Obtaining a Granted Euro-PCT Patent Before PCT National Phasing Deadline

Before the EPO parameters are defined as features which are based on directly measurable properties or combinations of several variables in the form of formulae. This might be a claim defined by the viscosity of a composition, or the particle size of a powder, for example. Relying on such features to define an invention is commonplace within the chemical sphere and can be very useful. However, their utility is not limited to such subject matter and they could be used to define characteristic features in a broad range of technologies. The EPO has developed a large amount of case law which...

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...

It does not seem possible to write any review of 2020 without mentioning Covid-19. However in this case we shall limit it to noting that the cancellation of most in-person oral proceedings at the EPO lead to a comparatively low number of published decisions by the electronic and software-focused boards of appeal (247 vs 339 in 2019) and that Board 3.5.03 held the first appeal hearing by video conference in May 2020. Previously only Examining Division Oral Proceedings had been held by video conference and rarely; it will now be quite routine, saving costs for applicants. On substantive issues it was...

The Technical Board of Appeal of the European Patent Office (EPO) issued its written decision in case T844/18 on 6 November 2020. The central issue was whether the patentees were legally entitled to claim priority. If not, the patent would be invalid for lack of novelty.

The UK Supreme Court has handed down an important judgment1 which is likely to have global implications for how standard essential patents (SEPs) are licensed in the future. Background A standard essential patent (SEP) is a patent which covers technology which is required (i.e. is essential) to be used in order to implement a technical standard (for example such as 2G, 3G and 4G in the telecommunications industry). Conforming to the technical standard allows devices from different manufacturers to operate together and to use the same infrastructure. Standard Setting Organisations (SSOs) bring participants together to evaluate technologies for inclusion in a new standard....

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 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 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,...

Patent protection may be obtained in the UK either by filing a European patent application with the European Patent Office and then validating a granted European patent in the UK, or by filing of a UK national patent application with the UK Intellectual Property Office (UK IPO). It is possible to file a UK patent application directly with the UK IPO, with or without a claim to priority from an earlier (e.g. foreign) patent application, or to enter the UK national phase from a PCT application. The official fees payable to the UK IPO for prosecution of a UK national application...

2019 has been another busy year for the EPO Boards of Appeal covering computer-implemented inventions, although the most significant case has not reached a conclusion.  In T 0489/14 (Pedestrian simulation/CONNOR) of 22.2.2019 questions relating to the patentability of simulations and modelling were referred to the Enlarged Board of Appeal, which has not yet set a timetable for a hearing and decision.  Although the questions asked are primarily related to the narrow field of simulation of physical systems, it is possible that the answers given could have a broader impact by affecting what is considered technical.

On 23 October 2019, Kitchin LJ handed down a judgment, available here , which brought to an end a 13-year long dispute between Professor Ian Shanks OBE FRS FREng and Unilever.  The case concerns a compensation claim made by Professor Shanks, in connection with several patents owned by Unilever directed towards glucose monitoring devices, for which Professor Shanks was the sole inventor (the “Shanks patents”).  Professor Shanks considered that his patents were of outstanding benefit to Unilever and, in accordance with Section 40(1) of the UK Patents Act 1977 (PA ’77), that compensation was due.

The EPO has recently revised the Rules of Procedure of the Boards of Appeal (RPBA) 1 . The revised RPBA will come into force on 1 January 2020. The revisions are fairly extensive and are primarily concerned with harmonising the practices of the various different Boards of Appeal. The EPO is also hoping that the changes will increase the overall efficiency of the appeal procedure. Many of the changes may require users of the European patent system to modify their day-to-day practice, both during first instance proceedings and in subsequent appeals. 

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.

Two recent decisions of an EPO Technical Board of Appeal emphasise the need for a proper technical context to be set out in claims to render an abstract idea patentable. The two appeals, by Ab Initio Technology LLC, related to inventions in the field of parallel processing, a field that seems on the face of it highly technical. However, the inventions were claimed as processes for converting computation graphs into a form better adapted for parallel processes but without specifying any steps of performing any processing, parallel or otherwise. At this level of generality the Board considered the inventions to...

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.

EPO Technical Board of Appeal 3.5.07 has, in case T 0489/14 (Pedestrian simulation/CONNOR), referred questions to the Enlarged Board of appeal concerning what is to be considered technical in the fields of design and simulation. The cases of Designing optical systems/Philips and Circuit Simulation I/Infineon have long been cited as precedent that the design or simulation of a technical system is itself technical and eligible for patent protection. However, some more recent cases have put limits on that proposition, suggesting that the technical system must be defined with sufficient specificity and that the purpose of the simulation might also be...

