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.

Red card for Orange

In a previous post, I gave an example of a French patent which was revoked because it was considered as not relating to an invention but to a mere discovery.

Still on the subject of patent eligibility, the same section of the Paris Tribunal de Grande Instance (TGI), chaired by the same presiding judge, Ms. Courboulay, confirmed their relatively harsh stance on this topic, this time in relation with a computer-implemented invention. The judgment was already reported on the Blog du droit européen des brevets but since it is really remarkable I thought it would be worth mentioning it here as well, just in case some readers missed it.

The telecommunications giant Orange brought an infringement action against its competitor Free, based on European patent No. EP 2044797. Unsurprisingly, Free filed a revocation counterclaim, and, as the title of this post suggests, Orange lost the case. Indeed, the court revoked all of the patent claims which were asserted by Orange.

Some of these claims were held invalid due to lack of novelty, but this is not the part of the decision which I would like to discuss. I would like to focus on claims 12, 13, 14 and 15.

Claim 12 read as follows:

Computer program product downloadable from a communication network and/or stored on a computer-readable medium and/or executable by a microprocessor of a mobile terminal (2) including means for detecting the radio field (160) of a base station (16) of a home local area network (150), said home local area network including one or more home equipments (11-14) connected to a home gateway (15), said mobile terminal (2) including means for exchanging data with said gateway via a radio link with the base station (16), characterized in that it includes program code instructions for sending to said home gateway (15), in response to detection of the radio field (160), information relating to the establishment of a multimedia session in progress between said mobile terminal (2) and an applicative system (20), and in that it further includes program code instructions for displaying a list of home equipments sent by the home gateway (15) and means for selecting at least one home equipment (11; 12; 13; 14) in said list.

The court was apparently not very happy with how this claim was drafted. They stated:

Article 52 EPC is perfectly clear and does not require any interpretation: programs for computers as such are excluded from patentability, and this is because they are protected by copyright.  

The emphasis on “as such” was put by the court, and the way I understand it, the expression was interpreted as meaning that programs for computers are “inherently” or “absolutely” excluded from patentability.

But, wait a minute, isn’t this understanding completely at odds with the position taken by the Boards of appeal of the EPO? After all, the Enlarged Board of Appeal, in its opinion G 3/08 on computer programs, stated that:

The present position of the case law is thus that […] a claim in the area of computer programs can avoid exclusion under Articles 52(2)(c) and (3) EPC merely by explicitly mentioning the use of a computer or a computer-readable storage medium (reasons, 10.13).

In other terms, according to the case law that the Enlarged Board endorsed, the wording “as such” in Article 52 means quite the opposite to what the TGI believes, i.e. it means that only pure computer programs can possibly be excluded from patentability, but any mention of a technical feature such as a computer or a storage medium is sufficient to escape exclusion from patentability. To make this easier to understand, the Enlarged Board made a comparison between computer programs and pictures (also excluded from patentability as such), which can be printed on a (patentable) physical support:

a claim to a computer implemented method or a computer program on a computer-readable storage medium will never fall within the exclusion of claimed subject-matter under Articles 52(2) and (3) EPC, just as a claim to a picture on a cup will also never fall under this exclusion.

The TGI was evidently well aware of the EPO case law on the issue but was unimpressed:

It cannot be validly argued, as the sole defense to deny nullity of these two claims, that the practice of the EPO is to admit claims to programs for computers by calling them ‘program-products’.

In fact, it cannot be accepted that a mere trick of language would make it possible to grant patents contra legem. Indeed, the grant of patents to computer programs, even if they are called program products, is not supported by any statute or by any difficulty of interpretation of the EPC, and on the contrary those are clearly excluded as such from patentability.

Claims 13 and 14 contained the same wording of “computer program product” as claim 12 and they were therefore smashed for the same reason.

As for claim 15, it was directed to a “storage medium storing the program according to any one of claims 12 to 14”, but the court found that this does not make any difference:

In this case, and in view of the way claim 15 of the EP’797 patent is drafted, it appears that the storage medium does not have any particular technical feature. It is again a dressing which does not make it possible to escape the exclusion from patentability which concerns computer programs. There is in fact no more information on this storage medium in the description of the patent, and Orange has obtained a protection and the consequent monopoly on an object the only function of which is to contain computer programs which are excluded from patentability.

Claim 15 was therefore canceled as well.

A storage medium suitable for storing non-inventions.

Scathing comments in a ruling often add some spice to it, and Ms. Courboulay did not skimp on those. In this respect, her statement on the EPO’s contra legem practice of granting patents to computer program products is nothing short of astonishing. I will leave it up to the readership to decide for themselves whether the red card mentioned in the title of this post should in fact be shown to her court rather than to the claimant.

But beyond this parfum de scandale, applicants should keep in mind that, at least according to latest case law, claims directed to computer programs seem to be simply outlawed in France. Therefore, they should definitely include method claims in their French or European applications if they want the novelty and inventive step of their inventions to be assessed at all.

In view of the very firm stance taken by the court in Orange, I would not bet on any argumentation advocating the technical character of computer program inventions in front of the TGI.

