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

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...

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.

Parameters are characteristic values of a product or process which are generally based on directly measurable properties. Typical examples of such features are the melting point of an alloy, the particle size of a powder or the performance of a material when subjected to stress in a particular way. Parameters can usefully be relied upon to define an invention before the EPO and they can be the most effective way of ensuring that the claims provide an adequate scope of protection for an inventor’s contribution. They are commonly used within the chemical field, but could find applicability in a wide variety...

In 2021, reporting of the case law of the EPO Boards of Appeal in the field of IT & computer-implemented inventions has been dominated by two topics: the Enlarged Board’s decision relating to simulation and the rejection of two applications for inventions created by the artificial intelligence “DABUS” for failure to designate a human inventor. The simulation decision could well become the most important decision in this field as it endorses and summarises 20 years of case law since the well-known Comvik decision. The DABUS decisions follow the line taken in the UK and US that a human inventor must...

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.

Last year we provided a review of 21 EPO Board of Appeal cases relating to “antibody inventions” that were decided and published between January 2018 and January 2021. At the time, we observed that this relatively small number of decisions was consistent with our view that there had been relatively little case law in this field, despite the high number of applications and patents relating to antibodies that have been prosecuted at the EPO in the same period. Now considering the activity of the Boards of Appeal in the calendar year of 2021, we see some evidence that the trend...

When IP-protected goods are placed on a particular market by, or with the consent of, the IP right holder, there is a generally accepted legal concept worldwide that the corresponding IP rights are ‘ exhausted ’ at least in the market in question. This means that the owner of the IP rights cannot subsequently rely on them to prevent the further distribution or resale of those goods within the relevant market.

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...

In G 3/14 the EPO Enlarged Board of Appeal 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.

It is possible at the EPO to accelerate the search and/or examination of any application using the accelerated prosecution procedure (PACE) 1 . To use the procedure, it is necessary to file a PACE request online using the appropriate form. Other than this, there are no special requirements to qualify for PACE: the request can be filed at any time, no official fee is payable and no special reasons need be given. 

The Enlarged Board of Appeal of the EPO has, in case G 01/19 (Pedestrian simulation), issued a decision regarding the patentability of simulations under the EPC. This decision was eagerly awaited as the referral to the Enlarged Board raised fundamental questions about the patentability of simulations at the EPO.  Given that simulations of technical systems had generally been considered patentable with some caveats to be applied on a case by case basis, this decision had the potential to have wide reaching consequences regarding a significant and growing area of innovation in Europe. 

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 .

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 High Court of England and Wales has recently handed down its judgment in Illumina Cambridge Limited vs Latvia MGI Tech SIA and others. This is one of the last judgments handed down in the High Court by Mr Justice Birss, who was recently elevated to the Court of Appeal. The judgment touches on a number of important aspects of patent infringement and validity, including the first application of the recent Supreme Court decision in Regeneron Pharmaceuticals Inc vs Kymab Ltd relating to sufficiency. In this briefing we consider four aspects of the judgment: one relating to sufficiency of disclosure, one...

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.

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...

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...

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.

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.

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 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.

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".

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...

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...

In 2015 the Boards of Appeal of the EPO continued to develop the “Comvik” approach to examining mixed inventions, that is inventions involving both technical and non-technical features, but again declined to define what is and is not technical.  This article discusses some statistics from 2015 of the various Boards of Appeal that consider software inventions and some interesting or notable decisions. 

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).

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.

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.