Terminal lawsuit

Standard-essential patent (SEP) litigation is something of a venture, as already illustrated in a previous post. The “terminal lawsuit” reported in today’s post provides yet further illustration. In fact, not only was this a lawsuit on a terminal, namely an electronic payment terminal, but it also turned out to be terminal for the patent proprietor’s business strategy.

The story begins, as always in such a case, with licence negotiations between a patent proprietor, Koninklijke KPN NV, which I will be happy to simply refer to as KPN, and another big player, France-based Ingenico Group. The standard at stake is the EMV standard, which stands for Europay, Mastercard, Visa. Self-understandably, this is a standard relating to payment cards, payment terminals, and the protocols according to which they interact together.

KPN owns European patent EP 0873554. Ingenico manufactures and markets EMV-compliant payment terminals and KPN argued that the patent is implemented by the EMV standard. KPN sued Ingenico for infringement in front of the Paris Tribunal de grande instance after the licence negotiations failed.

In short, KPN lost. For the long story, we need to refer to the very detailed judgment which is dated April 14, 2016.

A key part of the discussion relates to the determination of the scope of protection of the patent. The judgment contains a number of interesting (albeit sometimes controversial) statements in this respect.

Here is claim 1 of the patent. Not exactly an easy read, but we have seen worse, haven’t we:

Method of protectedly performing a transaction using an electronic payment means and a payment station, the method comprising:

– an initial step, in which:

– the payment station transfers a first random value to the payment means,

– the payment means, in response to said first random value, transfers a first authentication code to the payment station, which authentication code is determined on the basis of at least a first start value, a first random value and first transaction data of the payment means using a predetermined process, the process further producing a first end value,

– a further step, in which:

– the payment station transfers a second random value to the payment means,

– the payment means transfers a second authentication code to the payment station, which authentication code is determined on the basis of at least a second start value, the second random value and second transaction data of the payment means using said process, the second start value being based on the first end value.

The scope of claim 1 was in dispute. Claim 1 generically mentions an “electronic payment means”. But the defendant argued that the term should be construed as only covering a card containing units to be debited, and not other electronic cards such as bank cards.

This claim construction was of course vigorously fought by the plaintiff, since the allegedly infringing payment terminals were used with bank cards. Said KPN:

[…] The embodiment mentioned in the description concerning prepayment electronic cards does not restrict the scope of the invention, which relates to any payment mode using a chip card such as a bank card. The transfer of the balance can be omitted or replaced by an acknowledgment receipt or by a card authentication. […] In the claims as well as the description and drawings, in particular Figure 1 which shows a chip card used to make a payment in a shop and connected to the card carrier’s bank and the shopkeeper’s bank, the expression “electronic payment means” encompasses any type of chip card and not only a prepaid, rechargeable card. This expression, […] just like the terms “chip card” or “smart card”, covers any type of payment card, including bank cards. 

The court started with making a few general remarks on claim interpretation. The following passage in particular, on claim drafting, caught my attention and might leave some patent attorneys flabbergasted:

[…] The structure of the claim is essential for determining the […] scope of protection afforded by the right. The claim preamble sets forth the state of the art, whereas the characterizing part, introduced by the words “characterized in that”, sets out the elements which make up the invention, namely the novel and inventive means taken in their form and function, which apply to the object comprised in the state of the art and benefit from exclusive protection. The characterizing part is only considered “in relation” with the preamble because the latter is the support for the former, and because the means for which protection is claimed apply to the product described in the preamble. This relation, just like the interpretation which is made in the light of the description and drawings, does not result in an extension of protection to elements which cannot benefit from a monopoly for they are comprised in the state of the art; but it identifies the concrete subject-matter of the means which make up the invention. The violation of the exclusive right is in fact characterized not by the reproduction of elements in the preamble but by that of the means claimed in the characterizing part

Many professionals (including myself) are uncomfortable with the idea that the interpretation of a claim should depend on where in the claim the “characterized in that” phrase is placed. The division of the claim into two parts may not necessarily accurately reflect the contribution of the invention to the art: only one piece of prior art is usually taken into account when drafting a two-part claim; the applicant may not agree with the characterizing portion demanded by the examiner but may not have a lot of leeway to challenge his/her position; etc.

Although it makes perfect sense for the court to focus on what the invention is really about, relying on the two-part form to perform this analysis could lead to unfair outcomes.

