The widely anticipated European Patent Office (EPO) decision in case G 1/21 has been delayed thus far by ongoing discussions in relation to partiality of the members of the Enlarged Board of Appeal, which has been the subject of two interlocutory decisions.
Following the first of those decisions, the composition of the Board was changed by order of 20 May 2021. The appellant (opponent, Rohde & Schwarz GmbH & Co KG) made submissions raising further objections, including requests for replacement of additional members of the Enlarged Board and referencing for the first time the issue of “personal interest” of the members. In a non-public discussion during the originally scheduled (first) oral proceedings of 28 May 2021, the issue of suspected partiality was discussed. The (second) oral proceedings to decide on the referred question was postponed to 2 July 2021, in order that a decision could be issued on the further allegations of suspected partiality. That second interlocutory decision of the Board was issued on 28 June, the week of the oral proceedings, dismissing all of the appellant’s objections.
While the delay of the discussion of the actual legal issue, referred by the Board of Appeal in T 1807/15, may appear frustrating to many, it has been widely accepted that it is essential for the public to have confidence that a fair and unconflicted decision will be reached by the members of the Board. As put by Siemens AG in their amicus curiae brief: “there is a conflict between a timely decision vs. … a high-quality decision”, and most of the nearly 50 parties who have submitted amicus curiae briefs appear to concur that the importance of a high-quality decision outweighs the desire for expedient certainty.
The suspected partiality alleged by the appellant was based on the involvement of certain Board members in the drafting of new Article 15a RPBA, which entered into force earlier this year – this new Article states that the Boards of Appeal can hold oral proceedings by videoconference without requiring the consent of the parties to this format. The present referral, in which the Enlarged Board will decide whether oral proceedings by videoconference are compatible with the legal right to oral proceedings (Article 116(1) EPC) if all parties to the proceedings have not consented, could be decided in direct contravention with the provisions of that new Article. Thus, there is a question as to whether a legal conflict exists between Article 116 EPC and the new Article 15a RPBA, as the latter appears to be based on the view that oral proceedings by videoconference must be compatible with Article 116 EPC. This conflict would render the particular Board members unable to take an impartial view, because they had performed legislative acts under that assumption which could then be found to contravene the EPC by the decision in this case.
Due to this alleged conflict, the appellant raised objections of suspected partiality against the Chairman and two technical members of the Board in its original composition (X and Y), citing their involvement in bringing Article 15a RPBA into force. One of the legal members (Z) also made submissions about their own involvement in preparing the legislative proposal for amending the RPBA as part of a working party, and requested under Article 24(2) EPC that the Board decide on their continued participation.
The suspicions against X and Y were reasoned with reference to the consultation between the President of the Boards of Appeal and the Presidium (of which X and Y were members) in relation to the proposal for Article 15a RPBA, alleging that the subsequent adoption and approval of that Article signified a positive majority within the Presidium. By a first interlocutory decision dated 17 May 2021, a recomposed Enlarged Board (with all of the objected members replaced pursuant to Article 24(4) EPC) decided that the Chairman and legal member Z were to be replaced in view of their suspected partiality, but technical members X and Y were to remain on the Board in its revised composition. This distinction was made in view of the differences in the level of involvement of each party in the process of bringing the new Article into force, with the Board considering that the Chairman had played an active role in passing legislation and that the visible involvement of legal member Z in drafting that legislation would not inspire confidence in the impartiality of an Enlarged Board comprising Z. The Board concluded that merely sitting on the advisory Presidium of the Boards of Appeal was not enough to objectively justify a suspicion of partiality, as there was no evidence of a majority vote or particular opinion of those members. The revised composition of the Board was adopted by order of 20 May 2021.
