Introduction to Supplementary Protection Certificates for Medicinal Products

With the entry into force of Regulation (EU) 2019/933 on 1 July 2019, the EU introduced a so-called “manufacturing waiver” by amending existing Regulation (EC) 469/2009 concerning supplementary protection certificates (SPCs).  Scope of the manufacturing waiver The amendments to the existing SPC Regulation have excluded certain acts from the protection conferred by SPCs. In particular, a third party (referred to as a “maker”) is permitted to manufacture a medicinal product protected by an SPC for the exclusive purpose of export to countries outside the EU 1 .

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,...

It is fairly common at the EPO in the fields of chemistry and biotechnology for applicants/patentees to rely upon data that are not present in the application as filed, and that were generated after the priority/filing date, to support arguments in favour of inventive step. Such data are often referred to as “post-published data”. They are often used to evidence some technical advantage associated with the claimed invention, as compared with disclosures in the prior art. That enables the patentee or applicant to define the “objective technical problem” solved by the claimed invention as that of providing an improved product...

Introduction It is a fundamental requirement of patent law that, in exchange for a monopoly right, a patent must disclose the claimed invention in sufficient detail to allow a person skilled in the relevant technical field to reproduce the invention. This requirement is known as sufficiency of disclosure in European practice and enablement in the US. Therefore, a biological deposit is often made, usually with an International Depositary Authority (IDA) under the Budapest Treaty, to ensure that subject matter relating to biological material that is not publically available and/or which cannot be adequately described by other means, is sufficiently disclosed. The sufficiency/enablement...

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.

Article 53(c) EPC specifies various patentability exclusions, including “diagnostic methods practised on the human or animal body”. This exclusion was considered in opinion G1/04 1 of the Enlarged Board of Appeal. The Enlarged Board identified two requirements that must both be met for a claim to be excluded from patentability. Firstly, the claimed method must include all the steps necessary to reach a medical decision on diagnosis. Secondly, all the technical steps of the method must require the presence of the human or animal body. This two-part test has subsequently been developed in several Technical Boards of Appeal decisions.

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.