Judge, Court of Cassation (Commercial, Financial and Economic Division)
Between 30 May 2012 and 30 May 2014, the Commercial Division of the French Court of Cassation delivered some 60 judgments in cases concerning French, European or international patents.
The purpose of this paper is not to analyse these judgments in detail but rather to take a closer look at those cases that raised new questions in the following areas:
- requests for limitation of patent claims or for reinstatement of patent rights
- the limitation period for actions to establish rights to a French patent and the European patent replacing it
- supplementary protection certificates (SPCs): conditions for their grant and requests for provisional measures to avert their imminent infringement.
I. Requests for limitation of patent claims or for reinstatement of patent rights: appeals against decisions taken by the Director General of the French National Institute of Industrial Property (INPI)
A. Requests for limitation of patent claims
The law of 4 August 2008 supplemented by the decree of 30 December 2008 introduced into French law a procedure for voluntary limitation of a French patent under the authority of INPI.
Under Article L. 613-24 of the French Intellectual Property Code (CPI):
"Patent proprietors may at any time relinquish either the entire patent or one or more claims under the patent, or limit the patent's scope by amending one or more of its claims.
Relinquishment or limitation requests shall be submitted to the National Institute of Industrial Property under conditions laid down by regulation.
The Director of the National Institute of Industrial Property shall examine the request for conformity with those conditions.
Relinquishment or limitation shall have retrospective effect from the filing date of the patent application.
The second and third paragraphs shall apply to limitations under Articles L. 613-25 and L. 614-12 CPI."
Two recent appeals, one concerning a French patent and the other concerning the French part of a European patent, saw questions on the application of this article raised before the Court of Cassation for the first time.
1. French patent
The question raised by the first appeal concerned the relationship between Article L. 613-24 CPI and Article L. 613-25 CPI, both of which confer jurisdiction to rule on patent validity.
Under Article L. 613-24 CPI, requests for limitation are filed with INPI, whereas appeals against decisions taken by the INPI Director General to grant, refuse or maintain industrial property rights fall within the jurisdiction of the Paris Court of Appeal. Such appeals exclusively challenge only the legality of said decisions, so the Court of Appeal may only set them aside or dismiss the appeals, and may under no circumstances amend the decisions of the INPI Director General.
Article L. 613-25 CPI, which is referred to in the last paragraph of Article L. 613-24, stipulates in its first paragraph:
"A patent shall be revoked by court decision:
(a) if its subject-matter is not patentable under Articles L. 611-10, L.611-11 and L. 611-13 to L. 611-19;
(b) if it does not disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art;
(c) if its subject-matter extends beyond the content of the application as filed or, if it was granted on a divisional application, beyond the content of the initial application as filed;
(d) if, after limitation, the scope of protection has been extended."
Falling within the jurisdiction of the Paris Regional Court (tribunal de grande instance), revocation of a patent may be sought by way of a standard action, a counterclaim or a preliminary objection to an action.
Are the two procedures provided for in these two articles mutually exclusive or complementary? Does a third party who is being sued for patent infringement and is challenging the patent's validity before the Regional Court have standing to lodge an appeal with the Court of Appeal against a decision taken by the INPI Director General granting the patent proprietor's request for limitation?
In the case in question, company T, which was being sued for patent infringement before the Paris Regional Court, sought the patent's revocation by way of a counterclaim. During those proceedings, company R (the patent proprietor) filed a request for limitation of the patent, which was granted by INPI.
Company T's appeal to the Paris Court of Appeal against the decision taken by the INPI Director General was declared inadmissible.
An analyst commenting on the Court of Appeal judgment noted with interest that it ruled on the "division of competence between the Regional Court adjudicating on a patent's revocation and the Court of Appeal adjudicating on the legality of the administrative decision allowing a request for limitation, even if the legal basis is debatable."
