All out disclosure

I have already expressed the view several times on this blog that public prior use is usually a very difficult argument to prevail on, due to the extremely demanding standard of proof which is normally required.

And this can of course be frustrating for a third party that positively knows that there has indeed been a public prior use.

But from time to time, the argument does succeed, and it is then always instructive to see what made success possible.

In the present case, the German cosmetic company Beiersdorf AG (think NIVEA®) is the owner of European patent EP 1834630. They initiated legal proceedings against two French companies which are part of a U.S. group, namely Laboratoire Bioderma and DIPTA, which later became Naos and Naos Les Laboratoires respectively (hereafter “Naos“).

Beiersdorf deemed that Naos’ cosmetic products Photoderm AR SPF 50+, Photoderm Laser SPF 50+ and Photoderm Spot SPF 50+ infringed claims 1 to 3 of the EP’630 patent.

In the course of the proceedings, the French part of patent was limited in front of the INPI, as is very usual in patent litigation in this country.

Naos did not dispute that the allegedly infringing products implement the subject-matter of the EP’630 patent. But they argued that the patent claims are invalid because one of these products, Photoderm Spot SPF 50+, was publicly disclosed before the priority date of the patent.

Let’s now have a look at claim 1 of the patent as limited during litigation (the two other claims at stake are dependent claims):

Cosmetic preparations comprising active ingredient combinations comprising:
(i) glycyrrhizin and/or glycyrrhetic acid and
(ii) 2,4-bis{[9-(2-ethylhexyloxy)-2-hydroxy]phenyl}-6-(4-methoxyphenyl)-1,3,5-triazine, 

characterized in that they contain from 0.001 to 0.5 % by weight of glycyrrhizin and/or glycyrrhetic acid, relative to the total weight of the preparation. 

The main purpose of the claimed “preparations” is to increase pigmentation of the skin and avoid UV damage to the skin. Compound (ii) is also known as Tinosorb S, which is much easier to write and read, thank you very much.

Naos explained that preparatory steps had been taken prior to March 1, 2006 (the priority date of the patent) to put Photoderm Spot SPF 50+ on the market. The body of evidence provided by Naos was the following:

  • A letter sent to a laboratory in Brazil on December 1, 2005.
  • A product datasheet certified by the Chamber of commerce of Lyon on November 31, 2005, intended for registering the product with the Brazilian administration.
  • Product datasheets sent to French and Portuguese poison control centers on December 6, 2005.
  • Various letters for the purpose of registering the product in Ukraine, Greece, Romania and Venezuela, sent in January-February 2006.
  • A pass for press sent to a printing company for printing the Photoderm Spot packages in December 2005-January 2006.
Sending letters all around the place.

Some of the evidence was discarded by the court.

In particular, the pass for press was deemed to be an insufficient disclosure because the packaging to be printed did not contain any information on the amounts of the ingredients in the product.

All of the other documents contained the complete information on the composition of the product. However, the letter sent to the French poison control center was also discarded because the center had to treat it in a confidential manner, under French law.

Regarding the rest of the documents, the court stated the following:

[…] On the one hand, as many as five pieces of evidence of a disclosure to third parties, on a number of territories, in France and abroad (Brazil, Portugal, Ukraine, Greece, Romania, Venezuela), of the qualitative and quantitative formula of the product at stake, were filed. These documents were sent between December 1, 2005 and February 23, 2006, which is before the priority [date]. On the other hand, these documents were sent to different recipients able to appreciate their contents, as they are used to processing this kind of information, since they were intended either for laboratories or for foreign people and/or authorities in order precisely to prepare the launch of the product and/or to obtain the required authorizations, thus aiming at a distribution to the public. Besides, some shipments were accompanied by a “free sale certificate” which precisely suggests that the communication made was specifically intended to be distributed to the public. 

Lastly and most importantly, none of these documents comprises any express mention of confidentiality by DIPTA, which carried out the shipments to these recipients, and thus any prior identification by this company of their confidential character. Only the one sent to the poison control center in Portugal made an implicit reference to this as it mentioned a shipment under “sealed envelope”, as well as the shipment for registering the product in Venezuela as it mentioned the “restricted use quali-quantitative formulas for actives and substances”. However, these mentions, which are not present in the other shipments and which are vague and unclear, do not make it possible to deduce an express request for confidentiality. 

