Journal

The CIPA Life Sciences Conference 2022

28-29 November 2022 | The Midland Hotel, Manchester

Celebrating the first two-day event since 2019, the CIPA Life Science Conference 2022 took place in the centre of Manchester at the Midland Hotel. It was a conference packed with delegates and a busy agenda, bringing life science patent professionals together to hear the latest updates in the life sciences field. The organisers and delegates were grateful to the sponsors, Patent Seekers, Sun IP and John Venn & Sons, who helped again to host a great Life Science Conference.

It is worth mentioning that the speakers highlighted their views were their own.

Day 1

Simon Wright (Schlich & Co.) warmly welcomed the delegates and reflected on last year’s one-day event at the Francis Crick Institute in London. Simon also chaired the first morning session, which was all about updating delegates on the Unified Patent Court (‘UPC’). Simon noted that the UPC is the biggest change to the patent system since the introduction of the EPC almost 50 years ago, and thus it is something all of us will need to get to grips with.

At the time of the conference, the UPC Sunrise Period was still due to start on 1 January 2023 . However, this has since been superseded by the update of 5 December 2022 (coincidentally, the day this report was first drafted), whereby the start of the Sunrise Period was postponed (at least) two months to 1 March 2023. The Agreement on a UPC (UPCA) is thus now expected to enter into force on 1 June 2023.

Preparing for the UPC

The first update on “Preparing for the UPC” came from Kevin Mooney (Simmons & Simmons). Kevin is the only UK lawyer who is a member of the Expert Group advising on the implementation of the UPC, and is currently the Chairman of the Committee tasked with drafting the Rules and Procedure of the UPC. Kevin discussed three key issues: training, testing, and strong identity authentication.

Regarding training, Kevin reminded delegates of the announcement earlier in 2022 that UPC Presidium and judges had been appointed, including six full-time legally qualified judges (‘LQJs’), 28 part time LQJs, and 51 part-time technically qualified judges (‘TQJs’) – 85 judges in total. Advanced training for the appointed UPC judges will take place in early 2023 (currently scheduled for January and February/March). One particular aspect the judges will require training on the new UPC case management system (‘CMS’), which Kevin describes as “complex, but not complicated”. Kevin emphasized the need for judges, and other users of the UPC CMS, to devote time to testing and understanding the CMS. This is particularly essential because opting patent applications or patents out of the UPC will be done through the CMS.

On that note, Kevin highlighted an amendment to Rule 5b of the UPCA, which governs the basic opt-out provisions, and which came into effect on 1 September 2022. Rule 5b will now require all proprietors, of all designated states, and all holders of supplementary protection certificates (‘SPCs’) to opt-out. The change is that “all designated states” has replaced “all Contracting States” – this means the patent must be opted out in all states where it was granted. In practice, it is expected that proprietors will appoint a person to make the opt-out application on their behalf. Keven emphasized that European Patent Attorneys (‘EPAs’) will need to upload, in the CMS, relevant certificates authorizing legal practice, and that the (to-be-appointed) UPC Registrar will check the entitlement of EPAs. Which brings us to strong identity authentication: Kevin noted that each person who intends to use the CMS must have an account with strong identity authentication. For those who do not know, this is a method of verifying the identity of a user or device that is intrinsically stringent enough to ensure the security of the system it protects by withstanding any attacks it is likely to encounter. This was a particularly hot topic of the day, and one that other speakers also touched on in their UPC updates.

A European perspective on the UPC

Next up we had “a European (Patent Attorney) perspective” on the UPC from Andrãs Kupecz (Pinsent Masons). Andrãs started by reminding delegates that EPAs will have an important role in UPC litigation due to having “two faces” – referring to both legal and technical expertise. For example, the technical expertise will help EPAs “get into the minds” of the TQJs, and as the EPC is a major source of law for the UPC, EPC expertise will be especially useful in litigation teams. Andrãs referred to three specific examples of where the knowledge of EPAs will be indispensable.

Firstly, EPAs will be needed to understand how the EPC and UPC interact in respect of Article 115 EPC and central limitation or revocation, and advise clients on the likelihood of a stay of proceedings by the UPC whilst the central limitation/revocation proceedings are ongoing at the EPO.

