ECJ rules on Aranesp reference this Thursday

This coming Thursday, 2 September, sees the handing down by the Court of Justice of the European Union of its ruling in Case C-66/09 Kirin Amgen. This is a reference for a preliminary ruling from Lithuania, noted by The SPC Blog when the Advocate General's Opinion was published here. The underlying dispute relates to the effective date of the Lithuanian marketing authorisation for Aranesp.

English, Portuguese and Slovak are the only languages in which the Advocate General's Opinion is not so far available (it's good to know that the Opinion was translated into Maltese, though one wonders whether -- given the notorious shortage of Maltese translators -- the Court of Justice has nothing more pressing to translate into that language.

Medeva: still time to comment

On 25 June The SPC Blog reported on the questions that the Court of Appeal (England & Wales) has referred to the Court of Justice of the European Union for a preliminary ruling in Case C-322/10 Medeva v Comptroller General of Patents. For the record, this case deals with SPCs for multi-component vaccines against multiple diseases and seeks a determination as to whether the product is protected by the basic patent and therefore is subject of a valid marketing authorization

The UK's Intellectual Property Office is currently seeking comments from interested persons which will presumably help shape the UK government's approach towards this action, in which it is a party. If you'd like to offer the IPO the benefit of your thoughts on the questions, please email the office here by 27 August 2010. Meanwhile, the Court's deadline for receipt of comments is 25 October 2010.

If you've forgotten the questions, here they are again:

"On Article 3(a)

1. Regulation 469/2009 (the Regulation) 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 absence of Community harmonisation of patent law, what is meant in Article 3(a) of the Regulation 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 the Regulation 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 the Regulation and, if so, what are those further or different criteria?

4. For the purposes of Article 3(a), 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), 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"?

On Article 3(b)

6. Does the SPC Regulation and, in particular, Article 3(b), permit the grant of a Supplementary Protection Certificate 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 2001/82/EC which is the first marketing authorization that places the single active ingredient or combination of active ingredients on the market?".

AB Hässle combination product case: informal translation available

Niklas Mattsson (European Patent Attorney and Swedish Authorized IP Attorney, Awapatent AB) has kindly written to The SPC Blog as follows:

"Listed on your Resources website is a pretty interesting Swedish case, AB Hässle, which is cited in the UK Takeda case and provides the same reasoning with regard to the question of whether a combination product is covered by a basic patent relating to only one of the components. The question of course is highly interesting in light of the Medeva ECJ referral.

In connection with some casework relating to the same issue some years ago, I had occasion to prepare an informal, translation of the Swedish decision into English. If you would like to post it to the Resources web site, you’re more than welcome to use it, in the interest of “promoting the dissemination of legal information".

The SPC Blog thanks Niklas very much for his thoughtfulness and hopes that other readers, when the opportunity arises, will be able to promote knowledge and understanding in our field of interest in the same way.

The translation can be read here and will soon be posted on the Resources site too.

MPA offers discount via SPC Blog

Martin Paltnoi (MPA Research) has contacted me and has told me all about his company's newInteractive Online Report & Search Services. He adds

"We would be happy to provide our services at a generous discount if contacted through the SPC Blog".

These services include (i) European Drug Patent Status Review, which covers major product/preparation patent information plus allied supplementary protection certificates for all products on the market in 27 European territories, (ii) EU 1st Marketing Authorisation, (iii) MPA SPC Watch, which identifies SPCs for all 27 member states in the EU, with additional information available for up to 39 countries and (iv) UK/ROI Veterinary Drug Patent Status Review, which covers major product/preparation patent information plus allied SPCs for all veterinary medicines on the market in the UK and the Republic of Ireland.

While this blog does not endorse any products or services -- and has no specific information concerning the discounts -- it is always gratified to see anyone who is prepared to offer to supply anything to its readers on favourable terms.

The AtoZGenerics iPad app

In "Patent firm blazes trail with new drugs app for the iPad", a short article in The Belfast Telegraph by Anne Madden, it is reported that Patentnav, based at the Northern Ireland Science Park, has created AtoZGenerics, which is said to be one of the first patent information applications for iPads.

AtoZGenerics offers information on European and US patent expiry dates, which can often be difficult to find. The company's founder, Dr Eddie O'Gorman, says:

"The AtoZ Generics app contains a lot of valuable information that can be difficult to find, and all for only 59p. It provides expiry dates on US patent term extension and UK Supplementary Protection certificate expiry dates, as well as approximate global drug sales."

