Source: http://thespcblog.blogspot.co.uk/2011_11_01_archive.html
Timestamp: 2017-11-18 17:44:19
Document Index: 46344266

Matched Legal Cases: ['Art.3', 'CJEU ', 'CJEU ', 'Art. 3', 'Art. 3', 'Art. 3', 'Art. 3']

The SPC blog: November 2011
Court of Rome applies Medeva, suspends provisional relief
From Evelina Marchesoni (Bird & Bird) comes an update to The SPC Blog's recent post on the Italian proceedings on valsartan and hydrochlorotiazide.She writes:
"On 11 November 2011 the Court of Rome granted a preliminary injunction requested by Novartis enforcing its SPC no. C-UB1999P000648, expiring on September 25, 2012 and covering the medicinal product “Cotareg” (valsartan + HCTZ).
In his decision the dudge ordered Mylan to stop manufacturing, commercializing, advertising, distributing, importing, exporting, storing and/or offering in any form (including the request of insertion in the so called “transparency list”) the generic products of Cotareg.
Mylan appealed against this interim order and, after the issue of the decision of the Court of Justice in Case C-322/10 Medeva and Case C-422/10 Georgetown, sought an application to stay the preliminary injunction pending appeal.
Mylan pointed out that, also in light of the Court of Justice's ruling, Novartis’s certificate claiming the combination of valsartan and HCTZ was invalid according to Article 3(a) of the Regulation, as it referred to a basic patent, EP 0 443 983, which did not provide such a combination.
By his decision, issued on 25 November 2011, the President of the IP Division of the Court of Rome, considering that on 24 November 2011 the decisions from the ECJ were published and they affirmed that Art.3(a) of the Regulation should be interpreted “as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate”, ordered the provisional suspension of the preliminary injunction decision.
This short decision of the Court of Rome, which you can access in full here (in Italian) probably constituted the first application in Europe of the interpretation of the Court of Justice decisions in the Medeva and Georgetown cases.
Discussion of the appeal is scheduled for 16 December 2011".
Thank you, Evelina, for this information, which is much appreciated.
Posted by Jeremy at 10:27 pm 1 comments
Labels: italy, Valsartan
SPCs for combination products –
CJEU Medeva and Georgetown judgment
There are a number of combination product cases pending before the Court of Justice of the European Union that, when taken together, probe almost every aspect of the Regulation’s requirements for a valid SPC to be obtained. The CJEU’s judgment in the Medeva and Georgetown cases has been handed down on Thursday 24 November, the first in the series of cases referred to that court. Following up the AIPPI event on the topic in September, Hugh Goodfellow. Partner at Carpmaels & Ransford, has agreed to host a Rapid Response, to provide the opportunity to discuss and debate the implications of this Judgment.
If you would like to attend this event, whether you are a member or not, please register at:
www.aippi.org.uk/medeva
SRA and IPReg, and (pending approval) BSB, CPD: 1.5 hours. AIPPI United Kingdom is accredited under the Solicitors Regulation Authority’s and the Bar Standards Board’s CPD schemes.
Posted by Jeremy at 9:48 pm 0 comments
Labels: Medeva, rapid response seminar
Also delivered today is the judgment of the Court of Justice of the European Union in Case C‑422/10, Georgetown University, University of Rochester, Loyola University of Chicago v Comptroller General of Patents, Designs and Trade Marks, this being a reference for a preliminary ruling from the Patents Court, England and Wales.
The Georgetown SPC applications
A pappilomavirus
In June 1993 Georgetown University applied for a European patent entitled ‘Papillomavirus vaccine’, for a human papillomavirus (PV) L1 protein capable of inducing neutralising antibodies against papillomavirus virions. There are many human papillomavirus (HPV) genotypes, which are grouped according to the similarity of their DNA sequences. Types 6 and 11 are responsible for condylomas, whereas types 16 and 18 are responsible for precancerous lesions in the genital region and also cervical cancer. The Georgetown University patent claims included a vaccine for the prevention of papillomavirus infection, comprising at least that protein, or fragment thereof, of, among others, HPV‑16, HPV‑18 or HPV‑16 and HPV‑18 together. That patent, granted on 12 December 2007, is due to expire on 23 June 2013.
