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.

Representatives don’t count

Being a representative myself, my feelings tend to get hurt when I am told that representatives do not matter. Except, that is, when this is in the best common interest of attorneys and their clients, as in the present case.

In December 2013, Spanish company Agromet Ejea SL filed a French utility certificate application through its local French representative.

This is already an unusual start, since utility certificates are a rare species. But wait until you hear about the rest of the facts, which are rather unusual as well.

The second renewal fee for the utility certificate was due on December 31, 2014, and was not paid in due time. It was not paid either by the end of the 6-month grace period. This led the Institut National de la Propriété Industrielle (INPI) to issue a decision of noting of lapse dated August 31, 2015. This decision was notified to the French representative on September 3, 2015.

When the INPI sends you flowers.

A request for restoration of right was filed on November 16, 2015. The INPI rejected this request as inadmissible as it was filed too late.

The French provision on restoration of right is article L. 612-16 of the Code de la propriété intellectuelle. It is very similar to article 122 and rule 136 EPC. In particular, it is specified in the French provision that the request for restoration must be filed within two months of the removal of the cause of non-compliance.

The INPI considered that the cause of non-compliance had been removed upon notification of the decision of noting of lapse to the French representative on September 3, 2015. Therefore, according to the position of the office, the request for restoration should have been filed by November 3, 2015 at the latest.

The owner of the utility certificate appealed the decision in front of the Paris Cour d’appel.

They did well, as the court set aside the decision of the INPI and offered a different computation of the time limit for filing the request for restoration:

Contrary to the position of the [INPI], the legitimate excuse and the removal of the cause of non-compliance […] are appraised with respect to the owner of the IP right and not their representative

In the present case, Agromet Ejea SL stated that they entrusted a Spanish patent law firm with the filing and handling of the utility certificate […], which appointed firm [X] for France. They proved the deficiencies of their representatives in their submissions and with their exhibits, which led to the non-payment of the renewal fee […]. In December 2014, the email reminders of the French representative to the Spanish representative did not reach their destination due to an error of electronic address. In 2015, the IP portfolio management software of the French representative broke, preventing a reminder of the time limit for late payment. The employee of the French firm in charge of the file made several mistakes, leading to the termination of her employment agreement on September 9, 2015, with an effective departure on October 20, 2015. Finally, the decision of noting of lapse of August 31, 2015, notified on September 3, 2015 to the French representative was only communicated to the Spanish representative on October 12 and 16, 2015. The latter only informed the right owner on October 19, 2015. 

Besides, Agromet Ejea SL established that they inquired about the status of their right. Their Spanish representative asked the [French] representative about this by email on July 6, 2015. In view of the above, it can be derived, on the one hand, that Agromet Ejea SL could rely on a legitimate excuse for not paying the renewal fees of its IP right within the prescribed time limits, due to its representatives’ faults; and on the other hand that the cause of non-compliance was only removed on October 19, 2015, when they were made aware of the decision of lapse, or at the earliest when it was published in the BOPI on September 25, 2015

Thus, on November 16, 2015, since the two-month time limit had not yet expired and the payment of the surcharge was made on the same day, the request for restoration of Agromet Ejea SL was admissible.

In summary, the court held that the request for restoration was admissible and well-founded.

It is well known that the notion of legitimate excuse is assessed in a much more lenient manner in France than at the EPO.

In fact, a mistake made by a representative is a legitimate excuse per se, as illustrated by the present case. There is no need to demonstrate that the omission was the result of an isolated mistake within a satisfactory system for monitoring time limits, as demanded by the EPO. Fortunately so for the applicant in the present case, in view of the large number of deficiencies noted by the court…

But today’s decision illustrates that this different perspective also extends to the computation of deadlines.

According to established case law of the Boards of appeal, “the removal of the cause of non-compliance is a matter of fact which has to be determined in the individual circumstances of each case“. More particularly, “the removal of the cause of non-compliance occurs […] on the date on which the person responsible for the application (the patent applicant or his professional representative) is made aware of the fact that a time limit has not been observed“.

