Life Science - Regulatory & IP

Our Life Science Regulatory & IP team advises clients on all legal matters that are specific to Life Science. For example, we advise clients on pharmaceutical products, medical devices, technical aids, nutritional agents, dietary supplements, food and cosmetics.

Our Life Science Regulatory & IP team has unique and long-standing experience of providing advisory services on all the legal areas that are specific to Life Science.

Our advisory services cover all aspects from contract formation to litigation, including against public authorities. We aim to always being in a position to serve as a sounding board for our clients and always provide constructive and value-creating advisory services.


Our expertise includes the following areas: 

Regulatory

  • Clinical and pre-clinical trials involving pharmaceutical products, including good clinical practice (GCP)
  • Market access, including
    - Product classification, marketing authorisation and regulatory data protection
    - Labelling rules and CE marking
    - Off-label recommendations
    - Pricing, reimbursement rules and substitution
    - Good manufacturing practice (GMP) and good distribution practice (GDP) for pharmaceutical products
  • Marketing, sponsoring and advertising, including
    - Use of platforms such as apps, blogs, help desks and social networks
    - Nutrition, health and beauty claims
  • Cooperation between industry and health professionals, hospitals, universities, organisations, etc

IP

  • Enforcement of patents and supplementary protection certificates (SPCs)
  • Parallel imports of pharmaceutical products and medical devices, including in relation to specific mechanism (patents)

Agreements

  • Clinical trial agreements
  • Collaboration agreements
  • Research & development agreements
  • Licence agreements
  • Material transfer agreements
  • Non-disclosure agreements

Ratings

  • Top-ranked team offering notable expertise in all areas of IP law. Best known for advising pharmaceutical and life sciences companies on patent law issues, including in high-profile contentious cases. Represents notable brands in trade mark matters and also in relation to copyright issues. 

    "Very quick at grasping issues and their track records are brilliant. The team consists of extremely gifted lawyers"

    "Very proactive in offering solutions and presenting new cases" (2019)
  • Plesner is listed in "Band 1" as regards Intellectual Property (2019)
  • Plesner continues to impress in our research, emerging as the leading player in the Danish market for patent work. (2017)
  • 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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