Sigrid Achenbach

Should the EPO reject and invention because it was arrived at by immoral means? This recent decision from the Boards of Appeal (T 2510/18) finds that the only moral grounds for an exclusion from patentability are those relating to the commercial exploitation of the invention, and not to how the invention was derived. https://lnkd.in/eV4veJSS

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The German Parliament Bundestag adopted the revised Medical Research Act. The legislation among other aspects, will: ➡ Facilitate the implementation of decentralized clinical trials ➡ Create a legal basis for the publication of standard contractual clauses for trials ➡ Accelerate the conduct of mono-national clinical trials ➡ Task a specialized ethics committed in charge of special procedures at federal level ➡ Limit price confidentiality to pharmaceutical companies with research departments located in Germany ➡ Hold price negotiations first, then give manufacturers incentives to select whether the price should be confidential or public 🔗https://hubs.li/Q02HtFrg0 #EU #clinicalresearch #clinicaltrials

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Yesterday the Bundestag passed the new Medical Research Act (#Medizinforschungsgesetz / #MFG) that decisively strengthens Germany as a centre of medical research and aim at accelerating access to new therapeutic options. The law addresses framework conditions to improve the development of clinical trials, authorization procedures and reimbursement / pricing rules. 👇 ✔️ Adaptations of the AMNOG guardrails, that defined additional discounts or price caps, which might now be revised if a relevant proportion of the clinical trial takes place in Germany (= at least 5 % of German patients in the study population). ✔️ The introduction of confidential reimbursement prices, that has been highly discussed before the #MFG. Manufacturers might now request, the confidentiality of their negotiated prices if they accept additional rebates of 9% and fulfil requirements that show their substantial research activities in Germany ✔️Adaptations to speed up authorization procedures for clinical drug trials, by introduction of binding standard contractual clauses and the shortening of the negotiations and decision making between manufacturers and German hospitals on clinical trials. ✔️ Implications for DiGA and digitalization by addressing processes as certification of data protection and extending the deadline for the introduction of the TI messenger ePA. 💡 The MFG received positive feedback from pharmaceutical companies, medtech companies and digital health provider, although some critics as always remain. 📣The strategic implications and possible opportunities for actions, require a more detailed inspection, which we will gladly provide in the upcoming weeks. If you want to find out more about how the new reimbursement rules might offer opportunities for your business, check our first strategic digest of the 5%-hurdle in the comments. #AMNOG #MFG #reimbursement #pricing

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While Euro 2024 is fast approaching…   Next week, on 3 June 2024, the Unified Patent Court (UPC) will be under the spotlights as it will hear a request for preliminary injunction by a Dutch company Ballinno suing the UEFA.   In April 2024, Ballinno has filed a patent infringement suit against the UEFA, as Ballinno alleges that UEFA has used its patented VAR technology without authorization.   Ballinno owns European Patent EP 1 944 067 covering a method and system for detecting an offside situation, in which an audio signal is analysed to determine the moment a player kicks the ball, which a referee can then use to determine if another player was offside at the moment the ball was kicked. Thus, EP 067 is an extension of video-assistant referee (VAR), specifically applied to the offside rule.   To be continued… #Patents #UPC #Euro2024

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📯 Vienna is calling. Two of Austria's best-known patent attorney firms are joining forces to focus more closely on the UPC. Austrian law firms are currently not only active with an above-average number of cases at the UPC. The market is also on the move. With SONN Patentanwälte and Haffner & Keschmann, two very well-known law firms are joining forces. In future, three of the six leading Austrian patent attorneys selected by JUVE Patent last year work in the new firm. #patent #patentlaw #patentlitigation   Marc Keschmann Daniel Alge Rainer Beetz

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More insight into how the UPC operates: here a hearing about inventive step in which the Central Division (Munich) said that inventive step is a legal question and not a technical one - and so the questioning of technical experts is not necessary. Interesting reading indeed.

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The questions of how and if the description should be used to interpret the claims of a patent have been referred to the Enlarged Board of Appeal of the EPO (G1/24). The correct approach to claim interpretation is critical to all aspects of substantive patent law, in every technical field. This case is certainly one to watch. https://lnkd.in/eWaVgSiW

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More on the UPC win for Celltrion today!

