Settle in with the Chat Français for some French carb loading of delicious, fresh patent decisions from the first half of 2020 |
Finding it difficult to keep up with an ever-changing world in the midst of a health, environmental, social and political crisis, while keeping up with patent law? Do not worry, the IPKat is doing a series of half-yearly "catch-ups" of the main European patent law jurisdictions before we all start a new "school year". In this post, the French Kat's friends Raphaëlle Dequiré-Portier, Julie Pailhès, Luca Chevallier and Camille d'Angerville at Gide Loyrette Nouel in Paris report on the first half of this year's patent cases in France. Over to Raphaëlle, Julie, Luca and Camille:
In this post, we will report on 4 noticeable patent cases of the French Courts in the first half of 2020:
- The first two are landmark cases dealing with conflicts of jurisdiction in the context of multi-jurisdictional litigation and clearly show that the French Courts will not sit on the bench. These decisions may have significant strategic impact in the future.
- The two other cases deal with SPCs : brace yourselves, and get ready to read all about the latest French developments in the ongoing sagas over the Truvada and ezetimibe+simvastatin.
But first, let us begin by overviewing the significant changes to French patent law that have occurred further to the French Law n°2019-486 of May 22, 2019 relating to the growth and the transformation of companies (known as the "PACTE law") and subsequent set of regulations (Décret n°2020-15 of 8 January 2020, Ordonnance No. 2020-116 of 12 February 2020, Décret n°2020/225 of 6 March 2020, and Arrêté of 6 March 2020).
#1 Significant changes to French patent law
The new set of rules amend the French patent law on several aspects. Although they have different dates of entry into force, note that all of them are now effective.
Here are the main changes you should bear in mind:
#1 Significant changes to French patent law
The new set of rules amend the French patent law on several aspects. Although they have different dates of entry into force, note that all of them are now effective.
Here are the main changes you should bear in mind:
1. It strengthens the examination of patent applications: Previously the INPI (the French patent office) only examined the 2 criteria of novelty and industrial application before granting a patent, but the examination process now also extends to the inventive step assessment.2. It introduces a patent opposition procedure before the INPI: Any third party may now file an opposition against a French patent before the INPI within 9 months following the publication of the mention of the grant of the patent (as from 1 April 2020). Interestingly, there is no standing requirement. The limitative grounds for opposition are the following:- lack of novelty, inventive step or industrial application;
- exclusions / exceptions from patentability;
- insufficiency of disclosure;
- extension of the subject matter beyond the content of the application as filed, or in case of divisional applications, the initial application.3. It changes the statute of limitation of patent invalidity and infringement actions: Patent invalidity actions are not subject to a statute of limitations anymore. Infringement actions are still subject to a five-year limitation period, but the starting point of this limitation period is amended: it is no longer the day when the infringing acts were committed, but the last day when the claimant was aware or should have been aware of these facts.
4. It modernizes the utility certificate: The duration of the utility certificate has been extended from 6 to 10 years from the date on which the application was filed. Moreover, the applicant may now convert its utility certificate application into a patent application.5. It creates a provisional patent application: The provisional patent application is simpler, more affordable and faster than the traditional patent application. Inventors who file a provisional patent application will have 12 months from its filing to complete their patent application or to transform their provisional application into a utility certificate.
#2 SEP - Suing the French branch of ETSI gives jurisdiction to the French Courts to hear the claims against a foreign SEP owner, despite a pending dispute abroad between the same parties (except for the addition of ETSI)
TCL / Philips - ETSI, Paris Court of First Instance (Tribunal Judiciaire), Interim Order, 6 February 2020, RG No. 19/02085
The well-known Dutch group (yes, we're referring to Philips here) is the owner of a standard essential patent (SEP) portfolio related to UMTS (3G) and LTE (4G) standards, declared as such with the ETSI. Following the failure of licensing agreement negotiations between the two parties, Philips sued TCL for patent infringement before the High Court of Justice of England and Wales in 2018. To cut the ground from under Philips' feet, TCL initiated proceedings in France in early 2020 before the Paris Court of First Instance (Tribunal Judiciaire de Paris) suing not only Philips but also the France based ETSI.
