Three strikes – you’re out

One, two, three strikes you’re out. Today, I will be discussing an invalidity decision again, and a rather remarkable one. It is not every day that three different grounds of nullity are held against a patent, including what some practitioners could consider as their white whale, namely… the lack of industrial application.

The origin of the case is a dispute between two inventors owning a French patent and a corresponding European patent relating to a cloth coated with mother-of-pearl, and their licensee, Van Robaeys Frères. As part of the dispute, the patent proprietors in particular requested from the Dunkerque Tribunal de grande instance (TGI) that the license agreement should be terminated. The disgruntled licensee retaliated by filing a nullity suit in front of the Paris TGI – which, as explained in a recent post, has exclusive jurisdiction in patent matters.

The first part of the judgment is dedicated to an inadmissibility defense based on an alleged lack of standing. This has actually been a serious defense since a famous Barilla case three years ago, in which a nullity claimant was found to lack standing because they had not demonstrated that they were preparing for carrying out acts prohibited by the patent.

Yet, in the present case, the nullity claim was quite logically found to be admissible:

With respect to patent nullity actions, those who can act are those who can establish that, at the time the complaint is filed, the claims which are sought to be revoked, are or may be an impediment for carrying out their economic activity, because they work or plan to work in the field of the patented invention. In this case, as a licensee in a license agreement on the exploitation of the French patent for which a termination is requested by the licensor, Van Robaeys Frères has an economic activity notably in the field of linen cloths, and thus has standing for seeking nullity of the patents of Mr. Thierry D’Arras & Albert Paoli, which it will no longer benefit from due to the termination. 

That being settled, let’s have a quick look at the two patents at stake, FR 2941712 (FR’712) and EP 2393979 (EP’979). Claim 1 of EP’979 reads very simply:

A cloth comprising a support and a light deconstructing layer characterized in that said layer comprises mother-of-pearl.

Claims 2 to 8 are dependent claims. Claim 9 relates to:

A method for preparing a cloth according to one of claims 1 to 8, comprising a step to impregnate a support in a mother-of-pearl solution.

Claim 10 depends on claim 9, and claim 11 is directed to

The use of a cloth according to one of claims 1 to 8 or of a cloth obtained with the method according to claims 9 to 10 to manufacture products which reflect away the infrared such as blind fabrics, tent fabrics and clothing.

The claims of FR’712 are identical to those of EP’979, except that claim 1 of FR’712 is somewhat broader as it also recites the alternative of using a substance equivalent to mother-of-pearl.

Mother and her pearls
Mother and her pearls

The first ground of nullity upheld by the court was a lack of novelty due to the inventors’ own activities before the priority date. More precisely, Van Robaeys argued that the invention was disclosed to the public in two ways: because of trials at the Centre européen du non-tissé (CENT) a couple of months before the priority date, and because of a meeting at the Ecole polytechnique a couple of weeks before the priority date.

The inventors’ defense was that both events were confidential. But the court held that this was not adequately proven. In particular, it seems that the court was of the opinion that explicit confidentiality agreements should have been in place, which was apparently not the case:

However, it can only be derived from the exchange of emails concerning the 2008 trials that a draft of confidentiality agreement was received by [the inventors]; and concerning the [meeting] of January 2009, it can be derived from the report dated January 19, 2009 on the meeting at Polytechnique that it was intended that all documents would be confidential, that “the university insists on the execution of a confidentiality agreement”, that “a draft of confidentiality agreement” was received by Mr. … from Polytechnique, but no confidentiality agreement was submitted by the parties. 

Yet, it is conventional to execute an agreement of this type […]. 

The court did not investigate whether it could be considered that there was an implicit obligation of confidentiality due to the circumstances of the two disclosures – and it is possible that the patent proprietors did not phrase the argument in this manner.

