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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 not to cover an alleged infringement, the Patentee can then bring forward one of the pending divisional applications, perhaps after amending the claims to take account of issues raised during the challenge to the parent patent.
This practice can, of course, significantly increase the time and expense required for third parties to clear the way for launch of a competing product. Such third parties can face the prospect of multiple sequential litigation as various divisional applications are granted by the EPO.
The case of Fujifilm Kyowa Kirin Biologics (“FKB”) v AbbVie Biotechnology Ltd involves the Humira® antibody, the highest selling prescription drug in the world by global sales. Patent protection for the antibody per se is due to expire in October 2018. FKB is seeking to clear the way for the launch of a biosimilar product, and to that end had opposed a patent held by AbbVie for specific dosages of Humira®.
AbbVie initially contested the EPO opposition proceedings on its dosage patent, but in November 2015 AbbVie disapproved the text of the granted patent. This led to the automatic revocation of the European patent without a reasoned decision from the Opposition Division. However, AbbVie had filed four divisional applications, the last of which was said to claim essentially the same subject matter as the parent patent which had been revoked.
FKB therefore asked the High Court to grant a Declaration to the effect that it was obvious, at the priority date of the patent applications at issue, to use its biosimilar product to treat various diseases at the relevant dosages. If such a Declaration were to be granted, it would of course prevent AbbVie from asserting any patents derived from any of its divisional applications against the FKB biosimilar product when it is launched in the UK.
AbbVie applied to strike out FKB’s action on the basis that the High Court does not have the necessary jurisdiction to grant the Declaration, and Judge Henry Carr heard the application2.
When considering whether or not the case could proceed, the High Court reviewed Arrow v Merck3 from 2007. In that case Arrow applied for a Declaration that as of July 1997 it was obvious to use sodium alendronate trihydrate in the form of a tablet containing about 70 mg active ingredient for oral administration for the treatment of osteoporosis. Arrow wanted this Declaration in order to forestall any future infringement actions brought by Merck based on yet-to-be granted divisional patents which covered such a product. If Arrow’s product was an obvious one to make in 1997, the priority date of the yet–to-be granted divisionals, then any patent infringed by that product would necessarily lack inventive step.
The Arrow case was obviously a powerful precedent – so much so that Judge Carr coined the phrase “Arrow Declaration” to describe the sort of order which FKB was seeking. In the previous Arrow case, the High Court had decided that the English court could in principle grant declaratory relief along the lines sought by Arrow (although the case then did not progress further because Merck withdrew the designation of UK in the European division applications at issue). Further, there was a corresponding Dutch litigation between Arrow and Merck where the Dutch court did proceed to issue a Declaration that the alendronate tablets at issue were obvious at the relevant date.
Faced with the Arrow v Merck precedent, AbbVie argued that the court was wrong in that earlier case to conclude that it is permissible to make Declarations about whether or not a product is obvious.
AbbVie’s arguments were that:
The High Court acknowledged that there were force in these submissions, but ultimately dismissed these arguments and held that the English High Court did have jurisdiction to grant an “Arrow Declaration” to the effect that specific products were obvious at a particular date. However, the Court did accept that such Declarations should not be granted as a matter of course, simply because there are pending applications at the EPO. A full analysis of facts will be needed in each case. The Court also helpfully outlined the factors to be considered in determining whether or not a Court should entertain proceedings for an Arrow Declaration, as follows.
On the facts of this case these criteria were satisfied by FKB, and the Court therefore permitted the proceedings for Declaratory relief to proceed.
Given the real difficulties which can be faced by generic companies seeking to clear the way for a product launch in the face of multiple pending divisional applications, it is likely that such “Arrow Declarations” in the High Court will become an increasingly important weapon in the armoury available to generic companies. By way of example, Samsung Bioepis UK Limited has issued a claim in the same terms as FKB’s claim for the same product. In many cases, these “Arrow Declarations” will represent an efficient and cost effective option for achieving legal certainty in a short timescale.
Innovator companies will therefore need to consider carefully their strategy when filing divisional applications, to minimise the risk that an Arrow Declaration might become an option for generic challengers. J A Kemp is well placed to advise on the issues to consider either when seeking to optimise patent protection for an existing product, or when seeking to clear the way for launch of a competing product.