Following the first interlocutory decision, the appellant raised further objections of suspected partiality and personal interest in submissions made in the week leading up to the first scheduled oral proceedings; those additional objections and the non-public discussion are the subject of a second interlocutory decision by the Board dated 28 May 2021 and made available on 28 June 2021. In the further submission filed before the first oral proceedings, the appellant objected that the first interlocutory decision referred to brief comments submitted by the replaced members (Reason 9), providing details of their involvement in drafting/approving Article 15a, to which they had only been alerted at the time the first decision was issued. The further objections are well summarised in the second decision – they essentially relate still to requests for replacement of members X and Y for reasons of suspected partiality, as well as the Rapporteur on the grounds of a new allegation of suspected partiality, and an allegedly improper application of Articles 2(2) and 2(3) of the Business Distribution Scheme of the Enlarged Board of Appeal (BDS) in replacing “members” (i.e. those listed under Article 2(1)(a) BDS, including the replacement members in this case) with their “alternates” (i.e. the additional members listed under Article 2(1)(b)BDS).
However, the Enlarged Board in their second decision dismissed all of the appellant’s objections of suspected partiality. In particular, the Board did not consider any of those objections to be reasoned and supported by facts or evidence, because some of the allegations were speculative as to the content of the comments submitted by the members – “we have reason to believe…” – and others made in a general and non-person specific manner. The Board concluded that it had performed its duty in considering the facts available to it at the time of the earlier decision (including the aforementioned comments), i.e. there was no basis for a request of the appellant to be provided with those comments. The appellant extended its objection of suspected partiality to all of the five internal members of the revised Board, who were also present on the original Board, based on allegations that their agreement with the Chairman might be beneficial to them in being selected to remain members of the Enlarged Board; these were, unsurprisingly, deemed late-filed and inadmissible. The appellant had also raised for the first time the question of members having a “personal interest” (Article 24(1) EPC), referencing an alleged bias of the internal members because of their personal preferences for a particular mode of working either remotely or in person. This objection was considered inadmissibly late, overly general, and not substantiated – in particular, the Board noted that no direction of bias was indicated by the appellant. Furthermore, such a general objection would apply to any member of the Board, such that replacement of the objected members could not alleviate the party’s concerns. Finally, in relation to the objection that the replacement of members was improper, the Board did not see any legal provision under which this objection could be considered to be raised; it was not deemed to fall within Article 24 EPC, and so the Enlarged Board was not empowered to change its composition.
The reasoning given in the dismissal of those requests is fully consistent with the first decision, which sets out the legal principles developed in the case law concerning the application of Article 24 EPC (Reasons, point 10):
a. the right to object to a judge for reasons of suspicion of partiality is meant to prevent judges from being influenced in their decision-making … by considerations other than the arguments they consider factually and legally relevant for the case under consideration;
…
e. suspicion of partiality of a judge has to be determined by two tests: firstly, a subjective test requiring proof of actual partiality of the judge concerned, and secondly an objective test, whether the circumstances of the case give rise to an objectively justified fear of partiality;
f. with respect to the subjective test it is presumed that a duly and lawfully appointed judge is personally impartial, unless there is proof of the contrary;
g. with respect to the objective test … [t]his criterion excludes subjective suspicions on the part of the party who makes the objection.
Following a minor delay due to technical difficulties, the Board in its amended composition convened on 2 July 2021, together with three representatives of the appellant and three representatives appearing on behalf of the President of the EPO. The parties were asked to summarise their cases and make any additional oral submissions, with the Board noting the receipt of a further letter of the appellant containing requests addressed only to the Chairman shortly before midnight on 30 June 2021.
The appellant maintained their position on the improper replacement of members of the Enlarged Board with their alternates, and made several allegations about the “diligence” of the Enlarged Board in the proceedings to date: (i) that they had not provided the appellant with a copy of the minutes of the first oral proceedings pursuant to Rule 124 EPC; (ii) that the appellant had agreed to a shorter time limit in a future summons which applied a time pressure to the case, which the Board itself had not “coped” with in issuing a decision so shortly before the second oral proceedings; and (iii) that the Board was not acting fairly in relation to the time it took to provide reasons in a decision as compared with the time made available to the appellant to respond to them, at a direct cost to the party being represented at the proceedings (their client).
