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.

Will time tell?

Hot from the press comes a brand new decision of the Paris Cour d’appel which may leave many practitioners skeptical – if not utterly unhappy.

Many thanks to Grégoire Desrousseaux for forwarding this important judgment!

The statute of limitations in connection with patent nullity actions is a recurring topic.

A few weeks ago on this blog, Matthieu Dhenne criticized the very notion of a limitation period for nullity claims.

Am I just in time for a nullity suit?

Not only does today’s ruling confirm once again that the general statute of limitations, as amended in 2008, does indeed apply to patent nullity claims. But it also contains a surprising finding concerning the starting point of the limitation period.

The context is the following.

Two individuals, Mr. and Mrs. Halgand, filed a French patent No. FR 2840634 in April 2003. The patent was granted in February 2005 and then assigned to a company called Matériaux Equipements Plastiques (MEP) in 2006. The technical field is the protection of purlins or rafters.

Starting from February 2013, there were a number of exchanges between MEP and another company, Raccords et Plastiques Nicoll (Nicoll). According to MEP, Nicoll was exploiting a purlin protection system falling within the scope of their patent, without any authorization. Nicoll did not agree with these allegations.

This finally led Nicoll to launch the first strike and file an action for declaratory judgment of non-infringement in front of the Paris Tribunal de grande instance (TGI). At the same time, Nicoll also claimed that the patent was invalid and requested its revocation. The original applicants of the patent were forced to intervene in the lawsuit as a result of the assignment’s guarantee. MEP counterclaimed for (inter alia) patent, copyright and trademark infringement.

In November 2014, the TGI revoked claims 1 to 10 of the French patent and rejected MEP’s counterclaims. MEP and Mr. and Mrs. Halgand appealed, which leads us to the ruling issued by the Cour d’appel last Friday.

Unlike the TGI, the Cour d’appel held that Nicoll’s nullity claim was time-barred and thus inadmissible.

The argument had already been discussed in first instance, but the TGI had rejected it, holding that:

[…] Only an in concreto appraisal of the point in time at which the nullity claimant effectively became aware of the right which is asserted against them can be made in order to determine the starting point of the limitation period. 

In this case, the starting point of the limitation period is the formal notice sent by [MEP]’s patent attorney […] on February 25, 2013. Therefore, the nullity action against the FR’634 patent contained in the complaint filed on October 4, 2013 is not time-barred. 

This first instance ruling was in keeping with a number of other recent decisions by the TGI, which all emphasized the necessity to assess the starting point of the limitation period on a case by case basis. The relevant date was consistently said to be that on which the claimant knew or should have known of the patent, in view of the specific facts of the case. See for instance B/E Aerospace Inc. & B/E Aerospace Systems GmbH v. Zodiac Aerotechnics, reported here as well as Actelion v. Icos Corporation, reported there.

The appeal judges seem to have gone in a different direction. Here is a translation of the relevant passage in the judgment:

Article 2224 of the Code civil provides for an in concreto appraisal for the limitation period, by setting the starting point of the limitation period to the day on which the owner of a right knew or should have known the facts making it possible for them to assert this right.

Even though the publication of a patent application does not create rights for the proprietor, the publication of the patent is an acknowledgment of its rights. 

It cannot be denied that the publication of a patent is a way for third parties to know their rights, and that a professional who works in the same area as the patent proprietor and who puts on the market a new product must comply with rights which have been made public, without possibly relying on unawareness. 

Moreover, Nicoll, like MEP, works in a very specialized area and has business relationships with Mr. Halgand, who presented a PVC dressing product for purlins and rafters. On that date, the patent application […] had not yet been filed and Nicoll refused to cooperate on the development of a common project in October 2002, letting Mr. Halgand know that they would get in touch with him if they changed their minds. But [Nicoll] does not deny that [Mr. Halgand] then provided prototypes, so that [Nicoll] was perfectly aware of Mr. Halgand’s work and of his plan to file a patent, although Mr. and Mrs. Halgand only filed the patent in suit in 2003, which was granted in 2005. 

Even if MEP sent a formal notice of cease and desist, they did not start infringement proceedings. It is Nicoll which, denying any act of infringement, initiated proceedings for a declaratory judgment of non-infringement and for nullity of the Halgand patent.