In December 2007, relying on a marketing authorisation (MA) granted to Sanofi Pasteur in September 2006 for the medicinal product Gardasil, containing HPV‑6, HPV‑11, HPV‑16 and HPV‑18 purified proteins obtained from yeast cells (Saccharomyces cerevisiae), Georgetown University filed four SPC applications, identifying the product as ‘the recombinant L1 protein’ of HPV‑6, HPV‑11, HPV‑16 and HPV‑18 (SCP/GB07/079, SCP/GB07/073, SCP/GB07/080 and SCP/GB07/078), respectively. Relying on an MA granted to GlaxoSmithKline Biologicals in September 2007 for the medicinal product Cervarix, containing HPV‑16 and HPV‑18 purified proteins obtained from insect cells (Trichoplusia ni), Georgetown University filed two SPC applications identifying the product as ‘the recombinant L1 protein of papillomavirus type 16 as expressed by an insect cell’ (SCP/GB07/071) and ‘the recombinant L1 protein of papillomavirus type 18 as expressed by an insect cell’ (SPC/GB07/70), respectively.
The UK IPO rejected all these applications for failure to comply with the condition laid down in Article 3(b) of Regulation 469/2009, since the medicinal product for which the MA was granted contained more active ingredients than those for which SPC protection was sought.
The Rochester SPC applications
In March 1994 the University of Rochester applied for a patent entitled ‘Production of human papillomavirus capsid protein and virus-like particles’ for ‘a method of expressing the human papillomavirus capsid protein coding sequence of type 6 ([HPV]-6), type 11 ([HPV]-11) …’. The patent claims included a ‘purified recombinant human papilloma virus-like particle or capsomere which comprises human papillomavirus 16 ([HPV]-16) L1 capsid protein expressed from an L1 protein coding sequence …’ and ‘… a multivalent vaccine comprising a virus-like particle from different human papilloma viruses’. That patent was granted on 25 May 2005 and is due to expire on 7 March 2014.
T IPO granted the University of Rochester SPCs based on the MAs for Gardasil and Cervarix, identifying the product as ‘the combination of the virus-like particles of the recombinant Ll protein of human papillomavirus types 6, 11, 16 and 18’ (SCP/GB07/018) and ‘the combination of the virus-like particles of the recombinant Ll protein of human papillomavirus types 16 et 18’ (SCP/GB07/076). However, it refused to grant a SPC based on the MA for Cervarix identifying the product as ‘the virus-like particle of the recombinant L1 protein of human papillomavirus type 16 as expressed in an insect cell’ (SCP/GB07/075), for failure to comply with the condition laid down in Article 3(b).
The Loyola SPC application
In October 1995 Loyola University of Chicago applied for a patent entitled ‘Papilloma virus-like particles, fusion proteins and process for producing same’. The patent claims included ‘recombinant-produced papilloma virus-like particles that are formed after expression of the viral structure proteins Ll or Ll and L2, characterised in that one or more sections of the Ll protein are deleted, wherein the ability to form virus-like particles remains’. That patent was granted on 10 May 2006 and is due to expire on 8 October 2015.
The UK IPO granted a SPC to Loyola University of Chicago identifying the product as ‘the combination of the virus-like particle of the recombinant L1 protein of human papillomavirus types 16 and 18’ based on the MA for Cervarix (SCP/GB07/077). However, it refused to grant a SPC based on the MA for Cervarix identifying the product as ‘the virus-like particle of the recombinant L1 protein of human papillomavirus type 16 as expressed in an insect cell’ (SCP/GB07/069), since the application thus worded, based on the MA for Cervarix, failed to comply with the conditions laid down in Article 3(b).
The appeal and reference
The Patents Court, before which all three SPC applicants appealed, decided to stay the proceedings and refer the following question to the Court for a preliminary ruling, which is worded in the same terms as the sixth question referred by the Court of Appeal (England and Wales) in Case C 322/10 Medeva.
‘Does … Regulation [No 469/2009] and, in particular, Article 3(b), permit the grant of a [SPC] for a single active ingredient or combination of active ingredients where:
(a) a basic patent in force protects the single active ingredient or combination of active ingredients within the meaning of Article 3(a) of … Regulation [No 469/2009]; and
Initially this case was joined with Case C‑322/010 for the purposes of the oral procedure and the judgment. However, in view of the factual differences between the situations at issue in the main proceedings, the cases were disjoined.