The Chairman dismissed these allegations, considering that the second interlocutory decision did not require a response and contained the necessary information which would form minutes of the first proceedings. The appellant was asked to formulate a formal request, should they wish to continue this debate. The first of those requests was that the Enlarged Board declare itself incompetent (!) to deal with the referral by an improper application of Article 2 of the BDS, and that the oral proceedings then be postponed until a new order was issued by the Chairman for a revised composition of the Board to be formed. The representatives of the President of the EPO requested that the appellant’s requests be rejected and a discussion on the point of law be conducted as soon as possible, which was considered to be in the public interest.
After an interruption for deliberation, the Board unsurprisingly dismissed the requests of the appellant and proceeded to the discussion of the referred question.
Finally, the panel entered into the long-awaited discussion of the fundamental legal issues at hand. The scope of the referral, the proper mode of interpretation of Article 116 EPC and purpose of oral proceedings, an assessment of the legal effect, if any, of the modus operandi of the EPO in the circa 40 years to date on the rights of parties, and the question of the effect of consent of parties to proceedings were all discussed. Proceedings were terminated for deliberation of the Board, and we expect a decision in writing in the coming weeks.
Mathys & Squire is delighted to be ranked in the 2021 edition of the IAM Patent 1000: The World’s Leading Patent Professionals directory – the ‘go-to’ guide identifying ‘top patent professionals in key jurisdictions around the globe’. Shining a spotlight on outstanding firms and individuals in patent practice, the guide is compiled based on feedback following an extensive research process involving around 1,800 interviews over a five month period.
In addition to our firm ranking, a record number of Mathys & Squire patent attorneys have been highlighted as recommended individuals: partners Alan MacDougall, Paul Cozens, Dani Kramer, Andrew White and Anna Gregson have all been featured in this year’s edition, alongside Jane Clark, Martin MacLean, Craig Titmus and Chris Hamer, who have been recognised in the guide for a number of years.
The ‘dynamic’ Mathys & Squire is praised for its ‘exceptional’ service, and the team is applauded for helping “clients to adapt their strategies in line with business developments and proactively respond[ing] to changing external circumstances.” A source commented: “Communication is clear and concise, even in relation to the most highly specialised and technical patent applications.”
For more information, and to view the rankings and individual testimonials in full, visit the IAM website here.
Last week the European Patent Office (EPO)’s Enlarged Board of Appeal gave its decision in case G 4/19, in which it had been asked to clarify whether or not double patenting is excluded under the European Patent Convention (EPC), and if so, how that exclusion should be interpreted. The Enlarged Board’s answer essentially confirms existing EPO practice, but stops short of providing the full extent of clarification that had been sought.
Some EPC states, including the UK, have provisions under their national law which aim to prevent double protection for the same invention by both a patent granted under national law and one granted by the EPO. However, the EPC does not contain any explicit provisions banning double protection of the same invention by two EPO-granted patents.
Despite this, the EPO’s practice in recent years has been to refuse to grant patents in circumstances where two applications belonging to the same applicant have identical claims, have the same filing or priority date, and designate overlapping groups of contracting states. In such situations the EPO requires the applicant to either choose one application to proceed to grant, or else to amend the claims of one or both applications, or amend the designated states to remove overlap. As legal basis for this practice the EPO has relied on the notion that “an applicant has no legitimate interest in proceedings leading to the grant of a second patent for the same subject-matter if the applicant already possesses one granted patent for that subject-matter”.
This practice has been highly controversial, not least as it originates from obiter dicta in two earlier Enlarged Board decisions which were concerned with the assessment of added matter in connection with divisional applications, and not with the issue of double patenting per se. The legal basis for these obiter dicta, and so for the EPO’s consequent practice, was uncertain. Questions had also arisen as to the interpretation of this exclusion: for example could an applicant be said to have a ‘legitimate interest’ in obtaining two patents for the same subject-matter based on the additional year of protection provided by one application claiming priority from an earlier application with the same claims?
In decision T 318/14 of 7 February 2019, Technical Board of Appeal 3.3.01 considered the issue of double patenting in detail. After reviewing the legislative background to the EPC and the provisions of the EPC itself, the Board came to the conclusion that it was questionable whether or not the EPC provided any legal basis for the EPO’s practice, and that it may be more appropriate to introduce a prohibition on double patenting through a revision to the EPC rather than through case law. In view of this uncertainty, the Board referred a detailed series of questions to the Enlarged Board of Appeal to seek to clarify whether a legal basis existed for the EPO’s practice excluding double patenting; and, if such a basis existed, what conditions could give rise to a double patenting objection.
