Call for comments for C-443/17 (Abraxis Bioscience)

The UK IPO is seeking comments on CJEU case C-443/17 (Abraxis Bioscience) with a view to advising the UK government as to whether it wishes to make representations in this reference.  Comments should be sent by email to policy@ipo.gov.uk by 6 September 2017.

As a refresher, the question referred to the CJEU in this case is as follows:

Is Article 3(d) of the SPC Regulation to be interpreted as permitting the grant of an SPC where the marketing authorisation referred to in Article 3(b) is the first authorisation within the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?

UKIPO seeks comments on C-567/16

The UKIPO is seeking comments on CJEU case C-567/16 (Merck Sharp and Dohme Corporation) with a view to advising the UK government as to whether it wishes to make representations in this reference.  The deadline for filing submissions is coming up very soon - 6 January 2017.

The questions referred to the CJEU are:

1. Is an End of Procedure Notice issued by the reference member state under Article 28(4) of European Parliament and Council Directive 2001l83/EC of 6 November 2001 on the Community code relating to medicinal products for human use before expiry of the basic patent to be treated as equivalent to a granted marketing authorisation for the purposes of Article 3(b) of European Parliament and Council Regulation 469/2009/EC of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) (the “SPC Regulation”), such that an applicant for an SPC in the Member State in question is entitled to apply for and be granted an SPC on the basis of the End of Procedure Notice?
2. If the answer to question (1) is no; in the circumstances in question 1, is the absence of a granted marketing authorisation in the Member State in question at the date of the application for an SPC in that member state an irregularity that can be cured under Article 10(3) of the SPC Regulation once the marketing authorisation has been granted?

Many thanks to Andrew Hutchinson (Simmons & Simmons) for pointing this out!

UK asks: should IPO Opinions service cover SPCs?

Last week the UK's Intellectual Property Office announced a consultation on plans to expand its excellent and badly under-used (and non-binding) Patent Opinions service. Surprisingly, this consultation was aimed at the SPC community too.  The proposals are rolled in together with proposals for the SME-directed Mediation Service, which is a little confusing, not least because only half as much time has been allocated for consultation on mediations.  Anyway, according to the information available:

"The Intellectual Property Office (IPO) ... set out proposals to expand its Patent Opinions Service and is seeking views from business on how to improve its Mediation Service.

The Government is committed to providing SMEs with the economic environment and framework they need to grow. The Hargreaves Review identified a number of barriers facing SMEs trying to making the most of their Intellectual Property. One of these was the cost of managing IP, in particular resolving disputes surrounding the enforcement of their own IP rights and defending themselves against allegations of infringement made by others.

...  The IPO’s Patent Opinions Service allows individuals or companies to request an opinion on the validity or infringement of a patent and is well used. A review of this service demonstrated a high desire from users for expansion of the service to aid resolution of further patent disputes. Government is now consulting on the following proposal:

• expanding the questions relating to patent validity that can be the subject of an opinion; 

• expanding the service to offer opinions as to whether a Supplementary Protection Certificate ('SPC') is valid or is infringed; 

• giving the IPO the power to consider revoking a patent following issue of an opinion which concludes it is invalid.

The IPO provides a Mediation Service to any parties involved in an IP dispute who wish to resolve matters without resorting to the Courts. However, uptake of this service is low and the IPO is therefore seeking comments and supporting evidence from key stakeholders and IP right holders on the reasons for this. This will be used to determine what service, if any, the IPO should be offering to support speedier and lower cost dispute resolution".

The Patent Opinions Service consultation will run for 12 weeks and concludes on 4 September 2012. Please send your comments here.

Thank you, John Miles (Potter Clarkson), for the link.

IPO decision on Cetuximab and irinotecan

The UKIPO has released a decision on SPC applications SPC/GB/04/037 and SPC/GB/04/038 in the name of Imclone Systems, Inc. Ltd. and Aventis Holdings Inc.

