A makeshift win

I am happy to introduce another contribution by Lionel Vial to this blog, for a new update on the war waged by French courts on second medical use claims. Today, Lionel tells us about one such claim which bravely survived a first instance judgment, only to be later butchered on the appeal battlefield:

It is often tempting to rule out of hand seemingly makeshift arguments but the decision we discuss today is a reminder of why it is always a bad idea to do so. It is also yet another reminder that it is not easy to be Swiss in France nowadays.

The decision in question was rendered by the Cour d’appel de Paris on November 3, 2015 (Ethypharm SA v. Alkermes Pharma Ireland Ltd.). It notably dealt with the appeal of Ethypharm against the decision of the Tribunal de Grande Instance (TGI) de Paris of December 21, 2012 to uphold claim 9 of European patent EP 0644755 (the ‘755 patent), which Ethypharm was found to infringe.

The ‘755 patent was filed on June 1, 1993 and was granted on March 19, 1997, i.e. well before the entry into force of EPC 2000. Accordingly, claim 9 is under the form of a so-called Swiss-type claim (i.e.use of a substance or composition X for the manufacture of a medicament for therapeutic application Y”). It reads as follows:

The use of particles consisting essentially of a drug substance having a surface modifier adsorbed on the surface thereon in an amount sufficient to maintain an average particle size of less than 400 nm or a pharmaceutical composition thereof for the preparation of a medicament for hastening the onset of action after administration to a mammal, with the proviso that the drug substance is other than naproxen or indomethacin.

It can be seen that the scope of the claim is rather extensive as it basically covers any process of manufacture of a medicament with particles of a drug substance (different from naproxen or indomethacin) having an average size of less than 400 nm, thanks to the use of a surface modifier which adsorbs onto the drug substance, for increasing the speed with which the substance will exert its activity upon administration.

While all the arguments set forth against the validity of the claim had failed in the first instance, in the course of the second instance Ethypharm found a new motive to be opposed to the validity of claim 9, namely that the claim would cover a method of treatment of the human or animal body and that it would be therefore excluded from patentability.

According to Ethypharm, this would be because claim 9 does not relate to a specified substance or composition but relates to all existing active substances without specifying their therapeutic use, since it covers the use of nanoparticles of any medicament for treating any disease, any patient, by any administration route and with any dosage.

The patentee, Alkermes, made the mistake of not offering any counter argumentation.

In this regard the Court first notes, somehow ironically, that Alkermes apparently intended to respond to the argument, in view of the following statement in their written submissions:

To conclude, we will say a word on the argument of “revocation of claim 9 because it relates to a method of treatment” a last resort makeshift which replaced the equally exotic argument of “nullity of the further medical use claim”.

However, nothing of the sort could be found by the Court in the rest of these written submissions.

This proved to be fatal in the present case, because the argument surfed on the French courts’ supercilious approach to claims liable to cover methods of treatment (see our previous posts here and there) and was thus found to be persuasive by the Court:

[…] In application of that text [i.e. EPC 1973] a European patent can be granted for any further medical use of a known substance or composition, provided the claim is drafted under the so-called “Swiss-type” form, of the use of a product for obtaining a medicament used in a novel therapeutic application;

[…] It is thus necessary that a determined specific substance has a new therapeutic use which is distinct from the state of the art, since a simple claim to a method relating to a therapeutic treatment is not patentable;

[…] In the present case claim 9 of the patent at stake relates to any drug substance, with the only exceptions of naproxen and indomethacin, already taught in the state of the art, with the sole aim of hastening the onset of its action upon its administration to a mammal;

[…] When reading the claim, it appears that it relates to no known determined substance or composition with the view of obtaining a medicament for a novel and determined therapeutic use;

[…] Indeed the claimed hastening of the onset of the action of the medicament is only a mode of action of a medicament, which is by the way undefined, and cannot be considered as a therapeutic use of this medicament;

[…] Accordingly claim 9 only teaches a hastened mode of therapeutic treatment applying to any drug substance (naproxen and indomethacin being excluded) for treating any disease and applying to any patient, whatever the mode of administration of the drug and its dosage;

[…] As a consequence the claim will be revoked […].

The Court thus considered that although it was in the form of a Swiss-type claim, the fact that neither (i) the drug substance nor (ii) the therapeutic use were specified meant that claim 9 was to be considered as covering a method of treatment.

