New opposition extensions

Since July 1, 2016, the EPO has implemented a new procedure to accelerate opposition proceedings. The EPO’s target is to reduce the total time needed for a decision in “straightforward cases” to 15 months, calculated as from expiry of the opposition period.

In keeping with this ambitious goal, the time period allocated to patent proprietors to reply to an opposition has been reduced. Or, to be more precise, the nominal period remains four months from the issuance of a communication by the EPO. But, formerly, a two-month extension was automatically granted upon request, and my understanding is that use was very often made of this possibility.

Nowadays, this extension is only “granted in exceptional, duly substantiated cases“, as indicated in the Guidelines, E-VIII, 1.6.

A few weeks ago, I filed a substantiated request for such an extension of the time limit on behalf of a patent proprietor, which was denied. I must say that I felt a little bit upset (if not offended), especially because I had the impression that in some occasions, when the shoe was in the other foot (i.e. I was representing the opponent), similar requests had been granted to the adverse patent proprietor.

Thinking a little bit about this, I realized that we have little to no information as to what an “exceptional” case is supposed to be for the EPO.

The only further, indirect, indication in the Guidelines is the paragraph which follows the one quoted above, and which concerns “other proceedings, for any communication raising a matter of substance“, whenever an extension up to a total of more than six months is requested. It is specified that this type of extension “should be allowed only exceptionally, when the reasons given are sufficient to show convincingly that a reply in the period previously laid down will not be possible. Such exceptional circumstances might be e.g. the fact that a representative or client is so seriously ill that he cannot deal with the case in time; or the need to perform extensive biological experiments or tests. On the other hand, foreseeable or avoidable circumstances (e.g. leave, pressure of other work) should not be accepted as a sufficiently exceptional circumstance”. 

Whether the same standard applies to a two-month extension in opposition proceedings (only in an “exceptional case“) as to an extension of more than two months in examination proceedings (which should be “allowed only exceptionally“) is anyone’s guess. I assume that formality officers have more specific internal guidelines, but by definition we know nothing about those.

In order to find out more, and without having the time to perform a very thorough analysis, I decided to take a random sample of opposition cases.

More precisely, I had a quick look at a number of opposed patents granted in June 2016 (opposition time limit in March 2017). I discarded all unusual cases (opposition withdrawn early, request for revocation of the patent filed in response to the opposition). There were approximately 150 cases remaining in my sample.

The first teaching is that no request for extension of time is filed in the vast majority of cases.

In my sample, the rate of request for extension of time was less than 18%. I assume that it may be even lower nowadays, as professionals are probably even more aware of the new policy now than they were back in March or April 2017. This is probably a significant change in the behavior of patent proprietors.

The second teaching relates to the success rate of requests for extension. I found that an extension is refused approximately 60% of the time.

Conversely, it is directly granted in approximately 30% of cases. The remaining cases (approximately 10%) are those where a request for extension is initially denied and then granted further to a second attempt.

Extension granted.

It is then interesting to enumerate various reasons offered in requests for extension, whether they were deemed sufficient or not by the EPO.  Please note that some requests contained several of the reasons listed below.

Some of the losing reasons first:

  • No justification at all – a non-starter of course.
  • Complexity of the opposition proceedings.
  • Necessity to coordinate the opposition case with other cases (parallel divisional applications, national invalidation trials).
  • A large number of cited documents, requiring extensive discussions.
  • A large number of pages to translate.
  • Difficulties understanding the opponent’s case.
  • Summer break season making a number of people unavailable for comments.
  • Instructions from a foreign client awaited.
  • Difficulties getting in touch with the inventor.
  • Difficulties getting in touch with staff having left the company.
  • Waiting for input from R&D.
  • Intention to prepare affidavits.
  • Change of representation.

And now some of the winning reasons:

  • Technical expert had a car accident.
  • Several oppositions filed.
  • Public prior use argument raised by the opponent.
  • Experiments being carried out by the proprietor.
  • Need to study an experimental report filed by the opponent.
  • Difficulties getting in touch with the inventor.
  • Many lengthy prior art documents cited.
  • Change of representation.

As a takeaway, I would say that, in order for a request for extension of time to be considered as relating to an “exceptional case“, any reason related to the normal conduct of business should be avoided.

