Haunted

In the patent profession, cases have this way of always coming back at us.

You may work hard on a case and complete a difficult action, possibly with some sense of achievement (or relief). But then, a few months or years later, the case is back with a vengeance.

Happy about the way you have drafted your patent application, having navigated through all of the prior art and the inventor’s wishes? Wait until you get the search report. Enjoying your ride or flight back home after having been steam-rollered in opposition oral proceedings? Let’s meet again in 2 years’ time for the appeal. Satisfied that you have managed to digest the other party’s 300-page submissions just in time to file your reply in court? As well you should, although next time you will get 350 pages from them.

And so it is with this blog.

Almost exactly 2 years ago, I published a post on Ethypharm SAS v. Merck Sharp & Dohme Corp. 

Now that the appeal judgment has been handed down, it seems like a good time to revisit this litigation.

Most appeal judgments in France confirm the first instance decisions (it is said that the confirmation rate is around 80%). But this one did not confirm, which makes it all the more interesting.

As a reminder, the case pitches Ethypharm as a nullity plaintiff against Merck Sharp & Dohme Corp. (MSD), defendant and owner of the patent in suit, EP 1455756.

The first topic addressed in my previous post was the assessment of whether the action was time-barred. On this aspect, the appeal judges came to the same conclusion as their colleagues below, with a slightly different reasoning.

The TGI had decided that the starting point for the 5-year limitation period was the date of the EPO Board of appeal’s decision (July 7, 2014), announced during the oral proceedings, per which the patent under opposition was to be maintained in amended form.

As noted in my post, this finding was already a deviation from earlier case law.

The Paris Cour d’appel took an even later date as a starting point, namely the day on which the amended patent was published by the EPO (September 23, 2015). Said the court: “this is when the modified patent became opposable to third parties“.

An entirely reasonable finding, but which makes it more difficult than ever to know and predict how this limitation period should be computed in general. Case law keeps going all over the place. Fortunately, the statute has now been amended so as to take away this disastrous limitation period. We will still have to live with this legal mess, but less and less so.

The other notable point in my earlier post was that I felt there may be some contradiction in the TGI’s position regarding sufficiency on the one hand and inventive step on the other hand.

As a reminder which is probably quite necessary (at least for me), claim 1 reads as follows:

A nanoparticulate composition comprising the compound 2-(R)-(1-(R)-(3,5-bis(trifluoromethyl)phenyl)ethoxy)-3-(S)-(4-fluoro)phenyl-4-(3-(5-oxo-1H,4H-1,2,4-triazolo)methylmorpholine [a.k.a. aprepitant], or a pharmaceutically acceptable salt thereof, the compound having adsorbed on the surface thereof at least one surface stabilizer in an amount sufficient to maintain an effective average particle size of less than about 1000 nm; where “effective average particle size of less than about 1000 nm” means that at least 95% of the particles, by weight, have a particle size of less than about 1000 nm.

Ethypharm’s insufficiency challenge failed at first instance, as the court noted that there was a prior U.S. patent disclosing the so-called “Nanocrystal” method, for making nanoparticles with a surface modifier adsorbed thereon, having an average size of less than 400 nm. This Nanocrystal patent also taught that such nanoparticles improve the bioavailability of poorly water-soluble actives.

Ethypharm also argued lack of inventive step of claim 1 over this Nanocrystal patent, but the attack failed. The lower court held that the teaching of the Nanocrystal patent could not be applied in an obvious manner to aprepitant, and that there were many technical uncertainties.

I was not completely comfortable with the articulation between both positions.

Maybe the appeal judges also had trouble with this approach: while they agreed that the invention was sufficiently disclosed in the patent, they held that it lacked inventive step.

Starting with sufficiency, the court tackled plausibility, an essential phase of most pharma cases. The court repeated the now well-established French criterion per which the patent must “directly and unambiguously reflect the therapeutic effect” at stake. But then they added that “it is not systematically required that the description of the patent should contain tests, this condition is not required in case of a product claim”. A helpful comment, quite in line with the Boards of appeal’s stance on the matter.

The court further remarked that the patent in suit made reference to the U.S. Nanocrystal patent, which made it plausible for the skilled person that nanoparticulate aprepitant had improved bioavailability. Ethypharm did not demonstrate that this was not the case and thus did not discharge its burden of proof. In fact, it appears that some test reports were filed by the plaintiff to support the sufficiency challenge, but they were deemed inconclusive.

