A light ruling

The case discussed today is not a light case of patent infringement. Nor is it a case of light patent infringement. It is rather a case of patent infringement regarding light technology, namely LED-based lamps emitting light in multiple colors.

The litigation at stake pits Philips Light North America Corporation against France-based Commerce Spectacle Industrie (CSI).

This is a multifaceted dispute, but the prong of the litigation of interest to us today is Philips’ infringement claim against CSI based on the French part of European patent No. EP 1016062, and CSI’s counterclaim for revocation.

As a one sentence summary, the Paris Tribunal de grande instance (TGI) held that the patent was valid but that infringement was not sufficiently proven.

For once, let’s start with the infringement part of the decision.

Claim 1 of the patent as maintained in amended form in opposition proceedings at the EPO reads as follows:

An illumination apparatus comprising:
– a plurality of light emitters of at least two different colours adapted to be coupled to a power circuit including a power source and a common potential reference;
– driver means for driving the plurality of light emitters, the driver means comprising at least two switches connected to the plurality of light emitters and said power circuit and corresponding to respective current paths of the at least two different colour light emitters;
– a controller for periodically and independently opening and closing the at least two switches, the controller having an alterable address assigned to itself such as to identify and respond to a respective portion of an input data stream assigned thereto, which data stream portion is assigned to that controller;
– each light emitter being an LED; and
– said controller being arranged to generate a plurality of PWM signals, the PWM signals having uniform frequency, each signal corresponding to a respective colour of the plurality of LEDs of different colours, each said PWM signal causing a respective one of the at least two switches to be opened and closed at the uniform frequency according to respective independent duty cycles, and wherein said data stream portion comprises data for determining the respective duty cycles of the at least two different colour LEDs.

An enlightening invention.

Philips’ case primarily relied on experimental tests conducted on the allegedly infringing lamps by an expert appointed by them.

CSI criticized the report drafted by the expert. One major criticism was that Philips’ expert had used an oscilloscope for the experimental tests, without following the procedure set out in the instruction manual for this apparatus. In particular, the expert’s report did not show that the oscilloscope had been preheated for 30 minutes as recommended in the manual, and that a proper calibration had been performed.

CSI added that there were a number of loopholes in Philips’ demonstration, namely that “the expert report does not mention a periodic opening and closing of the switches, that [Philips] does not show how the current paths are and does not establish the presence of respective current paths […], that they never show how a switch would be connected to the diodes“.

Did the court see the light, readers are probably wondering?

Of course the answer depends whose side you are on, but the court did find that CSI’s criticisms had merit:

For each product, [Philips] relies on measures made with an oscilloscope, the conditions of use of which are not specified in the expert report […], although it is true that the instruction manual [….] notably requires a preheating of at least 30 minutes and a calibration before each use so as to allow optimal measurements […]. These basic precautions were not taken, so that the measurements obtained are necessarily suspect. It cannot be understood how the absence of a calibration could have no impact on the shape or (supposedly uniform) frequency of the signals, nor how the absence of preheating would not affect the measurements. The [alleged] continuous use [of the oscilloscope] for all measurements after the first one, which cannot be determined in the absence of any timing information in the report, and which cannot be derived from the order of the annexes which does not necessarily reflect the order of the operations, is not proven and may not compensate for a possible original malfunction.

Frankly, I am not sure what to make of all this.

On the one hand, we all remember from our science classes that calibration is not just for window-dressing. Did the expert proceed according to accepted practice or not? If the report is silent on this, the defendant and the judges cannot know for sure.

But on the other hand, any experimental report can always, always, be criticized for some choices that were made in the setup, or some omissions in the report itself.

Therefore, wouldn’t it be reasonable to consider that, if one party has taken the trouble of conducting experimental trials to prove its case, and if the other party wants to challenge the results of the trials, this other party should also make the effort of conducting counter trials – instead of simply pointing to potential loopholes?