Holidays, the need to coordinate several cases or to receive instructions from a distant client are not sufficient by themselves.

On the other hand, a truly unexpected event, such as a car accident, is not necessarily required.

Opposition proceedings that are more complex than usual often also qualify. But it is then necessary to be specific as to the unusual complexity of the case. Experimental testing, public prior use and multiple oppositions apparently meet the standard.

That said, there is still a grey area.

For instance, in a number of cases, it seems that a change of representation (which is very common after an opposition is received) is by itself sufficient to guarantee an extension of time – but not always. Similarly, difficulties to reach the inventors, or the number and length of cited documents, are sometimes viewed as giving the right to an extension of time, and sometimes not.

There was even a real surprise among the selection of cases that I looked at. Namely, a law firm explained that they had difficulties getting instructions from their client in Texas, as there had been disruptive floods in this area. Apparently, this was not deemed exceptional enough for the formalities officer…

In summary, you can never know for sure whether your request for extension of time will be granted or not, but looking at examples in other cases certainly helps making a prediction and tailoring your arguments.

On the other hand, as long as the patentee files at least a couple of requests in due time (typically, that the opposition be rejected, and that oral proceedings be summoned prior to any adverse decision), I think that in many cases it is still OK to submit a detailed argumentation shortly afterwards. There is no basis in the Guidelines to discard the patentee’s argumentation simply because it was filed after the initial deadline. In fact, arguments and amended claims filed before the oral proceedings, as long as within the R. 116 time limit, are usually always admitted into the proceedings. Only the filing of evidence within the R. 116 time limit is typically challenged and examined as to admissibility.

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.

When early means late

One of the things I like best about blogging is I can sometimes hear interesting whispering from my flock of little birds.

Recently, little birds flying from Munich have brought me tidings of significant developments about to take place at the EPO, in the form of a new program called User Driven Early Certainty.

It turns out that the EPO will introduce the possibility for applicants to postpone the start of substantive examination for a maximum period of 3 years. The new program is scheduled to kick off on July 1, 2018 – in other words, tomorrow.

We have been hearing rumors about this for quite a while, but now more details start being available – finally. As a disclaimer, the explanations below are based on a preparatory document issued by the EPO. Some provisions may of course change when they are finally implemented.

One big little bird.

Here are the main highlights.

First, the procedure remains unchanged up until conclusion of the search stage.

Second, as a new procedural option, the applicant will be given the opportunity to request a postponement of the start of substantive examination. This will need to be done within the 6 months’ time window for filing a reply to the European search report or supplementary European search report (R. 70 and 70a EPC) or to an international search report drawn up by the EPO, after entering European regional phase (R. 161 EPC).

This request will need to be filed online using a dedicated form. It should be filed together with the request for examination or confirmation of an earlier examination request and, where applicable, the reply to the search opinion.

If the request is validly filed, the EPO will not begin substantive examination of the application before the expiry of a 3 year-period calculated:

  • from the expiry of 6 months after the date on which the European Patent Bulletin mentions the publication of the European search report, for an EP-direct application; or
  • from a valid entry into European regional phase, for a Euro-PCT application.

For divisional applications, the postponement period will be limited in relation to the earliest application, namely:

  • 5 years calculated from the earliest application’s filing or priority date, for an EP-direct application; or
  • 3 years from entry into European regional phase of the earliest application, for a Euro-PCT application.

It can be derived from these rules that the postponement period should normally end approximately 5 years from the priority date for an EP-direct application, and up to 5 years and a half (67 months) from the priority date for a Euro-PCT application.

Furthermore, the applicant can file a request to lift the postponement at any time. Filing a request for PACE or PPH would also have the same effect.

The request for postponement will be free, but the payment of existing fees (examination fee, designation fee, renewal fees, etc.) will still have to be performed in due time and cannot be delayed owing to the postponement.

In order to preserve the interests of competitors potentially affected by pending patent rights, a postponement is lifted if the EPO receives third party observations, provided that they are non-anonymous and substantiated.

By “substantiated” is meant that at least one specific objection (on novelty, inventive step, clarity, sufficiency of disclosure, non-patentable subject-matter, exceptions to patentability, industrial applicability or unallowable amendments) must be raised together with a brief indication of the facts and evidence presented in support of this objection.

