Bio-Science Law Review - Volume 17 - Issue 1
LIFE SCIENCES DISPUTES: IS INTERNATIONAL ARBITRATION THE FUTURE
MICHAEL DAROWSKI Gowling WLG (UK) LLP
As the life sciences sector becomes ever more international, so disputes arise across borders. This article considers why international arbitration is increasingly the dispute resolution method of choice for these disputes.
NUFFIELD COUNCIL ON BIOETHICS – GENOME EDITING AND HUMAN REPRODUCTION: SOCIAL AND ETHICAL ISSUES
Pinsent Masons LLP
In July 2018 the Nuffield Council on Bioethics concluded an enquiry prompted by developments in gene editing technology and published its report, ‘Genome editing and human reproduction: social and ethical issues’. This article highlights issues raised by the enquiry, including ethical and social issues that could impact different groups, namely: (1) the people immediately involved (prospective parents and the future person); (2) others in society who may be indirectly affected and society as a whole; and (3) future generations, and the human species in general.
THE CJEU’S LATEST RULING ON ARTICLE 3(a): CASE CLOSED?
Park Grove IP0
Mike Snodin discusses the ruling of the CJEU in C–121/17 (Teva UK & Others), as well as the extent to which the further guidance provided in that ruling will help to settle current and future cases in which there is a dispute over whether the product for an SPC is ‘protected’ by a patent in the sense of Article 3(a) of the SPC Regulation.
ESTABLISHING UNFAIRLY HIGH PRICES: THE IMPLICATIONS OF THE CAT’S JUDGMENT IN FLYNN AND PFIZER v COMPETITION AND MARKET AUTHORITY
ALISON JONES AND CHRISTOPHER STOTHERS
Freshfields Bruckhaus Deringer LLP
Research and development of new and innovative pharmaceutical treatments is important but expensive and risky. Although patents, regulatory data exclusivity and other factors can result in pharmaceutical manufacturers and distributors holding significant market power, the rewards available are, to some extent, constrained by limitations in healthcare budgets (whether public or private). Nonetheless, the price of drugs has been attracting considerable attention across the globe, especially where price increases have been dramatic, implemented over a short period of time and relate to drugs which are old.
The recent judgment of the UK’s Competition Appeal Tribunal (CAT) in Flynn and Pfizer v Competition and Market Authority (CMA) for charging unfairly high prices for an anti-epilepsy drug, has reaffirmed that, however lurid the headline, any challenge to pricing on competition grounds must be carefully reasoned. The CAT’s judgment, and the appeal against it, also has important implications for other competition investigations pending before the CMA into high pricing in the pharmaceutical sector.
SPECIFIC MECHANISMS: THE COURT OF JUSTICE OF THE EU CLARIFIES WHEN PATENTEES CAN OPPOSE PARALLEL IMPORTATION OF PATENTED DRUGS FROM NEW INTO OLD MEMBER STATES
DR MICHELE GIANNINO
Desogus Law Office
In the preliminary judgment issued in Pfizer v Orifarm, the Court of Justice of the EU found for the holders of patents and supplementary protection certifications covering pharmaceutical products, holding that the rights holders can prevent the import of protected drugs from the new EU Member States by relying on the Specific Mechanisms appended to the Acts of Accession, provided that at the time of the patent filing in the old Member States, an equivalent protection was available in the new Member States.
TOUGHENING UP AUSTRALIAN PLANT BREEDERS’ RIGHTS
KIM O’CONNELL, SCOTT BOUVIER AND VEG TRAN
King & Wood Mallesons, Sydney
Significant changes to the regulation of Australian plant breeders’ rights are due to come into effect from February 2019. The new laws are anticipated to provide greater certainty and valuable commercial outcomes for rights holders and investors in the Australian agricultural sector. This comment provides an overview of the key changes and their likely impact on stakeholders.