29 June 2016
31 December 2021
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...
10 December 2021
The issue of “double patenting” arises in the EPO when one applicant files two European patent applications with closely related claims and the same effective filing date. Two situations where double patenting commonly needs to be considered are: when the claims of a divisional application overlap with the claims of its parent application; and when a first European patent application claims priority from a second European patent application and the claims of the first application overlap with the claims of the second application.
08 October 2021
Introduction Supplementary Protection Certificate (SPCs) for medicinal products are intellectual property rights intended to compensate patent holders for the loss in effective patent term that results from the time taken to receive marketing authorisations for such products. An SPC takes effect at the expiry of the normal term of the patent on which it is based, and expires at whichever is the earlier of (i) 15 years from the first marketing authorisation in the EU/EEA, and (ii) 5 years from the expiry of the basic patent. Usually, therefore, the maximum term of an SPC is 5 years. However, the term of an...
21 September 2021
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 will become increasingly important as more and more biological medicinal products, and their competing biosimilars, enter the marketplace. We expect to see the issue arise before the national courts of the EU and the UK, and ultimately – at least for EU member states – the question is likely to require a referral to the CJEU. Until that happens, however, arguably the best available guidance is that provided by the EFTA court in 2015, in its...
20 September 2021
An orphan drug, or orphan medicinal product, is a medicine that is developed to treat a rare disease, defined as a disease affecting a relatively small number of people as a proportion of the population. In recognition of the fact that the commercial market for such medicines is small, regulators have sought to provide economic incentives for their development. In this briefing we review the major aspects of orphan drug legislation and the available incentives in the EU/EEA and UK.
20 September 2021
In order to place a new medicinal product on the market in Europe, it is necessary first to obtain a marketing authorisation. Most applications for marketing authorisations are made through a centralised procedure with the European Medicines Agency (EMA) which effectively leads to authorisation in all EU/EEA member states1, although other routes are available. Regardless of the route, an application for marketing authorisation must be supported by a dossier, referred to at the EMA as the common technical document (CTD), which demonstrates the quality, safety and efficacy of the medicinal product. The dossier will include non-clinical pharmacology and toxicology data,...
16 August 2021
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.
12 August 2021
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...
28 July 2021
This introductory briefing sets out what a biological deposit is, why a biological deposit may be needed, and basic requirements for making a biological deposit and relying on it in a patent application, with a particular focus on practice before the European Patent Office (EPO). A complementary briefing goes on to consider strategic aspects relating to biological deposits, including how it might be possible to remedy certain deficiencies relating to them.
28 July 2021
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...
23 June 2021
Crowdfunding can be a great way of raising funds. However, if you fund your business in this way you need to consider carefully how to protect your valuable intellectual property (IP). Crowdfunding involves wide and rapid disclosure of information. This can be beneficial to your business but may also pose some risks to your IP.
04 June 2021
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.
04 June 2021
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.
04 June 2021
Parameters are generally used in patent claims to define subject matter which cannot be expressed in terms of structural features. They are often relied upon for inventions in the chemical field, but can in fact be used in any technical area. Parameters can relate to features that can be measured directly, such as the density or melting point of a substance; measured indirectly, such as the tacticity of a polymer; or that can be calculated, such as the superficial velocity of a flow in a reactor. They can also be expressed in terms of relationships between such features.
04 June 2021
European Patent Office (EPO) opposition procedure comprises two parts: opposition division (first instance), and, if relevant, appeal. A typical procedure is set out on the attached flow chart. It is also possible to petition the Enlarged Board of Appeal for review of the appeal decision under certain very limited circumstances. There are some fixed time limits in the overall procedure, such as the deadline for filing an opposition and an appeal. However, there is also some flexibility in the procedure. The EPO announced in June 2016 that it aims to issue first instance decisions on “straightforward” oppositions within 15 months....
24 May 2021
Whatever the technology, IP can form a significant intangible asset for a company. In addition to legally protecting the company’s products and activities from being copied by competitors, IP can generate revenue through licensing or sales, it can protect market share and increase return on a company’s R&D investment. IP therefore plays a vital role in establishing the value of a company. When looking to invest in a company that holds IP, a good understanding is needed, not only of what IP a company holds, but how that IP adds value to the company. IP is not just a matter...