Usually, the receipt of a noting of loss of rights or negative decision is considered by the EPO as making the person in charge aware of the non-observance. In most cases, the relevant person is the European representative; but in other cases, it can be the applicant, or even a foreign patent attorney (see here), depending on the specifics of the case.

In contrast, the position of the Cour d’appel seems to be that only the receipt by the applicant can be relevant. Interestingly, the Cour d’appel also offered another possible starting point for the time limit, namely the publication of lapse in the BOPI (Bulletin officiel de la propriété industrielle), which is the local equivalent of the European patent bulletin.

In this case, the time limit was found to have been complied with irrespective of the exact starting point. But if the request for restoration had been filed e.g. on December 1, 2015, it would then have made a world of a difference whether the starting point was October 19 or September 25. So, it is somewhat strange that the court did not more clearly state its position.

The one unfortunate thing about this case though is that one of the very few advantages of utility certificates as opposed to patents is their reduced cost. But in this instance, I would not bet that any money at all was ultimately saved, in view of all the efforts necessary to keep the certificate alive.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 1, April 25, 2017, Agromet Ejea SL v. Directeur général de l’INPI, RG No. 16/11489.

A true vade mecum to SPC law

A few days ago, a very interesting decision on the blockbuster drug Truvada® landed on my laptop courtesy of Matthieu Dhenne. According to the decision, Gilead’s request for preliminary injunction to halt the distribution of Mylan’s generic version of Truvada® on the French territory was denied on September 5, 2017.

Soon thereafter, a most interesting report on the decision reached my inbox courtesy of Lionel Vial.

Owing to both of them, my main remaining task was to find a title and a patent illustration for the post. So, if those are neither apt nor witty, that’s on me.

As you will see, this decision is a good opportunity to revisit the CJEU case law on combo SPCs, since there is a UK-based pending reference to the CJEU in connection with the Truvada® litigation.

I will now leave the floor to Lionel.

Today we report about France’s contribution to the ongoing pan-European litigation over generics of Truvada®.

Truvada® (Gilead) is an anti-HIV drug comprised of the combination of Tenofovir Disoproxyl Fumarate (TDF) and Emtricitabine (FTC). It has received a relatively important media exposure since it became, in 2012, the first drug to be approved by the Federal Drug Agency (FDA) for Pre-exposure Prophylaxy (PreP) of HIV infection. As such, the TDF/FTC combination can be used to reduce the risk of sexually acquired HIV-1 infection in adults who do not have HIV but are at high risk of becoming infected. By way of example, the so-called IPERGAY clinical study has evidenced that this combination allowed 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.

As will be readily spotted by our trained readers, the main question of law arising from this wording 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 (hereafter the « SPC regulation »).

Intense litigation over the validity of the SPCs has ensued, which has notably led Justice Arnold of the High Court of England and Wales to request a preliminary ruling of the CJEU on the question of knowing “What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the SPC Regulation?” (yes, again). The case is pending as C-121/17.

The current status of selected SPCs is summarized in the following table:

Country Decision of the patent Office Validity status
Belgium Granted Ruling on the merits pending
Germany Granted Ruling on the merits pending
Great-Britain Granted Ruling of the High Court stayed pending C-121/17
Ireland Granted Ruling on the merits pending
Italy Granted Ruling on the merits pending
The Netherlands Rejected Ruling of the Court of Appeal stayed pending C-121/17
Spain Rejected Rejection overturned by the Administrative Court of Madrid
Sweden Rejected Rejection upheld by the Court of Appeal

It is now France’s turn to take position on the validity of the SPC.

French SPC No. 05C0032 was granted on December 21, 2006 and will expire on February 24, 2020. Mylan obtained a generic marketing authorization for the TDF/FTC combination on December 16, 2016. On July 13, 2017, Gilead requested a preliminary injunction under urgency proceedings to prohibit the sale of Mylan’s generic. The case was heard on August 11, 2017. Meanwhile, Mylan offered its generic for sale on July 26, 2017, i.e. one day after the term of the basic patent. The ruling was rendered on September 5, 2017.