The Court of Cassation dismissed the ensuing appeal in a judgment of 30 May 2012. It upheld the Court of Appeal's finding that "under Article L. 613-25(d) CPI it is a matter for the court adjudicating on the patent's revocation to determine when the purported limitation of a claim would result, not in a reduction of the patent's scope, but in an extension thereof. Failure to observe this article is an absolute bar to admissibility"; and that "the ground presented by company T in support of its appeal requesting that the decision of the INPI Director General be set aside amounts in reality to an argument for revoking the patent relied on in the infringement proceedings against it".
2. European patent
The second appeal sought a definition of what should be understood as limitation of a claim through the application of Article L. 613-24 CPI. Does the addition of another composition constitute an extension or a limitation of the claim? Must the added feature have been claimed?
In the case in question, company S, the proprietor of EP 90 300 779 entitled "Fungicides", applied for on 25 January 1990 and granted on 23 March 1994, lodged a request with INPI on 28 September 2009 for limitation of the French part of the patent. It requested that claim 8 be defined as a fungicidal composition comprising, in addition to a fungicidally effective amount of a compound according to claim 1 (propenoic acid compound) and a fungicidally acceptable carrier or diluent therefor, another compound having a biological activity selected from a list of defined compounds.
The INPI Director General refused the request and the Paris Court of Appeal dismissed company S's appeal against that refusal.
When examining the appeal against the Court of Appeal's judgment, the judge-rapporteur referred to the provisions of Article 123 EPC and cited decisions of the EPO boards of appeal in cases T 2017/07, T 999/10 and T 783/09.
In decision T 783/09, the board of appeal held that the subject-matter of the amended claim, which consisted of a selection from two lists of compounds, fulfilled the requirements of Article123(2) EPC, particularly since "all combinations resulting from the combination of the elements of the two lists according to the passage on page 21 are directly and unambiguously disclosed in that passage. ... Thus, each of the combinations according to claim 1 is disclosed in an individualised manner in the application as filed and therefore there is no breach of Article 123(2) EPC in this respect."
In the appeal case before the Court of Cassation the combination claimed in amended claim 8 was described on pages 39 to 41 of the patent's translation; the description of the patent indicated expressly that the composition could contain other compounds having a similar or complementary fungicidal activity, and provided examples of compounds included in the list in amended claim 8.
This claim, both in its original wording and in the version refused by INPI, related to a fungicidal composition comprising a compound according to claim 1 and a carrier or diluent. Company S wanted to add another element to this composition in the new claim.
Adding a feature to the combination therefore narrowed the scope of claim 8 without modifying its subject-matter, which remained a fungicidal composition. Furthermore, claim 8 was "open" in so far as it used the term "comprising" instead of "consisting of". Finally, adding the said feature did not cause a third party not infringing the original claim to infringe the new claim because, for there to be infringement in future, a compound according to claim 1 (azoxystrobine) had to be reproduced not only with a carrier or diluent, but cumulatively with an active ingredient according to claim 1, a carrier or diluent and a biologically active compound.
In its ruling of 19 March 2013, the Court of Cassation therefore set aside the Court of Appeal's judgment as follows: "As can be seen from the Court of Appeal's reasoning and the earlier reasoning it endorsed, it based its dismissal of the appeal against the decision taken by the INPI Director General to refuse this request on the conclusion that the proposed amendment of claim 8 adds another compound to the composition comprising a compound according to claim 1 and a carrier or diluent referred to in the original text, even though neither the claim for which the amendment is requested, nor any other claim, mentions a compound comprising a second active ingredient.
Since the Court of Appeal reached this conclusion without examining whether the subject-matter of the amended claim was disclosed directly and unambiguously in the description of the patent as granted, its decision lacks any legal basis".
B. Requests for reinstatement of patent rights
In a judgment delivered on 14 May 2013, the Court of Cassation examined an appeal concerning the possible implications of the entry into force of the London Agreement on 1 May 2008 for the admissibility of a request for reinstatement of a European patent for which the translation had not been supplied by the time limit under Article L. 614-7 CPI, as worded prior to
the entry into force of the law of 29 October 2007.
Article L. 614-7 CPI, as then worded, obliged the proprietor of a European patent not drafted in French to supply INPI with a translation of it.
