For the sake of the argument

As I have already mentioned here, one reason why I do not often comment on decisions from the Boards of appeal of the EPO on this blog is that any interesting decision that comes out is instantly shot at by all good bloggers around the place before I even get a chance to draw my metaphorical gun.

So, sorry folks, no breaking news from me today, as Laurent Teyssèdre has already been here, as well as others.

But I could not let this one decision T 1914/12 go without a comment or two.

First, because it is highly interesting. Second, because it is in French (so, maybe some non-French speaking colleagues would benefit from further highlights). Third, because I was involved in the case at hand in the first instance proceedings, so this one brings back a number of memories.

The catchword of the decision can be translated as follows:

Boards of appeal do not have any appraisal power with respect to the admissibility of late arguments which are based on facts that are already part of the proceedings (decision diverging from T 1621/09).

A brief presentation of the facts of the case will probably suffice, before summarizing the very thorough legal discussion in the decision.

The patent at stake is entitled “Method of adhesively bonding a strip of flexible fabric to a substrate“. It was opposed after grant and revoked by the opposition division, for lack of inventive step (as well as extension of subject-matter as far as some of the auxiliary requests are concerned).

In the course of the appeal proceedings, the opposition was withdrawn, and the patent was transferred to the previous opponent. Not that this circumstance is really critical.

The key issue is that, for the first time on appeal, the new patent proprietor identified a further distinguishing feature relative to one of the main cited prior art references.

In a written communication, the Board expressed the preliminary opinion that this was a late argument and that its intention was not to admit it into the proceedings. But the Board, for once presided by the legal member, later changed its mind and came to the opposite conclusion. As a result, the first instance decision was set aside, and the case remitted to the first instance for further prosecution.

But before reaching this conclusion, the Board performed a very thorough analysis of the law pertaining to late facts and arguments.

A fancy EPO appeal clock.

The starting point for the discussion is article 13(1) of the Rules of procedure of the Boards of appeal (RPBA), per which:

Any amendment to a party’s case after it has filed its grounds of appeal or reply may be admitted and considered at the Board’s discretion. The discretion shall be exercised in view of inter alia the complexity of the new subject matter submitted, the current state of the proceedings and the need for procedural economy. 

So the question is: does the discretionary power of the Board apply to a situation such as the one at hand, where a new distinguishing feature is identified by the proprietor at a late stage?

As a first step (section 7.1 of the reasons), the Board reviewed in great detail the notions of “facts” and “arguments” and their respective definitions, based on the common understanding of the terms, of the legal understanding of the terms, and on the specific use of the terms in the EPC and case law.

Clearly distinguishing between facts and arguments is not just a matter of hair-splitting. Depending on whether a late submission is viewed as a fact or an argument, the fate of the submission may differ – even in first instance.

As a side note, in one opposition I have handled, a new inventive step attack based on a timely filed document only later identified as a possible closest prior art document was considered by the opposition division as pertaining to a “new fact” and not merely a “new argument” and it was thus not admitted into the proceedings. The Board set aside the first instance decision – but I don’t know yet if this point will be discussed in the reasons or not.

Anyway, the definition offered by the present Board (reasons, 7.1.4) is the following (in my own translation as always):

A “fact” can be understood as a factual (or allegedly factual) element or a circumstance on which a party bases its case, whereas an “argument” designates a proposition that a party bases on one or more facts and which supports the case that it puts forward. 

The Board then gave the example of a lack of novelty attack:

  • The party’s case (“moyen” in French) is that the claimed subject-matter is comprised in the state of the art.
  • One argument is e.g. that the subject-matter is disclosed in paragraph [0017] of D1.
  • Another argument is e.g. that the skilled person understands the paragraph in a certain manner, in view of common general knowledge, and thus views a certain feature as implicitly disclosed.
  • The textual content of the paragraph is a fact.
  • The copy of the document or of its translation is a piece of evidence.

As a next step, the Board addressed the central issue of whether late arguments can be disregarded or not.

Here, the first interesting remark is that the text of the EPC is not the same in the three official languages.

The English version of article 114(1) reads:

In proceedings before it, the European Patent Office shall examine the facts of its own motion; it shall not be restricted in this examination to the facts, evidence and arguments provided by the parties and the relief sought. 