If any readers gain experiences of this app which they'd like to share, the SPC Blog will be delighted to hear from them.

Ireland fee hike: your chance to comment

The Irish Patents Office has announced that Ireland's Department of Enterprise, Trade and Innovation is conducting a review of the fees charged for Supplementary Protection Certificates. This seeks to engage with interested parties to seek their views on the proposal to review the current application and renewal fees for Supplementary Protection Certificates. Responses should be received by close of business on Friday 30th July 2010. The rationale for changing fees is as follows:

"Fees for Supplementary Protection Certificates fall somewhat outside the rationale for keeping fees for intellectual property protection low, as the circumstances for granting SPCs are very different to those for granting patents. As a Supplementary Protection Certificate will provide patent protection to a pharmaceutical company up to a maximum of 25 years, a balance must be struck between paying a premium for
continued market monopoly and allowing for entry into the market for generic medicines.

By comparing current fees charged for Supplementary Protection in all Member States of the European Union, Ireland is currently the fourth least expensive country. In cost per head of population (per million) Ireland ranks as the tenth least expensive country of the EU 27, in line with countries with a population of approximately 10 million, namely Belgium, Sweden, Portugal and the Czech Republic. The preliminary fees for consultation as set out would bring Ireland closer in line with countries with similar population size such as Denmark, Finland and Slovakia".

The proposed new fees and European averages are indicated in tabulated form here.

What is a product? Cetuximab has its day in court

Giving judgment yesterday in the Patents Court (England and Wales) in Yeda Research and Development Company Ltd v Comptroller General of Patents [2010] EWHC 1733 (Pat), Mr Justice Lewison dismissed Yeda's appeal against the Dr Lawrence Cullen's decision to refuse its application for two SPCs.

The facts are a bit complicated. Yeda applied for a cancer treatment patent in 1989 which was granted in 2002 but later expired. This patent taught that two forms of agent were used to kill tumour cells: cytotoxic agents and cytostatic agents (which included monoclonal antibodies). Yeda had found that the combined treatment of one of the novel monoclonal antibodies with anti-neoplastic drugs provided a more efficient treatment for inhibiting the growth of human cancer cells than did the use of the new monoclonal antibody of the anti-neoplastic agent by itself. Claim 1 of the patent was for "A therapeutic composition comprising (a) a monoclonal antibody and (b) an anti-neoplastic agent" and Claim 2 covered "The therapeutic composition of Claim 1 for separate administration of the components". Claim 6 was for "Use of (a) a monoclonal antibody and (b) an anti-neoplastic agent, as defined in any one of claims 1 to 5, for the preparation of a therapeutic composition for treating cancer". The chosen monoclonal antibody was cetuximab (Erbitux) and the chosen anti-neoplastic agent was irinotecan.

The European Commission granted market authorisation for use of the patent in June 2004, the authorisation being stated to be for "the medicinal product "Erbitux – cetuximab". The clinical particulars described the product so authorised as 'Erbitux in combination with irinotecan ... for the treatment of patients with...(EGFR) expressing metastatic colorectal cancer...".

Relying on the Commission's authorisation Yeda made two SPC applications (the 037 and 038 applications). The 037 application specified the product to be protected as "cetuximab in combination with irinotecan". Lawrence Cullen refused to grant the SPC on the basis that, since the authorisation was for cetuximab alone, the application did not comply with Article 3(b) of Regulation 1768/92 since the SPC was not for the product for which authorisation was granted. The 038 application specified the product to be protected as "cetuximab". Lawrence Cullen rejected this application too, since cetuximab alone was not the invention protected by the patent with art 3(a), which requires that the product be protected by the patent.

Yeda appealed in respect of both refusals. The really interesting bit related to the 038 application. Here Yeda argued that, since a combination of cetuximab and irinotecan was needed in order to make up the "therapeutic composition" claimed by Claim 6, the combination would take place inside the patient's bloodstream. Accordingly, if someone supplied cetuximab with the intention that it would be administered to a patient, that supply would be a supply of a means for putting the invention into effect. It would be obvious to the supplier of the cetuximab that it was intended to put the invention into effect -- which would amount to secondary infringement under the Patents Act 1977, s.60(2). Under European case law, whether a product is protected by a basic patent in force is a question of domestic law. Cetuximab was therefore protected by the basic patent in force. On behalf of the Comptroller of Patents it was argued that, if Yeda had to rely on the making of the therapeutic composition inside the body of the patient during the course of treatment, it was actually claiming a method of treatment which was barred from being patented under section 4A(1) of the 1977 Act. Discussion arose in the course of proceedings as to whether it was appropriate or necessary for the court to refer a series of questions to the Court of Justice of the European Union for a preliminary ruling.