The court concluded that the formula of the Photoderm Spot SPF 50+ product was indeed made available to the public before the priority date of the patent.

Since the formula comprises 0.1% of glycyrrhetic acid and 1.5% of Tinosorb S, claim 1 was found to lack novelty – the same conclusion applying to dependent claims 2 and 3. Therefore, Beiersdorf’s action failed.

Every public prior use case is unique. And I have the distinct feeling that the outcome of this one is closely related to the large number of (inter-related) disclosures of the cosmetic formula.

One or two shipments might have been possible to overcome, but multiple shipments were probably too high of a hurdle. Although the court recalled that the burden of proof lies with the nullity claimant, it was certainly more difficult for Beiersdorf to convince the judges that shipments carried out all over the place were all confidential – in the absence of an explicit mention on the letters.

It can be surmised that, even if the court had not concluded that there was a lack of novelty, Naos would then anyway have been in a quite good position for a non-infringement defense based on prior user’s rights – which was their auxiliary argumentation.

CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre, 2ème section, March 9, 2018, Beiersdorf AG v. Naos & Naos Les Laboratoires, RG No. 14/08701.

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.

Not sailing to victory

Thanks to Jérôme Tassi, I was made aware of a new French decision revoking a patent due to extension of subject-matter.

As I mentioned no earlier than in last week’s post, this is a ground for nullity that needs to be taken very seriously nowadays. There may previously have been a perception that added matter objections were deemed to fail in front of a court of law, and that painstaking dissections of the exact wording originally used in patent applications should be reserved for hearings taking place at Erhardtstrasse. But if so, this perception is no longer accurate.

The patent at stake is EP 2179917 to the Swiss company Createx SA.

This patent (EP’917) was filed as a divisional application stemming from EP 1531979, itself originally filed as a PCT application published under No. WO 2004/005009.

The technical field is the manufacture of fabric for sails. Yes, as in sailing boats. This is about as exotic as you can get when dealing with patent case law.

On December 31, 2015, Createx and its licensee, the U.S. company North Sails Group LLC, filed a patent infringement complaint against the French companies Incidences La Rochelle and Incidences Technologies.

On August 22, 2016, Createx filed a request for limitation of the French part of EP’917 with the INPI. It can be assumed that this was a reaction to some invalidity arguments brought forward by the defendants. The limitation was granted by the INPI on September 27, 2016.

The defendants counterclaimed for nullity of the EP’917 patent and as announced at the beginning of this post, the Paris Tribunal de grande instance (TGI) did in fact hold the patent invalid for extension of subject-matter beyond the content of the parent application as filed.

The patent as limited contains two independent claims, namely claim 1 directed to a fabric and claim 13 directed to a sail. Let’s focus on claim 1 only:

A fabric comprising:

a plurality of strips, each of the strips being formed from a plurality of substantially parallel reinforcing elements formed of threads arranged in a unidirectional manner, the threads being made of thousands of filaments distributed over the width of each strip, each of the substantially parallel reinforcing elements comprising said substantially parallel filaments; and an activated resin encasing the filaments to form a fabric;

wherein part of each strip is disposed on the juxtaposed strips; 

wherein at least some of the plurality of strips partially overlap adjacent strips, at least some of the strips substantially overlap over a length of each strip, at least some of the strips are arranged in parallel, so that a first end of a strip substantially overlap with a first end of another strip. 

Some sails look more threatening than others.

The key issue here is that the parent application as filed did not contain any claim directed to such a fabric or to a sail as recited in claim 13. All original claims related to a method of manufacturing a fabric, using a particular system.