Note the term “arguments” here. But the French version is in fact quite different, as it solely refers to “moyens invoqués” and “demandes présentées“. I would tend to translate the general term “moyens invoqués” by “the party’s case“. The German version does not specifically mention arguments either.

The Board noted that the English version seems to more accurately express the intentions of the drafters of the EPC (is that generally the case? the Frenchman asks), and therefore adhered to this English version in the rest of the reasoning.

Now the key part of the reasoning is that the English version of the second paragraph of article 114, on which the discretionary power of the EPO to disregard late submissions is based, does not refer to arguments:

The European Patent Office may disregard facts or evidence which are not submitted in due time by the parties concerned. 

This is in contrast to the first paragraph mentioned above, which deals with examination of the EPO’s own motion.

Based on the difference between the two paragraphs, the Board concluded that the discretionary power of the EPO is strictly limited to facts and evidence and does not extend to arguments.

Now going back to article 13(1) RBPA, there is a reference here to an “amendment to a party’s case“, which is not very explicit. But the notion of a party’s case is further defined in article 12(2):

The statement of grounds of appeal and the reply shall contain a party’s complete case. They shall set out clearly and concisely the reasons why it is requested that the decision under appeal be reversed, amended or upheld, and should specify expressly all the facts, arguments and evidence relied on. […]

So, on the face of it, it can be surmised that article 13(1) RPBA, via its implicit reference to article 12(2), empowers the Board with the right not to admit a late modification of the arguments of a party on appeal.

But, reviewing the Travaux préparatoires for the current version of the RPBA, the Board found that a proposed article 13(1) containing an explicit reference to arguments was rejected in the drafting process.

Thus, the Board held, the intent seems to have been in fact not to encompass arguments within the purview of article 13(1). See section 7.2.1 of the reasons.

Then, the Board reviewed the relevant case law in detail (section 7.2.2 of the reasons), and found a number of decisions pursuant to which arguments are not subjected to the Boards’ discretionary power.

But then there are T 1069/08 and above all T 1621/09, which decided otherwise. Especially in T 1621/09, an analysis of the travaux préparatoires was performed but the deletion of the word “arguments” in the drafting process of new article 13(1) was not noted.

In the wake of these two decisions, the Board counted 17 later decisions which relied on the principles set out in T 1069/08 and T 1621/09 without questioning them. A couple of recent decisions have however decided the other way around.

As a conclusion, the Board expressed its disagreement with the approach of T 1069/08 and T 1621/09 (section 7.2.3 of the reasons).

The final reason put forward by the Board for such disagreement is that the RPBA should not “lead to a situation which would be incompatible with the spirit and purpose of the Convention” (article 23), which would precisely be the case if article 13(1) RPBA were to be interpreted as encompassing arguments, although article 114(2) EPC, which prevails, does explicitly not refer to arguments, among the late submissions which may be disregarded.

One first question immediately comes to mind: is this question ripe for a referral to the Enlarged board of appeal?

After all, there are a number of diverging decisions, it seems. I guess the answer may depend on whether the Boards which issued T 1069/08 and T 1621/09 will stand their ground or change course.

The second question that I have is: what about the upcoming revised version of the RPBA?

A few months ago, there was a public consultation at the EPO on a draft. I do not know where this project stands right now. But, for what it is worth, there was a new paragraph 2 in article 12 in this proposal, which reads:

In view of the primary object of the appeal proceedings to judicially review the decision under appeal, a party’s appeal case shall be directed to the requests, facts, objections, arguments and evidence on which the decision under appeal was based.

Beside the fact that there is a new concept here (namely “objections“), this provision seems to introduce a limitation to what kind of arguments a party is allowed to file on appeal – namely, those on which the decision under appeal was based.

If one follows the reasoning of T 1914/12, wouldn’t this proposed provision breach article 114 EPC?


CASE REFERENCE: T 1914/12, Board 3.2.05, June 13, 2018, Gaztransport et Technigaz.

The single question

When you come to think about it, most of the issues that are discussed on a daily basis in patent cases seem to always boil down to one single question: same or different?

Take novelty: is the claimed subject-matter the same as that of the prior art or is it different? Or take infringement: does the allegedly infringing product or process differ from the claims of the patent? The list continues with extension of subject-matter, priority, etc.

