Georgetown ruling also out

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
(b) a medicinal product containing the single active ingredient or combination of active ingredients together with one or more other active ingredients is the subject of a valid authorisation granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC which is the first [MA] that places the single active ingredient or combination of active ingredients on the market?’

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.

Medeva ruling now out

The Court of Justice of the European Union gave its ruling this morning in Case C‑322/10, Medeva BV v Comptroller General of Patents, Designs and Trade Marks, a reference for a preliminary ruling from the Court of Appeal (England and Wales).

 Bordetella pertussis

In brief, in April 1990 Medeva applied for a European patent for a method for the preparation of an acellular vaccine against Bordetella pertussis (whooping cough agent), also known as ‘Pa’. This preparation consisted of a combination of two antigens as active ingredients -- pertactin and filamentous haemagglutinin (‘filamentous haemagglutinin antigen’). Their ratio was such as to provide a synergistic effect in vaccine potency. The patent was granted by the EPO on 18 February 2009, expiring on 25 April 2010.

Medeva filed five SPC applications with the UK's IPO, seeking supplementary protection for DTPa-IPV/HIB vaccines covering diphtheria (D), tetanus (T), whooping cough (Pa), poliomyelitis (IPV) and/or meningitis (Haemophilus influenzae, also known as ‘HIB’). In support of those applications, Medeva submitted marketing authorisations (MAs) granted by the French, German and UK authorities for a range of medicinal products each of which contained, in addition to the combination of pertactin and filamentous haemagglutinin, between eight and 11 other active ingredients.

In November 2009 the IPO refused to grant the SPCs applied for. In the case of four of the applications, more active components or ingredients were specified in the applications for SPCs covering those components than were identified in the wording of the claims of the basic patent, and they were not therefore protected by the basic patent under Article 3(a) of Regulation 469/2009. As for the fifth application, while the active components or ingredients identified in the patent were the same as those specified in the SPC application (ie combination of pertactin and filamentous haemagglutinin), the MAs submitted in support of that application did not fulfil the conditions laid down in Article 3(b) since they related to medicinal products containing nine active ingredients, that is to say vaccines which did not contain only the active components or ingredients specified in the SPC application and in the patent claims.

Medeva appealed unsuccessfully to the High Court and then again to the Court of Appeal, which stayed the proceedings and referred the following questions for a preliminary ruling:

‘1 Regulation No 469/2009 … recognises, amongst the other purposes identified in the recitals, the need for the grant of an SPC by each of the Member States of the Community to holders of national or European patents to be under the same conditions, as indicated in recitals 7 and 8 [in the preamble to that regulation]. In the absence of Community harmonisation of patent law, what is meant in Article 3(a) of … Regulation [No 469/2009] by “the product is protected by a basic patent in force” and what are the criteria for deciding this? 

2 In a case like the present one involving a medicinal product comprising more than one active ingredient, are there further or different criteria for determining whether or not “the product is protected by a basic patent” according to Article 3(a) of … Regulation [No 469/2009] and, if so, what are those further or different criteria? 

3 In a case like the present one involving a multi-disease vaccine, are there further or different criteria for determining whether or not “the product is protected by a basic patent” according to Article 3(a) of … Regulation [No 469/2009] and, if so, what are those further or different criteria? 

4 For the purposes of Article 3(a) [of Regulation No 469/2009], is a multi-disease vaccine comprising multiple antigens “protected by a basic patent” if one antigen of the vaccine is “protected by the basic patent in force”? 

5 For the purposes of Article 3(a) [of Regulation No 469/2009], is a multi-disease vaccine comprising multiple antigens “protected by a basic patent” if all antigens directed against one disease are “protected by the basic patent in force”?
…
6 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 the SPC Regulation; and
(b) a medicinal product containing the single active ingredient or combination of active ingredients together with one or more other active ingredients is the subject of a valid authorisation granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC which is the first [MA] that places the single active ingredient or combination of active ingredients on the market?’

The Court has just ruled as follows:

"1. Article 3(a) of Regulation ... 469/2009 ... must 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.

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.

Novartis mystery case heads for ECJ: can anyone help?