Well, at any rate it does not look like this is the approach followed in France. The infringement plaintiff has the burden of fully proving the existence of the infringement, and the burden does not shift to the defendant by providing evidence which is anything short of bullet-proof.

That said, it seems that in the present case the demonstration of infringement was incomplete anyway, irrespective of the credibility of the expert’s report. And this would have been by itself sufficient to throw out the infringement claim – although the judgment does not contain many details:

Assuming that these measurements were sufficient, they would demonstrate an independent command of colors, but not the existence of “respective current paths” […], i.e. paths related to each light source, since independence does not per se imply an exclusive assignment. And the diagrams supplied for each product only show one light source, which prohibits any appraisal of the “respective” character of the current paths. 

Philips’ solace was that the patent was found to be valid. CSI had only raised lack of inventive step as a ground of nullity.

As a confirmation of a now well-established trend, the court followed the problem and solution approach for assessing inventive step – primarily because the parties themselves used this reasoning.

Here is the court’s summary of the appraisal to be conducted:

Since the parties, at least primarily, apply the non-mandatory “problem/solution” approach, it will be adopted […] by the court. It requires, in order to allow an objective examination of the inventive step without hindsight: 

– objectively identifying the closest prior art, i.e. a prior art reference which discloses subject-matter developed for the same purpose or having the same goal as the claimed invention and essentially having similar technical features requiring few structural modifications, 

– assessing the technical results achieved by the claimed invention relative to this prior art, 

– defining the technical problem which the invention purports to solve by obtaining these technical results, 

– examining whether, in view of the closest prior art, the skilled in the art would or would not [have been] suggested with the claimed technical features to achieve the results obtained by the claimed invention. 

In brief, this quite closely matches the EPO’s beloved reasoning.

In the present case, the parties seemed to agree that there were two partial problems at stake. Here, again, the court relied on the EPO practice, even making reference to the Guidelines for examination:

As set out in section G-VII, 7 of the Guidelines for examination at the EPO, if the claimed invention is in principle considered as a whole, which excludes that the inventive step of a combination of features be appraised for each feature taken in isolation, such a separate appraisal is necessary if the claim is made of a juxtaposition of features, and not of their combination which implies that the functional interaction between them produces its own technical effect exceeding the sum of the technical effects that they individually produce, namely a synergy effect. 

Applying these principles to the EP’062 patent, the court focused on the first partial problem only, and found that some of the claimed features were in fact neither disclosed in the closest prior art, nor in the suggested secondary reference. Therefore, it was simply impossible to arrive at a conclusion of lack of inventive step. Besides, the rationale offered by CSI for combining the documents together did not take into account the technical problem at stake in the patent. And the respective prior art documents contained contradictory teaching.

All in all, there were thus several reasons to find the claim inventive, without even having to look at the second partial problem.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre, 1ère section, November 16, 2017, Philips Lighting North America Corporation v. SAS Commerce Spectacle Industrie, RG No. 15/09326.

Publicity stunt

There is no such thing as bad publicity, some say. Or, as Oscar Wilde wrote, there is only one thing in the world worse than being talked about, and that is not being talked about. 

This rule may have some merit in show business and in U.S. politics, but it is clearly inaccurate in the trade and industry business.

A recent illustration can be found in one of those never-ending French patent disputes, where judgments keep popping up every 2 to 3 years, namely Newmat v. Normalu.

In this dispute, Newmat is the patentee and original plaintiff, and Normalu the original defendant.

As a non-exhaustive summary, in October 2004, Normalu was found guilty of patent infringement at first instance. This was finally confirmed on appeal in May 2010 (in case you are wondering, yes that took a while, but only because there was a first appeal judgment which was set aside by the Cour de cassation, and the case was remitted back to the Cour d’appel).

The litigation continued for the purpose of damages computation. In January 2012, the Paris Cour d’appel issued its final ruling on damages.

A few months thereafter, Newmat published a document entitled “Legal information note on Newmat v. Normalu Barrisol – decision on patent infringement relating to a profiled part for hanging suspended ceiling”. The document contained the court order from the appeal ruling of 2010.