The court regretted that, in the present case, “the structure of claim 1 does not comply with the implementing regulations since it does not comprise a clearly stated characterizing part“. The court seems to have overlooked that R. 43 EPC explicitly provides that the two-part form should be used “wherever appropriate“, as opposed to in all circumstances. The Guidelines for examination provide a number of examples in which it is not appropriate to use the two-part form.

Actually, after reading this judgment, I think it is certainly advisable to avoid casting a claim into a two-part form whenever possible since this may unduly restrict claim interpretation in subsequent litigation.

The court then turned to a detailed analysis of the contents of the description of the patent.

In passing, the court noted that the file wrapper should not be taken into account in the claim construction process:

[…] Examination proceedings and potential variations between the application and the granted patent are irrelevant in the context of analyzing the scope of the patent, which is solely made considering the latter, because on the one hand it defines the protection from the publication under article 64 of the Convention (since the protection conferred by article 67 to the patent application is only temporary) and on the other hand legal certainty explicitly mentioned in the interpretative protocol of article 69 demands that third parties can determine the extent of protection solely based on reading the patent without having to embark on uncertain interpretation of the applicant’s intent in view of modifications made since filing. 

Makes sense. Although, shouldn’t a distinction be made between statements made by patentees during prosecution that third parties may want to rely on vs. self-serving statements?

Anyway, back to the (complex) analysis of the description and drawings.

The court came to the conclusion that the invention is about a closed dialogue between the card and the terminal, as opposed to one which would include a bank server – as would be the case if the electronic payment means were a bank card.

One of the main arguments raised by the patent proprietor was probably that Fig.1 of the patent does schematically show the interaction of the card and terminal with respective banks. Here is what the court had to say about the drawing:

[Fig. 1] is not explained an the dotted line between the card or terminal and the bank is not defined. The association between the card and the bank and the one between the terminal and the bank are not understandable. The only exchanges described are those between the card and the terminal and then between the banks, which take place respectively during and after the transaction phase […]. And, the sentence “During a transaction there basically does not take place communication between the payment station and the payment institution in question (so-called offline system)” means that there is absolutely no exchange between the card or terminal and the bank, not only because it is defined by the expression between brackets, but also because the sentence is a reminder of the risks of abuse attributable to this lack of communication […].  

And so here is the overall conclusion:

Thus the sole payment means contemplated in claim 1 […] is a card comprising a balance of units to be debited or credited and not a bank card. The fact that the latter is also a payment means and is designated under this generic name in the EMV specifications is irrelevant. The transaction data transferred to the terminal is restricted (with the exception of authentication codes) to the balance on the card. Consequently, the protection of the process does not extend to securing bank card transactions, which necessitates an open and more complex dialogue.  

So all of this did not bode well for the patentee’s infringement claim, since Ingenico’s terminals are meant to be used for payments via bank cards.

They did preserve the patent though, as Ingenico’s counterclaim for invalidity was unsuccessful.

Among others, an auxiliary objection of extension of subject-matter was raised in case the court were to retain a broad interpretation of claim 1. That is a “squeeze“-type, either-I-am-not-infringing-the-patent-or-there-was-some-extension-of-subject-matter-but-you-cannot-have-it-both-ways-type of argument. The court bought the narrow claim interpretation and accordingly rejected the auxiliary objection.

Credit card: the nightmare of teleshopping addicts.
Suggestion for a crosswords definition of electronic payment means: the nightmare of teleshopping addicts.

A few more words on the infringement part of the judgment. First, the court noted a technical difference between the subject-matter of claim 1 and the EMV standard – which I am not going to comment on.

Second, and more interestingly, the court held that there was no contributory infringement anyway, irrespective of whether the patent was implemented in the standard.

The court stated that the statutory provisions on contributory infringement need to be appraised in a very strict manner. In particular, there can only be contributory infringement if “means for implementing the invention […], relating to an essential element thereof” are supplied by the alleged infringer.

Ingenico is accused of selling payment terminals compliant to standards which implement the patented process. […] The essential element [of the invention] lies in the dependence between the second authentication code and the first one. It is the sole novel and inventive element which provides the desired security. And it is exclusively performed by the undefined and unclaimed function of the card. […] The role of the terminal is limited to sending the card a random value to initiate the authentication step. This phase was known from the prior art and is not novel. 