Secondly, EPAs’ experiences with auxiliary requests (‘ARs’) at the EPO will be invaluable. The UPC will be a front-loaded system and so it will be recommended (and perhaps even necessary) to file all potential ARs at the beginning of UPC proceedings, along with suitable substantiation (e.g., why the ARs meet the necessary requirements, where the amendments find basis, etc.). New ARs that were not present in proceedings before the UPC Court of First Instance (‘CFI’) are very unlikely to be admitted during UPC appeal proceedings, drawing some parallels to the EPC Rules of Procedure of the Boards of Appeal (‘RPBA’) 2020.

The third example related to parallel EPC opposition and UPC proceedings, and what the UPC might do in this instance. The UPCA provides the UPC with discretion to stay proceedings. Andrãs suggested that in rare circumstances, cases with “immediate and important impact” might require parallel proceedings. However, it seems there is unlikely to be any fixed rules about when UPC proceedings might or might not be stayed, as it will depend on various complex factors, including the number of ARs and how they relate to each other. Again, EPAs’ experience with stays of proceedings at the EPO will be useful to draw from in such situations. To conclude. Andrãs confirmed he thought the future was bright for UK EPAs regarding the UPC, and joked that he “looked forward to seeing us in court”!

Getting ready for the UPC

Next we heard two in-house perspectives: “Getting Ready – Life in a Large Pharma” by Alison McGhee (AstraZeneca), and “Getting Ready – Life in a Small Biotech” by Marcus Dalton (CureVac SE). Alison was up first, reflecting on previous consultations with outside counsel back in 2016 when the UPC was looking like it would come into effect, as well as more recent consultations. Specific challenges for large pharma include the need to review and consider strategies for large portfolios of hundreds or thousands of patents and SPCs. Of course, as the UPC start date has been pushed back over time, this has meant needing to repeat and extend such reviews to ensure information and strategies are up to date. In particular, Alison warned that it appears to be possible to opt out someone else’s patent if you accidentally enter a wrong identifying number – so it is critical to check the numbers of documents in opt-out applications. In addition, as the opt-out applications have to be filled in manually, it will be hugely time consuming to apply for all patents in a large portfolio to be opted out. Further complexity is added by the fact that some parts of the drug discovery pipeline in large pharma might not all be in-house, but with external partners. Having the appropriate machinery and systems to differentiate between EP and UP patents and proceedings, particularly regarding translations and fees, etc., will be vital. Alison also noted that “most people are opting out most patents”, with some were being more selective – though she had not heard of anyone keeping all patents in the UPC. The main reason for opting out appeared to be because of uncertainty – the risk of not opting out and being subject to a UPC with operations and decisions that are currently unknown may be too great, especially for blockbuster.

Marcus Dalton (CureVac SE) followed with a perspective from a small biotech company, which may have different considerations from large pharma – in particular, costs and finances. Marcus noted that in many situations it may be cheaper to stay in the UPC rather than pay renewal fees for separate patents granted by the EPO. The trade off, however, is of course that essentially all your eggs are in one basket. Another consideration is geographical scope, due to certain countries having already declared they will not participate in the UPC (e.g., the UK, Spain, Poland and Croatia), and some countries having not yet decided (e.g. Ireland). The territorial scope of the UP will be fixed at the time of registering for unitary effect – so if more territories join after that time, unitary effect cannot be extended to any additional territories. Marcus also emphasised the importance of renewing all their partnerships to ensure it was clear who was capable of or in charge of making the decision to opt out. Echoing Alison’s concerns, Marcus also commented on the current lack of case law and thus uncertainty on how cases will be dealt with under the UCPA. The considerations and concerns between small and large pharma thus appear similar, but the scale of operations and portfolios is tied to the scale of UPC preparations.

What should you be doing now?

A final (for that session!) UPC update was provided by Hazel Ford (Mathys & Squire). Hazel focused on some particular aspects that can be done now, before the sunrise period begins. For example, if there are pending patent applications with a Rule 71(3) EPC communication already issued, that you would like to register for unitary effect, then use further processing (Article 121 EPC) or disapprove the text intended for grant and request a minor amendment to delay grant.

