It-which-must-not-be-named

Some pharma cases are somewhat delicate to discuss in a blog post.

Case in point, if I provide the commercial name of the drug at stake in today’s litigation, I am afraid that this post may be classified as a spam and may thus never reach my email subscribers.

You see, it is the sort of drug which is prescribed for the treatment of erectile dysfunction, and which keeps coming up in these pestering unsolicited email messages that you may receive on a daily basis.

Just to be clear, today’s drug-which-must-not-be-named is not the famous one that starts with a V (containing sildenafil as an active compound), but the other famous one that starts with a C (containing tadalafil as an active compound).

He-who-must-not-be-named.

Icos Corporation (of the Eli Lilly group) is the owner of a number of European patents in connection with the C. drug.

First, there is EP 0740668, which was the basic patent for a French Supplementary Protection Certificate (SPC No. FR 03C0017), which expired in November 2017. Second, there are EP 1173181 and EP 1200092, designated as “secondary patents” by the Paris Tribunal de grande instance (TGI).

In November 2014, generic drug company Mylan obtained a marketing authorization (MA) related to the C. drug. In January 2016, Mylan initiated nullity proceedings with respect to the EP’181 and EP’092 patents in front of the Paris TGI. The parties later reached a settlement agreement with respect to EP’092, so that only the fate of EP’181 remained to be decided upon. Icos Corporation and the French distributor Lilly France counterclaimed for infringement of EP’181. The first instance judgment was issued in May 2018.

EP’181 or equivalents thereof were or are also litigated in other countries. According to the summary provided by the court, the patents were revoked in Germany, the United Kingdom, Canada and Japan. It may thus come as little surprising that the same outcome was achieved in this country. On the other hand, the ground for nullity that the TGI took into consideration is relatively unexpected, as will be apparent below.

But before getting there, let’s first look at the statute of limitations defense raised by Icos.

Mylan argued that the statute of limitations is not applicable to patent nullity suits. This argument was rejected by the court, in keeping with earlier decisions.

Turning to the determination of the starting point for the limitation period, the court recalled its now established principle of an in concreto determination.

The court thus explained that the grant of the EP’181 patent was not the starting point for the limitation period. The general principle is the following:

The starting point for the limitation period must thus be set at the date, determined in concreto, at which Mylan was or should have been aware of EP’181, due to its intent to market a generic of the drug [C.], which led to the MA obtained on November 21, 2014, since this patent is an impediment to its exploitation.  

In this case, a determining factor to be taken into account was the date at which Icos obtained its own MA:

In this case, the first MA for [C.] was granted in November 2002. By way of application of article R. 5121-28 of the Code de la santé publique, the generic company can only apply for an MA as from the eighth year after the grant of the originator’s MA, and cannot be granted one before the tenth year. Therefore, Mylan could not file an MA application before November 2010.

This reasoning is fully consistent with that applied in another recent case which already involved Mylan.

However, this is not the end of the story here. The court further held:

In this case, an additional fact should be taken into account in the in concreto analysis of standing and the starting point for the limitation period. […] [Namely, Icos corporation] filed a request for limitation of the EP’181 patent on February 14, 2014 with the European patent office, and the limitation of the patent was published on March 25, 2015. 

Thus the patent enforceable against Mylan could only be known on this date, so that the starting point for the limitation period is March 25, 2015. 

In another recent case, the starting point of the limitation period was postponed by a court to the date of the decision of the Board of appeal of the EPO in the opposition appeal regarding the patent at stake. The relevant paragraph of this decision may be worth quoting again here:

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

We now have a confirmation that limitation proceedings, just like opposition proceedings, may result in a postponement of the limitation period for nullity actions.

It remains to be seen how general this principle is and in particular whether it extends e.g. to the impact of other lawsuits involving third parties.

Turning now to the merits of the case, claim 1 of EP’181 as limited reads as follows:

A pharmaceutical unit dosage composition comprising 1 to 5 mg of [tadalafil], said unit dosage form suitable for oral administration up to a maximum total dose of 5 mg per day.

Independent claim 10 is a Swiss-type claim containing similar features.

Mylan raised all classical grounds for nullity, but the court focused on insufficiency of disclosure.

After reviewing the description of the patent, the court noted the following facts:

  • There are several molecules belonging to the class of type 5 phosphodiesterase (PDE5) inhibitors.
  • Among them, particular reference may be made to sildenafil, the active compound of V., marketed at the priority date of the patent in doses of 25, 50 and 100 mg.
  • However, sildenafil generates a number of side effects, such as facial red patches, or a lowering of blood pressure.
  • The invention thus relates to a low dosage of the known alternative drug tadalafil, in order to provide an effective treatment of erectile dysfunction without the side effects associated with sildenafil.
  • The patent also contains a number of examples showing the efficacy and the absence of side effects of low dosage forms of tadalafil.