This is a defense that might have been successful in front of a Board of appeal of the EPO. There are not enough details in the judgment to really understand the full circumstances of the disclosures, but one could probably argue that there was a common understanding by the participants that the information made available during the trials and the meeting was provided in confidence.

So, are French courts more severe than the EPO on this issue? That’s very possible, as this is not the first decision that I have seen where an explicit confidentiality agreement is viewed as necessary in order to disqualify a disclosure as a public one. On the other hand, another decision issued by another section of the Paris TGI earlier in 2015 (and that I might comment on in a further post) accepted that the supply of prototypes to a lab for testing purposes implies a duty of confidentiality for the lab.

The bottom line is that, even if French courts may not draw the line at exactly the same position as the Boards of appeal of the EPO, in the end the question of whether a disclosure is considered as a confidential one or a public one is extremely fact-dependent, and there are never two exactly similar situations.

With that, claims 1 to 5 and 11 were found to lack novelty, which left claims 6 to 10 still standing.

Lack of inventive step was the next ground of invalidity tackled by the court, and it was quickly discarded. Indeed, it seems that none of the documents relied on by the claimant disclosed the use of mother-of-pearl on a cloth for filtering infrared and ultraviolet rays without interfering with visible light, which was the technical problem at stake.

Thus, the court turned to insufficiency of disclosure, which as readers may know is not a ground of invalidity that patent proprietors should take lightly in this country.

At this point, the judgment gets very surprising.

The court started by examining claim 6, which recites that “the light deconstructing layer is continuous“. According to the court, the description sets out that a continuous layer can be obtained by dipping or spraying, so that there is no insufficiency issue.

But then, the court turned to method claims 9 and 10 and explained that the notion of “mother-of-pearl solution” recited in these claims raises significant difficulties:

It is only mentioned in claim 10 that the mother-of-pearl solution comprises 10 to 20% mother-of-pearl, and it is mentioned in the description […] that “said mother-of-pearl is a powder of mother-of-pearl. Among the powders of mother-of-pearl which can be used in the invention, the one obtained by grinding the inside of mollusk shells can be cited.” 

Yet, the patent does not provide any indication on the formulation of the mother-of-pearl solution, although this element is essential since it defines the composition of the “layer” which needs to be homogeneous during preparation, its condition, its ability to penetrate or not the support or its ability to adhere to said support. 

Thus, it can be derived from the opinion drafted by Prof. D. […] that “the possibility to implement the invention depends on the possibility to implement the method of claims 9 and 10 […]. On the chemical standpoint, the term ‘solution’ is not sufficient to make it possible to carry out the invention and it raises many questions. Mother-of-pearl is mainly formed of calcium carbonate in the aragonite crystalline form, and it is very poorly soluble in water. One needs to know exactly what the solution is made of.”

The technical opinion of the engineer Mr. V. […] is consistent with this and adds that the composition the solution should probably vary depending on the fiber which is used […]. 

Therefore, the court held that method claims 9 and 10 are invalid due to insufficiency of disclosure and then added that “the product of claims 6 to 8 is also invalid because the methods for making the cloth are invalid“.

To say the least, this wording is clumsy. After stating that there was no defect of insufficiency of disclosure in claim 6, the court sort of changed its mind and held that the claim was invalid because the method of claims 9 and 10 is insufficiently disclosed.

It would certainly have been much clearer to start with claims 9 and 10, and then explain that since the skilled person does not know how to carry out the claimed manufacturing method, and in the absence of another readily available method, the product claims necessarily suffer from the same defect.

This clumsy wording notwithstanding, the court’s reasoning seems to make perfect sense. The analysis relies on experts’ opinions and it is true that the description of both patents is quite short and does not provide very detailed information, and in particular no example – in contrast to another recent case discussed here.

And finally, the white whale, i.e. the court’s position on the lack of industrial application of the patent:

It can be derived from the exchanges of emails in June 2011 between the parties as well as from the affidavit of Mr. J in charge of the project […] that the inventors faced unresolved difficulties of implementation of the non-woven linen cloth awnings coated with mother-of-pearl solution in a continuous layer, and it is not demonstrated that these difficulties only concerned roller awnings [as alleged by the defendants]. 