Soon, likely 1 January 2023 although not yet confirmed, there will be transitional provisions allowing early requests for unitary effect (use EPO Form 7000, no official fee associated) – though note that these will not in fact delay grant, and other actions will be required to achieve delay. The transitional provisions will also allow requests for the EPO to delay grant until UPC Day 1 (use EPO Form 2025, again no official fee associated). CIPA has made these forms available in an easier-to-find location than the EPO. Hazel recommended starting to train people to use these forms and update procedures before the sunrise period begins, and getting ready to file opt-out requests (i.e., request instructions, make decisions, consider ownership information and confirm which signatures and authorisations will be required – and get them ready!). Hazel also noted updates to the UPC CMS were made that very morning that will now allow opt-out requests to be tested – apparently, new log-in details are required to do this, and support was only provided for IT issues, with the three-week testing period due to end on 16 December 2022.

Returning to strong authentication, Hazel alerted delegates to the ability to test this provision starting from 10 December 2022. The strong authentication requirements use a smart card system, and because a separate certificate is needed to e-sign documents, it is recommended for convenience to obtain a single smart card that can both confirm identity and e-sign documents. However, such cards appear to be difficult to get hold of. For example, there are at present limited suppliers offering suitable smart cards that meet the UPC’s stringent requirements, and those that are suitable are expensive (200 per card). Since every person who wishes to access the CMS will need a suitable smart card, the cost could add up very quickly. In addition, because the cards are needed to confirm identity, identity must be confirmed for the card to issue… thus, the card must either be collected in person (difficult for UK-based EPAs if the main suppliers are based in Continental Europe), or a video call can be booked with certain suppliers. However, appointments for such video calls may have a long waiting list. Hazel also noted that actually getting onto the register of UPC representatives is also difficult: registration cannot happen until the start of the sunrise period, and requires the use of the CMS and the strong authentication smart card, so is unlikely to be a fast and easy process. Hazel finished by encouraging anyone eligible to be on the UPC register to file their certificates in the new year (or as soon as the sunrise period begins, if later – which we now know it will be). Delegates were informed at this point that CIPA would be hosting a webinar on 12 January 2023 about registering as a UPC representative.

Official updates from the IPO and EPO

After a coffee break we then moved to the annual updates from the Patent Offices. Steve Rowan (EPO) first presented “From Challenges and Opportunities” (originally titled “Internal Views”), followed by “External Views” from Christopher Rennie-Smith (Rennie-Smith Consultants).

Steve Rowan is the current EPO Vice-President for the Patent Granting Process and was presenting via video call – despite a few brief moments where the feed skipped, this worked well. Steve spoke of significant challenges since Covid-19 and how the EPO has “reimagined, reset and reinvented” its procedures in various ways. He reflected back on the EPO Strategic Plan 2023, launched in 2019, which aimed to ensure the EPO had the best staff and tools, developed quality products, and be sustainable (amongst other goals). On the latter point, the EPO has committed to working towards the UN Sustainability goals and will publish reports on, for example, clean energy technology, in the future to inform researchers and policy makers.

One of the EPO’s major updates in 2022 was the launch of “MyEPO Portfolio”, a new digital platform where an entire patent portfolio can be reviewed, and that allows interaction with the examiner for certain elements. The EPO plans to continue developing MyEPO and adding more functionality. Another major update from this year was the confirmation that video conferencing (‘ViCo’) for oral proceedings (‘OPs’) during examination and opposition proceedings will now be the default arrangement. This enabled access to justice in a disrupted period, and also resulted in a ten-fold increase in the number of observers, particularly clients based in America or Asia, who were able to watch or participate with more accessibility than when OPs are held in-person. Steve did emphasise that OPs will still be held in-person if there are serious reasons to do so.

Steve next reported on progress made to timelines at the EPO: for example, they are targeting that 90% of searches will be completed in six months, and 80% of examinations in 36 months – currently, the average time is 8.7 months for searches to take place. They are also trying to clear a backlog of old cases from pre-2017 – several thousands of patents have already been cleared, with around 6000 left to work through.