SPC/GB/04/037 is for the combination of products cetuximab, a monoclonal antibody, and irinotecan, an anti-cancer agent, whereas SPC/GB/04/038 is for cetuximab alone. Both applications rely on the same basic patent EP0667165, which claims a therapeutic composition comprising a monoclonal antibody such as cetuximab, and an anti-neoplastic agent, such as irinotecan. The patent however does not disclose compositions or the use of monoclonal antibodies on their own. The same marketing authorisation (MA) EU/1/04/282/001 for the medicinal product "Erbitux" was cited in support of both SPC applications.

The hearing officer, Dr L. Cullen, held that the MA has to be considered in its entirety in deciding exactly what product can be protected by an SPC. It is not possible to just take account of the clinical particulars. The marketing authorisation was found to authorise "Erbitux", which comprises the product cetuximab, and not the product cetuximab and irinotecan, as claimed by the applicant. The MA was therefore found not to be a valid authorisation in support of SPC/GB/04/037 for the product "cetuximab in combination with irinotecan" according to Article 3(b) of the SPC regulation.

The basic patent was not considered to protect cetuximab which is the subject of SPC application SCP/GB/04/038 according to Article 3(a).

Both applications were rejected in accordance with Article 10(4) after the applicant was provided with an opportunity to correct the irregularities of each of the application.

You can read the decision in full on the IPO website here.

More IPO decisions on Vaccines - this time on HPV

Gardasil also played a role in the Intellectual Property Office's recent decision on eight applications for SPCs for single active ingredients on different strains of the L1 protein of the Human Papillomavirus (HPV). The applications were in the name of Georgetown University, one in the name of Loyola University of Chicago and one in the name of University of Rochester.

"One application concerned the recombinant L1 protein of Human
Papillomavirus (HPV) strain HPV6; one application concerned the recombinant L1
protein of Human Papillomavirus (HPV) strain HPV11; three applications concerned
the recombinant L1 protein of Human Papillomavirus (HPV) strain HPV16 and three
applications concerned the recombinant L1 protein of Human Papillomavirus (HPV)
strain HPV18. Although in the name of three applicants, these applications all
currently relate to a single licensee.

Two marketing authorisations were filed in support of these eight applications Gardasil (RTM) which comprises the recombinant L1 proteins of Human
Papillomavirus (HPV) strains HPV6, HPV11, HPV16 and HPV18 and Cervarix (RTM) which comprises the recombinant L1 proteins of Human Papillomavirus (HPV) strains HPV16 and HPV18. [...]

The eight SPC applications were found not meet the requirement under Article 3(b), because the marketing authorisations filed in support of each of these applications
comprises a further one or three active ingredients in addition to the active
ingredient listed in the product definition of that SPC application. Thus, in
each case, a valid authorisation has not been supplied to place the product (for
which an SPC has been applied) on the market as a medicinal product.
Since in accordance with Article 10(3) an opportunity to correct the irregularities
with these applications has been given, they were rejected under Article 10(4). "

Read the decision here.

IPO refuses SPC for Circadin

In the recent UK Intellectual Property Office decision of Neurim Pharmaceuticals (1991) Ltd's application, BL O/384/09, hearing officer Dr C Davies rejected an application to an SPC because it did not comply with Article 3(d) of Regulation (EC) 469/2009.

The facts of the case are as follows: Neurim Pharmaceuticals filed an application for the product melatonin (Ciracadin) based on EP 0518468 (concerning the use of melatonin to correct a distortion or deficiency in the plasma melatonin profile of a human subject) and authorisation EU/1/07/392/001 as the first authorisation to place the product on the market.

The examiner observed that the cited marketing authorisation was not the first authorisation to place melatonin on the market as a medicinal product because there was an earlier authorisation to another company for a composition comprising melatonin for use in sheep to initiate an early breeding season.

The applicants disagreed arguing that the Regulation should be interpreted teleologically and on such an interpretation the SPC should be granted and that the application does meet the requirements of Article 3(d).

The hearing officer held that, although the applicant was correct in arguing that the SPC Regulation had to be given a teleological interpretation, the case could not be distinguished from the ECJ decision in Pharmacia and the case law was clear that the intended use of the medicinal product could not be taken into account when considering the relevance of an earlier marketing authorisation.