Under Article R. 614-8 CPI, as then worded, that translation had to be submitted to INPI within three months of the publication of the mention of the grant of the patent in the European Patent Bulletin. Otherwise the patent would be invalid in France.
Article R. 614-9 CPI provided that failure to supply the translation of the European patent would be published in the Official Industrial Property Bulletin.
Under the London Agreement, the contracting states to the European Patent Convention have largely dispensed with the requirements regarding translation.
France having dispensed with said requirements, Article L. 614-7 CPI was amended by the law of 29 October 2007 and its new provisions were declared applicable from entry into force of the London Agreement on 1 May 2008. Moreover, Article R. 614-8 CPI was repealed with effect from 1 May 2008 by a decree dated 27 June 2008.
Further, Article L. 612-16 CPI provides that:
"Where an applicant has not complied with a time limit set by INPI, he may request reinstatement of his rights if he is able to cite a legitimate reason for such non-compliance and if the direct consequence of non-compliance has been refusal of his patent application or of a request, forfeiture of the patent application or patent or the loss of any other right or means of redress.
The request must be submitted to the INPI Director General within two months of removal of the cause of non-compliance. The omitted act must be completed within that period. The request shall only be admissible within a period of one year from expiry of the time limit not complied with."
In the case before the Court of Cassation, company H was the proprietor of European patent No. EP 1 460 304. The application, which designated France, had been filed on 12 March 2004, and its grant had been published in the European Patent Bulletin on 9 January 2008. Company H then failed to supply a French translation of the European patent within three months of said publication. The INPI Director General therefore published this failure in the Official Industrial Property Bulletin of 31 October 2008.
A request filed by company H on 2 February 2009 for reinstatement of its rights was declared inadmissible by decision of the INPI Director General dated 18 January 2011 on the ground that it was out of time because it had been filed more than two months after removal of the cause of non-compliance, the relevant period having started on 31 October 2008.
The Court of Appeal dismissed company H's appeal against that decision.
Reviewing this judgment, the Court of Cassation dismissed the appeal and upheld the Court of Appeal's finding that as the question whether a French translation must be provided for a European patent definitively granted more than three months before 1 May 2008 – the date on which the London Agreement entered into force – forms part of the examination of the merits of the request for reinstatement, that question can only be examined if the request is admissible.
II. Limitation period for actions to establish rights to a French patent and a corresponding European patent
In a judgment delivered on 7 January 2014, the Court of Cassation gave a ruling for the first time on the application of the time limit under Article L. 611-8 CPI where an action to establish rights relates to both a French patent and a corresponding European patent.
In the case in question, Mr M had filed a French patent application entitled "Motorized overhead door with lateral (gas) springs" on 24 April 1998, naming himself as inventor. The patent was granted on 2 June 2000 with the publication number 2 777 935. Mr M also filed a European patent application in his own name on 23 April 1999 under the number EP 0 952 293, the mention of grant of which was published on 3 July 2002. On 17 November 2004, Mr R with whom Mr M had had a professional relationship of several years' standing, brought an action against Mr M, seeking to establish his rights to the French and European patents on the basis that Mr M could not claim to be the sole inventor and had exceeded his rights under an agreement they had concluded on 21 April 1998.
The Regional Court found that Mr M and Mr R were co-inventors of the motorized overhead door with lateral (gas) springs, which was the subject-matter of the French and European patents, and that the action to establish rights was admissible and well founded.
The Court of Appeal overturned that judgment and declared the action inadmissible as time-barred.
It should be noted here that, based on Articles 2, 74 and 139(3) EPC and availing itself of the freedom afforded by the last article, the French legislator has adopted a rule prohibiting double entitlement to the same invention under a national right and a European right.
Under Article L. 614-13 CPI, "where a French patent relates to an invention for which a European patent has been granted to the same inventor or to his successor in title with the same date of filing or the same priority, the French patent shall cease to have effect at either the date on which the period during which opposition may be filed against the European patent expires without opposition having been filed or the date on which the opposition proceedings are closed and the European patent maintained […]".