Long story short, TCL claimed that Philips refused to negotiate licenses on FRAND conditions and therefore did not comply with the commitments made in the context of its membership to the ETSI. It requested the Court to impose such licences on Philips and to enjoin the ETSI to contribute to this outcome.
As a main claim, TCL asked the Court to:
TCL / Philips - ETSI, Paris Court of First Instance (Tribunal Judiciaire), Interim Order, 6 February 2020, RG No. 19/02085
The well-known Dutch group (yes, we're referring to Philips here) is the owner of a standard essential patent (SEP) portfolio related to UMTS (3G) and LTE (4G) standards, declared as such with the ETSI. Following the failure of licensing agreement negotiations between the two parties, Philips sued TCL for patent infringement before the High Court of Justice of England and Wales in 2018. To cut the ground from under Philips' feet, TCL initiated proceedings in France in early 2020 before the Paris Court of First Instance (Tribunal Judiciaire de Paris) suing not only Philips but also the France based ETSI.
Long story short, TCL claimed that Philips refused to negotiate licenses on FRAND conditions and therefore did not comply with the commitments made in the context of its membership to the ETSI. It requested the Court to impose such licences on Philips and to enjoin the ETSI to contribute to this outcome.
As a main claim, TCL asked the Court to:
- rule that Philips' declarations of essentiality to the ETSI must be construed as a promise to grant a FRAND license to TCL on all the patents held by Philips and declared essential for UMTS and LTE standards;
- enjoin Philips to grant such a license on FRAND conditions to be determined by the Court;
- enjoin ETSI to participate in the granting of this licence;
- rule that the conditions offered by Philips are not FRAND-compliant.
First, Philips raised the lack of jurisdiction of the Paris Court based on EU Regulation n°1215/2012 (aka the "Brussel I bis Regulation"). This Regulation basically sets the principle that jurisdiction shall be based on the defendant’s domicile (often called the "natural jurisdiction") but also provides a number of exceptions.
Leaving apart the exception set forth by Article 7.1 in relation to contractual matters which was under discussion between the parties but not settled by the Judge, Article 8.1 provides that a person may, where he is one of a number of defendants, also be sued "in the courts for the place where any one of them is domiciled, provided the claims are so closely connected that it is expedient to hear and determine them together to avoid the risk of irreconcilable judgments resulting from separate proceedings".
Yet, Philips argued that there is no close connection between the claims against Philips and those against the ETSI within the meaning of article 8.1, adding that the ETSI would not be a "real defendant" due to the vague nature of the claims brought against it.
The Judge disagreed.
Referring to CJEU, C-145/10, Eva-Maria Painer vs. Standard Verlags GmbH, the Judge started by recalling that the "close connection" criteria requires the same situation of fact and law. The Judge then found that the claims at hand relate to the same factual situation (the alleged non-compliance by Philips to the ETSI's IP rules) and while they have different legal bases this does not rule out an identity of legal situation, especially as they are all subject to French law further to the ETSI rules of procedure.
The Judge further observed that :
- the claims against the ETSI cannot be held artificial since the ETSI has legal means to ensure that its members comply with their intellectual property obligations,
- a decision that would require the ETSI to participate in the granting of a license, if necessary by implementing the measures provided for in its internal regulations, and another decision that would rule that Philips has complied with its obligation to offer TCL a license under FRAND conditions would be irreconcilable,
- while Brussels I bis sets the principle that jurisdiction shall, except provided otherwise, be based on the defendant’s domicile, Philips is not domiciled in the jurisdiction of the UK Courts.
Nonetheless, the Judge ruled that the condition of triple identity of cause, subject-matter and parties underlying this Article was not met. The Judge stressed that the pending matter in the UK is an infringement proceedings, only based on the UK part of 2 EP patents among the relevant portfolio, by which Philips aimed at obtaining an injunction and damages against TCL, while the French proceedings also involved ETSI and aimed at determining whether Philips has offered a worldwide licence on a patent portfolio under FRAND conditions.