Turning then to inventive step, MSD’s case was that increasing bioavailability was a complex problem, and that there were many parameters to be taken into account.

To them, reducing the size of aprepitant particles to less than 1000 nm was not an approach that the skilled person would have used.

But the court relied on expert’s evidence showing that the dissolution rate is often a limiting factor in bioavailability; and that reducing the particle size of a drug makes it possible to increase the contact surface area between the undissolved active and the solvent, which generally increases the dissolution rate. Reference was made in particular to a 1982 textbook.

MSD countered that reducing the particle size to less than 1000 nm was not commonly practiced at the priority date, and had been little explored. The court was not persuaded. Some nanoparticulate drugs were tested already in the 1990s, and it had been proposed in a general manner that a poorly soluble drug could be reduced to a nano size. The Nanocrystal technology of course was also taken into consideration. Not just the patent, but also a press release by Elan Technologies, according to which their process was broadly applicable to many poorly soluble actives.

MSD further relied on a document showing that micronization of aprepitant did not give satisfactory results, so as to show that the skilled person would not have continued with this approach. But the document was an internal one and the skilled person would of course not have been aware of it.

In the end, the court did not deny that there were several possible approaches for the skilled person, but found that the nanoparticulate approach was nevertheless obvious to try:

Even if the skilled person knew of other methods and if the EP’299 patent only showed tests on three different active ingredients, he […] knew that nanonization improved the bioavailability of poorly soluble active substances and was thus incited, based on converging information […], to start research on this pathway in order to improve the bioavailability of aprepitant when used as a drug.

The Board of appeal decision per which the patent was maintained in amended form, namely T 210/11 (Board 3.3.07) reached an opposite conclusion of course:

It results that the skilled person, looking for a solution to the problem as defined above, faces multiple possible solutions to said problem of low bioavailability of aprepitant, and would not be conducted by the teaching of documents (5), (6) or (7) to the use of a nano-particulate composition of aprepitant.

Ethypharm was not a party to the opposition proceedings at the EPO, and the Paris court may have been presented with additional evidence that the Board did not see.

But my overall impression is that this is basically a matter of the court and the board placing the inventive step bar at different heights. This may be one of those grey-area cases, with complex facts to consider, which may very well go one way or the other depending on who looks at them.

This is the end of the story – for now, unless there is a cassation appeal and the case comes back to haunt this blog again.

Here it comes again.

CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 1, October 29, 2019, SAS Ethypharm v. Merck Sharp & Dohme Corp., RG No.18/03876.

A technical silver lining

They say that every cloud has a silver lining.

Thinking about a recent Philips case in which not one, not two, but three patents were revoked by the Paris Tribunal de grande instance (TGI), this saying seems quite fitting.

From the perspective of IP right holders, the dark cloud is of course that we have just been presented with yet another confirmation that patent validity is severely appraised in France. But the silver lining is that, although software patents were at stake, the court did not strike them down for just being that, but on the contrary fully acknowledged the technical nature of the inventions.

The case at hand was certainly a big one for Philips.

Not only were three patents involved, but there were also parallel proceedings against several unrelated defendants.

So much so that there were in fact four judgments issued on the same day: one pitching Philips against HTC, another against Asus, another against Archos and the last one against Wiko.

Philips reproached all defendants for not joining their “Touch enabled device” license program, and retaliated by filing an infringement action based on European patents No. EP 1384134, EP 0888687 and EP 1571988.

The four judgments look substantially identical, so it should be sufficient to look at only one of them.

Claim 1 of EP’134 reads as follows:

A data processing apparatus having a user interface assisting in searching for information from an ordered list a data array, the apparatus comprising:
an array scroller responsive to user actuation; and
a helper character-generator, actuated by continued user actuation of the array, the helper character generator being operative to display a helper character representative of a portion in the list being scrolled.

In brief, this is a user interface invention. The context is that of a long list of elements. In order to facilitate the retrieval of one element in the list by the user, a so-called “helper character” appears. This helper character may represent e.g. a first letter of a name or a first digit of a telephone number. It is thus representative of a cluster of entries in the list. By scrolling from helper character to helper character, the user may select a desired cluster, and then browse within this cluster instead of browsing through the entire list.

Choosing the right song in a menu, a critical decision to make.

The defendants argued that this was a mere presentation of information, and thus not an invention under art. 52 EPC.