However, double entitlement to the French patent and the European patent persists as long as the European patent has not been irrevocably granted.
In the case in question, in the absence of any opposition, the European patent became irrevocable on 3 April 2003, and since it was not argued that any of the French patent's claims were not included in the European patent, the European patent replaced the French patent in its entirety.
Under Article L. 611-8 CPI, which applies equally to French patents and the French part of European patents: "Entitlement proceedings shall be barred after three years from publication of the grant of the industrial property title".
By the time Mr R brought the action to establish his rights, the period for opposing the grant of the European patent had already expired on 3 April 2003 (3 July 2002 + nine months). The European patent having replaced the French patent on that date in accordance with Article L. 614-13 CPI, entitlement proceedings could no longer be instituted in relation to the French patent (although this argument was not relied on by Mr M). With respect to the French part of the European patent, however, the period for instituting entitlement proceedings had only begun on publication of grant of the European patent, i.e. on 3 July 2002, so that they were not yet time-barred when they were brought on 17 November 2004.
The Court of Cassation therefore overturned the Court of Appeal's judgment as follows: "The Court of Appeal declared the entitlement proceedings in respect of EP No. 0 952 293 time-barred on the basis that the period for bringing such proceedings had begun the day the French patent was granted.
In so ruling, even though the European patent, in so far as it designated France, had completely replaced the French patent as from 3 April 2003 (i.e. before the proceedings were instituted), so that the three-year period for bringing an action to establish rights to the European patent did not start until 3 July 2002, the Court of Appeal thus breached the CPI provisions cited above."
III. Supplementary protection certificates (SPCs)
A. The conditions for granting an SPC
An appeal raised the issue of the interpretation of Article 3(a) of Regulation (EC) No. 469/2009.
On 23 July 2002, Boehringer Ingelheim Pharma submitted to INPI SPC application No. 02C0028 on the basis of Regulation (EC) No. 1768/92 (codified by Regulation (EC) No. 469/2009). The application referred to a marketing authorisation (MA) granted in the European Union on 19 April 2002 under No. EU/1/02/213/001 for a pharmaceutical speciality with the active ingredients telmisartan and hydrochlorothiazide, and indicated that the basic patent was EP No. 502 314 entitled "Benzimidazoles, drugs containing these compounds and process for their preparation", which had been granted on 20 May 1998 on the basis of application No. 92 101 579 filed on 31 January 1992.
The INPI Director General refused the SPC application on 9 December 2010 on the ground that the basic patent did not protect the combination of telmisartan and hydrochlorothiazide, and that telmisartan had already been the subject of an MA (No. EU/1/98/089/001 of 11 December 1998) and an SPC.
Boehringer filed an appeal against that decision on 25 February 2011.
In the meantime, on 14 December 2011, Boehringer filed a request for limitation of the French part of the basic European patent. This request, completed on 19 December 2011, was refused by the INPI Director General on 26 April 2012.
In a judgment of 8 June 2012, the Court of Appeal dismissed the appeal against the refusal to grant an SPC.
As shown by the documents submitted to the Court of Cassation on appeal against that dismissal, an appeal filed on 25 July 2012 against the decision dated 26 April 2012 to refuse the request for limitation was still pending.
Also, Boehringer had filed a second request for limitation of the claims on 17 September 2012, and the relevant proceedings were still pending before the INPI Director General.
Should the Court of Appeal, when asked to cancel the INPI Director General's decision to refuse an SPC application, have stayed the proceedings in view of the parallel request for limitation of the basic patent's claims?
In a judgment of 26 November 2013, the Court of Cassation upheld the Paris Court of Appeal's decision not to stay the proceedings and to dismiss the appeal.
The Court of Cassation recalled that when a stay in proceedings is not provided for in the law, the decision to grant it is at the discretion of the trial judges, and that because the Court of Appeal has to rule in the light of the circumstances prevailing when the decision was taken, the ground for appeal that the judgment would be deprived of its legal basis, and so have to be annulled, if the limitation were granted, was irrelevant. It also dismissed the ground for appeal relating to the merits of the decision and refused to refer questions to the CJEU for a preliminary ruling.