05 May 2021
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.
03 May 2021
A common misconception is that ownership of IP rights associated with a product gives an automatic right to make and sell that product. However, IP rights such as patent and design rights are best viewed as ‘negative’ rights, which allow the owner to prevent other parties from using the invention, mark or design. They do not provide an automatic right to practice the invention or to use the design.
03 May 2021
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 .
29 April 2021
The efficacy of PPH varies from territory to territory. In some patent offices there is a history of examination being influenced by the granting of a patent by particular patent offices; PPH may work well for such patent offices. In other patent offices, requesting PPH only results in acceleration and does not guarantee allowance.
29 April 2021
The aim of the Patent Prosecution Highway (PPH) is to provide a way for applicants to use positive examination results from one patent office to streamline prosecution in a second patent office. An evolving network of different PPH agreements exists between various patent offices, including most major patent offices. For both the European Patent Office (EPO) and the UK Intellectual Property Office (UKIPO) requesting PPH results in acceleration of examination and does not guarantee allowance.
01 April 2021
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).
31 March 2021
Obtaining patents for polymorphs can be challenging. However, before the European Patent Office, there is no general rule which makes polymorphs less patentable in principle than other subject matter. With careful drafting and consideration of any specific advantages associated with the polymorph of interest, European patents directed to polymorphs of commercial significance can be obtained. Such patents can act as additional barriers to entry of generic products onto the market, and can thus be very useful in managing the life cycle of a patent estate for pharmaceutical and other biologically active compounds.
08 March 2021
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...
01 March 2021
The European Patent Office (EPO) applies the same basic patentability criteria to antibodies as to other inventions. However, the high volume of applications in this area means that examiners have developed standardised approaches to assessing “antibody-specific” issues and these have recently been formalised in a new section of the EPO’s Guidelines for Examination (G, 11, 5.6; issued March 2021). For an explanation of the basic approach adopted by the EPO, please see our related briefing Antibodies in the European Patent Office – Basic Principles or ask your usual J A Kemp contact. This briefing is intended to develop those Basic...
01 March 2021
Over recent years, antibodies have become increasingly important as therapeutic drugs and large numbers of patent applications are filed in this area (>1000 granted by the European Patent Office (EPO) in 2019). Whilst patentability is assessed in the same way as for any other invention, the high volume of cases means that examiners have developed standardised approaches to assessing “antibody-specific” issues. These informal principles have recently been formalised in a new section of the EPO’s Guidelines for Examination ( G, 11, 5.6 ; issued March 2021).
16 February 2021
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...
10 February 2021
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...
01 February 2021
In the UK, marking patented products as patented is not compulsory. However, there are several benefits to marking products as patented and both guidance from the UK Intellectual Property Office, and UK law, effectively encourage this practice. However it is important for patentees considering marking their products as patented to ensure that this is done correctly because failure to do so can potentially lead to adverse consequences. This briefing provides an overview of patent marking in the UK and some practice points for patentees to bear in mind when considering whether and how to mark their products.
27 January 2021
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...
07 December 2020
This document is intended to provide a brief introduction to Supplementary Protection Certificates (SPCs) for plant protection products. For more detailed information, please speak to your usual J A Kemp contact.
07 December 2020
This document is intended to provide a brief introduction to Supplementary Protection Certificates (SPCs) for medicinal products. For more detailed information, please see our full briefing on this topic.
02 December 2020
What are SPCs? A Supplementary Protection Certificate (SPC) is an intellectual property right available for active ingredients of human and veterinary medicinal products requiring marketing authorisation 1 . The highest tribunal hearing disputes involving SPCs for EU member states is the Court of Justice of the European Union (CJEU). Historically there have been numerous referrals to the CJEU on points of law relating to SPCs and this is expected to continue. Some of the key decisions are discussed below.
24 November 2020
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.
