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 inventive step or indeed sufficiency.
Experimental evidence is also frequently needed to ascertain the fact of whether or not an allegedly infringing product falls within the claims of a patent. For example, are the particle sizes of the allegedly infringing product within the range specified in the patent? Is there any of the infringing product in the mixture being marketed? Unless the opposing party is prepared to admit the fact in question, the party asserting the fact will need to prove it by experiment.
Experimental evidence is permitted in a number of jurisdictions in Europe, including in oppositions at the European Patent Office (EPO). However, the most rigorous testing of experimental evidence, and therefore the most reliable evidence, is in the High Court of England and Wales.
Any party may submit a report of an experiment at the EPO or in a civil law trial, but the content of that report cannot be challenged in cross-examination and there is little opportunity to explore the details of the experiment or how the experimental protocol was decided
upon. There is therefore scope for what Lord Justice Jacob, a former Court of Appeal judge, called ‘‘litigation chemistry,’’ by which he meant that experimental protocols can be finessed in order to obtain the ‘‘correct’’ result. The procedure at the High Court of England and Wales ensures that experimental evidence can be thoroughly tested by the opposing side.
A party wishing to rely on an experiment to prove a fact in High Court proceedings must first serve on the other side a Notice of Experiments. This is a formal document, usually served after disclosure or discovery and before expert evidence is exchanged, which sets out the facts which the party seeks to establish and gives full particulars of the experiments proposed to establish them (CPR 63 PD 7.1). The party receiving the Notice must respond stating whether or not each fact is admitted and may request the opportunity to inspect a repetition of some or all of the experiments detailed in the Notice.
The party seeking to rely on the experiment must then apply to court for permission, which will generally be granted unless the court deems the experiment’s expense
disproportionate to the probative value, and the party will then repeat the experiment in the presence of the opposition. The witnessed repeat will then be the results that will be relied on at the trial, not the results included in the original Notice. The party seeking to rely on the experiments will include in the trial documents a copy of the Notice, a copy of a report of the repeat, and an expert witness will give evidence as to what the experiments prove. The expert can be cross-examined on any aspect of the design, the repeat, and the significance of the experiments.
The opposing party may wish to conduct its own experiments, either to prove facts it wishes to prove in reply, or to try to disprove facts seemingly proven by the first round of experiments.
A ‘‘live’’ performance in any industry inevitably entails risk, and live scientific experiments are no exception. Experiments can fail and if it fails during the witnessed repeat then the party seeking to rely on those experiments will all of a sudden have a missing link in the chain of evidence on which they rely. They will not be permitted to rely on the data in the Notice of Experiments unless the judge agrees and even then very little weight will be given to it. So, how best to prepare and design experiments so as to minimize the risk of them failing?
First, the golden rule is to keep experiments simple. The more complicated the experiment, the more likely it is to go wrong. Ascertain the narrowest facts to be proven by experiment and design the simplest experiment sufficient to prove those facts. Anything more is a hostage to fortune.
For example, I was once involved in a case which hinged on the question of whether or not a skilled team would have identified a new member of a virus family. In order to identify the new member at the priority date, the skilled person would have had to obtain tissue infected by the virus, extract template DNA from that tissue, design some PCR (polymerase chain reaction) primers and then perform PCR on the extracted DNA using those primers.
At first it seemed that we would have to repeat that entire experiment in order to prove our point. However, on reflection we realized that certain steps, such as obtaining infected tissue and extracting the DNA, would have been routine at the time and there was no need for us to repeat them and to risk them going wrong. The only critical fact we needed to prove was that the primers our expert says he would have used would have worked. We therefore simplified the experiment down to the single, easily performed step of testing the primers in a PCR experiment on some pre-prepared DNA.
The opposition objected, saying that our experiment did not prove that the skilled person could have conducted all the steps of the experiment at the priority date, because we used reagents unavailable at the priority date, namely the purified DNA of the then unknown virus. At trial the judge agreed with us that those were routine steps and that any competent laboratory would have been able to execute them. Our simple experiment worked and proved to be valuable evidence that the primers the skilled person would have selected would have been effective.
Second, the expert witness who will testify at the trial about the experiment and what it proves must be fully involved in designing the protocol. The expert must be able to explain and justify all decisions relating to the design and execution of the experiment. If the expert is asked a question and answers unconvincingly, the evidential value of the experiment will be lessened.
Third, try not adjust the protocol over a series of ‘‘work up’’ experiments until you obtain the ‘‘correct’’ result. Documents relating to work up experiments must be disclosed to the other side, and if it is apparent from those work up experiments that various conditions or other aspects of the protocol had to be finessed in order to make the experiment give the desired result, then that may well reduce the evidential value of the experiment.
Fourth, practice the experiment. Laboratory technicians are not robots and can get nervous when conducting an experiment in the presence of eminent professors, half a dozen lawyers and other assorted hangers on (including, usually, a video recorder). Practice makes perfect and so if it is not too expensive then it is well worth performing a dry run or two (note these are not work up experiments, but dry runs).
Experimental protocols tend to be designed carefully, and sometimes the carefully designed protocol conceals a gift to the other side. Success or failure of an experiment can depend on seemingly small factors so it is important, when witnessing a repeat, to take a note of every detail no matter how seemingly insignificant. Once back in the office the team can pore over the details to try to identify aspects of the protocol on which the opposition’s expert should be cross-examined.
As mentioned above, it is open to either side to conduct Experiments in Reply. This could be a repeat of the other side’s protocol under different conditions in order to show a different result.
