Patentability in small doses

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

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

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

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

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

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

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

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

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

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

Claim 1 of the patent as limited reads as follows:

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

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

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

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

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

The court noted the following:

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

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

The court then further held:

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

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

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

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

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

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

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

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

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

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

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


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

Crunching numbers

In a previous post, I reported on the article that I recently co-authored with Lionel Vial and Laura Barona in Propriété industrielle, on the latest figures of French patent litigation. The focus of the post was on the validity stats, which are of course of paramount importance. But it turns out the article contained more interesting stats. Here are thus some further highlights from this work.

Basically, the further questions that the article purported to answer are the following:

  • Who is involved in patent litigation in France?
  • What patents are litigated in France?
  • What is the interplay between patent litigation and other post-grant proceedings?
  • What is the infringement conviction rate?

Once again, the methodology that we used is summarized at the end of the post.

That’s Laura, Lionel and I tallying up patents on our hexadecimal abacus.

First, who is involved in patent litigation.

We looked into this both in terms of type of parties, and in terms of geographical origin of the parties – claimants and defendants alike.

Typically, patent litigants are legal entities. Only 10% are natural persons. Among these legal entities, the vast majority are private companies. Within our sample, there are almost no universities or research institutes involved. Then, among those private companies, 68% are SMEs, 24% are large entities (or subsidiaries thereof), and only 7% are medium-sized businesses.

69% of all parties involved are French, and only 31% are foreign. Among the subgroup of foreign parties, more than a quarter are our German neighbors. Chinese and South Korean parties come in second and third (at 10% each). U.S. parties only rank fourth among foreign parties (7%). This ranking is somewhat surprising, especially if we compare it to the top nationalities of applicants for European patent applications. According to the annual report recently released by the EPO, 22% of all European patent applications filed in 2017 originated from the U.S., 18% from Japan, 16% from China, 11% from Germany and 6% from South Korea.

It should be noted that, in the sample that we studied, almost all Chinese parties were defendants in infringement suits, whereas the relatively high ranking of South Korean parties was mainly due to only two very active right holders, namely Sehyang Industrial Co. and Dae Sung Hi Tech Co.

Second, what patents are litigated.

We conducted a very rough classification of all litigated patents into three main technical fields: chemistry/biology/health sciences; electronics/IT; and mechanical engineering/construction. We realized that there is a strong imbalance here, since 81% of litigated patents relate to the latter field of mechanical engineering/construction. The other patents are almost equally distributed between chemistry/biology/health sciences and electronics/IT.

There is one area though in which biochem prevails over other fields, namely nullity actions. This is in keeping with the common practice of generic drug manufacturers to clear the way by trying to invalidate some patents before putting their products on the market.

37% of all litigated patents are French (national) patents, and 63% are European patents. French patents used to outnumber European ones, but the trend changed in 2009 as shown by Pierre Véron in his study and it has apparently remained relatively steady since then.

We also looked at how old the patents are by the time legal proceedings are initiated. The average age is 13.5 year old. Thus, mainly mature inventions give rise to litigation. Clearly, a substantial amount of time is required before a technology develops to the extent that it attracts significant infringement – or that it becomes worth it for a third party to attempt to get rid of a patent.

This is one of the reasons why our current local debate on the statute of limitations in connection with nullity claims is so sensitive.

Third, the interplay between patent litigation and other post-grant proceedings.

By post-grant proceedings is meant two different scenarios: opposition at the EPO and limitation (either at the EPO or locally at the INPI).

The rate is the same in both cases: approximately 19% of European patents litigated in France are/were subjected to opposition proceedings, and approximately 19% of litigated patents (both French and European ones) were subjected to limitation proceedings.

By way of comparison, the overall opposition rate is less than 4%, and the overall limitation rate is probably much, much lower. Of course it is no surprise that more important / valuable patents are more opposed than others. I often like to think in terms of the dog that did not bark, and in this respect it is probably more remarkable that as much as 81% of European patents litigated in France are granted unopposed. This is certainly related to the above remark that most patents are already fairly old by the time they are worth being litigated.

