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German FSA releases new Transparency Code
  • Eversheds LLP
  • Germany
  • August 22 2014

German Association FSA "Voluntary Self-regulation for the pharmaceutical industry" ("Freiwillige Selbstkontrolle für die Arzneimittelindustrie"

German Federal Supreme Court on whether therapy-related instructions may contribute to patentability in case of a claim directed to a substance for use in therapeutic treatment (decisions of February 25, 2014 Cases X ZB 513 and X ZB 613 Collagenase
  • BARDEHLE PAGENBERG Partnerschaft mbB
  • Germany
  • July 14 2014

Therapy-related instructions ("therapiebezogene Anweisungen") may contribute to patentability if they objectively aim at allowing, enhancing

Generic drug and API producers deal with the Bolar exemption
  • McDermott Will & Emery
  • Germany
  • February 26 2014

To allow generic drug companies to enter the market as seamlessly as possible after expiration of patent rights, the Bolar exemption allows certain

German perspective on new EU clinical trials regulation
  • McDermott Will & Emery
  • Germany
  • October 29 2014

On June 16 2014 EU Regulation 5362014 on Clinical Trials on Medicinal Products for Human Use entered into force. Once it becomes applicable, the

EU pricing & reimbursement
  • Hogan Lovells
  • Belgium, Czech Republic, France, Germany, Italy, Netherlands, Russia, Spain, United Kingdom
  • November 10 2014

This newsletter provides comprehensive overviews of the system of pricing and reimbursement of medicinal products and medical devices in EU Member

Los genéricos y las empresas que les suministran: nueva cuestión prejudicial
  • Abril Abogados
  • European Union, Germany
  • February 22 2014

El tribunal superior de justicia de Dusseldorf (Alemania) ha elevado cuestion prejudicial al Tribunal de Justicia sobre la relacion

Pre-expiry offers to supply after patent term expiry
  • Taylor Wessing
  • Austria, Germany, United Kingdom
  • August 6 2013

Patent infringement by pre-expiry offer to supply a product after the patent has expired is an area of acute difficulty in Austria. In Austria, two

Pricing for new innovative drugs public payers attempt new approach
  • McDermott Will & Emery
  • Germany
  • June 18 2014

In 2011 an additional benefit assessment for innovative drugs and consecutive price negotiations known as the AMNOG procedure entered into force

Bolar exemption - C-66113 - Astellas Pharma referral to the CJ
  • D Young & Co
  • European Union, Germany
  • April 7 2014

The Dusseldorf Court of Appeal has referred questions to the Court of Justice of the European Union (CJ) concerning the applicability of the

Johnson & JohnsonNovartis another challenge to pay for delay: is this ever permissible?
  • Bryan Cave LLP
  • European Union, France, Germany, Italy, United Kingdom
  • January 14 2014

In the latest challenge to so-called “pay for delay” or “reverse payment” agreements, on 10 December 2013, the European Commission fined the