It is true that the first final value is calculated partly based on this random value. But the essential element does not lie in this use but in the conservation of the cryptographic residue from the processing as a first final value, which is the basis for the second code. The terminal is not involved in this process. The fact that it is mentioned in claim 1 (in the part which should actually have been the preamble) is irrelevant. 

The invention covered by claim 1 is implemented by the function of the card, which is the subject-matter of product claims. It is not implemented by the terminal […]. 

Therefore, no matter whether the claims are reproduced (literally or by equivalence) by the EMV standards, the means supplied by Ingenico, i.e. the terminal, cannot generate the result of the invention and does not relate to a constitutive element thereof. 

The way I understand French case law, very schematically, contributory infringement applies if an invention is made of two interacting parts, for instance the wipers discussed here. But if the novel and inventive features of the invention lie in one element only, and if someone then supplies another element to be used with the former, there is no infringement.

I think the case law is clear in this respect, which is certainly a very good thing.

CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 1ère section, April 14, 2016, Koninklijke KPN NV v. SA Ingenico Group, RG No. 14/11998.

Take the long way home

Some critics of IP French courts sometimes complain that judges have a tendency to take shortcuts and to always look for the easy way out of a case instead of dealing with all difficult questions. Today’s case may prove them wrong, as the court took the long way home instead of the short one, by combining three pieces of prior art in order to arrive at a finding of lack of inventive step – although two or even one would probably have been sufficient.

Italian company Imball Center Srl sued two subsidiaries from the same group ITM Entreprises (hereafter collectively referred to as ITM) for infringement of the French part of European patent EP 1885622 (EP’622). The patent relates to a thermal bag for food, and ITM was accused of providing infringing bags to French retailer Intermarché.

ITM filed a nullity counterclaim on the grounds of lack of novelty and lack of inventive step.

Claim 1 of the patent reads as follows:

A thermal bag made of thermally insulating composite material folded to form a bottom and welded along lateral borders to form a body of the bag with a mouth at the level of which a handle is applied, said handle having a closing device for said mouth, said composite material defining a bottom folded in an accordion-like fashion opposite the mouth of the bag, and said handle having a shorter length than the length of said mouth when the bag is in the flattened position; characterized in that a laminar stiffening element of the accordion-like bottom is disposed inside the bag. 

The lack of novelty argument was based on four thermal bags on sale before the priority date of the patent, respectively called the Intermarché orange bag, the Intermarché red bag, the Carrefour bag and the Thiriet bag.

The court accepted that all bags were prior art, relying on a variety of evidence: catalogues, affidavits, orders, etc. Interestingly, indirect evidence was also relied on in order to prove the date of some bags, such as the presence of an old logo on a bag, or the presence of a phone number in a format no longer in use for years.

However, the court held that the thermal bags in question did not have a bottom folded in an accordion-like fashion, as required by the main claim of the patent. Since the judgment is relatively concise on this aspect, it is not entirely clear whether the prior art bags clearly had a different type of bottom, or whether there was simply not enough evidence that the prior art bags had a bottom as claimed. Anyway, as already explained in a previous post, providing a perfect demonstration in the context of a public prior use is often extremely challenging.

Concerning inventive step – which turned out to be the patent’s killer – the court first noted that the parties agreed on the fact that a so-called Link patent was the closest prior art.

The claimed invention seems to differ from the Link patent due to (i) the bottom folded in an accordion-like fashion, as well as (ii) the presence of the laminar stiffening element.

The court then turned to another reference, called the Moravek patent, which disclosed distinguishing feature (ii), i.e. the laminar stiffening element. The court used a problem and solution-type of reasoning as regards the combination of Link and Moravek:

[…] Although the invention of the Moravek patent differs from the one proposed by the EP’622 patent in that it does not disclose an insulated bag made of a thermally insulating composite material and does not disclose a bottom folded in an accordion-like fashion […], the skilled person, confronted with the technical difficulty of improving the convenience of the insulated bag, would be enticed to refer to the Moravek patent, the objective of which is precisely to allow the support of the bag’s opening during the introduction of produce into the bag on a sales counter, with a strengthening panel mounted on a pivot which is lowered when the bag is opened owing to air pressure. 