The court was apparently quite puzzled by the patent as a whole:

The problem expressed in the description of the patent is to provide a principle which avoids the issues of red patches and side effects of sildenafil by a particular dosage of tadalafil. 

Indeed, and as rightly noted by Mylan, no side effect associated with tadalafil is mentioned in the patent, so that the dosage suggested for tadalafil curiously addresses a problem associated with another active compound. 

The court then referred to a standard mentioned in the so-called “finasteride” judgment of December 6, 2017 by the Cour de cassation, commented on this blog:

[…] When a claim relates to a [second] therapeutic application of a substance or composition, obtaining this therapeutic effect is a functional technical feature of the claim. Therefore, in order to meet the requirement of sufficiency of disclosure, it is not necessary to clinically demonstrate this technical effect; but the patent application must directly and unambiguously reflect the claimed therapeutic application, so that the skilled person can understand, based on commonly accepted models, that the results reflect this therapeutic application.

The court then came back to the technical problem presented in the patent:

Icos Corporation and Eli Lilly do not dispute that no prior art document describes any side effect related to the use of tadalafil.
And they cannot validly argue that the absence of documentation in this respect does not amount to the absence of a problem, because the onus is on them to show that there was a problem to be solved and that it is solved by the teaching of the patent.
It thus appears that the problem described in the patent relates to sildenafil and not tadalafil, and it cannot be extrapolated that both active compounds have the same side effects, unless one were to admit the resolution of artificial or speculative problems.
In fact, the examples cited in the patent demonstrate that the dosage mentioned in the patent does not address the listed “problems”. 

In summary, the problem to be solved cannot be considered as the reduction in the side effects of tadalafil, because such side effects were not known in the prior art – only side effects of sildenafil were known.

Most of the examples of the patent also do not demonstrate the existence of side effects of tadalafil associated with higher dosages, so that these were held not to “reflect” the alleged therapeutic application (using the wording of the Cour de cassation).

The conclusion reached by the three-judge panel will not doubt cause a stir, as the invention recited in claim 1 was found not to be sufficiently disclosed in the patent.

The finasteride case related to a second therapeutic application invention, for a known molecule. It is well accepted both at the EPO and in French national courts that the new therapeutic application has to be demonstrated in a plausible manner in the patent, otherwise the patent is insufficient.

Yet, in the present case, claim 1 is a classical product claim, with no functional feature. According to EPO case law, there should be no problem of insufficiency of disclosure, because the skilled person is able to manufacture the composition containing the active substance at stake in the claimed dosage range. The question of whether said claimed dosage range provides any technical benefit or not only pertains to the appraisal of inventive step.

Now, as regular readers of this blog are well aware, the French approach to validity is much more fluid than the EPO’s.

If a court is convinced that an invention does not properly solve the alleged technical problem, or that the technical problem is artificial, this can give rise to a number of invalidity objections, including insufficiency of disclosure. My understanding is that the technical problem tends to be viewed by French courts as an integral part of the claimed invention itself.

But there is yet another cause for controversy in the judgment.

I mentioned above that most of the examples of the patent do not demonstrate the existence of side effects of tadalafil associated with higher dosages. That said, there is one example, namely example 7, which does analyze in detail the occurrence of various side effects depending on the dosage of tadalafil. The table of results is in fact even reproduced in the judgment. The court first remarked that some side effects are not present at all at any dosage. So far so good. But, regarding those side effects which are indeed shown to be less frequent in the claimed dosage range than at a higher dosage, the court noted:

Regarding headache, back pain and myalgia […], the reasoning is the same because these effects were never previously observed.

This part of the judgment seems to imply that, at least in the context of drug dosage patents, the existence of the technical problem to be solved must be acknowledged in the prior art, and cannot be demonstrated for the first time in the patent itself.

The invention can thus not be a so-called “problem invention“.

Things should be put into perspective, though, and the present case may not necessarily be generalized. Maybe the court did not believe that example 7 was convincing at all. At the very least, the fact that the dosage originally claimed in the patent, namely from 1 to 20 mg, had to be later restricted to 1 to 5 mg, due to some relevant prior art, certainly contributed to the court’s perception of the patent being invalid.

In fact, the court reviewed all the following claims and concluded that they suffered from the same deficiencies as claim 1, mentioning a lack of inventive step in passing for some of them. Fluidity of the grounds for nullity indeed.