According to the UK's IPO, Case C-442/11 Novartis AG v Actavis UK Limited is the latest SPC dispute to be referred to the Court of Justice for a preliminary ruling. According to the IPO, this case --  another reference from the High Court for England and Wales -- raises the following questions:

"Where a supplementary protection certificate has been granted for a product as defined by Regulation 469/2009 for an active ingredient, are the rights conferred by that certificate pursuant to Article 5 of the Regulation in respect of the subject matter as defined in Article 4 of the Regulation infringed:

i. by a medicinal product that contains that active ingredient (in this case valsartan) in combination with one or more other active ingredients (in this case hydrochlorothiazide); or

ii. only by a medicinal product that contains that active ingredient (in this case valsartan) as the sole active ingredient?"

This seems to be a bit of a mystery. Martijn de Lange (Netherlands Patent Office) has told The SPC Blog:

"I totally missed that reference and I can't find it on BAILII or with Google either. Maybe you could put it on the blog and possibly some reader may supply it". 

This blogger hasn't been able to find any reference to it on the Curia website either. Can anyone help?

nb If you were planning on submitting comments on this reference to the UK IPO so that the government can decide what, if any, position it wishes to take, the IPO's notice does not stipulate a deadline by which submissions must be made. Having said that, you would be well advised to email your comments here, if you have any, as soon as possible.

Note on recent ECJ memantine and galantamine rulings

Thanks are due to Herwig von Morze for drawing The SPC Blog's attention to a recent summary, "European Court of Justice holds SPCs for old medicinal products invalid", which was prepared by Ana-Laura Morales of Spanish law firm Grau & Angulo and published last week by International Law Office. The note deals with the ECJ's recent rulings in the memantine and galantamine cases (covered by this weblog here and here). .

More questions to the Court of Justice

A few months ago, we reported on Medeva's appeal against the UK IPO's decision to refuse an SPC application here

The SPC blog has found out that the Court of Appeal for England and Wales will be referring questions to the ECJ on the meaning of Article 3a and 3b of the SPC regulation, in the context of combination products. We haven't seen the questions, yet, but when we do you'll be the first to know.

ECJ Ruling on AHP Manufacturing v BIE

The judgement is out on ECJ case C-482/07 AHP Manufacturing BV v Bureau voor de Industriële Eigendom, also operating under the name Octrooicentrum Nederland, available here in French, German, Dutch and other languages, but unfortunately, not yet in English.

Here are the essentials questions and (distilled) answers:

1. Does Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, as subsequently amended, and more specifically Article 3(1)(c) thereof, preclude the grant of a certificate to the holder of a basic patent for a product for which, at the time of the submission of the application for a certificate, one or more certificates have already been granted to one or more holders of one or more other basic patents? - No

2. Does Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products, as subsequently amended, and more specifically recital 17 and the second sentence of Article 3(2) thereof, give rise to a different answer to Question 1? - No

Art. 3(1)(c) of Council Regulation 1768/92, in consideration of Art. 3(2) second sentence of Regulation 1610/96, should be interpreted such that it does not preclude the grant of a certificate to the holder of a basic patent for a product for which at the time of submission of the application, one or more certificates have already been granted to one or more holders of one or more basic patents. (see paragraph 43 of the decision)

3. When answering the previous questions, is it relevant whether the last application submitted, like the previous application or applications, is submitted within the period prescribed by Article 7(1) of Regulation (EEC) No 1768/92 or that prescribed by Article 7(2) of Regulation (EEC) No 1768/92? - No

4. When answering the previous questions, is it relevant whether the period of protection afforded by the grant of a certificate pursuant to Article 13 of Regulation (EEC) No 1768/92 expires at the same time as, or at a later time than, under one or more certificates already granted for the product concerned? - No

5. When answering the previous questions, is it relevant that Regulation (EEC) No 1768/92 does not specify the period within which the competent authority, as referred to in Article 9(1) of that Regulation, must process the application for a certificate and ultimately grant a certificate, as a result of which a difference in the speed with which the authorities concerned in the Member States process applications may lead to differences between them as to the possibility of a certificate being granted? - No

We'll provide more specifics on the reasoning in a later posting.

