows that it has a cutout in the internal part of the canula, made of a single longitudinal segment oriented towards the end wall of the canula, which is identical to [what is claimed]. However, the cutout of the Aireo product does not comprise a segment having a direction other than the direction of the axis of the cylinder (transversal segment) [as claimed], so that the cutout is not made of the two segments defined in the characterizing portion of claim 1.

In such a situation, the function of the feature which is not literally reproduced must be established, and then it must be determined whether another feature in the alleged infringement provides the same function or not. 

The relevant discussion in the appeal judgment is the following:

PDPR argues that the collar on the canula, which forms a translation stop, makes it possible to rotate the canula on the adapter up to the longitudinal segment where, subsequently, the lug of the adapter slides in the groove of the Aireo product, which thus generates a longitudinal translation of the canula.

However, the alleged function of mechanical guiding by the collar present on the Aireo product is not of the same quality as that of the PDPR invention. Indeed, in the PDPR invention, when the canula and the adapter are assembled, the lug of the adapter is immediately inserted into the transversal segment of the cutout of the canula where it is mechanically directed into the longitudinal segment of this cutout, whereas such guiding is not ensured with the same efficacy by the collar of the Aireo product due to is planar and smooth surface.

In other terms, according to the claimant, the same function of mechanical guiding was present both in the claim and in the alleged infringement.

But the court did not accept this, since this function was not achieved with the same efficiency in both cases. This is related to the part of the equivalents’ test that reads: “a same function for a result of a same nature, if not of the same degree“. 

So, the court did stick to the classic test, but applied it in a fairly unusual manner. It is not everyday that equivalents are discarded because the common function is partly achieved but not with the same degree of efficacy as in the patent.

Now, for the sake of completeness, there were other reasons for the court not to accept the suggested equivalence: 

Besides, the alleged function of mechanical guiding is admittedly possible but absolutely not necessary, contrary to the device recited in claim 1 of the patent, nor even useful. Indeed, the user of the Aireo product wanting to fix the canula onto the adapter can easily match the lug of the adapter with the groove (longitudinal segment) of the canula, and therefore achieve a translation of the canula owing to its longitudinal segment by simply making a visual (not mechanical) alignment, without needing to resort to a rotative motion involving the planar and smooth surface of the collar, whereas the user of the canula according to the PDPR patent, in order to attach it to the adapter, must necessarily impart a rotation using the transversal segment of the canula, followed by a translation using the longitudinal segment of the canula (mechanical guiding).

So, the function was not necessary nor useful in the defendant’s product. This can probably be translated into: the common function argued by the plaintiff is in fact an artificial one.

Finally, the plaintiff’s case also failed on another prong of the equivalents’ test, which is whether the function could be protected or not in view of the prior art. The court found that the function (in the same context) was in fact known from the prior art, so that the scope of the claim could not validly be extended to the alleged equivalent:

Anyway, infringement by equivalence is not present if the means of the allegedly infringing product are of a different form relative to those which are claimed, and the function performed by these means, identical to that performed by the means of the claimed invention, is known from the prior art.

In this case, the function of mechanical guiding attributed by PDPR to the surface of the collar of the Aireo product combined with the cutout in the internal part of the canula of a longitudinal segment oriented towards the end wall of the canula is known from the prior art. It is notably disclosed in the abovementioned Saurou document (WO 92/04878). […]

Some interesting fine-tuning of the doctrine indeed!


CASE REFERENCE: Cour d’appel de Paris, Pôle 5 chambre 1, June 13, 2017, Itena Clinical v. Produits Dentaires Pierre Rolland, RG No. 15/10544.

Defense ripped to shreds

Today’s case relates to a shredder for plant materials. And while I was browsing online desperately looking for some kind of introductory witticism for this post, I came across a fiction character called the Shredder, to whom a very detailed Wikipedia page is dedicated. It turns out the Shredder is a villain in the Teenage Mutant Ninja Turtles comics – which I must confess I really do not know anything about.

It is actually fascinating to find out that the Shredder’s webpage is significantly longer than the Wikipedia page on, say, the European Patent Convention. Just to put things into perspective.

So back to what I might indeed attempt to comment on, i.e. a dispute between Société d’Equipements pour l’Environnement (or SEE), owner of a French patent No. FR 2795661 and a European patent No. EP 1066883 (EP’883 claiming the priority of FR’661), and Rabaud, against which the two patents were asserted.

There are at least four different points which are of interest in the judgment handed down by the Cour d’appel de Paris on this case:

  • The invalidation of several claims of FR’661 for insufficiency of disclosure.
  • The finding that Rabaud’s shredder called Xylomix infringes the French part of claim 1 of EP’883 by equivalence.
  • An additional finding of contributory infringement.
  • The rejection of a false marking claim.

Let’s have a look at the invalidity issue first. Claim 1 of the priority patent FR’661 is quite different from claim 1 of the subsequent patent EP’883, which is why this invalidity issue only applies to the former.

Claim 1 of FR’661 concerns a shredder having a shredding rotor, wherein, in particular, “the rotor is suitable for creating an air flow for ejecting matter towards the ejection zone“.

The court noted that the claim does not define how the air flow is created, and that the description of the patent is also silent on this. Specific features seem to be present in the drawings, but without any explanation:

[….] The drawings do not make it possible for the skilled person to understand what the means for creating the air flow in claim 1 is, since the inverted S-shaped line which can be seen on Figures 2 to 4 and the inverted S-shaped double line which can be seen on Figure 6 are not captioned, unlike the other elements making up the rotor, and do not make it possible to interpret claim 1 in such a way that the means is made of ventilation blades. 