Since [Nicoll] was disturbed in the manufacture and marketing of its products due to this formal notice which they believed was ill-founded, it was their right to make the disturbance stop and they had standing to request a declaratory judgment. On the other hand, they could not extend this right by starting a nullity action in relation with a patent which was duly published, past the limitation deadline which must be computed from the publication. But they may rely on this ground as an exception defense within the infringement action against them. 

Now, MEP filed a claim for damages in court due to infringement and requested that the court should state that its patent FR 2840634 is valid, and that there are [acts of] copyright infringement, trademark infringement and disparagement, free-riding and misleading advertising. 

As a consequence, the rights of MEP should be examined first, and Nicoll is admissible to rely on a nullity exception. 

In summary, according to the court, the starting point for the limitation period is the patent grant in 2005, and not the cease and desist letter of 2013.

Let’s look at the silver lining first: if it is indeed a general rule that all nullity suits have to be filed within 5 years from the date of grant, then at least this rule is easier to apply than the one created by the TGI.

This is because the latter requires to have a detailed look at all relevant facts. In Actelion for instance, the court conducted a very complex assessment of scientific articles, annual reports of the company, patent applications and marketing authorizations.

In this respect, the approach adopted in today’s ruling increases legal certainty and predictability.

Now, the big grey cloud: it just does not make sense that a party should automatically be time-barred from filing a nullity suit possibly months or years before actually contemplating a commercial exploitation to which the patent at stake could be a possible obstacle.

The consequences could be potentially disastrous for generic drug companies willing to clear the way prior to launching a new product.

The Cour d’appel clearly stated that patent nullity can always be argued as a defense to an infringement claim, without any time-bar (except that the court in such a case will not officially revoke the patent). By the way, in the rest of today’s judgment, the court did examine the validity of the patent and actually came to a different conclusion from the TGI, holding that the claims are valid.

But the availability of a nullity defense is not going to help generic companies (and others) willing to preemptively knock down a patent before launching a product, precisely in order to avoid launching at risk. Indeed, in such a scenario, it is my understanding that the action would be fully inadmissible if time-barred.

There is still room for some doubt as to whether the Cour d’appel has just set a general rule here, the starting point always being the date of the patent grant, at least for professionals working in a specialized area; or whether the court’s finding should be viewed as limited to the specific facts of the case.

We should bear in mind in this connection that the nullity plaintiff had already been in contact with the patent applicants even before the grant of the patent – and this may have been a critical point for the court.

If the latter view were correct, then this decision would certainly be less at odds with the TGI’s usual approach. It would simply mean that the Cour d’appel had a different appraisal of the facts from the TGI but not that the very principles applied by the first instance judges are wrong.

What else? Well, Nicoll was held not to have infringed the patent, nor to have committed acts of copyright infringement, trademark infringement, free-riding, and the like, and MEP was found liable for disparagement, like in first instance.

What next? Well, time will tell – or not.

Will the TGI now implement this ruling and adopt a new approach for computing the limitation period or keep the current one? Will some desperately needed clarification come from the Cour de cassation? Will the lawmaker correct the unfortunate consequences of the 2008 amendment of the general statute of limitations in patent law?

I would at least not bet on the latter option anytime soon.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, September 22, 2017, Mr. and Mrs. Halgand & SAS Matériaux Equipements Plastiques v. SAS Raccords et Plastiques Nicoll, RG No. 14/25130.

Clarifying priority

Pharma cases are among the most complex of patent cases. Take the zoledronic acid infringement and nullity litigation for instance. No sooner than two weeks ago, I reported on a creative preliminary objection defense raised by the manufacturer Sanochemia Pharmazutika AG – which was rejected by the Paris Tribunal de grande instance (TGI), with a confirmation on appeal.

At the end of the post, I said that the case was worth watching for further developments, and that the decision reported on was just an amuse-bouche. Well, after the amuse-bouche, we now have a starter to feed on. For the main course, i.e. the judgment on the merits, we will have to wait a little bit longer.

Patent pending on an tray configured for accommodating amuse-bouche.

As always, a few words of context should be helpful.

