Introduction to Supplementary Protection Certificates for Medicinal Products

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.

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

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.

Recent weeks have seen important developments in the debate on patent-eligibility of plants in Europe, with the EPO’s Boards of Appeal and its President, Administrative Council and member states pulling in opposite directions. The President has now referred questions, published today, to the Enlarged Board of Appeal, but the admissibility of the referral is uncertain, so it is unclear how or when the Enlarged Board will react. Applicants in this field will therefore face further delay and uncertainty. More generally, this is also a highly unusual, polarised situation that highlights the potential for conflict between different branches of the European...

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.

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.

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.

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.

On 14 May 2020 , the EPO’s enlarged board of appeal issued its decision in case G3/19 (“Pepper”). This derives from a referral made to the enlarged board by the EPO president in April 2019, which aimed at resolving some outstanding questions regarding patent-eligibility of plants under Article 53(b) EPC . Contrary to earlier case law, G3/19 confirms that plants that are the products of essentially biological (i.e. breeding) processes are not patent-eligible.

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...

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”.