Normalu deemed that this internet publication was an act of unfair competition and therefore sued Newmat, to claim damages. This new branch of the litigation culminated in an appeal ruling from the Paris Cour d’appel issued in May 2015. In the ruling, the court found that Newmat was indeed guilty of unfair competition but limited the amount of damages to the minor amount of 5,000 euros.

Normalu was so disappointed with the outcome that they filed an appeal on points of law. The Cour de cassation rejected Normalu’s appeal on October 18, 2017.

Let’s have a closer look at the facts of the case.

In the first judgment of 2004 in which Normalu was found guilty of infringement, the court granted Newmat’s request that the order of the decision should be published in three journals or newspapers selected by Newmat, up to a cost of 3,000 euros per publication, to be paid by the defendant.

Such a “publication order” is a classical measure quite often ordered by the courts when there is an infringement verdict. An explicit legal basis for this type of order was in fact added to the statute in 2007 (article L. 615-7-1 of the Code de la propriété intellectuelle). It is seen as a complementary remedy to the trouble caused by the infringement.

A novel and inventive way to communicate on judgments

However, Newmat did not implement this publication order. Instead, they published the abovementioned “legal information note” on their website, and published links to this note in their newsletter and on Twitter.

Normalu argued that Newmat was only authorized by the court to publish the order of the judgment in the form mentioned in the judgment, i.e. in three journals or newspapers. Newmat was not authorized to give the judgment another and arguably broader form of publicity, and should thus be held liable.

The Paris Cour d’appel disagreed and noted that the infringement judgment was public, so that Newmat was free to communicate on it as they wished. The publication order in the judgment did not restrict in any way Newmat’s ability to publish the judgment in a different manner (at its own expenses, one can add). Therefore, the only issue that the court ought to check was whether there was any abuse in Newmat’s communication, and in particular if this communication was disparaging or otherwise represented an act of unfair competition.

In other words, the Paris Cour d’appel did not see any issue in principle with the publication of the judgment on Newmat’s own initiative; but it was nevertheless necessary to check whether the contents and the form of the publication were appropriate.

At this point, the court noted that the text published on the website was neutral and did not comprise any comment – so far so good. Then the court remarked that the text published on Newmat’s website was identical to the order actually contained in the infringement judgment, but for two exceptions.

The first exception was that the part of the order relating to the designation of an expert (for the assessment of damages) was omitted from Newmat’s publication. This was found by the judges to be without any consequence, as the reader was not misled due to the omission.

The second exception was that the order of the infringement judgment referred to the company Normalu, whereas Newmat’s note mentioned “Normalu (Barrisol)” instead. Barrisol seems to be a trade name under which Normalu operates and markets its products.

Newmat explained that it was necessary to specify that Normalu was Barrisol, so that the reader coud properly understand the provided information. On the other hand, Normal argued that, in view of the well-known reputation of the Barrisol trademark, the mention added by Newmat resulted in increasing the impact of the judgment publicity, beyond the exact wording of the judgment.

On this respect, the Cour d’appel sided with Normalu, which led to the conclusion that Newmat had indeed committed an act of unfair competition.

Turning to the computation of damages, Normalu claimed that they had to launch a radio advertising campaign in May 2012 in order to mitigate the effect of Newmat’s online communication. But the appeal judges held that the link between the radio ads and Newmat’s wrongdoing was not adequately proven by Normalu. This led the court to set the amount of damages to the rather symbolic amount of 5,000 euros.

Normalu pleaded its case again in front of the Cour de cassation, but as mentioned above, the supreme court judges found no error in the 2015 appeal decision and rejected Normalu’s appeal on points of law.

