Incomplete secondary evidence pleaded late in proceedings has no chance against prima facie obviousness in High Court decision
A 163-page judgment for Pfizer Limited v. GlaxoSmithKline Biologicals S.A. & Anor [2024] EWHC 2523 was handed down on 7 October 2024 by Mr Justice Mellor. The decision concerns the requirements of secondary evidence with respect to obviousness, particularly when assessing the skilled team and the common general knowledge (CGK), including what can be used as supporting secondary evidence and how the need for such evidence should be pleaded when defending an obviousness attack. Another decision point concerned the behaviour of experts had they been part of a real-world research team without any subjective motivations when considering the prior art in light of the CGK. The case concerned two UK patents owned by GSK, each claiming vaccination strategies, including the use of the F subunit vaccine in its prefusion form (Pre-F) and the construction of a stabilised F antigen in Pre-F, against respiratory syncytial virus (RSV), a condition causing bronchiolitis and pneumonia particularly in vulnerable people by infecting the lower respiratory tract.[1] Pfizer sought revocation of both patents and GSK counterclaimed for infringement. Infringement The parties each construed the expression ‘a soluble F protein polypeptide comprising an F2 domain and an F1 domain’ in different ways, in particular the meaning of ‘polypeptide’. The Judge accepted the Claimant’s construction that a polypeptide consisted of a single chain of amino acids linked by amido bonds. As the Claimant’s RSVpreF product consisted of two polypeptides linked by covalent disulphide bonds, it fell outside of the scope of normal infringement.[2] The judge further considered that what the patents disclose and what they claim are distinct, and that the patents clearly disclosed more than was claimed which subsequently formed the basis of Pfizer's claim for Arrow relief.[3] Mellor J applied the Actavis[4] questions to assess infringement by equivalence, determining that the Claimant’s product achieved the result of stabilisation in a substantially different way than the claimed method. As the patents described other methods of stabilisation, the judge determined that the claimed method of stabilisation was intended by the patentee to be strictly applied.[5] The Skilled Team The judge noted the different approaches taken by the parties in instructing their respective technical experts, with the Defendant’s experts kept completely separate and with no line of communication between them, and found that this would have been too narrow an approach to the prior art and CGK.[6] The judge agreed with the Claimant’s evidence of real-world teams led by a vaccinologist, and that a structural biologist would have, at the priority date, advised on structural issues of the F-proteins being investigated.[7] The CGK There was much discussion in the judgment on the areas of CGK in dispute, namely whether the F as well as the G protein was part of the CGK at the priority date. While Mellor J accepted Pfizer’s case that the F protein was part of the CGK, he reserved his decision until he considered the secondary evidence in case GSK was right about hindsight of the experts affecting the make-up of the CGK. Obviousness The prior art consisted of extracts from an RSV symposium as a related paper from the same presenter on the structure of the parainfluenza virus type 5 F protein (PIV 5)[8], classified in the same viral family as RSV. The prior art teaches the use of a C-terminal trimerization domain to stabilise the F protein of the PIV F protein in its prefusion conformation. Mellor J considered that if the skilled team had made a prefusion F construct and had added a trimerization domain to further stabilise the protein, then it would be “obvious and routine” for the skilled team to assess its immunogenicity using the techniques such as those described in the patent, and that they would be reasonably confident in its success. The judge, again, reserved his conclusion until he had considered the secondary evidence.[9] Secondary evidence Regarding the development and utility of secondary evidence in litigation, Mellor J pointed out that secondary evidence “must be kept in its place”, that “[i]ts usefulness must depend in significant part on how complete and how testable it is”, and the importance of supporting it with oral evidence “from real-world participants on what was going on”.[10] The judge further considered that secondary evidence can serve a useful purpose provided that it is pleaded earlier in the proceedings (rather than in closing submissions) giving opposing parties and their expert/s the opportunity to respond to it, as well as providing for more appropriate case management directions and cross-examination.[11] Conclusions Overall, Mellor J noted there was a prima facie case on obviousness over the prior art on the primary evidence for both the GSK patents, and that the secondary evidence was not “complete enough or anywhere near persuasive enough to displace that prima facie evidence.” As such, the patents were found invalid.[12] Further, the Claimant was granted an Arrow declaration on the basis that it would provide a useful purpose[13] in giving the Claimant commercial certainty in the UK, citing the principles set out in Fujifilm[14]. The judgment can be found here. [1] [1]-[4]. [2] [513]-[517]. [3] [491]. [4] [2017] UKSC 48. [5] [547]-[553]. [6] [310]. [7] [45], [74]. [8] [638]-[647]. [9] [669]-[681] [10] [783]. [11] [39], [800]-[801]. [12] [799]. [13] [840]-[843]. [14] [2017] EWHC 395, [365]-[371].