I assume that the condition that the observations should be “non-anonymous” will still be fulfilled even if the third party is solely identified as a law firm, or a straw man, or a straw man in a law firm. There is no requirement for the third party to show a legitimate interest in lifting the postponement.

Also, if substantiated and non-anonymous third party observations are filed before the applicant requests a postponement, the request for postponement will be rejected.

When the postponement period ends, the subsequent fate of the application depends on how the postponement is lifted:

  • If the postponement ends due to the expiry of the maximum 3 year-period, the case will then be treated in a normal manner, in accordance with the priorities defined by the EPO.
  • If the applicant requests a treatment under PACE or PPH, the examining division will take its next action in an accelerated manner, as provided in the PACE and PPH programs.
  • Finally, if the postponement ends due to the filing of third party observations, the examining division will issue the next action within three months of receipt of the observations.

The applicant can of course still withdraw the application and get a refund of the examination fee if the examination phase has not started yet.

On a legal standpoint, since the timeline for requesting examination is not affected by the new program, and only the actual start of examination by the EPO is, the new procedure does not require an amendment of the EPC or of the implementing regulations.

It will thus simply be based on a notice to be published in the EPO’s Official Journal.

Turning to transitional provisions, the new procedure will enter into force on July 1, 2018 and apply to EP-direct applications for which the mention of the publication of the European search report occurs on or after this date, and to Euro-PCT applications which enter the European phase on or after this date.

What can we make of all this?

On the one hand, the new procedure brings additional flexibility to patent applicants, while preserving to some extent the interests of third parties, as they can have a direct impact on the handling of applications of concern to them. In this respect, the new system prima facie seems relatively fair and balanced. It is also probably a good thing that the early issuance of the search report will not be affected, as the outcome of the search is of general interest to the applicant and to the public.

On the other hand, I cannot for the life of me understand the name of the program, User Driven Early Certainty. I cannot figure out what kind of early certainty there is in postponing examination for 3 years. But after all, according to one the most important books of the 20th century, war is peace and freedom is slavery. Accordingly, and on a much less tragic note, early can certainly be late.

Many thanks for the heads-up, little birds, and please continue whispering.

Weaker together?

Best wishes to all readers of this blog!

I am sure most of them have made their list of new year’s resolutions. Among those, there might be the resolution of keeping up to date with SPC case law. And this is one which can just as easily be dropped by the end of January as the resolution of going to the gym three times a week.

Luckily, Patent My French! is happy to oblige, courtesy of Lionel Vial. He reports below on an interesting recent decision illustrating one further way in which an SPC application can be derailed.

The appeal decision we discuss today was rendered by the Paris Cour d’appel on December 19, 2017 in a case of rejection of a supplementary protection certificate (SPC) application by the Institut National de la Propriété Industrielle (INPI).

Was this decision an advance Christmas present for the appellant or rather a late visit from the Père Fouettard (aka Father Whipper)? This is what we are going to see.

Good old Indy – the best approximation of Père Fouettard that can be found in a patent.

French SPC application No. 14C0081, in the name of Medivir AB (bear in mind the name of the holder, it is important in the present case!), was filed on November 14, 2014, on the basis of European patent EP 1713823 and of marketing authorization (MA) No. EU/1/14/924. The MA is held by Janssen-Cilag International N.V. and is for simeprevir (Olysio®), a medicinal product indicated for the treatment of chronic hepatitis C.

According to the decision (online file inspection is not available for this SPC), during the examination procedure, Medivir AB received a communication from the INPI, probably stating that it contemplated rejecting the application in view of co-pending SPC application No. 14C0076.

French SPC application No. 14C0076, held by Medivir AB and Janssen Sciences Ireland UC (here again, mind the name of the holders), was filed on October 7, 2014, on the basis of European patent EP 1912999 and of the same MA for the same product (i.e. simeprevir).

In response to the communication, Medivir AB requested a stay in the examination procedure of SPC application No. 14C0081 until a decision was rendered for co-pending SPC application No. 14C0076.

French SPC No. 14C0076 was then granted on July 28, 2015 and SPC application No. 14C0081 was rejected on January 13, 2017 on the ground that EU regulations 469/2009 (the pharmaceutical SPC regulation) and 1610/96 (the phytosanitary SPC regulation) forbid that several SPCs be granted to a same holder (Medivir AB) in regard of a same product (simeprevir). The INPI stressed that Medivir AB did not justify why the fact that it was a co-holder of SPC n°14C0076 would warrant the grant of a further protection (for SPC application No. 14C0081).

