€325 million Funding for Semiconductor Research and Innovation in the UK and the EU

Europe’s Chips Joint Undertaking has bolstered its support for the semiconductor industry by announcing three funding calls with a combined value of up to €325M. The funding calls are to create: a pilot line for photonic integrated circuits (PICs), semiconductor chip competency centres, and a cloud-based design platform. As the UK is part of the Chips Joint Undertaking, the funding is available to both EU and UK companies. This first funding call is up to €180M for pilot lines for the development, testing, and small-scale production of PICs. This aims to facilitate companies making the treacherous leap “from lab to fab”. The up to €120M of funding for chip competency centres aims to provide access to expertise and facilities for experiments. These services are primarily for start-ups and SMEs and will reduce the barrier-to-entry for small companies. Further, the centres will augment the development and design capabilities of existing companies. The design platform funding is up to €25M to create a cloud-based platform for semiconductor chip design. To enhance collaboration and support smaller companies without the capacity to develop their own in-house platform, the design platform will be open access. This funding will reenforce Europe’s strong community of PIC companies and provide opportunities to produce valuable IP. Much of the innovation and creation will be collaborative and state-sponsored. Whilst this can dramatically increase the output of these projects, it also places rights-holders in a minefield of joint development agreements, joint ownership, and licensing agreements. The EU often directs companies to co-ownership of IP. Whilst this can initially provide a simple solution, co-ownership often proves problematic later. For example, when an owner wants to sell or licence their IP, deals can be hamstrung by co-owners. It will be important for companies to carefully consider IP before undertaking such projects. Having an effective IP strategy and IP agreements in place before collaboration and innovation starts will prove vital in the long-term success of such projects - even when dealing with open access or open-source platforms. Companies can apply for funding through the Chips Joint Undertaking’s website. The deadline to apply for funding for the PIC pilot line, the competence centres, and the design platform are 5pm CEST on 17 September 2024, 2 October 2024, and 10 October 2024 respectively. This funding is part of the Chips for Europe initiative under the Chips Act see Andrew Thompson’s article on the EU Chips Act here.

Spotlight

EIP welcomes Litigation experienced Patent Attorney in Germany

EIP is continuing its growth in Germany. Earlier this year, Isabelle Schaller and Sebastian Fuchs became part of a quartet of partnership promotions. This was reflective of the positive development of the German office over the past years. A further progression of EIPs German patent litigation capabilities is the addition of a skilled and experienced patent attorney. We are delighted to announce that we are today adding Felix Hütt to our German team. Felix is a litigation experienced German and European Patent Attorney, who, besides handling litigation related validity challenges, is also an experienced UPC Representative. Before joining EIP, Felix honed his skills in the patent litigation team of Hogan Lovells International LLP. Felix's work in major patent litigation campaigns, including standard essential patents (SEPs), has equipped him with extensive experience across various technology fields. His specialties include information and communication technology, semiconductor technology, electrical engineering, software, and optics. This experience makes him an excellent addition to EIP’s already widely recognised team of communications, computing, and electronics experts. Felix said: “I am thrilled to be joining a dynamic team that has made a name for itself in big litigation. I look forward to bringing my experience and expertise to the table to work with the team in advising and representing clients on the most complex and significant matters.” Christof Höhne, Partner at EIP’s Düsseldorf office said: “It is great to see EIP’s team in Germany growing and developing. Earlier this year, we had two Partner promotions within the team. Now, with Felix joining, we are complementing our skillset. We are confident that Felix will play a key role in the continued growth of EIP.” External coverage to date: EIP Hires Patent Litigator From Hogan Lovells In Germany, Law360 Hogan Lovells patent litigator joins EIP in Germany, WIPR EIP welcomes litigation-experienced patent attorney in Germany, The Patent Lawyer Managing IP weekly update

