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.
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.
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.
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.
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 , 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.
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.
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:
Decision of the patent Office
Ruling on the merits pending
Ruling on the merits pending
Ruling of the High Court stayed pending C-121/17
Ruling on the merits pending
Ruling on the merits pending
Ruling of the Court of Appeal stayed pending C-121/17
Rejection overturned by the Administrative Court of Madrid
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.
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?
Easter always brings back chocolaty memories. The question as a child growing up in the Northeastern part of France on Easter morning was whether eggs had been brought by the Easter bunny. And the question as a child also growing up in the Southeastern part of France was whether eggs had been brought by the Easter bells.
It has been a while since the Easter bunny and the Easter bells stopped feeding me with chocolate. But this year there was an even better surprise on Sunday morning, in the form of an SPC-related guest post by Lionel Vial. And as all readers will probably acknowledge, SPCs are a delicacy of their own.
Here is to Lionel.
The case discussed on this Easter day relates to a ruling of the Paris Cour d’appel dated January 20, 2017 which upheld a decision of the French patent and trademark office (INPI) to reject an application for a supplementary protection certificate (SPC) for a biological medicinal product.
French SPC application No. 11C0054 was filed on December 14, 2011 by Laboratoire Français du Fractionnement et des Biotechnologies (hereafter LFB), a French company specializing in medicinal products purified from human blood. The SPC application was based on French patent No. 2722992 filed on July 28, 1994, which claimed a method for the manufacture of a C1-esterase inhibitor concentrate (claim 1), as well as the concentrate obtained by the method (claim 11).
The SPC application was further based on marketing authorization (MA) No. EU/1/11/688/001 for Cinryze® comprising “C1 inhibitor, human (INN)” as active ingredient.
For those whose curiosity goes beyond patent law, C1 is one of the proteins forming the complement system, which itself is part of the innate (i.e. non-adaptive) immune system. The C1 inhibitor is a natural protein, found in blood, the role of which is to regulate the activation of the complement system. The C1 inhibitor is especially useful for individuals suffering from a rare autosomal dominant disease, caused by a deficiency of functional endogenous C1 inhibitor, which manifests itself in the form of angioedema attacks.
The SPC application was rejected on December 22, 2014 by the INPI for not complying with Article 3(d) of Regulation (EC) No. 469/2009 (hereafter the SPC regulation), i.e. the MA for Cinrize® was considered not to be the first authorization to place the product on the market as a medicinal product.
This was because a prior MA had been issued on June 28, 1999 for Esterasine comprising “human C1 esterase inhibitor” as active ingredient.
LFB lodged an appeal against the decision of the INPI before the Paris Cour d’appel and essentially argued that the human C1 inhibitors of Cinrize® and Esterasine were in fact two different products.
The precise arguments used by LFB are not very clearly summarized in the decision.
But it appears that LFB stressed that the way biological medicinal products, such as Cinrize®, are manufactured has an impact on their molecular structure, which, in the present case, was evidenced by a half-life of 56 hours for Cinrize® vs. 30 hours for Esterasine.
This did not convince the Cour d’appel which considered that:
The regulation relating to SPCs does not provide for exceptions to the definitions of a “product” and a first MA for biological medicinal products or blood products which would allow defining them as a function of their methods of manufacture or under their commercial names; it is therefore irrelevant that the SPC application is based on an MA for the “Cinryze” drug since the product protected by the basic patent is “the C1 inhibitor, human”; [besides] if LFB, after having initially claimed the latter, has amended the application by claiming “the C1 esterase inhibitor of the Cinryze drug”, this limitation made after the objections of the INPI cannot be effective since either the patent or the MA only relate to the “C1 inhibitor” as active ingredient of the Cinryze drug.
To put it more clearly, the Cour d’appel took a very formal approach of Article 3(d) of the SPC regulationand simply considered that, if the names of the active ingredients mentioned in two different MAs are the same, then both MAs in fact relate to the same product, without further consideration as to the true physicochemical identity between the two products, as in the case of biological medicinal products obtained by different methods of manufacture.
LFB also argued that, in the assessment report of the European Medicines Agency (EMA) which led to the MA, the purified and concentrated C1 INH (i.e. C1 inhibitor) after pasteurization and nanofiltration is considered as the active substance.
The Cour d’appel responded that
the subject matter of this report was a marketing authorization application for Cinryse, so that, if [the report] specifies what its active ingredient is, it does not conclude that it would be a new product, the novelty of the medicinal product being different from that of its active ingredient; accordingly this does not contradict the decision of the INPI.
Moreover, the Cour d’appel noted that this latter argument was not submitted to the INPI which, therefore, could not do otherwise than decide that the MA for the drug Cinryze was not the first one for the active ingredient which is the “C1 inhibitor, human”.
It is to be noted that the latter argument was however decisive in overcoming the objection of the Dutch patent office based on Article 3(d) of the SPC regulation for the corresponding SPC application in that country (NL SPC application No. 300510), thereby securing the grant of an SPC.
It is therefore tempting to imagine that the fate of the French SPC application could have been changed for the best had the attention of the INPI examiner been drawn to the definition of the active substance in the assessment report of the EMA.
As a final note, this case reminds us of the ruling of the Paris Cour d’appel of April 12, 2016 which upheld the decision of the INPI to reject SPC application No. 08C0003 covering Cervarix®(GlaxoSmithKline Biologicals) which was discussed here.
In that case also the Cour d’appel refused to take into account the impact of the manufacturing process of biological products (production in yeast cells vs. insect cells) on their structure, sticking to the definition of the product given in the MA.
One can wonder if this literal approach, which has the advantage of simplifying examination of SPC applications, is in keeping with the fundamental objective of the SPC regulation which is to make up for the insufficiency of the period of effective protection of a medicinal product under a patent to cover the investment put into pharmaceutical research as recalled by the CJEU in C‑130/11 (Neurim).
Indeed, in the present case, it appears from the assessment report of the EMA that new clinical data was produced for the C1 inhibitor of Cynrize® in support of the MA application. This is probably because the C1 inhibitor of Cynrize® is a biological product the structure of which depends on the manufacturing process, thereby making it impossible to rely on clinical data obtained with previous C1 inhibitors.
It is generally considered that clinical trials amount for the larger part of investment in drug development. It could therefore be considered that the active ingredient of Cynrize® is a new product the development of which necessitated investment entitling it to SPC protection.
As such, when assessing conformity with Article 3(d) of the SPC regulation, perhaps the necessity to generate specific clinical data in order to obtain an MA for a biological product should be the primary criterion for determining if an MA is the first one to place the biological product on the market, rather than simply determining if the name of the active ingredient is the same one as that of a prior MA.
Thank you Lionel. Easter being about resurrection even more than about chocolate eggs, it remains to be seen whether this SPC application may come back to life on cassation appeal.