Medivir AB appealed the rejection decision on April 12, 2017 and notably argued that the holder of a first SPC as sole proprietor is a different entity from the co-holders, taken as a whole, of a second SPC, because the rights of a co-holder are under the control of the other holders, and that it is of no importance in this regard that the sole proprietor of the first SPC is also a co-holder of the second SPC.

The INPI responded that a holder of several patents on the same product cannot have several SPCs granted for the same product.

The INPI stated that, according to the case law of the CJEU, several SPCs can be granted for a same product on the basis of several patents, provided the patent holders are different (see e.g. C-181/95 Biogen and C‑482/07 AHP). In the present case, Medivir AB having already been rewarded by the grant of SPC No. 14C0076, a second SPC cannot be granted to it.

The time has now come to open the Christmas present. Will it be a shiny SPC or a dreadful whip? Let’s see what the Court had to say:

Medivir has made the choice to team up with Janssen Ireland UC to commonly develop patent EP 1912999 and, even though Medivir knew of the difficulties associated with applying for two SPCs on the same products, it chose to favor the application based on patent EP 1912999, of which it is a co-holder, over the application based on patent EP 1713823.

Co-ownership of patent EP 1912999 does not prevent it from being worked by Medivir, pursuant to Article L. 613-29 of the Code de la propriété intellectuelle [on the co-ownership of patent applications and patents].

As such, in view of the choices made by Medivir, co-holder of patent EP 1912999 which forms the basis for a SPC, it cannot apply for another SPC for the same product on the basis of patent EP 1712823 of which it is the sole holder.

Accordingly, its appeal will be rejected.

Well, a whip it is then!

To sum up, the Court decided that when considering ownership of an SPC or SPC application, the different holders of a same SPC or SPC application should not be considered as a single entity but individually.

Although this decision may appear to be in line with recent case law of the CJEU stressing that a patent holder should not be afforded a compensation for the delay to the commercial exploitation of his invention by providing him with an additional period of exclusivity when he was already afforded one (see e.g. C‑443/12 Irbesartan, paragraph 40), it does not appear entirely coherent to us.

Indeed, as was noted by Medivir AB during the appeal proceedings, if the same reasoning was applied to a situation where the SPC No. 14C0081 had first been granted to Medivir AB alone, it would have probably led to the rejection of SPC application No. 14C0076, thereby depriving Janssen Sciences Ireland UC of the right to be compensated for the delay to the commercial exploitation of its invention.

That is, unless the Court would have considered that the situation was different and called for another appraisal because Janssen Sciences Ireland UC did not have the possibility to choose between two SPC applications.

In any case, considering that (i) Medivir AB and (ii) Medivir AB + Janssen Sciences Ireland UC are different patent holders appears to be a more coherent solution to conciliate the principles that SPC protection should be made available to different patent holders in regard of a same product on the one hand, and that SPC protection should not be made available more than once for a same patent holder in regard of a same product on the other hand.

It is to be noted that in the Netherlands both corresponding SPCs have been granted.

In the meantime, before the situation above eventually gets clarified in France, it is advised to avoid such ownership configurations.

In this regard, for the sake of a witty conclusion, a mechanism could be imagined whereby Medivir AB’s SPC application No. 14C0081 would have been assigned to a third party under an agreement granting an exclusive license to Medivir AB. Looking for such a third party, the Saint Regis Mohawk Tribe would appear to be just the right candidate to consider…

As always, thank you Lionel for this report.

I guess the other side of the coin is that, if the Cour d’appel had ruled in favor of Medivir, it might then have been possible to circumvent the prohibition of several SPCs to the same holder by putting together various co-ownership agreements.

Definitely a thorny issue then, which means that it will end up in front of the CJEU sooner or later.

By the way, did the CJEU also make some new year’s resolutions to make SPC law more simple and predictable for everyone? For sure, we will soon find out.


CASE REFERENCE: Cour d’appel de Paris, Pôle 5 chambre 1, December 19, 2017, Medivir AB v. Directeur Général de l’Institut National de la Propriété Industrielle, RG No. 17/07741.