Here is original claim 1 by way of comparison with the limited claim in the divisional patent:

A method of manufacturing shaped and reinforced fabrics, characterized in that it consists in making a fabric made of a membrane which encases continuous alternated reinforcing elements in a press which comprises an upper vessel the lower part of which is made of a supple element and a lower vessel the upper part of which is made of a supple element, the upper vessel comprising a shaping lath the shape of which can be adjusted by setting rods and the adjusting shape of which causes the three-dimensional elastic deformation of the supple elements and thus of the membrane and reinforcing elements within the press, into an active position in which the lath has a shape and an inactive position in which the shaping lath is inactive and does not cause any deformation of the membrane and reinforcing elements which are pressed flat, in that the portions of the membrane and of reinforcing elements are prepared before pressing on a conveyor belt which is disposed on a preparation table which then places these portions under the press with pressure and heat, and in that the portions of membrane and reinforcing elements overlap during the preparation so that they make a homogeneous fabric at the outlet of the press, which comprises flat portions and three-dimensional-shaped portions according to multiple shapes determined by the setting of the shaping lath upon pressing each membrane portion and reinforcing elements, the length of which is determined by the width of the press and preparation table. 

Here is the court’s take on this:

Through this rule [of the prohibition of extension of added matter], it is to be ensured that the patent proprietor cannot improve its position by adding elements that are not disclosed in the application as filed, which would be such as to confer an undue advantage by obtaining a different monopoly from the one initially claimed, which may harm legal certainty for third parties who rely on the content of the initial application.

In this case, the [parent] application as filed […] is exclusively directed to an invention which relates to a manufacturing method […]. It thus clearly derives from this initial application that the subject-matter of the protection does not relate to the product “fabric”. The EP’917 patent […] is no longer directed to a manufacturing method but expressly to products, and more particularly a “fabric” […] and a sail […]. 

[…] By altering the subject-matter of the patent […], the patent proprietor may now have a protection on any identical product independently of its manufacturing method. 

Thus, the patent proprietor necessarily increased the scope of protection initially requested, since this patent makes it possible to include within the scope of the patent products why may be obtained by different methods than the one claimed in the initial application. It is further noted that this modification also led the proprietor to encompass within the scope of protection of the patent […] a product which was not explicitly mentioned in the initial application, namely a “sail”, which cannot be entirely assimilated to [a fabric] and which was not within the subject-matter of the initial invention except through a mere reference to the prior art, which is not sufficient to include it within the perimeter of protection. 

The content of the (parent) application as filed has to be considered as a whole, including the claims, description and drawings. Due to some of the words used by the court in the above quote, there could be a suspicion that the court really focused on the claims only and confused extension of subject-matter with extension of scope of protection. But I doubt that this suspicion would be well-founded.

Indeed, not only did the original set of claims not contain any claim to a fabric or a sail, but also the original description did not recite a fabric or a sail as such as subject-matter of the invention.

Thus, it was considered that the shift in scope of protection could not be expected by third parties relying on the original application documents, which offended legal certainty. This is reminiscent of a Nestec decision already discussed on this blog.

In this earlier case, a claim to a device for the extraction of a capsule plus the capsule itself, in combination, was found to offend article 123(2) EPC because this category of product was not originally claimed, and could only be indirectly derived from the application based on how the capsule interacted with the device in operation.

I must say that, upon reading the claims of EP’917 (even before the French national limitation) and comparing them with the parent PCT as filed, I was curious about the examination process. Indeed, it seems that the divisional claims were completely drafted from scratch, combining pieces of wording from several passages of the original disclosure. This is not to say that such thorough redrafting necessarily adds matter. It may be allowable in some cases. But in my experience the EPO almost always at least requires detailed justifications that the skilled person would indeed directly and unambiguously derive the new claims from the original disclosure, which must not be treated as a reservoir from which you are allowed to pick and choose any combination of features.

To my surprise, it seems that the applicant did not submit any indication of a support for the claimed features when filing the divisional application, and that the examiner did not ask any questions and directly agreed to grant a patent.

So I wonder what happened here, and why the applicant was not even asked for any clarification by the EPO. This took place in 2009-2010, which is not that long ago.

CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 2ème section, February 9, 2018, Createx & North Sails Group LLC v. Incidences Technologies & Incidences SailsRG No. 16/00023.

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.

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.