The inventors claimed that products according to the patent were manufactured and marketed, but only photographs and invoices were provided as evidence, which did not make it possible for the court to determine whether the invention was actually implemented in those products or not.

This lack of industrial application is in fact very similar to an insufficiency of disclosure. So, the whale may not be so white after all, upon closer inspection. But it is true that if an invention cannot be carried out by the skilled person, then it is not possible to make it or use it “in any kind of industry, including agriculture” as Article 57 EPC puts it.

And that was the last nail in the patents’ coffin.

As a final word, we should always bear in mind that French court are strictly bound by the parties’ submissions; therefore, surprising court’s findings may sometimes only reflect unusual parties’ submissions. But to some extent, it seems like this judgment is really a pearl.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 1ère section, September 10, 2015, SA Van Robaeys Frères v. D’Arras & Paoli, RG No. 13/12618.

Prior art to no purpose

French courts and the Boards of appeal of the EPO are supposed to apply the same validity rules to European patents. But in fact a patentee’s chances to withstand a validity challenge differ between Paris and Munich depending on the nature of this challenge. So much so that one could go as far as saying that, depending on which strongest arguments a third party may have against a patent, either an opposition at the EPO or a nullity action before the Paris Tribunal de Grande Instance (TGI) would be a better option.

Some previous posts have illustrated that French courts tend to have an extremely restrictive, and actually rather surprising, approach concerning patentability of therapeutic inventions or computer programs (see e.g. here or here).

One recent decision illustrates another interesting discrepancy, with a patent found novel but insufficiently disclosed in France, whereas it could very well have been held sufficiently disclosed but lacking novelty by a Board of appeal – although this assumption will never be tested, since no opposition was filed.

I will address the novelty aspect in the present post and the sufficiency aspect in a next post.

The patent at stake is European patent No. EP 1490005, assigned to The General Hospital Corporation (hereafter General Hospital). General Hospital, together with its exclusive licensee Zeltiq Aesthetics Inc., sued a small business named Clinipro for infringement of the patent, both in Spain and in France. It seems that the patent was held invalid in Spain (although a preliminary injunction had been obtained first). Unfortunately, the French judgment does not explain on which grounds the patent was found invalid by the Spanish judges (it would have been interesting to be able to make a comparison with the French approach).

In first instance, the Paris TGI held that the patent was valid and infringed. At that time, only lack of novelty and lack of inventive step had been raised as an invalidity defense by Clinipro. On appeal, Clinipro added an insufficiency challenge, which carried the day.

By the way, this is yet another difference, a procedural one, with respect to EPO proceedings, since an opponent would not be allowed to introduce a new ground for opposition at the appeal stage – unless the patentee agrees to it, said the Enlarged Board of Appeal with a deadpan sense of humor.

Claim 1 of the patent reads as follows:

A device for selectively disrupting lipid rich cells in a non-infant human subject by cooling, comprising:

– cooling means for cooling a local region of the subject’s skin to selectively disrupt lipid rich cells of the region, while, concurrently therewith, maintaining the subject’s skin at a temperature whereby non-lipid rich cells are not disrupted, wherein the cooling means are adapted to cool the lipid rich cells to a temperature between about -10°C and about 25 °C, 

– a temperature control unit for controlling the temperature of the cooling means, and temperature measuring means which are adapted to measure the temperature of the subject’s skin and/or the temperature in the subject’s skin and/or the temperature on the surface of the subject’s skin; characterized in that 

– the temperature control unit is further adapted to control the temperature of the cooling means such that the temperature of the subjects skin and/or the temperature in the subject’s skin and/or the temperature on the surface of the subject’s skin does not fall below a predetermined minimum temperature on the basis of the temperature of the subjects skin and/or the temperature in the subject’s skin and/or the temperature on the surface of the subject’s skin.  