"On the first ground for appeal:
Boehringer contests the judgment (...);
Given, however, that a stay in proceedings pending a final decision on a request for limitation of a patent's claims is not provided for in the law, the decision to grant same is at the discretion of the trial judges. This ground cannot be accepted.
On the second ground for appeal:
In support of its challenge to the dismissal of its appeal against the decision taken by the INPI Director General on 9 December 2010, Boehringer submits that:
(1) Although the CJEU stated in its Medeva judgment dated 24 November 2011 (C-322/10) that the active ingredients for which a supplementary protection certificate is requested must be 'specified in the wording of the claims of the basic patent relied on in support of the SPC application', that does not necessarily mean that the names of those active ingredients must be mentioned explicitly in the wording of the claims. In the case of a combination of two active ingredients, it is sufficient for the wording of the claims to cover the relevant combination. This is achieved if a claim covers the use of an active ingredient for the preparation of a medicinal product having a certain effect, and if the description envisages the possibility of preparing such a medicinal product by combining the active ingredient with the second active ingredient in question and gives the person skilled in the art all means needed for the preparation of the medicinal product. In deciding otherwise, the Court of Appeal breached Article 3(a) of Regulation No. 1768/92, in conjunction with Article 69 EPC.
(2) Alternatively, a preliminary CJEU ruling must be sought on whether 'the product is protected by a basic patent in force' within the meaning of Article 3(a) of Regulation No. 1768/92 when, without mentioning explicitly the combined active ingredients for which the supplementary protection certificate is requested, the wording of the claims in the basic patent, as interpreted in the light of the description, still covers their combination.
However, the CJEU held (in C-322/10 Medeva, 24 November 2011) that 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 must be interpreted as precluding the competent industrial property office of a member state from granting an SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the SPC application. According to the Court of Appeal's judgment, the basic patent relates to benzimidazoles, but only telmisartan, given its structure, belongs to that family. The Court of Appeal also notes that while claim 9 of the basic patent, the only claim relied on in support of the appeal, mentions the use of a compound for the preparation of a medicinal product, it is not directed to a combination with an active ingredient such as hydrochlorothiazide. Based on these findings and assessments, which indicate that the wording of claim 9 of the patent as granted covers only a single active ingredient belonging to the benzimidazoles family and does not explicitly reference a combination with another active ingredient, the Court of Appeal rightly came to the conclusion that, on the basis of patent No. 502 314, an SPC could only be granted for a composition combining telmisartan and hydrochlorothiazide. The second ground for appeal is therefore unfounded;
On the third ground for appeal:
In support of its challenge to the Court of Appeal's finding that there were no grounds for ordering a stay of proceedings and for dismissing its appeal against the decision taken by the INPI Director General on 9 December 2010, Boehringer submits that:
(1) Since limitation of the scope of a patent has retroactive effect from the application's filing date, the limitation of the claims of the basic patent deprives the INPI Director General's decision to refuse to grant an SPC on the basis of the text of the original patent of any legal basis. In the present case, Boehringer sought, by letter of 14 December 2011 to the INPI Director General, to limit the scope of the French part of EP No. 502 314, which served as the basis for its SPC application No. 02C0028. An appeal against the decision taken by the INPI Director General on 26 April 2012 to refuse that request for limitation is currently pending before the Paris Court of Appeal. If the limitation sought is granted, that will deprive the contested judgment dismissing the appeal against the decision taken by the INPI Director General on 9 December 2010 to refuse its SPC application No. 02C0028 based on European patent No. 502 314 of its legal basis, so that the judgment will have to be annulled.
(2) By letter of 17 September 2012, Boehringer submitted a second request to limit the scope of the French part of European patent No. 502 314. If the limitation sought is granted, that will deprive the contested judgment dismissing the appeal against the decision taken by the INPI Director General on 9 December 2010 to refuse its SPC application No. 02C0028 based on European patent No. 502 314 of its legal basis, so that the judgment will have to be annulled.