The Novartis group owns European patent No. EP 1296689 on a further therapeutic indication of the drug zoledronic acid, for the treatment of osteoporosis. According to Novartis, their drug Aclasta® is covered by this patent. The Teva group on the one hand and Biogaran on the other hand hold marketing authorizations for a generic version of Aclasta®.

In January 2014, Novartis initiated proceedings against Teva alleging infringement of the EP’689 patent. In March 2014, Biogaran filed a nullity action in relation with this patent. Finally, in December 2014 and January 2015, Novartis initiated proceedings against Biogaran and two other companies alleging again infringement of the EP’689 patent. All of these proceedings have now been linked together in front of the TGI.

The validity of a divisional patent, EP 1591122, was later also challenged by Biogaran. Turns out this divisional patent is currently undergoing opposition proceedings at the EPO. The patent was maintained in amended form in first instance, and the outcome of the appeal should be known any time soon (more on this aspect below).

The French trial date was initially set on April 26, 2017, but the parties agreed to a postponement to Q1 2018, i.e. after the decision of the Board of appeal.

Meanwhile, motions were filed both by Teva and Biogaran in front of the judge in charge of case management. These motions gave rise to two parallel orders dated June 8, 2017, which I am reporting on today.

The issue raised by these motions is the following. The EP’689 patent, and therefore also the divisional EP’122 patent, are based on a PCT application filed on June 18, 2001, claiming priority from two U.S. applications of June 20, 2000 and February 9, 2001 respectively. It seems that the validity of the priority claims may be critical for the validity of the patent. I assume that this is because relevant prior art was published between the priority date and the filing date of the PCT.

Both priority applications were filed in the name of the inventors, as was mandatory at the time under U.S. law. But the PCT application was filed in the name of Novartis AG for all designated states except Austria, where the applicant is a local Novartis company.

In such a (common) situation, it is a frequent line of attack by nullity claimants to question the entitlement of the applicant(s) of the subsequent application to claim priority.

This line of attack is based on the wording of article 4.A.1 of the Paris Convention:

Any person who has duly filed an application for a patent, or for the registration of a utility model, or of an industrial design, or of a trademark, in one of the countries of the Union, or his successor in title, shall enjoy, for the purpose of filing in the other countries, a right of priority during the periods hereinafter fixed.

Article 87(1) EPC contains a similar provision. It is established case law that, when the applicant of the subsequent filing is not the same as the applicant of the first filing, a valid transfer of the right to claim priority to the first filing must have taken place before the date of the subsequent filing. Otherwise, the priority claim is invalid.

In the present case, Biogaran and Teva challenged that the inventors and original applicants have properly transferred the right to claim priority to the original filings to Novartis AG (the applicant for France in the PCT filing). They therefore deemed that the priority is invalid.

Novartis of course maintained that the priority was validly claimed and offered some justifications without however providing all of the underlying agreements.

As a consequence, Biogaran and Teva requested that Novartis should be ordered to supply copies of these underlying agreements. This encompasses the employment agreements of the three inventors, as well as relevant agreements between different entities of the Novartis group. The inventors themselves should be ordered to supply copies of their employment agreements to Novartis, to the extent that this would be necessary, asked Biogaran and Teva.

As could be expected, Novartis requested that the judge in charge of case management should reject these requests.

Based on the two orders issued on June 8, 2017, the judge was apparently quite sensitive to the arguments developed by the nullity claimants. At the very least, the judge noted that serious doubts have been raised regarding the entitlement of Novartis AG to claim priority to the two U.S. applications.

Let’s have a closer look at the arguments. Quoting from the Biogaran order:

For Biogaran, there is no evidence that the inventors held the rights that they allegedly assigned to Novartis on the day of the alleged assignment of May 2, 2001. 

As far as I understand from this passage, there was an alleged assignment from the inventors to Novartis AG before the filing date, but the question was whether the inventors still held the rights on the invention (and thus the right to claim priority) on that date.

The judge further explained:

Biogaran states that in many countries, and notably in the U.S., Switzerland and France, the right of the employer to claim inventions made by employees in the course of their employment agreement derives from the law or from the employment agreement. 

Regarding the Swiss inventor Trechsel who is said to reside in Switzerland, in the country of the applicant Novartis AG, Biogaran mentions that his employer is the Swiss company Novartis Pharma AG. 