However, with this reasoning it appears that the Court merely assimilates Swiss-type claims to further medical use claims according to Article 54(5) EPC 2000, thereby casting aside the literal sense of Swiss-type claims, which is to cover a process for the manufacture of a medicament. As a reminder, in decision G 5/83, the Enlarged Board of Appeal of the EPO ruled that it is legitimate in principle to allow claims directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application, even in a case in which the process of manufacture as such does not differ from known processes using the same active ingredient.

Should Swiss army knives also be considered as excluded from patentability?
Should Swiss army knives also be considered as excluded from patentability?

Accordingly, the sanction for a Swiss-type claim which is found not to benefit from the special approach of novelty defined in decision G 5/83, for instance because the claim does not relate to a specified therapeutic application, should rather be to consider that the intended therapeutic use is not limiting. This approach is notably illustrated by decision T 1758/07 (see paragraph 3.4.3).

Applied to the present case, the finding of the Court according to which the hastening of the onset of the action of the medicament cannot be considered as a therapeutic use could thus have led to reformulating claim 9 as the use of particles consisting essentially of a drug substance having a surface modifier adsorbed on the surface thereon in an amount sufficient to maintain an average particle size of less than 400 nm or a pharmaceutical composition thereof for the preparation of a medicament suitable for hastening the onset of action after administration to a mammal, with the proviso that the drug substance is other than naproxen or indomethacin.

Incidentally, this would also have had the valuable advantage of doing without the rather confusing notion that a claim found not to relate to a therapeutic use could be considered at the same time to cover a method of treatment.

Thank you Lionel for this report. As already mentioned in last week’s post, the TGI and the Cour d’appel are quite strictly bound by the (written) submissions of the parties. So, not every surprising ruling can be blamed on the courts themselves.

As a postscript I would also like to bring the first instance decision to readers’ attention.

One issue that was discussed in this decision was the admissibility of the disclaimerwith the proviso that the drug substance is other than naproxen or indomethacin” in claim 9. This “undisclosed disclaimer” was introduced to distinguish the claimed invention from a prior art under Art.54(3) EPC. The TGI applied the test set out in decisions G 1/03 and G 2/03 of the Enlarged Board of Appeal (without quoting those) and held that the disclaimer passed the test and was allowable. This issue is not addressed again in the appeal ruling since the claim was found invalid on another ground.

I thought that some readers irritated by the marked deviation of French case law from EPO case law on the topic of patent eligibility might find solace in this remarkable illustration of consistency.


CASE REFERENCE: Cour d’appel de Paris, pôle 5, 1ère chambre, November 3, 2015, Ethypharm SA v. Alkermes Pharma Ireland Ltd., RG No. 2012/23743.

The undetected fall

Today’s patent is directed to a method for detecting a person’s fall. Such a method has utility in for instance taking care of elderly people. However, in this case, I am afraid that at least one fall went undetected, namely the court’s own fall into the trap of so-called “patent substitution”.

Taking one step back, the case was brought by a certain Laurent M. against his employer Telecom Design. As a side note, it is the INPI’s (French patent office’s) practice to redact people’s names in the court rulings that they publish. Although the need to protect privacy is understandable, this sometimes makes decisions more difficult to read. Besides, oftentimes, these people’s names are available on the public record anyway. For instance, Laurent M. is a designated inventor in a patent identified in the decision, and it is somewhat difficult to miss his full name on the patent’s front page.

Anyway, Laurent M. was hired in February 2008 by Telecom Design. Info Network Systems (INS), Telecom Design’s mother company, filed a French patent application directed to a method for detecting a person’s fall on January 12, 2009. One year later, the same company filed a European patent application claiming the priority of the French patent application. Laurent M. was designated as an inventor on both applications, together with two managers of the company.

Laurent M filed suit against Telecom Design and INS in front of the Paris Tribunal de grande instance (TGI), claiming that he was the sole inventor of this invention, and that he had made the invention before joining Telecom Design. Thus, he claimed, the French IP belonged to him.

Laurent M. won in first instance, since the court acknowledged that he was the sole inventor, and ordered the transfer of the French IP to him. Telecom Design and INS appealed. During the appeal proceedings, Laurent M. requested that the European patent (which had been granted in the meantime) should also be transferred to him.