18 November 2020
The European Patent Office (EPO) uses oral proceedings as a means to bring pre-grant examination and post-grant opposition proceedings to a close. Oral proceedings will be appointed when the EPO considers it expedient to discuss outstanding issues face to face and/or at the request of any party to the proceedings. Consequently, the majority of EPO oppositions conclude with oral proceedings. Oral proceedings are rarer during pre-grant examination, but are typically appointed when the EPO intends to refuse the application. The Boards of Appeal also hold oral proceedings during the appeal procedure.
28 August 2020
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....
22 July 2020
The deadline for requesting entry of a PCT application into the European regional phase is 31 months from the filing date or, if priority has been claimed, from the priority date (Rule 159(1) EPC). However, if this deadline is missed, remedies are available that may permit entry into the European regional phase later than this deadline.
10 July 2020
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.
10 June 2020
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.
01 June 2020
What is a patent? A patent is a legal monopoly granted by a government in return for public disclosure of an invention. A granted patent gives the proprietor the right to prevent others using the invention in the territory to which the patent applies. A patent does not, however, give a positive right to use an invention. There may be earlier patents for other inventions that an inventor may need to license to exploit his own invention.
30 April 2020
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,...
25 March 2020
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...
22 January 2020
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.
12 November 2019
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.
08 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...
13 February 2019
In 2014, the EPO launched the Early Certainty initiative to speed up the patent granting process. This initiative has resulted in speedier establishment of search reports and a shorter examination procedure. As can be seen from the chart, the result is that the number of EP patents granted since the launch of the initiative has increased far more quickly than the number of patent applications filed. This is confirmed by our experience, in which a quicker turnaround time has been noticeable, with an increasing number of applications proceeding to grant directly after a response to the search report is filed.
13 February 2019
This briefing explores the options available to applicants in the event that the deadline for filing a PCT has been missed. In this context we refer to the deadline for filing a PCT application that is set by the twelve month deadline for claiming priority under the Paris Convention. A successful claim to priority may be important, particularly if the applicant has disclosed their invention after filing their first application and wishes to proceed with national and/or regional phases in which no grace period is provided for disclosures by the inventor/applicant.
13 February 2019
Re-establishment of rights under Article 122 EPC may be used to recover rights lost as a result of missing a deadline set by the European Patent Office. The requirements of this provision are shared with a number of restoration systems worldwide. There is much variation from regime to regime. However, the European Patent Office approach is well established, with a history of case law that makes it clear what is needed to successfully recover rights in Europe.
13 February 2019
The central issue when seeking restoration or re-establishment of rights in many countries is establishing that due care was taken. This is certainly true of cases before the European Patent Office. This paper reviews what issues may need to be addressed in order to demonstrate due care to the European Patent Office when preparing grounds for re-establishment of rights. Other offices, such as the International Bureau, follow a similar approach to the European Patent Office.
31 January 2019
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.
04 December 2018
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.
19 October 2018
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...
25 July 2018
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.
06 July 2018
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.
15 June 2018
Trade secrets, and the law relating to them, can seem a bit of a ‘black art’, but the basics are very simple. In summary, companies should 1) know what their trade secrets are and 2) take steps to keep them secret.
14 June 2018
The EPO has long adopted an approach to consideration of inventive step known as the problem and solution approach. Although this approach is fundamentally the same across most technical areas, special considerations apply for software related inventions. Firstly, the EPO looks for an invention to be the technical solution to a technical problem and so disregards non-technical aims/features, which are common in software fields. Secondly, the EPO Boards of Appeal often have quite high expectations of the capabilities of the ordinary person skilled in the art and thus a high threshold for inventive step. We discuss these issues below with...
05 March 2018
Claiming small entity status on a US application or patent provides a reduction in official fees. Most fees (e.g. basic filing fee, examination fee, search fee, etc.) are reduced by 50%, so the saving is significant. There are some risks but these may be mitigated. Where available, small entity status is attractive to many applicants.
17 January 2018
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.
10 January 2018
The European Patent Office (EPO) uses the term “ disclaimer ” to refer to a negative feature in a claim of a patent application. Negative features are those which exclude certain subject matter from the scope of protection. While a positive feature in a claim may for instance take the form “ wherein the composition comprises X ”, a disclaimer would take the form “ wherein the composition does not comprise X ”.
14 December 2017
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.
14 November 2017
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.