Nevertheless, we patent attorneys or lawyers do not get bored, because this multifaceted single question is in fact extremely complex and gets renewed all the time. The most perfect example is probably supplementary protection certificates (SPCs), an area of law in flux if there ever was one.

Spot the differences – a patent attorney’s favorite game.

Merck Sharp & Dohme Corp. (MSD) is the owner of European patent No. EP 0720599. The patent is directed to the treatment and prevention of atherosclerosis and more particularly to a class of compounds called hydroxy substituted azetidinones, among which the molecule known as ezetimibe.

Ezetimibe is in fact explicitly recited in claim 8 of the patent.

Of note are also claims 9, 16 and 17, which are worded as follows:

9. A pharmaceutical composition for the treatment or prevention of atherosclerosis, or for the reduction of plasma cholesterol levels, comprising an effective amount of a compound as claimed in any one of claims 1 to 8, alone or in combination with a cholesterol biosynthesis inhibitor, in a pharmaceutically acceptable carrier.

16. A pharmaceutical composition of any of claims 9, 12 or 15 wherein the cholesterol biosynthesis inhibitor is selected from the group consisting of HMG CoA reductase inhibitors, squalene synthesis inhibitors and squalene epoxidase inhibitors.

17. A pharmaceutical composition of claim 16 wherein the cholesterol biosynthesis inhibitor is selected from the group consisting of lovastatin, pravastatin, fluvastatin, simvastatin, Cl-981, DMP-565, L-659,699, squalestatin 1 and NB-55 598.

Two SPCs were successively granted by the French patent office (INPI) based on this European patent, namely:

  • First, SPC No. 03C0028, for a medicament comprising ezetimibe as an active, based on a marketing authorization (MA) for the drug Ezetrol®.
  • Second, SPC No. 05C0040, for a medicament comprising a combination of the active compounds ezetimibe and simvastatin, based on an MA for the drug Inegy®.

The European patent expired in 2014. The first (mono) SPC expired on April 17, 2018. The term of the second (combo) SPC is April 2, 2019.

In August 2017, the generic drug company Biogaran obtained an MA for a combination of ezetimibe and simvastatin and began preparing for the launch of this generic version of Inegy®.

In December 2017, Biogaran filed a nullity action against the combo SPC in front of the Paris Tribunal de grande instance (TGI). In February 2018, the U.S. MSD company and its French subsidiary initiated urgency proceedings and requested an injunction against Biogaran in view of an imminent infringement threat.

On April 5, 2018, an order was issued per which MSD’s request for injunction was denied. An appeal was filed, and the Paris Cour d’appel dismissed MSD’s appeal on June 26, 2018.

French legal proceedings are, as a general rule, not extremely quick. But sometimes they can be, as the present case shows. In fact, I did not even have time to become aware of and report on the first instance order, before the appeal ruling came out. Well, the fact that this blog has been somewhat slow in the past few months does not help, I will grant you that.

The reason why the President of the Paris TGI denied MSD’s request in the order of April 2018 is that the combo SPC was considered as invalid. This was confirmed on appeal.

Before delving into the details of the ruling, we need to go back, as always, to article 3 of the SPC regulation (officially known as Regulation (EC) No. 469/2009 of the European Parliament and of the Council):

A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:
(a) the product is protected by a basic patent in force;
(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;
(c) the product has not already been the subject of a certificate;
(d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product. 

Biogaran contended that the combo SPC was invalid for non-compliance with articles 3(a), 3(c) and 3(d). Their position was that:

  • regarding article 3(a), simvastatin is not claimed “as such” in the EP’599 patent, but merely as a substance known from the prior art, which can be used together with ezetimibe, which is claimed “as such“;
  • regarding article 3(c), an SPC had already been granted for the product at stake (namely the mono SPC), because the combination of the drug Ezetrol® with a statin such as simvastatin was already contemplated notably in the summary of product characteristics (SmPC) for this drug; and
  • regarding article 3(d), the MA for Inegy® was not the first MA for the product at stake, for the same reasons.

Interestingly, two further SPC applications similar to the granted combo SPC, namely for the combination of ezetimibe with atorvastatin, and of ezetimibe with rosuvastatin, were rejected by the INPI in February 2018.