Spotlight
EIP welcomes Xiaofan Chen as new Partner to strengthen China capabilities
EIP is delighted to announce the appointment of Xiaofan Chen as a new partner, further enhancing our capabilities in the Chinese market. Xiaofan Chen brings nearly two decades of experience as a Chinese qualified patent attorney, having worked with both Chinese and international firms. His expertise will be instrumental in navigating the complexities of the Chinese market for our clients. Xiaofan Chen has been recognised as a leading individual in the Legal 500 Asia-Pacific and IAM Patent 1000 for his work in transactions and prosecution. His industry expertise spans automotive, building and construction, e-commerce, energy, food and beverage, manufacturing, materials technology, mechanics, and software and IT. At EIP, he will provide strategic IP advice on patent filing and prosecution, and global IP strategy, particularly focusing on China. In addition to his extensive experience in patent prosecution, Xiaofan Chen is one of the first patent litigators to be officially registered with the Supreme People's Court in China. He has successfully represented international and Chinese clients in patent invalidation, patent infringement, and administrative cases in China. His litigation experience brings a valuable dimension to the non-contentious patent prosecution and advisory work he undertakes for clients. Magnus Hallin, CEO at EIP, commented: We are thrilled to have Xiaofan join our team. His extensive experience and deep understanding of the Chinese market will be invaluable to our clients. With Xiaofan on board, we are well-positioned to offer comprehensive IP services in China, including freedom to operate analysis, patent landscaping, invention harvesting, litigation advice and commercial agreements. Xiaofan Chen added: I am excited to join EIP and contribute to the firm's growth in the Chinese market. EIP's strong presence in the UK, Germany, Europe, and the US, combined with my expertise in China, will allow us to provide seamless global IP services to our clients. EIP's China offering includes strategic advice on navigating the Chinese market and close collaboration with partners in China. With Xiaofan Chen's appointment, EIP is set to further strengthen its position as a leading IP firm in the global market. External press coverage: Patent Lawyer Magazine: EIP welcomes Xiaofan Chen as new Partner to strengthen China capabilities Solicitors Journal: EIP boosts china expertise - Solicitors Journal WIPR: EIP strengthens China practice with experienced patent litigator | Careers | World IP Review MIP: This week on MIP: USPTO’s AI ban | SEP wars latest | Managing Intellectual Property
EIP launches Ampliphy
EIP has launched a new new strategic IP and legal service specifically for semiconductor chip designers and deep tech electronics and photonics companies called Ampliphy. The service is designed to help early stages companies develop effective IP strategies that maximise value. Ampliphy combines EIP's industry and technical experience to address the challenges and complexity of the sector with the added benefit of commercial advice from your multidisciplinary team. Visit the Ampliphy page to learn more about the service.