Given that the requests for limitation of the claims of patent No. 502 314 were submitted to the INPI Director General on 14 December 2011 and 17 September 2012, and that the Court of Appeal hearing the action for annulment of the decision taken by the INPI Director General on 9 December 2010 to refuse the SPC application has to rule in the light of the circumstances prevailing when the decision was taken, the third ground for appeal is irrelevant."
B. Requests for provisional measures
Like other European courts, the Court of Cassation has had to deal with appeals concerning requests for provisional measures prohibiting the marketing of generic medicinal products close to the expiry date of an SPC.
In one of those appeals, it was submitted that the assessment of the credible nature of the alleged attack infringed Articles 4 and 5 of Regulation (EC) No. 469/2009 of 6 May 2009.
Having learnt that the Actavis Group and Actavis France intended to market two generic medicinal products comprising valsartan and hydrochlorothiazide (HCTZ) as the other active ingredient, Novartis, the proprietor of European patent EP No. 0 443 983, valid up to 12 February 2011 and relating to the active ingredient valsartan, and of SPC No. 97 C0050 expiring on 13 November 2011, and Novartis pharma, its exclusive licensee for the French part, brought an action against Actavis Group and Actavis France, seeking various injunctions on pharmaceutical compositions reproducing the features of the Novartis patent and SPC.
By order of 28 January 2011, the court issued a provisional injunction, subject to a fine for non-compliance, against the Actavis Group and Actavis France. In a judgment of 16 September 2011, the Court of Appeal set aside that order and refused the Novartis requests.
In a judgment of 15 January 2013, the Court of Cassation, referring to the preliminary ruling issued by the CJEU on 9 February 2012 in Novartis v Actavis (C-442/11) on a question from the High Court of Justice of England and Wales, quashed the Court of Appeal's judgment and, noting that the SPC had expired on 13 November 2011, refused to remit the case to the Court of Appeal because there were no longer any grounds for granting provisional measures:
"By order of 9 February 2012 (C-442/11), the Court of Justice of the European Union ruled that Articles 4 and 5 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 meaning that, where a product consisting of an active ingredient was protected by a basic patent and the holder of that patent was able to rely on the protection conferred by that patent for that product in order to oppose the marketing of a medicinal product containing that active ingredient in combination with one or more other active ingredients, a supplementary protection certificate granted for that product enables its holder, after the basic patent has expired, to oppose the marketing by a third party of a medicinal product containing that product for a use of the product, as a medicinal product, which was authorised before that certificate expired.
Refusing the requests of Novartis/Novartis pharma the Court of Appeal held that the contested generic speciality, which is composed of valsartan in combination with HCTZ, does not amount to the same product as valsartan, the only product covered by SPC No. 97C0050. Consequently the marketing of a medicinal product with valsartan as the active ingredient is unlikely to constitute infringement and breach the rights held by Novartis/Novartis pharma in relation to the active ingredient.
Since the Court of Appeal came to this conclusion without examining whether or not the rights conferred on Novartis/pharma by patent No. EP 0 443 983 would have allowed them to oppose the use of valsartan as a medicinal product in the contested generic specialities that combine it with HCTZ, and whether or not those generic products therefore infringe SPC No. 97C0050, which, like the basic patent, relates to valsartan and confers on Novartis/Novartis pharma rights identical to those under that patent, its decision lacks any legal basis.
Since the provisional measures expired on 13 November 2011, the appeal has become redundant.
For the above reasons, the Court, in accordance with Article 627 of the Civil Procedure Code:
ANNULS IN ITS ENTIRETY, the Paris Court of Appeal's judgment given between the parties on 16 September 2011;
considers the appeal to have become redundant;
decides there are no grounds for referral."
In a further case between Novartis/ Novartis pharma and the companies Sanofi and Zentiva, distributors of the generic medicinal products manufactured by Actavis, the Court of Cassation will decide on 16 September 2014 whether, given the particular circumstances of the case, it was permissible to apply for the provisional measures without a prior exchange of arguments at an oral hearing.