It is in order to address this additional request by the plaintiff that the Cour d’appel had to deal with the notion of “patent substitution”, which is a principle laid down in Article L. 614-13 of the Code de la propriété intellectuelle:

Insofar as a French patent covers an invention for which a European patent was granted to a same inventor or his successor in title with the same filing date or priority date, the French patent ceases to be in force either at the date at which the time limit for filing an opposition to the European patent expires without any opposition being filed, or at the date at which the opposition proceedings are closed, the European patent being maintained.

However, if the French patent is granted at a later date than either one or the other mentioned in the previous paragraph, as the case may be, this patent does not come into force. [….]

In other terms, in order to avoid a form of double protection on the French territory, a European patent is said to substitute for a French patent, when both patents have three elements in common:

  • Same inventor(s).
  • Same filing or priority date.
  • Same invention.

The court applied this test to the Telecom Design invention and concluded that the European patent had substituted for the French patent, so that the French patent had ceased to be in force on July 19, 2012 (i.e. at the end of the EPO opposition period).

However, this finding is problematic for at least two reasons.

The first reason is that, believe it or not, there was no French patent at all. Looking at the INPI file wrapper, the application never proceeded to grant. The application was declared lapsed on September 30, 2013 for failure to pay the fifth renewal fee. It seems that a request for restoration of rights was submitted and rejected by the INPI – but it is not possible to get more detailed information online.

Article L. 614-13 is quite clear in that substitution can only apply to a granted national patent and not to a national patent application. This makes sense since the claims are not necessarily in a final form until the patent is effectively granted (although in France the opportunities for an applicant to amend claims are more restricted than at the EPO).

I am not sure that the court is to blame for what seems like a serious mistake. Indeed, French courts are strictly bound by the submissions of the parties, and we do not know in this case whether either party submitted that the French patent application had not proceeded to grant, and drew the proper legal consequences from this fact.

The second reason why the court’s finding is in my opinion problematic is that they applied the above “substitution test” differently from traditional case law.

According to said traditional case law, substitution takes place only to the extent that the scope of protection afforded by both patents is identical. So, if the French patent has a broader scope of protection than the European patent, which is actually very frequent, then the French patent partly survives, with respect to the subject-matter not covered by the European patent. This view is supported by the wording “insofar as a French patent covers an invention for which a European patent was granted […]” in Article L.614-13.

In Telecom Design, the Cour d’appel seems to have changed its tune.

The priority French patent application contains thirteen claims in total: twelve to a method for detecting a fall, and one to a device for detecting a fall. The European patent contains ten claims: nine method claims, and one device claim.

The court first noted that both descriptions are identical. Then, the court compared the two set of claims and found that

[…] claim 1 of the European patent is the contraction of claims 1 to 4 of the French patent [sic].

In fact, the features recited in claim 1 of the European patent are those of claims 1, 2 and 4 of the French patent application, but not claim 3. The features of French claim 3 were left out in European claim 1 as granted. But the court ignored this and considered that the limitations of French claim 3 are nevertheless implicitly present in European claim 1:

[…] it is true that claim 3 of the French patent [sic] […] is not expressly contained in claim 1 of the European patent, but nevertheless it is implicitly included in its scope due to the interpretation of this claim which must be made by reference to paragraph [0062] of the description, which expressly mentions it. It is reminded that according to Article 84 [EPC], claims define the protected subject-matter and must be supported by the description.

This is a bold statement. INS clearly voluntarily drafted a main European claim without the features of French claim 3. Stating that these features are implicitly contained in the main European claim in spite is a daring and non-obvious conclusion which would require at least some detailed explanations as to why the description makes it so clear that the missing features are implicitly present.

A fall can never be fully prevented, but at least it can be made more enjoyable.
A fall can never be fully prevented, but at least it can be made more enjoyable.

More importantly, it is plain to see that the scope of protection afforded by the European patent is (much) more restricted than the scope of protection of the French patent application. It is thus strange that the court finally held that

[…] the French patent [sic] and the European patent relate to exactly the same invention […].

For the sake of completeness, the device claims were also different, one limitation present in the French claim having been removed in the European claim. Again, the appeal judges took a shortcut and stated that

[…] although [claim 10 in the European patent] does not expressly contain the reference to the notion of battery life of the detection device in claim 13 of the French patent [sic], said reference is also implicitly included in its scope by the interpretation that needs to be made in view of paragraphs [0096] to [0099] of the description which expressly mention it.