In its decision G 4/19, the Enlarged Board recognised that it was being asked to provide a comprehensive ruling on all of these outstanding questions. However, it opted to keep its decision very narrowly focused, and to consider only the issue of legal basis for a double patenting exclusion without exploring the wider implications of such an exclusion beyond the underlying facts of the case which had led to the referral.
The decision provides a lengthy – although, to this author, not entirely convincing – survey of the legislative history behind the EPC, coming to the conclusion that a prohibition on double patenting arises from the intent of the legislator as it may be derived from the travaux préparatoires to the EPC. In the Enlarged Board’s view, this prohibition arises if a patent “claims the same subject-matter as a European patent which has been granted to the same applicant and does not form part of the state of the art pursuant to Article 54(2) and (3) EPC”. The prohibition is applicable if a patent:
This prohibition only applies to the extent that the two applications/patents designate overlapping groups of contracting states.
Given the focus of the Enlarged Board’s decision on providing a legal basis for the EPO’s existing practice, important questions are left unanswered. In particular, the Enlarged Board essentially restricted itself to the facts of the underlying case, in which the same legal entity had acted as applicant in respect of two patent applications having identical claims, one of which claimed priority from the other. The Enlarged Board’s decision therefore provides a legal basis for the EPO to continue refusing patent applications in situations having similar facts, i.e. where the claims and the applicant are undoubtedly the same. However, the wording of the decision leaves open the possibility of disputes regarding the identification of ‘the same subject-matter’. For example, regardless of current EPO practice, does this also potentially apply to partially overlapping claims? The criteria for identification of “the same applicant” have also been left unaddressed. Current EPO practice is to interpret this narrowly, such that a prohibition on double-patenting can be circumvented by, for example, assigning one of the patents or applications to another company within the same corporate group. However, further challenges to the interpretation of these provisions cannot be ruled out.
The Enlarged Board’s stipulation that the prohibition applies only in respect of overlapping designated states also leaves questions unanswered as to how this might be enforced in practice. For example, if both patent applications are still pending, at what point does any overlap in respect of the designated states need to be removed, and how will the EPO monitor to ensure that this is complied with, e.g. if a decision to grant one application has been announced but not yet come into force?
The decision may therefore come as a disappointment in some respects, given that the Enlarged Board has passed up the opportunity to define clear tests and to set clear limitations on the scope of this prohibition. On the other hand, given the criticism which has been levelled at the Enlarged Board for the wide-ranging repercussions and heavily political nature of a number of its other recent decisions, the relative restraint of this decision may be welcome, in that it does not signify any immediate changes to the EPO’s existing practice.
The Chartered Institute of Trade Mark Attorneys (CITMA) recently reported that over 70,000 UK trade mark applications have been filed this year (between January and April 2021), compared to just 37,000 for the same period in 2019 and 2020. 2021 has also seen a surge in monthly international trade mark applications figures, passing the 2,000 mark for the first time in February.
With such a rapid increase in trade mark applications in the UK – almost double the number for the equivalent period in 2019 and 2020 – comes the heightened risk of infringement and dilution. Watching services – in which brand owners’ trade marks are monitored for potentially conflicting new applications across an individual country, region or even worldwide basis – should therefore be prioritised. Mathys & Squire is able to offer a competitively-priced watching service for all trade mark clients. We offer such services on a tiered basis depending on our clients’ requirements.
In the event that clients are alerted to a third party application which is of concern, our team is experienced in assisting clients in opposing such applications in the UK to preserve the distinctive character of their trade marks. We are also well-equipped to assist in settling such conflicts, for instance by way of negotiating coexistence agreements, offering a pragmatic, commercial approach to such conflicts.