There is a particular focus on the quality of communications such as search and examination reports being issued, and Steve reminded delegates that there is a responsibility on applicants and attorneys as well to help by ensuring their communications are also good quality. In feedback provided to the EPO on this topic, three main areas came up:

1. invalid objections or reports not covering all claims;
2. inconsistencies across examiners; and
3. unclear communications.

The EPO is or will be trialing involving all search examiners involved in a search in the writing of the opinion, forming technology communities that bring together examiners working on certain inventions to look at differences and try to harmonise approaches, and a new structured approach for setting out objections. Steve encouraged the use of the feedback tool to continue helping the EPO to identify areas for improvement.

Next up was Christopher Rennie-Smith (Rennie-Smith Consultants), a former chairman of an EPO Board of Appeal and member of the Enlarged Board of Appeal. Contrasting the updated title of Steve’s talk, Christopher considered “doubts to difficulties” relating to: plants, plausibility, priority entitlement, amending descriptions, the ten-day rule, and prior disclosure. Christopher briefly reminded delegates of the decision of G 3/19, which held that Rule 28(2) EPC does apply to plant parts and products resulting from essentially biological processes. He reported that several decisions pre-1 July 2017 (the date from which G 3/19 does not retroactively apply) that did not align with G 3/19 have been overturned on appeal since G 3/19 – apparently these cases were not stayed while G3/19 was deliberating (e.g., between the referral and the decision) and R28(2) was the only reason for each decision. Christopher expressed concerns that this meant boards were under pressure to decide cases, and reminded delegates that an article on the topic by Mike Snodin (Park Grove IP) was published in the CIPA Journal, October 2020.

Plausibility of course referred to G 2/21. Christopher addressed the opinion shared by some that the referral conflates substantive law and the law of evidence, and considered the two main positions regarding plausibility: ab initio plausibility (a stricter requirement where patentee should possess entire invention on application) and ab initio implausibility (less rigorous). Ab initio implausibility is more favourable for second medical use cases, which typically rely on clinical tests that are often done after the application is filed. Thus, there may be a difference in opinion overall between technical fields. Christopher noted with interest that the provisional opinion does not once mention the words “plausible” or “plausibility”, and that the Board intend to only consider plausibility with respect to inventive step and not sufficiency, despite also being relevant to sufficiency. However, the opinion does use the phrase “presence or absence of significant doubts” – which, whilst sounding closer to ab initio implausibility than plausibility, is perhaps confusingly similar to the language of (in)sufficiency. OPs were held on 24 November 2022; the Board stated that an opinion would be issued “speedily”.

Moving to the topic of priority and G 1/22 and G 2/22, Christopher wondered if Question I whether the EPO has jurisdiction to decide whether a party claims to be a successor in title as referred to in Article 87(1)(b) EPC is admissible. The referring board states that the issue was considered in T 844/18, which held the EPO had to decide entitlement questions, and agreed with this decision – and even stated that the only challenge at present was based on J11/95 during OPs, which was “unconvincing”. So Christopher expressed doubt that Question I was admissible.

Question II asks if the “PCT joint applicants approach is acceptable”, e.g., where additional applicants for an EP application have always been allowed provided the earlier applicant(s) or their successor(s) is (or are) also present as applicants. The referring board describes one particularly appealing argument for this approach: the Hague Court of Appeal decision 30 July 2019 (right to priority determined by national law of the country granting or nullifying patents), e.g., the EPC for an EP patent. However, Boards of Appeal often apply national law, and there is no formal “EPC law of priority transfer”, which would lead to needing to consider implied agreements. Christopher wondered whether this was easier than deciding whether there was a transfer under national law, and whether national or EPC law would be used to decide if there was an applied agreement. No provisional opinion has yet issued, nor OPs date set, for G 1/22 and G2/22.

Next we turned to the ongoing and somewhat controversial topic of amending the description to confirm with amended claims. Several decisions in 2022 related to the description amendments, but Christopher wondered whether this would end up being another question for the Enlarged Board, since there still appear to be conflicting decisions issuing. Christopher finished by briefly touching on the  abolition of the “ten-day rule” from the EPC (by amending Rule 126(2) EPC; this will take effect from 1 November 2023 and will be publicized by the EPO and CIPA), and prior disclosure, observing that the decision on T 1634/17 is still awaited, despite OPs being held on 25 November 2021.

