Current Law Journal Content
Washington & Lee Law School
Current Law Journal Content
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Bio-Science Law Review
Volume 11, Issue 4, 2010
OFF-LABEL USE AND PROMOTION: RISKS AND POTENTIAL LIABILITY
LIESBETH WEYNANTS, CARLA SCHOONDERBEEK, CHARLOTTE WEYNE
This article looks into the risks posed by, and the potential liability for, the off-label use and promotion of medicinal products. The term "off-label use" is first clearly defined and distinguished from other types of use, such as unauthorised use and unlicensed use. In addition, a general overview of the specific regulatory framework for the authorisation of medicinal products and the rules and practices on the use and prescription of such products is provided in order to clarify the context in which off-label use can occur. This context is further illustrated with a few well-known examples. The point is made that the distinction between the regulation of the pharmaceutical industry and the regulation of medical care at the individual patient level mirrors the distinction between off-label promotion and off-label prescription and use. The issues are analysed from the standpoint of industry, the government and healthcare practitioners. The overview of pharmaceutical industry regulation emphasises the potential liability for off-label promotion, from both an EU and a US perspective. With respect to healthcare practitioners, their freedom to prescribe is underscored although several criteria to ensure correct off-label prescription are suggested as well. Finally, the impact of off-label use on the governmental reimbursement system is investigated. To conclude, a number of recommendations to achieve a better balance between all parties involved in the off-label debate are listed.
INTELLECTUAL PROPERTY ASPECTS OF GM AGRICULTURE (PART II)
The two parts of this article examine best practices to deal with any legal liability arising from the development, cultivation and use of GM crops by governments, the agricultural research and development organisations, plant breeders, farmers, and exporters. The heads of liability considered include tort, contract, trade practices and fair trade laws, intellectual property laws, and biosafety laws.
EPO ALLOWS DOUBLE PATENTING WHERE PATENTEE HAS LEGITIMATE INTEREST
HSU MIN CHUNG
Many practitioners will encounter double-patenting objections before the European Patent Office. A recent Technical Board of Appeal decision, however, suggests that the bar to double patenting should not be applied so broadly and, in the future, it may be possible for an applicant to obtain two patents for the some invention provided that he has a legitimate interest in the grant of the second patent.
THIRD TIME LUCKY FOR THE PCC
The Patents County Court in England and Wales has undergone a transformation. Out is the procedure that essentially aped that in the high Court and in comes a slimmed down procedure with limited costs recovery and (soon to be) and intended cap on the recovery of damages. The jurisdiction relies on more detail to be provided to the PCC at the beginning of the case such that the CMC becomes on opportunity for the judge, His Honour Judge Birss, to give detailed directions to trial. The usual trappings of high Court litigation will largely be absent from this procedure with limited disclosure and evidence whilst the opportunity to request experiments is likely to be extremely restricted. We review two of the most recent decisions and analyse how the PCC's approach to these cases can instruct practitioners on the manner in which that Court is intending to manage litigation. The first of these cases focuses on the grounds upon which applications to transfer cases from the PCC to the High Court will be considered and the second is instructive for the level of detail into which HHJ Birss was prepared to delve to prepare the case for trial. The directions in the latter case were notable for the willingness of the PCC not only to fix a trial date at the CMC (no "trial window" as is usual in the High Court), but also the fix a date for judgment. One wonders whether or not this will become the norm in the PCC and/or whether such initiatives will have an impact on the manner in which the judges in the High Court manage patent cases both at CMC stage and in preparation for trial.
EUROPEAN COMMISSION - Competition - R & D and Specialisation Exemption Regulations and Horizontal Co-operation Agreements Guidelines - EUROPEAN PARLIAMENT AND EUROPEAN COURT OF JUSTICE - European Patents - Initiatives on the implementation of a unified patent system - EUROPEAN PATENT OFFICE - Patents - Broccoli and Wrinkly Tomatoes Cases G2/07 and G1/08