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.

2018 has been a year of increased productivity for at least those Boards of Appeal that cover software inventions (Boards 3.5.01 and 3.5.03 to 3.5.06). In particular Board 3.5.01 has returned to a similar level of productivity as the other Boards now that it has a Chairman. The main controversies continue to be the proper treatment of mixed inventions (those involving non-technical aims or features as well as technical ones) and how to determine what is and is not technical.

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.

This is the fourth year in a row that sections of the EPO guidelines for examiners relating to computer implemented inventions (CII) have been significantly amended. These amendments have come about as a result of a project within the EPO to harmonise the treatment of inventions involving computers and software across all examining divisions. In the EPO, inventions not relating to computer science per se are handled in various examining divisions according to the function performed by the computer and its software. Thus, significant variation in practice had arisen between different examining divisions. This year’s set of amendments is the...

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

The EPO operates a PCT service, PCT Direct, available to PCT applications which: name the European Patent Office as International Searching Authority; and claim priority from an earlier patent application which was searched by the EPO.   If a new PCT application fulfils both of these criteria, the Applicant may file a “PCT Direct letter” providing informal comments with the application. The Search Examiner is obliged to consider those comments when preparing the International Search Report and the Written Opinion on patentability.

A patent that has been granted by the European Patent Office may subsequently be made effective in any of the countries for which a designation, extension or validation fee has been paid. This process is commonly known as “validation” of the European patent. Some countries impose translation requirements as part of the validation procedure. In general, any required translations must be submitted within three months of the grant date of the patent.

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.

The EPO announced in January 2018 a number of changes to the rules and fee structure that come into force on 1 April 2018.  The key changes are (a) discontinuation of the reduced search fee for most European regional phase applications, (b) expansion of the window in which the third year renewal fee can be paid, and (c) changes to fee structure, including an increased appeal fee for most corporate appellants.  These changes are discussed in further detail below.

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 EPO has published its yearly update to the Guidelines for Examination, which came into force on 1 November 2017.  The updated Guidelines for Examination can be found here , with a list of the amendments made compared to the current version available here .

The EPO has published its yearly update to the Guidelines for Examination, which came into force on 1 November 2017.  The updated Guidelines for Examination can be found here , with a list of the amendments made compared to the current version available here .  An overview of the changes is provided in our news item here .

In May 2017, we reported  on two “CardinalCommerce” decisions 1  by EPO Technical Board of Appeal 3.5.01 that introduced the concept of a “notional business person” into in the examination of mixed inventions (inventions including both technical and non-technical features).  A new decision by the same Board ( T0630/11/Waterleaf ) provides some clarification of this approach, warning against over limiting what the notional business person can do and perhaps limiting the utility of the CardinalCommerce to applicants seeking to patent mixed inventions.

The UK Supreme Court’s judgment in Lilly v Actavis has profound implications for the scope of protection provided by patent claims in the UK. The judgment moves away from the principle that the patentee should enjoy the full extent, but no more than the full extent, of the monopoly that a reasonable person skilled in the art, reading the claims in context, would think he was intending to claim. Rather, following this new decision, a patent claim in the UK can be infringed by products or processes that are not within the ambit of the language used in the claims.

The planned European Union-wide patent court and related patent right will not launch in December as planned. The Unified Patent Court preparatory committee said June 7 that the delay was caused by several countries failing to agree to the protocol on UPC Provisional Application. The protocol allows parts of the UPC agreement, the controlling document for the court, to come into effect earlier.

The software industry has been a major beneficiary of the R&D tax credit regime in the UK.  Although more obviously suited to the manufacturing and pharmaceutical industries, the software industry can also benefit from UK Patent Box legislation. One aim of the Patent Box legislation is to provide an additional incentive to locate in the UK high-value jobs associated with the development and exploitation of patented technologies.  To achieve this the Patent Box legislation allows companies to pay a lower rate of UK corporation tax for profit attributable to qualifying patented technology.

Mr Justice Birss gave an important decision on 5 April 2017 concerning FRAND undertakings. FRAND stands for ‘fair, reasonable and non-discriminatory’ and the FRAND undertaking is the undertaking a patentee has to give when declaring a patent to be essential (‘essential’ meaning that it would inevitably be infringed by operating in accordance with a given standard) to the standards setting organisation (SSO) that it will grant licences on FRAND terms. Until this decision it was not clear exactly what ‘fair, reasonable and non-discriminatory’ meant nor the exact legal standing of the FRAND undertaking and while this decision cannot provide all...