This morning the Court ruled as follows:
"Article 3(b) ... must be interpreted as meaning that, provided the other requirements laid down in Article 3 are also met, that provision does not preclude the competent industrial property office of a Member State from granting a supplementary protection certificate for an active ingredient specified in the wording of the claims of the basic patent relied on, where the medicinal product for which the marketing authorisation is submitted in support of the supplementary protection certificate application contains not only that active ingredient but also other active ingredients".
As with this morning's earlier post on Medeva, comments will follow in due course.
Posted by Jeremy at 10:55 am 0 comments
The Court has just ruled as follows:
2. Article 3(b) of Regulation ... 469/2009 must be interpreted as meaning that, provided the other requirements laid down in Article 3 are also met, that provision does not preclude the competent industrial property office of a Member State from granting a supplementary protection certificate for a combination of two active ingredients, corresponding to that specified in the wording of the claims of the basic patent relied on, where the medicinal product for which the marketing authorisation is submitted in support of the application for a special protection certificate contains not only that combination of the two active ingredients but also other active ingredients".
Comments to follow, as well as a post on this morning's other ruling in Georgetown.
Posted by Jeremy at 10:26 am 4 comments
Spain: court orders change in practice in ganirelix ruling
The SPC Blog has learned from its friend Herwig von Morze that it has been the long-established practice of the Spanish Patent Office to refuse the grant of an active ingredient with its salts. Now, however, following an appeal to the Spanish Federal Court, the Spanish Patent Office has been ordered to grant an SPC for ganirelix and its salts based on the rationale of the Farmitalia decision.
We are chasing up further information on this decision and hope to be able to report on it in greater detail soon.
Posted by Jeremy at 11:03 pm 0 comments
Labels: active ingredient plus its salts, Spain
Düsseldorf Novartis/Actavis order now in English too
In "Düsseldorf valsartan/HTC proceedings referred for preliminary ruling" (here) The SPC Blog received an update from Thomas Bopp and Henrik Holzapfel (Gleiss Lutz, Düsseldorf, acting for the Actavis defendanta) on the proceedings in Novartis/Actavis before the Düsseldorf District Court. The update contained the order of that court in the original German, here.
The SPC Blog has since received two English translations of the order of the Düsseldorf District Court.
The first translation to arrive came from Cordula Tellman and Frank-Erich Hufnagel (Freshfields Bruckhaus Deringer LLP), which you can read as a pdf file here. As Cordula and Fran-Erich kindly explain, the Court reconfirms the position which it expressed in its ruling in the previous preliminary injunction proceedings: that is, a protection certificate granted for a single active ingredient (e.g. valsartan) would be infringed by a medicinal product containing this single active ingredient, even if combined with another active ingredient (e.g. valsartan + hydrochlorothiazide). The Court discusses in detail the arguments brought forward by the parties and gives extensive reasoning for its opinion that the SPC is infringed (see in particular paragraphs 17, 20, 22, 24, 28 and 30 of the order).
The second translation, which arrived in a welter of emails following the resumption of this blogger's internet connectivity, came from Thomas and Henrik. You can read it as a pdf file here.
The SPC Blog is grateful to the lawyers of both firms for their efforts to make the ruling and the reasoning of the Düsseldorf court both available and accessible to the SPC community and for their enthusiasm for the subject.
Posted by Jeremy at 11:38 am 0 comments
Labels: ECJ reference, Germany, Valsartan
Düsseldorf valsartan/HTC proceedings referred for preliminary ruling
The SPC Blog has received from Thomas Bopp and Henrik Holzapfel (Gleiss Lutz, Düsseldorf) an important update on the proceedings between Novartis on the one hand and Actavis Deutschland GmbH and Actavis Malta Ltd on the other before the Düsseldorf District Court (Thomas and Henrik are representing the two Actavis companies in the action on the merits pending before the Düsseldorf District Court). This is what they have told us:
"The SPC Blog entries of 21 and 24 March 2011 (here and here, respectively) provided the following information:
1. On 8 March 2011, the Düsseldorf District Court held in preliminary injunction proceedings (case nos. 4b O 280/10 and 4b O 287/10) that Actavis' products containing the active ingredients valsartan and hydrochlorothiazide (HCT) would infringe Novartis' German SPC relating to valsartan (DE 196 75 036).