An Ocean Apart – Differences in US and EPO claim interpretation

Recent cases from the US Federal Circuit and the EPO Boards of Appeal highlight how the two jurisdictions have reached strict, and completely opposite, approaches to interpreting claims in light of the description. These cases demonstrate the need for care when drafting and amending specifications during examination, and consideration of different practices in different jurisdictions. We start in Europe, with decision T1628/21 (Nike Innovate C.V v Adidas AG), an appeal from an EPO Opposition about sports clothing that helps the wearer ‘feel’ body position, to help improve their form. Key to the case was a lower back position feedback system. To avoid prior art, Nike needed to argue that the feedback system was a separate component, distinct from the item of clothing itself. Nike’s patent claimed: “An article of apparel, comprising a garment structure (200)... characterised by a lower back position feedback system (202) engaged with the garment structure at the lower back portion”. The question for the Board was whether this formulation was restricted to a separate lower back position feedback system, or whether it could include a feedback system integral with the garment structure. To US eyes, this would be an easy question. Nike had explicitly stated in the description that integrally formed feedback systems “do not form part of the present invention”. Surely Nike’s claim could not encompass such disclaimed matter? Indeed, the EPO Board of Appeal did find this an easy question to answer, but reached completely the opposite conclusion. The Board stated that the “principle of primacy of the claims” excludes the use of the description and drawings for limiting the claims if an interpretation of the claim in the light of common general knowledge already leads to a technically meaningful result. In other words, if the claim is clear on its face, the EPO will not even look to the description to help with interpretation. The Board found that both possible interpretations (distinct and integral) were clear and valid from the claim alone, and so the claim lacked novelty over the prior art. Nike may have tried to disclaim subject-matter in the description, but the Board would only consider a disclaimer in the claim itself. It’s worth noting that one of the reasons the Board gave for considering “engaged with” to encompass the ‘integral’ meaning was the use of “characterised by” in the claim, which the Board suggested can be understood as introducing further limitations to the garment structure, rather than defining a necessarily "separate" further component. The wording “characterised by” was actually added by the examiner, not Nike, just before grant of the patent. This is part of the EPO’s insistence on using the “two-part form”, a form similar to the US Jepson-style claiming (without the Jepson format’s assumed admission of prior art). Although likely not decisive in this case, this is a reminder to at least consider arguing against use of the two-part form before the EPO. Turning to the US, the Federal Circuit’s decision in Chewy, Inc. v. International Business Machines Corp., 2022-1756 (Fed. Cir. Mar. 5, 2024) makes clear that the wording of the description is very important to US claim interpretation. The patent here related to presenting “advertising objects” on a computer. The question was whether the claim limitation “selectively storing advertising objects” necessarily involved pre-fetching the objects. Pre-fetching was described in the description, but not included in the claim. The Federal Circuit concluded that pre-fetching was required, because the written description “consistently describe[d]” pre-fetching. The Court took particular aim at the “Summary of the Invention” section of the description, which included the pre-fetching feature. Judge Moore noted this did not say a “preferred embodiment”, but rather “the invention”. Judge Moore also highlighted that the method in this section was described as a “method for presenting advertising in accordance with this invention”, which the Judge deemed to be “magic language...language that binds you, whether you like it or not”. Thus, the claim had to be read as including the pre-fetching limitation from the written description. In summary then, in Europe a patentee tried unsuccessfully to bind themselves with a disclaimer in the description. In the US, a patentee accidentally bound themselves by using, among other things, standard (at least in Europe) terms such as “summary of the invention”. So what is the moral of this story? Perhaps “the grass is always greener on the other side”? The patentees here would likely have appreciated the other jurisdiction’s rules. Or, more helpfully, ensure that your applications are drafted and prosecuted with an awareness of the conflicting rules on both sides of the Atlantic. And maybe even seek the help of a friendly trans-Atlantic patent firm, like EIP.