Last, Philips invoked article 30 of the Regulation dealing with related actions as follows :
"1. Where related actions are pending in the courts of different Member States, any court other than the court first seised may stay its proceedings.2. Where the action in the court first seised is pending at first instance, any other court may also, on the application of one of the parties, decline jurisdiction if the court first seised has jurisdiction over the actions in question and its law permits the consolidation thereof.3. For the purposes of this Article, actions are deemed to be related where they are so closely connected that it is expedient to hear and determine them together to avoid the risk of irreconcilable judgments resulting from separate proceedings."
But the Judge refused to decline jurisdiction considering that there is no risk of irreconcilable judgments since the FRAND licence issue will proceed in the UK only if TCL does not renounce to its right to a license for the UK.
This pre-trial decision, although not definitive yet, paves the path to multiple proceedings in France involving foreign SEP owner together with the ETSI to determine whether the former complied with FRAND conditions and ETSI regulation, possibly in the context of multi-jurisdictional disputes.
Pro tip : You better watch out for this one, this is definitely a "must follow" case.
[The IPKat notes additional discussion as to this French decision can be found by Mr Justice Mann in dismissing TCL's application to stay the UK proceedings pending the French proceedings which will be subject to a separate Kat post - here. Do French lawyers agree withMann J's analysis?]
#3 SEP - filing an anti-suit injunction before a Californian court, seeking to prohibit a German patentee from suing in France for infringement of his patent pending the outcome of the litigation brought in California, infringes the right of the patentee to bring proceedings before the only competent judge to rule on the infringement of its title and the French courts therefore have jurisdiction
Motorola - Lenovo / IPCom, Paris Court of Appeal, 3 March 2020, RG No. 19-21426
The German patent licensing company IPCom GmbH & Co. KG ("IPCom") acquired a telecoms patent portfolio covering 2G, 3G and 4G standards and in particular patent EP 1 841 268 B2 ("EP 268"), essential to mobile telecommunication standards.IPCom declared to ETSI that it would grant licenses on FRAND conditions on its essential patents.
#3 SEP - filing an anti-suit injunction before a Californian court, seeking to prohibit a German patentee from suing in France for infringement of his patent pending the outcome of the litigation brought in California, infringes the right of the patentee to bring proceedings before the only competent judge to rule on the infringement of its title and the French courts therefore have jurisdiction
Motorola - Lenovo / IPCom, Paris Court of Appeal, 3 March 2020, RG No. 19-21426
The German patent licensing company IPCom GmbH & Co. KG ("IPCom") acquired a telecoms patent portfolio covering 2G, 3G and 4G standards and in particular patent EP 1 841 268 B2 ("EP 268"), essential to mobile telecommunication standards.IPCom declared to ETSI that it would grant licenses on FRAND conditions on its essential patents.
In September 2018, it proposed to the Chinese IT equipment provider Lenovo (which also owns Motorola) to agree to a licensing offer of its patent portfolio on these terms. After the failure of licensing discussions, in March 2019, the US entities of Lenovo were the first to initiate proceedings against IPCom before the District Court of the Northern District of California. They claimed that IPCom's licensing offer was not proposed on FRAND conditions and requested the Court to set the terms for a worldwide FRAND license for the IPCom patent portfolio. In July 2019, IPCom counterclaimed by initiating infringement proceedings based on EP 268 in the UK.
On September 2019, Lenovo extended the proceedings to include a motion for anti-suit injunction (commonly referred to as an "anti-anti-suit injunction"), to prevent IPCom from pursuing infringement proceedings initiated in the United Kingdom in July 2019, and from initiating any other proceedings before a foreign court based on the patents concerned by the FRAND license.
IPCom retaliated on October 2019 by suing the French entities of Lenovo before the judge in charge of emergency interim proceedings (juge des référés) of the Paris Tribunal de grande instance, seeking the withdrawal of this motion for anti-suit injunction. Otherwise speaking, IPCom replied to the motion for anti-suit injunction filed by Lenovo in the US by a motion for an anti-anti-suit injunction in France.
