IP Updates

The UK Intellectual Property Office (UKIPO) has launched a consultation on proposed changes to the UK Patents Act in respect of exemptions to infringement given to those conducting clinical and field trials. The deadline for filing submissions is 19 December 2012.

Background and current practice

Prior to the Trade Marks Act 1994 ("the Act") a given trade mark registration could cover only one class of goods or services. This often resulted in separate registrations being obtained for the same trade mark in a number of classes.

The Act updated the position and allows a single registration to exist in a number of classes. Despite this, there have remained reasons to seek multiple registrations in separate classes for the same trade mark.

The Act also makes provision for the merger of identical registered trade marks, in different classes, providing that these are in common ownership. If two registrations have different registration dates (and therefore different renewal dates) then the resulting merged registration would bear the later of those dates.

The main benefits of merging are easier administration of registrations, and reduced renewal fee costs because it is only necessary to pay a single renewal fee for each merged registration rather than a renewal fee for each separate registration prior to merger.

On 19 July 2012, the Court of Justice of the European Union (CJEU) delivered a judgement that is binding upon all EU patent offices and courts and should significantly liberalise the system of supplementary protection in Europe.

In the case in question, Neurim Pharmaceuticals (C-130/11), the CJEU upheld the validity of a Supplementary Protection Certificate (SPC) for a new medical use of a known pharmaceutically active ingredient. The ruling should allow SPCs to be based upon patents on (and marketing authorisations for) such new medical uses, regardless of the existence of earlier authorisations of the compound for different uses.

It is not yet clear whether the ruling allows SPCs for "old" active ingredients in other situations, for example based upon patents for new formulations. However, the logic of the ruling provides new hope that such SPCs might now also be allowable.

As has been widely reported, the European Council on 29 June 2012 agreed the location of the Central Division of the Unified Patent Court (UPC), stating that this was the last remaining hurdle to the creation of a unitary patent right in Europe. The Council's announcement was echoed by the President of the EPO.

However, the process of creating an EU unitary patent and a unified patent court is far from over. We would like to reassure clients that no decisions need to be made, or probably should be made, concerning their patent portfolios, in the light of these EU developments, for some time to come.

In common with some other countries, such as Belgium, the UK is introducing a change to the tax system that is intended to encourage companies:

• to undertake R&D,
• to protect the resulting intellectual property by means of patents and
• to locate patent-holding companies in the UK (so that the revenue from licensing is subject to UK taxes).

The change comes into effect on 1 April 2013.

On 3 May 2012, Advocate-General Verica Trstenjak delivered her opinion in the Neurim Pharmaceuticals case (C-130/11) that is pending before the Court of Justice of the EU (CJEU).

The opinion delivered by A-G Trstenjak is non-binding but will be taken into consideration by the CJEU when it reaches its final decision later this year. If confirmed by the CJEU, the conclusions would have a profound, liberalising effect on SPC practice in Europe for new medicinal products that contain previously authorised active ingredients.

SPCs

Supplementary Protection Certificates (SPCs) are national rights in Europe that protect authorised uses of a "product" (an active ingredient or a combination of actives) that has been subject to patent protection. The protection provided by SPCs is particularly valuable, as it can provide an effective barrier to generic competition for up to five (or even five and a half) years beyond patent expiry.

Following hot on the heels of important SPC decisions issued in late 2011, the Court of Justice of the European Union (CJEU) has now issued a reasoned order in the Novartis v Actavis case (C-442/11).

On 25 November 2011, the Court of Justice of the European Union (CJEU) decided three cases relating to Supplementary Protection Certificates (SPCs) by reasoned order (i.e. without a hearing). The orders follow judgements already handed down in the Medeva (C-322/10) and Georgetown University et al (C-422/10) cases that we previously reported in our IP Update No. 165. The following are further points of note.

The Court of Justice of the European Union (CJEU) ruled yesterday in an important case (C-125/10, Merck Sharp & Dohme Corp. v Deutsches Patent- und Markenamt), relating to Supplementary Protection Certificates (SPCs). The decision of the CJEU is binding upon all national patent offices and courts, and dictates how the term of an SPC is calculated, especially in view of a 6-month extension of term that may be available.

In essence, the CJEU has approved "Model A" of an article published on 7 July 2007 by Mike Snodin and John Miles of this firm, which introduced the revolutionary concept of zero and negative term SPCs.

That is, the CJEU has decided that SPCs can be granted even if they initially have a zero or negative term, i.e. if less than 5 years and 1 day has elapsed between patent filing and Marketing Authorisation (MA) issuance. This is because, provided that at least 4 years, 6 months and 1 day has elapsed from between patent filing and MA issuance, a zero or negative term SPC can serve as the basis for an extended SPC with a positive term.

The particular factual background to this case is discussed in our IP Update no. 153 (relating to the opinion of the Advocate-General that has effectively been confirmed by the Court). However, the essential points of the case, as well as possible actions that you may wish to take, are outlined below.

On 24 November 2011, the Court of Justice of the European Union (CJEU) delivered its judgement in two seminal cases relating to Supplementary Protection Certificates (SPCs). Potter Clarkson represented Georgetown University, University of Rochester and Loyola University of Chicago in one case and the party in the other case was Medeva. Our IP Update No 155 discusses the corresponding Advocate General's opinion, which opinion is superseded by the present judgement. The ruling provides significant clarity and is binding on all EU national patent offices and courts.

On 2 November 2011, the UK Supreme Court (formerly the House of Lords) handed down its decision in Human Genome Sciences Inc (HGS) v Eli Lilly and Company (Lilly), which was primarily concerned with the issue of industrial applicability of claimed biological material. The judgment provides some welcome clarification of the level of disclosure required for industrial applicability in this field to be recognised. The full decision can be found at tiny.cc/neutrokine.

Taking away with one hand, giving with the other?

Background: stem cell research, controversy and the law

Stem cells are able to differentiate into specialised cell types and therefore have great potential as tools for therapeutic tissue and organ regeneration. As a result, they are the focus of a considerable amount of academic and industrial research.

In our Newsletter issued in April of this year, we reported the publication of the Advocate General's opinion in the dispute between Interflora and Marks & Spencer, concerning the latter's bidding on the INTERFLORA trade mark as a "keyword", so that their website link features in a Sponsored Link/Adword section on the first page of results after "Interflora" is entered into the Google search engine.

Interflora sued Marks & Spencer in the UK for trade mark infringement, and the Court of Justice of the European Union (CJEU) has now responded to certain questions that were asked of it by the UK Court.

The UK Intellectual Property Office has called for those having an interest in the industrial design field to comment on the relationship between design and innovation.

The consultation has resulted from a recommendation in the Hargreaves Review of IP and Growth of the establishment of a legal framework that positively supports innovation in design-related industries.

Mike Snodin, a member of our SPC & Regulatory group, has published an article in the journal Scrip Regulatory Affairs that challenges the manner in which many patent offices in Europe calculate the terms of Supplementary Protection Certificates (SPCs) that are based upon a centralised (European Commission / European Medicines Agency) marketing authorisation.

US patent reform is moving the US patent system much closer to those of other countries, but there remain significant differences, particularly in how the availability of public disclosures and earlier patent applications as prior art is determined. In assessing the new opportunities that the new US patent system may present, it is important not to forget the requirements in territories outside the US.