One-two-three

Still warm from the press and courtesy of Matthieu Dhenne, come tidings of the fall of another important pharma IP, namely the Atripla SPC (Supplementary Protection Certificate).

Atripla is marketed as a pink tablet with “123” impressed on one side. It contains a combination of three anti-HIV drugs, namely efavirenz, emtricitabine and tenofovir.

The U.S. pharmaceutical giant Merck Sharp & Dohme Corp. (MSD) owns European patent No. EP 0582455, entitled “benzoxazinones as inhibitors of HIV reverse transcriptase“. The patent was filed on August 3, 1993.

Two SCPs were filed and granted in France based on the EP’455 patent, and on two successive marketing authorizations (MAs):

  • The first one, FR01C0012, was filed on April 10, 2001 and granted on May 18, 2001. It protected the active efavirenz per se. This SPC expired on November 20, 2013.
  • The second one, FR08C0021, was filed on May 27, 2008 and granted on November 20, 2009. It protects the triple therapy combination of efavirenz, emtricitabine and tenofovir (marketed as Atripla) and is set to expire on August 2, 2018.

On September 20, 2016, Mylan initiated legal proceedings against MSD in France, claiming that the FR’021 SPC is invalid. The Paris Tribunal de grande instance (TGI) issued its judgment on November 30, 2017.

The judgment is interesting both regarding the admissibility of the action and  the merits.

As far as admissibility is concerned, the nullity defendant claimed that Mylan was time-barred from requesting the nullity of the SPC.

As a first line of response, Mylan argued that the general statute of limitations in our Code civil, which provides a five-year limitation period for “personal or movable actions“, is not applicable to actions for nullity of an IP right. Unsurprisingly, the court disagreed, in keeping with recent case law at the first instance and appeal levels. The TGI made in particular reference to a trademark ruling by the Cour de cassation dated June 8, 2017. For the court, applying this ruling by analogy leads to the conclusion that an action for revocation of an SPC is indeed subject to the limitation period under ordinary law.

That being said, the real interesting point is the determination of the starting point for the five-year limitation period. Although there has been a lot of discussion (including on this blog) concerning the starting period for patent nullity cases, there has been no clear guidance for SPC nullity actions, as far as I am aware of.

MSD’s case was that the starting point for the limitation period was the publication of the SPC application. The court disagreed and set the following principles.

The starting point for the limitation period must be set to the day, determined in concreto, when Mylan knew or should have known, because it intended to market a generic version of the drug which received an MA on December 13 [2007], for the combination of [the] three actives, which is protected by the SPC, which represents an impediment for its business.

So, we all get the idea there – although a couple of words may be missing, which happens from time to time when your sentences are too long, and this is probably why my blog software keeps blaming me for using more than the recommended threshold of 25% of sentences containing more than 20 words.

The general principle of an in concreto assessment is in keeping with the TGI’s previous decisions in patent revocation cases. The court went on:

[…] Only the SPC matters as an impediment, and not the patent. 

One should not refer to the date of grant of the patent, since the validity of the patent is not challenged by Mylan, which acknowledges that the efavirenz active compound is the subject-matter of the invention protected by the EP’455 patent and then by the [FR’012] SPC which expired on November 20, 2013. 

Only the validity of the [FR’021] SPC […] is challenged […]. 

Thus the publication of the grant of the patent cannot be set as the starting point for the limitation period, as it would in fact require an unrealistic watch from stakeholders and is unrelated to the development of the project which gives standing to sue. 

Mylan’s standing does not derive from the publication of the title, be it the patent or the SPC, but from its concrete intent to market the same drug. 

In this case, they have to check that this intent to market the product does not infringe any IP, and if this is the case, to seek its revocation before launching. 

Watching patent or SPC registers cannot be required from stakeholders before they intend to develop a competing product. 

[…] In the present case, the first MA for Atripla […] was granted on December 13, 2007. In view of article R. 5121-28 of the Code de la santé publique, the generic company can only apply for an MA starting from the eighth year after the grant of the MA for the original drug, and cannot be granted one before ten years. 

Therefore, Mylan could not apply for an MA before December 13, 2015, and could not obtain it before December 13, 2017. As a consequence, the date at which Mylan’s standing can be taken into account is December 13, 2015, which is the date starting from which it could apply for an MA. Thus, Mylan is not time-barred as it had until December 13, 2020 to start legal action.