Lewison J dismissed both appeals. In his view

* What constitutes a "product" must be strictly construed, looking at what it is, rather than what it does, and taking into account only its active ingredients.

* The Commission's authorisation decision clearly identified the medicinal product, 'Erbitux – cetuximab' as its subject-matter -- no other medicinal product was identified. It alluded to irinotecan only in order to explain how cetuximab was used. This could not constitute a marketing authorisation of a product consisting of both cetuximab and irinotecan.

* Given the restrictive interpretation of the term "product", to incorporate the notion of secondary infringement into the SPC regime would be illegitimate. While this was not acte clair, it was in any event a matter for national rather than European law, so no reference would be made for a preliminary ruling from the Court of Justice of the European Union.

SPCs and anticompetitive conduct: the General Court speaks

Case T-321/05 AstraZeneca v Commission, a complex decision delivered by the General Court of the European Union at the beginning of this month, is not only about SPCs as such -- it concerns the rectitude or otherwise of the Commission's assessment that AstraZeneca, the UK's second-largest pharma company, misled patent officials and flouted antitrust rules in order to keep generic competition at bay with regard to its Omeprazole product.

The General Court upheld most of the Commission's finding but reversed the finding that AstraZeneca breached EU rules by withdrawing market approvals for older versions of its medicine in Denmark and Norway, thus preventing market entry by generic producers and parallel importers. Some interesting comments concerning abuse of dominant position and SPCs can be found in the judgment, which is some 920 paragraphs long. A few examples:

"361 ... the Commission applied Article 82 EC correctly in taking the view that the submission to the patent offices of objectively misleading representations by an undertaking in a dominant position which are of such a nature as to lead those offices to grant it SPCs to which it is not entitled or to which it is entitled for a shorter period, thus resulting in a restriction or elimination of competition, constituted an abuse of that position. The question whether those representations were objectively misleading must be assessed in the light of the specific circumstances and context of each individual case. ...".

"366 ... the Court rejects the applicants’ argument that the existence of specific remedies which make it possible to rectify, or even annul, patents and SPCs granted unlawfully justifies application of the competition rules only where an anticompetitive effect is demonstrated. Where behaviour falls within the scope of the competition rules, those rules apply irrespective of whether that behaviour may also be caught by other rules, of national origin or otherwise, which pursue separate objectives. Similarly, the existence of remedies specific to the patent system is not capable of altering the conditions of application of the prohibitions laid down in competition law and, in particular, of requiring, in cases of behaviour such as that at issue in the present case, proof of the anticompetitive effects produced by such behaviour".

The SPC Blog may return to this decision again, if time and resources permit.

Medeva CJ Reference Questions

The sealed order of the Court of Appeal for the Medeva case, kindly provided by Tim Mitcheson, can be read here.

In short, the questions referred to the Court of Justice are as follows:

On article 3(a)

1. Regulation 469/2009 (the Regulation) 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 absence of Community harmonisation of patent law, what is meant in Article 3(a) of the Regulation 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 the Regulation 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 the Regulation and, if so, what are those further or different criteria?

4. For the purposes of Article 3(a), 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”?For the purposes of Article 3(a), 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”?

On Article 3(b)

6. Does the SPC Regulation and, in particular, Article 3(b), permit the grant of a Supplementary Protection Certificate 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 200 1/83/EC or 200 1/82/EC which is the first marketing authorization that places the single active ingredient or combination of active ingredients on the market?

Medeva Appeal Judgment Handed Down

The Court of Appeal of England and Wales (Lord Justice Etherton and Lord Justice Elias) has handed down the judgment on the appeal in Medeva's SPC Application (our previous postings on the matter can be read here).

In sum, the Court decided to make a reference to the Court of Justice for a preliminary ruling on each of the questions below:

(1) What is the test by which to determine whether “the product is protected by a basic patent in force” for the purposes of Article 3(a)?
(2) Should a different test be applied in cases where the product is a multi-disease vaccine?
(3) Is it sufficient for the purposes of Article 3(a), in the context of a multi-disease vaccine, that the basic patent in force protects one aspect of the product?
(4) For the purposes of Article 3(b) may the product be limited to that part of a multi-disease vaccine as is protected by the basic patent in force?

At the time of posting, the judgement was not available on Bailii, but you can read it here.