26 July 2017
Experimental evidence can play a valuable role in patent litigation. It is not uncommon in patent validity proceedings for an expert will say to they would, when presented with a piece of prior art, have conducted a particular experiment in order to progress the research. Without then conducting the actual experiment that they said they would have done, it is impossible to know what the result of that experiment would have been. Knowing the result of that experiment is sometimes critical to a case, such as when the defendant argues the patent is invalid due to lack of novelty or...
21 July 2017
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.
01 July 2017
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.
31 May 2017
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.
29 May 2017
Intellectual property (IP) rights are legal rights which provide protection for your innovative and creative endeavour. For example, IP could relate to something that you have created, such as a brand, an invention or a design, or could relate to information that you have developed or collated. When people talk about IP, they usually mean IP that can be registered: trade marks, patents and designs. However some IP rights arise automatically (so-called unregistered rights), such as copyright and unregistered designs. Each form of IP right has a different purpose in protecting a different aspect of your work and can be...
12 May 2017
When seeking patent protection, most companies start with a single national patent application but may then wish to seek protection in other countries. This briefing outlines points to consider in selecting the countries to cover, the international schemes available and the timing of the decisions to be taken. There are several advantages to filing a UK application first, even if you are not UK based. The UK Intellectual Property Office carries out searches quickly and cheaply; this can give you an indication of the patentability of your invention before you incur the costs of filing in other countries. UK applications must...
03 May 2017
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".
04 April 2017
You have a new technical idea. When will you be ready to draft a patent specification? When will it be appropriate to file an initial application at the Patent Office? Are there any potential issues with filing an application early and making a follow-up application later? This Briefing sets out some of the factors to consider in addressing such questions.
01 April 2017
The Supreme Court, the highest Court for England and Wales, has given guidance as to considerations to take into account when deciding whether an activity can be regarded as “making” a patented product and thus infringing a patent. This Decision has relevance for activities including reconditioning and repairing of patented articles and for sale of spare parts and even consumables of larger patented articles. The Decision makes it clear that the question of whether an activity is “making” is “one of fact and degree”. The Decision concludes that there are no fixed principles nor any single simple test to assess what constitutes...
01 February 2017
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...
02 January 2017
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...
19 May 2016
In the 2016 decision T 2440/12-Fluid flow simulation/SIMCON, Technical Board of Appeal 3.5.07 has found that a commercially available software package makes the methods it embodies available to the public because it could be run line-byline in a virtual machine (VM).
12 May 2016
The Patent Box makes the existence of a patent more attractive, whatever the breadth of the patent’s claim, so long as it covers the product (or process or service). A company may wish to adapt its strategies both for filing and prosecuting patent applications and for patent and patent application abandonments.
12 May 2016
In order to benefit from the Patent Box, the beneficiary must be a qualifying company as defined in the legislation. We discuss here the requirements of a qualifying company.
12 May 2016
In order to benefit from the Patent Box, a company must hold or have an exclusive license to a qualifying IP right. Here we discuss the definition of a qualifying IP right.
12 May 2016
We discuss here issues relating to which income streams can qualify for the Patent Box. The Patent Box legislation defines what income streams count as relevant IP income. The calculation of relevant IP income is used in determining an amount deductable from the profits of the trade for the calculation of UK Corporation Tax liability. Determining the amount deductable from the profits of the trade will ultimately lead to the amount of UK Corporation Tax due being equivalent to paying a rate of 10% on the relevant IP income (following certain deductions as explained in our separate Briefing “Patent Box...
12 May 2016
A company must elect in to the Patent Box regime in order to take advantage of the reduction in payable UK Corporation Tax. For some companies there may be advantages in delaying entry into the Patent Box. This Briefing looks at this issue.
12 May 2016
We outline here the accounting steps which are necessary to calculate the Patent Box benefit. We also present a simplified example calculation which may help you to estimate the amount of saving in UK Corporation Tax you might expect to make if you were to elect in to the Patent Box regime under either the pre- or post- 1 July 2016 Patent Box rules.
28 January 2016
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.
26 November 2015
A patent is a legal monopoly granted by a government in return for public disclosure of an invention. A granted patent gives the proprietor the right to prevent others using the invention in the territory to which the patent applies.