In their ruling, the appeal judges made extensive reference to the Actavis judgment of the CJEU, C-443/12.

According to this ruling:

[…] where, on the basis of a patent protecting an innovative active ingredient and a marketing authorisation for a medicinal product containing that ingredient as the single active ingredient, the holder of that patent has already obtained a supplementary protection certificate for that active ingredient entitling him to oppose the use of that active ingredient, either alone or in combination with other active ingredients, Article 3(c) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as precluding that patent holder from obtaining – on the basis of that same patent but a subsequent marketing authorisation for a different medicinal product containing that active ingredient in conjunction with another active ingredient which is not protected as such by the patent – a second supplementary protection certificate relating to that combination of active ingredients.

The facts in Actavis were somewhat different from those of the present case. In Actavis, the patent at stake protected irbesartan and a first MA had been obtained for the mono drug. Then, a second MA was obtained for a combo drug comprising irbesartan and a diuretic, hydrochlorothyiazide (HCTZ). But HCTZ was not specifically named in the patent, whereas in the present case simvastatin is expressly designated in claim 17 of the patent.

That said, this different circumstance does not appear to be essential in view of the broad exclusionary language used in the order of Actavis. The Cour d’appel therefore directly applied Actavis as follows:

[…] MSD, based on the one hand on the EP’599 patent protecting the new active ezetimibe, and on the other hand of the MA […] for Ezetrol® containing ezitimibe as a single active compound, obtained […] SPC ‘028, making it possible to object to the use of said active, either alone or in combination with other actives.
MSD, based on the same patent but on a later MA […] for a different drug Inegy® containing the active ezetimibe in combination with another active, simvastatin, which is not, as such, protected by said patent, requested a second SPC on this combination of actives.
It should be added that the reasons of judgment C-443/12 specify that it is not allowable for the proprietor of a basic patent in force to obtain a new SPC […] every time it markets […] a drug containing, on the one hand, the active protected as such in its basic patent and constituting  […] the core inventive advance of this patent, and on the other hand, another active, which is not protected as such by said patent. 
It is not challenged in this case that simvastatin, which is an active of the category of statins or “HMG CoA reductase inhibitors” is not protected as such by this patent, nor in fact by another patent. 

As a result, the combo SPC was held invalid under article 3(c).

MSD’s defense was that there were two inventions in the basic patent. The first invention was a new class of compounds including ezetimibe. The second invention was the use of ezetimibe with statins.

The court replied that only ezetimibe is a novel active compound. The court also noted that, based on the description of the patent, the combination of compounds did not involve an inventive step (or should this be “inventive advance”? the French expression “activité inventive” can be used for both terms). Although MSD filed an expert declaration to support such inventive step, the court held that such declaration could not cure the lack of inventive step based on the patent itself.

The court also agreed with Biogaran’s auxiliary argument per which, assuming that the mono and combo drugs were considered as different products, the SPC would still be invalid, under article 3(d) this time, because the MA for Inegy® would not be the first MA for the product, because the SmPC for this drug mentioned the association with statin compounds, and in particular simvastatin.

On a procedural standpoint, the outcome of the judgment is thus that the rejection of MSD’s request for injunction is confirmed. The nullity action on the merits is still pending, although of course we now have a good indication of how this is likely to turn out.

Going back to the central question asked at the beginning of this post, “same or different?“, is a drug containing ezetimibe together with a statin compound “the same” as a drug containing ezetimibe as the single active, for the purpose of SPC law? 

The answer appears to be much more complex than the question.

As a Post Script to this report, Biogaran’s invalidity argument based on article 3(a) was not really discussed in the appeal judgment. However, it is notable that a new CJEU ruling has been issued in this connection, namely C-121/17. Since it has already been reported on many blogs (see e.g. here), I will not go over it in detail, but I just wanted to mention it, as Lionel Vial had previously reported on the opinion of the Advocate General in this case on this blog.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 1, June 26, 2018, Merck Sharp & Dohme Corp. & MSD France v. Biogaran, RG No. 18/52397.

