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Life Science

Our specialists have knowledge of the industry and are able to steer clear of any challenge and create value and opportunities for our clients.

Practice Areas

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“The team acquits itself with particular distinction in hotly contested cross-border litigation for pharmaceutical companies, although it is also gaining ground in the food and dietary supplement sector”

Intellectual Property - IAM Patent 1000, 2015

“Accura is making major strides on the market, thanks in part to its valuable pharmaceutical clientele”

Intellectual Property - IAM Patent 1000, 2012

“Full-service outfit Accura continues to cement its reputation for contentious and transactional assignments with a throrough and agile team representing both domestic and international corporations”

Intellectual Property - IAM Patent 1000, 2013

“The firm was good in court and the case was managed efficiently. Very responsive”

Intellectual Property - Chambers and Partners, 2015


Our advisory services on life science


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Litigation

Accura has experience in representing various pharmaceutical companies in complex patent disputes before the national courts at every level.

We assist with everything from the initial legal assessment and suggested remedy to possible settlement negotiations with the other party and – if deemed necessary - subsequent legal proceedings.

In order to effectively end the infringing use of a patent as soon as possible,  many clients prefer to request a preliminary injunction.

Before granting an interim injunction, the court must be satisfied that it is likely:

  • that the acts against which the injunction is granted will infringe the patent owner's right;
  • that the alleged infringer is likely to perform such acts; and
  • that the purpose of proceedings will be lost if the patentholder is to seek relief only by way of proceedings before the ordinary courts.

The patentholder is not required to prove his case, but only to show to the court that the above conditions are likely to be fulfilled.

A patentholder may also apply for a search order in order to secure the preservation of evidence of the infringement and its extent. This will be allowed by the court if the patentholder is able to render it likely that the alleged infringer has infringed or will infringe the patentholder's right and that there is reason to believe that evidence of the infringement and its extent may be obtained from the premises where the search is to be carried out.

This search may relate to any material being relevant to the assessment of whether and to what extent an infringement is taking place or has taken place. The search must be followed by ordinary infringement proceedings.

Recent cases:

  • Mirxx v. Santaris (mRNA)
  • H. Lundbeck v. Sandoz (escitalopram)
  • MSD v. Orifarm (Singulair)
  • Sanofi Pasteur MSD (complaint before the Ethical Committee for the Pharmaceutical Industry (Etisk nævn for Lægemiddelindustrien))


Legal guide quotes:

  • "The firm was good in court and the case was managed efficiently. Very responsive". (Intellectual Property – Chambers & Partners, 2015).

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Parallel imports

Accura has assisted clients in several leading cases on parallel imports before the Higher Courts and the Danish Supreme Court. The majority of these cases have dealt with trademark issues relating to repackaging of pharmaceutical products and assessment of possible co-branding, de-branding and partial de-branding.

Recent cases:

  • MSD v. Orifarm (Cozaar)
  • MSD v. Orifarm (Nuvaring)

 


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Regulatory matters

Accura guides clients through all aspects of regulatory law, from obtaining marketing authorisations and distribution rights to legislative restrictions on advertising of pharmaceutical products. We also advise clients on the standards for GMP and GCP.

The relevant legislation is complex and comprehensive and, despite being increasingly harmonised within EU, the legislation still differs for each EU Member State. Accordingly, an outline of strategic market behaviour is important.   

Our advisory services on regulatory matters include:

  • Requirements for commercialisation and distribution
  • Restrictions on advertisements
  • Terms for clinical trials
  • Pharmacovigilance
  • Industry-specific food regulation
  • Product life cycle maintenance

 


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Licensing and commercial agreements

Accura assists clients with the negotiation and drafting of a variety of agreements within the field of life science, including license agreements, material transfer agreements, research collaboration agreements, research and development agreements, clinical trial agreements and supply and distribution agreements.

We have experience in handling such agreements and are able to combine our commercial knowledge within the life sector with our general legal expertise.

Recent cases:

  • Dako – co-operation agreement regarding cancer diagnostics
  • MSD – co-operation agreement regarding vaccines
  • MC2 Biotek – license agreement with Moorfields Pharmaceuticals

 


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Transactions

Accura is a market leader within M&A and has advised clients on the largest cross-border transactions in Denmark in 2012, 2013, 2014, 2015, and 2016.

While the focus on law and the fine details remain at the heart of our business, we are accessible, committed, and dedicated to providing our clients with clear advice throughout the transaction process in order to create and maximise value.

Transactions within the life science sector are often complicated due to the many authorisations, contracts and license agreements to be transferred. Accura advises clients on the best and most efficient way of conducting the transaction and ensures that all agreements as well as the future production and distribution comply with delegated legislation.

Furthermore, we have experience in conducting legal due diligence on behalf of both the buyer and the seller - also in relation to specific life science issues.

Recent cases:

  • Divestment of Statens Serum Institut (SSI)
  • Divestment of Baxter A/S
  • Divestment of Dako A/S
  • Divestment of Biometer International A/S
  • Divestment of Unisense Fertilitech A/S
  • Merger between Falck Healthcare and Tryghedsgruppen's healthcare activities
  • Divestment of Xellia Pharmaceuticals AS


Legal guide quote:

  • "Full-service outfit Accura continues to cement its reputation for contentious and transactional assignments with a thorough and agile team representing both domestic and international corporations". (IAM Patent 1000, 2013).

 

Contact

Henrik Juul Hansen
Henrik Juul Hansen

Partner, Attorney-at-Law

Mobile: +45 3078 6740
henrik.juul.hansen@accura.dk

Morten Bruus
Morten Bruus

Partner, Attorney-at-Law

Mobile: +45 3078 6695
morten.bruus@accura.dk

Thomas Weincke
Thomas Weincke

Partner, Attorney-at-Law

Mobile: +45 3078 6678
thomas.weincke@accura.dk

Dan Ermose
Dan Ermose

Associate Partner, Attorney-at-Law, LL.M., CIPP/E

Mobile: +45 3078 6710
dan.ermose@accura.dk