As to the significant discrepancy between French case law and EPO practice, there are other striking examples (not just in the software field), and I will probably come back to this issue in future posts.

CASE REFERENCE: Tribunal de Grande Instance de Paris, 3ème chambre, 1ère section, SA Orange v. SAS Free & SAS Freebox, June 18, 2015, RG No. 14/05735.

Revocation out of thin air

Patent eligibility has been quite a hot topic in the U.S. since the Alice, Myriad and Mayo Supreme Court decisions. Whether a patent simply attempts to preempt an abstract idea or a law of nature or whether it is truly directed to an application of those – worthy of patent monopoly – is, as far as I can understand, the million-dollar question that everyone now has to struggle with on the other side of the Atlantic, and will have to struggle with in the foreseeable future.

Over here, on the Old Continent, things look pretty different, on the face of it. The EPO has set a low threshold for the so-called “technical character” requirement, actually such a low threshold that it is barely a threshold at all. Of course, this is not the end of the story, because “non-technical features as such, do not provide a technical contribution to the prior art and are thus ignored in assessing inventive step” as the November 2014, soon-to-be-revised Guidelines for examination nicely put it. So, inventive step can be a real challenge, but patent eligibility is at least one concern that applicants can forget about, right?

Well, we may have to think again, in view of a judgment from the Paris Tribunal de Grande Instance (TGI) of July 3, 2014.

This case is an action for revocation brought by a company named Evinerude against French patent No. FR 2822237 assigned to Aair Lichens. According to the first and only claim of the patent, the invention relates to the use of lichens exposed to sources of emission of chlorinated compounds, and used in the form of transplants or cultivars, for making quantitative measurements of polychlorodibenzodioxine (PCDD) or polychlorodibenzofurane (PCDF) compounds and evaluating their impact on the environment.

Indeed, it turns out that lichens are good indicators of the presence of PCDD and PCDF air pollutants. Thus, by measuring the amount of these chemicals in lichen samples, it is possible to evaluate the level of atmospheric pollution that they have been exposed to.

An elegant breathing device which could become handy in case of a polychlorodibenzodioxine or polychlorodibenzofurane leak.
An elegant breathing device which could become handy in case of a polychlorodibenzodioxine or polychlorodibenzofurane leak.

It looks like the PCDD and PCDF-loaded Parisian air was not favorable to Atlantic coast-based Aair Lichens, since the TGI revoked the patent based on Article L.611-10 of the Code de la Propriété Intellectuelle, which mirrors Article 52 of the European Patent Convention and provides a list of things which are not inventions, discoveries being the first item in the list.

The court started by recalling the long-standing principle that

A mere discovery cannot be patentable. Actually, the discovery preexists man’s intervention, whereas the invention is the result thereof. A discovery thus does not bring any novelty to the state of the art since it is at the stage of sheer knowledge. However, although the subject-matter of a discovery is not patentable, a practical application can give rise to the grant of a patent.

In this case, the invention relied on the discovery of a natural phenomenon, namely the absorption of PCDD and PCDF compounds present in the ambient air by lichens. The patent proprietor’s position was however that the patent was not directed to this discovery per se but rather to process steps of measuring the amounts of these chlorinated compounds in lichens and then evaluating their impact on the environment. But the court was not convinced, and replied as follows:

As it is drafted, the only claim of the patent does not protect the process steps but merely the statement that measurements can be made to evaluate the impact on the environment, which is not a process invention. The technical means for carrying out this statement could be protectable if they were described and claimed as such.

The patent was thus revoked.

To me, this looks more like a US-type approach than an EPO-type approach. After all, it seems that the court’s reasoning could be applied in a similar manner to many use claims which are routinely granted by the EPO.

An important caveat is that the patent at stake was somewhat light, with four pages of description and a single claim. It appears from the file wrapper that the application was drafted and prosecuted by the inventor himself, which is always risky. In fact, it is not every day that one comes across a claim starting with the words “the invention relates to”. The text does contain an example of measures performed in samples taken from various geographical areas, but there are no detailed explanations in the text on a possible process to be implemented. Also, the court noted that the skilled person, at the filing date, already knew that the pollution of a site by PCDDs and PCDFs results in atmospheric contamination, and that these compounds are easily absorbed by plants such as lichens [sic, I am not sure lichens can be considered as plants] so that these are good pollution indicators.

In other terms, one could infer from the court’s findings that the patent could also have been revoked for insufficiency of disclosure or lack of novelty or inventive step.

It is difficult to assess to what extent these flaws played a part in the TGI’s decision. Would the situation have been different if the patent had contained more technical information or if the prior art had been less relevant? It is certainly possible. But on the other hand, the way the claim was drafted did seem to play a critical part in the decision.

Therefore, when an invention relates to an application of a natural phenomenon, applicants would be well advised to draft at least some claims reciting the invention in terms of practical process steps and not just use claims broadly covering the basic concept of the invention.

CASE REFERENCE: Tribunal de Grande Instance de Paris, 3ème chambre, 1ère section, Evinerude SARL v. Philippe Giraudeau & SARL Aair Lichens, July 3, 2014, RG No. 10/14406.