The limitation rate of 19% shows how popular this tool has proven as a defense against nullity claims or counterclaims since its introduction into French law in 2008. In fact, the proportion of limited patents goes up to 27% if we consider only appeal decisions.

On the other hand, on a validity standpoint, we have not noted a better survival rate of limited patents relative to non-limited patents in our sample.

Fourth and last, the infringement conviction rate.

Here, the magic number is 35%. That is, 35% of infringement claims are successful (which means that the patent at stake is not found invalid, and is found to be infringed).

And now a few take-away messages.

There are of course some high profile patent lawsuits in this country, for instance in the pharma field. However, most typically, patent litigation in France involves domestic SMEs and concerns mechanical engineering.

This is a sign that French patent litigation might be underrated and overlooked among a number of stakeholders, and first and foremost foreign companies.

There are many possible reasons for this.

Admittedly, many patents are invalidated by French courts, as regularly illustrated on this blog. However, this trend does not seem any worse than in other major European markets, such as the U.K., where courts are well-known to be quite strict on a validity standpoint, but also Germany, as explained in my previous post. Besides, the infringement conviction rate of 35% seems reasonably high (bearing in mind that the large number of cases which are settled before a written decision is issued are not taken into account in any statistical study).

Perhaps the main reason is thus more cultural than anything else. Multinational companies tend to eye towards the U.K., for linguistic reasons and also because of the perception that local judges are extremely skilled; and towards Germany, as it is renowned for its quick decisions, its patentee-friendly bifurcated system and its Demogorgon – I mean, the much envied and much dreaded injunction gap.

But why not also eye towards France:

  • because of the saisie-contrefaçon, which is a powerful tool in the hands of right holders to gather evidence of infringement;
  • because, overall, the likelihood of success seems to be similar here to neighboring countries;
  • because it can be relatively cheap (no expensive disclosure, expert testimony and lengthy hearings like in the U.K., no court fees like in Germany);
  • because we have a large pool of good practitioners, both attorneys at law and patent attorneys, who are fully proficient in English.

And I have not even yet begun to tell you about the food and those beautiful farmhouses in the Luberon waiting to be bought and renovated.


METHODOLOGY: the study was based on a review of all judgments on the merits issued between January 1, 2016 and July 31, 2017, both at first instance and on appeal, in which at least one issue of patent validity or patent infringement was decided upon. The sample of judgments was obtained from the Darts-ip database. They were manually analyzed by us. Interim orders as well as orders from a case management judge were excluded. Judgments from the Cour de cassation, as well as judgments concerned with other issues (computation of damages, employees’ inventions, etc.) were also excluded. The final sample contained 100 decisions, representing a total of 118 litigated patents.

Some valid figures

Lionel Vial, Laura Barona and I have recently published an article in “the orange journal. For those readers who are not overly familiar with the French patent scene, this is the nickname of LexisNexis’ Propriété Industrielle.

This article looks at key figures of French patent litigation, based on a sample of recent decisions which were manually reviewed. In this post, I will present some highlights from this work.

As the devil is in the detail, especially when stats are concerned, the methodology that we used will be summarized at the end of the post.

The main takeaway message from our study is probably that the recent overall patent invalidation rate in France is high, at approximately 56%.

This invalidation rate conflates both patents subjected to nullity actions and patents subjected to infringement actions in which a nullity counterclaim was filed.

Now, before all patent holder readers start fleeing our country out of desperation, let me immediately add that this comes with a number of caveats.

First, we have only studied court decisions on the merits. 

However, many patent lawsuits are settled before going to trial, so that a decision on the merits is never issued. It can be postulated that patents that give rise to settlement may on average be stronger than patents that get to be actually ruled on by a court – although there are of course many different factors that come into play when a party decides whether to settle or not. Anyway, the overall invalidation rate may not reflect the actual strength of all patents that are litigated.

Second, the 56% invalidation rate corresponds to patents of which at least one claim was declared invalid by a court.

Admittedly, in the vast majority of cases, when one independent claim is declared invalid, all dependent claims that are reviewed by the court are also declared invalid (what I would call the “throwing the baby out with the bathwater” approach). On the other hand, some dependent claims of the patents in suit are frequently not examined at all, simply because their validity is not challenged (which generally means that these claims are not asserted against a defendant). As a result, even when a patent is counted as invalid in the above figure, it may in fact contain some valid claims (although, again, this is usually not apparent from the decision).

