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.

Cook’in cooked

There is nothing like home-made food. Unfortunately, it seems like kitchens are never roomy enough to accommodate all those nice and fancy appliances for making soups, ice creams, bread, fondue and all that jazz. But as far as courtrooms go, some extra space can always be found for new kitchen appliance lawsuits.

In two previous posts, I discussed a case brought by Vorwerk & Co. Interholding GmbH against various companies responsible for the marketing of food processors of the MyCook brand in France. This case was indeed a good example of how patent infringement damages can be computed in our country.

It turns out that another case was also brought in parallel by the same company, based on the same patent, against other defendants (Guy Demarle Grand Public SAS et al.) responsible for the marketing of another food processor branded as Cook’in. Cook’in was held by the Paris Tribunal de Grande Instance (TGI) as infringing Vorwerk’s patent, just like MyCook – although readers may recall that the appeal judgment on the merits in the MyCook case was set aside by the Cour de Cassation for procedural reasons, so that the Cour d’appel will have to reconsider the issue afresh.

The reasoning adopted by the TGI on the question of infringement in the Cook’in case is very similar to that previously adopted by the TGI and the Cour d’appel in the MyCook case. So, in a way, the recent Cook’in TGI decision is not really surprising; but the decision is a very interesting example of how the doctrine of equivalence is applied in France.

According to well-established case law, two technical means are deemed equivalent if they are of a different form, but perform a same function for a similar result. An additional condition is that the function in question must be protectable.

In this case, claim 1 of the patent reads as follows:

Kitchen machine with a stirrer vessel and a drive for an agitator in the stirrer vessel, wherein the stirrer vessel in its lower region can be heated up, wherein the stirrer vessel is covered by an inserted lid, characterised in that on the inserted lid is arranged a top piece which has a perforated bottom for preparation by steaming of foods, wherein the perforations are formed in a cooking material support of the bottom of the top piece and condensate or moisture formed is conducted back into the stirrer vessel.

This claim was not literally infringed by the Cook’in apparatus for the following reason, according to the court:

The Cook’in machine of the defendants differs from the kitchen machine of the patent in that it does not comprise a lid between the stirrer vessel and the perforated element for steam cooking. This latter element comprises a flange in its lower part on which a seal is arranged, which makes it possible to directly attach it on the stirrer vessel.

The court then made a comparison between how the Cook’in apparatus operates and how the patented machine operates and, applying the traditional test, came to the conclusion that the different technical means that are used did in fact have the same function for a similar result:

[…] Even though the Cook’in machine does not have the insertable lid as taught by claim 1 […], the embossed annular part of the vapor bowl associated with the seal disposed on the periphery provides a means of a [different] form which has the same function, namely ensuring that the cap is above the stirrer vessel, for the same result, i.e. making vapors rise from the stirrer vessel to the upper part of the cap through the dedicated openings and reintroducing the condensates into the stirrer vessel. 

Various arguments were put forward by the defendants in order to show that the Cook’in apparatus did not operate in the same way as the claimed invention, but those were not deemed persuasive by the court.

The defendants also argued that the “inserted lid” feature in claim 1 was an essential feature of the invention which necessarily had to be reproduced in order for the patent to be infringed.

The interesting point about this argument is that this feature of the “inserted lid” was not present in claim 1 as filed and was added during prosecution. So, can the doctrine of equivalence be used at all in this situation? Yes, said the court. The fact that a feature was added during prosecution does not preclude a finding of infringement by equivalence on this very feature:

Vorwerk modified its claim by adding a lid, and the EPO examiner considered that the arrangement of the steam cooking container over the lid was a novel and inventive arrangement. 

Nevertheless, such novelty and inventiveness were acknowledged relative to a prior art where the pierced basket for steam cooking was positioned below the lid. 

Therefore, what was considered as novel and inventive was not so much the presence of the lid, but rather the fact that the steam cooking part was positioned above the stirrer and heating vessel. 

Thus, the scope of claim 1 does not prevent a possible infringement despite the absence of the intermediate lid, if it is established that the means of the Cook’in machine have the same functions for the same result as those of the patent. 

The analysis made by the court here relates to the second part of the equivalence test set forth above, i.e. whether the function of the equivalent means was “protectable“. In the present case, it seems that the function was protectable because the general idea of having a steam cooking recipient arranged above a stirrer vessel was a novel and inventive concept.

There are some devices in which the presence of a lid is absolutly essential.
There are some devices in which the presence of a lid is absolutly essential.

The bottom line of the court’s approach (which is indeed the traditional approach in France) is therefore to assess what the contribution of the invention to the art really is about. A third party’s product implementing the same inventive concept in a different manner will be held infringing, irrespective of the exact claim wording selected by the drafter.

Another interesting point to note about this decision is the computation of damages. Contrary to the parallel Vorwerk v. Taurus litigation, the court (in a different composition) did not appoint an expert but directly proceeded with the assessment of damages. The result of this assessment was similar but not exactly identical to the one made in Vorwerk v. Taurus.