They state that the employer of the inventors Richardson and Horowitz who reside in the USA was Novartis Pharmaceuticals Corporation and that therefore their employment was regulated under U.S. law and that it is necessary to determine if Horowitz and Richardson, according to the applicable U.S. law, assigned their invention (including the right to claim priority) to their employer. 

We thus have the complex picture of a multinational team of inventors having two different employers, both of which are different from the company that filed the PCT application.

Novartis, on the other hand, denied that any challenge against the entitlement to priority can be validly raised by third parties to the relevant agreements, such as Biogaran and Teva.

On the merits, Novartis’ response relied on an affidavit of a manager, who explained that there was a general policy in the Novartis group to the effect that Novartis AG was the applicant of all PCT applications, so that the rights on this invention were necessarily assigned to this company.

Here is what the judge had to say in this respect:

However, even if this affidavit makes it possible to understand that the wish of the Novartis group was that Novartis AG should own all the patents of the group, it does not provide any indication on the fate of an employee’s invention with respect to his direct employer. 

Novartis does not clearly explain the status of the three inventors and even more so does not provide the court with any information in order to make sure that at the time of filing the U.S. applications or between these U.S. applications and the assignment to Novartis AG of May 2, 2001, they indeed owned the inventions, and these had not been assigned to their respective employers due to their agreements or under U.S. or Swiss law. 

It is important for Novartis AG to take a position on this issue by supporting its argumentation on any useful communications. Therefore, the case management judge invites their counsel under article 765 of the Code de procédure civile to do this as further stated in the order below. Nevertheless, at present the judge does not have to specifically issue an order regarding the three employment agreements, the existence of which is not proven, and which at any rate are supposed to have been executed by third parties to the present litigation; nor regarding the other evidence requested by Biogaran. 

The court will rule on the merits in view of the arguments and evidence provided by the parties, on the admissibility […] of a challenge of the priorities and, if necessary, on Novartis AG’s right to claim priority in its patent application to the U.S. applications […]. 

As a result, the judge refused to issue any specific orders for the production of documents. But on the other hand she did invite Novartis to provide further information and evidence.

This looks like a mixed outcome. On the one hand, the nullity claimants (infringement defendants) did not get the specific orders that they requested. This is not very surprising as French judges are traditionally reluctant to issue such orders unless relatively strict conditions are met, especially when third parties are involved. Discovery is definitely not a part of French legal culture.

On the other hand, the patentee was explicitly invited to provide further information and evidence, which may mean that their case is currently viewed as incomplete and thus weak.

Clarifying the priority has thus been flagged a priority by the judge.

Another important step for this lawsuit was certainly the oral proceedings concerning the divisional patent which took place on September 13 and 14, 2017 in front of Board of appeal 3.3.01. That’s case T 0239/16.

If any reader has information on the outcome of these oral proceedings, you are more than welcome to post a comment. At the time I am drafting this post, there is no news on the EPO website.

The outcome of these oral proceedings will be most interesting for two reasons. First, the Board’s decision will necessarily impact the French litigation. Especially if the divisional patent is revoked.

Second, priority has also been (quite understandably) discussed in depth in front of the Board. Quite frankly I did not have the courage to really delve into the thick file wrapper. The link is here. But based on the communication issued by the Board on June 9, 2017, it seems that priority is the big topic.

According to the Board’s rapporteur, first, the validity of the priority claim has to be assessed in terms of claimed subject-matter (under G 2/98). Second, if the priority holds after this assessment, entitlement to priority must be discussed. A complex legal discussion can be expected, especially on the key and preliminary issue of whether the EPO has the power at all to decide on the legal entitlement to the right of priority. In fact, the rapporteur seems to have some sympathy with Novartis’ arguments in this connection, according to the above communication.

The issues raised in the Board’s communication are too complex to be addressed here. In fact, one of Novartis’ requests is a referral to the Enlarged Board of Appeal.

Again, I look forward to hearing about what actually happened in Munich last week.

And at any rate, this is definitely a case to keep on the watch list.