Third, the 56% figure is based only on patents the validity of which was challenged.

But not all litigated patents go through a validity review by the court. In fact, 27% of all patents mentioned in the sample that we looked at did not give rise to any validity challenge. This is significant proportion.

It is possible that these other, non-reviewed patents are stronger on average. But other explanations are possible as well. For instance, these cases may correspond to infringement defendants who have less money to spend on litigation.

This third caveat is also probably the reason why the above figure markedly differs from the lower and often-quoted invalidation rate of 27% found by Pierre Véron in a famous study. Pierre Véron’s sample was much larger than ours, but is now an older one (as it covered the period of 2000-2009). Sabine Agé recently presented additional figures for the period of 2010-2016. She said the invalidation rate varied between 21% and 42% depending on the years.

However, as far as we understand, in these studies, patents that were not challenged on a validity standpoint were counted as valid; whereas such patents are excluded from the sample on which our own figure is based.

Lucky numbers in litigation.

That being said, how does this French figure of 56% invalidation compare with other European jurisdictions?

Well, it is particularly instructive to look at the situation in Germany, since this country attracts the vast majority of the European patent litigation “market” due to its perceived patent-friendliness.

Believe it or not, but it seems (based on figures released in 2016) that the partial or total patent invalidation rate at the Bundespatentgericht and the Bundesgerichtshof is approximately 80%. More precisely, there is a 44% rate of total invalidation, whereas 36% of patents are maintained in amended form. Only 20% of patents survive a nullity challenge in their granted form.

Now, the French figure and the German one cannot be directly compared, due to differences between the two systems. Indeed, there is no claim amendment in front of a French court. Besides, frequently, some dependent claims in a patent are never actually looked at by French judges, for the reasons recalled above.

But it is anyway quite doubtful that patents fare much better in Germany than in France, on a validity standpoint. Actually the opposite could be true.

Another striking conclusion of course is that, whatever the jurisdiction, a significant proportion of granted patent claims which ultimately go to trial are found invalid. This may be an important fact to bear in mind, at the time the EPO has just released its annual report, with the usual emphasis on quality.

The quality of the work done by a patent office is certainly extremely complex to assess. But maybe more attention should be paid to court decisions in this connection. After all, European judges are those who have the last say on what a “good” or “bad” patent is.

A couple more figures before you go, especially on the distinction between French and European patents, and on the various grounds for nullity.

Approximately one third of patents litigated in France are French national patents, while two thirds are French parts of European patents.

It turns out there is a significant discrepancy between the invalidation rates for these two categories, namely: 41% for European patents and 78% for French patents.

The conclusion is pretty straightforward: European patents are stronger than French patents. This is not surprising. Since the INPI does not perform a complete examination of French patent applications, the granted claims in a French patent are usually the sole responsibility of the applicant. It is therefore always tempting to pursue overly broad claims in a French national patent, which makes them more prone to a nullity challenge.

As to the various grounds for nullity leading to the invalidation of patent claims, we found the following breakdown:

  • Lack of novelty: 15%;
  • Lack of inventive step: 54%;
  • Extension of subject-matter: 10%;
  • Insufficiency of disclosure: 15%;
  • Others (non-patentability…): 6%.

So, most patent claims are revoked for lack of inventive step. The 54% figure that we found is in full agreement with Sabine Agé’s recent presentation, based on a larger sample of decisions.

The relatively large number of patent claims which are deemed to lack inventive step certainly reflects a national take on this issue which is much more flexible than the EPO’s problem-and-solution somewhat rigid framework.

Other, maybe less known, notable facts include a recent surge in added matter-based invalidations, as French case law tends to align on EPO case law in this respect; as well as a relatively large number of insufficiency-related invalidations. My personal view is that French courts tend to be more severe than the EPO on the appraisal of sufficiency.