As a final note, this is probably one of the last judgments penned by Ms. Courboulay, who, given her seniority and her involvement in many conferences and events, was often considered as the leading judge in the 3rd (IP) chamber of the Paris TGI.

Ms. Courboulay has now officially retired; but given the large number of important rulings which she authored, there is little doubt that her influence will continue to be felt in the coming years.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 1ère section, April 5, 2018, Mylan v. Lilly France & Icos Corporation, RG No.16/05073.

A clear judgment

For better or worse, lack of clarity is not a ground for opposition at the EPO. This is not to say that lack of clarity is not be a frequent issue in granted patent claims. But there is not much you can do about it. Unless, that is, the lack of clarity also translates into a different type of defect which happens to be a ground for opposition. Such as insufficiency of disclosure, lack of novelty or extension of subject-matter.

So it is a very common game during opposition proceedings for patentees to claim that objections raised against their patents are disguised clarity attacks. And for opponents to reply that no, they are much more than that.

At which point do unclear things become so unclear that they can actually not be reproduced?

The same game can also be played in front of national courts, as lack of clarity is not a ground of nullity either. 

The game seems to be somewhat less popular there. But today’s judgment issued by the Paris Tribunal de grande instance (TGI) provides an illustration.

Guerbet is a French company specialized in medical imaging products. It owns a French patent No. FR 2927539 on a composition of contrast agent. Bayer Pharma (which I probably do not need to introduce) filed a nullity suit against this patent in July 2015. In May 2016, Guerbet’s patent was limited at the INPI.

Interestingly, this French patent is part of a much broader family including several European applications or patents, two of which were opposed by several competitors. But the litigation was restricted to this French priority patent.

The court nicely summarized the invention in the judgment. The patent at stake relates to an MRI (Magnetic Resonance Imaging) contrast agent formulation.

The formulation is based on a metal of the lanthanide series, such as gadolinium, which is complexed by a macrocyclic chelate, known as DOTA. Free lanthanide is toxic, therefore it needs to be bonded in the complex. In fact, a slight excess of chelate is desirable in order to prevent any risk of undesirable release of free metal within the patient’s body.

But the excess of chelate needs to remain small because the chelate itself is also toxic – although, I assume, less so than gadolinium. An amount of excess free chelate of 0.002 to 0.4% has been found to be optimal. One difficulty is how to accurately achieve this precise dosage on the industrial scale, and in a stable manner. The invention consists in a preparation process in which a certain concentration of free chelate or free lanthanide is achieved in an intermediate formulation, and then an adjustment is carried out in order to reach the proper concentration specifications.

There are two independent process claims 1 and 2 in the patent as limited at the INPI.

For once, let’s start with looking at claim 2:

A process for preparing a liquid pharmaceutical formulation containing a complex of macrocyclic chelate with a lanthanide and a mol/mol amount of free macrocyclic chelate of between 0.002% and 0.4% […], the macrocyclic chelate being DOTA and the lanthanide being gadolinium, said process comprising the following successive steps:
a) determination of a theoretical target concentration in free macrocyclic chelate Ctcl in the final liquid pharmaceutical formulation;
b) preparation of a liquid pharmaceutical composition containing the complex of macrocyclic chelate with a lanthanide, and free macrocyclic chelate and/or free lanthanide, by mixing free macrocyclic chelate and free lanthanide in a solution, so as to obtain complexation of the lanthanide by the macrocyclic chelate, the amounts of free macrocyclic chelate and of free lanthanide added being such that there is a deviation between the amounts of added free macrocyclic chelate and free lanthanide and stoichiometric proportions, and such that all the lanthanide is complexed and Ccl > Ctcl, […];
c) measurement in the pharmaceutical formulation obtained in step b) of the concentration of free macrocyclic chelate Ccl, the concentration of free lanthanide Cll being equal to 0;
d) adjustment of Ccl so as to obtain Ccl=Ctcl and Cll being equal to 0, by suppressing free macrocyclic chelate and/or by adding free lanthanide and/or by modifying the pH. 

Claim 1 is very similar except that at step b) all the lanthanide is not complexed. The amount of free lanthanide is measured at step c) and more free marocyclic chelate is added at step d) to achieve the target concentrations.

This now leads us to the objection of extension of subject-matter raised by Bayer Pharma.

Bayer Pharma noted that there is a contradiction in step b) of claim 2, which refers to the preparation of a composition which may contain free lanthanide, although it is specified at the end of the step that all the lanthanide is complexed. Such a combination of features was not disclosed in the original application as filed, they said. They also added that the claim was the result of an intermediate generalization, since the feature that all the lanthanide is complexed at step b) was originally disclosed only in connection with a particular embodiment, called case B (involving in particular the use of an excess of macrocyclic chelate at step b)).

