ARTICLES
BIODIVERSITY LAWS: AN EMERGING REGULATION ON GENETIC RESOURCES OR ‘IP ON LIFE’ THROUGH THE BACKDOOR?
CHRISTOPH HERRLINGER AND MICHAEL A. KOCK
Syngenta International AG, Switzerland

Genetic resources (GR) such as wildlife plants, animals, or microorganisms are the foundation of civilized life on earth and the raw materials of many industries. Various biodiversity laws, which claim their origin to the  Convention on Biological Diversity (CBD) and the related Nagoya Protocol, deviate from the original scope of the CBD and could substantially affect the right to access, transfer, and use GR. The EU regulation for implementation of the Nagoya protocol – as currently discussed – would establish a “quasi IP right”, without novelty or inventive step test, with the requirement for every user to obtain a license and pay royalties without exhaustion or expiration after 20 years, and with a dependency provision which would encumber all resulting products and all products made from these products. If implemented this legislation would establish a restriction to the use of biodiversity more severe and difficult to manage than any constrain resulting from the patent system. The current status of the regulation, its deviation from the CBD, interaction with other legislations such as plant breeders’ rights and resulting implications for users of GR are discussed. The dilemma to enable a fair benefit sharing but not to overwhelm and potentially disrupt an entire industry sector requires creative solutions based on the principle “Free access but not access for free.” Options how to evolve International Treaty for Plant Genetic Resources in Food and Agriculture in this direction are presented.

LEGAL DEFINITION OF HUMAN GENES AND PATENT ELIGIBILITY IN THE LIGHT OF THE MYRIAD CASE
NATALIA A. KAPETANAKI
Free University Brussels

The long-standing practice of the USTPO and of the EPO has been to treat genes as chemical compounds.  Therefore, like other chemical compounds, DNA molecules have been considered to fall under the patent eligible subject matter when isolated and purified from their natural state or when synthesized in a laboratory from their chemical starting points. However, besides their dominant representation as chemical compounds, legal theory refers also to the concept of the genes as information carriers. According to this concept, genes consist in something more than their component chemical molecule; that is, the scientific information they carry. This article examines these two concepts of genes and particularly the case of human genes in the light of recent US Supreme Court’s decision in the Myriad case. By doing so, the analysis shows that the adoption of each of the two concepts as the legal definition of the human gene had a direct impact on its patent eligibility as the subject matter of composition patent claims, while the principle of mere isolation for patentability, applied in the case of gene sequences, seemed to be an insufficient standard of patentability.

CASE COMMENTS
TEVA’S RECORD OF PREVIOUS ‘AT RISK’ LAUNCHES BEFORE PATENT EXPIRY IS DEEMED RELEVANT TO WHETHER AN INJUNCTION SHOULD NOW BE ORDERED AGAINST IT
MERCK SHARP DOHME CORP AND ANOTHER V TEVA PHARMA BV AND ANOTHER
JONATHAN BALL
Norton Rose Fulbright LLP, London

In the recent case of Merck Sharp and Dohme Corp and another v Teva Pharma BV and another, the patentee sought a final ‘quia timet’ injunction to restrain a threatened pre-SPC expiry launch of generic efavirenz by Teva. The court’s decision provides a useful detailed exposition of the relevant law on ‘quia timet’ injunctions. It also brings into focus that where a generic manufacturer has not cleared the patent issue away first but is in a position to launch, it must either commit to stay off the market until patent expiry or to at least inform the originator in advance of launch (so the originator can seek relief from the court at the time). Otherwise it will find it very hard to resist an injunction of this nature. Of particular interest in this case is that the court deemed Teva’s track record of previous ‘at risk’ pre-expiry launches of relevance to the level of ‘threat’ in this case, and hence a factor to be considered when weighing up whether an injunction should be ordered.

BOOK REVIEW
PHARMACEUTICAL INNOVATION, COMPETITION AND PATENT LAW – A TRILATERAL PERSPECTIVE
JOSEF DREXL AND NARI LEE (EDS)