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  • Article

    OLG Hamburg On The Inadmissibility Of Issuing Pharmaceutical Prescriptions Over The Internet

    In its reference decision of 15 August 2023 (Ref.: 5 U 93/22), the Hanseatic Higher Regional Court of Hamburg ruled on the issuing of prescriptions for prescription-only medicines...
    GermanyFood, Drugs, Healthcare, Life Sciences
    Taylor Wessing
    Taylor Wessing
  • Article

    Germany – A Major Hub For Patent Litigation

    With the Unified Patent Court now stalled for at least the near future, U.S. life sciences companies will continue to face the question of where to bring patent infringement cases in Europe.
    GermanyFood, Drugs, Healthcare, Life Sciences
    Reed Smith (Worldwide)
    Reed Smith (Worldwide)
  • Article

    European Biosimilar Updates – Formycon's Ustekinumab And Alvotech's Cetrolizumab Pegol

    On June 26, 2025, Formycon AG ("Formycon") announced a distribution agreement with Teva Group subsidiary Ratiopharm GmbH ("Ratiopharm") for the semi-exclusive commercialization...
    GermanyFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Boost For Digital Health In Germany – Restrictions On Remote Treatment Could Be Overturned In May 2018

    At the next Annual General Meeting of the German Medical Association (Deutscher Ärztetag), the current restrictions on remote treatment by German physicians will most likely be overturned.
    GermanyFood, Drugs, Healthcare, Life Sciences
    Hogan Lovells
    Hogan Lovells
  • Article

    The Medical Devices Regulation – Key Dates And Roadmap For The Implementation Of The New Rules

    The Regulation (EU) 2017/745 on Medical Devices (MDR) entered into force in 2017. Although most of the provisions will only apply as of 26 May 2020, the time for impact assessments ...
    European UnionFood, Drugs, Healthcare, Life Sciences
    Mayer Brown
    Mayer Brown
  • Article

    Germany Is Going To Specify Safety Expectations For Reimbursable Digital Health Applications

    Last month, Germany introduced the Digital Health Service Act, which grants German patients access to reimbursable digital health applications.
    GermanyFood, Drugs, Healthcare, Life Sciences
    Hogan Lovells
    Hogan Lovells
  • Article

    Important For Start-Ups: Confidentiality Agreements And Material Transfer Agreements (MTAs)

    A crucial step for start-ups on the road to success is ensuring that their innovations and trade secrets are adequately protected.
    GermanyFood, Drugs, Healthcare, Life Sciences
    Taylor Wessing
    Taylor Wessing
  • Article

    Herbert Smith Freehills Kramer Comments For LSIPR On Small Molecule Litigation In The UPC

    Life sciences-related cases started at a low level during the first years of the UPC's existence (about 25% of cases) and focused initially on the medtech sector.
    GermanyIntellectual Property
    Herbert Smith Freehills Kramer LLP
    Herbert Smith Freehills Kramer LLP
  • Article

    Europe's Pharma Reform: How The Discussion Affects Strategic Decisions Today

    The EU's pharmaceutical reform package represents the most comprehensive overhaul of the bloc's medicines framework in two decades
    European UnionFood, Drugs, Healthcare, Life Sciences
    Mayer Brown
    Mayer Brown
  • Article

    For Medical Devices, “Possible Use” Amounts To Infringement Only If The Use Is In Line With Medical Practice

    The UPC Munich Local Division (the LD Munich) has dismissed an infringement action relating to a medical device. It confirmed that a device can still infringe a patent, even if it is normally operated in a non-infringing way, as long as the patent-infringing use remains possible.
    GermanyIntellectual Property
    A&O Shearman
    A&O Shearman
  • Article

    LD Hamburg, October 21, 2025, Order In The Proceedings For Provisional Measures, UPC_CFI_553/2025

    To establish jurisdiction, at least the plausible allegation of infringing acts in the country in question is necessary.
    GermanyIntellectual Property
    Bardehle Pagenberg
    Bardehle Pagenberg
  • Article

    Expected Amendments Of The Medical Device Regulation Will Most Likely Increase The Attractiveness Of Investments In The Sector

    Investments in the health care sector are very popular since the start of the COVID-19 pandemic. In Germany, there has been a particular interest in the strong German medical technology sector...
    GermanyFood, Drugs, Healthcare, Life Sciences
    Oppenhoff
    Oppenhoff
  • Article

    Just-In-Time: Trends & Future Developments In Supply Chains - Issue 2

    "Just-In-Time" is a series of written interviews with experts from different backgrounds, all of whom have extensive experience with supply chains, including knowledge of current trends...
    GermanyFood, Drugs, Healthcare, Life Sciences
    Mayer Brown
    Mayer Brown
  • Article

    New CJEU Ruling On The Borderline Between Medicinal Products And Medical Devices: Key Takeaways

    The boundary between medicinal products and medical devices remains a recurring issue for companies developing or marketing borderline products and courts, which has already been the subject of numerous decisions.
    GermanyFood, Drugs, Healthcare, Life Sciences
    A&O Shearman
    A&O Shearman
  • Article

    RD Nordic-Baltic, January 21, 2025, Procedural Order On Costs For Access To Pleadings And Evidence, UPC_CFI_380/2023

    A member of the public does not bear the costs of a request for access to written pleadings and evidence...
    GermanyIntellectual Property
    Bardehle Pagenberg
    Bardehle Pagenberg
  • Article

    G1/07: EPO Enlarged Board Rules on Methods of Surgery

    One contrast between Europe and some other jurisdictions, notably the U.S., concerns the restrictive practice relating to patent claims for medical methods.
    GermanyIntellectual Property
    Jones Day
    Jones Day
  • Article

    EU Commission Consultation On High-Risk AI Systems: Key Points For Life Sciences And Health Care

    On 6 June 2025, the European Commission launched a targeted stakeholder consultation on the classification and regulation of high-risk artificial intelligence (AI) systems under the EU Artificial Intelligence Act (AI Act).
    European UnionFood, Drugs, Healthcare, Life Sciences
    Greenberg Traurig
    Greenberg Traurig
  • Article

    EU MDR And IVDR Implementation: New Transitional Regime Enters Into Force

    On March 20, 2023, the new transitional regime for medical devices in the EU and the EEA became effective when Regulation (EU) 2023/607 (the "Regulation")...
    European UnionFood, Drugs, Healthcare, Life Sciences
    Morrison Foerster
    Morrison Foerster
  • Article

    Bundestag Debates Government Bill On Medicines Shortage

    In a move to tackle the severe shortage of medicines, the German Federal Government has adopted the draft Act to Improve the Supply of Medicines and Avoid Shortages...
    GermanyFood, Drugs, Healthcare, Life Sciences
    Gleiss Lutz
    Gleiss Lutz
  • Article

    LD Düsseldorf, June 1, 2026, Order On Procedural Security, UPC_CFI_998/2026 Et Al

    When assessing the requirement for a procedural security, namely the question whether the Claimant has “sufficient means” to compensate the Defendant for the legal costs incurred in the proceedings, only the financial situation of the Claimant should be taken into consideration, but not the financial situation of the holding company behind the Claimant.
    GermanyIntellectual Property
    Bardehle Pagenberg
    Bardehle Pagenberg

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