Is this an isolated decision, or does it mean that the identity of invention (for the purpose of patent substitution) should now be appraised globally – basically checking only if the respective descriptions are the same? Maybe the Cour de cassation will shed some light on this, if a cassation appeal has been filed – which I do not know.

By the way, for those readers who are interested in the final outcome for Mr. M. and his employer, Mr. M. was indeed confirmed by the Cour d’appel as the sole inventor of the invention at stake. But the court decided that the invention was made in the course of Mr. M.’s inventive mission with his employer. So, the first instance decision was reversed and the court did not order the transfer of either of the French application or the European patent from INS to him. He was however awarded an amount of 50,000 euros as a retribution for his invention, and 20,000 euros of damages in relation to moral prejudice.


CASE REFERENCE: Cour d’appel de Paris, pôle 5, 1ère chambre, June 30, 2015, Telecom Design SA & Info Network Systems SA v. Laurent M., RG No. 2013/10097.

Wooly invalid patent

So, this is probably not a very good pun to start a new year with; but you have to admit that there are no easy puns with mineral wool, which was the subject-matter of today’s patent – a patent which was found to lack inventive step by Board of appeal 3.3.05.

The problem and solution approach is a must for any inventive step reasoning at the EPO. The first step of this approach consists in determining the closest prior art.

However, practically speaking, it is also very useful to run the approach backwards: if, as the patentee, you realize that, starting from prior art document A, it is much easier to arrive at a conclusion of non-obviousness than starting from prior art document B, then you know you need to push for the selection of A as the closest prior art, and thus come up with arguments disqualifying B. Of course, the opposite is true if you are an opponent.

One strategy sometimes used by patentees to get around a prior art reference which would make their lives miserable if selected as the closest prior art is to explain that this prior art reference is not a realistic starting point for the skilled person.

A typical example of a document which would not be a realistic starting point is one which has a lot of features in common with the claimed invention, but in a different context. As stated e.g. in T 870/96, the closest prior art should be a document

which [the] skilled person would have realistically taken under the “circumstances” of the claimed invention insofar as these circumstances can be retrieved in one item of the prior art. Consequently, among these “circumstances”, aspects as the designation of the subject matter of the invention, the formulation of the original problem and the intended use and the effects to be obtained should generally be given more weight than the maximum number of identical technical features (reasons, 4.1).

Now, in today’s decision T 2579/11, inventive step of the opposed patent had to be assessed in view in particular of two relatively similar prior art references, documents A5 and A6. These prior art references were in fact similar for a good reason: A5 was the priority document of patent application A6.

The patentee argued that the closest prior art was A6 and not the priority document A5. It is straightforward to guess why the patentee made such a submission: the claimed invention related to a mineral wool comprising a number of compounds within specific concentration ranges or concentration ratios. Both A5 and A6 disclosed mineral wools containing the same compounds as the claimed invention. But the examples disclosed in A6 differed from those of A5. In examples 2 and 5 of A5, only the concentration ratio MgO/CaO was outside of the claimed range. In contrast, in some of the examples of A6, not only was the MgO/CaO ratio outside of the claimed range, but in addition the alumine content was above the claimed maximum threshold. Or, in other examples, the alumine content was within the claimed range but then the MgO/CaO ratio was further away from the claimed values than in examples 2 and 5 of A5.

As a result, it was easier to arrive at a finding of lack of inventive step starting from A5 than starting from A6, since fewer modifications needed to be made starting from A5.

Artificial sheep from which mineral wool can be sheared
Artificial sheep from which mineral wool can be sheared

In order to try to disqualify A5 as the closest prior art, the patentee offered the following argumentation:

A5 is accessible only in the examination file wrapper of A6. The skilled person has no reason to start from priority document A5 since he/she has a more elaborate text available, which was filed after one year of additional research. The fact that examples 2 and 5 of A5 were not included in A6 shows that they were not valid examples. Therefore, document A6 is the closest prior art (facts and submissions, VII).

But this did not fly with the Board. The Board first of all noted that both A5 and A6 had the same purpose (which was also the purpose of the claimed invention), namely providing mineral wool which can be dissolved in a physiological medium, and which can be fibered by centrifugation (reasons, 2.2.5). Second of all, in terms of features in common with the claimed invention, it was concluded that, for the reasons already set forth above, “the wools according to examples 2 and 5 of A5 request fewer structural modifications than the wools of A6” (reasons, 2.2.6).