The patentee’s tale

For some time, I wondered why the name “Gilead” in the trendy, horrifying, Margaret Atwood inspired TV show The Handmaid’s Tale sounded familiar to me. And then I realized that, yes of course, this is also the name of a famous pharmaceutical company, well known in the patent profession for being currently involved in a number of prominent litigation and opposition cases.

To some extent, patent disputes are like TV shows: they develop in episodes; sometimes unexpectedly, and sometimes not so much.

Lionel Vial reports on a recent decision (which was supplied courtesy of Matthieu Dhenne):

Following-up on our previous report on the refusal of Gilead’s request for preliminary injunction against Mylan in the Truvada® litigation in France based on SPC No. 05C0032, which was handed down on September 5, 2017, the judgement on the merits has now been rendered by the Paris Tribunal de Grande Instance on May 23, 2018.

A parallel decision was also handed down the same day (with the same outcome) with Biogaran as the generic drug manufacturer requesting the nullity of the SPC; it is commented upon here.

As a brief reminder, Truvada® (Gilead) is an anti-HIV drug comprised of the combination of Tenofovir Disoproxyl Fumarate (TDF) and Emtricitabine (FTC) approved for Pre-exposure Prophylaxy (PreP) of HIV infection, since it has been shown to allow for a reduction of 86% of the risk of being infected by HIV.

Truvada® was covered until 25 July 2017 by European patent EP0915894. The effects of the patent have been extended by supplementary protection certificates (SPCs) which will expire between 21 and 24 February 2020 depending on the countries. The SPCs are based on European Union marketing authorization EU/1/04/305/001 and on claim 27 of the basic patent, which reads as follows:

A pharmaceutical composition comprising a compound according to any one of claims 1-25 [N.B. tenofovir disoproxil is claimed in claim 25] together with a pharmaceutical carrier and optionally other therapeutic ingredients. (Emphasis added).

In summary, the essential question asked to the Tribunal is whether the use of the expression “other therapeutic ingredients” to refer to emtricitabine (FTC) is indeed sufficient to protect the TDF/FTC combination pursuant to Article 3(a) of Regulation (EC) No. 469/2009 of the European Parliament and of the Council (i.e. the SPC regulation).

So has the Tribunal confirmed its previous provisional opinion on the invalidity of the SPC or has it changed its mind? Let’s see:

[…] The patent on the basis of which SPC No. 32 under litigation was granted neither mentions, in the wording of its claims, emtricitabine, the active ingredient to which the SPC relates in combination with tenofovir disoproxil, nor does it make it necessarily and specifically identifiable, nor does it mention a functional formula implicitly but necessarily and specifically relating to emtricitabine, so that the product is not protected by the basic patent and that the condition laid down in Article 3 (a) of Regulation (EC) No 469/2009 is not fulfilled.

The future of TV shows envisioned in the 80s.

After the first round, the second round is also for Mylan then. Let’s wait for the third round (appeal), bearing in mind that by then the CJEU should have handed down its own decision on the subject (pending as C-121/17).

In this regard, it should be reminded that the Advocate General in his opinion delivered on April 25, 2018 has considered that the Court should answer the question referred for a preliminary ruling by the High Court of Justice of England and Wales as follows:

Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products precludes the grant of a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent. The fact that a substance or combination of substances falls within the scope of protection of the basic patent is a necessary, but not sufficient, requirement for it to constitute a product protected by a patent within the meaning of Article 3(a) of Regulation No 469/2009. A product is protected by a patent within the meaning of Article 3(a) of that regulation if, on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and precisely identifiable in the wording of the claims of the basic patent. In the case of a combination of active ingredients, each active ingredient in that combination must be specifically, precisely and individually identifiable in the wording of the claims of the basic patent. (Emphasis added).

Applied to SPC No. 05C0032, the Advocate General is thus of the opinion that “It would appear, subject once again to verification by the referring court, that, on 26 July 1996, the claimed priority date of the patent at issue in the main proceedings, it would not have been obvious to a person skilled in the art that the active ingredient emtricitabine was specifically and precisely identifiable in the wording of the claims of that patent” (emphasis added).

Of course the opinion of the Advocate is not binding on the CJEU, but at present it appears there isn’t much suspense left for the third round.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre, 2ème section, May 25, 2018, SAS Mylan v. Gilead Sciences Inc. et al., RG No. 16/14214.

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.