As could be expected, the judge performed a quite thorough appraisal of the case law of the CJEU regarding Article 3(a) of the SPC regulation as applied to this case, notably:

  • C-322/10 (Medeva): active ingredients have to be specified in the wording of the claims;
  • C-443/12 (Actavis v. Sanofi): the basic objective of the SPC regulation is to compensate for the delay to the marketing of what constitutes the core inventive advance [i.e. the technical contribution] that is the subject of the basic patent;
  • C-493/12 (Eli Lilly): where the active ingredient is covered by a functional formula in the claims, Article 3(a) does not preclude the grant of a supplementary protection certificate for that active ingredient, on condition that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question.

The French judge also noted that in cases C-443/12 and C-577/13 (Actavis v. Boehringer), the CJEU had considered that the core inventive advance forming the subject of the respective basic patents was limited to the compound the invention of which was sought to be protected, even though combinations with other compounds (which invention did not form the subject of the patent) were mentioned.

A patented robot to help you find your way through SPC case law.

In the case at hand, the French judge thus considered that the SPC was “in all likelihood invalid”, because none of the conditions defined the case law of the CJEU were apparently fulfilled.

Here is the relevant part of the decision (based on the English translation distributed by cabinet Schertenleib):

It appears that claim number 27 is drafted so broadly that it does not describe any specific active ingredient that should be combined with tenofovir disproxil [NB: this a reference to C-322/10]; it thus does not protect a combination that is likely to result in entitlement to the grant of a patent.

Moreover, the combination claimed as active ingredient “tenofovir disoproxyl + emtricibatine” is not implicitly but necessarily and specifically taught in the description [NB: this is a reference to C-493/12], there is no indication whatsoever that would enable the person skilled in the art to choose emtricibatine and it quite evidently does not constitute the core of the invention [NB: this is a reference to C-443/12].

If tenofovir disoproxil indeed constitutes the subject matter of the basic patent, the combination of tenofovir disoproxil with any other therapeutic ingredient cannot constitute a separate invention.

On the one hand, this combination as claimed in claim No. 27 is not a functional claim because it does not describe the structure that should be produced and the function that the second product should fulfill in order to build this structure. [NB: this is a reference to C-493/12]. On the other hand, assuming that this claim was functional, the steps defined by the Dutch Patent office in order to determine whether emtricibatine was sufficiently taught by the patent as being the necessary therapeutic ingredient of claim number 27 are relevant:

1 – Upon reading the phrase formulation in the context of the patent and in the light of their general knowledge, would the person skilled in the art think of the active therapeutic ingredient (biological)?

2 – Would the person skilled in the art think immediately of antiviral agents?

3 – Would the person skilled in the art immediately deduce that these antiviral agents designate anti-HIV agents?

4 – At the priority date, would the person skilled in the art have immediately thought of emtricitabine as anti-HIV agent?

Based on the description and as was perfectly highlighted by the Dutch Office of Industrial Property, no specific combination has been claimed, no relevant element has been reported so as to induce the person skilled in the art to select emtricitabine especially as there is no indication leading one to select a second antiviral agent as the “other therapeutic ingredient” let alone an antiviral anti–HIV agent.

As a consequence, Gilead’s request for preliminary injunction was refused. It now remains to be seen if this preliminary conclusion will be upheld when the case will be tried on the merits.

Finally, we would like to go back to Justice Arnold’s request for further guidance of the CJEU on the question “what are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the SPC Regulation?”. Apparently, Justice Arnold’s goal was to get a ruling establishing that, pursuant to Article 3(a), SPCs for combinations of active ingredients should be reserved for cases where the combination, as distinct from one of the active ingredients, embodies the inventive advance of the basic patent. But perhaps the Truvada® case was not the best one for such a reference to the CJEU.

Indeed, as emtricitabine is only purported to be specified by the expression “other therapeutic ingredients”, there is a chance the CJEU will not feel it necessary to go beyond its previous ruling according to which active ingredients have to be specified in the wording of the claims.

Well, to Lionel’s latter point, UK courts have always been quite prolific in asking SPC-related questions to the CJEU. As we know, this will probably soon come to an end. So maybe this was something of a last chance for them to try and get a final answer to a longtime puzzle?