2. The Düsseldorf District Court ordered Novartis to file actions on the merits.
On 8 April 2011, Novartis filed such action on the merits (jointly) against Actavis Germany and Actavis Malta (case no. 4b O 66/11).
The latest news is that that on 8 November 2011 the Düsseldorf District Court decided to stay the infringement proceedings.
The question of whether the scope of protection of an SPC which has an active ingredient as its subject matter also extends to a combination of this active ingredient with a further active ingredient was regarded as decisive for the outcome of the infringement proceedings. Obviously, this question is precisely what the dispute between the parties is about. The court did not want to decide the question. It was considered necessary that the interpretation of Articles 5, 4 SPC Regulation be clarified by the Court of Justice of the European Union (CJEU). The Düsseldorf District Court referred the following question for a preliminary ruling to the CJEU:
"Must Articles 5, 4 of EC Regulation No. 469/2009 be interpreted to mean that the protection conferred by a certificate granted for a single active ingredient (in this case valsartan) extends to an embodiment that contains this single active ingredient in combination with another active ingredient (in this case valsartan + hydrochlorothiazide)?"
The Düsseldorf District Court also summarised the parties' pleadings, which differ to a certain extent from those in the parallel UK proceedings (where the High Court made a referral which is already pending before the CJEU as Case C-442/11)".
Thomas and Henrik have kindly sent us the order of the Düsseldorf District Court that the proceedings are stayed and referred to the CJEU, which readers can access here.
Posted by Jeremy at 2:02 pm 0 comments
Valsartan and hydrochlorothiazide combination: Rome rules
From Daniela Ampollini (Trevisan & Cuonzo Avvocati, Parma, Italy) comes information concerning a recent decision of the Court of Rome concerning a Novartis combination SPC, which this weblog reproduces here with grateful thanks:
"On 11 November 2011 the IP Chamber of the Court of Rome granted the motion for preliminary injunction requested by Novartis AG and Novartis Farma S.p.A. against Mylan S.p.A. on the basis of Novartis’ Italian valsartan and hydrochlorothiazide SPC, the active ingredients in Novartis’ Co-Diovan medicinal product (which is marketed in Italy as Co-Tareg).
The motion had been filed within the context of a nullity action initiated last September by Mylan, aiming at the revocation of Novartis’ SPC for alleged violation the provisions of the SPC Regulation, in which action Novartis had cross-claimed for infringement of its rights.
The grounds of invalidity raised by Mylan were substantially based on the assumption that: (i) the SPC would be invalid as the medicinal product Co-Diovan would not be “protected by a basic patent in force” considering that the basic patent EP 443983 did not claim the combination of valsartan and hydrochlrorothiazyde as such and that the “infringement test” (according to which a product is protected by a patent if it “infringes” the patent) would not be the correct test to use in interpreting Art. 3(a) of the SPC Regulation; and (ii) Art. 3(c) of the SPC Regulaton would have also been breached by the valsaran and hydrochlorothiazide SPC as another SPC on valsartan had already been granted based on the same EP ‘983 patent.
The Court of Rome first noted that the urgency requirement had been met sinceNovartis had produced pre-orders, indicating that Mylan had pre-marketed the drug, as well as the fact that Mylan had officially communicated to the association of Italian wholesalers that its generic version of Co-Diovan would be in the market as of 15 November 2011 (i.e. after the expiry of the valartan SPC-- but not after the expiry of the valsartan and hydrochlorothiazide SPC). It then endorsed the application of the infringement test as to Art. 3(a) of the SPC Regulation and clarified that Art. 3(c) was not breached if the products in question (in this case the product valsartan and the combination product valsartan and hydrochlorothiazide) are different, and therefore found that there had been infringement of a valid SPC.
The injunction is also noteworthy as it includes a prohibition that Mylan make pre-marketing activity (such as the collection of orders and pre-orders) before the expiry of the SPC, an order of recall of the products that have already been delivered to Mylan’s customers, and an order to notify the Italian Drugs Regulatory Authority with a view to preventing the inclusion of the generic in the substitution list of equivalent drugs.