Let’s now examine the novelty attacks against this claim, which failed.

The novelty standard applied in France, which is invariably cited in each decision including this one, is that

[…] in order to be comprised in the state of the art and thus lack novelty, the invention must be entirely found in a single piece of prior art in all certainty, with the same elements which make it up, in the same form, the same arrangement and the same mode of operation in order to achieve the same technical result

The last part of the sentence is very noteworthy: a prior art disclosure will take away novelty of a claim if and only if, not just the structure of the invention is taught in the prior art disclosure, but also the function and technical result of said invention.

This is particularly significant in a case such as the present one which deals with a claim directed to a “device for” – here, “a device for selectively disrupting lipid rich cells in a non-infant human“.

The court not only fully relied on this feature in the novelty analysis, but in fact also took into account the general purpose stated in the patent, which is to reduce orange-peel skin by destroying subcutaneous fat tissue without damaging the dermis or the epidermis.

Thus, when analyzing a first prior art reference called Thorner, the court stated that:

[…] The invention thus disclosed by this patent application is only intended for treating diseased or injured animal tissues, for instance inflamed limbs, by cooling the limb to a temperature of between 13 and 18°C or skin cancer by cooling the limb to temperatures below zero. 

[…] This prior art therefore does not disclose a set composed of the same means having the same function and leading to the same result as the patent at stake, namely selectively cooling lipid-rich cells in a non-infant human subject so as to break those up and reduce the excess of fatty cells without causing damage to other tissues. 

Turning to another prior art reference called SI Industries, the court used a similar reasoning:

[…] The invention thus disclosed by this patent application is only intended for cooling (or warming up) a limb in a controlled manner below the normal temperature of the body in a medical treatment, in order to eliminate the excess of fluid stored in muscular compartments further to a wound so as to avoid the occurrence of the compartment syndrome related to excessive pressure on nerves and blood vessels. 

[…] Similarly, this prior art does not disclose a set composed of the same means having the same function and leading to the same result as the patent at stake. 

Fat and cold are not always incompatible.
Fat and cold are not always incompatible.

This approach is very different from the EPO’s, which is well summarized in section F-IV, 4.13 of the Guidelines for examination:

If a claim commences with such words as: “Apparatus for carrying out the process etc…” this must be construed as meaning merely apparatus suitable for carrying out the process. Apparatus which otherwise possesses all of the features specified in the claims but which would be unsuitable for the stated purpose or would require modification to enable it to be so used, should normally not be considered as anticipating the claim.

Therefore, if a Board of appeal had examined novelty of claim 1 of this patent, it would certainly have focused on whether the prior art devices were suitable, i.e. could potentially be used, for the claimed purpose, and not on whether the claimed purpose was disclosed per se in the prior art.

The Paris approach is thus much more lenient with patent proprietors than the Munich one.

I am not sure which one is the best one, but I can see two advantages with the French way of handling novelty.

First, it may provide increased legal certainty, as it may be easier to assess whether the function and result of a claimed device are disclosed in the prior art than to figure out whether a prior art device could potentially be used in the same way as the claimed invention. I think this latter question leaves more room for interpretation and discussion: is the new use simply a matter of changing the settings of the prior art device, or would structural redesign be necessary as well?

Second, especially in the medical device field, it makes it possible to more adequately reward innovation, taking into account the prohibition of therapeutic or surgical use claims. If we take the present case, a new method of disrupting lipid-rich cells might not be patentable, since it is probably considered as being of a therapeutic and/or surgical nature. However, it may make sense to grant a patent on an apparatus specifically designed to implement this new method, if there is an actual (novel and inventive) invention involved.

The real paradox however is that, in those situations where the EPO does fully take into account a claimed purpose in a novelty analysis, as is the case with second medical use claims, French courts tend to be reluctant to do the same. I am thinking in particular of dosage regimen features, which tend to be ignored by French courts if they are not considered as relating to a “different technical teaching” (see e.g. here).