But the court was not convinced that this feature could not be generalized to other embodiments, and considered that the contradiction mentioned by Bayer Pharma was a mere lack of clarity, not an issue of extension of subject-matter:

Although this functional feature is made explicit for one of the three variants of the manufacturing process (case “B”), without being contemplated for cases A and C, it remains that it is indeed contemplated as an option disclosed in the initial application. Its title, related to a process for manufacturing a formulation, can lead the skilled person, who is a chemist used to combining different formulas, not to consider that this feature is excluded of all the other embodiments. The fact that this requirement […] can be in contradiction with another feature of this claim (namely the presence of free lanthanide) may potentially be a matter of lack of clarity but not of undue extension of the subject-matter of the patent. 

This clarity discussion then continues in the next part of the judgment dedicated to Bayer’s insufficiency objection.

Here is what the court had to say in this context (as usual, I am taking the liberty of slicing our beloved never-ending sentences into shorter phrases):

[…] It can be derived from common general knowledge that it is impossible for both free lanthanide to be present and for the complexation of the lanthanide to be total. Therefore, [the skilled person] will read the patent in a manner which will give it effect. [The patent] recites various steps for making the dissolution process, measuring and adjusting. [The skilled person] will understand that the total complexation of lanthanide can be performed later and that this circumstance does not result in an impossibility to reproduce the [invention], which requires to implement claim 2 as a whole, without focusing on one of its steps only without taking the other ones into account. 

Here, the approach of reading the patent in a constructive manner, with a “mind willing to understand“, as they are wont to say at the EPO, goes as far as making it possible to ignore an apparent contradiction in the wording of a claim.

In other words, the skilled person is presumed to resolve the contradiction by correcting and adding information to the claim.

It is not really surprising that the French court adopted this approach, in view of the longstanding tradition in this country of extensively relying more on the description for interpreting the claimed invention, instead of focusing on the exact wording of the claims.

Apart from this, the rest of the insufficiency discussion is also quite enlightening.

Regarding claim 1 in particular (the variant wherein there is some free lanthanide left at the end of step b)), Guerbet relied on example 2 of the patent.

But Bayer Pharma said that the example was not according to claim 1. Actually, when reproducing this example, a significant amount of free chelate was obtained at the end of step b). This is a problem because, at the following measuring step c), the concentration of free chelate is supposed to be zero, according to claim 1.

The TGI addressed this objection by stating that claim 1 does not require that all the chelate should necessarily be complexed at the end of step b). Otherwise, measuring step c) would actually be useless.

The court added:

Consequently, this step c) comprises a functional feature – achieving a total complexation of DOTA – in order to perform the measurement of free gadolinium which will precisely be made on a sample taken during step c), and which would be useless if the complexation of DOTA were total at the end of step b), as alleged by Bayer Pharma. 

Therefore, even if step c) of claim 1 does not explicitly mention that it requires a modification of the collected sample, this modification implicitly derives from the functional feature that it requires to perform the desired measurement, namely a concentration in free macrocyclic chelate Ccl that has to be equal to zero.

Here again, the court did not restrict the interpretation to what the claim actually recites.

Although the claim is silent as to the collection of a sample and the modification of the sample before performing the measurement, the court considered that these features are implicitly present in the claim in view of the description and in particular example 2.

The court also accepted Guerbet’s explanations that the modification of the sample at step c) could be performed by raising the pH through the addition of meglumine, and that the skilled person could rely on common general knowledge to perform such a modification.

Bayer Pharma further argued that the range of pH making it possible to achieve full complexation was not known. The court again sided with Guerbet on this aspect and accepted that a specialized scientific article and a university textbook discussing chemical equilibriums in general provided the skilled person with the necessary information.

Thus, the process of claim 1 was found to be sufficiently disclosed.

Turning again to claim 2, the patent in suit does not contain any example of implementation. But the court was satisfied that the process of claim 2 was analogous to the process of claim 1, so that it could also be carried out without undue burden.

In keeping with the case law of the Boards of appeal of the EPO, the presence of an example of a chemical invention in the patent is thus not an absolute requirement for sufficiency of disclosure to be acknowledged:

Thus, the skilled person, who may implement claim 1 as indicated above, for the same reasons […], is also able to implement claim 2 notably by relying on common general knowledge, so that the absence of an example to illustrate this claim does not make it insufficiently disclosed. 