Finally, the Board addressed the patent proprietor’s argumentation as follows:

Once a priority document has been made accessible to the public, it belongs to the state of the art under article 54(1)(2) EPC like any other publicly available document. The papers of a patent application on the one hand and a priority document on the other hand are then entirely distinct documents, even if the latter is made accessible to the public through the publication of this application. The fact that a later application generally has a more detailed description than the priority application can therefore not, by itself, justify that the priority document should be discarded in favor of the later application when the closest prior art is selected. The fact that an embodiment and/or an example contained in the priority application are not included in the application claiming the priority does not by itself allow one to conclude that such embodiment and/or example were less preferred, or less valid. 

[…] Even assuming that the later application A6 contains results of complementary research, nothing indicates that examples 2 and 5 of A5 which are not included in A6 would be invalid or of poor quality or insufficiently disclosed (reasons, 2.2.7).

Thus, examples 2 and 5 of A5 were deemed to represent the closest prior art, and the rest of the problem and solution approach analysis led the Board to the revocation of the patent due to lack of inventive step.

To some extent, it seems to me that a parallel could be made with other cases such as T 741/91 or  T 334/92, where an old prior art document was rejected as a candidate closest prior art because said document had been ignored in the relevant field and had not given rise to further development.

Here, the priority document A5 was dated at most one year prior to the subsequent application A6, so this was not a very”old” document by any means. But the common trait is that, in both situations, an argument was made that a prior art reference should be disregarded as the closest prior art, not because of its intrinsic contents, but rather because of extrinsic evidence that the reference would not count in the eyes of the skilled person. In T 2579/11 the argument failed, whereas it succeeded in T 741/91 or T 334/92. This may just be a matter of the extrinsic evidence being persuasive enough or not.

As a side remark on a procedural aspect of the present decision, the Board skipped the novelty objections and only took position on inventive step as this was sufficient to reach the conclusion that the patent should be revoked. Similarly, the Board focused on inventive step of the most restricted claims defended by the patent proprietor, namely auxiliary request No.3, the conclusion on this request also applying to the previous, broader requests.

This is a reminder that Boards of appeal have a lot of leeway for dealing with submissions of the parties in the order that they see fit, and for getting to the final decision in the most efficient manner. However, shortcuts such as the present one may seem somewhat unorthodox. In particular, there was an objection of lack of novelty of the main request and the first auxiliary request over A5 (as well as over another document A3). This means that the Board decided that these requests involved no inventive step over A5 without ruling whether the claims at stake were even novel over A5.


CASE REFERENCE: Board of Appeal 3.3.05, T 2579/11, Laine minérale / Saint-Gobain, March 10, 2015

A remedy worse than the disease?

Before leaving the floor to Lionel Vial for the second part of his thorough report on the recent Merck v. Actavis appeal decision (the first part is here), I would like to follow up on the issue of patent eligibility of dosage regimen inventions in France.

Indeed, such inventions were again deemed to be excluded from patentability in at least two relatively recent first instance decisions, namely:

The Akzo decision was issued before the Merck v. Actavis appeal ruling went out but this is not the case for the Mylan decision.

In this second decision, the written proceedings were formally closed on February 10, 2015 and the hearing took place on March 9, 2015. This is later than the January 30, 2015 Merck v. Actavis appeal ruling, but not much later. It is possible that neither the parties nor the first instance judges were aware of the outcome of the Merck v. Actavis appeal in due time, which could be the reason why the position taken by the first instance court is not in line with that of the appeal judges.

The other posible explanation is that the Tribunal de grande instance de Paris might not be in a mood for applying Merck v. Actavis. Such an attitude would not be unheard of – it even has a name in the French legal system, “resistance” of the lower courts.

We will thus have to wait for further cases to know for sure.

Now, back to Lionel, on a different aspect of Merck v. Actavis.

We have seen in our previous post that the Cour d’appel de Paris, in its decision of January 30, 2015 (Merck Sharp & Dohme v. Actavis Group & Alfred E. Tiefenbacher) affirmed that posology features were admissible in further medical use claims.

Still, in view of the lack of novelty finding of the Court regarding claims 1 to 3 of European patent No. EP 0724444 (the ‘444 patent) filed on October 11, 1994 in the name of Merck & Co, the decision as a whole does not make it much easier for patentees to defend such claims in France.