On 8 November 2019, the juge des référés of the Paris Court of First Instance:
On September 2019, Lenovo extended the proceedings to include a motion for anti-suit injunction (commonly referred to as an "anti-anti-suit injunction"), to prevent IPCom from pursuing infringement proceedings initiated in the United Kingdom in July 2019, and from initiating any other proceedings before a foreign court based on the patents concerned by the FRAND license.
IPCom retaliated on October 2019 by suing the French entities of Lenovo before the judge in charge of emergency interim proceedings (juge des référés) of the Paris Tribunal de grande instance, seeking the withdrawal of this motion for anti-suit injunction. Otherwise speaking, IPCom replied to the motion for anti-suit injunction filed by Lenovo in the US by a motion for an anti-anti-suit injunction in France.
On 8 November 2019, the juge des référés of the Paris Court of First Instance:
- prohibited Lenovo from filing any further motion for anti-suit injunction before any foreign court.
- ordered Lenovo to withdraw its motion for an anti-suit injunction in the US proceedings insofar as it related to judicial proceedings initiated by IPCom for alleged acts of infringement of EP 268 committed by Lenovo on the French territory;
This decision was accompanied by a penalty fee of EUR 200,000 per violation and per day of non-compliance.
On November 2019, Lenovo withdrew its motion for anti-suit injunction. In parallel, IPCom sued Lenovo before the Paris Tribunal de grande instance for patent infringement based on EP 268. On 20 January 2020, the juge des référés rejected IPCom’s request of a preliminary injunction after having considered in particular that the measures of prohibition, recall and confiscation of products which was for a period of a few weeks in view of the patent expiry date of February 15, 2020, were clearly disproportionate and could create a distortion between the parties enabling IPCom to take an undue advantage of the situation and impose non-FRAND conditions.
Lenovo filed an appeal against the first instance decision of the Paris Tribunal de grande instance. The Paris Court of Appeal ("Court of Appeal") rendered its decision on March 3, 2020. It agreed with the juge des référés that had retained the territorial jurisdiction of the French courts. Indeed, it stated that if the anti-suit injunction was granted, the patentee would be deprived from the possibility to act before the French Courts to assert its rights and would then suffer damages on this territory.
The Court of Appeal added that the juge des référés belongs to the jurisdiction called upon to determine the merits of the dispute relating to the infringement action that the motion for anti-suit injunction was precisely trying to prevent.On the merits, the Court of Appeal confirmed the first instance decision regarding the withdrawal by Lenovo of its motion for anti-suit injunction.
It held that the anti-suit injunction, if issued by the Californian judge, would create a "manifestly unlawful disturbance" (trouble manifestement illicite) to the patentee, because it would infringe its right to protect his title before the only judge competent to rule on infringement committed in France, and this in defiance of not only the provisions of the French Intellectual Property Code but also the rights granted by European legal standards (right to respect for property, right to a fair trial and right to an effective remedy).
Consequently, the anti-suit injunction, by the mere disturbance it causes due to the infringement of a fundamental right and independently of the assessment of its conformity with the "international public policy" (ordre public international), characterizes a manifestly unlawful disturbance.
The Court of Appeal then considered that ordering Lenovo to withdraw its motion for anti-suit injunction was the "only appropriate means" of ending this manifestly unlawful disturbance.
However, the Court of Appeal overturned the second part of the first instance decision which prohibited Lenovo from filing any further motion for anti-suit injunction before any foreign court. The Court of Appeal held that the sole possibility of such a filing, whereas there is no longer any such motion currently pending, cannot suffice to characterize a manifestly unlawful disturbance.
Pro tip: This prominent international patent case which symbolizes the first intellectual property litigation involving a commonly named "anti-anti-suit injunction" initiated in France, definitely deserves its share of attention.