The existence of a large number of new applications on the register highlights the importance of performing trade mark register searches prior to filing new trade mark applications in order to assess the risk of conflicts arising early on in the application process. Our team has access to a searching platform which mines data from registries around the world, including the UKIPO, which allows our team to assess the risk in clients adopting new trade marks.
Please do not hesitate to get in contact if you would like any more information regarding the services mentioned above.
Mathys & Squire has been ranked as a leading European patent firm by the Financial Times (FT) for the third year since the inception of Europe’s Leading Patent Law Firms report.
The list is based on recommendations by over 3,200 clients and peers, for services around patent prosecution and patent strategy consultation. In addition to the leading firm ranking, Mathys & Squire is delighted to be featured in four of the specialist sectors this year: Biotechnology & Food, Chemistry & Pharmaceuticals, Electrical Engineering and IT & Software.
We would like to thank all our clients and contacts who have taken the time to recommended the firm as part of the FT’s research.
To access the full report and rankings tables, please visit the FT website here.
The 2021 edition of Managing IP’s IP STARS directory, providing independent research, rankings and analysis across 151 jurisdictions, 1,645 firms and 7,000 practitioners, has now been launched.
Mathys & Squire is delighted to congratulate Jane Clark, Paul Cozens and Hazel Ford, who have all been named as ‘Patent Stars’, as well as Margaret Arnott, Gary Johnston and Rebecca Tew, who have been ranked ‘Trade Mark Stars’. Additionally, David Hobson and Andrew White have been featured as ‘Notable Practitioners’ in the latest guide.
These IP Stars are senior practitioners who have been recommended or identified as leaders in their firm and/or jurisdiction.
The firm is also pleased to have maintained its rankings for ‘Patent prosecution’ and ‘Trade mark prosecution’ in the 2021 directory.
Rising Star rankings are due to be released in September 2021.
For more information, and to view the rankings in full, visit the IP STARS website here.
In this article for Intellectual Property Magazine, Mathys & Squire partner Juliet Redhouse and technical assistant Angela Stephen examine the different strategies for lengthening patent coverage at the European Patent Office (EPO).
It can be difficult to balance the need to file patent applications early on during drug product development and the length of time it takes to obtain regulatory approval. As patent term is calculated from the date of filing, much of the 20-year patent term has already passed by the time the drug product gets to market. A successful patent strategy needs to extend well beyond the time taken for regulatory approval. This article explores the patent strategies that can assist in extending protection around the drug product.
In addition to the drug product itself, separate patent protection may be obtained for secondary aspects including therapeutic indications, the drug product formulation, methods of manufacturing the drug product and drug combinations. These categories are discussed below, along with examples of what a claim under each category might look like when presented to the EPO.
Antibody X against target Y, comprising heavy chain CDRs1-3 of SEQ ID NOs: 1-3 and light chain CDRs1-3 of SEQ ID NOs: 4-6, respectively
For new drug products, the initial patent application will be directed to the drug product itself. Typically, the drug product will be defined by its structure. For example, a chemical compound may be defined by a Markush structure or a specific chemical formula, and an antibody may be defined by the six CDR sequences that are required for binding. At the EPO, there can be some flexibility as to what level of structural definition is required. For example, in the field of antibodies, an antibody may be defined solely by a functional property such as its target epitope, if it is shown that the prior art antibodies do not possess this functional property.
Product X for use in the treatment of breast cancer
It may be possible to obtain separate patent protection for a therapeutic indication following the initial drug product application. However, this can be difficult because treatment of the therapeutic indication with related drug products may already be known and/or data relating to the therapeutic indication may have been included in the initial drug product patent application to support inventive step. A later patent application for the therapeutic indication of the drug should ideally be filed before the drug product patent application is published, so that the latter application is not citable at the EPO as prior art for lack of inventive step.
Product X for use in the therapy of breast cancer, wherein product X is administered at a dose of 0.5-1.0 mg/day
It is well established at the EPO that more specific aspects of a known therapeutic indication may be protected. For example, the particular dosage regimen of a known drug product for a known therapeutic indication may be patentable. In practice, demonstrating an inventive step can be a significant hurdle for dosage regimens at the EPO because determination of the dosage that yields the best effect when the effect as such is already known is considered to be routine. A dosage regimen may, however, be patentable if the prior art teaches away from using the claimed regimen.