Anyway, if General Hospital benefited from a liberal stance of the Cour d’appel in the first part of the judgment, alas the bad surprise for them came in the second part, which I will deal with in a next post.


CASE REFERENCE: Cour d’appel de Paris, Pole 5, chambre 1, January 12, 2016, Patrick M. & Clinipro v. The General Hospital Corporation & Zeltiq Aesthetics Inc., RG No. 13/13050

Hidden in plain sight

Sometimes, an object is best hidden in plain sight. Like the diamond in the crystal chandelier of Alfred Hitchcock’s classic motion picture Family Plot.

The same can be true of Easter eggs, which many readers may have hunted over the weekend – successfully, I hope.

And the same can be true of a teaching in a prior art document, based on a recent decision which left a number of us wondering whether Board of Appeal 3.3.10 may have discarded or at least amended a long-standing novelty test endorsed by the Enlarged Board of Appeal.

A well hidden technical disclosure in an Easter egg
A well hidden technical disclosure in an Easter egg

Lionel Vial reports on that case.

The decision we will discuss today relates to the difficult question of knowing under which conditions the chemical composition of a product is made available to the public.

Decision T 719/12 was rendered on October 29, 2015 on an appeal formed by the proprietor (appellant) of European patent No. 1539673 against the decision of the opposition division to revoke the patent. The decision of the opposition division was based on the lack of novelty of the subject-matter of claims 9 and 10 in view of the disclosure of document (1) (Blicke et al. (1942) J. Am. Chem. Soc. 64:451 to 454).

Claims 9 and 10 respectively claimed the compounds of formulae II and VI:

F2

wherein R1 can be a thienyl (i.e. the cycle shown in formula VI), R2 can be a C1-8 alkyl (i.e. a -CnH2n+1 group where 1 ≤ n ≤ 8) and R4 is methyl (-CH3), ethyl (-CH2CH3), isobutyl (-CH2CH(CH3)2) or tert-butyl (-C(CH3)3).

Document (1) identified the compound methyl-2-(α-thenoyl)-ethylamine by its chemical name. For those not versed in the chemical arts, here is what it looks like:

methyl-2-(α-thenoyl)-ethylamine
methyl-2-(α-thenoyl)-ethylamine

It can readily be seen that this compound falls within formulae II and VI of the opposed patent.

Indeed, this fact was contested by neither of the parties as is noted by the Board in point 2 of the reasons for the decision and the question was rather whether methyl-2-(α-thenoyl)-ethylamine had been made available to the public.

There the Board recalled that:

It is the established jurisprudence of the Boards of Appeal that the subject-matter described in a document can only be regarded as having been made available to the public, and therefore as comprised in the state of the art pursuant to Article 54(1) EPC, if the information given therein is sufficient to enable the skilled person, at the relevant date of the the [sic] document, to practise the technical teaching which is the subject of the document, taking into account also the general knowledge at the time in the field to be expected of him (see T 206/83, OJ EPO 1987, 5) (point 2.2. of the Reasons).

However, even though document (1) aimed at synthesizing methyl-2-(α-thenoyl)-ethylamine through a Mannich reaction or the steam distillation of the corresponding tertiary amine, the authors of the document could neither isolate it nor obtain it when the reactions were actually carried out, in spite of the use of conditions which were considered favorable for its formation. The Board thus went on to consider that document (1) alone did not make the compound methyl-2-(α-thenoyl)-ethylamine available to the public, since the specific attempts to prepare it, which are described in said document, failed (see point 2.2 of the Reasons).

The opponent (Respondent) replied by arguing that document (1) did nonetheless make the compound methyl-2-(α-thenoyl)-ethylamine available to the public, since on repeating the preparation of the tertiary amine methyl[di-2-(α-thenoyl)-ethyl]amine 5 of document (1) in experimental report V1 it submitted, the compound methyl-2-(α-thenoyl)-ethylamine was indeed produced (but went unnoticed by the authors of document (1)).