Court of Appeal affirms death of Bayer’s blood clotting patent in expedited hearing

The Court of Appeal announced at the conclusion of the hearing, on 16 May 2024, that Bayer’s appeal in the rivaroxaban litigation against a finding of invalidity following challenges by a number of generic pharmaceutical companies, which we have previously reported on (link), would be dismissed with reasons to follow. Lord Justice Arnold taking the lead in this judgment has now provided the Court of Appeal’s reasoning. Background The Hight Court found Bayer’s patent, which claims the use of rivaroxaban for the treatment of thromboembolic disorders for once-daily oral administration to a human patient, invalid for lack of inventive step over two pieces of prior art which were cited as “Harder” and the “Kubitza posters”. Bayer had already obtained a preliminary injunction from the High Court ahead of expiry of its compound patent on 1 April 2024, which we have previously reported on (link). The interim injunction was due to last until the hand down of the High Court judgment (12 April 2024) but the judge then extended it until 29 April 2024 in the form of order hearing heard of the same day. 29 April being the deadline for the Court of Appeal to make its decision on whether to grant Bayer permission to appeal the High Court’s decision. The Court of Appeal gave permission to appeal and extended the preliminary injunction until that hearing. Given the number of generic pharmaceutical companies interested in entering the rivaroxaban market and it being Bayer’s largest-selling drug, the Court of Appeal expedited the appeal and it was heard on 16 May 2024. Issues Bayer, as the appellants, were only given permission to appeal on two grounds, grounds 1, broken into three sub-grounds, and 5. As a result of having grounds 2, 3 and 4 refused, Bayer applied for permission to amend their grounds of appeal to raise a new ground (the “Application to Amend”). During the appeal hearing, Bayer’s counsel also advanced a further ground in oral argument without applying to amend Bayer’s grounds of appeal (the “Unpleaded Ground”). The Court of Appeal heard full argument on this despite the absence of any amendment application. The Application to Amend Bayer’s submissions revolved around the judge’s misunderstanding, misinterpretation and inconsistent approach of the evidence before him, which allegedly meant his assessment of obviousness was incorrect. In Bayer’s Application to Amend, the emphasis was that the judge had inferred too much into the status in the field of three of the authors of the Harder prior art (Dr Harder, Dr Misselwitz and Professor Breddin), leading to the skilled team simply taking the authors’ statements at face value. Lord Justice Arnold did not accept this submission, and instead found that the first instance judge’s findings were correct and rationally supported by the evidence before him. Grounds 1(1) and 5 In assessing the likelihood of success, Bayer claimed that the judge erred in law and principle by failing to apply the correct standard when considering the cited prior art together with the common general knowledge at the priority date (ground 1(1)) and that he failed to grapple with the key question of whether the skilled team would have a reasonable expectation of success based on the prior art (ground 5). Lord Justice Arnold did not accept these submissions on the premise that Bayer were misreading what the first instance judge was saying and not following his reasoning, nor had any error of principle been identified for ground 5. The Unpleaded Ground Bayer also claimed that the first instance judge’s acceptance of the respondents’ evidence was inconsistent as he seemed to have accepted the respondents’ experts’ evidence (one being an expert clinician and the other an expert pharmacologist) but went on to reject part of the respondents’ expert clinician’s evidence later in the judgment. Lord Justice Arnold did not accept this argument and reminded everyone that it is commonplace in patent cases for judges to accept the main thrust of expert witnesses’ evidence without accepting their evidence on every point. Additionally, the rejected part of evidence did not impact the pharmacologist’s evidence. Grounds 1(2) and (3) Bayer submitted that the first instance judge erred in placing weight on Bayer’s decision not to adduce “invention story” evidence in this jurisdiction, having done so in other jurisdictions. Lord Justice Arnold did not believe this to be correct and that the judgment made clear that the first instance judge did not place any weight on the absence of “invention story” evidence in reaching his conclusion as to obviousness. In fact, obviousness is to be objectively assessed from the perspective of the skilled person or team and the manner in which the inventor(s) actually gets to the invention is legally irrelevant. Conclusion The Court of Appeal concluded that the first instance judge made no error of principle in his assessment of obviousness. His conclusions were rationally supported by the expert evidence before him. The judgment is available here.

T 0192/22 - Is a first medical use claim a magic bullet?