In particular, regarding the principle of the online communication performed by Newmat, the court held that:

legal decisions are public; thus the provisions of article L. 615-7-1 Code de la propriété intellectuelle (per which in case of an infringement verdict, the court may order any appropriate measure of judgment publicity, such as by poster or by a full or partial publication in newspapers or online communication services that it designates, in a form to be specified and at the expenses of the infringer), do not exclude the victim’s right to proceed, at its own expenses, with any other publicity measure regarding the condemnation granted to it.

This is a relatively important point.

It means that plaintiffs do not have to ask for the court’s permission before communicating on a ruling which is favorable to them. As long as they communicate at their own expenses, they can do it directly – under the proviso that they remain completely neutral and more generally do not act in an abusive manner.

I would add that it may not be a good idea for a plaintiff to publicize a first instance judgment which is not yet final.

Concerning now the form and contents of Newmat’s communication, the Cassation judges stated that the Cour d’appel was free to appraise the facts as it did, and thus that it issued a legally valid decision.


CASE REFERENCE: Cour de cassation, chambre commerciale, October 18, 2017, Normalu v. Newmat, No. 15-27136.

The bell always rings twice

This blog has now been around long enough for the same case to make it to a post several times, when new developments come up.

The present post is thus a sequel to my earlier comments on the litigation between Airbus Helicopters and Bell Helicopter Textron Inc.

As a reminder, the Paris Cour d’appel found Bell guilty of infringement of French patent No. FR 2749561 directed to a landing gear with skids.

Bell filed an appeal on points of law, and the Cour de cassation has now issued its judgment rejecting the appeal. Many different legal points were raised by Bell, but certainly the most interesting one relates to the finding of infringement concerning the so-called first version of helicopter Bell 429. This first version was a prototype, which was:

  • included in Bell’s catalogue;
  • shown in September 2005, which was reported on the website of a helicopter enthusiast (although Bell argued that this was a confidential presentation);
  • and put up on the website of Rotor & Aircraft, Bell’s distributor in France.

Bell’s defense was that this first version of the helicopter was not yet approved for sale. But the appeal judges noted that:

Offering for sale extends to any material operation aiming at putting a product in contact with potential customers, at preparing a commercial launch, even if said product, which in the present case was not yet approved, could not be marketed.

A helicopter prototype at a very early stage.

The “prototype” defense was raised again by Bell in front of the Cour de cassation, according to the seven following points.

First:

A mere prototype [was presented] in a private context and within a narrow circle of specialists; the prototype had not yet flown, and was later subjected to several modifications; in the absence of any prior certification, it could not be marketed; [this] cannot correspond to putting on the market nor even to a preparatory act for such putting on the market.

As a result, said Bell, the court breached the statute, by deciding that an offer for sale could relate to a product which could not be marketed.

The cour de cassation replied that the standard applied by the Cour d’appel was the right one, in particular because “the presentation of the product as a prototype can divert part of the clients of the patented product“. 

Second, the presentation of the first version of the landing gear was quickly followed by the marketing of the second version of the gear. Also, the certification of the second version was based on tests performed on the first version. Thus, the presentation was at best a preparation for the sale of the second version, and not an offer for sale of the first version.

The supreme court judges disagreed. In fact, the Cour d’appel had held that Bell intended to market the first version of the landing gear at the time it was presented.

Third, Bell blamed the appeal judges for relying on acts committed outside of France: an offer for sale abroad in a catalogue, and presentations in exhibitions in the U.S. and Canada. They said that only acts committed in France could possibly constitute an infringement.

However, for the Cour de cassation, the Cour d’appel did not hold any acts committed abroad as acts of infringement. They simply noted that the presentation in France had been preceded by offers for sale abroad. As I understand it, it is therefore OK to refer to acts committed abroad in order to characterize the overall context.

Fourth, Bell submitted that the report of the first version on a website owned by a helicopter enthusiast was an act committed in a private and non-commercial context – which is an exception to infringement.

Fifth, regarding the presentation of the helicopter on Rotor & Aircraft’s website, Bell argued that the landing gear could not be identified on the pictures appearing on the website.