Here is the court’s position on this objection:

Displaying the helper character involves continuous actuation by the user in a scrolling array. 

The patent thus relies on the user taking an active part, via an improved interface interacting with him, thus creating a particular technical effect due to the actuation by the user, allowing a faster choice in an array of elements. 

By combining several modes of scrolling down a list of elements, the patent teaches an adaptive user interface for searching and displaying, and thus does not just present information “as such”. It should also be emphasized that the purpose of the invention is to facilitate the selection of an element in a large set of data, on small size devices, taking into account their specific ergonomic design. 

Therefore, the EP’134 patent undeniably implements technical means to obtain a technical solution to a technical problem. Its subject-matter is thus patentable. 

I asked my partner Aujain Eghbali, who is an ace at computer-implemented inventions, what we can make of this.

His main comment was that this is the same type of reasoning that the EPO could have made. He added that the court’s reasoning is in fact quite patent-friendly even by EPO standards.

In particular, the court relied on the ergonomic character of the human/machine interface when assessing the technical nature of the invention. The Boards of appeal of the EPO have sometimes adopted a similar approach (see T 1779/14) but the Guidelines for examination do not take any clear position on the technical nature of such innovations. Section G-II, 3.7.1 suggests that a “physical ergonomic advantage” could be considered as a technical contribution, but specifically in relation with user input.

The court also took note of a statement in the description of the patent, per which human-machine interaction is particularly challenging when the device is small, due to the physiology of the user. Although effects relying on human physiology are acknowledged in the EPO Guidelines (section G-II, 3.7), they are not commonly accepted by examiners as having a technical character, Aujain said.

Going back to the judgment, the EP’134 patent was thus found to meet the requirements of article 52 EPC.

Further objections of insufficiency of disclosure and lack of novelty were also rejected. But the patent finally died of lack of inventive step.

However, it is important to note that all features of claim 1 were fully taken into account in the inventive step reasoning, in keeping with the court’s finding that the claim related to a technical solution to a technical problem.

The court’s negative opinion on the patent was thus fully based on relevant disclosures identified in the prior art. So, this is your good old, traditional, prior art-based lack of inventive step, if you will; not a this-is-not-technical-enough lack of inventive step.

In more detail:

The EP’036 document teaches that, upon continuous actuation of the scrolling key, the first names are sequentially displayed, in the alphabetic order, for each letter, thus providing a search tool. 

Starting from this search tool disclosed in EP’036, the skilled person, namely an electrical engineer experienced in designing user interfaces for portable electronic devices, confronted with the problem of selecting an element in a scrolling list on a small size screen, would achieve claim 1 of the EP’134 patent, since the search tool of the EP’036 prior art (underlining the first letter of a name) is only a visual alternative to the generation of a help character, which is anyway taught by the US’949 document. 

The EP’036 document also taught scrolling cluster by cluster, allowing the user, by maintaining the scrolling key pressed, to go from letter to letter in the directory, without having to go through all names starting with the same letter. 

Therefore, the features of claim 1 of the EP’134 patent derive from the state of the art. 

Next up was EP’687, another user-interface patent.

See in particular claim 1:

An electronic device comprising:
– at least one display;
– a controller arranged to cause the display to show a rotating menu comprising a plurality of menu options,
which menu is disposed off centre in the display so that at least one option is rotatable off the display at any one time, whereby an arbitrary number of options may be added to the menu without changing its format.

Again, the court fully acknowledged the technical character of the invention:

[…] The EP’687 patent aims at improving a user interface for a screen. To this end, it allows displaying a menu comprising a plurality of options as well as adding an arbitrary number of options to the menu without changing its format. It thus provides a better identification of options. 

The objective of the EP’687 patent is to facilitate adding more articles to the menu without making the display more complex, as long as at least one option in the menu is out of the screen due to the rotating menu being off-centered. 

Therefore, the patent makes it possible for the user to interact with the device, while adding any number of options to the menu, without modifying the format and while keeping their own character making their identification easier.

Consequently, the EP’687 patent, which ensures a better identification of menu options for the user, by means of a controller which combines a particular option display format and a double function of rotation and addition of options, obviously implements technical means to provide a technical solution to a technical problem. Its subject-matter is thus patentable. 

Like for the previous patent, Philips was also able to fend off insufficiency and lack of novelty challenges, but then stumbled on inventive step, as the prior art was deemed to be very similar to the invention.

The third patent was directed to an activity monitor. Its technical character was not challenged. It was revoked for lack of inventive step all the same.