This did not convince the Board:

[…] the Board holds that in view of the categorical statement in document (1) that despite attempts to synthesise it, the secondary amine could be neither isolated nor obtained, the skilled person, at the date of publication of document (1), would not have seriously contemplated repeating its teaching in order to undertake further investigations as to whether the secondary amine was formed after all. Thus, regardless of whether the report V1 repeats the method of document (1) exactly, the Appellant contesting this fact (see point IV above), the skilled person had no motivation to perform the steps in the experimental report V1 which are not disclosed in document (1), namely of analysing the product mixture obtained or of recrystallising from the mother liquor (point 2.3 of the Reasons, emphasis added).

Hence, even if methyl-2-(α-thenoyl)-ethylamine were inevitably produced by a method described in document (1), since its presence remained undetected by the skilled person, it had not been made available to the public (point 2.3 of the Reasons, emphasis added).

Well so long for the astute novelty attack, but doesn’t that ring a bell? G 1/92 of course:

The chemical composition of a product is state of the art when the product as such is available to the public and can be analysed and reproduced by the skilled person, irrespective of whether or not particular reasons can be identified for analysing the composition (emphasis added).

Except that the Board appeared to favor an opposite view to that of the Enlarged board of appeal. Unfortunately, the Board did not discuss the particulars of this case with respect to G 1/92, leaving us in uncertainty as to the interpretation of this decision: is it to be understood as going against G 1/92 or can it be reconciled with it?

Let’s try to see by ourselves.

A reminder of the case behind G 1/92 might be useful at this stage.

G 1/92 followed from a question referred to the Enlarged board of appeal by the President of the EPO pursuant to Article 112(1)(b) EPC which arose as consequence of decision T 93/89. It was held in this latter decision that if the composition of a commercially available product (e.g. aqueous polyvinyl ester dispersion) can be established only by a chemical analysis, the ingredients of the product (e.g. polyvinyl acetate, native starch, polyvinyl alcohol) have not been made available to the public unless there was a reason for experts to investigate it (see Headnote and point 8.2 of the Reasons).

The case at hand thus differs from the case at the origin of G 1/92 in that the product is not “directly” available to the public since it has to be manufactured before it can submitted to a chemical analysis (as opposed to a commercially available product). As such, decision T 719/12 could be interpreted as meaning that when a product is not commonly available to the public and needs to be manufactured to become so, then it would become relevant that one of skill in the art should have a special motivation to perform the manufacture and the analysis of the product.

However, this point of view is not totally satisfying as this would amount to making a distinction between the different means by which any information is made available to the public under Article 54(1) EPC, i.e. public use vs. written description, which is something G 1/92 specifically warned against (see point 1.2 of the Reasons).

Accordingly, even though the Board in decision T 719/12 does not explicitly take position against G 1/92, one might wonder whether after more than 23 years of good service the latter has not been silently euthanized.

Thank you Lionel. It is indeed somewhat strange to read about the absence of motivation for the skilled person in the context of a novelty analysis.

Of course, the facts of the case were very specific, with on the one hand a prior art document explicitly stating that a compound is not obtained, and on the other hand a recreation of the prior art by the opponent showing that the compound is indeed obtained.

Such recreations are always heavily criticized by the patent proprietor, as there are inevitably some details missing in the prior art disclosure, which need to be completed by the experimenter – and this case is no exception (see section IV of the Summary of Facts and Submissions).

With that in mind it does not really come as a surprise that the Board preferred to rely on the explicit statement in the prior art document rather than on a posterior, disputed, demonstration. But the reasons put forward by the Board do come as a surprise.


CASE REFERENCE: Board of Appeal 3.3.10, T 719/12, Lonza AG v. Merck Patent GmbH, October 29, 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.