Sixth, there was no evidence of the presentation of the first version in the Paris air show, since the bailiff’s report did not precisely describe the landing gear.

The Cour de cassation did not provide a detailed answer and simply referred to the appeal judges’ discretionary power for appraising the available evidence.

Seventh, the Cour d’appel refused to acknowledge that the acts committed related to the statutory experimental exception, because no test and no act of research were performed when the first version of the landing gear was presented. However, Bell said, the sole use of the landing gear could by itself aim at studying its behavior and therefore relate to the experimental exception.

But the cassation judges decided that the absence of evidence of any experimental testing was sufficient to reject the experimental exception.

Many other grounds were raised, regarding the validity of the patent, the validity of the infringement seizure report and the infringement by equivalence of the second version of the landing gear. They were all discarded.

One rather enjoyable part of the discussion relates to the way the bailiff drafted the infringement seizure report. The bailiff used in some instances the word “we” instead of “I“, so that it could not be determined, Bell said, what the bailiff had actually personally done or witnessed. The court replied that the use of the pronoun “we” was commonplace and could not be relied on to deduce that the bailiff had not carried out the seizure himself.

I wonder whether the pronoun “we” is that commonly used to designate a single individual. It is rather a specificity shared mainly by royalties and bailiffs, I would say.

Anyway, the take-away message from this important ruling remains that the presentation of a prototype can be considered as an offer for sale and thus an act of infringement, even if the product at stake is not yet marketable.


CASE REFERENCE: Cour de cassation, chambre commerciale, July 5, 2017, Bell Helicopter Textron Inc. & Bell Helicopter Textron Canada Ltd. v. Airbus Helicopters, case No. B 15-20.554.

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.

Beware, drafters!

This may well be the fourth post almost in a row on a pharma case. Although pharma patent litigation is typically not hyperactive in France, each single case usually generates many interesting questions.

Today is no exception, not only from the litigation perspective but also from the viewpoint of a patent drafter. There are in fact at least two aspects in the decision of the Paris Tribunal de grande instance (TGI) which can be taken as significant warnings for patent attorneys.

The patent in suit is EP 0984957, owned by Swedish company AstraZeneca AB, and it looks quite simple and straightforward.

Claim 1 of the patent simply reads: “the magnesium salt of S-omeprazole trihydrate“.

S-omeprazole, also known as esomeprazole, is a blockbuster drug used in the treatment of gastric ailments. The patent is directed to a specific form of the drug.

Claims 2-4 further specify the form of the drug. Claims 5-8 relate to a process for the preparation of the drug. Claim 9 relates to a pharmaceutical composition comprising the drug of claim 1 and another one. Finally, claim 10 is a Swiss-type claim mentioning the treatment of a gastric acid-related condition.

In July 2011, AstraZeneca initiated infringement proceedings against Ethypharm based on this patent in view of the exploitation by this French company of generic esomeprazole.

Ethypharm of course filed a counterclaim for nullity in due time. But things did not go smoothly, and the lawsuit seemed to drag on forever.

First, an expertise was ordered so as to sort out the documents seized during an infringement seizure. Second, the parties discussed and initially agreed to the designation of another expert, as far as I understand in order to weigh on whether there was an infringement or not. Third, this expert was finally not designated, as AstraZeneca admitted that the generic esomeprazole on the market no longer infringed the patent (while maintaining that there had been infringement in the past). Fourth, AstraZeneca was compelled to file the experimental evidence based on which the above admission was made.

In summary, the judge in charge of case management certainly had her work cut out for her. And this leads us to the judgment issued by the TGI on June 23, 2017.

The first aspect of the decision that deserves a discussion is claim interpretation.

The patent proprietor stated that claim 1 covered any magnesium salt of S-omeprazole trihydrate. But, according to the defendant, claim 1 only protects a specific form of magnesium salt of S-omeprazole trihydrate.

The court went for the latter interpretation.