METHODOLOGY: this study was based on a review of all judgments on the merits issued between January 1, 2016 and July 31, 2017, both at first instance and on appeal, in which at least one issue of patent validity or patent infringement was decided upon. The sample of judgments was obtained from the Darts-ip database. They were manually analyzed by us. Interim orders as well as orders from a case management judge were excluded. Judgments from the Cour de cassation, as well as judgments concerned with other issues (computation of damages, employees’ inventions, etc.) were also excluded. The final sample contained 100 decisions, representing a total of 118 litigated patents.

Follow-up on priority and on SPCs

Dear readers, this is just a brief follow-up post on two topics previously addressed on this blog: partial priority at the EPO and vaccine SPCs.

First, partial priority at the EPO. This was already addressed in the past here and especially there, where I talked about the decision of the Enlarged Board of Appeal G 1/15.

Since then, another decision T 282/12 has been issued and has swiftly been presented on all good blogs (here, here and there).

In this decision, it was ruled that the priority of a claim was partially invalid because the alleged priority document was partially not the first application for the invention at stake.

As I have previously observed, although G 1/15 was almost unanimously welcome by the patent profession as a cure to the toxic divisional plague, the relatively flexible and generous approach of partial priority adopted in this ruling can also turn against patent proprietors when they file successive similar applications.

In this respect, T 282/12 is not really groundbreaking. The same already happened in T 1222/11, the decision which was the first one to theorize the “generous approach” later endorsed by G 1/15. In this earlier decision, the refusal of the patent application at stake was confirmed by the Board due to the invalidity of a priority claim in view of an earlier application (by the same applicant) which contained the same examples as the alleged priority document. I always thought that it was somewhat paradoxical that this decision considered as life-saving by many in fact killed the patent application at stake.

There is one remaining issue which may give rise to additional discussions, though.

T 282/12 states that the priority is only partially, and not fully, invalid if part of the claimed subject-matter was disclosed by the same applicant in an earlier application than the priority document. T 1222/11 was in my opinion not so clear in this respect. However, is it really certain that this is consistent with the Paris convention and the EPC? After all, these treaties do not expressly contain the notion of a “partial first application“.

So, it remains to be seen whether future decisions will be fully in line with this aspect of T 282/12 or not. It also remains to be seen what national courts will make of all this, as they are not bound by the Enlarged Board’s findings – least of all French courts if I may say so.

In the meantime, extreme caution should be exerted when filing successive applications on similar subject-matter, especially when the supporting examples are the same. 

Second topic, totally unrelated to the first one: vaccine SPCs.

Almost two years ago, Lionel Vial reported on this blog on the refusal of an SPC application filed by GlaxoSmithKline Biologicals (GSK) for the Cervarix vaccine by the INPI, and on the confirmation of this refusal by the Paris Cour d’appel.

Interestingly, another French SPC application was filed by a different applicant, namely the Loyola University of Chicago, still for the Cervarix vaccine, and based on the same marketing authorization as the GSK application.

The same causes often produce the same effects. Thus, this second SPC application was also refused by the INPI, and the appeal filed by Loyola was dismissed by the Paris Cour d’appel.

As explained by Lionel in the earlier post, the Cour d’appel considered that the active substance in the Cervarix vaccine was in fact the same product as the active substance in the earlier Gardasil vaccine, for which an SPC had already been granted to GSK.

The Cour d’appel did not change its mind in the Loyola case and reminded that only one SPC can be granted per product. The fact that the patent mentioned in the SPC application as well as the applicant were different did not change anything.

To Loyola’s credit, whether both active substances are actually the same is not straightforward here. This is because one critical protein in the Cervarix vaccine is obtained differently (via insect cells rather than yeast cells), and is truncated, relative to the same protein in the Gardasil vaccine. Therefore, it was probably worth giving it another try despite the previous negative decision.

An interesting variation of the insect pictured in the earlier Cervarix post.

Loyola made ample reference to its own patent and to a later scientific publication as evidence that the difference in protein structure had an impact on biological properties.

But the court said:

[…] The INPI rightly states that this change is minor […]. Even though the appellant claims a different structure and different properties, they do not show that these modifications are anything but minor, as the active substance remains the same and the preventive purpose remains the same. The INPI rightly states that an increase in the capacity to form VLPs, a higher yield, a higher purity level, a more regular shape, a reduction in the risk of cellular DNA encapsidation or even a better stability, are changes which do not alter the nature of the active substance or its preventive purpose; they do not make it possible to conclude that the products are different. 