[…] In fact, on the other hand, this ventilation means is precisely described in claim 1 of [EP’883], at [paragraphs] [0033] to [0035] of the description, and is captioned in Figures 2 to 4 and 6 (with reference 16) and reproduced in three-dimensional view on Figure 7, which implies that without this description of the means for creating the air flow, the skilled person was not able to implement the invention simply based on common general knowledge. 

A finding of insufficiency of disclosure is not a common thing. And when this finding is in the mechanical field, it is all the more uncommon. Even if the ventilation blades were not mentioned in FR’661, it may not be too difficult for the skilled person to think of such blades as a possible means for generating an air flow. So, was there something specific about the shape or positioning of the ventilation blades which was not obvious to achieve for the skilled person?

The judgment does not tell. But clearly the more detailed explanations in the European patent were held against the French patent. So, drafters had better be careful about leaving claimed functional features unexplained in the description.

See how easy it is to create an air flow?
See how easy it is to create an air flow?

After invalidating claim 1 of the French patent (as well as all other dependent claims asserted by SEE, for the same reason), the court turned to the European patent. Apparently no invalidity defense was raised by Rabaud, which was of course of a great help to the patent proprietor.

Rabaud focused on a non-infringement defense. 

Claim 1 of EP’883 reads as follows (adding the same feature analysis taken up by the court):

a. A shredder, more particularly intended for reducing plants or other materials,

b. comprising a feeding section

c. and an ejection section,

d. between which is arranged a chamber provided with shredding means

e. which consist of a rotor including specific tools depending on the type of plants or materials to be shredded, in alternating positions,

f. i.e.: cutting tools intended for shredding a type of plants,

g. and defibring and bursting tools intended for shredding other types of hard plants or materials,

characterized in that,

h. on the same rotor are also positioned ventilation means, positioned with respect to said cutting tools, so as to define the gauge of the chunks of plants or other materials cut by said cutting tools, allowing the discharge of the shredded plants and other materials out of said chamber,

and in that,

i. in said shredder, said cutting tools, said defibring and bursting tools and said ventilation means are positioned with respect to each other, depending on the direction of the rotor rotation, so as to successively allow the defibring or the bursting operation, the definition of the gauge of the chunks to be cut, the cutting and the discharge of the shredded plants or other materials, 

j. so as to serve as a multipurpose active drum. 

The defendant argued that features h. and i. were not reproduced by the Xylomix apparatus.

Regarding feature i., Rabaud argued that Xylomix’ flails (defibring and bursting tools) do not act on the plant materials before its knives (cutting tools), whereas such a particular order of operation is required by claim 1. But the court was not convinced, especially because they said the order of operation is defined more particularly in a dependent claim 6, so that claim 1 is broader.

The judgment does not specifically address the word “successively” in feature i., which may support Rabaud’s defense. My understanding is that the court interpreted this adverb as simply introducing the various operations, as opposed to requiring a certain order between them. Such interpretation may be debatable. Also, depending claim 6 further specifies driving sections for the flails and knives and does not just add an order of operation to what is recited in claim 1.

As for feature h., the infringement theory was based on equivalence. As a reminder, under French practice and as recalled in the judgment itself:

Two means are held equivalent when, although they are of a different structure, they have the same function for achieving a result of a similar nature or degree. 

In the Xylomix apparatus, the gauge is obtained by way of dedicated metal sheets and not by the ventilation means as required by feature h. Nevertheless, the court acknowledged that the gauge function is achieved in the Xylomix apparatus like in the patent and that the result is of a similar nature. Therefore, there was infringement by equivalence.

One effective defense against the doctrine of equivalence generally consists in arguing that the doctrine does not apply because the claimed function is known from the prior art. But in this case it seems that the defendant did not rely on any prior art at all, which is why the court did not have to examine this particular aspect.

The third interesting point in the judgment relates to contributory infringement. In addition to Xylomix devices having both flails and knives, which were found to be a direct infringement of the patent, Rabaud also marketed “simple” Xylomix devices, with only knives or only flails. Also these simple devices were held to infringe under article L. 613-4 Code de la propriété intellectuelle. Said the court:

[…] The Xylomix shredder brochure intended for Rabaud’s customers, which was seized during the infringement seizure, highlights that it is possible with one rotor to rapidly transition between knives, flails or dual mode, and that the rotor, pictured as “3 in 1” is the only one “capable of addressing all market needs”. 

As rightly noted by the first instance judges, the user who bought a shredder having a “simple” rotor can then buy knives or flails, which are sold separately from the shredder, so as to make it work in a dual mode and thus implement the patented invention without having a right to do so. 

What I think is the most interesting question though is whether all simple rotor sales will be taken into account in the assessment of damages, or only a fraction of those. But this question has been left unanswered so far as the court did not rule on damages, an expertise being ongoing in parallel.

Fourth, and last, false marking. SEE claimed that, in addition to patent infringement, Rabaud was also guilty of unfair competition, due to various mentions in their commercial brochures dating back to 2011. One mention in particular was that Xylomix was “patented“, which was in fact not the case. The first instance judgment sided with SEE on this question, but the Cour d’appel reversed this part of the judgment. The reversal was based on the fact that Rabaud had filed a French patent application in 2009 and then a European patent application in 2010. The French patent was granted in 2014.

The bottom line seems to be that it is OK to put the cart before the horse and refer to a “patented” device when in fact the patent is still pending. Not that I would recommend doing so, though.


CASE REFERENCE: Cour d’appel de Paris, Pôle 5, chambre 1, May 17, 2016, Rabaud v. Société d’Equipements pour l’Environnement, RG No.14/10335.