#4 Preliminary injunction / SCP - When dealing with a claim for preliminary injunction, the judge shall take into consideration the proportionality of the measures requested
MSD / Mylan, Paris Court of Appeal, 14 February 2020, RG 19/06114
MSD / Sandoz, Paris Court of Appeal, 14 February 2020, RG 19/03820
In October 2017, Mylan brought an invalidity claim against MSD's ezetimibe+simvastatin SPC (No. 05C0040) before the Paris Court of First Instance. MyIan started the marketing of its ezetimibe+simvastatin generic in April 2018 and MSD launched in November 2018 a preliminary injunction (PI) proceeding before the pre-trial judge dealing with the main proceedings on the merits. In March 2019, the pre-trial judge granted a preliminary injunction, ordered the payment of provisional damages and the recall of Mylan's products from the commercial networks. Mylan appealed this decision.
The Court of Appeal interpreted the conditions laid down in Articles 3a) and c) of the SPC Regulation (Regulation 469/2009) in the light of Sanofi C-443/12, Georgetown C-484/12 of 12 December 2013, Boehringer C-577/13 of 12 March 2015 and Gilead C-121/17 of 25 July 2018, and found that there were serious challenges to the validity of the SPC in suit on the basis of which provisional measures were requested.
Therefore, the court held that SPC for ezetimibe+simvastatin was "likely to be invalid" on the basis of Article 3(a) combined with 3(c) of the SPC Regulation (Regulation 469/2009), which is one of the criteria in France for the grant or dismissal of a PI, and overturned the first instance decision.
Relying on recital 22 and Article 3§2 of the directive 2004/48/EC of 29 April 2004 on the enforcement of intellectual property rights, the Court held as a general statement that the judge dealing with a preliminary injunction claim shall take into consideration the proportionality of the measures requested in the specific case, and in particular the seriousness and irreparable nature of the damage allegedly suffered.
Applying this requirement for proportionality, the Court found in this case that:
On November 2019, Lenovo withdrew its motion for anti-suit injunction. In parallel, IPCom sued Lenovo before the Paris Tribunal de grande instance for patent infringement based on EP 268. On 20 January 2020, the juge des référés rejected IPCom’s request of a preliminary injunction after having considered in particular that the measures of prohibition, recall and confiscation of products which was for a period of a few weeks in view of the patent expiry date of February 15, 2020, were clearly disproportionate and could create a distortion between the parties enabling IPCom to take an undue advantage of the situation and impose non-FRAND conditions.
Lenovo filed an appeal against the first instance decision of the Paris Tribunal de grande instance. The Paris Court of Appeal ("Court of Appeal") rendered its decision on March 3, 2020. It agreed with the juge des référés that had retained the territorial jurisdiction of the French courts. Indeed, it stated that if the anti-suit injunction was granted, the patentee would be deprived from the possibility to act before the French Courts to assert its rights and would then suffer damages on this territory.
The Court of Appeal added that the juge des référés belongs to the jurisdiction called upon to determine the merits of the dispute relating to the infringement action that the motion for anti-suit injunction was precisely trying to prevent.On the merits, the Court of Appeal confirmed the first instance decision regarding the withdrawal by Lenovo of its motion for anti-suit injunction.
It held that the anti-suit injunction, if issued by the Californian judge, would create a "manifestly unlawful disturbance" (trouble manifestement illicite) to the patentee, because it would infringe its right to protect his title before the only judge competent to rule on infringement committed in France, and this in defiance of not only the provisions of the French Intellectual Property Code but also the rights granted by European legal standards (right to respect for property, right to a fair trial and right to an effective remedy).
Consequently, the anti-suit injunction, by the mere disturbance it causes due to the infringement of a fundamental right and independently of the assessment of its conformity with the "international public policy" (ordre public international), characterizes a manifestly unlawful disturbance.
The Court of Appeal then considered that ordering Lenovo to withdraw its motion for anti-suit injunction was the "only appropriate means" of ending this manifestly unlawful disturbance.