The judgment then goes on with addressing an inventive step attack, which was also rejected.

Bayer Pharma’s nullity action thus failed. Who said pharma-oriented patents are always invalidated in this country?


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre, 2ème section, March 23, 2018, Bayer Pharma Aktiengesellschaft v. Guerbet, RG No. 15/12348.

All out disclosure

I have already expressed the view several times on this blog that public prior use is usually a very difficult argument to prevail on, due to the extremely demanding standard of proof which is normally required.

And this can of course be frustrating for a third party that positively knows that there has indeed been a public prior use.

But from time to time, the argument does succeed, and it is then always instructive to see what made success possible.

In the present case, the German cosmetic company Beiersdorf AG (think NIVEA®) is the owner of European patent EP 1834630. They initiated legal proceedings against two French companies which are part of a U.S. group, namely Laboratoire Bioderma and DIPTA, which later became Naos and Naos Les Laboratoires respectively (hereafter “Naos“).

Beiersdorf deemed that Naos’ cosmetic products Photoderm AR SPF 50+, Photoderm Laser SPF 50+ and Photoderm Spot SPF 50+ infringed claims 1 to 3 of the EP’630 patent.

In the course of the proceedings, the French part of patent was limited in front of the INPI, as is very usual in patent litigation in this country.

Naos did not dispute that the allegedly infringing products implement the subject-matter of the EP’630 patent. But they argued that the patent claims are invalid because one of these products, Photoderm Spot SPF 50+, was publicly disclosed before the priority date of the patent.

Let’s now have a look at claim 1 of the patent as limited during litigation (the two other claims at stake are dependent claims):

Cosmetic preparations comprising active ingredient combinations comprising:
(i) glycyrrhizin and/or glycyrrhetic acid and
(ii) 2,4-bis{[9-(2-ethylhexyloxy)-2-hydroxy]phenyl}-6-(4-methoxyphenyl)-1,3,5-triazine, 

characterized in that they contain from 0.001 to 0.5 % by weight of glycyrrhizin and/or glycyrrhetic acid, relative to the total weight of the preparation. 

The main purpose of the claimed “preparations” is to increase pigmentation of the skin and avoid UV damage to the skin. Compound (ii) is also known as Tinosorb S, which is much easier to write and read, thank you very much.

Naos explained that preparatory steps had been taken prior to March 1, 2006 (the priority date of the patent) to put Photoderm Spot SPF 50+ on the market. The body of evidence provided by Naos was the following:

  • A letter sent to a laboratory in Brazil on December 1, 2005.
  • A product datasheet certified by the Chamber of commerce of Lyon on November 31, 2005, intended for registering the product with the Brazilian administration.
  • Product datasheets sent to French and Portuguese poison control centers on December 6, 2005.
  • Various letters for the purpose of registering the product in Ukraine, Greece, Romania and Venezuela, sent in January-February 2006.
  • A pass for press sent to a printing company for printing the Photoderm Spot packages in December 2005-January 2006.
Sending letters all around the place.

Some of the evidence was discarded by the court.

In particular, the pass for press was deemed to be an insufficient disclosure because the packaging to be printed did not contain any information on the amounts of the ingredients in the product.

All of the other documents contained the complete information on the composition of the product. However, the letter sent to the French poison control center was also discarded because the center had to treat it in a confidential manner, under French law.

Regarding the rest of the documents, the court stated the following:

[…] On the one hand, as many as five pieces of evidence of a disclosure to third parties, on a number of territories, in France and abroad (Brazil, Portugal, Ukraine, Greece, Romania, Venezuela), of the qualitative and quantitative formula of the product at stake, were filed. These documents were sent between December 1, 2005 and February 23, 2006, which is before the priority [date]. On the other hand, these documents were sent to different recipients able to appreciate their contents, as they are used to processing this kind of information, since they were intended either for laboratories or for foreign people and/or authorities in order precisely to prepare the launch of the product and/or to obtain the required authorizations, thus aiming at a distribution to the public. Besides, some shipments were accompanied by a “free sale certificate” which precisely suggests that the communication made was specifically intended to be distributed to the public. 

Lastly and most importantly, none of these documents comprises any express mention of confidentiality by DIPTA, which carried out the shipments to these recipients, and thus any prior identification by this company of their confidential character. Only the one sent to the poison control center in Portugal made an implicit reference to this as it mentioned a shipment under “sealed envelope”, as well as the shipment for registering the product in Venezuela as it mentioned the “restricted use quali-quantitative formulas for actives and substances”. However, these mentions, which are not present in the other shipments and which are vague and unclear, do not make it possible to deduce an express request for confidentiality. 