CASE REFERENCE: Tribunal de grande instance de Paris, ordonnance de référé, September 5, 2017, Gilead Sciences Inc. et al. v. SAS Mylan, RG No. 17/57112.

No claim is etched in stone

The appeal ruling reported on today kept people waiting for a very long time, but the wait was worthwhile for case law observers, as it contains a number of interesting aspects.

The patent at stake is EP 0570484. It was filed on February 4, 1992 and claimed a priority back to February 4, 1991. The patent proprietor, Trikon Technologies Inc., had an infringement seizure conducted in September 2006 and then sued Alcatel Vacuum Technology France (AVTF) for infringement of the patent.

In case you are wondering what the usual pun in the title of this post is about, the patent relates to high density plasma machines for depositing or etching a substrate.

Over the course of the litigation, the original companies disappeared, the patent was sold, so, in order not to get lost, I will simply refer to the parties as the plaintiff and defendant, or similar designations.

In the first instance judgment dated March 3, 2009, the patent claims asserted by the proprietor were revoked by the Tribunal de grande instance for lack of novelty.

The plaintiff appealed, and this is when the case got dormant for a very long time. Presumably both sides dragged their feet. Well, when I say the case got dormant, this is not entirely accurate, as a lot actually happened.

First, the proprietor initiated central limitation proceedings at the EPO – and later abandoned it.

Then, a national request for limitation was filed at the French patent office (INPI), and was finally granted in September 2012, after a number of objections by the patent office and the defendant acting as a third party.

In May 2014, the defendant filed a motion for canceling the order for infringement seizure. Never too late! The appeal judgment does not mention what the objection was, but it was certainly a serious one, as the plaintiff gave up and withdrew its seizure exhibits from the record. Finally, the appeal went to trial in December 2016.

As I said, there are several interesting aspects in the ruling, but I will focus on the appraisal of the limited claims by the appeal judges.

First, an unconventional objection was raised by the defendant. According to article 564 of the Code de procédure civile, “new claims” may not be filed on appeal. By “new claims” is meant legal claims, not patent claims of course. The question is which claims filed on appeal are really new and which ones are not so new. In particular, according to article 566:

Parties may also make requests explicit if they were virtually comprised in the claims and defenses submitted to the first judge, and add thereto any claims which are an accessory thereto, a consequence thereof, or a complement thereto.  

In this case, claim 1 of the patent as limited comprised new features which had thus not been debated in first instance. The defendant then argued that the infringement case based on claim 1 as limited was a “new claim” according to article 564 and thus inadmissible. A very interesting argument indeed, but a long shot, as the court noted that the patent proprietor was entitled to limit its claims “at any time“, and that the limitation was retroactive, pursuant to article L. 613-24 of the Code de la propriété intellectuelle.

Therefore, this inadmissibility defense was rejected. It is true that if it had been successful, the benefits of limitation during litigation would have been considerably affected.

The second way the defendant challenged the limitation was by asserting that the subject-matter of the limited claims extended beyond the contents of the application as filed.

Here is claim 1 as limited, wherein the highlighted portion represents the main changes relative to claim 1 in the application as filed:

A system for generating a high density plasma comprising:

a plasma confinement chamber of cylindrical form;

means for injecting a gas to be ionized into the chamber;

means disposed adjacent the chamber for generating a longitudinal magnetic field in the chamber; and

means for generating high frequency energy at a frequency of 13.56 MHz and at power in the range of 100 W to 5 kW, comprising an impedance adaptation circuit;

the system being characterized in that an antenna forming means comprises:

a single loop element encompassing the cylindrical chamber, the loop element being disposed in a plane at an angle of in excess of 45° to the central axis of the chamber, and positioned in an intermediate region along the length of the chamber, said single loop element being coupled to the means for generating high frequency energy. 

State of the art etching… in 1899. For a bit of nostalgia: the patent was granted 4 months after filing.

The court started by restating the standard to be applied, which was accurately imported from the EPO doctrine:

The content of the application as filed must be interpreted as encompassing the description, the claims and drawings, as well as any teaching, even implicit, directly and unambiguously deriving therefrom, as understood by the skilled person.