Product X for use in the treatment of breast cancer in patients carrying the ABC variant of XYZ gene
In certain circumstances the EPO considers the treatment of a particular patient subgroup with the drug product to be novel over the prior treatment of a broader patient group with the drug product, and the treatment of the specific patient subgroup may therefore be the subject of a later patent application.
Product X for use in the treatment of leukaemia
A later patent application for a new therapeutic indication may be warranted if there is data available supporting that treatment of the new indication with the drug product.
A pharmaceutical composition comprising 2.0 to 5.0 wt % product X, 5.0 to 10.0 wt % excipient Y and the remainder up to 100 wt % water
A patent to the commercial formulation of the drug product can provide another layer of protection. The technical effect of a particular formulation may be related to improved stability or may solve a problem such as low solubility. The scope of protection is likely to be narrow, with the claims limited to the particular drug product. In the case of antibodies, this is often the full sequence of the antibody. The concentrations of the drug product and the components of the formulations are also typically required, often within narrow ranges of the exemplified compositions in the patent application.
A crystalline form of product X having an x-ray powder diffraction pattern comprising peaks at 7.9°, 9.8° and 13.2° ±0.2° 2theta as measured by x-ray powder diffraction using an x-ray wavelength of 1.5406 Å
Patents can also be directed to particular crystalline forms of a drug product, generally defined by reference to peaks in its x-ray power diffraction pattern. In such cases, it is important that a method for obtaining the claimed crystalline form that does not require the use of seed crystal is described in the patent application. The EPO does not accept arguments that crystalline forms are inherently unpredictable and therefore non-obvious, and therefore evidence that the claimed crystalline form is associated with a surprising advantage over the prior art is also crucial. In this respect, evidence of improved filterability and drying characteristics of the amorphous form of a drug substance is not generally accepted, because the EPO considers these to be expected advantages of crystalline forms.
A method of purifying monoclonal antibody Y, comprising the steps of…
There may be patentable aspects to manufacturing the drug product, for example to overcome difficulties in large-scale production, or achieving a high level of purity. As for formulations, such improvements are often considered by the EPO to be tied to the particular drug product. The patent examiner may also require very specific details of the method in the claim, unless it can be shown that they are not required for achieving the effect. For example, if an improved purity has been shown using a particular wash buffer composition, this may be required in the claim unless this improved purity is demonstrated using a different wash buffer.
Composition comprising product X and product Z for use in the treatment of breast cancer
Patents for new combinations of two or more active ingredients can provide useful protection when patent protection for the single active ingredients has expired. To satisfy inventive step at the EPO, synergism of the combination greater than the additive effect of the single active ingredients needs to be shown.
The main factors that influence patent filing strategy are the availability of supporting data and the timing of upcoming disclosures.
A guiding principle at the EPO is that if a technical effect is relied on for the patentability of the claimed subject matter, such as improved binding affinity of the drug product, or improved stability of the formulation, this technical effect must have been made plausible at the filing date of the patent application. If the technical effect of the claimed invention is not rendered plausible in the patent application, then it is unlikely to be taken into account and this will increase the likelihood of the invention being found to lack an inventive step, or lack enablement if the technical effect is stated in the claim. If the technical effect of the claimed subject matter is plausible at the filing date, post-filed data may be filed to support an inventive step. However, plausibility cannot be shown solely by post-filed data.
The nature and amount of data required to demonstrate plausibility will depend on the technical effect being asserted and the scope of the claim. The EPO has been clear that any kind of experimental data for showing plausibility is acceptable, and that in vivo or clinical trial data are not necessarily required. For example, for therapeutic indications, in vitro data is accepted if the observed effect directly and ambiguously reflects the therapeutic indication. In some cases, it may be possible to rely on data that is available in the prior art to demonstrate plausibility.
