Current Law Journal Content
Washington & Lee Law School
Current Law Journal Content
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Bio-Science Law Review
Volume 8, Issue 5, 2005/2006
TALKING SERIOUSLY ABOUT PATENTS
Commissioner McCreevy's latest proposals to solve the impasse over how to proceed to the next stage with the Community Patent and The European Patent Agreement are set in context and Gareth Morgan argues for more active engagement in the policy making process by the bio-science sector.
ANGIOTECH: A TALE OF TWO JURISDICTIONS
CAMILLA SMITH AND SHELLEY BLYTHE
In January this year decisions were handed down by two of Europe's highly regarded forums for patent disputes: the Court of Appeal in England and the Hague District Court. The decisions relate to the same companies and the same Patent and yet they conflict with each other. On the one hand the English Court found that the Patent was invalid and on the other, the Hague District Court found that the Patent was at least partially valid and infringed. The patent in suit related to a taxol eluting stent which was used in preventing restenosis. One of the main differences was the way the courts sought to answer a question posed by the English First instance judge, namely "is the Patent vulnerable only if it can be shown that the skilled person would have an expectation of success sufficient to induce him to incorporate taxol in a drug-eluting stent, or is it sufficient that without any expectation of success he would test or screen taxol". The Courts' answers to this question lead them to consider both the patent and the prior art in very different ways. This case highlights the differences between the Dutch use of the 'problem-solution' method for determining obviousness and the English Court's use of the 'Windsurfing' test. The Courts also consider the circumstance when the 'obvious to try' argument applies and submissions regarding the 'likelihood of success' and 'commercial success' in a patent context.
BOLAR PROVISIONS IN THE UNITED KINGDOM
HSU MIN CHUNG
In his Review of intellectual property last year, Andrew Gowers noted that the UK Patents Act currently provides some exceptions to infringement that facilitate research. However, he felt that the scope of these exceptions was unclear and feared that this lack of clarity could hamper research into patented areas of science and technology if scientists were forever fearful of being sued for infringement. This is particularly relevant in the pharmaceutical field, where generics manufacturers often wish to carry out trials prior to the expiration of a patent so as to introduce their products immediately on expiry of that patent. This article takes a closer look at the exceptions that are currently provided to facilitate research in the UK and highlights some of the areas which are still open to interpretation, in particular with respect to clinical trials.
INTELLECTUAL PROPERTY RIGHTS IN CLINICAL DATA
The importance of clinical data to securing marketing authorization for a drug product is clear. This note considers the intellectual property position in the EU with respect to clinical data. Unlike patents, which attach to the drug candidate, it is less clear what intellectual property rights attach to the clinical data derived from its testing. Typically, when it comes to protecting information, an obvious source of possible intellectual property protection is copyright. It would, however, be very difficult to maintain that individual data constitute copyright works. In the EU, database rights provide another possible source of intellectual property protection for individual data stored in databases, but these rights have been construed narrowly. To establish the existence of database rights in the clinical data of interest, an investigation is required of the relevant databases in which the clinical data is collected, together with the processes by which the data is generated, checked, approved and entered into each relevant database. If the intellectual property attaching to the clinical data cannot be established, then the data developer or a subsequent acquirer needs to consider the implications of competitors potentially having undeterred access to the informational advantages provided by the clinical data.
PATENTS AND PLANT VARIETY RIGHTS IN THE EU
If an individual develops a new variety of a plant through traditional or recombinant techniques of plant breeding, there are pοtentially two routes of protection open to them for the protection of such a variety within the EU: the patent system or the grant of plant variety rights. There are differences between these systems and this article will seek both to review the nature of these rights and to describe the way in which the two regimes interact. It should be noted that these EU regimes co-exist with national systems, but this article will focus on these rights at the EU level.
AUSTRALIA - Joint Patentees and Entitlement to Grant of a Patent - FRANCE - Bio-similars and 'Bolar' Clauses - implementation of Directive 2004/27/EC on the Community code relating to medicinal products for human use - NEW ZEALAND - Swiss Type Claims - A recent development in New Zealand Law - Re Genentech Inc and Washington University, Patent Application no 539505 - UNITED KINGDOM - Patents - UK Enantiomeric Form Patent held insufficient News - Hybrids and Chimeras Regulations - The UK WEEE Regs - The new European REACH Regulation
THE EC COMPETITION LAW ON TECHNOLOGY LICENSING, FRANK L. FINE