OK, and what about the accordion-like bottom? Well the court said the skilled person would turn to the bags on sale before the priority date, and it particular to the Intermarché red bag. But wait a minute, didn’t the court previously state that these bags did not disclose the accordion-like folded bottom? Yes indeed, but at this point the court added that the Intermarché red bag had a folded bottom which was strictly equivalent to an accordion-like one:

[…] It is a fact that the Intermarché red bag comprises folds at the bottom, in order to form this bottom, although the configuration of the folds is not strictly identical to that provided in EP’622. However, although this difference results in the novelty of the invention as stated above, it is not sufficient in itself to characterize an inventive step for the skilled person whereas the purpose of the feature is identical and it provides the same effects. 

[…] It should be noted that the red Intermarché bag, as it is designed, can perfectly be folded into an accordion shape, so that this feature, although it is the result of an additional manual operation as set out by Imball, is reproduced by the bag. Therefore, the skilled person reading the prior art, with common general knowledge, was able to achieve this result without any inventive step by simply looking at and handling products on the market. 

I started this post by saying that the court had taken the long way rather than the short one. Actually, it seems to me that it would have been much easier to start from the Intermarché red bag as the closest prior art, and to simply state that the sole distinguishing feature of the claimed invention was the shape of the folds at the bottom of the bag, which was obvious to achieve for the skilled person using his or her basic skills and common general knowledge. The way I understand the case, Link and Moravek were not necessary for the reasoning.

As a reminder, French courts are strictly bound by the submissions of the parties, and may not really come up with a reasoning of their own. In this case, it seems that the Link patent was considered as the closest prior art by both parties. So it may well be the defendant who actually took the long way – maybe out of fear of contradicting their novelty challenge, but I am just speculating.

The shortest way?
The shortest way?

Now, two other notable points in this judgment.

First, the court also revoked a number of dependent claims, also for lack of inventive step. For most of those, it seems that the Intermarché prior use already disclosed the claimed features – although the court also referred to further prior art references such as a Martineau patent or a Pakzad patent, in a superfluous manner.

Second, although the patent infringement claim obviously failed due to the revocation of the patent, the court did however find the defendant guilty of unfair competition and awarded 500,000 euros of damages to Imball.

The facts were the following: until February 2012, Imball supplied insulated bags according to the EP’622 patent to ITM. Then ITM stopped the business relationship with Imball and started buying bags from a Malaysian company, L&A Packaging. The Malaysian bags marketed in France by ITM were very similar to Imball’s own patented bags. The court also noted that ITM had the complete specifications of Imball’s bags in its hands and had even asked Imball for samples a few months before the end of the supply relationship, for evaluation and testing purposes – which, in retrospect, may look a little bit like a smoking gun.

The court held:

Therefore the defendant had all the information on the characteristics of the bags made by Imball, and decided, simultaneously with the end of the business relationship with Imball, to get supplies from L&A Packaging so as to market bags at a lower cost. They were aware that said bags were a quasi-literal reproduction of the bags produced by Imball. The manufacturer was necessarily able to benefit from Imball’s know how. This characterizes a disloyal attitude, because it led to knowlingly put a large quantity of quasi-identical products on the market resulting in an obvious confusion with Imball’s products. 

In this respect, the mere fact that the bags sold by the defendants have an Intermarché logo is not enough to avoid the risk of confusion. The risk of confusion must be assessed, on the one hand, from the perspective of the public at stake, i.e. in this case professionals in the field, such as those purchasing bags to market them in their distribution network, and not consumers; and on the other hand in view of the technical similarity of the products, which is established in this case, independently of the logo with which they are effectively marketed. 

Most patent infringement complaints comprise an ancillary unfair competition claim. The latter very often fails if the main infringement claim is successful, as the facts underlying both claims are generally similar, whereas case law demands different facts. Nevertheless, an unfair competition claim can be a valuable fallback claim if the infringement claim fails, and if some actual copying has taken place.

Interestingly, in today’s case the evidence for the acts of unfair competition was obtained during a patent infringement seizure. I am always somewhat surprised that this procedure, which is supposed to be exceptional and therefore strictly limited by its purpose (the demonstration of an alleged patent infringement), can be later used to support a different claim.

CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre, 2ème section, March 11, 2016, Imball Center v. Consommables Et Matériels & ITM Alimentaire International, RG No. 13/12818.

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.

Of yeast and insects

It is with great pleasure that I am hosting a new contribution by Lionel Vial on this blog. Today, Lionel asks the question whether the regulatory specificity of biological medicinal products has just been denied by French courts.