The court referred to article 69 EPC and the protocol on the interpretation, and remarked that “the judge must not make any interpretation if the claim is self-sufficient and should not denature the claim on the pretext of claim interpretation“.

One may wonder if the court did not do just that, i.e. interpret a claim based on the description, although the claim seemed quite self-sufficient.

At least from an EPO perspective, I have little doubt that a claim simply entitled “the magnesium salt of S-omeprazole trihydrate” would be seen as covering any magnesium salt of S-omeprazole trihydrate based on its plain wording.

But this is not the option that the court used. Instead, the court had a close look at the description of the patent and noted inter alia the following:

Since the wording of claim 1 does not comprise any determiner, one should refer to the description and drawings to interpret it, with respect to the skilled person […]. 

It is also specified that omeprazole and its salts as well as the R and S enantiomers of omeprazole and their salts are known from the art […] and that the magnesium salt of the S enantiomer of omeprazole exists in different forms. 

As mentioned in the description, the field of the invention does not relate to a “novel form of S-omeprazole” as suggested by the title of the patent, since this molecule was already identified, but a “novel form  of trihydrate of the magnesium salt of the S-omeprazole” […], which implies that it is a trihydrate form other than known from the art, with specific features such as “substantially pure” […], devoid of magnesium salts of R-omeprazole […] and devoid of other forms of magnesium salts of S-omeprazole (including the dihydrate form used for the preparation of the composition). 

This product is said to be “highly crystalline” […] since it has a larger crystallinity than any other form of magnesium salt of S-omeprazole, including trihydrate forms […]. 

This compound is characterized by an X-ray powder diffractogram [XRD] which shows main peak positions and intensities […], or by spectroscopy […]. 

Crystalline forms at their best

In support of its proposed interpretation, AstraZeneca filed an affidavit by a doctor Byrn, as well as a judgment by the New Jersey district court on a corresponding U.S. patent, per which the magnesium salt of esomeprazole trihydrate was novel at the time the invention was made and the patent was to be interpreted in a broad manner.

By the court was not convinced and noted that

the prior art previously disclosed a non-pure form a magnesium salt of S-omeprazole trihydrate, as can be derived from the laboratory tests performed on molecules recited in previous patents […]. [And] it can be deduced from the aforementioned elements in the description (notably the very title of the patent and the wording of the claims, the use of determiners in the text of the description such as “A” or “This” […] to mention the product […]) that the invention does not relate to any trihydrate of magnesium salt of S-omeprazole as suggested by AstraZeneca, but to a specific trihydrate having defined features (substantially pure, crystalline, with specific peaks) […]. 

The court repeatedly stated in the judgment that some magnesium salts of esomeprazole trihydrate were known from the art. But it does not seem to me to clearly stem from the patent itself. It is possible that the recreation of prior art esomeprazole could show that this particular salt form was already present, but isn’t this rather an issue of novelty of the claim?

Also, it is extremely striking that the court placed so much emphasis on how the description was drafted.

Here is the thing, I think. Paragraph [0009] of the patent for instance starts with: “the magnesium salt of S-omeprazole trihydrate obtained according to the present invention is substantially free from magnesium salts of R-omeprazole“. Then paragraph [0010] starts with: “the compound of the invention is characterized by the positions and intensities of the major peaks […]“.

If my understanding is correct, it could have made a world of a difference if these paragraphs had mentioned that the compound “according to some embodiments” is substantially free from other salts, or that the compound of the invention “may be” characterized by certain positions and intensities of peaks.

Therefore, beware drafters! Even if you get what you consider a broad claim granted, it may be interpreted by a court in a much narrower manner if the description gives the impression that the invention has a number of other essential features.

Surprising? Well, with Munich eyes, certainly. But not really if you are familiar with French case law.

Today’s decision is for instance very reminiscent of the approach recently taken in the rosuvastatin case. Even electronics cases are handled in a similar manner, as illustrated here.