As a reminder, claim 1 of the ‘444 patent read:

The use of 17β (N-tert-butylcarbamoy-l)-4-aza-5-alpha-androst-1-ene-3-one [i.e. finasteride] for the preparation of a medicament for oral administration useful for the treatment of androgenic alopecia in a person and wherein the dosage amount is about 0.05 to 1.0 mg.

The Court based its decision regarding novelty on two documents.

The first document was European patent No. EP 0285382 (the ‘382 patent) filed on March 30, 1988 in the name of Merck & Co. Inc. According to the Court, the ‘382 patent discloses the use of finasteride for treating androgenic alopecia, as well as, in the case of benign prostatic hypertrophia, oral administration of finasteride and the administration of a dose of finasteride from 5 to 2000, preferably from 5 to 200 mg and in particular of 5, 10, 25 50, 100, 150, 250 and 500 mg. However, the ‘382 patent does not specify the dose claimed in the ‘444 patent.

The second document, the so-called “document S”, is an article by Elizabeth Stoner (one of the inventors of the ‘444 patent): The clinical development of a 5 alpha-reductase inhibitor, finasteride (1990), J. Steroid Biochem. Mol. Biol. 37:375-8. According to the Court this article discloses the use of finasteride for the preparation of a medicament for oral administration useful for the treatment of androgenic alopecia, wherein the dose of the active principle finasteride may vary from 0.04 to 1 mg. It is important to note that the Court did not mention that alopecia treatment by finasteride at this dosage was disclosed in this document. A close reading of the article indeed confirms that it is not the case.

In view of these documents the Court considered that:

With this document S, all the teachings of the Merck patent [i.e. the ‘444 patent] are already disclosed while this patent does not additionally comprise a specific, different technical teaching, from that of the EP 0285382 prior art, so that claim 1 of the EP 0724444 patent is deprived of novelty.

Claim 2: The use as claimed in claim 1 wherein the dosage is 1.0 mg.

This claim thus also lacks novelty, since the S document discloses this dosage in combination with claim 1 which is devoid of any novel technical effect.

Claim 3. The use as claimed in claim 1 or 2 wherein the treatment is of male pattern baldness.

The document EP 0285382 also relates to male pattern baldness and destroys the novelty of this claim combined with the two other revoked claims.

There are worse things than androgenic alopecia, such as having your hair cut by this machine
There are worse things than androgenic alopecia, such as having your hair cut by this machine

What can we make of all this?

First, we believe that each of the two documents leads to an independent lack of novelty finding regarding claim 1 by the Court.

Thus, when considering document S, the Court apparently construed the term “useful for” of claim 1 as simply meaning “suitable for” (in the sense of the Guidelines for Examination in the EPO, section F-IV, 4.13). Accordingly, the simple fact that document S discloses a medicament which could be used in the treatment of alopecia with the dosage specified in claim 1 is considered novelty destroying by the Court, even if this potential use is not mentioned in the document.

In doing so, the Court did not apply decisions G 1/83, G 5/83 and G 6/83 of the Enlarged Board of Appeal (EBA) of the EPO which allowed Swiss-type claims (e.g. the use of compound X for the manufacture of a medicament for the treatment of disease Y) in the EPO’s practice. As a reminder, according to these decisions, it is justifiable to derive the novelty of the preparation of the medicament from a new therapeutic use of said medicament.

In other words, the Court did not consider that the Swiss-type claim 1 of the ‘444 patent could be considered as a further medical use claim. As the Court did not elaborate on its construction of claim 1 in view of document S, it can only be speculated that the Court would have decided differently if the claim had stuck to the phrasing of the Swiss-type claim devised by the EBA, i.e. the use of finasteride for the preparation of a medicament for oral administration useful for the treatment of androgenic alopecia in a person and wherein the dosage amount is about 0.05 to 1.0 mg.

As then regards the lack of novelty finding based on the ‘382 patent, the decisive point in the ratio decidendi of the Court appears to be the lack of “different technical teaching” associated to the posology feature.

The Court derived this requirement from point 6.3. of the reasons in G 2/08:

Therefore, it is important to stress that, beyond the legal fiction of Article 54(5) EPC, for the assessment of novelty and inventive step of a claim in which the only novel feature would be the dosage regime, the whole body of jurisprudence relating to the assessment of novelty and inventive step generally also applies.