10x Genomics patent revoked
NanoString Technologies Europe Limited v. President and Fellows of Harvard College (UPC 252/2023) Decision of 17 October, 2024 (ORD_598480/2023[1]) This decision from the Central Division in Munich relates to EP2794928 belonging to President and Fellows of Harvard College, of which 10x Genomics is the licensee. 10x Genomics was refused a provisional injunction against NanoString on the basis of this patent (reported here[2]) – the Munich local division had doubts about the validity of the patent at least according to the claims as granted, and was not convinced that it was actually infringed. NanoString Technologies Europe Limited filed a revocation action against the patent at the UPC at the Munich Central Division on 27 July 2023. There was already pending a national revocation action in Germany related to the same patent, filed on 29 July 2022 by NanoString Technologies Germany GmbH. Lis Pendens The patent proprietor objected to the action on the basis of the lis pendens rules with respect to the prior German action. This objection was withdrawn at the oral hearing, but the Court considered that it was under obligation to nevertheless examine its international jurisdiction of its own motion since this was required under the Brussels I recast Regulation. Since the claimants in the UPC and German actions were not the same company, the Court considered that the situation did not fall under Article 29 of the Brussels I recast Regulation, which would require a mandatory stay. Instead, the case fell under the “related actions” provisions of Article 30 of the Brussels I recast Regulation, in which a stay is discretionary. The Court exercised its discretion to proceed with the action and not order a stay, because it had been requested to do so by the parties who stated their wish to have legal certainty as soon as possible. Moreover, the proceedings were at an advanced stage and the case was ready for a decision, so the procedural benefit of a stay at this stage would be limited, while a decision from the German Bundesgerichtshof was not expected for at least a year. In addition, a stay would cause delay in respect of the countries covered by the patent other than Germany; while it would be possible in principle to stay only the German part of the UPC action, this would have little benefit in terms of procedural economy. Validity The Court construed the claim more broadly than contended for by the proprietor, and on that basis it considered that the claims as granted lacked novelty over the prior art of Göransson. This is a similar conclusion to that in the provisional injunction proceedings. In particular, the Court construed the term “sample” broadly according to the description of the patent. It rejected the proprietor’s argument that Göransson does not disclose the detection of analytes “in a sample” because the sample is genomic DNA and in Göransson it is not this genomic DNA that is fixed on the slides, but only laboratory-amplified fragments derived from the genomic DNA (termed ASMs) – the Court considered that the term “sample” in the claims was broad enough to include ASMs prepared from genomic DNA and fixed on a microscopic slide as disclosed by Göransson. The Court consider eight auxiliary requests lodged with the defence to revocation, but declined to admit the further auxiliary requests filed later. Each of the eight auxiliary requests considered were acknowledged to be novel with regard to Göransson, but were considered to lack inventive step. The UPC noted that it had come to same conclusion as the Bundespatentgericht on essentially similar grounds. It was also noted that the conclusion was substantively in line with the findings of the UPC Court of Appeal in the NanoString/10x Genomics appeal which dealt with similar issues in respect of a related patent.[3] Accordingly, the Court ordered that the patent be revoked in its entirety. [1] https://www.unified-patent-court.org/en/node/1200 [2] https://eip.com//knowledge_hub/article/10x_genomics_not_successful_second_time_around/ [3] https://eipamar.com/en/knowledge_hub/article/why_did_the_court_of_appeal_reverse_the_local_division_injunction_in_10x_genomics_vs_nanostring/
Philips successfully asserts wireless charging patent at the UPC
Koninklijke Philips N.V. v. Belkin GmbH, Belkin Limited, Belkin International, Inc. (UPC_CFI_390/2023) Decision of 13 September 2024 (ORD_598464/2023)[1] Philips asserted their patent EP 2867997[2], relating to wireless charging, against Belkin at the Munich local division of the UPC. The UPC found the patent both valid and infringed. The Qi wireless charging standard defines interactions between a power transmitter and a power receiver. According to the prior art standard, there was a mandatory configuration phase initiated by the power receiver. The patent in suit in this case provides for an additional ‘negotiation phase’ which can be requested by the power receiver. Claim 20 (directed to the power transmitter) includes the limitation: “means for acknowledging … by transmitting an acknowledgement … being indicative of an accept or rejection of the request […]” The ‘request’ here relates to the request to enter the negotiation phase. The issue of infringement hinged on whether a device which only ever transmitted an acknowledgement which indicated ‘accept’ (and never sent a ‘reject’) was within the scope of the claim. The defendant argued that the acknowledgement must be capable of indicating both accept and reject. The court found in favour of the claimant’s broader construction, based on an extensive review of the patent specification. This discloses an example (paragraph 46) where it is mandatory, for a transmitter which supports the negotiation phase, to accept a request for that phase. It also discloses (paragraphs 172-173) various examples where no