The main point which was discussed was, again, the rate of the indemnifying royalty to be applied. The court was apparently unconvinced by the submissions of either party in this respect and therefore they preferred to rely on the expert’s report from the other case. Although the defendants were different and the infringing device was different, the rationale for determining the proper rate could indeed be applied in a similar manner.

The court noted that three options for the indemnifying royalty rate were offered by the expert, namely 1.5%, 3% and 4.5%. The court explicitly approved the methodology used by the expert, and then came up with its own figure without any clear justification:

In view of the above, in view of the profits made by the defendants, of the advantageous economic situation of [the defendants] due to the marketing of the patented invention without a license, the court can assess the harm suffered without granting the request for additional information, and the indemnifying royalty rate should be fixed to 4%.  

This figure of 4% does not correspond to any of the three options proposed by the expert in Vorwerk v. Taurus, although it is indeed within the expert’s range. But, more importantly, this is not the same figure as the one selected by the court in Vorwerk v. Taurus where a rate of 3% was ultimately chosen by the court! (Again, the composition of the court was different.) Unfortunately, there is no explanation as to why the Cook’in infringement is worth one third more than the MyCook infringement.

At the very least, this inconsistency should be a reminder that courts have a fairly wide discretionary power when it comes to determining the quantum of damages.


CASE REFERENCE: Tribunal de Grande Instance de Paris, 3ème chambre, 4ème section, July 2, 2015, Vorwerk & Co. Interholding GmbH v. SAS Guy Demarle Public et al., RG No. 12/11488.

 

Longitudinal vs. roughly longitudinal: same difference?

The third and last one of the series of posts on how French courts seem to have gotten stricter on extension of subject-matter is dedicated to a dispute between two French truck manufacturers, Chéreau and Frappa. The former sued the latter for infringement of two European patents concerning buffers mounted at the rear end of the vehicle chassis.

Once again, both patents (one of which had gone through and survived opposition proceedings at the EPO) were revoked by the Paris TGI for extension of subject-matter.

Of these two revocations, one was based on a relatively typical reasoning of intermediate generalization: some features were taken from the description and imported into claim 1, and the court decided that it was not allowable to isolate these features from the others with which it was originally disclosed in combination.

The other revocation is more remarkable. The file wrapper of the patent can be found here. Claim 1 as filed related to a vehicle chassis comprising, inter alia, a thrust element. Claim 2 as filed specified that the thrust element was a thrust arm with roughly longitudinal mobility relative to the chassis. In claim 1 as granted, the thrust element was restricted to a thrust arm with longitudinal mobility relative to the chassis. In case you have not noticed, the term “roughly” disappeared in the process, and this turned out to bring about the demise of the patent.

At first sight, the amendment may look like pretty innocuous. In fact, examiners often protest against the presence of vague adverbs such as “roughly”, “approximately” and the like in patent claims, and they regularly request that the applicant should get rid of them before grant. This is hardly ever seen as an issue at all from the added matter standpoint.

So, in the present case, if there was support in the original disclosure for “roughly” longitudinal mobility, why wasn’t there any support for longitudinal mobility as such? In order to understand this, one needs to have a closer look at the application as filed, which contained only one detailed embodiment of the displacement of the thrust arm.

According to this embodiment, the thrust arm rotates around an axis by a few degrees, and this is said to be tantamount to a longitudinal displacement. This comment is quite understandable because, if you zoom in on a portion of a circle, it looks pretty much like a straight line (if my math memories are correct, this is what they call a first order approximation).

In the light of the description, the term “roughly longitudinal” in original claim 2 was therefore interpreted by the court as actually referring to a pivotal movement. By deleting the adverb “roughly”, this was changed to a truly longitudinal movement, but such change was not properly supported by the application as filed.

Quoting from the judgment:

“By omitting the adverb ‘roughly’, Chéreau can argue that claim 1 covers any longitudinal displacement and no longer only a rotation displacement of the thrust arms.

Departing from the roughly longitudinal displacement corresponding to a rotation of a few degrees mentioned in the description, claim 1 covers the longitudinal mobility of the thrust arms by the deletion of the adverb ‘roughly’”.

So, paradoxically, by specifying that the displacement is longitudinal and not just “roughly longitudinal“, the applicant had shifted the scope of protection to claim an aliud. The innocuous-looking amendment was therefore not so innocuous after all.

An example of a pivotal arm having a roughly longitudinal displacement.
An example of a pivotal arm having a roughly longitudinal displacement.

Now, having reporting on this third recent example of added matter ruling, I would certainly be interested in knowing what readers think about this general approach which to me is very reminiscent of EPO practice. Is such harmonization to be welcome? Or are French judges being more Catholic than the pope?


CASE REFERENCE: Tribunal de Grande Instance de Paris, 3ème chambre, 4ème section, SAS Jean Chéreau v. SAS Frappa, November 6, 2014, RG No. 12/10879.