In summary, the present case seems to confirm a trend recently seen in a Thales decision and on the contrary to drift further away from past case law in which the stance on patent eligibility was considerably stricter.

How apropos then that the INPI (French patent office) has just published an updated version of its examination guidelines containing two new sections C.VII.1.3.1 and C.VII.1.3.2 on computer-implemented inventions.

One section is dedicated to CAD and computer simulations. The other one relates to AI. Both provide additional guidance as to what should be considered technical or non-technical, again quite in line with the EPO approach. Maybe the next revision will contain some additional thoughts on graphical user interfaces?


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 1ère section, July 11, 2019, Koninklijke Philips NV v. SAS HTC France Corporation & HTC Corporation, RG No. 16/02073.

Would a “could” suffice?

Comparing EPO and French case law on validity is one of this blog’s favorite topics.

Today’s post will be dedicated to a cornerstone of the EPO doctrine: the could/would approach in the inventive step reasoning.

The could/would approach was actually nicely summarized by the Paris Cour d’appel in a Sandoz v. Eli Lilly decision (January 13, 2012), making explicit reference to the European case law book that all European patent attorneys have on one of their shelves:

As can be derived from established case law of the Boards of appeal of the EPO, the question is not whether the skilled person could have made the invention by modifying the state of the art, but whether he would have done so in the hope of achieving the advantages that were really obtained in the light of the technical problem at stake, because the state of the art contained suggestions in this respect. 

So far so good, and all supporters of pan-European harmonization must be satisfied.

Not so fast, though, as some recent decisions seem to show that the could/would approach is not as inscribed in the DNA of French IP courts as it is in the EPO’s DNA. Here is an example. 

Modelabs Mobiles is a French company which distributes mobile phones and other IT devices. Modelabs Mobiles filed a French patent application No. FR 3063299 on February 24, 2017, directed to a casing for locking and immobilizing a phone.

Just after the publication of the application, Modelabs Mobiles proceeded with an infringement seizure against its competitor Wiko, on October 23, 2018, and soon thereafter filed an infringement suit, based on the FR’299 application (yes, this is possible before the grant of the patent under French law).

The patent was granted on April 12, 2019. On June 7, 2019, Modelabs filed a claim for preliminary injunction with the judge in charge of case management, and further requested a provisional damages award of more than 2 million euros. Modelabs argued that the existence of infringement acts was likely, and that since the defendant was in a restructuring process, there was a risk that damages could not be recovered.

The judge in charge of case management ruled on September 13, looking first at whether the patent was apparently valid.

Here is claim 1 of the patent:

Casing, in particular intended to contain a telephone, comprising:

– a first shell and a second shell that close onto one another so as to close the casing by rendering its contents inaccessible,

– a slide that is movable in translation on the first shell, comprising at least one coupling member, and which can be actuated from outside the closed casing so as to be positioned by translation in a first, a second or a third positions, wherein the first shell, the second shell and the coupling member(s) are arranged so that, when the casing is closed:

– at least one coupling member is coupled to the second shell when the slide is in the first position, thus opposing the opening of the casing,

– at least one coupling member is coupled to the second shell when the slide is in the second position, thus opposing the opening of the casing,

– the coupling member(s) is/are free when the slide is in the third position, thus allowing the opening of the casing, the casing further comprising:

– a device for locking the slide on one of the shells in the first position, actuable only by means of a dedicated tool from the outside of the casing when this casing is closed,

– first means for reversible immobilization of the slider in the second position,

– second means for reversible immobilization of the slider in the third position.

In summary, this casing can be used for protecting a phone in a store. The casing has three configurations: one which is fully locked, and which requires a tool (e.g. a magnetic one) to be unlocked; one which is unlocked and closed; and one which is unlocked and open. The transitioning between the unlocked / closed and unlocked / open positions can be performed without using an external tool.

Locked – unlocked

Wiko relied on three prior art documents against the novelty and inventive step of the main claim. The judge found that the claim was novel.

Regarding in particular the so-called EP’090 prior art reference, the judge held:

[…] The “movable member” which can correspond to the “slide” of the invention of the patent can be positioned in two different positions, and not three. In order to ensure an anti-theft function, a safety device must be added, comprising an “inserted” external element whereas, in the casing claimed by Modelabs, the safety device is fully part of said casing even if it requires the use of an external tool to be deactivated. 

A similar conclusion was reached regarding the two other prior art references.