Following on, Julyan Elbro (IPO) provided a whistlestop tour of updates from the IPO, including workloads and timelines, the status of the EPO contract, the transformation programme, ST26 implementation, and the impact of the Retained EU Law Bill. Regarding workloads and timelines, there has been an increased demand since Covid-19 that resulted in a growing backlog. However, Julyan was pleased to report there are now almost no backlogs for delivering customer service standards. The contract with the EPO for searches is still on going for some technologies, though not life science-based inventions. The IPO will not be sending any more searches to the EPO as it is now delivering searches in six months. Since April 2022, the IPO has reduced the examination backlog and there are now no cases older than 44 months (there may be a few “hangovers” on their second or subsequent examinations, which the IPO is aiming to get through by April 2023). The Transformation Programme continues, with lots of internal progress relating to online and remote working, but progress still required for external communications, for example reducing paper usage for communicating with applicants. The IPO intends to develop and launch a fully digital service for accessing all files and communications relating to patents and SPCs – and eventually designs, trade-marks and copyright as well. A first launch is expected in September 2023. Regarding ST26 (the new WIPO standard for sequence listings), Julyan expressed thanks for those who gave feedback to the IPO about ST26, and confirmed that UK divisional applications can use the original sequence listing filed with the original parent application, rather than needing to file a converted ST26 sequence listing. Finally, Julyan commented on the Retained EU law Bill, which is being discussed by Parliament at the moment, and which intends to bring an end to the existence of EU law in the UK law following BREXIT. This will have a big impact on trade marks and designs which are harmonised with the EU, but less so patents.

SPCs – Recent decisions and making SPC cases available on IPSUM

In the last talk before lunch, Lawrence Cullen (IPO) spoke more specifically about SPCs. The online inspection service will extend to SPCs: files from the 1 January 2017 should be available through this system before the end of the current financial year – approximately 340 files or so. Some hearings relating to SPCs have taken place or are scheduled to take place, relating to further use of drugs, whether combinations are really combinations, if evidence of an effect must be in the SmPC (summary of product characteristics), and when evidence to prove qualification for paediatric SPC extension must be provided. Finally, Lawrence reported that the IPO is working hard to get through the SPC backlog and is aiming for the first communication to be issued within two months of filing the SPC application, from March 2023.

UPC interactive panel session

The afternoon sessions were chaired by Dev Crease (Keltie) and first returned to the UPC with an interactive panel session. Several of the morning’s speakers were present: Kevin Mooney (Simmons & Simmons), Andrãs Kupecz (Pinsent Masons), Marcus Dalton (CureVac), and Hazel Ford (Mathys & Squire). Tom Carver (White & Black Legal), author of an article about the UK, the UPC and the Mocambique rule (another hot topic of the session) in the November 2022 issue of the CIPA Journal, was also on the panel. Frederick Nicolle (Simmons & Simmons) also briefly joined the panel from the audience to provide his personal experiences of obtaining a suitable smart card for strong authentication, echoing many of the factors Hazel discussed earlier in the day. A delegate also shared their experience of being able to book a video appointment with another provider to confirm their identity and have their smart card issued. One concern that seemed particularly pertinent to the life sciences field is the risk of the UPC becoming (too) heavily influenced by non-life science sectors, potentially to the detriment of life science patent proprietors, if many are opting out of the UPC – as also noted by Alison McGhee (AstraZeneca), earlier in the day. Something for us all to think about! One suggested strategy was to file a divisional application, and then keep one of the parent or divisional in the UPC, and opt the other out. The questions put to the panel led to Kevin coining a new catchphrase – “If in doubt, opt out!”.

Bioinformatics, machine learning and AI: Finding a path to therapy in complex biological data

After another tea break, we finished the first day with two more technically-minded presentations. The first, “Bioinformatics, Machine Learning and AI: Finding a Path to Therapy in Complex Biological Data” was by Camille Terfve (Mewburn Ellis LLP) and Liz Elmhirst (Achilles Therapeutics). Camille began with an introduction to bioinformatics (analysing data and finding biological insights using computers), artificial intelligence (AI; using computers to perform tasks that normally require human intelligence), and machine learning (an AI method for performing such a task). Bioinformatics and AI can be applied wherever there is data, and at various stages or aspects of biotech and pharma (e.g., drug design and discovery, patient stratification, medical image or genomics analysis, and so on); and patent publications relating to such technology are increasing.