In particular, the claimed definition of the dosage regime must therefore not only be verbally different from what was described in the state of the art but also reflect a different technical teaching.

Furthermore, assuming for the sake of argument that the claimed modalities of the dosage regime would only consist in a mere selection within the teaching of a broader prior disclosure in the state of the art, then novelty could only be acknowledged if the criteria developed in the jurisprudence of the boards of appeal with respect to selection inventions would be fulfilled. One typical issue in such kinds of cases is whether the dosage regime defined in the claim has been shown to provide a particular technical effect as compared with what was known in the state of the art.

In the present case, the Court did not state whether it considered that the subject-matter of claim 1 ought to be treated as a selection invention, but nonetheless applied a high standard regarding this novelty requirement, by equating it with a requirement of a showing of a different technical effect over the prior art, which goes beyond what is usually required for a selection invention, or even for inventive step assessment, before the EPO.

Claim 1 of the Merck patent [i.e. the ‘444 patent] recites a dose from about 0.05 to 1.0 mg and this patent specifies, as mentioned above, that ‘it would be desirable to administer the lowest dosage possible of a pharmaceutical compound to a patient and still maintain therapeutic efficacy’.

However, this patent does not indicate that the retained dosages could yield a different result from that obtained with the different dosages specified by the prior patent. The assays reported in the text of the patent indicate that the dosage of 0.2 and 1 mg/day during 6 weeks is ‘useful for the treatment of alopecia’ but nothing indicates that the technical results are different from those yielded by the prior patent. It is not demonstrated that the claimed dosage has an effect on the efficacy or the outcome of the treatment.

It is neither demonstrated that the dosage claimed in the Merck patent leads to potential side effects different from those yielded by the dosages of the prior art.

In any case, regardless of whether the standard applied by the Court should be one of novelty or inventive step, it is likely that, in the present case, the report, by one of the cited experts, that the side effects of finasteride were similar for a dosage of 5 mg or 1 mg convinced the Court that the claimed invention did not deserve a patent.

Accordingly, while this decision establishes that posology features may well be admissible in further medical use claims in France, patentees should still expect a hard time defending them, especially when the claims are of the Swiss type.

Many thanks Lionel, and happy holidays to all – and this includes pharma innovators and generic drug manufacturers alike!


CASE REFERENCE: Cour d’appel de Paris, pole 5, 2ème chambre, January 30, 2015, Merck Sharp & Dohme Corp. v. Actavis Group EHF et al., RG No. 10/19659.

Getting the dosage right

Today I am very happy that this blog is hosting a guest post from Lionel Vial. I am sure Lionel would agree that he is a little bit of a “drug addict“. Yes, to avoid any misunderstanding, this is short for “pharma patent addict“.

So, here is what Lionel has to say about recent French case law developments regarding the patentability of dosage regimen inventions in our country.

The local position regarding the admissibility of posology features in further medical use claims has been the subject of a long lasting controversy which ended this year.

As our distinguished readers surely remember, on February 19, 2010 the Enlarged Board of Appeal (EBA) of the European Patent Office (EPO) decided that where it is already known to use a medicament to treat an illness, Article 54(5) of the European Patent Convention (EPC) does not exclude that this medicament be patented for use in a different treatment by therapy of the same illness, in particular where a dosage regime is the only feature claimed which is not comprised in the state of the art (G 2/08)

A French judge though is not one to be impressed by a 44-page long decision from the EPO, and even the EBA, as is evidenced by the decision of the Paris Tribunal de Grande Instance (TGI) of September 28, 2010 (Actavis Group & Alfred E. Tiefenbacher v. Merck Sharp & Dohme).

This case notably dealt with an invalidity action brought against claims 1, 2 and 3 of European patent No.0724444 (the ‘444 patent) in the name of Merck & Co. filed on October 11, 1994 and granted on August 6, 1997, for an alleged lack of industrial application, lack of novelty and lack of inventive step.

Claim 1 of the ‘444 patent read:

The use of 17β (N-tert-butylcarbamoy-l)-4-aza-5-alpha-androst-1-ene-3-one for the preparation of a medicament for oral administration useful for the treatment of androgenic alopecia in a person and wherein the dosage amount is about 0.05 to 1.0 mg.