However, regarding inventive step, the judge made the following comments:

In view of the state of the art […], the skilled person already knew casings for products on sale, having an integrated locking system, which can be actuated by a dedicated external tool such as a magnetic tool, preventing access to the content of the casing in the absence of said tool without breaking the packaging itself. 

Admittedly, the casing at stake, relative to [this prior art], provides an intermediate position in addition to the mere locked/unlocked alternative. but this mode of using the casing (simply closed in a reversible manner) does not address the technical problem that the invention purported to solve, which was to make the content of the casing safer. 

Besides, it can be legitimately questioned whether the skilled person requires a particular inventive step in adding an intermediate position between the locked/unlocked positions for the coupling member supported by the slide […], in order to keep the casing closed in a reversible manner (thus that can be manually actuated, without a dedicated tool), in view of the state of the art. Indeed, the addition of such an intermediate position prima facie seems to rather logically derive from [the prior art]. 

Therefore, the prior art submitted as a defense provides a serious possible ground for nullity [of the patent]. 

As you can see, the judge does not seem to reason in terms of what the skilled person would have done, but rather in terms of what he or she could have done.

Indeed, although there does not seem to be any suggestion or motivation in the prior art to have this intermediate closed/unlocked position for the slide, as far as I can tell from the judgment, the judge nevertheless concluded that it would have been “logical” for the skilled person to include such an additional position.

By way of comparison, here is the position taken by the EPO examiner in charge of the search report for the French application (based on different, but presumably similar prior art):

Such a casing with three positions for the slide and “reversible immobilization means” […] is completely unknown in the state of the art. Hints pointing to this direction are also absent. 

So, what can we make of this? One interpretation of course is that the inventive step threshold is higher in France than at the EPO. This is of course very possible. Another interpretation is that the judge had questions or doubts and simply did not want to grant a preliminary injunction and preferred to let the case continue on the merits.

That said, my attention was also drawn by the following statement:

Modelabs did not provide any argumentation regarding the inventive step of its patent which differs from the novelty argumentation. 

As always, we should keep in mind that, in view of our rules of civil procedure, and based on a longstanding tradition, French judges limit the scope of their decisions to the arguments put forward by the parties. Therefore, in the absence of any reference in the patentee’s submissions to the could/would approach, it is unsurprising that the judge did not use this reasoning.

Thus, I could say (or make that rather: I would say), that argumentation in French patent litigation has to be complete, including explanations on the legal standards to be applied – or else… 

As a next step, if the case continues on the merits, we will see whether the three-judge panel of the court uses the same or a different approach.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 3ème section, ordonnance du juge de la mise en état, September 13, 2019, SAS Modelabs Mobiles v. SAS Wiko, RG No. 18/13517.

The “pays” of the PIs?

A hardly understandable question, I know.

“Pays” is the French word for “country”. As for PIs, this term refers of course to preliminary injunctions. A PI is the most dreaded weapon of right holders.

But this legendary prize is also famous for being extremely hard to seize, notably in France. Although… could the trend have recently changed?

One ruling in particular which was issued last June in a prominent pharma case gave rise to a lot of comments. But another ruling issued just one month later also followed a somewhat similar path.

French chemical company Minakem sued two companies of the M2i group, namely Melchior Material and Life Sciences France (MMLS) and M2i Salin (M2i). MMLS owns a patent family on a method for making bromo methyl cyclopropane and bromo methyl cyclobutane. Minakem claimed ownership of this patent family and also complained that MMLS and M2i infringed its own patent No. FR 3010997, filed a few months before the priority date of the MMLS patent family. The two actions were joined as a consolidated case.

The ruling reported today does not contain much information on the context of Minakem’s ownership claim. It is an order issued by the judge in charge of case management, who was presented with a motion for PI by the plaintiff. MMLS and M2i raised invalidity and non-infringement as means of defense – but both grounds of defense were rejected.

Let’s start with validity first. The defendants argued that claim 1 of the Minakem patent lacks inventive step over a so-called Bayer document.

Now seems like a good time to have a look at the claim, which is quite straightforward:

A method of preparing bromo methyl cyclopropane comprising a step a) of reacting cyclopropylcarbinol with a complex of triphenylphosphite and bromine. 

Making reference to the problem and solution approach for the inventive step reasoning, the judge first noted that all parties agreed that the Bayer document was the closest prior art. According to this document, bromo methyl cyclopropane is prepared by reacting triphenylphosphine with cyclopropylcarbinol, and, after cooling, adding bromine.