negotiation phase occurs: the receiver does not request negotiation; the receiver requests negotiation, but the transmitter does not support it, and sends an explicit rejection; the transmitter does not support the feature and ignores, without responding, any request. The receiver assumes, from the absence of any response, that the transmitter does not support the request; and the transmitter supports the feature but elects to “fall back to a [legacy] power transmission strategy (and associated communication strategy)”. The court understood that in case 4), this meant that the transmitter appeared to behave as in case 3), i.e., no response is transmitted at all (and therefore could not be within the scope of the claim in any case, because there is no acknowledgement at all). The court used a two-step approach to understand the claim scope: Does the description describe the possibility that an acknowledgement might only indicate ‘accept’? If yes, does the claim reflect such an embodiment? Based on the example in paragraph 46, the answer to question 1 was ‘yes’. To answer the second question, the court stated that the correct approach was to read the claim together with the description and figures; the claim must be understood so that there are no contradictions between the claim and the description. The paragraph 46 embodiment must only be considered excluded from the claim scope if it was clear from the claim that something different was claimed. The court nevertheless emphasized that the wording of the patent claim takes precedence over the description. The court considered that the plain reading of the claim did not require the claimed transmitter to be capable of sending a rejection in response to the request. There being nothing in the specification to counter this presumption, the court found that it was not necessary for a transmitter to have means for sending an acknowledgement indicating ‘reject’. On this basis, the claim was infringed. Commentary Courts in Germany (LG Dusseldorf and the BPG/Federal Patent Court) had previously concluded that the transmitter must be able to send both accept and reject responses. In the present judgment, the question addressed is whether or not it is mandatory for an infringing device to be capable of sending a rejection. However, the claim refers to an “acknowledgement … being indicative of an accept or rejection”. It is not clear why the focus was on whether ‘being indicative of’ was a limitation of the substance of the actual response(s) sent by the transmitter, rather than a limitation of the format of the acknowledgement. In particular, the court does not appear to address the following question: Would a device which always sent an ‘accept’ acknowledgement infringe the claim if the format of the acknowledgement (as specified by the Qi standard) also allowed for a rejection? In any case, the UPC local division did not consider that the claim language itself inherently required the possibility of both alternatives. However, in hypothetical analogous claims to a ‘vehicle capable of travelling forwards or in reverse’ or ‘an indicator indicative of a forward or reverse gear’, it seems readily apparent that ‘or’ represents mutually exclusive options which must nevertheless both be satisfied (“conjunctive OR”). Instead, the court gave significant weight to the example of paragraph 46 and construed the claim explicitly with the effect of including that example within the claim scope. Before describing the example in which it is mandatory for transmitters to accept any request for the negotiation phase, paragraph 46 also discloses that “In some embodiments, it may also be optional between negotiation phase capable devices, and may possibly only be entered if desired by the power receiver. Although the negotiation phase will be optional, it may be mandatory that new devices support it.”. The skilled person may understand from this that devices (including power transmitters) could have the possibility to avoid the negotiation phase in at least some cases, consistent with the need for an acknowledgement capable of indicating both accept and reject. This would appear consistent with the ‘conjunctive OR’ interpretation. Paragraph 46 forms part of the ‘Summary of the invention’ section. This section begins at paragraph 41: “According to an aspect of the invention there is provided method of operation …according to claim 1 comprising …”. However, the remainder of that paragraph does not reflect the granted claim, but rather the independent claim in the application as filed (see WO 2014/001983 A1) and does not include the ‘accept or rejection’ limitation. The patent was published in 2016. Since then, practice at the EPO has evolved to require applicants to amend the description (and, particularly, the ‘Summary of invention’ section) to be more strictly aligned with the claims. In this case, it is unlikely that the granted patent would have included paragraphs 41 and 46 in their current form, had such an alignment been carried out. The conclusion of the court might, in such case, have been quite different. Conclusion Applicants should take care that, in complying with a request for aligning the claims and description, unintended consequences for claim construction cannot arise. In court proceedings, parties should be alive to whether or not such alignment has been carried out, and whether this should be taken into account in claim construction. [1] https://www.unified-patent-court.org/en/node/1087 [2] Prosecution history: https://register.epo.org/application?number=EP13759578&lng=en&tab=doclist
Intervention by patent pool administrator permitted