What is somewhat paradoxical is that the TGI calls for an in concreto appraisal but then defines what could possibly be a general rule for SPC cases, namely that the starting point for the limitation period is the date at which third parties may start applying for their own MAs.

We will need to wait for further cases to know for sure whether this is indeed a general rule or not.

Turning to the merits of the case, the discussion and the ultimate reasoning of the court are extremely similar to what can be found in the recent decision on Truvada, also reported on this blog a few weeks ago. 

Truvada is another anti-HIV drug based on the combination of tenofovir and emtricitabine. The SPC at stake in today’s decision relates to the combination of the same compounds, plus a third one, efavirenz. And the problems raised by this other combination are analogous.

According to article 3(a) of the SPC regulation (regulation (EC) No. 469/2009 of the European Parliament and of the Council), an SPC “shall be granted if, […] (a) the product is protected by a basic patent in force“.

How to determine whether a product can be considered as being “protected” by a basic patent has been the subject of intense litigation and numerous rulings from the CJEU, which are mentioned in the TGI’s judgment. Again, readers of this blog can refer to the Truvada post, which contains a short summary of the most important CJEU case law prepared by Lionel Vial.

CJEU case law on the interpretation of the SPC regulation: each ruling always leads to more referrals.

In the present case, none of the claims of EP’455 explicitly recites the combination of the three active compounds of the combination. Instead:

  • efavirenz is covered by a generic formula in claims 1 and 5 and is singled out in claims 2 and 12 (as well as in claims 8 and 9 but in combination with other drugs different from tenofovir and emtricitabine);
  • tenofovir and emtricitabine are not cited in the patent;
  • claims 7 and 16 relate to the combination of a generic formula (covering efavirenz), or of efavirenz specifically, together with a nucleoside analog;
  • tenofovir and emtricitabine belong to this category of nucleoside analogs.

According to the court, this is insufficient to consider that the combination of the three active compounds is protected by the EP’455 patent pursuant to article 3(a).

Says the court:

It turns out that the description never explicitly cites either tenofovir or emtricitabine which are not identified in the EP’455 patent, be it individually or collectively in a composition. And in addition the specific combination claimed as an active product “efavirenz + emtricitabine + tenofovir” is not implicitly but necessarily and specifically taught in the description, and no indication makes it possible for the skilled person to select emtricitabine and tenofovir as nucleoside analogs. 

In fact, if I understand correctly, emtricitabine and tenofovir were not even identified and known yet as anti-HIV drugs at the filing date of the EP’455 patent.

Furthermore, the court refused to consider the claims relied upon by MSD (reciting nucleoside analogs) as “functional claims” because “they do not describe the structure which should be present nor the function that the second and third products should have in this structure“.

For the sake of completeness, the court stated that even if the claims were considered as functional, the four-step test established by the Dutch patent office would then not be satisfied. Again, this same test was discussed in the previous Truvada post, so I will not describe it again here.

As a consequence, the SPC was found to be invalid under article 3(a).

By way of overkilling, the court added that the SPC was also invalid in view of article 3(c) of the SPC regulation, per which an SPC “shall be granted if, […] (c) the product has not already been the subject of a certificate“.

In this case, another SPC had been granted based on the same EP’455 patent, namely the efavirenz SPC. MDS relied on the Georgetown CJEU decision (C 484/12). According to this decision, article 3(c) does not preclude the grant of one SPC for a combination of active ingredients, and another SPC for a single active ingredient, based on the same patent.

Nevertheless, according to the TGI, Georgetown is only applicable if the mono and combo products are separate inventions.

In one brief paragraph, the court then held that:

the combination of efavirenz with emtricitabine and tenofovir does not represent a separate invention which may give the right to a second SPC. For this second reason, SPC [FR’021] is invalid under article 3(c) of the regulation. 

Those readers in favor of pan-European consistency (which probably means most readers of this blog) will be happy to know that the TGI’s decision mirrors a similar ruling in the UK handed down on March 21, 2017, per which the corresponding UK SPC was declared invalid by Mr. Justice Arnold.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 1ère section, November 30, 2017, Mylan SAS v. Merck Sharp Dohme Corp., RG No. 16/14466.