CASE REFERENCES: Tribunal de grande instance de Paris, 3ème chambre 4ème section, ordonnance du juge de la mise en état, June 8, 2017, Novartis AG et al. v. Teva BV et al., RG No. 14/01134. Tribunal de grande instance de Paris, 3ème chambre 4ème section, ordonnance du juge de la mise en état, June 8, 2017, Biogaran SAS v. Novartis AG et al., RG No. 16/10894.

A true vade mecum to SPC law

A few days ago, a very interesting decision on the blockbuster drug Truvada® landed on my laptop courtesy of Matthieu Dhenne. According to the decision, Gilead’s request for preliminary injunction to halt the distribution of Mylan’s generic version of Truvada® on the French territory was denied on September 5, 2017.

Soon thereafter, a most interesting report on the decision reached my inbox courtesy of Lionel Vial.

Owing to both of them, my main remaining task was to find a title and a patent illustration for the post. So, if those are neither apt nor witty, that’s on me.

As you will see, this decision is a good opportunity to revisit the CJEU case law on combo SPCs, since there is a UK-based pending reference to the CJEU in connection with the Truvada® litigation.

I will now leave the floor to Lionel.

Today we report about France’s contribution to the ongoing pan-European litigation over generics of Truvada®.

Truvada® (Gilead) is an anti-HIV drug comprised of the combination of Tenofovir Disoproxyl Fumarate (TDF) and Emtricitabine (FTC). It has received a relatively important media exposure since it became, in 2012, the first drug to be approved by the Federal Drug Agency (FDA) for Pre-exposure Prophylaxy (PreP) of HIV infection. As such, the TDF/FTC combination can be used to reduce the risk of sexually acquired HIV-1 infection in adults who do not have HIV but are at high risk of becoming infected. By way of example, the so-called IPERGAY clinical study has evidenced that this combination allowed for a reduction of 86% of the risk of being infected by HIV.

Truvada® was covered until 25 July 2017 by European patent EP0915894. The effects of the patent have been extended by supplementary protection certificates (SPCs) which will expire between 21 and 24 February 2020 depending on the countries.

The SPCs are based on European Union marketing authorization EU/1/04/305/001 and on claim 27 of the basic patent, which reads as follows:

A pharmaceutical composition comprising a compound according to any one of claims 1-25 [N.B. tenofovir disoproxil is claimed in claim 25] together with a pharmaceutical carrier and optionally other therapeutic ingredients.

As will be readily spotted by our trained readers, the main question of law arising from this wording is whether the use of the expression “other therapeutic ingredients” to refer to emtricitabine (FTC) is indeed sufficient to protect the TDF/FTC combination pursuant to Article 3(a) of Regulation (EC) No. 469/2009 of the European Parliament and of the Council (hereafter the « SPC regulation »).

Intense litigation over the validity of the SPCs has ensued, which has notably led Justice Arnold of the High Court of England and Wales to request a preliminary ruling of the CJEU on the question of knowing “What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the SPC Regulation?” (yes, again). The case is pending as C-121/17.

The current status of selected SPCs is summarized in the following table:

Country Decision of the patent Office Validity status
Belgium Granted Ruling on the merits pending
Germany Granted Ruling on the merits pending
Great-Britain Granted Ruling of the High Court stayed pending C-121/17
Ireland Granted Ruling on the merits pending
Italy Granted Ruling on the merits pending
The Netherlands Rejected Ruling of the Court of Appeal stayed pending C-121/17
Spain Rejected Rejection overturned by the Administrative Court of Madrid
Sweden Rejected Rejection upheld by the Court of Appeal

It is now France’s turn to take position on the validity of the SPC.

French SPC No. 05C0032 was granted on December 21, 2006 and will expire on February 24, 2020. Mylan obtained a generic marketing authorization for the TDF/FTC combination on December 16, 2016. On July 13, 2017, Gilead requested a preliminary injunction under urgency proceedings to prohibit the sale of Mylan’s generic. The case was heard on August 11, 2017. Meanwhile, Mylan offered its generic for sale on July 26, 2017, i.e. one day after the term of the basic patent. The ruling was rendered on September 5, 2017.

