Bio-Science Law Review - Volume 14 - Issue 4

Plant breeding innovations: free access but not access for free. A new approach to facilitate FRAND licences for plant-related patents
Syngenta International AG, Switzerland

Patents on seeds are heavily debated. On one hand they foster urgently needed plant-related innovations, on the other hand they could limit the 'freedom-to-breed' and access to genetic diversity. As an attempt to flip this dilemma, a diverse group of vegetable seeds companies created the International Licensing Platform (ILP) for vegetables, which provides easy and immediate access to vegetable-related patents. The solution includes a unique combination of features - including baseball arbitration - and has gained broad support in the vegetable seed industry. It is a first prototype for establishing open source in the plant patent area by developing the use of patent rights from an exclusion right to a liability regime based on the principle of 'free access but not access for free'.

Intellectual Property Protection of New Varieties of Plants in Sub-Saharan Africa: Overview of Existing Regimes (Part 2)

The 1994 WTO TRIPs Agreement requires WTO members, except least developed countries (for the time being if they do not want to) to provide some form of intellectual property protection to plant varieties, but does not oblige them to utilise a specific IP tool (between patents or sui generis Plant Breeders' Rights) for such protection. In this article, the African Agricultural Technology Foundation (AATF) has sought to provide an overview of the approaches adopted by 33 jurisdictions across Africa for the protection of new varieties of plants using either a sui generis system (UPOV-based or not) or the patent system. These jurisdictions include the two main African regional intellectual property organizations, the Organisation Africaine de la Propriété Intellectuelle (OAPI) and its English-language counterpart, the African Regional Intellectual Property Organization (ARIPO), and 31 national regimes for plant variety protection in Africa. Part 1 of the article appeared in Vol 14 issue 3 BSLR.

Case Comments
CJEU rules on the requirements for protecting carrier proteins using Supplementary Protection Certificates (SPCs)
JENNIFER O'FARRELL Boult Wade Tennant, London

Supplementary Protection Certificates (SPCs) extend the duration of protection conferred by a European patent for a medicinal product requiring marketing authorisation. The Court of Justice of the European Union (CJEU) has recently handed down the latest in a series of judgments (C-631/13) which seeks to clarify what can, and cannot, be protected under EC Regulation No 469/2009 (the SPC Regulation). Here the CJEU has decided that an SPC may be granted for an active ingredient covalently bound to another substance only if the active ingredient for which supplementary protection is sought has a therapeutic effect covered by the wording of the marketing authorisation.

Restrictions Governing International Trade in Genetic Resources Enter Into Force
WilmerHale, Washington D.C.

On 12 October 2014, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits from their Utilization ('the Protocol') entered into international force.  The Protocol is designed to further implement provisions of the Convention on Biological Diversity governing access to and utilisation of 'genetic resources' and 'traditional knowledge'.  As numerous countries move to implement these provisions, those who utilise biological materials from plants, animals, bacteria and other organisms for scientific research and commercial development must be especially mindful of these emerging requirements. Foreign government authorities are closely following the actions of US and European companies and research organisations under laws governing access to and utilisation of genetic resources and traditional knowledge.  That will continue to be case as these authorities move to ratify and implement the Protocol.  Stakeholders should secure an understanding of this evolving legal framework, both at the international level and on the domestic front and, where applicable, at the community level.  Those operating in this area should also seriously consider developing policies and adopting measures that reduce the risk of legal liability, patent invalidation, adverse publicity and reputational damage that may flow from an alleged violation of this new regime.

Broccoli & Tomato: Free or not free? Decisions G 2/12 and G 2/13 of the Enlarged Board of Appeal
MICHAEL KOCK Syngenta International AG, Switzerland

The Enlarged Board of Appeal of the European Patent Office ruled in a clear and well-argued decision of 25 March 2015 that the exception for essentially biological processes under Article 53(b) EPC does not have a negative effect on the allowability of a product claim directed to plants, even if the plant is claimed by a product-by-process based on an essentially biological process, and even if the only method available at the filing date for generating the claimed plant is an essentially biological process. The EBA considered it of no relevance that the protection conferred by the product claim extends to the generation of the claimed product by an essentially biological process. The practical and political consequences of the decision are discussed.

Novartis' patent on a transdermal therapeutic system for the administration of rivastigmine found invalid, clearing the way to 'generics' to the Exelon Patch.
Pat Duxbury
Wragge Lawrence Graham & Co

The High Court of England and Wales (Patents Court) has ruled that Novartis' patent to the transdermal therapeutic system (TTS) of its Exelon Patch is invalid. The patent was obviousness in light of an earlier Novartis patent filing. It was also invalid for added matter, the ruling being an example of the dangers of conceptual development in the course of prosecution of a patent, in this case a divisional. The decision clears the way for the launch of 'generic' rivastigmine patches. Had the patent been valid, the defendants' (Focus, Actavis and Teva) patches would have infringed.

English Court of Appeal rules on the construction of Swiss form patent claims in Warner-Lambert v Actavis
Luke Kempton and Ailsa Carter Wragge Lawrence Graham & Co

The Court of Appeal of England and Wales has ruled that no subjective intent is required for the infringement of a patent claim in Swiss form. While the court confirmed Arnold J's decision not to award interim relief on the basis of the 'balance of justice', the judge's conclusion that Warner-Lambert had no arguable case on infringement (direct and indirect) was overturned. Floyd LJ also raised questions regarding the interpretation of section 60(2) of the Patents Act (indirect infringement by supply of means, relating to an essential element of the invention, for putting the invention into effect) and the availability of relief (interim and final) for infringement of a second medical use patent. The judgment paves the way for a very interesting first instance trial of the main action in June/July 2015.