The court concluded that the formula of the Photoderm Spot SPF 50+ product was indeed made available to the public before the priority date of the patent.

Since the formula comprises 0.1% of glycyrrhetic acid and 1.5% of Tinosorb S, claim 1 was found to lack novelty – the same conclusion applying to dependent claims 2 and 3. Therefore, Beiersdorf’s action failed.

Every public prior use case is unique. And I have the distinct feeling that the outcome of this one is closely related to the large number of (inter-related) disclosures of the cosmetic formula.

One or two shipments might have been possible to overcome, but multiple shipments were probably too high of a hurdle. Although the court recalled that the burden of proof lies with the nullity claimant, it was certainly more difficult for Beiersdorf to convince the judges that shipments carried out all over the place were all confidential – in the absence of an explicit mention on the letters.

It can be surmised that, even if the court had not concluded that there was a lack of novelty, Naos would then anyway have been in a quite good position for a non-infringement defense based on prior user’s rights – which was their auxiliary argumentation.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre, 2ème section, March 9, 2018, Beiersdorf AG v. Naos & Naos Les Laboratoires, RG No. 14/08701.

Patentability in small doses

Dosage regimen inventions are one of those subjects wherein French law tends to be unique in the European patent law landscape.

By way of a reminder, patent eligibility of claims directed to dosage regimen inventions was denied in a number of court decisions. In the finasteride litigation, the Paris Cour d’appel finally seemed to align with the principles set out in decision G2/08 of the EPO’s Enlarged Board of Appeal, as it acknowledged that posology features are allowed in further medical use claims. See a summary in a previous post here.

However, first instance judges did not seem willing to follow this case law, as shown by two further decisions from the Paris tribunal de grande instance (TGI) reported on at the beginning of this other post.

In December 2017, the Cour de cassation issued its ruling on the finasteride case. The main topic of the decision however is sufficiency of disclosure, as explained in this post. Some have argued that this decision from the supreme court implicitly “acknowledged the patentability of dosage regime claims“. I tend to disagree, as it seems to me that this was simply not decided upon by the cassation judges.

A few months later, we now have a clear confirmation that the issue of patent eligibility of dosage regimen inventions is absolutely not settled.

The case at hand relates to European patent No. EP 1448207 owned by Hungarian company Richter Gedeon Vegyeszeti Gyar RT (Richter) and licensed to French company Laboratoire HRA Pharma (HRA). In June 2013, the generic drug manufacturer Mylan initiated nullity proceedings in front of the Paris TGI. Mylan launched a generic drug in early 2014. Richter tried to get a preliminary injunction against Mylan, which was denied in June 2014.

The French part of the European patent was voluntarily limited in front of the Institut National de la Propriété Industrielle in October 2014, by turning product claim 1 into an EPC 2000-type therapeutic use claim; and by merging Swiss-type claims 2 and 3 together.

On June 9, 2015, the TGI handed down its decision on the merits, revoking the patent. Richter and HRA appealed.

On March 2, 2018, the Cour d’appel confirmed the first instance decision.

The drug at stake in this lawsuit is levonorgestrel, a hormonal substance used as an emergency birth control medicine.

Claim 1 of the patent as limited reads as follows:

Pharmaceutical composition as single application dose, containing 1.5 ± 0.2 mg of levonorgestrel as active ingredient in admixture with known excipients, diluents, flavoring or aromatising agents, stabilizers, as well as formulation-promoting or formulation-providing additives, commonly used in the pharmaceutical practice, for use in emergency contraception by administering a single application dose up to 72 hours after the coitus.

Claim 2 of the patent, also modified by way of the national limitation, is the following:

Use of 1.5 ± 0.2 mg levonorgestrel for the preparation of a pharmaceutical for emergency contraception by administration of a single application dose up to 72 hours after the coitus.

At the priority date of the patent, levonorgestrel was already widely known and used for emergency contraception. It was administered in two doses of 0.75 mg each. The invention thus consisted in replacing these two doses by a single dose of 1.5 mg.

Dosage regimen patents in France are like a game of Hide & Seek.

The court noted the following:

The invention neither modifies the sought contraceptive purpose, nor the used substance (levonorgestrel), nor the total dose of 1.5 mg, nor the administration of the product within 72 hours of non-protected coitus. 

Indeed, it is not challenged that taking two doses of 0.75 mg levonorgestrel is tantamount to one dose of 1.5 mg levonorgestrel, as the additives are not the subject-matter of the invention and anyway are identical for Noverlo 1.5 mg and for Noverlo 0.75 mg.