The preliminary injunction is now subject to appeal and, in any event, to confirmation at the outcome of the merits proceedings".
You can read the court's order in the original Italian here, and in English translation here
Posted by Jeremy at 12:40 pm 0 comments
JIPLP note on Medeva, Georgetown Opinion available online
"Supplementary Protection Certificates for combination products" is the title of a Current Intelligence note by Tim Powell and Rebecca Lawrence (Powell Gilbert LLP) on the Advocate General's Opinion of 13 July 2011 in Joined Cases C322/10 Medeva and C422/10 Georgetown University.
The Fourth Chamber of the Court of Justice of the European Union will -- as regular readers of this weblog know -- be giving judgment on Thursday 24 November. It may be a few weeks till the printed version of Tim and Rebecca's note is published in the Journal of Intellectual Property Law & Practice (JIPLP). Meanwhile, you can read it in full on the jiplp weblog here.
Valsartan: French court upholds ex parte preliminary injunction
The SPC Blog has received further information on the French Valsartan litigation from Laëtitia Benard (Allen & Overy, Paris). This relates to the very recent decision of the Paris First Instance Court on 31 October 2011, ruling on an attempt by Sanofi to remove the preliminary injunction which had previously been granted ex parte Laëtitia (whose firm acted for Novartis in these proceedings) takes up the story from here:
Further to a preliminary injunction rendered on an ex-parte basis against Sanofi on 27 October 2011, which ruled that Sanofi's generic medicines containing a combination of Valsartan and HCTZ infringed the SPC of Novartis for Valsartan and ordered the prohibition of the manufacturing, the importation, the offer for sale, the holding, the storing and the marketing of the infringing medicines as well as the recall of these medicines from all the distribution channels, Sanofi sought the withdrawal of this ex-parte order on the ground that the infringement was challengeable.
Ruling on Sanofi's recourse, the President of the Paris First Instance Court rendered an inter-partes decision on 31 October 2011, confirming the ex-parte preliminary injunction previously issued as well as the measures ordered. This ruling is in accordance with the previous decisions of the Paris First Instance Court and of the Losartan decision from the Paris Court of Appeals.
The main findings of the President of the Paris First Instance Court are as follows:
"Article 5 of EC Regulation No. 469/2009 provides that subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations.
Thus, since the basic patent covering the active ingredient at stake, Valsartan, protects the owner of the patent against any non-allowed manufacture or marketing of pharmaceutical products containing this active ingredient, an SPC protects its owner against any non-allowed manufacture or marketing of any further pharmaceutical products containing this active ingredient and whose marketing would have been allowed before the expiry of the certificate.
Infringement is characterised when the claims of the patent are reproduced in the litigious product.
The protection conferred by SPC No. 97C0050 covers the active ingredient that is the subject-matter of EP No. 0 443 983, i.e. Valsartan, which has been the subject-matter of an MA for the treatment of hypertension, cardiac insufficiency and myocardial post-infarction.
In the present case, it is not challenged that the Valsartan Hydrochlorothiazide Zentiva product is a generic product of Valsartan and that it reproduces the claims of the patent relating to the Valsartan active ingredient. It does not matter that another active ingredient is present in the pharmaceutical product, because this is a mere addition that does not change the features of the claimed active ingredient. Therefore, since the claims of the patent are reproduced, the infringement is sufficiently likely for the measures of Article L. 615-3 to be implemented.
The preliminary injunction measures as well as the measures of recall of the products already marketed must therefore be maintained".
An appeal can still be lodged against this decision.
Posted by Jeremy at 11:19 am 1 comments
Five weeks ago, The SPC Blog announced the impending publication of a major work on SPCs: Ergänzende Schutzzertifikate mit pädiatrischer Laufzeitverlängerung / Supplementary Protection Certificates with Paediatric Extension of Duration -- a commentary on the law relating to SPCs by Dr Christopher Brückner (Patentanwalt, Apotheker, Bardehle Pagenberg, Munich) and Peter von Czettritz (Rechtsanwalt, Preu Bohlig & Partner, Munich). An introduction to this work's content and methodology can be found here.
The SPC Blog has learned today that this commentary is now available for purchase. You can buy it from the publisher's website here for the very reasonable price of EUR 298. Enjoy!
Posted by Jeremy at 6:58 pm 0 comments