The EIP team was pleased to receive the BoA Decision on T 0197/22 earlier this month, providing the reasons for revocation of Translate Bio’s EP 3318248 B1 at the oral proceedings held in March, where we represented one of the Opponents. The patent related to mRNA transfer vehicles, with the Main Request broadly being directed towards mRNA encapsulated in a liposomal formulation for use in therapy. This technology is highly relevant to those working in the field of mRNA-based therapies. Is a first medical use claim a magic bullet? Should a Proprietor be entitled to bar others from using a prior art transfer vehicle to deliver a nucleic acid for use in any therapy if their use together was not disclosed, despite how variable the resulting products’ mechanisms of action can be in vivo depending on the therapy? This case was particularly interesting due to the atypical first medical use claims at issue. First medical use claims under Articles 53(c) and 54(4) EPC typically spring to mind language such as “substance X for use as a medicament”, wherein “substance X” is an active ingredient (having a clear chemical composition) that has not been used in therapy before. In this case, however, the claims did not define what protein the mRNA should encode, what disease it should treat, or the composition of the liposome (other than its size and broad categories of required lipids). Indeed, all of these play a crucial role in achieving the desired therapeutic effect. Proteins encoded by mRNA molecules can have drastically different mechanisms of action depending on their purpose, which can range from vaccines to replacement therapies. This is in contrast to a new class of antibiotics, for example, where the members usually share the same mechanism of action. It is not generally required for a patent to show that a compound is suitable for each and every disease in order for a first medical use to be sufficiently disclosed. That said, how far can one exploit this without falling foul of Article 83 EPC? In the present case, as mentioned, the claims left the nature of the intended therapy, the encoded protein and liposome composition to be determined. This means that the patent sought to claim an entire platform of mRNA-based therapies, whilst only disclosing very limited data and no quantification of expression of any therapeutic protein. Ultimately, in the Decision, the Board came to the conclusion that the patent did not provide sufficient proof of concept regarding the suitability of the claimed formulations for use in therapy. The issue regarding how broadly one can define a genus composition in a first medical use claim while making only a single therapeutic effect plausible for one member of the genus is perhaps ripe for further clarification by the Boards of Appeal.

T 1762/21 – The EPO Board of Appeal Clarifies the Term “Inextricably Linked” When Assessing an Intermediate Generalisation