24 September 2015
Third party patents can represent significant obstacles to achieving a commercial goal. The opposition procedure at the European Patent Office (EPO), if used successfully, can provide a cost-efficient mechanism for removing or limiting a troublesome patent. As a general rule, it is relatively cheap compared to national litigation and the centralised procedure means that revocation or limitation of a European patent in the opposition procedure applies in all of the validation states. However, EPO oppositions are often slow, in particular when the appeal stage is taken into account.
03 September 2015
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).
05 March 2014
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”.
18 November 2013
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.
01 October 2013
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.
19 September 2013
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.
18 September 2013
Transforming research carried out in institutions such as universities and hospitals into commercial products and services can be a long and complex journey, but the results can provide significant income for the institutions involved, as well as improving the lives and prosperity of the public. IP often plays a central role in the success or failure of a project. It is crucially important to adopt the right strategies, both in terms of how an IP portfolio is grown and how it is used.
28 August 2013
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.
16 August 2013
Article 53(c) EPC specifies a number of exceptions to patentability in the field of medicine, including “ methods for the treatment of the human or animal body by surgery ”. These exceptions to patentability were included in the EPC on socio-ethical and public health grounds to ensure that medical and veterinary practitioners remain free to take any action necessary to treat or diagnose illnesses.
12 March 2012
After your patent application has been filed at one (or more) of the many Patent Offices around the world, it will be processed by that Patent Office. This is known as the patent “prosecution” process. This Briefing provides an overview of what to expect. However there are many local differences to take into account. The law and practice that govern the details of the procedures followed by the Patent Office vary widely from country to country. The cost involved and the time taken to process applications also vary from country to country, and indeed from case to case.
12 March 2012
Which new ideas are worthy of a patent application? How should the applications be drafted and prosecuted? When should they be filed? Where in the world should they be filed? How long should applications and granted patents be maintained? A systematic answer to these questions is provided by a patent strategy. A patent strategy is part of an overall intellectual property (IP) strategy. It is usually the most important part of such a strategy for technology-based companies. The IP strategy should follow the company’s R&D strategy which in turn should follow its overall business strategy.
06 November 2018
The Court of Appeal has given its decision in the appeal against Birss J’s decision in Unwired Planet International Ltd v Huawei Technologies Co Ltd relating to standard essential patents (SEPs) and how to determine fair, reasonable, and non-discriminatory (FRAND) terms. The Court of Appeal upheld Birss J’s decision (which we reported here) in all respects except one, holding, in summary, that a global licence was FRAND in this case, and that the FRAND requirement does not require the patentee to grant licences on equal terms to all third parties. The Court of Appeal overturned Birss J’s decision that there...
02 August 2018
The CJEU has dismissed Nestlé’s appeal on the acquired distinctiveness of the KitKat bar. The Court has re-affirmed the principle that, for an EU trade mark to be registered on the basis of acquired distinctiveness through use, the acquisition of distinctive character needs to be shown in every Member State of the EU in which it did not, ab initio, have such character. It remains to be seen whether the CJEU decision signals the end for Nestlé’s trade mark registration, or is merely one decision in a series of appeals set to continue for some years to come.
04 April 2017
The Intellectual Property Enterprise Court (IPEC) is an alternative venue to the High Court of England and Wales for intellectual property litigation, patent, design, trade mark, copyright and trade secret cases. The IPEC typically hears less complex cases than the High Court (Patents Court), and provides monetary caps on claims. The IPEC (formerly known as the Patents County Court) has proved attractive, in particular for small and medium sized enterprises (SMEs), as a fast and cost effective IP litigation forum. There is a cap on the monetary value of claims before the IPEC of £500,000. J A Kemp’s Litigation and Dispute...
04 April 2017
Whether or not it is worth filing intellectual property rights IPRs in China is likely to be influenced by how you plan to develop your business. Are you planning to exit by selling your business, or assigning or licencing your product globally? Most investors and buyers will look for Chinese IPRs, and if you have none then this may affect the level of interest, or the price you can obtain. If on the other hand you are planning to grow your business yourself, then you should consider whether the cost of filing and maintaining an intellectual property right in China...