The court then further held:

Besides, the description of the patent does not contend that the invention makes it possible to obtain better results to avoid pregnancies, or to reduce side effects, but that its purpose is to solve the problem of the difficulty for patients to comply with the taking of the second dose within a period of twelve hours from the first one, while achieving at least the same results without additional side effects. 

Thus, and insofar as the sole contribution of the ‘207 patent consists in taking the product which is identical in its substance, in its total dosage and for the same indication, in one take instead of two without any novel technical contribution or benefit other than the comfort of a single take, the first instance court rightly held that the invention is not patentable under article 53(c) of the European patent convention. 

There you have it, dosage regimen inventions can still be held non-patentable as relating to mere methods of treatment.

This applied similarly to purpose-limited composition claim 1 and to Swiss-type claim 2. This is not surprising as French courts do not typically attach importance to the exact manner in which claims are drafted. They focus on what the invention really is about.

As a further comment, we should never read too much in any given court decision.

In particular, I do not believe the present decision to be a complete reversal relative to MSD v. Actavis. In the present ruling, the court insisted on the fact that there was absolutely no technical contribution, in their opinion: same total dosage, no reduction in side effects, no efficacy improvement. In a different context, with a new dosage providing for instance improved efficacy or fewer side effects, the court might have come to a different conclusion, based on the existence of an actual technical contribution to the art.

As if one deadly wound were not enough, the court inflicted two additional ones to the patent, in a clear effort to make Richter’s way to a cassation appeal as difficult as possible.

The court thus held that the claims of EP’207 lacked novelty over clinical trials on the 1.5 mg dosage which were publicly reported on by the World Health Organization before the priority date.

And the court finally held that the claims lacked inventive step, also in view of the clinical trial reports.

As a final remark, it is somewhat paradoxical that the patent was revoked as relating to a method of treatment, whereas a method of contraception is in principle not considered at least by the EPO as a method of treatment – as pregnancy is not a disease. See example 3 in section G-VI, 7.1.2 of the Guidelines for examination. I do not know whether the argument was raised during litigation or not.

That said, if one adopts this approach, it then means that perhaps the EPO should not have granted claim 2 of the patent at least in this specific form, as the exceptional Swiss-type claim drafting format is not applicable to non-medical uses (so that the claim would or should have been found to lack novelty).


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, March 2, 2018, Richter Gedeon Vegyeszetu Gyar RT & SAS Laboratoire HRA Pharma v. SAS Mylan, RG No. 15/16651.

Not sailing to victory

Thanks to Jérôme Tassi, I was made aware of a new French decision revoking a patent due to extension of subject-matter.

As I mentioned no earlier than in last week’s post, this is a ground for nullity that needs to be taken very seriously nowadays. There may previously have been a perception that added matter objections were deemed to fail in front of a court of law, and that painstaking dissections of the exact wording originally used in patent applications should be reserved for hearings taking place at Erhardtstrasse. But if so, this perception is no longer accurate.

The patent at stake is EP 2179917 to the Swiss company Createx SA.

This patent (EP’917) was filed as a divisional application stemming from EP 1531979, itself originally filed as a PCT application published under No. WO 2004/005009.

The technical field is the manufacture of fabric for sails. Yes, as in sailing boats. This is about as exotic as you can get when dealing with patent case law.

On December 31, 2015, Createx and its licensee, the U.S. company North Sails Group LLC, filed a patent infringement complaint against the French companies Incidences La Rochelle and Incidences Technologies.

On August 22, 2016, Createx filed a request for limitation of the French part of EP’917 with the INPI. It can be assumed that this was a reaction to some invalidity arguments brought forward by the defendants. The limitation was granted by the INPI on September 27, 2016.

The defendants counterclaimed for nullity of the EP’917 patent and as announced at the beginning of this post, the Paris Tribunal de grande instance (TGI) did in fact hold the patent invalid for extension of subject-matter beyond the content of the parent application as filed.

The patent as limited contains two independent claims, namely claim 1 directed to a fabric and claim 13 directed to a sail. Let’s focus on claim 1 only:

A fabric comprising:

a plurality of strips, each of the strips being formed from a plurality of substantially parallel reinforcing elements formed of threads arranged in a unidirectional manner, the threads being made of thousands of filaments distributed over the width of each strip, each of the substantially parallel reinforcing elements comprising said substantially parallel filaments; and an activated resin encasing the filaments to form a fabric;

wherein part of each strip is disposed on the juxtaposed strips; 

wherein at least some of the plurality of strips partially overlap adjacent strips, at least some of the strips substantially overlap over a length of each strip, at least some of the strips are arranged in parallel, so that a first end of a strip substantially overlap with a first end of another strip. 