The judge then held that there are two differences between the claimed invention and the teaching of the Bayer document, namely:

  • The use of triphenylphosphite instead of triphenylphosphine as a reactant: this is a one-letter difference in the name, and more importantly, three additional oxygen atoms in the molecule.
  • The use of a complex of triphenylphosphite and bromine, instead of adding bromine in a subsequent step.

Two documents were offered as secondary references, designated as D.G. Coe and Eli Lilly.

D.G. Coe teaches that triphenylphosphite can be used as a reactant to make alkyl halides (a class which encompasses the bromo methyl cyclopropane at stake here). But the judge noted that, according to the document, the reaction does not work similarly with all alcohols, and in particular that it provides very unsatisfactory results with cyclohexanol. Since cyclohexanol is a cyclic compound, just like cyclopropylcarbinol, the judge was convinced that the skilled person would have been dissuaded by D.G. Coe from reacting a triphenylphosphite complex with cyclopropylcarbinol, as claimed.

As for the second reference, Eli Lilly, it also discloses complexes of the type triphenylphosphite / halogen (e.g. bromine), as well as their potential use for a reaction with aliphatic alcohols, for making alkyl halides. But the document also emphasizes a new use for making vinyl halides by reacting these complexes with enol compounds. The judge concluded that Eli Lilly rather teaches to react the claimed complex with other compounds than aliphatic alcohols such as cyclopropylcarbinol. I am not sure I quite understand why the fact that the document both refers to a traditional use and to a new use of a chemical complex makes the traditional use less obvious than the new use. But on the other hand, it is true that the focus of the document is not on the preparation of alkyl halides.

What I actually found to be perhaps the most instructive in the judge’s reasoning is a mention of two side arguments.

First, the judge noted the following, regarding the sequence of steps in the claimed invention (first, formation of the bromine / triphenylphosphite complex, and then reaction with cyclopropylcarbinol):

This sequence is all the more important as MMLS and M2i precisely insisted on it in order to justify the inventive step of their own patent application filed in the United States, so as to discard the Bayer document which was cited as a prior art, since it disclosed a different order of introduction of reactants. They notably argued that “the particular order of the steps is essential to avoid a side reaction resulting in the opening of the tight ring, thus leading to the formation of a brominated alkene (bromobutene)” and that “this method is advantageous relative to the state of the art”.

This has the flavor of a file wrapper estoppel, and one based on a foreign file wrapper, at that.

But as is usually the case, this only comes as an additional consideration at the end of the reasoning in the ruling.

Second, the judge emphasized that both of the proposed secondary references were fairly old. D.G. Coe was dated 1954, and Eli Lilly was dated 1980.

A strong flavor of secondary indicia of inventive step, if you will.

Some fairly old prior art.

The other defense raised by MMLS and M2i was non-infringement.

The judge in charge of case management thus had to decide whether the existence of infringement was likely or not.

The process implemented by the defendants was known owing to an infringement seizure report.

The main non-infringement argument was that, in the defendants’ process, bromine is used in excess in the reaction with triphenylphosphite (TPP). This leads, they said, to the formation of bromo triphenoxy phosphonium bromide as an intermediate. This is not a TPP / bromine complex as recited in claim 1 of the Minakem patent, they argued, because of the presence of the bromide ion in the intermediate. In contrast, the TPP / bromine complex does not comprise a bromide ion and, according to the description of the patent, it is obtained with an excess of TPP (rather than an excess of bromine). They also insisted that the difference is significant, as their own process leads to a lower proportion of bromo butene by-product than the claimed one.

The judge was not convinced. He noted that the starting materials of the MMLS / Mi2 process are the same as those of the Minakem patent. So is the order of the reaction steps. The judge was not convinced either by the alleged difference in molar proportions of reactants:

[…] The scope of claim 1 of the FR’997 patent is not limited by any proportion, so that it does not necessarily and only cover a process limited to equivalent amounts of bromine and [TPP], and anyway the bromine excess alleged by MMLS and M2i is only low in view of the figures which were communicated. 

It is noteworthy that Minakem filed an affidavit from a chemistry professor that challenged the influence of the relative amount of bromine on the purity of the product.

The judge also noted that the different bromo triphenoxy phosphonium bromide intermediate relied upon by the defendants was not mentioned by the employees who were interrogated during the infringement seizure. And that this intermediate is not mentioned in MMLS’s own patent applications either.