Liz then introduced us to the work of Achilles Therapeutics, involving AI to develop personalized T cell therapy based on tumour-infiltrating lymphocytes (TILs). In particular, they use AI to identify clonal mutations (“neoantigens”) present only on tumor cells from a particular tumor or individual, which can then be used to design personalised T cells which target those clonal neoantigens to treat the tumor (or tumors). The AI methods that identify the neoantigens are complex, and Liz shared how difficult it had been at first to find a patent attorney with sufficient technical background to be able to understand their inventions and assist with seeking patent protection – to the point that they had kept their information confidential for several years, before revisiting the patent idea, and finding Camille. Liz and Camille emphasized how critical it is to have attorneys with the right technical background to really understand bioinformatics inventions, and encouraged those involved in recruitment to ensure they are considering and seeking such candidates. Between them, Liz and Camille considered the various challenges in protecting bioinformatics inventions, including the eligibility of such subject matter in the UK, US and Europe. Camille particularly recommended ensuring patent applications contain lots of details to explain how to carry out the bioinformatic methods, and data to show that the methods work, and, in the US at least, requesting an interview with the examiner to walk them through the invention.

On the verge of impossibility: Caring for all permutations of comorbidities influencing fate of drugs in special populations

Professor Amin Rostami (University of Manchester) then presented “On the Verge of Impossibility: Caring for all permutations of comorbidities influencing fate of drugs in special populations”. Amin discussed in depth how “virtual” humans or patients can be built and used for pharmokinetic/pharmacodynamic (‘PK/PD’) modeling of how the body responds to the administration of a drug dose, and how this has been viewed by regulatory authorities. Such virtual humans have arisen from the problem of patient variability: in clinical trials, it is not possible to test for all possible permutations of comorbidities such as kidney function, age, disease status, pregnancy, etc. Kidney function, or renal impairment, is a particular example of a known problem: there is a lack of explicit dosing recommendations for patients suffering renal impairment at the point of drug entry to market. Virtual models were designed that allowed the prediction of what having renal impairment would mean for the PK/PD of a known drug. Ten years down the line, there are now several examples of drug labels that feature results from virtual trials. Amin noted in particular that there has been a focus on genetics and genetic variability for a long time now, but that that genetics do not explain all variability in patient response to drugs. He also emphasised the importance of collecting extensive and well-thought through metadata when collecting patient samples, as this will allow for powerful bioinformatics analyses to make associations between variability in patient characteristics and drug response.

After the enjoyable and well-attended drinks reception, The Honorable Mr Justice Mellor welcomed delegates to the formal dinner with a pre-dinner talk, during which he revisited two hot topics of the day – plausibility and, you guess it, the UPC. This delegate did not stay much past the post-dinner coffee, as by that time the level of noise caused by a room full of patent professionals catching up had left me unable to hear the person sat next to me! It was brilliant to see everyone enjoying themselves, and I enjoyed hearing about their evenings at coffee the next morning.

Day 2

Untangling the CRISPR IP landscape: Misperceptions and reality in CRISPR Licensing

Kristina Cornish (Kilburn & Strode) chaired the talks on the second day, which kicked off with Kam Dhaliwal (KamTec LifeScience Partners) “Untangling the CRISPR IP Landscape” and discussing “Misperceptions and Reality in CRISPR Licensing”. Kam gave delegates a brief reminder of the history of the development of CRISPR technology and then proceeded to map out which parties currently hold foundational and/or supplemental patents relating to CRISPR technology in Europe, the USA, China and Japan. As many will be aware, the CRISPR patent landscape is complex and ever-changing, with ongoing interference (or equivalent) proceedings in the US and other territories. After walking delegates through the different patent estates owned by “CVC” (California/Vienna/Charpentier), Broad, Toolgen, Sigma, and Vilnius, Kam explained how the CVC patent position is dominant outside of the USA, despite the ongoing proceedings inside the US. Kam also took the opportunity to dispel certain misconceptions, for example that because the Broad won (some) recent decisions in the US, there is no need for a CVS licence in the US (not true), or that licences are not required if only doing research due to a research exemption (often not true, or at least risky). Essentially, users of CRISPR technology will need to be prepared to take multiple licences, e.g., for IP belonging to CVC and the Broad, to have freedom to operate.