However, the Court of Appeal overturned the second part of the first instance decision which prohibited Lenovo from filing any further motion for anti-suit injunction before any foreign court. The Court of Appeal held that the sole possibility of such a filing, whereas there is no longer any such motion currently pending, cannot suffice to characterize a manifestly unlawful disturbance.
Pro tip: This prominent international patent case which symbolizes the first intellectual property litigation involving a commonly named "anti-anti-suit injunction" initiated in France, definitely deserves its share of attention.
#4 Preliminary injunction / SCP - When dealing with a claim for preliminary injunction, the judge shall take into consideration the proportionality of the measures requested
MSD / Mylan, Paris Court of Appeal, 14 February 2020, RG 19/06114
MSD / Sandoz, Paris Court of Appeal, 14 February 2020, RG 19/03820
In October 2017, Mylan brought an invalidity claim against MSD's ezetimibe+simvastatin SPC (No. 05C0040) before the Paris Court of First Instance. MyIan started the marketing of its ezetimibe+simvastatin generic in April 2018 and MSD launched in November 2018 a preliminary injunction (PI) proceeding before the pre-trial judge dealing with the main proceedings on the merits. In March 2019, the pre-trial judge granted a preliminary injunction, ordered the payment of provisional damages and the recall of Mylan's products from the commercial networks. Mylan appealed this decision.
The Court of Appeal interpreted the conditions laid down in Articles 3a) and c) of the SPC Regulation (Regulation 469/2009) in the light of Sanofi C-443/12, Georgetown C-484/12 of 12 December 2013, Boehringer C-577/13 of 12 March 2015 and Gilead C-121/17 of 25 July 2018, and found that there were serious challenges to the validity of the SPC in suit on the basis of which provisional measures were requested.
Therefore, the court held that SPC for ezetimibe+simvastatin was "likely to be invalid" on the basis of Article 3(a) combined with 3(c) of the SPC Regulation (Regulation 469/2009), which is one of the criteria in France for the grant or dismissal of a PI, and overturned the first instance decision.
Relying on recital 22 and Article 3§2 of the directive 2004/48/EC of 29 April 2004 on the enforcement of intellectual property rights, the Court held as a general statement that the judge dealing with a preliminary injunction claim shall take into consideration the proportionality of the measures requested in the specific case, and in particular the seriousness and irreparable nature of the damage allegedly suffered.
Applying this requirement for proportionality, the Court found in this case that:
"In any event, there is no justification for the proportionality of the measures ordered in first instance having regard to the interests at stake relating to reference and generic medicinal products having obtained the authorizations of the public authorities, whereas a financial harm cannot – except exceptional circumstances which are not justified in the present case, the SPC in suit expiring on 2 April 2019 i.e. less than a month after the first instance decision – be regarded as irreparable or even difficult to repair, since it may give rise to the award of damages."
Pro tip: To our knowledge, this is the first time the Paris Court of Appeal asserts and applies with such clarity a "principle of proportionality" in a PI proceeding.
On the same day, the Paris Court of Appeal handed down exactly the same decision in a case opposing MSD to Sandoz with respect to the alleged infringement of the same SPC, and also overturned the PI granted by the President of the Paris Court of First Instance.
#5 SPC - a product composed of several active ingredients with a combined effect is protected by a basic patent where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination
Gilead Sciences Inc. and al. / SASU Mylan, Paris Court of Appeal, 19 June 2020, RG No. 18/15906
The well-known Truvada litigation offers the opportunity to revisit case law on combination products.
Truvada, is a combination of two antiretroviral drugs : tenofovir disoproxil ("TD") and emtricitabine ("FTC"). It is used both as a treatment for HIV-positive people and for prevention in at-risk populations. It benefited from a significant media exposure notably because of its excellent results to reduce the risk of contracting HIV from sex.
Gilead Sciences Inc. ("Gilead") owned :
- the European patent EP 0915894, filed on 25 July 1997, covering the use of TD (without any specific mention of FTC) used alone or in combination with "other therapeutic ingredients", notably for treating HIV, until it expired on 24 July 2017 ("EP 894");
- the European Union marketing authorization granted on 21 February 2005 for Truvada, a combination of TD and FTC;
- the supplementary protection certificate ("SPC") in force until 21 February 2020, covering the combination of TD and FTC ("SPC No. 32"). Gilead has also requested and obtained SPCs in many other European countries.