A recent decision from a Technical Board of Appeal of the European Patent Office provides clarity as to how “intermediate generalisations” are assessed for added matter. This decision states that certain features can be omitted from a claim if they are not necessary for achieving the technical effect of the claim. This potentially marks a shift towards greater flexibility for claim amendments, highlighting that not every disclosed feature must be defined in the claims if a skilled person would understand such features are not necessary. In this case, the Board emphasised that features unrelated to image optimisation in a breast tomosynthesis system can be left out of the claim if they do not contribute to optimisation of the acquired images, even if they contribute to the general functioning of the system. Background T 1762/21 concerns an appeal from the opponent. The appellant requested that the patent be revoked because, among other things, an amendment involved added matter. The appellant argued that several features, essential for the system of claim 1, had been omitted from the claim when being amended. They therefore argued that the claims contained an unallowable intermediate generalisation. The Patent The patent relates to a breast tomosynthesis system. Breast tomosynthesis is a three-dimensional imaging technology which acquires X-ray images of a breast at multiple angles during a short scan involving the movement of an X-ray tube. The individual images are then reconstructed into a series of thin high-resolution slices that can be displayed and analysed. Claim 1 as originally filed related to the X-ray tube itself. The X-ray tube has an anode, a cathode, a focusing cup, a port and a controller. The port allows X-rays to pass through to define a static focal spot, which impinges the breast. The controller is coupled to at least one of the anode, the cathode, and focusing cup, and modifies at least one characteristic of the static focal spot during the exposure period. Claim 2 defined two options: (i) the characteristic being a location of the static focal spot, or (ii) the characteristic being a size of the static focal spot. During prosecution, the claim was amended to focus on option (i) of claim 2, to define the tomosynthesis system as a whole (which comprises the X-ray tube), and to define in more detail how the controller controls the location of the static focal spot. Granted claim 1 therefore defined a system comprising the X-ray tube, a detector, and compression paddles (to hold the breast in place). Granted claim 1 further defined that the controller is configured to cause the X-ray tube to move in a first direction during the exposure period to move the static focal spot within the X-ray tube in a second direction, opposite from the first direction, so that a resulting effective focal spot appears to be fixed in space, relative to one of the breast and/or the detector, during the entire duration of the exposure. The result of this movement is said to increase image sharpness. Issues The main argument of the appellant was that claim 1 now defines a system, but several essential features from the description are omitted. They argued that the basis/support in the specification for defining a system could only come from paragraphs [0010] and [0020]. Those paragraphs read as follows: [0010] Figure 1 illustrates a breast tomosynthesis system 100 which includes an X-ray tube of the present invention. [0020] Figure 1 illustrates a tomosynthesis system 100 which includes an X-ray tube 110, upper and lower compression paddles 130, 135, an anti-scatter grid 140 and a detector 160. The X-ray tube 110 includes a cathode 112, an anode 114 that is mounted on a shaft 116 and rotated by a motor 118, a tube port 120. Also shown attached to the X-ray tube are a filter 122 and a collimator 124. The appellant argued that paragraph [0020] mentions several features that are not defined in claim 1, such as a scatter grid, the qualification of "upper and lower" for the compression paddles, and the configuration of the anode, a filter and a collimator. As a consequence of the omission of these features, embodiments other than those disclosed in the application as filed fall under the scope of protection. They therefore argued that the claims amounted to an intermediate generalisation. Board of Appeal Decision The Board of Appeal disagreed with the appellant. The Board stated that: “When assessing the allowability of an intermediate generalisation, it has to be established whether, because of this generalisation, the claim presents technical information which extends beyond what was directly and unambiguously disclosed, be it explicitly or implicitly, to the person skilled in the art using common general knowledge in the application as filed. This is the "gold" standard for assessing any amendment for its compliance with Article 123(2) EPC.” “The person skilled in the art is presented with subject-matter extending beyond the application as filed when an amended claim includes only some features of an originally disclosed combination and the features left out of the claim were understood, by the person skilled in the art, to be inextricably linked to the claimed ones. This is the case if the person skilled in the art would have regarded the omitted features to be necessary for achieving the effect associated with the added features. In such a situation, the amended claim conveys the technical teaching that the effect can be obtained with the claimed features alone, which is in contrast with and extends beyond the originally disclosed subject-matter that the whole combination of features was needed.” In this specific case, the Board noted that: “the features of these claims relate specifically to optimising the acquired images by acting on the focal spot. Features in the description concerned with other aspects of the system, such as the way the X-rays are generated or the way the breast is fixed in place on the detector, may be left out of the claims as long as they are not relevant to the optimisation, even if they contribute to the general functioning of the tomosynthesis system.” “the omission of a scatter grid, of the qualification of "upper and lower" for the compression paddles, of the anode being mounted on a shaft and rotated by a motor, of a filter, of a collimator, of a glass vacuum tube, of the cathode in the form of a heated filament and of the form of the focusing cup… is not problematic. The person skilled in the art would have recognised that the omitted features do not contribute to optimisation of the acquired images by acting on the focal spot…. The person skilled in the art would have been aware of several alternative mechanical arrangements for such control and is thus not presented with technical information which was not directly and unambiguously derivable from the application as filed.” The Board therefore concluded that claim 1 did not involve added matter. The appeal was dismissed, and the patent was maintained as granted. Conclusions This decision seems to be a softening of the EPO’s stance on assessing whether a claim amendment adds matter. Previously, it may have been more difficult to argue that features can be left out of a claim without the specification including an explicit reference to those features being optional, or being interchangeable with alternative features known to the skilled person. This decision implies that such an explicit statement is not needed if the skilled person would inherently know this. It will be interesting to see whether this decision is an outlier, or if future Boards will follow suit. The decision can be found here.

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