We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.
Lexology logo
  Request new password

Search results

Order by most recent / most popular / relevance

Results: 1-10 of 211

EU: interim measures awarded against EMA, preventing the Agency from disclosing clinical trial data to third parties

  • Bird & Bird
  • -
  • European Union
  • -
  • May 13 2013

On 25 April 2013 the President of the General Court of the EU Court of Justice made an order granting interim measures in favour of AbbVie and

Upcoming amendments to the Polish pharmaceutical law

  • Bird & Bird
  • -
  • Poland
  • -
  • May 20 2013

The Polish Ministry of Health has recently published two draft amendments to the Act on Pharmaceutical Law. They implement the EU directives with

Madrid Court of Appeal confirms patentability of dosage regimes

  • Bird & Bird
  • -
  • Spain
  • -
  • April 24 2013

The Madrid Court of Appeal recently confirmed that inventions consisting of the use of a known substance for the treatment of a known disease, where

Access to medicinal product dossier’s documents

  • Bird & Bird
  • -
  • European Union
  • -
  • July 28 2010

On 7 July 2010, the European Ombudsman published its Draft Recommendation of his inquiry into complaint 25602007BEH against the European Medicines Agency ("EMA") concerning the refusal to disclose clinical study reports and corresponding trial protocols concerning certain anti-obesity medicinal products which were submitted by two pharmaceutical companies to the EMA with a view to obtaining marketing authorisations

China issues new GMP

  • Bird & Bird
  • -
  • China
  • -
  • March 7 2011

China's new drug GMP, entitled Drug Manufacturing Quality Management Standards (2010 revision) (the "New GMP") was issued as an order by the Minister of Health on 17 January 2011

Generic drug pricing: unfair competition and imminent infringement

  • Bird & Bird
  • -
  • Spain
  • -
  • April 17 2013

The Barcelona Court of Appeal recently handed down a judgment regarding unfair competition and the risk of imminent patent infringement relating to

Edwards Lifesciences AG v Cook Biotech Incorporated

  • Bird & Bird
  • -
  • United Kingdom
  • -
  • July 17 2009

Mr Justice Kitchin handed down a decision only four weeks after the hearing, finding Cook’s patent invalid and not infringed by Edwards’ SAPIEN heart valve

End of German Olanzapine battle: Federal Supreme Court upholds patent

  • Bird & Bird
  • -
  • Germany
  • -
  • March 11 2009

On December 16, 2008 the Federal Supreme Court gave its judgment determining the validity of the Olanzapine patent, this was further to its revocation by the Federal Patent Court at first instance

EPO Enlarged Board of Appeal rejects patent that requires human embryos for implementation

  • Bird & Bird
  • -
  • United Kingdom
  • -
  • December 31 2008

In its decision of 25 November 2008 the EPO Enlarged Board of Appeal (EBA) considered four questions referred to it by the EPO Technical Board of Appeal concerning a patent application by Wisconsin Alumni Research Foundation (WARF) with claims to “a cell culture comprising primate embryonic stem cells…”

EDPS opinion on European Commission proposal for regulation on clinical trials on medicinal products

  • Bird & Bird
  • -
  • European Union
  • -
  • February 4 2013

The EDPS has issued an opinion on the European Commission's proposal for a Regulation on clinical trials on medicinal products for human use