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👉 HTA for #Zolgensma gives insights on the legal option of the German #HTA body to oblige routine practice data collection and reassessment.   Zolgensma (active substance: onasemnogene abeparvovec) was approved in March 2020 for treatment of patients with spinal muscular atrophy (SMA). Zolgensma is an adeno-associated virus-based gene therapy. The pivotal study CL-303 is a single-arm study that enrolled 22 patients. Zolgensma is available in Germany.   🏆German HTA rating: To date Zolgensma was assed only once. Initial German #HTA was suspended in December 2020 as Zolgensma exceeded the sales threshold for orphan drugs (📍see previous post on #orphan drug reassessment). The German HTA without orphan drug privilege started in May 2021 and resulted in November 2021 in no additional benefit, because no RCT comparing Zolgensma vs. the appropriate comparator #Spinraza exists.   💵 Launch price: € 1,945,000. Zolgensma is a one-time treatment. Reimbursement price: € 1,385,000 (two price reductions, only one price reduction seems to be associated with the result of an HTA). Cumulative Rebate: 29 %.   📘 Special features of reimbursement: Zolgensma is subject to routine practice data collection (a specific kind of #RWE collection). This obligation restricts the prescription of Zolgensma to physicians, who participate in the required data collection (📍learn more in the forthcoming post). Zolgensma is also subject to the #ATMP Quality Assurance Guideline (like #Kymriah and #Yescarta).   💡 If an orphan drug exceeds the sales threshold during the HTA, the assessment will be suspended and a new HTA is initiated. Even though no additional benefit was granted for Zolgensma, Zolgensma itself is now part of the appropriate comparative therapies in SMA (compare HTA resolution for #Evrysdi from March 2024). 💡The obligation for routine practice data collection restricts the use of Zolgensma to physicians, who participate in the required data collection. This might hinder fast market entry.

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On 17 July 2024, the new Regulation on standards of quality and safety for substances of human origin intended for human application has been published on the Official Journal of the EU. The Regulation was adopted by the Council on 27 May 2024 and approved by the European Parliament on 24 April 2024. The Commission Proposal was tabled in July 2022. The new EU rules will: -support the continued provision of SoHO therapies, now and in the future, based on high safety and quality standards and up-to-date technical rules -extend protective measures to new groups of patients, to donors and to offspring born from medically assisted reproduction -improve harmonisation across Member States, facilitating cross-border exchange of SoHO and improving patient access to the therapies they need -create conditions for safe, effective and accessible innovation in a unique sector driven by public health services and voluntary and unpaid donations - improve crisis preparedness and resilience to safeguard access to therapies -implement digital-ready policies -contribute to the European Health Union by pooling of technical expertise and achieving economies of scale. Next steps The new Regulation will apply as from 7 August 2027, 3 years after its publication and entry into force, with an extra year for certain provisions.

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The German Bundestag passed the Medical Research Act on 4 July 2024. This lays the basis for significantly accelerated approval procedures for all mononational clinical trials in Germany. In addition, the extremely lengthy approvals for studies covered by the "Strahlenschutzverordnung" (Radiation Protection Ordinance) in the past will be shortened to the same time for all studies in future. This improved approval process is of utmost importance for all early phase trials run in Germany. AGAH participated in the development of the law by commenting on it as a professional association. We were extremely pleased to note that the legislative process was handled very quickly. Unfortunately, the binding shortening of the deadlines for the authorisation of substantial modifications, which we so strongly recommended, is still missing. But here we are still hoping for final improvements. #EarlyPhase; #ClinicalPharmacology; #ClinicalTrials

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In-house competition law advice and (lack of) legal privilege at EU level: Just noticed this from the European Commission's press release on the recent Teva fine - "In the decision, the Commission also relied on documents from Teva's in-house lawyers who were involved in the design of its abusive strategy to protect Copaxone. In-house lawyer communications are not privileged under EU law." An interesting example of this long-standing issue arising in practice. Of course, the same applies to non-EEA qualified external lawyers (including those only qualified in the UK or U.S.).