We then carried on with updates on the CRISPR IP landscape, with Thomas J. Kowalski (Duane Morris) providing a more US-focused perspective. Thomas provided more detail of the complexities of the various CRISPR interference cases in the US, in particular how the patent and non-patent (e.g., scientific literature) disclosures relate to each other. At present, Broad have been deemed the first inventor of claims involving CRISPR in eukaryotic cells where the crRNA and tracr are fused together or are single guide or sgRNA or chimeric RNA, which is considered patentably distinct from claims not limited to a eukaryotic cell from CVC. However at least one appeal is pending, as well as several other interferences relating to CRISPR technology, and so the situation still cannot be considered settled. Thomas rounded up by considering some practical issues as well, such as if there will be an establishment of standard essential patents and/or a patent pool among players in the CRISPR field. Like Kam, Thomas touched upon licences, noting that multiple third parties have obtained licences to use CRISPR technology from various CRISPR IP rights holders. Thomas also recommended, for those drafting new applications relating to CRISPR technology, considering carefully exactly what aspect of CRISPR technology the invention relates to (e.g., new CRISPR enzymes, delivery of CRISPR system components, particular use of certain CRISPR systems, etc.), and tailoring the claims and disclosure at the outset, ensuring that there is date to show a surprising effect or superiority.

Implementing an international divisional filing strategy

The session finished with a change of topic, as Andrew Teuten (Sagittarius IP), walked delegates through “Divide and Conquer: Implementing an International Divisional Filing Strategy”. In particular, Andrew went through two specific scenarios in which a divisional application might be filed: 1) when there is a clear lack of unity; and 2) filing a divisional as a prosecution strategy. Andrew broke each scenario down by considering sets of territories:

1. countries where there is a deadline around grant stage and no advance planning is required;
2. countries with a hard deadline or a deadline based around an “acceptance deadline”;
3. countries with a potentially early deadline; and
4. countries with strict rules where it may not be possible or advisable to voluntarily divide to extend prosecution or separate subject matter.

Andrew’s talk was very comprehensive and covered considerations of many territories – this delegate fears there is not enough room in this article to sufficiently do justice to Andrew, and would advise reaching out to him directly if you have specific questions relating to specific territories or aspects of divisional applications.

US case law and practice

After some welcome coffee, Drew Hissong (Wenderoth, Lind & Ponack LLP) launched the final session of the conference with a US case law and practice update. Drew’s selection of cases covered two key areas: enablement and written description, and eligible subject matter. In particular, Drew discussed Amgen Inc. v Sanofi et al., in which the enablement of claims defining a monoclonal antibody in functional terms is at issue. The case has been referred to the Supreme Court (the first time the Supreme Court will address the enablement requirement since the enactment of the Patent Act in 1952), to discus whether the enablement requirements of 35 U.S.C §112 mean that the specification teaches those skilled in the art to “make and use” the invention, or must enable the “full scope of claimed embodiments” to be reached without undue experimentation.

Relatedly, in Juno v. Kite written description is at issue, and the question for the Supreme Court is whether the adequacy of the written description is measured by the statutory standard of “full, clear, concise and exact terms as to enable any person skilled in the art to make and use the same” (as per 35 U.S.C §112(a)), or the Federal Circuit’s test that the written description must demonstrate possession of the full scope of the claimed invention (including all “known and unknown” variations). Drew then turned to 35 U.S.C §101 and subject matter eligibility, discussing CareDx, Inc. v Natera, Inc. No 2022-1027 (Federal Circuit 2022); IBM Corp v Zillow Group, Inc. No. 2021-2350 (Fed. Cir. 2022); and American Axle v Neapco Holdings 967 F.3d 1285 (Fed. Cir. 2022) – each of which consider judicial exemptions. Drew reminded delegates that a new Bill is currently going through the US Congress which would reform section 101 and expand subject matter eligible for patent protection in the US. Finally, Drew mentioned a few practical US matters, such as the final rule regarding date of receipt of electronic submissions of patent correspondence (Eastern time zone rules regardless of where the submission is actually received), and upcoming training for foreign attorneys (foreign meaning USPTO-registered attorneys and agents living outside of the US).