NEC Corporation v TCL Communication Technology Holdings Ltd. & Others (UPC_CFI_153/2024) Order dated 2 October 2024 (ORD_46842/2024)[1] NEC Corporation (“NEC”) sued seven companies within the TCL group (“TCL”) for infringement of EP 2,863,637 (the “Patent”). TCL counterclaimed for revocation. NEC had contributed the Patent to an HEVC patent pool administered by Access Advance LLC (the “Applicant”). The Applicant is authorised to grant licences under patents within the pool to third parties. The Applicant applied to intervene in the proceedings. The Applicant has unsuccessfully been trying to negotiate a licence of the pool with TCL. It had entered into a non-disclosure agreement (“NDA”) with TCL covering the negotiations and cannot share details of these with NEC. In support of the intervention the Applicant argued that it has a genuine legal interest: to support NEC in opposing allegations that the Applicant has not offered a FRAND licence and is in breach of article 102 TFEU; and also that the Court determines the Patent to be valid and infringed. TCL objected to the application to intervene. NEC had no objection. Decision The Munich local division allowed the intervention because it meets the formal requirements of Rule 313.1, 313.2 and 313.4 RoP and the Applicant has a legal interest in accordance with Rule 313.1. The Applicant has a direct and present interest in the outcome because it is entitled to conduct negotiations and agree licences which cover the Patent and to collect and distribute royalties which would be affected if the Patent were found invalid or not infringed. There is no abuse of process by the application to intervene. Allowing the intervention will not necessarily mean that NEC gets access to the negotiation information covered by the NDA. A separate objection relating to commercially sensitive bilateral discussions between NEC and TCL and that these becoming known to the Applicant would violate article 101 TFEU also failed. A time limit was set for the Applicant to lodge a statement of intervention. As an intervenor, the Applicant is to be treated as a party and can see documents on the file. However information that has been designated as confidential in TCL’s defence will only be available to the individual employees named by the Applicant to which TCL has not objected. Rule 262A.6 RoP requires that at least one natural person of the party must have access to that confidential information. As regards information about bilateral discussions between NEC and TCL, the Applicant will not have access to that information until further notice. The Judge-rapporteur exercised his discretion not to make a reference to the CJEU on questions raised by TCL. Note - the Applicant was represented by the same legal representatives as NEC. No objection was made to this. NEC had instructed its representatives not to forward any information relating to the bilateral discussions to the Applicant. The Judge-rapporteur’s order included that NEC’s representatives should forward the parties’ previous statements and court orders to the Applicant. [1] https://www.unified-patent-court.org/en/node/1160. Further related orders were also issued in the same matter on 2 October 2024: https://www.unified-patent-court.org/en/node/1161; https://www.unified-patent-court.org/en/node/1194; https://www.unified-patent-court.org/en/node/1196
News Flashes
Incomplete secondary evidence pleaded late in proceedings has no chance against prima facie obviousness in High Court decision
A 163-page judgment for Pfizer Limited v. GlaxoSmithKline Biologicals S.A. & Anor [2024] EWHC 2523 was handed down on 7 October 2024 by Mr Justice Mellor. The decision concerns the requirements of secondary evidence with respect to obviousness, par...
EIP welcomes Xiaofan Chen as new Partner to strengthen China capabilities
EIP is delighted to announce the appointment of Xiaofan Chen as a new partner, further enhancing our capabilities in the Chinese market. Xiaofan Chen brings nearly two decades of experience as a Chinese qualified patent attorney, having worked with bot...
EIP launches Ampliphy
EIP has launched a new new strategic IP and legal service specifically for semiconductor chip designers and deep tech electronics and photonics companies called Ampliphy. The service is designed to help early stages companies develop effective IP str...
Company
Incomplete secondary evidence pleaded late in proceedings has no chance against prima facie obviousness in High Court decision
A 163-page judgment for Pfizer Limited v. GlaxoSmithKline Biologicals S.A. & Anor [2024] EWHC 2523 was handed down on 7 October 2024 by Mr Justice Mellor. The decision concerns the requirements of secondary evidence with respect to obviousness, par...
EIP welcomes Xiaofan Chen as new Partner to strengthen China capabilities
EIP is delighted to announce the appointment of Xiaofan Chen as a new partner, further enhancing our capabilities in the Chinese market. Xiaofan Chen brings nearly two decades of experience as a Chinese qualified patent attorney, having worked with bot...
EIP launches Ampliphy
EIP has launched a new new strategic IP and legal service specifically for semiconductor chip designers and deep tech electronics and photonics companies called Ampliphy. The service is designed to help early stages companies develop effective IP str...
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Internships at EIP with Emily Owen
EIP Career Talks is a special edition of EIP Talks where Chris Ball, Head of Talent Acquisition at EIP, speaks to a panel of EIPers about what it's like to build a career in the IP sector. In this episode, Chris talks to Emily Owen, Trainee Patent Att...
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11th February is International Day of Women and Girls in Science. To bring more awareness to the gender gap that still exists in STEM but also to some positive developments towards equality, we invited two of our Patent Attorneys to talk about their ex...
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