So, once again, insects and yeast – same difference.


CASE REFERENCE: T 282/12, (Coated tablets / JOHNSON & JOHNSON), Board of Appeal 3.3.07, November 9, 2017, Pfizer Inc. v. Johnson & Johnson Consumer Inc.

CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 1, December 19, 2017, Loyola University of Chicago v. Directeur Général de l’INPI, RG No. 2016/17848.

Will case law crystallize?

Today, it is back again to one of the topics regularly addressed on this blog, namely the statute of limitations for patent nullity actions in France (but not only!).

Matthieu Dhenne was kind enough to send me a brand new decision from the Paris Tribunal de grande instance (TGI) which, once more, sheds new light on this thorny issue.

The patent at stake is the French part of EP 1455756, to Merck Sharp & Dohme Corp. (MSD). The patent was granted on July 9, 2008. It was opposed by two generic drug manufacturers. At first instance, the patent was maintained in amended form, according to a decision dated December 3, 2010. The opponents appealed, and their appeals were dismissed by the Board of appeal in a decision dated July 17, 2014. The publication of the amended patent took place on September 23, 2015.

Soon thereafter, on December 2, 2015, Ethypharm filed a nullity action with the Paris TGI, requesting that the French part of the patent should be revoked.

Quite predictably, MSD argued that the nullity action was time-barred.

If one directly applied the recent case law of the Paris Cour d’appel (discussed here), this should be a winning argument. Indeed, the Cour d’appel has proposed that the five year-limitation period be computed from the date of grant of the patent. With this in mind, in this case, the limitation period would have ended on July 9, 2013.

But you and I know that things are not that straightforward, as the Paris TGI does not follow the case law of the upper court, and generally favors an in concreto determination of the starting point for the limitation period (see a recent example here).

Yet, in today’s ruling you will not find any protracted discussion of an in concreto starting point. Instead, the issue is disposed of in just one paragraph:

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

I must say I have mixed feelings about this.

My initial reaction was, oh no, you must be kidding me, there is now yet another way of determining the starting point for the limitation period? This is not legal uncertainty anymore, this is legal chaos.

A few seconds later, I thought, well yes, it does make sense after all, you can’t possibly be expected to shoot at a moving target. When a patent is modified during opposition proceedings, any appeal filed at the EPO has a suspensive effect, and thus it is only once the appeal proceedings are terminated that the content of the patent is final.

A party must act within five years from the date at which they knew or should have known that the patent at stake is a possible impediment for their current or future business activities, or else be time-barred (this is more or less what I understand to be the TGI’s usual position). And how can a party know this before the patent is even its final form?

However, this ruling raises more questions than it provides answers.

What if an opposition is rejected by the opposition division and the patent thus maintained as granted instead of as amended? Should the reasoning be the same? What if an opposition is filed by a straw man (which is allowable at the EPO) and there is thus an unverifiable suspicion that the nullity claimant itself may be the true opponent, in an attempt to artificially extend the limitation period by several years?

In his message to me, Matthieu Dhenne also noted that the court’s reasoning could be applicable to other situations: limitation proceedings, but also a prior nullity suit brought forward by a third party. Taking this one step further, he observed that a patent right can in fact be modified at any time and is therefore theoretically never “stabilized” until it expires (sometimes, it can even be retroactively “stabilized” only after its expiry). He thus suggested that the full consequence of the court’s reasoning should be that the limitation period can only start running at the expiry of the patent, so that the well-identified drawbacks of this limitation period should in practice never occur.

Matthieu added that there would thus be a complete parallelism between the limitation period for infringement actions and nullity actions. Accordingly, invalid patents would not be able to unduly hinder free competition.

Definitely an interesting suggestion, but is it really what the TGI had in mind? I am quite sure we can expect more surprises in future decisions.

Apart from this, the decision is worth the read beyond the admissibility part.