As could be expected, the judge performed a quite thorough appraisal of the case law of the CJEU regarding Article 3(a) of the SPC regulation as applied to this case, notably:

  • C-322/10 (Medeva): active ingredients have to be specified in the wording of the claims;
  • C-443/12 (Actavis v. Sanofi): the basic objective of the SPC regulation is to compensate for the delay to the marketing of what constitutes the core inventive advance [i.e. the technical contribution] that is the subject of the basic patent;
  • C-493/12 (Eli Lilly): where the active ingredient is covered by a functional formula in the claims, Article 3(a) does not preclude the grant of a supplementary protection certificate for that active ingredient, on condition that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question.

The French judge also noted that in cases C-443/12 and C-577/13 (Actavis v. Boehringer), the CJEU had considered that the core inventive advance forming the subject of the respective basic patents was limited to the compound the invention of which was sought to be protected, even though combinations with other compounds (which invention did not form the subject of the patent) were mentioned.

A patented robot to help you find your way through SPC case law.

In the case at hand, the French judge thus considered that the SPC was “in all likelihood invalid”, because none of the conditions defined the case law of the CJEU were apparently fulfilled.

Here is the relevant part of the decision (based on the English translation distributed by cabinet Schertenleib):

It appears that claim number 27 is drafted so broadly that it does not describe any specific active ingredient that should be combined with tenofovir disproxil [NB: this a reference to C-322/10]; it thus does not protect a combination that is likely to result in entitlement to the grant of a patent.

Moreover, the combination claimed as active ingredient “tenofovir disoproxyl + emtricibatine” is not implicitly but necessarily and specifically taught in the description [NB: this is a reference to C-493/12], there is no indication whatsoever that would enable the person skilled in the art to choose emtricibatine and it quite evidently does not constitute the core of the invention [NB: this is a reference to C-443/12].

If tenofovir disoproxil indeed constitutes the subject matter of the basic patent, the combination of tenofovir disoproxil with any other therapeutic ingredient cannot constitute a separate invention.

On the one hand, this combination as claimed in claim No. 27 is not a functional claim because it does not describe the structure that should be produced and the function that the second product should fulfill in order to build this structure. [NB: this is a reference to C-493/12]. On the other hand, assuming that this claim was functional, the steps defined by the Dutch Patent office in order to determine whether emtricibatine was sufficiently taught by the patent as being the necessary therapeutic ingredient of claim number 27 are relevant:

1 – Upon reading the phrase formulation in the context of the patent and in the light of their general knowledge, would the person skilled in the art think of the active therapeutic ingredient (biological)?

2 – Would the person skilled in the art think immediately of antiviral agents?

3 – Would the person skilled in the art immediately deduce that these antiviral agents designate anti-HIV agents?

4 – At the priority date, would the person skilled in the art have immediately thought of emtricitabine as anti-HIV agent?

Based on the description and as was perfectly highlighted by the Dutch Office of Industrial Property, no specific combination has been claimed, no relevant element has been reported so as to induce the person skilled in the art to select emtricitabine especially as there is no indication leading one to select a second antiviral agent as the “other therapeutic ingredient” let alone an antiviral anti–HIV agent.

As a consequence, Gilead’s request for preliminary injunction was refused. It now remains to be seen if this preliminary conclusion will be upheld when the case will be tried on the merits.

Finally, we would like to go back to Justice Arnold’s request for further guidance of the CJEU on the question “what are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the SPC Regulation?”. Apparently, Justice Arnold’s goal was to get a ruling establishing that, pursuant to Article 3(a), SPCs for combinations of active ingredients should be reserved for cases where the combination, as distinct from one of the active ingredients, embodies the inventive advance of the basic patent. But perhaps the Truvada® case was not the best one for such a reference to the CJEU.

Indeed, as emtricitabine is only purported to be specified by the expression “other therapeutic ingredients”, there is a chance the CJEU will not feel it necessary to go beyond its previous ruling according to which active ingredients have to be specified in the wording of the claims.

Well, to Lionel’s latter point, UK courts have always been quite prolific in asking SPC-related questions to the CJEU. As we know, this will probably soon come to an end. So maybe this was something of a last chance for them to try and get a final answer to a longtime puzzle?


CASE REFERENCE: Tribunal de grande instance de Paris, ordonnance de référé, September 5, 2017, Gilead Sciences Inc. et al. v. SAS Mylan, RG No. 17/57112.