CMA waiver based on "even SPC won't be enough" argument is rejected

Last Friday the Court of Justice of the European Communities made an Order in Case T‑52/09 R, Nycomed Danmark ApS v European Medicines Agency (EMEA), this being (i) an application for suspension of the operation of the EMEA’s decision of 28 November 2008 rejecting the application for a product-specific waiver concerning an ultrasound echocardiographic imaging agent for diagnostic purposes (perflubutane) and (ii) for the grant of interim measures. One of the arguments raised by Nycomed to try to get its waiver was that, if the marketing authorisation were delayed, it could not recoup its investment because of the limited patent life, even though the patent term could be "extended" by an SPC. Although this was no more than a side argument in Nycomed's effort to get a Community Marketing Authorisation (CMA), it did touch on the issue of patent term extension and therefore merits a brief mention here. Nycomed argued as follows:

"44 ... that delay also means that it will lose part of the effective protection period of the patents granted in respect of Imagify. The 20-year protection period for Imagify commenced on 27 February 1997 with the filing of the first patent application and will therefore lapse on 27 February 2017. The applicant cannot derive the benefits accruing from that protection before obtaining the CMA. The patent protection period may of course be extended beyond the 20-year period through the grant of a supplementary protection certificate, but the effective period resulting from the refusal to grant the waiver sought will still be shorter than that which the applicant would have obtained had the waiver been granted.

45 ... any delay in the launching of a patent-protected product will have considerable
impact on that product’s life-cycle turnover. Later market entry for the product will delay sales, and the potential turnover should not be calculated from the first year, when sales are modest, but rather in the year before loss of exclusivity, when product sales are peaking. In addition, a change in the order of entry of Imagify into the market in relation to other products will have a significant impact on the applicant’s market position if it reaches the market as manufacturer of the second ultrasound perfusion defect imaging product instead of the first, as is currently envisaged.

46 With respect to the irreparable nature of the alleged damage, the applicant acknowledges that Article 72(2) of Regulation No 726/2004 lays down a system of non-contractual liability for the EMEA, similar to that provided for by Articles 235 EC and 288 EC for the Community institutions. It submits, however, that it is not possible to compensate economically for the loss in turnover and profits and the
shortening of the protection period for its patent through the award of damages.
Entitlement to damages for loss suffered is subject to a set of conditions relating to the unlawfulness of the conduct alleged against the Community institution, the presence of damage and the existence of a causal link between the conduct and the damage complained of".

The Court was unimpressed. In the absence of "serious and irreparable" damage no interim measure might be ordered. What it says is worthy of note, though, if only because of its position regarding the nature of any damage suffered by a rights holder in relation to the loss of a portion of protection of its patent rights:

"63 ... the applicant argues that the damage suffered if the interim measures sought are not granted will be caused by the delay in introducing Imagify onto the market and by the loss of a corresponding portion of the protection period of its patents. It emphasises the significant impact of that delay on its position in the market for cardiac diagnostic products and the need for it to introduce Imagify onto that market as the first ultrasound imaging product in order to prevent another pharmaceutical company from gaining an edge and obtaining a CMA for a competing product, thereby acquiring a market share that it would not be able to acquire with Imagify present on the market.

64 However, the damage caused by such a delay in placing the product in question on the market, far from being able to be considered certain or, at the very least, sufficiently probable, is purely hypothetical in nature in that it presupposes the occurrence of future, uncertain events ... There is no certainty whatsoever that that product will be introduced onto the market, as it depends on the Commission’s granting a CMA, for which the applicant has expressly stated it ‘will be applying’ ... after successfully completing the validation procedure pending before the EMEA. In respect of that future authorisation procedure before the Commission, the applicant has not asserted, and even less established, that it would lead to the granting of the CMA, in the sense that the granting of that authorisation would be merely a formality.

....

67 With respect to the nature of the alleged harm, the applicant states that, during the period in which the placing on the market of Imagify is delayed, it will risk a loss in turnover and profits on sales of Imagify as well as a shortening of the effective protection period of the patents granted for the product, as any delay in launching a patent-protected product has a considerable impact on the turnover achieved for that product.

68 The applicant is thus alleging damage which must be regarded as being purely financial, in that it consists in loss of the income likely to result from future sales of a patent-protected product".