Some sails look more threatening than others.

The key issue here is that the parent application as filed did not contain any claim directed to such a fabric or to a sail as recited in claim 13. All original claims related to a method of manufacturing a fabric, using a particular system.

Here is original claim 1 by way of comparison with the limited claim in the divisional patent:

A method of manufacturing shaped and reinforced fabrics, characterized in that it consists in making a fabric made of a membrane which encases continuous alternated reinforcing elements in a press which comprises an upper vessel the lower part of which is made of a supple element and a lower vessel the upper part of which is made of a supple element, the upper vessel comprising a shaping lath the shape of which can be adjusted by setting rods and the adjusting shape of which causes the three-dimensional elastic deformation of the supple elements and thus of the membrane and reinforcing elements within the press, into an active position in which the lath has a shape and an inactive position in which the shaping lath is inactive and does not cause any deformation of the membrane and reinforcing elements which are pressed flat, in that the portions of the membrane and of reinforcing elements are prepared before pressing on a conveyor belt which is disposed on a preparation table which then places these portions under the press with pressure and heat, and in that the portions of membrane and reinforcing elements overlap during the preparation so that they make a homogeneous fabric at the outlet of the press, which comprises flat portions and three-dimensional-shaped portions according to multiple shapes determined by the setting of the shaping lath upon pressing each membrane portion and reinforcing elements, the length of which is determined by the width of the press and preparation table. 

Here is the court’s take on this:

Through this rule [of the prohibition of extension of added matter], it is to be ensured that the patent proprietor cannot improve its position by adding elements that are not disclosed in the application as filed, which would be such as to confer an undue advantage by obtaining a different monopoly from the one initially claimed, which may harm legal certainty for third parties who rely on the content of the initial application.

In this case, the [parent] application as filed […] is exclusively directed to an invention which relates to a manufacturing method […]. It thus clearly derives from this initial application that the subject-matter of the protection does not relate to the product “fabric”. The EP’917 patent […] is no longer directed to a manufacturing method but expressly to products, and more particularly a “fabric” […] and a sail […]. 

[…] By altering the subject-matter of the patent […], the patent proprietor may now have a protection on any identical product independently of its manufacturing method. 

Thus, the patent proprietor necessarily increased the scope of protection initially requested, since this patent makes it possible to include within the scope of the patent products why may be obtained by different methods than the one claimed in the initial application. It is further noted that this modification also led the proprietor to encompass within the scope of protection of the patent […] a product which was not explicitly mentioned in the initial application, namely a “sail”, which cannot be entirely assimilated to [a fabric] and which was not within the subject-matter of the initial invention except through a mere reference to the prior art, which is not sufficient to include it within the perimeter of protection. 

The content of the (parent) application as filed has to be considered as a whole, including the claims, description and drawings. Due to some of the words used by the court in the above quote, there could be a suspicion that the court really focused on the claims only and confused extension of subject-matter with extension of scope of protection. But I doubt that this suspicion would be well-founded.

Indeed, not only did the original set of claims not contain any claim to a fabric or a sail, but also the original description did not recite a fabric or a sail as such as subject-matter of the invention.

Thus, it was considered that the shift in scope of protection could not be expected by third parties relying on the original application documents, which offended legal certainty. This is reminiscent of a Nestec decision already discussed on this blog.

In this earlier case, a claim to a device for the extraction of a capsule plus the capsule itself, in combination, was found to offend article 123(2) EPC because this category of product was not originally claimed, and could only be indirectly derived from the application based on how the capsule interacted with the device in operation.

I must say that, upon reading the claims of EP’917 (even before the French national limitation) and comparing them with the parent PCT as filed, I was curious about the examination process. Indeed, it seems that the divisional claims were completely drafted from scratch, combining pieces of wording from several passages of the original disclosure. This is not to say that such thorough redrafting necessarily adds matter. It may be allowable in some cases. But in my experience the EPO almost always at least requires detailed justifications that the skilled person would indeed directly and unambiguously derive the new claims from the original disclosure, which must not be treated as a reservoir from which you are allowed to pick and choose any combination of features.

To my surprise, it seems that the applicant did not submit any indication of a support for the claimed features when filing the divisional application, and that the examiner did not ask any questions and directly agreed to grant a patent.

So I wonder what happened here, and why the applicant was not even asked for any clarification by the EPO. This took place in 2009-2010, which is not that long ago.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 2ème section, February 9, 2018, Createx & North Sails Group LLC v. Incidences Technologies & Incidences SailsRG No. 16/00023.