Life Science - Regulatory & IP

Vores Life Science Regulatory & IP team rådgiver om alle juridiske problemstillinger, der er specifikke for Life Science området. Vi rådgiver bl.a. om lægemidler, medicinsk udstyr, hjælpemidler, ernæringspræparater, kosttilskud, fødevarer og kosmetik.

Vores Life Science Regulatory & IP team har en unik og mangeårig erfaring med rådgivning om alle de særlige juridiske områder, der er specifikke for Life Science området. Vores rådgivning omfatter alle forhold fra indgåelse af aftaler til førelse af retssager, herunder mod offentlige myndigheder. Det er vores mål, at vi altid skal kunne fungere som sparringspartner for vores klienter og altid hjælpe med konstruktiv og værdiskabende rådgivning.

Vores ekspertise omfatter blandt andet nedenstående områder:

Regulatory

  • Kliniske og prækliniske forsøg med lægemidler, herunder God Klinisk Praksis (GCP)
  • Market access, herunder
    - klassifikation af produkter
    - markedsføringstilladelser og regulatorisk databeskyttelse
    - mærkningsregler og CE-mærkning
    - off-label rekommandationer
    - prisfastsættelse, tilskudsregler og substitution
    - god fremstillingspraksis (GMP) og God distributionspraksis (GDP) for lægemidler
  • Markedsføring, sponsorering og reklame, herunder
    - brug af platforme som apps, blogs, help desks og sociale netværk
    - ernærings- og sundhedsanprisninger samt "beauty claims"
  • Samarbejder mellem industri og sundhedspersoner, hospitaler, universiteter, organisationer mv.

IP

  • Håndhævelse af patenter og supplerende beskyttelsescertifikater ("SPC'er")
  • Parallelimport af lægemidler og medicinsk udstyr, herunder i forhold til Specific Mechanism (patenter)

Kontrakter

  • Clinical Trial Agreements
  • Collaboration Agreements
  • Research & Development Agreements
  • License Agreements
  • Material Transfer Agreements
  • Non-Disclosure Agreements

Ratings

  • Market-leading outfit offering long-standing experience and expertise across all areas of IP law. Highly regarded for its extensive experience in advising pharma originators on patent law. Strong trade mark practice trusted by high-profile clients. Its lawyers advise on prosecution, data protection and compliance issues.

    "This is a high-end, go-to firm for IP, with great attorneys."
    "Its lawyers have close knowledge of our procedures and portfolios, so we are able to act proactively on our matters."
     (2016)
  • Plesner sits comfortably at the apex of the Danish IP scene. It takes the lead on the vast majority of crucial patent suits on home soil – especially those with international relevance. It has practically cornered the market in terms of pharmaceutical originator work, with unmatched experience in clashes between innovators and generics. (2016)
  • Plesner is, as the only Danish law firm, highly recommended as regards all the four categories within Life Sciences, namely Regulatory, Intellectual Property, Corporate & Commercial and Competition/Antitrust. (2015)
  • Plesner is recognised as leading within all areas of Life Science. (2015)
  • Offers top-quality advice and representation on domestic and cross-border matters with an emphasis on patents. Particularly well known for assisting pharmaceutical patent originators. (2015)

  • "Mighty" full-service firm Plesner continues its reign at the apex of the market. The darling of many pharmaceutical giants, it is the only Danish firm to count three specialist patent litigators among its ranks. As such, it attracts the lion’s share of contentious instructions and is "probably the only firm in a position to turn down work".  (2015)
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