Volume 5, Issue 1

The article critically examines how Egyptian legislators made use of the degree of freedom left in the TRIPs Agreement for WTO Members to incorporate appropriate measures in their national laws aiming at meeting the public health needs and concerns, particularly access to quality health care and affordable pharmaceutical drugs. The article also explores and warns against the recent attempts made by a number of developed countries to impose TRIPs-plus obligations on several developing countries, including Egypt, for their detrimental effects on public health.

Introduction Are you a man or a mouse? This expression is used to encourage someone to be brave when they are frightened of doing something. It is also an expression which bears associations to John Steinbeck's novella Of Mice and Men, the title of which is taken from Robert Burns' poem to a Mouse, which is often quoted as “the best-laid plans of mice and men often go awry”. Thus, the title's ambiguity sketches not only the issue at stake in the current debate on the creation of chimera, hybrids and cybrids (cytoplasmic hybrids) for research, but also provocatively encourages us to regard this new possibility as an important step towards fulfilling the golden promises of stem cell research while simultaneously summarizing the worry that the creation of interspecies organisms is a slippery slope towards “the apocalyptic end of humanity”.

The birth in 1968 of Louise Brown, the first English test tube baby, was a beacon of hope to the estimated 1 in 7 couples who experience difficulty in conceiving a child. It was obvious that the process of assisted conception required regulation to deal with the legal and ethical ramifications of the developments science had given us and after much consultation and debate, The Human Fertilisation and Embryology Act 1990 was passed.

In the approximately two and a half years since the United States Supreme Court issued its opinion in Merck KGaA v. Integra Lifesciences I, Ltd . (“ Merck KGaA ”), the U.S. Court of Appeals for the Federal Circuit has issued an opinion on remand, and several decisions have issued from various federal district courts that ruled expressly or by implication that patented biotechnology “research tools” are exempt from infringement under 35 U.S.C. § 271(e)(1) under the “safe harbor” provision that was expanded in Merck KGaA . Thus, “research tools” should be accorded the same sheltering from infringement that more typical products and processes are given if they are reasonably related to a new drug approval application (“NDA”) that is potentially or actually submitted to the FDA. A brief overview of the Merck KGaA opinion is provided, how the Federal Circuit followed the Merck KGaA instructions on remand, and particularly, how federal district courts have applied the Merck KGaA doctrine since it issued in mid-2005.

This article addresses the Chinese legislation on patent protection for biotechnology. Section I presents a brief overview of China's intellectual property right protection regime for biotechnology; Section II describes the China's current patent legislation on biotechnology. Since April 2005, China has lunched the third amendment to its Patent Law. The related information of the third amendment to Chinese biotechnology patent policy is provided in the final section.

Introduction Stem cell research involving the use of embryos has been controversial in Australia and internationally, and at times has triggered emotive debates. This is because isolation of embryonic stem cells inevitably entails destruction of the embryo. Controversy is also fuelled by the interconnection between this debate and the debate about human cloning. Although there is by no means a consensus on the approach that should be taken to the regulation of this area, there is at least wide acceptance of the significant potential of stem cell research and the need to ensure that scientific progress in this field is not stymied by overly restrictive laws. The aim of this paper is to sketch the background to the regulation in Australia of stem cell research and human cloning, and to outline the current regulatory model as modified by amending legislation in 2006 to permit so called ‘therapeutic cloning’.