The TGI’s comment on dependent claims 2-4 is enlightening in this respect. Claim 2 mentions that the compound is highly crystalline. Claim 3 mentions that it is stable. Claim 4 mentions that it has a certain XRD pattern. A common way of looking at this would be to state that claim 1 is broader than claims 2-4 and thus is precisely not limited to the specific XRD pattern, or to a highly crystalline form, etc. But the court reached the exact opposite conclusion and noted that

these claims define the specific features of the compound mentioned in claim 1.

Now, one may criticize the court’s rewriting of straightforward claim 1 and the challenge this presents to legal certainty. 

But there may nevertheless be a possible justification for this bold approach.

As the patent only discloses one very specific crystalline form of trihydrate, it could be argued that the protection should be limited to this specific form and should not extend to other forms of trihydrate which were not actually made available to the public by the patent. Maybe this is what the judges had in mind.

After this section on claim interpretation, the judgment contains a section on sufficiency of disclosure and novelty.

Both grounds of nullity were discarded by the court. In fact, the objection of lack of novelty was put forward only in case the patentee’s broad interpretation prevailed – and this was not the case.

And then comes the other important point in the judgment, namely inventive step.

At this point, the patent was revoked, based on a very brief justification.

The court generally made reference to the problem and solution approach. The dihydrate form of the compound was the closest prior art. According to the patent, the new form is more stable and easier to characterize and synthesize.

But the court refused to take this statement of a technical problem into account:

Yet, beside the disclosure of the molecule on a new form (trihydrate) and the presentation of preparation and identification methods of this product, whereas the pharmaceutical industry wants to find further forms of an active, even if the properties to be expected from the new molecular forms are not known, the patent does not define any problem. It just mentions that the product is more stable, easier to synthesize and handle and identify, without however supporting this statement in the patent itself, by studies and researches and results. Thus, the patent does not mention a problem to be solved let alone demonstrate the resolution of this technical problem. 

Moreover, it is acknowledged that in front of the EPO or in litigation the patentee may refer to posterior tests, but these must consolidate results already contained in the patent […]. 

Therefore, claim 1 is invalid for lack of inventive step as it does not solve a technical problem.

To summarize: the patent does mention a technical problem solved by the invention. But in the absence of any experimental evidence in the patent that this problem is indeed solved, the problem is not taken into account. Post-published evidence is considered to the extent that it can merely supplement data already contained in the patent, but not replace it entirely.

So far so good, and the approach taken by the court seems consistent with EPO case law. See in this respect the catchword of oft-quoted T 1329/04:

The definition of an invention as being a contribution to the art, i.e. as solving a technical problem and not merely putting forward one, requires that it is at least made plausible by the disclosure in the application that its teaching solves indeed the problem it purports to solve. Therefore, even if supplementary post-published evidence may in the proper circumstances also be taken into consideration, it may not serve as the sole basis to establish that the application solves indeed the problem it purports to solve.

However, directly jumping to the conclusion that the claims lack inventive step, as the court did, is something a Board of appeal would probably not do.

Instead, they would likely reformulate the technical problem in a less ambitious manner, e.g. in this case as providing an alternative form of esomeprazole, and would then investigate whether it was obvious for the skilled person to achieve the claimed invention with this unambitious technical problem in mind.

Let’s assume for instance that it was technically difficult to make the trihydrate form. In this case, a Board could arrive at a finding of inventive step. In France, the absence of an ambitious technical problem is in itself indicative of a lack of inventive step.

This confirms that French courts are more severe in the appraisal of inventive step.

At any rate, here comes the second advice for drafters is: beware of the plausibility of the technical effects of the invention!

My understanding is that it is kind of a hot topic at the EPO these days. Well, it is an even more serious matter in this country.

And this does not just apply to “therapeutic” effects.

In this case, the alleged technical effect was not related to the treatment of an illness but rather to physical characteristics of the drug (stability, ease of handling…).

So, we are all doubly warned, I guess.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 3ème section, June 23, 2017, AstraZeneca AB v. Ethypharm, RG No. 11/11460.