In two Decisions published on 27 April 2017, EPO Technical Board of Appeal 3.5.01 has given valuable guidance on the treatment of inventions that implement business methods and given rare positive verdicts on two related applications. In the process, the Board has introduced the "notional business person" whose hypothetical actions need to be considered alongside the venerable "person skilled in the [technical] art".

The EPO introduced a revised accelerated prosecution procedure (PACE) on 1 January 2016. One key difference from the previous procedure is that it will now be possible to request PACE only once during the search procedure and only once during the examination procedure.

In decision G 1/151, the EPO’s Enlarged Board of Appeal ruled that an entitlement to partial priority arises for a generic claim in a European patent application in respect of subject-matter, disclosed in the priority filing, that is encompassed by the generic claim.  The Enlarged Board's conclusions prevent so-called "poisonous divisional" attacks, as well as the possibility of "self-collision" with the priority application, provided that the claims of the priority-claiming European application contain exclusively broadening amendments compared with the disclosure in the priority filing. However, the wider reasoning in the decision emphasises the continuing importance of carefully drafting both priority applications...

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”.

Notwithstanding surprising electoral developments in the UK and the US, 2016 was a continuation of business as usual for the Boards of Appeal of the EPO at least in relation to computer-implemented inventions. The Boards continued to apply the “Comvik” approach to examining mixed inventions, that is inventions involving both technical and non-technical features, but still did not offer any definition of what is and is not technical. Backlogs appear to have risen, due no doubt to the freeze on recruitment of Board members and consequent vacancies. This article discusses some statistics from 2016 of the various Boards of Appeal...

Since April 2014, it has been possible to file multiple divisional applications from any European patent application pending at the European Patent Office (EPO).   Divisional applications can be filed from a European application which is itself a divisional application.  Further, the EPO’s rules on double patenting are relatively liberal1.  In some cases, Applicants have used these rules to file multiple divisional applications with similar claims.  These divisional applications can then be kept pending at the EPO while challenges to the parent patent are determined in EPO opposition proceedings and/or in national litigation.  If the parent patent is revoked, or is found...

The UK Intellectual Property Office (UK IPO) and the European Patent Office (EPO) continue to receive reports of applicants and proprietors being approached for payment by firms offering to perform official processing such as registering patents and publishing patent applications.  These firms often use names, abbreviations and/or logos which are confusingly similar to those used by official offices such as the UK IPO, the EPO, and the World Intellectual Property Organization (WIPO).   

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).

In G 3/14 the EPO Enlarged Board of Appeal has ruled on the extent to which amendments made in EPO Opposition (and Opposition Appeal) proceedings may be examined for clarity, conciseness and support (Article 84 EPC).  They confirmed that compliance with Article 84 EPC may be examined only when, and to the extent that, the amendment introduces non-compliance with Article 84 EPC.  In particular an amendment which introduces the feature of a dependent claim may not be examined for Article 84 where the feature introduced corresponds to the complete dependent claim or is a simple alternative in such a claim.

Earlier this month a Judgment1 was issued by the Court of Appeal which reiterated the UK Courts’ approach to the exclusion of an invention relating to computer programs (as such).  The Court of Appeal rejected the Lantana application, upholding the Judgment issued by the Patents Court last year.  The Lantana claim includes two computers and a data retrieval system which allows a user at a first, local computer to obtain a file from a second, remote computer.  On request of the file, the local computer sends an email via the Internet to the remote computer, the email containing machine-readable instructions and an...

Section 7(2) of the Indian Patents Act requires that when an application is made “by virtue of an assignment of the right to apply for a patent for the invention” , then it is necessary to file “proof of the right to make the application” .  The so-called “proof of right” is normally a “Form 1” signed by the applicant and the inventors.  Alternatively, a certified/notarised copy of an assignment of rights in the invention in India from the inventors to the applicant can be filed in place of a “Form 1”. 

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.

Two recent decisions of an EPO Technical Board of Appeal recognise that recognition of human gestures, e.g. as a method of computer input, is technical.  The Board overturned refusal of two European patent applications relating to the recognition of specific sequences of human gestures using a computer touch pad.  In these refusals, the Examining Division had asserted that human gestures are inherently non-technical as a matter of policy and cannot therefore contribute to inventive step.

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.