08 December 2016
We are pleased to report the successful enforcement of our client Action Storage Systems Limited’s UK unregistered Design Rights in their highly successful eXtreme plastic locker. The IPEC judgement, handed down by Judge Hacon on 7 December, demonstrates the power of the unregistered Design Right in restraining copying and the power of disclosure in revealing evidence of copying. Various defences were raised and although none displaced the fact of infringement of the overall design, they did give rise to some interesting points of law.
01 November 2016
In July, the U.K. repealed a provision that provided a shortened term of copyright protection for ‘‘artistic works.’’ Because this change also revives protection that had expired under the old law but would be revived under the new, rights holders in certain industries such as furniture makers may now have resurrected rights that can be asserted against those copying their works.
10 February 2016
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.
23 June 2015
The Court of Appeal has delivered its decision on Roger Maier and Assos of Switzerland SA v. ASOS plc and ASOS.com Limited, the latest in a long-running series of trade mark disputes between Assos, the manufacturer of high-quality cycling clothing and sportswear, and Asos, the online fashion retailer. The case considers the extent to which an infringer is able to rely on the “own name” defence to trade mark infringement under Article 12 of the Community Trade Mark Regulation (CTMR).
16 June 2015
On 11 June 2015, the Opinion of Advocate General Wathelet was delivered in Case C-215/14, Nestle v Cadbury, a case concerning the registrability of the shape of the well-known Kit-Kat chocolate bar.
04 March 2015
In the first High Court trade mark judgement of 2015, Mr Justice Arnold recently delivered his decision in Enterprise Holdings, Inc v Europcar Group UK and Another  EWHC 17 (Ch). The well-known car rental companies were in dispute over the fact that both use an ‘e’ logo on a green background, with Enterprise claiming that Europcar’s use of its ‘e’ logo infringed Enterprise’s earlier rights in its own ‘e’ logo. Arnold J held that, although the marks were only similar to a low degree, there was a likelihood of confusion, and found in Enterprise’s favour on the grounds of trade...
19 December 2014
The CJEU has delivered its decision on Case C-205/13 Hauck GmbH v Stokke A/S & others regarding the registrability of shapes as trade marks. The case concerns the grounds for refusal or invalidity of a shape trade mark under Article 3(1)(e) of the Trade Marks Directive (2008/95/EC), which provides that a sign shall not be registered as a trade mark or, if registered, shall be liable to be declared invalid, if it consists exclusively of:
15 June 2014
Do Not Immediately Contact the Infringer! You may discover or suspect that someone is infringing one or more of your IP (intellectual property) rights. It could be a patent at the core of your business, a trade mark protecting your main brand or an important product design. When you become aware of the situation, you may be tempted to go straight into battle and take immediate action. Your first instinct may be to contact the infringer straight away and tell them to stop infringing.
05 March 2014
In a previous briefing (Design For “Trunki” Child’s Wheeled Suitcase Successfully Enforced), we reported the successful enforcement of Magmatic’s Community design for the “Trunki” against PMS International’s “Kidee Case”. PMS were, however, successful in their appeal, leading to the decision at first instance being overturned in the Court of Appeal. The appeal addresses some important questions regarding the interpretation of the registered design and on what level a comparison should be made with an alleged infringement.
29 July 2013
The Court of Justice of the European Union (CJEU) has recently issued its decision in response to a reference from the English Court of Appeal. In Case C-252/12, 18 July 2013, Specsavers International Healthcare Ltd, Specsavers BV, Specsavers Optical Group Ltd, Specsavers Optical Superstores Ltd v Asda Stores Ltd, the CJEU held that a figurative mark is put to genuine use where a word mark is superimposed over it, provided that the distinctive character of the figurative mark remains intact. The CJEU has also held that where a figurative mark is registered in black and white, but has been used...
20 March 2013
The Court of Justice of the European Union (CJEU) has recently handed down a rare judgment concerning the circumstances in which a trade mark can be found to have become the generic name of a product. In Case C-409/12 Backaldrin Osterreich The Kornspitz Company GmbH v Pfahnl Backmittel GmbH, 6 March 2014, the CJEU found that it is the perception of the end consumer, rather than intermediaries within the supply chain, which is determinative. If these consumers recognise a sign as the name of the product, rather than an indication of its trade origin, then the mark has become generic,...