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EU pharmaceutical reforms propose changes to regulatory protection periods http://spr.ly/6041qcMzd Dr. Christian Meyer and Dr. Gisela Grabow of Maiwald Intellectual Property discuss potential changes to the EU pharmaceutical regulation and their potential impact on data and market protection timelines for medicinal products #managingip #maiwald #patents #pharmaip

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Another #UPC #medtech case, and the Paris Local Division's first decision on the merits where the court revoked Dexcom's continuous glucose monitor #patent for all UPC countries, even with the existence of German national proceedings. Lots to unpick in this decision - read my and Nicolas Bitsch's thoughts in this Out-Law News article 👇 #unifiedpatentcourt #unitarypatent #patents #patentlitigation #lifesciences #pinsentmasons

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🔎 Our penultimate profile showcases Torggler & Hofmann Patent Attorneys. A small but canny patent attorney firm from Austria that knows how to use the UPC's divisions to best advantage. Read more about this nominee for the JUVE Patent Award UPC Firm of the Year 2025 on JUVE Patent now. #juvepatent #juvepatentaward

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Alive in transition. More time to get IVDReady. 🔬 Manufacturers of in vitro diagnostics (IVD) will likely have more time to comply with the stricter requirements set by the #IVDR. Yesterday the EU Parliament voted in favour of a proposal by the EU Commission to extend the transition periods. The Council still needs to adopt the measure, but this is expected to be a formality now. The amendment is an important step to secure and improve the availability of IVD on the EU market. The additional time depends on the type of device: - 12/2027 for high individual and public health risk devices (class D); - 12/2028 for high individual and/or moderate public health risk devices (class C); - 12/2029 for lower risk devices (class B). Companies are well advised to check whether they fulfill the conditions necessary to profit from these extended periods and to take appropriate steps to secure continuous IVDR compliance. #lifesciences #healthcare #regulatory #ivd #medicaldevice #mdr #cmslaw

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❗️𝗜𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝘁 𝗗𝗲𝗰𝗶𝘀𝗶𝗼𝗻 𝗯𝘆 𝘁𝗵𝗲 𝗨𝗻𝗶𝗳𝗶𝗲𝗱 𝗣𝗮𝘁𝗲𝗻𝘁 𝗖𝗼𝘂𝗿𝘁 𝗼𝗻 𝗙𝗥𝗔𝗡𝗗 𝗡𝗲𝗴𝗼𝘁𝗶𝗮𝘁𝗶𝗼𝗻 𝗣𝗿𝗮𝗰𝘁𝗶𝗰𝗲𝘀 ❗️ 𝙏𝙝𝙚 𝙘𝙤𝙪𝙧𝙩 𝙧𝙪𝙡𝙚𝙙 𝙩𝙝𝙖𝙩 𝙊𝙋𝙋𝙊 𝙞𝙣𝙛𝙧𝙞𝙣𝙜𝙚𝙙 𝙋𝙖𝙣𝙖𝙨𝙤𝙣𝙞𝙘'𝙨 𝙨𝙩𝙖𝙣𝙙𝙖𝙧𝙙-𝙚𝙨𝙨𝙚𝙣𝙩𝙞𝙖𝙡 𝙥𝙖𝙩𝙚𝙣𝙩 (𝙎𝙀𝙋) 𝙧𝙚𝙡𝙖𝙩𝙚𝙙 𝙩𝙤 4𝙂 𝙩𝙚𝙘𝙝𝙣𝙤𝙡𝙤𝙜𝙞𝙚𝙨. 𝙊𝙋𝙋𝙊'𝙨 𝙁𝙍𝘼𝙉𝘿 𝙙𝙚𝙛𝙚𝙣𝙨𝙚 𝙬𝙖𝙨 𝙙𝙞𝙨𝙢𝙞𝙨𝙨𝙚𝙙 𝙗𝙚𝙘𝙖𝙪𝙨𝙚 𝙩𝙝𝙚 𝙘𝙤𝙪𝙧𝙩 𝙛𝙤𝙪𝙣𝙙 𝙩𝙝𝙖𝙩 𝙊𝙋𝙋𝙊 𝙝𝙖𝙙 𝙣𝙤𝙩 𝙨𝙝𝙤𝙬𝙣 𝙨𝙪𝙛𝙛𝙞𝙘𝙞𝙚𝙣𝙩 𝙬𝙞𝙡𝙡𝙞𝙣𝙜𝙣𝙚𝙨𝙨 𝙩𝙤 𝙚𝙣𝙩𝙚𝙧 𝙞𝙣𝙩𝙤 𝙖 𝙡𝙞𝙘𝙚𝙣𝙨𝙚 𝙖𝙜𝙧𝙚𝙚𝙢𝙚𝙣𝙩 𝙤𝙣 𝙁𝙍𝘼𝙉𝘿 𝙩𝙚𝙧𝙢𝙨. Yesterday, the Unified Patent Court (UPC) LD Mannheim issued its first FRAND decision. This landmark ruling emphasizes inter alia the critical role of companies benefiting from standardized technologies to actively and productively engage in licensing negotiations. The decision underscores the responsibility of licensees to participate earnestly and in good faith in these negotiations. It strengthens the enforceability of SEPs and promotes fair, transparent licensing practices. Successful FRAND negotiations require both patent holders and licensees to take their roles and responsibilities seriously. 𝗜𝗺𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀 𝗳𝗼𝗿 𝗢𝘁𝗵𝗲𝗿 𝗖𝗼𝗺𝗽𝗮𝗻𝗶𝗲𝘀: This decision could have far-reaching consequences for companies using standardized technologies. They must engage proactively and in good faith in FRAND negotiations to avoid legal conflicts and secure fair licensing terms. 🤔 𝙒𝙝𝙖𝙩 𝙖𝙧𝙚 𝙮𝙤𝙪𝙧 𝙩𝙝𝙤𝙪𝙜𝙝𝙩𝙨 𝙤𝙣 𝙝𝙤𝙬 𝙩𝙝𝙞𝙨 𝙙𝙚𝙘𝙞𝙨𝙞𝙤𝙣 𝙬𝙞𝙡𝙡 𝙞𝙢𝙥𝙖𝙘𝙩 𝙛𝙪𝙩𝙪𝙧𝙚 𝙡𝙞𝙘𝙚𝙣𝙨𝙞𝙣𝙜 𝙣𝙚𝙜𝙤𝙩𝙞𝙖𝙩𝙞𝙤𝙣𝙨? #Patent #UPC #FRAND #Licensing #Negotiation Panasonic OPPO