It is known that Supplementary Protection Certificates (SPCs) make up a particularly tricky part of patent law. So tricky that national courts regularly feel the need to refer questions of law in this respect to the Court of Justice of the European Union (CJEU); and so tricky that the answers provided by the CJEU in its preliminary rulings have a tendency to fuel yet further references from national courts.

But when it comes to biological medicinal products, things can get even thornier, especially since policymakers may have primarily had chemical medicinal products in mind when the SPC regulation was drafted.

So let Lionel now explain how the difference may come into play.

The decision we discuss today was rendered by the Cour d’Appel de Paris on April 12, 2016 and deals with the appeal lodged by the Government of the United States of America against the decision of the Director of the INPI (French patent and trademark office) to reject SPC application No.08C0003 covering Cervarix® (GlaxoSmithKline Biologicals).

As a side note, we will first remind our readers that appeals against decisions of the Director of the INPI, such as rejections of patent applications or SPCs, are to be lodged directly to the Cour d’Appel de Paris, i.e. the second instance court, and not to the first instance Tribunal de Grande Instance de Paris.

Back to the case at hand, Cervarix® is a vaccine intended for use in women and girls from nine years old to protect against cancer of the cervix (neck of the womb) and precancerous lesions (abnormal cell growth) in the genital area (cervix, vulva or vagina) caused by certain types of the human papillomavirus (HPV). Cervarix® HPV-16/18 L1 AS04 vaccine contains recombinant C-terminally truncated major capsid L1 proteins of HPV types 16 and 18 as active ingredients. The L1 proteins of HPV-16 and HPV-18 are separately produced using a recombinant Baculovirus expression system and the insect cell line Hi-5 Rix4446 derived from Trichoplusia ni.

For those not versed in the biological arts, this basically means that the antigens contained in the vaccine are shortened versions of viral proteins from two different viruses (HPV-16 and HPV-18), which proteins have been produced in vitro in insect cells.

The SPC application was filed on January 18, 2008 on the basis of European patent EP 0662132 filed on September 3, 1993 and of the Marketing Authorization (MA) No.EU/1/07/49/001 of September 20, 2007. It was rejected on March 16, 2015 by the INPI.

The decision of the INPI was essentially based on the Actavis judgment C-443/12 of December 12, 2013 by the CJEU (following a reference for a preliminary ruling from the High Court of Justice of England and Wales), and more particularly on points 40 and 42 of this judgement:

40. Bearing in mind the objective of Regulation No. 469/2009 [i.e. the SPC regulation] […] – namely, to compensate the patent holder for the delay to the commercial exploitation of his invention by providing him with an additional period of exclusivity – first, the grant of the first SPC in respect of the single active ingredient irbesartan [i.e. the drug at stake in the judgment] has already afforded the holder such compensation and, second, the objective of that regulation is not to compensate the holder fully for the delay to the marketing of his invention or to compensate for such delay in connection with the marketing of that invention in all its possible forms, including in the form of combinations based on that active ingredient. […] (emphasis added) 

42. It follows that, in such a situation, Article 3(c) of Regulation No. 469/2009 precludes a patent holder from obtaining, on the basis of one and the same basic patent, more than one SPC in connection with irbesartan, since such SPCs would in fact be connected, wholly or in part, with the same product […]”

Indeed, another SPC No.07C0020 covering Gardasil® (GlaxoSmithKline Biologicals) was granted earlier on the basis of the same patent in regard of a L1 protein from HPV16. The INPI thus considered that this previous SPC also protected the C-terminally truncated form of the L1 protein, purported to be obtained by production from insect cells, and that the product for which SPC No.08C0003 was applied for had already been the subject-matter of a certificate.

As it appears from the ruling, the main argument of the appellant against the decision of the INPI was that the HPV16 L1 protein obtained from insect cells, which forms the subject-matter of SPC No.08C0003, is a different product from the HPV16 L1 protein obtained from yeast cells, which forms the subject-matter of SPC No.07C0020, because of the differences in the glycosylation pattern and amino acid chains depending on the cell type (yeast or insect) in which the protein is produced. Accordingly, the MAs of Gardasil® and Cervarix® relate to medicinal products having different active ingredients and SPC No.07C0020 and SPC application No.08C0003 relate to different products. In addition, pursuant to Articles 4 and 5 of Regulation (EC) No 1768/92 (i.e. the previous version of the SPC regulation), an SPC may not confer a protection extending to a product which is not the one related to the marketing authorization.