As I mentioned during the discussion, the Court of Cassation ruled in a decision of 16 September 2014 on whether, in the particular circumstances of the case in question, it was permissible to apply for provisional measures without a prior exchange of arguments at an oral hearing.
The facts of the case were as follows. Novartis AG claimed that the rights conferred by its European patent and SPC for valtarsan were being infringed by a generic product, valsartan hydrochlorothiazide, manufactured by Zentiva Lab in differing dosages. Together with Novartis Pharma, which held an exclusive licence for valtarsan, it applied for a preliminary injunction against Sanofi-Aventis France, Sanofi Winthrop Industrie and Zentiva, and for the communication of various information, on the basis of Article L. 615-3, first paragraph, of the Intellectual Property Code (CPI), which provides that "Any person entitled to bring an action for infringement may in preliminary proceedings request the competent civil court to order, under a penalty of a daily fine if necessary, against the alleged infringer or the intermediaries whose services it is using, any measure aimed at preventing an imminent infringement of rights conferred by the title or at stopping any continuation of the allegedly infringing acts. The competent civil court may also order emergency measures on an ex parte basis where the circumstances require that these measures should not be ordered inter partes, in particular where any delay would cause irreparable harm to the right-holder. The court, in preliminary or ex parte proceedings, may order the requested measures only if evidence, reasonably accessible to the claimant, makes it likely that its rights are being infringed or that such infringement is imminent".
As noted earlier, the Novartis SPC for valsartan expired on 13 November 2011. Since this date was imminent, the Novartis companies applied for an ex parte order to avoid any delay in implementing the measures. Their requests, filed on 27 October 2011, were granted on the same day by the President of the Court of First Instance in Paris.
Sanofi and Zentiva requested withdrawal of the order. In a decision of 31 October 2011, the President of the Court maintained the order in its entirety, except for the obligation to communicate information to identify the origin and distribution channels of the pharmaceutical products reproducing the claims of EP No. 0 443 983 and SPC No. 97C0050.
Following an appeal by Sanofi and Zentiva, the Paris Court of Appeal issued a judgment on 11 December 2012 revoking the order and rejecting the Novartis companies' requests.
This judgment too was appealed. Several arguments were put forward in support of the appeal, two of which are of interest for our work.
The first was that the Court of Appeal had failed to give the parties a hearing (le principe de la contradiction), because it had raised, of its own motion and without inviting them to comment, the question whether the circumstances of the case justified ordering the measures requested in ex parte proceedings.
Under French law, ex parte decisions on patent matters are subject to the general requirements laid down in Articles 493 ff of the Code of Civil Procedure. Article 496, paragraph 2, states: "If the request [for an ex parte order] is acceded to, any interested party may refer back to the judge who has given the order." Article 497 specifies that: "The judge will have the right to modify or withdraw his order, even if the matter is referred to the trial judge." Therefore, the judge ruling in ex parte proceedings is obliged, when considering the filing of the request, to verify that the requester has established circumstances which justify taking the measures sought without hearing the opposing party (the requirement under Article 493 for issuing an ex parte order).
The Court of Cassation endorsed the Court of Appeal’s action in carrying out this verification, which could not be done ex officio in the emergency procedure to obtain withdrawal of the injunction. "But the Court of Appeal, dealing with a request for withdrawal of an ex parte order, did not raise a legal question of its own motion in verifying whether or not the case was duly submitted to the judge. Therefore, it was not obliged to invite the parties to present their comments."
The second interesting line of argument criticised the reasons for the Court of Appeal's view that the requirements of Article L. 615-3 CPI for ordering a provisional measure on an ex parte basis were not met.
The Court of Cassation responded as follows:
"The two Novartis companies contest the judgment on the same grounds, submitting that:
(1) Under Article L. 615-3 CPI, as amended by the law 2007-1544 of 29 October 2007 implementing Directive 2004/48/EC, the competent civil court may order emergency measures on an ex parte basis where any delay would cause irreparable harm to the claimant. The Court of Appeal took the view that a delay likely to cause irreparable harm to the requester could not suffice in itself to justify applying for an ex parte order. In this respect, the Court of Appeal breached Article L. 615-3 CPI.