This paved the way to a battle all over Europe between Gilead and Mylan.
On 20 September 2016, Mylan sued Gilead before the Paris Tribunal de Grande Instance to obtain the revocation of French SPC No. 32. arguing that the combination of TD and FTC was not specifically claimed in EP 894, so that Article 3(a) of the SPC Regulation No 469/2009 of 6 May 2009 would have been breached and should have been an obstacle to the grant of the SPC.
Several pharmaceutical companies of Mylan brought an action seeking invalidation of the UK SPC equivalent to the French SPC No. 32 which led the UK Court to request a preliminary ruling of the CJEU on the following question "What are the criteria for determining whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the SPC Regulation?".
In an order dated 7 July 2017, the Paris Tribunal de Grande Instance dismissed the application for preliminary injunction with an emergency motion to be heard on very short notice ("référé d’heure à heure") filed by Gilead on the grounds that no infringement claim had been filed by Gilead as a counterclaim, and that no actual infringement was then alleged.
Mylan launched its generic of Truvada on the French market on 26 July 2017, the day after the expiry of EP 894.
The "interim order" (ordonnance de référé) of 5 September 2017 deemed serious the challenge of the validity of SPC No. 32 and rejected Gilead's request for a preliminary injunction to prohibit the sale of generic of Truvada.
On 25 May 2018, the Paris Tribunal de Grande Instance confirmed this interim order by invalidating the SPC No. 32.
On 25 July 2018, the CJEU replied to the preliminary ruling referred to it by Courts of England & Wales and stated that:
"Article 3(a) of Regulation No 469/2009 of the European Parliament and of the Council of 6 May 2009, concerning the SPC for medicinal products, must be interpreted as meaning that a product composed of several active ingredients with a combined effect is "protected by a basic patent in force" within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:
- the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and
- each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent".
On 19 June 2020, the Paris Court of Appeal (the "Court of Appeal") ruled that the Paris Tribunal de Grande Instance had correctly stated that if it was possible to admit that in order to be considered protected by the basic patent an active ingredient is not mentioned in the claims of the basic patent by means of a structural definition but simply by means of a functional definition, then it is also important to establish that these claims, interpreted in particular in the light of the description of the invention, implicitly but necessarily refer to the active ingredient in question in a specific manner.
However, the SPC's additional active ingredient, FTC, is neither explicitly mentioned in the claims of the basic patent nor in its description.
Furthermore, taking into account the state of its knowledge at the priority date of the patent (July 1996), the Court of Appeal ruled that a person skilled in the art could not have, necessarily and specifically, thought of emtricitabine when reading the claims of the patent, even if he/she knew that a combination of active ingredients was effective against the HIV.
Accordingly, it confirmed the first instance judgement in that it retained that "no functional formula necessarily and specifically targeted emtricitabine and that consequently the combination of the two products TD and emtricitabine could not be made the subject of an SPC on the basis of the EP 894 patent and consequently annulled SPC No. 32".
However, the SPC's additional active ingredient, FTC, is neither explicitly mentioned in the claims of the basic patent nor in its description.
Furthermore, taking into account the state of its knowledge at the priority date of the patent (July 1996), the Court of Appeal ruled that a person skilled in the art could not have, necessarily and specifically, thought of emtricitabine when reading the claims of the patent, even if he/she knew that a combination of active ingredients was effective against the HIV.
Accordingly, it confirmed the first instance judgement in that it retained that "no functional formula necessarily and specifically targeted emtricitabine and that consequently the combination of the two products TD and emtricitabine could not be made the subject of an SPC on the basis of the EP 894 patent and consequently annulled SPC No. 32".
Keeping up with French patent litigation: Half-year case law review 2020
Reviewed by Annsley Merelle Ward
on
Monday, October 05, 2020
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