In a case I worked on our client had based an anticipation attack on a patent on the existence of an experimental protocol in a scientific journal dated before the priority date. Our client the claimed the protocol produced, when followed, compound X, the subject of the patent. When our expert conducted an experiment following that protocol it resulted in compound X. However, when the other side ‘‘followed’’ the protocol no compound X was produced. At first glance both sides appeared to be conducting an identical experiment but producing different results. On closer inspection, our expert realized that the other side was using a different filter paper for a particular step of the experiment. Crucially, the prior art protocol specified a particular brand and pore size filter paper, which our expert had used, but the other side did not. The different filter paper appeared to prevent the production of compound X. It was a small and seemingly insignificant detail on which the fate of the patent turned.
Assuming your experimental evidence survives the witnessed repeat and cross-examination of your expert at trial unscathed then it can be extremely useful and reliable evidence when deployed in other jurisdictions. It is very difficult for a foreign judge or an EPO Examiner to gainsay evidence that has been through the mill of the intensive English proceedings and survived all attacks.
Conversely, an experimental report submitted at the EPO, unwitnessed and not subjected to cross examination, can be discredited fairly easily if later put into High Court proceedings. Experimental evidence prepared for U.S. proceedings has often been finessed to the point of becoming ‘‘litigation chemistry’’ and it can therefore be difficult to use it in English High Court proceedings. It is generally best to start afresh.
Seeking to rely on experimental evidence is high risk but can be high reward. There is no answer to a welldesigned and focused experiment used to prove a particular point. When designing the experiment, the aim should always be to remove any unnecessary frills: the simpler the better. When analyzing the opponent’s experiments, look closely at each choice of technique and reagent and question why it was used.
This article first appeared in Bloomberg BNA World Intellectual Property Report, Volume 31, Number 7, July 2017
26 July 2017
12 June 2019
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.
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...
09 April 2019
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...
27 March 2019
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 of numbers: the strengths...
22 March 2019
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.
05 March 2019
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. A situation where double patenting commonly needs to be considered is when the claims of a divisional application overlap with the claims of its parent application. Under such circumstances it is necessary to determine how much overlap between the claims of the two applications should be permitted. The case law has developed such that the EPO will generally allow substantial overlap between the claims.
28 February 2019
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...
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
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.
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.
11 February 2019
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.
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...
15 October 2018
On 12 October 2018 the UK Government published a further series of Technical Notices addressing various scenarios in which the UK leaves the European Union without an agreement, the so-called “no deal” or “hard” Brexit scenario. The Technical Notice dealing with plant variety rights and marketing of seed and propagating material is here. It had previously issued, on 24 September 2018, a Technical Notice relating to importing and exporting plants and plant products in the event of a “no deal” scenario, which is here. Its notice on trade marks and designs in a “no deal” scenario, which can be found...
25 September 2018
On 24 September 2018 the UK Government published a series of Technical Notices addressing various scenarios in which the UK leaves the European Union without an agreement, the so-called “no deal” or “hard” Brexit scenario. The Technical Notice dealing with Patents/SPCs, the unitary patent and the Unified Patent Court is here .
25 September 2018
On 24 September 2018 the UK Government published a series of Technical Notices addressing various scenarios in which the UK leaves the European Union without an agreement, the so-called “no deal” or “hard” Brexit scenario. The Technical Notice dealing with exhaustion of IP rights is here .
26 July 2018
On 25 July 2018 the CJEU gave its ruling in C-121/17 Teva UK Ltd and others v Gilead Sciences Inc.
26 July 2018
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  . 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.
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.
20 July 2018
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.
18 July 2018
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.
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...
01 June 2018
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.
17 May 2018
The European Patent Office (EPO) applies the same basic patentability criteria to antibodies as to other inventions, but it can sometimes appear that antibodies are treated as a special case. 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. The present briefing is intended to develop those Basic Principles into a guide to the drafting and prosecution of patent applications for antibody inventions.
16 May 2018
Although it is not unique to the field, the approach of the European Patent Office (EPO) can present significant challenges to applicants seeking to pursue claims to conventional antibody molecules. This briefing explores what we consider to be the basic principles of the EPO’s approach to this type of invention.
09 February 2018
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.
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.
30 November 2017
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 .
16 November 2017
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 .
14 November 2017
In May 2017, we reported on two “CardinalCommerce” decisions1 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.
20 October 2017
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.
20 October 2017
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 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.
09 June 2017
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.
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.
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...
12 May 2017
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...
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...
27 March 2017
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.
01 February 2017
In decision G 1/15, 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...
01 February 2017
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.
12 January 2017
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”.
31 August 2016
The protection of software inventions in Europe and the United States has often been described in terms of a pendulum swinging between a liberal position, in which almost anything can be protected, and a restrictive position, in which it is much harder to obtain patents for inventions relating to or using software. While the United States has recently taken a decisive swing to the restrictive side, the position in Europe has been relatively stable for the best part of a decade.
13 July 2016
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. ...
29 June 2016
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 liberal. 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...
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).
02 April 2015
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.
21 November 2014
Earlier this month a Judgment 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...
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.
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 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
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.
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...
25 September 2018
On 24 September 2018 the UK Government published a series of Technical Notices addressing various scenarios in which the UK leaves the European Union without an agreement, the so-called “no deal” or “hard” Brexit scenario. The Technical Notice dealing with copyright is here .
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.
15 March 2016
In the UK, a successful claimant in a patent infringement action is entitled to claim ‘damages’, that is monetary compensation for damage actually caused by the infringement (but not punitive damages), or an account of the infringer’s profits derived from the infringement. Damages are more commonly claimed than an account of profits so Design and Display v OOO Abbott provides useful, and rare, guidance from the Court of Appeal on how an account of profits should be assessed.
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,...