Comparative data will often be key for arguing an inventive step over the prior art. In particular, patent applications to the drug product formulation should include comparative data over a standard or prior art formulation, and patent applications to the manufacture of the drug product should include comparative data to a standard or prior art protocol. Data showing flexibility on various method steps or formulation components is also desirable, to support breadth for these features in the claim. Comparative data is also important for protecting crystalline forms, to show an unexpected advantage over the prior art forms of the drug product.
A patent application will need to be filed before a public disclosure so that it is novel over that disclosure. Disclosures may be in any form, including conference presentations, journal publications, clinical trial protocols and interim clinical trial results. Clearly, a good publication review system needs to be in place so that the patent attorney is aware of any upcoming disclosures by the technical teams. However, even when there are no planned public disclosures, it can be difficult to keep control of disclosures and maintain confidentiality, and this in particular can apply to clinical trials. It could therefore be appropriate in some cases to file patent applications at several stages of the clinical trial process to try to mitigate this issue.
If there are no planned disclosures, one option might be to retain the knowledge within the company as a trade secret. This could be appropriate for the optimized manufacturing process of the drug product, for example. However, again, it can be difficult to keep control over the disclosures, and the merits of filing a patent application to the manufacturing process should be considered.
Supplementary protection certificates (SPCs) are a form of extended protection in Europe for patented pharmaceutical products and agrochemicals after patent expiry. They are designed to compensate for up to five years of patent term that is lost while the product is going through regulatory approval. While a detailed review of SPCs is beyond the scope of this article, as only one SPC can be granted to each patent holder for a particular authorised product, strategic considerations on which patent to nominate for SPC protection, including the strength and scope of the patent, the potential expiry date of the SPC, and the eligibility of the patent for SPC protection, should be borne in mind.
The availability of patents for different aspects of a drug product can extend the patent protection of a drug product beyond the 20-year term provided by the initial product patent. Although the scope of protection generally reduces for the later, more specific patent filings, these patents can still confer meaningful protection of the drug product and provide a barrier to third parties. The precise patent filing strategy will depend on the particular circumstances of each case, including when data will be available to include in the application to support the plausibility of any technical effect that will be important for patentability, and the content and timing of any expected public disclosures.
This article was originally published in the June 2021 edition of Intellectual Property Magazine.
European patents can be opposed by ‘any person’ within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin. The phrase ‘any person’ includes anyone other than the patent proprietor themselves (G 3/93, G 3/97). Even a person listed as an inventor on a particular patent can oppose that patent (T 3/06).
In a recent appeal at the European Patent Office (EPO) (T 1839/18), the patent proprietor argued that the opponent did not have a legitimate interest in the outcome of the opposition and, therefore, the opposition should be found inadmissible. However, the EPO reaffirmed the principle of ‘any person’ oppositions, stating in the decision, among other things, that any person who starts opposition proceedings provides three main contributions to society at large:
(1) Undeserved monopolies may be revoked or limited to their due scope;
(2) industrial development is fostered in that the direction of innovation is not led astray by wrongfully granted monopolies; and
(3) legal certainty is enhanced.
Given that the opponent can be ‘any person’, this allows potential opponents to hide their true identity by filing the opposition as a ‘straw man’. Filing an opposition as a ‘straw man’ can have a number of advantages and disadvantages.
A potential opponent may wish to avoid alerting the patent proprietor to their interest in the patent potential infringement – for example, the potential opponent may wish to avoid bringing their activities to the attention of the proprietor.
Another reason may be to avoid upsetting an amicable relationship with the proprietor – for example, the potential opponent may be a business partner of the patent proprietor or even a licensee of one or more of the proprietor’s patents.
Additionally, a potential opponent may wish to avoid submitting publicly available arguments regarding, for example, particular interpretations of the patent. In this way, a potential opponent may avoid issues arising from prosecution history estoppel because the arguments filed in the opposition would not be attributed to the company behind the ‘straw man’.
In one example, a ‘straw man’ opponent requested the opposition proceedings to be accelerated to provide certainty regarding the fate of the opposed patent before the company behind the ‘straw man’ invested large sums of money into an area which potentially infringed the patent claims. The request for acceleration was denied because the ‘straw man’ opponent did not itself have a legitimate interest in the proceedings being dealt with rapidly. As the company behind the ‘straw man’ was not a party to the proceedings, there was found to be no reason why the interests of a third party should be attributed to the ‘straw man’ (T 0872/13).
