Introduction to Supplementary Protection Certificates for Medicinal Products

In our previous discussions of antibody practice at the EPO, we observed that there was a (perhaps surprising) lack of case law to support the evolving practice of the examining divisions. Despite the high number of applications and patents relating to antibodies that have been prosecuted at the EPO more recently (>1000 granted in 2019), the quantity of Board of Appeal decisions concerned with “antibody inventions” remains relatively low. We counted only 21 published decisions in the last 3 years that we considered meet this definition. Each of the 21 decisions arises from an application with a filing date between 1999...

The CJEU issued on 9 July 2020 its judgment in the Santen C-673/18 case. The full text of the judgment can be found here .  The Santen decision overturns the earlier Neurim C-130/11 decision, which had held that it is possible under certain circumstances to obtain an SPC for a new therapeutic application of an active ingredient, even if that active ingredient has previously been authorised for other therapeutic applications.  

On 30 April 2020 the CJEU gave its ruling in C-650/17 (Royalty Pharma). The judgment, which is reviewed in detail below, confirms that SPC applications are allowable when the product is not explicitly recited in the claims. However, it is implied that the product will need to be disclosed to a high degree of specificity elsewhere in the patent. The case was previously joined with C-114/18 (Sandoz and Hexal) because both referrals concern the interpretation of Article 3(a) of the SPC Regulation. Article 3(a) requires that: “A[n SPC] shall be granted if…    the product is protected by a basic patent in force” However,...

On 11 September 2019 Advocate General Hogan issued his Opinion in connection with the combined referrals to the CJEU in Royalty Pharma C-650/17 and Sandoz C-114/18. Both referrals concern the interpretation of Article 3(a) of the SPC Regulation, which requires that: “A[n SPC] shall be granted if…    the product is protected by a basic patent in force” The full text of the Advocate General's Opinion is available here. The Opinion is not binding on the CJEU. It is the role of the Advocates General to propose to the Court, in complete independence, a legal solution to the cases for which they are...

On 11 June 2019 the EU published Regulation (EU) 2019/933. This introduces a so-called “manufacturing waiver” by amending existing Regulation (EC) 469/2009 concerning supplementary protection certificates (SPCs). The new Regulation is the result of a trilogue inter-institutional negotiation procedure between the European Commission, Council and Parliament, which concluded in February 2019 and is discussed here . The compromise text underwent a formal first reading at the European Parliament on 17 April 2019. It was approved by Council on 14 May 2019 and signed by the European Parliament and Council on 20 May 2019.

The CJEU issued on 21 March 2019 its judgment in the Abraxis C-443/17 case. The full text of the judgment can be found here .  The referral in Abraxis C-443/17 was made by Mr Justice Arnold of the English High Court in a case concerning an application for an SPC for the oncology product ABRAXANE®. This product comprises the active ingredient paclitaxel formulated in albumin-bound paclitaxel nanoparticles. Paclitaxel had been the subject of earlier marketing authorisations, albeit in different formulations.

On 28 May 2018 the European Commission published 1 a proposal for a change in the law (see discussion here and here ), which would permit third parties to manufacture a medicinal product protected by a Supplementary Protection Certificate for the exclusive purpose of export to countries outside the EU.

On 25 July 2018 the CJEU gave its ruling in C-121/17 Teva UK Ltd and others v Gilead Sciences Inc.

The European Commission published on 28 May 2018 a proposal 1 for a “manufacturing waiver” to permit third parties to manufacture a medicinal product protected by a Supplementary Protection Certificate for the purposes of export to countries outside the EU. The Commission aims to have the new legislation in place by 2019.

To what extent will a Supplementary Protection Certificate (SPC) for a biological product be considered to encompass closely-related alternatives such as biosimilars? This question has been addressed by the EFTA court in Pharmaq v Intervet, and subsequently applied by the Norwegian Court of Appeal. This briefing provides an analysis of the case as well as our conclusions and recommendations for those seeking SPCs for biological products.

In two judgments handed down on 13 January 2017 Mr Justice Arnold decided to send questions on the SPC Regulation to the CJEU for a preliminary ruling.  In each case the question reflects the lack of clarity provided by earlier key CJEU decisions, Medeva 1 and Neurim 2 . Article 3(a) is the product “protected by a basic patent in force”.

In its decision in Generics (Mylan) V Yeda & Teva, the UK Court of Appeal considered the extent to which subsequent evidence can be relied upon for the determination of inventive step. The Court closely followed the approach adopted by the EPO to the consideration of such evidence. The decision provides a useful summary of the manner in which the technical contribution provided by a patent is assessed.

2017 was a year of change for the Boards of Appeal of the EPO: a new President 1   and a move out of the EPO’s oldest building in the centre of Munich to a suburb, Haar.  There has been some recruitment, but overall it appears there are still many vacancies on various Boards.  Overall the relevant Boards issued 10% more decisions than in 2016 and Board 3.5.01 in particular has significantly increased its output in the latter part of the year as it now has a chairman.

Since the UK Court of Appeal judgment in Menashe v William Hill, it has not been safe to assume that infringement of a patent claim including a processor or a processing step can be avoided by performing the processing on a server outside the UK.  A third judgement on this topic has recently been issued – making the score two for infringement and one for non-infringement – so it is instructive to consider what factors affect a finding of infringement.  We review the relevant points of the three cases and draw some practical conclusions.

The Supreme Court in the UK handed down its decision in Warner-Lambert v Actavis on 14th November 2018 (and a copy of the complete decision is available here ). The Supreme Court considered the following issues in its judgment: how much data is required in the application as originally filed to support a second medical use claim; and the circumstances under which “cross label use” for the patented indication of a drug sold by a competitor company can constitute infringement of a second medical use claim.

The UK Patents Act was amended on 1 October 2014 to clarify the extent to which conducting clinical trials to assess the safety and efficacy of a patented drug can constitute patent infringement.  This briefing contains a discussion of the amendments and of the situation before the future European Unitary Patent Court (UPC).

Many countries have provisions which allow for compulsory licences to be granted under exceptional circumstances.  However, in recent years, these provisions have only rarely, if ever, been used.

The High Court of England and Wales was asked for permission to serve proceedings for UK patent infringement on a Chinese manufacturing company.  In considering whether or not to grant permission, the court had to consider the burden of proof when establishing infringement of a process claim.  It also considered whether or not the Chinese company could properly be said to be a joint tortfeasor.