UK law update

Duncan Bull (Kilburn & Strode) followed up with a UK law update. In what felt like a change in tone from many of the updates, Duncan started by announcing it had been a “relatively uncontroversial year” in UK courts – since there have been only a few relevant Court of Appeal hearings, and no Supreme Court hearings. Duncan therefore ran delegates through a few cases which have interactions with parallel EPO proceedings, to show how the UK courts are paying close attention to the timeline of such proceedings.

Firstly, the two related “apixaban” cases: one relating to the apixaban compound formula (Sandoz & Teva v Bristol-Myers Squibb Holdings [2022] EWHC 822 (Pat)) and one relating to a formulation (Sandoz & Teva v Bristol-Myers Squibb Holdings [2022] EWHC 1831 (Pat)). The key attack in the compound case relates to plausibility. The decision discussed EPO plausibility case law in detail, and builds on the three-step sufficiency/plausibility test set out in FibroGen v Akebia [2021] EWCA Civ 1279. In the apixaban compound case, the judge ultimately determined that the patent was not plausible at filing because the structural evidence relied upon was insufficient to show that apixaban would bind its target to a useful degree. Duncan wondered whether, if the “implausible” case related to an application and not a patent, whether a rise in Arrow-style “lack of plausibility” declarations might occur.

Next, the “Flingolimod” case (Novartis v Teva (and Others) [2022] EWHC 959 (Pat)) was discussed, in which Novartis had applied for a preliminary injunction from the UK courts for a pending patent application. The application was initially refused, but the decision was successfully appealed, and the High Court considered that this delay was solely due to administrative reasons, and thus the claimant could seek interim relief for losses suffered between the generic entry and the date of grant. However, the judge emphasised this was an unusual case on its facts and did not issue an injunction – because the price of flingolimod is not determined by the NHS tariff and so generic entry would not impact the price of flingolimod.

We then turned to Neurim Pharmaceuticals & Flynn Pharma v Generics (UK) Ltd & Viatris UK [2022] EWCA Civ 699, relating to melatonin for treatment of insomnia. The case has a long and complicated history, whereby Neurim’s parent patent was revoked and Neurim’s appeal withdrawn prior to grant of a divisional patent with patentably indistinct claims, but has finally reached an end. Mylan was allowed to run an invalidity argument against the divisional case, relying on original evidence from the parent case, and the divisional application was held valid and infringed in the UK – though note EPO opposition proceedings are ongoing.

EP law update

Finally, Lee Chapman (Greaves & Brewster) provided an EP law update with a specific focus on Article 13 RPBA, describing the 2020 provisions as “Definitely Unlucky for Some”. Of course, Article 13 RPBA relates to amendment of cases – for example, introducing new arguments, documents, requests, etc. Such an amendment of an appeal case will only be taken into account after the expiry of period set by the Board under Rule 100(2) EPC, or if not issued then after notification of a summon to OPs, if there are exceptional circumstances justified with cogent reasons by the party concerned. Lee gave examples of exceptional circumstances and cogent reasons, and in particular referred to the example of T 2455/19 (decision not yet issued, Lee was speaking from his involvement in the case). In this decision, Patentee’s late-filed claim request were not admitted because a negative preliminary opinion does not count as an exceptional circumstance, and no cogent reasons were given why the requests were not filed earlier. Lee’s advice boiled down to: do not mess about on appeal, as patentee file claim requests which address all objections (not just the ones you agree with) and file them with grounds of appeal (or reply if respondent), and use features from the granted claims as much as possible. Lastly, Lee recommended not being afraid to delete problematic claims, to avoid regretting not doing so further down the line!

After thanking all of the organisers of the conference, the 2022 event drew to a close with lunch and a last chance for networking or catching up before heading home. The 2023 conference will return to The Brighton Grand Hotel, Brighton, on 16 and 17 November 2023.

Lindsay J. Pike (Mathys & Squire)