"How could you possibly mistake me for a yeast?" said the beetle.
“How could you possibly mistake me for a yeast?” said the beetle.

However the Court ruled that:

As is rightly pointed by the Director of the INPI, firstly, the basic patent claims (claim 1) “an isolated HPV16 capsomer structure comprising L1 capsid protein” which is not characterized by its manufacturing process and the patent does not explain the differences between the proteins asserted by the appellant, [the patent] referring to various manufacturing processes (insect cells such as for Cervarix, yeast cells such as for Gardasil, and even mammalian cells (cf. page 20 of the patent)), secondly, the asserted differences are not mentioned either in the MAs provided with the two SPC applications which relate secondarily to the manufacturing process without drawing any conclusion regarding the protein structure, and finally, SPC application No.08C0003 initially related – before the amendments brought by the applicant in relation with the forms and production methods in response to the objections from the INPI during the examination procedure of the application – to a product defined as “L1 proteins from type 16 human papillomavirus”, this definition being precisely that mentioned in SPC application No.07C0020 filed on March 20, 2007;

Article 1 of the previously cited Regulation defines the product as “the active ingredient or combination of active ingredients of a medicinal product”, without any reference to the manufacturing process of the active ingredient;

Accordingly, the HPV16 L1 protein comprised in Cervarix and that comprised in Gardasil constitute one and the same product within the meaning of the previously cited Regulation, regardless of their possible differences regarding their forms and their manufacturing processes;

It results from Articles 4 and 5 of the Regulation that the protection and the rights conferred by an SPC are framed by the basic patent and that the MA is used to determine the product forming the subject-matter of the protection; it is thus irrelevant, for assessing the regularity of the rejection of SPC application No.08C0003, whether this application is based on an MA specially obtained for Cervarix, which, even though it aims at treating the same pathologies, is different from Gardasil, which has a different MA, since the HPV16 L1 protein comprised in the two drugs is the same;

Under these conditions, the Director [of the INPI] was right in considering that SPC No.07C0020 granted on July 23, 202 also applied to the HPV16 L1 protein comprised in Cervarix, even if obtained from insect cells, and in rejecting SCP application No.08C0003 filed on June 18, 2008 by the Government of the United States of America.

Accordingly, the decision of rejection of SPC application No.08C0003 was upheld.

This decision is interesting in that the Court decided, following the INPI, that the protection conferred by an SPC extends beyond the physical product which can be found in the marketed medicinal product to encompass all products falling within the definition of the product in the SPC or SPC application.

This construction of Articles 4 and 5 of the SPC Regulation may not give rise to too much discussion for chemical medicinal products, as in addition to C-443/12 (Actavis) it could also be considered to be an application of the previous ruling of the CJEU in C-392/97 (Farmitalia) (“where a product in the form referred to in the marketing authorisation is protected by a basic patent in force, the supplementary protection certificate is capable of covering the product, as a medicinal product, in any of the forms enjoying the protection of the basic patent”). But it may give rise to more concerns as regards biological medicinal products, as in the present case.

In fact, it can be regretted that the present decision was not taken as an opportunity to discuss – and why not to request a preliminary ruling on – the question of knowing if the same standard is to be applied to chemical and biological medicinal products when applying Articles 4 and 5 of the SPC Regulation.

Indeed, the specificity of biological medicinal products has been recognized by European Union law. By way of example, Article 10 of Directive 2001/83/EC notably provides that where a biological medicinal product which is similar to a reference biological product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or differences in manufacturing processes of the biological medicinal product and the reference biological medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided.

Accordingly, in view of the objective of the SPC Regulation which is, as was recalled above, to compensate the patent holder for the delay to the commercial exploitation of his invention by providing him with an additional period of exclusivity, it could be questioned whether biological products obtained by different manufacturing processes could not be considered as truly different products and not merely as different forms of a same product.

As a final side note, we would like to add that the above-mentioned Actavis decision of the CJEU is only one of numerous rulings following from references from the High Court of Justice of England and Wales. It is with some sadness that the commentator in us sees the Brexit taking away the most active Case Law provider in SPC matters.

Although I share Lionel’s concern regarding Britain’s major contribution to SPC case law, maybe we should not be too sad too soon; after all there are still many unknowns as to what comes next.

CASE REFERENCE: Cour d’appel de Paris, Pôle 5 chambre 1, April 12, 2016, The Government of the United States of America v. Directeur Général de l’INPI, RG No. 15/12234.