• Good to see what has allready been achieved. Better to know what still needs to be done.
  • Precision, perfect timing and an eyefor what matters.
  • Doing the right thing at the right time.That's what seperates the best from the rest.
  • Achieving your goalswith a reliable partnerby your side.

Pharmaceuticals and biotechnology

Our Pharmaceuticals & Biotechnology industry group focuses on companies from the chemical-pharmaceutical industry, especially companies engaging in research and in the clinical testing, manufacture and distribution of pharmaceuticals and related chemical products.  Due to the regulatory requirements in connection with the harmonisation of the European pharmaceuticals market and the special safety requirements for the protection of health in the context of rapid medical progress, research companies and manufacturers in the chemical-pharmaceutical industry have to continually face new challenges in competition.  This is accompanied by increasing cost pressures in the health care industry - a result of the development of the health care sector and of the large number of legislative measures aimed at containing costs.

To be able to advise companies in this competitive environment on current and future topics in a competent and efficient manner, specialist lawyers and tax advisors from various disciplines work together at Luther on transactions and infrastructure projects, exchanging their knowledge about new developments on an ongoing basis.  In all the important practice areas, our clients can rely on specialists with experience in the relevant industry.

Our range of services:

Protection of Intellectual Property

  • Protecting technical inventions by applying for industrial property rights
  • Developing and establishing property right strategies
  • Advice in matters pertaining to competition law and pharmaceutical advertising law
  • Research and development contracts
  • Co-operation agreements in clinical pharmaceutical research

Public Commercial Law

  • Advising on pharmaceutical law at all stages, including product development, clinical testing, obtaining a marketing authorisation, manufacture, storage and distribution of pharmaceuticals
  • Advice on the classification of products with regard to the differentiation between pharmaceuticals, medical products, foodstuffs or cosmetics, chemicals and biocides
  • Approval procedure to obtain a marketing authorisation for pharmaceuticals, a license for wholesale trading in pharmaceuticals or a license to run a pharmacy
  • Authorisation procedure for chemicals and biocides
  • Legal assistance with regard to clinical testing

Commercial and Distribution Law

  • Providing advice and drafting contracts for the wholesale pharmaceutical trade and co-marketing of pharmaceuticals
  • Drafting contracts for the contract manufacturing of pharmaceuticals
  • Storage contracts
  • Restructuring of companies engaging in intra-European distribution and storage of pharmaceuticals

Technology, Media, Telecommunications

  • Advice on data protection issues
  • Advice regarding the online mail order selling of pharmaceuticals
  • Advice with respect to the creation, customising and implementation of software
  • Advice with respect to IT compliance

Corporate Law / M&A

  • Acquisition and sale of bio-technology companies and companies from the chemical-pharmaceutical industry
  • Participation in research projects
  • Formation of joint ventures and co-operations
  • Restructurings

Antitrust Law

  • German and European merger control
  • Advice regarding compliance issues and monetary fine proceedings under antitrust law

Public Procurement Law

  • Advice on public procurement law issues within the framework of discount agreements with health insurance providers
  • Participating in and organising invitations to tender in the health care sector

Litigation and Arbitration

  • National and international arbitration proceedings
  • Proceedings regarding pharmaceutical liability

Employment Law

  • Transaction-related employment law issues
  • Private and public collective bargaining law and service agreement law

Banking, Finance & Capital Markets

  • Equity and debt financing of acquisitions and participations
  • Financing infrastructure projects

Tax Law

  • Developing tax structures for transactions
  • Developing tax structures in connection with the formation of joint ventures and co-operations
  • Tax optimisation in connection with the intra-European distribution of pharmaceuticals
  • Advice on transfer pricing inside a company

Contact

Dr. Wulff-Axel Schmidt, Partner
Phone +49 69 27229 27078
wulff-axel.schmidt@luther-lawfirm.com

Pharmaceuticals and biotechnology