As a conclusion, the infringement of the Minakem patent was found to be likely. The judge thus granted Minakem the PI that they requested, without security in view of Minakem’s financial health. However, the judge rejected Minakem’s request for provisional damages. This is because the evidence for the proposed computation of damages offered by Minakem, based only on an affidavit of their CFO without any external auditing corroboration, was insufficient.

To be continued on the merits! MMLS and M2i have their work cut out for them: it seems like they need to find new arguments if they want to turn the tables and ultimately prevail. I am especially curious to see how the ownership claim in relation to the defendants’ patent family will unfold.


CASE REFERENCE: Tribunal de grande instance de Paris, ordonnance du juge de la mise en état, 3ème chambre 2ème section, July 6, 2018, Minakem v. Melchior Material and Life Science France & M2I Salin,RG No. 17/15019.

Will case law crystallize?

Today, it is back again to one of the topics regularly addressed on this blog, namely the statute of limitations for patent nullity actions in France (but not only!).

Matthieu Dhenne was kind enough to send me a brand new decision from the Paris Tribunal de grande instance (TGI) which, once more, sheds new light on this thorny issue.

The patent at stake is the French part of EP 1455756, to Merck Sharp & Dohme Corp. (MSD). The patent was granted on July 9, 2008. It was opposed by two generic drug manufacturers. At first instance, the patent was maintained in amended form, according to a decision dated December 3, 2010. The opponents appealed, and their appeals were dismissed by the Board of appeal in a decision dated July 17, 2014. The publication of the amended patent took place on September 23, 2015.

Soon thereafter, on December 2, 2015, Ethypharm filed a nullity action with the Paris TGI, requesting that the French part of the patent should be revoked.

Quite predictably, MSD argued that the nullity action was time-barred.

If one directly applied the recent case law of the Paris Cour d’appel (discussed here), this should be a winning argument. Indeed, the Cour d’appel has proposed that the five year-limitation period be computed from the date of grant of the patent. With this in mind, in this case, the limitation period would have ended on July 9, 2013.

But you and I know that things are not that straightforward, as the Paris TGI does not follow the case law of the upper court, and generally favors an in concreto determination of the starting point for the limitation period (see a recent example here).

Yet, in today’s ruling you will not find any protracted discussion of an in concreto starting point. Instead, the issue is disposed of in just one paragraph:

[…] It is only on [July, 7, 2014, i.e. the date of the Board of appeal’s decision] that the drafting of the patent which is sought to be revoked was stabilized and that Ethypharm was able to precisely know the content of the claims of said patent as well as all the facts making it possible for them to act, so that the action is not time-barred and is admissible. 

I must say I have mixed feelings about this.

My initial reaction was, oh no, you must be kidding me, there is now yet another way of determining the starting point for the limitation period? This is not legal uncertainty anymore, this is legal chaos.

A few seconds later, I thought, well yes, it does make sense after all, you can’t possibly be expected to shoot at a moving target. When a patent is modified during opposition proceedings, any appeal filed at the EPO has a suspensive effect, and thus it is only once the appeal proceedings are terminated that the content of the patent is final.

A party must act within five years from the date at which they knew or should have known that the patent at stake is a possible impediment for their current or future business activities, or else be time-barred (this is more or less what I understand to be the TGI’s usual position). And how can a party know this before the patent is even its final form?

However, this ruling raises more questions than it provides answers.

What if an opposition is rejected by the opposition division and the patent thus maintained as granted instead of as amended? Should the reasoning be the same? What if an opposition is filed by a straw man (which is allowable at the EPO) and there is thus an unverifiable suspicion that the nullity claimant itself may be the true opponent, in an attempt to artificially extend the limitation period by several years?

In his message to me, Matthieu Dhenne also noted that the court’s reasoning could be applicable to other situations: limitation proceedings, but also a prior nullity suit brought forward by a third party. Taking this one step further, he observed that a patent right can in fact be modified at any time and is therefore theoretically never “stabilized” until it expires (sometimes, it can even be retroactively “stabilized” only after its expiry). He thus suggested that the full consequence of the court’s reasoning should be that the limitation period can only start running at the expiry of the patent, so that the well-identified drawbacks of this limitation period should in practice never occur.

Matthieu added that there would thus be a complete parallelism between the limitation period for infringement actions and nullity actions. Accordingly, invalid patents would not be able to unduly hinder free competition.