(2) The SPC for the product contained in the medicinal products for which marketing authorisation has been obtained is granted to the holder of a European patent to compensate at least in part for the loss of protection in the period between the date of filing the patent application and the grant of marketing authorisation, since this loss of protection is considered to impede the recouping of investments in research. In the case at issue, the Court of Appeal considered that Novartis would not have incurred irreparable harm from the refusal of an immediate injunction to stop Sanofi from marketing its generic product. This view was based on the argument that "the investments made to discover the branded product were offset by the protection conferred over several years by the patent and the SPC." The Court of Appeal clearly failed to appreciate the essential purpose of SPCs, and therefore breached Articles 2, 3, 4 and 5 of Regulation 469/2009 of 6 May 2009 concerning SPCs for medicinal products.
(3) The competent civil court may order emergency measures on an ex parte basis where any delay would cause irreparable harm to the claimant. It is impossible, or very difficult, to measure ‘irreparable harm’ in monetary terms. In the case at issue, the Novartis companies had argued in their request that, if Sanofi were allowed to distribute its infringing medicinal products, even for just the seventeen days between the date of presenting the request and the expiry of the SPC, the consequences for Novartis would be the loss of part of its market share in France, accompanied by a swift fall in the price of its products containing valsartan, in France and then, rapidly, in the European Union, the launching of other generic drugs and the growth of parallel imports, and a disincentive to innovate – not to mention the disruption to the treatment of patients. In ruling that this harm could be "remedied by payment of damages", although the extent of the injury made any valuation very difficult or impossible, the Court of Appeal breached Articles 9-4 of Directive 2004/48/EC and L. 615-3 CPI.
4. Irreparable harm is also defined as harm of such scope and gravity that an award of damages to the victim cannot restore the situation that existed before the injury occurred. The adoption of measures to prevent or contain the injury before it happens would therefore appear to be the most appropriate means of dealing with cases of this kind. In the case at issue, the Novartis companies had argued in their request that, if Sanofi were allowed to distribute its infringing medicinal products, even for just the seventeen days between the date of presenting the request and the expiry of the SPC, the consequences for Novartis would be the loss of part of its market share in France, accompanied by a swift fall in the price of its products containing valsartan, in France and then, rapidly, in the European Union, the launching of other generic drugs and the growth of parallel imports, and a disincentive to innovate – not to mention the disruption to the treatment of patients. The Court of Appeal took the view that the harm described could be remedied by payment of damages and was therefore not irreparable, and failed to consider that a loss of market share, a price war, parallel imports and the disincentive to innovate could not be offset by awarding damages, and were therefore "irreparable". In this respect, the Court of Appeal breached Articles 9-4 of Directive 2004/48/EC and L. 615-3 CPI.
But although the SPC was due to expire seventeen days after the filing of the request, the Court of Appeal pointed out that it was still possible on 27 October 2011 to obtain, before 13 November 2011, a judicial decision respecting the principle of hearing both sides, by applying for an emergency motion to be heard immediately or within a very short timeframe. And given that there were doubts, when the requests were made, about the imminent marketing of the products in question, the Court held that the harm resulting from launching generics on the market seventeen days before the expiry of the SPC could be remedied by an award of damages. On the basis of these independent deliberations and findings, leaving aside the copious submissions criticised by the lower court, the Court of Appeal, which was not obliged to follow the parties in the details of their argumentation, concluded that the conditions justifying emergency measures under Article L. 615-3 CPI were not met, and that the request therefore lacked merit."
The Court of Appeal had shown there was no risk that, if both sides were heard, the harm resulting from the expected marketing of generic products might be irreparable. In accordance with Community case law, which took the very strict line that financial harm could be considered irreparable only under exceptional circumstances – for example if a company’s very existence was at risk, which was clearly not the case here – the Court of Cassation dismissed the appeal.