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The August 2024 edition of the The Landesärztekammer Hessen medical journal, entity that “represents the interests of Hessian doctors in all areas of medical practice”, includes a very enlightening discussion on a January 2024 judgement by the Regional Court of Frankfurt that challenges the legality of contracts between physicians and online pharmacy platforms that act as “mediation portals” for medical cannabis; these platforms openly advertise that individuals who register with the portal will acquire a medical cannabis prescription. “The Regional Court of Frankfurt am Main (with judgement of 23. January 2024, Az. 3-08 O 540/23) of the GmbH is prohibited from concluding contracts with doctors and doctors. It has found that this business model violates § 2 para. 4, §§ 17, 31 of the model professional regulations for German doctors, which complies with the professional regulations for doctors in Hesse (BO). Since the GmbH knowingly promotes the professional misconduct of the doctors with the contractual cooperation, it is indirectly liable under competition law as a participant” While this case may pertain exclusively to the German state of Hessen and its laws and regulations, the ethical/legal questions for physicians across the globe that choose to engage with these online portals are universal: 1. How independent are clinicians to make clinical care decisions, when being employed or contracted by entities that are established for the purpose of providing medical cannabis prescriptions? 2. Are online portals with no physical location suitable to adequately diagnose, trear amd follow up individuals with conditions for which medical cannabis can be prescribed? 3. For physicians that engage with these online platforms set up for the purpose of “facilitating” medical cannabis prescriptions, are fees and payments such that they do not constitute inducement to prescribe? “These new business conduct endanger the medical independence protected by the professional regulations. The judgement of the Frankfurt Regional Court therefore draws valuable limits in the cooperation of doctors with third parties and thus strengthens the trust of the patient, the payer and also the doctors in the Hessian medical profession” https://lnkd.in/gETPqjDk

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Another interesting article in the Ärzteblatt. New Medical Research Law Discussed in the Bundestag This week, Health Minister Karl Lauterbach presented the new Medical Research Law to the Bundestag. The legislation aims to streamline and expedite the approval processes for clinical trials and the authorization of pharmaceuticals and medical devices, while maintaining high safety standards for patients. Key changes include the establishment of an interdisciplinary federal ethics commission and regulatory adjustments to facilitate decentralized clinical trials. This initiative is part of a broader strategy to enhance Germany’s attractiveness as a hub for medical research and development. For more details, check out the full article on Ärzteblatt: https://lnkd.in/eE33cyGn #Healthcare #MedicalResearch #Germany #Bundestag #Legislation #Pharmaceuticals #patients

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