Definitely an interesting suggestion, but is it really what the TGI had in mind? I am quite sure we can expect more surprises in future decisions.

Apart from this, the decision is worth the read beyond the admissibility part.

First, it turns out that the nullity claim was held ill-founded on the merits and thus dismissed. As the patent in suit is a pharma patent, this is already quite remarkable. A majority of pharma patents which are litigated in this country are revoked one way or another.

Second, the decision tackles the very interesting issue of plausibility.

There has been a significant trend in France for patents to be revoked when they are held to be of a speculative nature. See for instance previous posts here, here and there.

In the present case, Ethypharm argued that the patent was of the speculative kind, which resulted in insufficiency of disclosure and lack of inventive step.

Now may be a good time to have a look at claim 1:

A nanoparticulate composition comprising the compound 2-(R)-(1-(R)-(3,5-bis(trifluoromethyl)phenyl)ethoxy)-3-(S)-(4-fluoro)phenyl-4-(3-(5-oxo-1H,4H-1,2,4-triazolo)methylmorpholine, or a pharmaceutically acceptable salt thereof, the compound having adsorbed on the surface thereof at least one surface stabilizer in an amount sufficient to maintain an effective average particle size of less than about 1000 nm; where “effective average particle size of less than about 1000 nm” means that at least 95% of the particles, by weight, have a particle size of less than about 1000 nm.

This drug composition is useful in the treatment of nausea and vomiting, especially those induced by a chemotherapeutic treatment. The short name of the active compound is aprepitant. According to the patent, the technical problem at stake was to improve the bioavailability of aprepitant. This is stated in the patent but no experimental test results are present, which led Ethypharm to consider that there was no evidence in the patent that the technical problem was properly solved.

Ethypharm also tried to use some of MSD’s posterior testing against them, by claiming that they proved that there were features missing in the patent which were essential for successfully implementing the invention.

The court was not convinced that there were indeed such essential features missing. The court also noted that there was a reference in the patent in suit to a prior U.S. patent disclosing the so-called “Nanocrystal” method, for making nanoparticles with a surface modifier adsorbed thereon, having an average size of less than 400 nm. This Nanocrystal patent also taught that such nanoparticles improve the bioavailability of poorly water-soluble actives.

Thus, said the court, the improvement in bioavailability provided by the nanoparticle form of aprepitant was plausible.

In such a case, the court continued, evidence which is external to the patent can indeed be taken into consideration for demonstrating that the technical problem is solved. The court then reviewed a number of articles and reports and was satisfied that the technical effect of improving bioavailability was well achieved.

In summary, this is an important decision for the fine-tuning of the appraisal of a speculative patent-type objection.

To me, the take-away message is that a reference in a patent to a prior art document disclosing a technical effect provides some plausibility that the technical effect is indeed achieved.

From drug crystals to crystal balls: could they possibly help us decipher future case law?

The patent survived other attacks of insufficiency of disclosure, extension of subject-matter and lack of inventive step. Quite remarkably, the main claim was in particular found to be non-obvious over the “Nanocrystal ” European patent of the same family as the U.S. patent mentioned above, which was used for supporting the plausibility of the technical effect.

The court held that:

[The “Nanocrystal” prior art] does not disclose chemical structures or features of drugs intended to be used by this process. It only mentions that it can be implemented with a large variety of medicinal substances, the substance having to be poorly soluble, that is less than 10 mg/mL, so that the skilled person does not know which actives […] can be tested with a reasonable expectation of success. He was all the less incited to do so that in December 2001, i.e. almost ten years after the priority date of [the Nanocrystal patent], the nanonization process, which has a number of constraints (in particular the heat released during milling may change the structure of the active substance and reduction to a very small size may create a problem of chemical and physical stability), was used on only four active substances (danazol, steroid A, compound WIN 63,394 and naproxene) with a verified effect on bioavailability […]. 

I have the uneasy feeling that there may be a contradiction here between the sufficiency and inventive step prongs of the court’s reasoning.

If the teaching of the Nanocrystal patent cannot be applied in an obvious manner to aprepitant, and if there are many technical uncertainties, why is it then not necessary for the MSD patent to contain evidence in the form of experimental tests showing that the process can in fact be effectively applied to this particular drug?


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 2ème section, January 26, 2018, Ethypharm SAS v. Merck Sharp & Dohme Corp., RG No. 16/01225.