This was followed by a long and complex discussion of the teaching of the application, which I will not attempt to fully reproduce here.

In a nutshell, the value of a frequency of 13.56 MHz was mentioned in claim 4 of the application, but (1) this value was not disclosed in association with a power range of 100 W to 5 kW, and (2) claim 4 depended on claims 2 and 3 which recited further features not included in claim 1 as limited.

So one issue was whether the value of 13.56 MHz was generally applicable to the power range of 100 W to 5 kW. And another issue was whether this value could be isolated from the other features disclosed in original claims 2 and 3.

Regarding the first issue, the court considered that the application generally taught a power range of 100 W to 5 kW and a frequency range of 2 to 50 MHz. One sentence in the description read: “to effect wave coupling and establish a high plasma current density, measured in mA/cm2, the antenna loop 12 is driven at 13.56 MHz and with RF energy of the order of 2.0 kW (in the range of 100 W to 5 KW) by the RF energy source 19“. This was interpreted as meaning that the whole power range could be achieved with the preferred frequency of 13.56 MHz, and that the value of 2.0 kW was only an example. The interpretation was confirmed by looking at the examples and figures.

The defendant argued that generating helicon waves required matching a certain frequency with a certain power, but the court did not agree that the invention was only about generating such helicon waves.

Regarding the second issue, original claim 2 mentioned a magnetic field of les than 1000 gauss, a plasma density of more than 1013/cm3 and a loop element at an angle of about 90° relative to the magnetic field; and original claim 3 mentioned a first plasma current and density peak in the grange of about 50 gauss and a second plasma and density peak in the range of about 400 gauss.

The court analyzed the application in detail again and came to the conclusion that these various features were not mandatory or essential, and not inextricably linked with the frequency value of 13.56 MHz.

Thus, there was no extension of subject-matter beyond the content of the application as filed. 

Why on earth original claim 4 was then exclusively dependent on claim 3, which itself depended on claim 2, and why this claim did not directly depend on the broadest claim 1, is unclear to me. Generally, this is a hint that the various technical features at stake are probably interconnected. Not in this case, apparently – but as I said, the technical discussion was quite complex.

Anyway, the patent as limited survived the added matter challenge. It also successfully passed novelty and inventive step challenges.

On the other hand, the court found that there was no evidence of infringement, and this is another interesting aspect of this case. As explained above, the evidence seized in 2006 was no longer part of the record, further to the late challenge brought by the defendant against the seizure order.

The plaintiff relied on technical manuals and technical specifications of the defendant’s various machines. The court did not even examine whether the technical information contained in these documents reproduced the subject-matter of the patent claims.

In fact, it was sufficient for the court to note that there was no clear evidence of any potentially infringing act (such as manufacturing, marketing or the like). The new assignee of the patent filed an affidavit by its vice president and CFO, but this affidavit did not convince the court:

The affidavit […] contains tables originating from Alcatel’s documentation and states that “Alcatel made and sold 129 litigious machines during the litigious time period”. This does not make it possible to identify the machines at stake. And, due to the quality of its author, it cannot represent objective evidence of the manufacturing or marketing of machines reproducing the features of the EP’484 patent. The court notes that, in view of the documents relied on by SPTS as to the number of machines allegedly manufactured and marketed, they did not undertake any effort making it possible to physically identify any one of the allegedly infringing machines. 

Technical documents do not demonstrate the actual manufacturing of the machines that they describe. And even if they were indeed manufactured, it is no possible to determine the date of manufacturing nor the manufacturer. 

Remarkably, the court also rejected a request for the appointment of an expert to assess the extent of infringement and the corresponding damages. 

The take-away message here is that infringement seizures are a powerful tool for IP right holders in this country. But if for some reason the infringement seizure falls apart, it becomes much more difficult for them to prove their case, and courts are generally unwilling to help them complete it.


CASE REFERENCE: Cour d’appel de Paris, Pôle 5 – chambre 2, March 10, 2017, TTI Liquidating Inc. et al. v. Pfeiffer Vacuum et al., RG No. 15/01226.