First, it turns out that the nullity claim was held ill-founded on the merits and thus dismissed. As the patent in suit is a pharma patent, this is already quite remarkable. A majority of pharma patents which are litigated in this country are revoked one way or another.

Second, the decision tackles the very interesting issue of plausibility.

There has been a significant trend in France for patents to be revoked when they are held to be of a speculative nature. See for instance previous posts here, here and there.

In the present case, Ethypharm argued that the patent was of the speculative kind, which resulted in insufficiency of disclosure and lack of inventive step.

Now may be a good time to have a look at claim 1:

A nanoparticulate composition comprising the compound 2-(R)-(1-(R)-(3,5-bis(trifluoromethyl)phenyl)ethoxy)-3-(S)-(4-fluoro)phenyl-4-(3-(5-oxo-1H,4H-1,2,4-triazolo)methylmorpholine, or a pharmaceutically acceptable salt thereof, the compound having adsorbed on the surface thereof at least one surface stabilizer in an amount sufficient to maintain an effective average particle size of less than about 1000 nm; where “effective average particle size of less than about 1000 nm” means that at least 95% of the particles, by weight, have a particle size of less than about 1000 nm.

This drug composition is useful in the treatment of nausea and vomiting, especially those induced by a chemotherapeutic treatment. The short name of the active compound is aprepitant. According to the patent, the technical problem at stake was to improve the bioavailability of aprepitant. This is stated in the patent but no experimental test results are present, which led Ethypharm to consider that there was no evidence in the patent that the technical problem was properly solved.

Ethypharm also tried to use some of MSD’s posterior testing against them, by claiming that they proved that there were features missing in the patent which were essential for successfully implementing the invention.

The court was not convinced that there were indeed such essential features missing. The court also noted that there was a reference in the patent in suit to a prior U.S. patent disclosing the so-called “Nanocrystal” method, for making nanoparticles with a surface modifier adsorbed thereon, having an average size of less than 400 nm. This Nanocrystal patent also taught that such nanoparticles improve the bioavailability of poorly water-soluble actives.

Thus, said the court, the improvement in bioavailability provided by the nanoparticle form of aprepitant was plausible.

In such a case, the court continued, evidence which is external to the patent can indeed be taken into consideration for demonstrating that the technical problem is solved. The court then reviewed a number of articles and reports and was satisfied that the technical effect of improving bioavailability was well achieved.

In summary, this is an important decision for the fine-tuning of the appraisal of a speculative patent-type objection.

To me, the take-away message is that a reference in a patent to a prior art document disclosing a technical effect provides some plausibility that the technical effect is indeed achieved.

From drug crystals to crystal balls: could they possibly help us decipher future case law?

The patent survived other attacks of insufficiency of disclosure, extension of subject-matter and lack of inventive step. Quite remarkably, the main claim was in particular found to be non-obvious over the “Nanocrystal ” European patent of the same family as the U.S. patent mentioned above, which was used for supporting the plausibility of the technical effect.

The court held that:

[The “Nanocrystal” prior art] does not disclose chemical structures or features of drugs intended to be used by this process. It only mentions that it can be implemented with a large variety of medicinal substances, the substance having to be poorly soluble, that is less than 10 mg/mL, so that the skilled person does not know which actives […] can be tested with a reasonable expectation of success. He was all the less incited to do so that in December 2001, i.e. almost ten years after the priority date of [the Nanocrystal patent], the nanonization process, which has a number of constraints (in particular the heat released during milling may change the structure of the active substance and reduction to a very small size may create a problem of chemical and physical stability), was used on only four active substances (danazol, steroid A, compound WIN 63,394 and naproxene) with a verified effect on bioavailability […]. 

I have the uneasy feeling that there may be a contradiction here between the sufficiency and inventive step prongs of the court’s reasoning.

If the teaching of the Nanocrystal patent cannot be applied in an obvious manner to aprepitant, and if there are many technical uncertainties, why is it then not necessary for the MSD patent to contain evidence in the form of experimental tests showing that the process can in fact be effectively applied to this particular drug?


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 2ème section, January 26, 2018, Ethypharm SAS v. Merck Sharp & Dohme Corp., RG No. 16/01225.