All specialists will have noted that being granted before the entry into force of Article 54(5) EPC 2000, the claim is under the so-called Swiss format. Besides, it recites a posology (i.e. dosage regime) feature, namely that the dosage amount is about 0.05 to 1.0 mg (underlined above).

At the priority date of the ‘444 patent, finasteride, the short name of 17β (N-tert-butylcarbamoy-l)-4-aza-5-alpha-androst-1-ene-3-one, was known to be an inhibitor of 5-alpha-reductase, the enzyme catalyzing the transformation of testosterone into the more potent androgen dihydrotestosterone (DHT). DHT is involved in several androgen-related disorders, such as mild-to-moderate benign prostatic hyperplasia and androgenic alopecia, i.e. baldness.

Finasteride was for instance known to be useful for treating alopecia through the reduction of DHT levels, as shown by European patent No.0285382 (the ‘382 patent) filed on March 30, 1988 in the name of Merck & Co. Inc.

The invention forming the subject-matter of the ‘444 patent was thus said to arise from the surprising and unexpected discovery that a low daily dosage of finasteride is particularly useful in the treatment of androgenic alopecia.

Forget about finasteride: proper hair styling is the real cure as instructed in the sequence of Fig.1-6
Forget about finasteride: proper hair styling is the real cure as instructed in the sequence of Fig.1-6

However, the TGI considered that a claim including such a posology feature in fact covered a method for treatment by therapy:

[As a consequence,] it is possible to patent a medicament with the view of treating a first disease and then a second but it is not possible to patent a posology adapted for treating these diseases as it would be an attempt at patenting a method of treatment by therapy, which is not allowed, as such a method is reserved to the field of care and depends from the sole liberty, and associated responsibility, of each physician.

Claim 1 of patent EP 0724444, of which the only novel feature over the prior art is the specified posology is thus excluded from patentability and must therefore be revoked in view of article 53c EPC 2000.

As for decision G 2/08, the TGI issued a concise appreciation thereof:

[Furthermore] Article 54(4) EPC which allows patenting a same medicament for a further therapeutic effect is completely silent on the allowability of patenting a particular posology. Accordingly, the answer of the Enlarged Board according to which “such patenting is also not excluded where a dosage regime is the only feature claimed which is not comprised in the state of the art” does not arise from the Convention but from an interpretation of what is a posology, i.e. a further medical use, which it is obviously not.

Apart from the slight errors in applying EPC 2000 rather than EPC 1973 and referring to Article 54(4) instead of 54(5) EPC, it can be retained that the first instance court essentially considered that establishing a posology is part of the exclusive practice of physicians and that it can therefore not be patented.

This decision was immediately applied by the French patent office (INPI), which included in its Guidelines for Examination a provision according to which a claim relating to a posology should be rejected.

An appeal was lodged against the decision of the TGI which led to a decision of the Cour d’appel de Paris of January 30, 2015.

Without addressing the merits of the arguments set forth by the Tribunal, the Court essentially followed the conclusion of decision G 2/08. This is what the Court of Appeal had to say:

It follows from the foregoing that if the patentability of a further medical use claim relying only on a posology feature may be allowed even for a patent depending from the EPC 1973 construed under the light of the later amendment of the convention and of the resulting case law, [the claim] must comply with the requirement of the existence of a different technical teaching, and for this reason it is necessary, as is stated by Merck, to also take into account the features relating to the dosage. [emphasis added]

The situation has thus been clarified in France regarding the admissibility of posology features in further medical use claims: such features are allowed – at least for European patents, that is. Indeed, the situation remains unclear regarding French patents, as the decision only addresses the EPC and because, to date, the INPI has not changed its Guidelines for Examination.

Still, the Court confirmed the first instance judgement by revoking claims 1 to 3. This time the revocation was pronounced on the ground of lack of novelty. The Court considered that the ‘444 patent did not comprise a different technical teaching from that of the ‘382 patent, even though the latter does not disclose the dosage amount claimed by the ‘444 patent. This is what we will look at in a next post.

Many thanks Lionel for this report, and looking forward to the second part of the story – especially because baldness is a serious thing indeed, not to be joked about as I very well know!


CASE REFERENCE: Cour d’appel de Paris, pole 5, 2ème chambre, January 30, 2015, Merck Sharp & Dohme Corp. v. Actavis Group EHF et al., RG No. 10/19659.