It appears in this case that the need for accelerated proceedings was greater than the need for anonymity for the company behind the ‘straw man’. If this had been determined before filing the opposition, then the opposition could have been filed in the name of the ‘true opponent’ which would likely have led to the request for acceleration to be allowed.
In another example, a ‘straw man’ opponent filed experimental evidence which allegedly showed that the patent in suit was not sufficiently disclosed. However, the provenance of this evidence was not provided, presumably because it would reveal the company behind the ‘straw man’, and as such the veracity of the evidence could not be assessed (T 0103/15).
This situation might have been avoided, if before the opposition was filed, the opponent identified that experimental evidence was likely needed to have the patent revoked or limited. Then, the opponent could have arranged for the experiments to be conducted by an independent third party whose identity could have been provided without exposing the identity of the company behind the ‘straw man’.
From the above review, it is clear that oppositions filed under a ‘straw man’ can be beneficial to a potential opponent’s business strategy, but that poor planning of the opposition can lead to unintended negative consequences for the opponent. Therefore, whilst it is certainly worth considering filing an opposition as a ‘straw man’ to obtain the advantages above, care should be taken to identify any potential pitfalls ahead of time to allow appropriate action to be taken to avoid the disadvantages.
Mathys & Squire is pleased to congratulate two of its clients – electric vehicle technology firm, BorgWarner Gateshead and battery manufacturer, Hyperdrive Innovation – following their recent acquisition by Silicon Valley-based company Turntide Technologies.
Backed by Amazon’s Climate Pledge Fund, Bill Gates and Robert Downey Jr, Turntide Technologies develops sustainability technologies that drive down energy consumption and operating costs in buildings, agriculture, and electric transport. The company has confirmed multi-year £100 million investment into BorgWarner and Hyperdrive – both based in the North East of the UK – helping to put the region at the forefront of the UK’s electric vehicle revolution.
Alongside the acquisition, Turntide Technologies has announced the launch of its new UK arm, Turntide Transport, a division focused on modernising intelligent motor systems throughout the commercial transportation industry.
Mathys & Squire has worked closely with BorgWarner and Hyperdrive for a number of years, supporting their IP strategies as both firms have rapidly grown and developed. We are delighted to hear news of this exciting next step and extend our congratulations to both companies, which – through their innovative work and tenacity – are leading the way in the electric vehicle sector.
A new partnership between Mathys & Squire Consulting and deep tech communications firm, Inkvine, has launched today to foster innovation and IP commercialisation and valuation in the technology sector. The partnership will provide client portfolios of both firms with access to the extensive domain expertise of the other, extending collective services to provide client support for long-term IP and market proposition.
Mathys & Squire Consulting – formerly known as Coller IP – is a wholly owned subsidiary of leading European patent and trade mark attorney firm, Mathys & Squire LLP. Together with its parent firm, Mathys & Squire Consulting specialises in providing independent advice and services across all legal and commercial aspects of IP, including due diligence, audits, valuation, training, innovation landscaping licensing, monetisation and competitive intelligence.
Inkvine helps breakout technology firms find their voice and capture emerging markets. Founded by Emily Ross in 2016, the company defines and executes complete go-to-market strategies – from positioning and core communications, to channel and funnel optimisation. Armed with a deep understanding of emerging technologies and backed by a distributed team of technology experts, Inkvine has helped a range of startups, foundations, and platforms cross the chasm from ideation to measurable growth.
Inkvine founder and CEO, Emily Ross, commented: “Intellectual property is such an important area for the companies we work with. Often they push the boundaries of technical capability and innovation and it’s critical that they have expert guidance through the complexities of IP, patents and trademarks, because it makes such a difference to long-term financial success. We are skilled at building brands and communicating remarkability, and IP is a significant part of the communications mix. Having IP expertise to draw on gives our customers clear commercial advantage.”
The two will be collaborating jointly on a number of innovation projects over 2021 and 2022, with the first project scheduled to launch in Q4.
