Current Law Journal Content
Washington & Lee Law School
Current Law Journal Content
an index to legal periodicals
Bio-Science Law Review
Volume 9, Issue 4, 2006/2007
EMBRYOLOGY— PROPOSED CHANGES TO THE STATUTORY DEFINITION OF A HUMAN EMBRYO
Research involving the creation or use of human embryos in the UK must comply with the Human Fertilisation and Embryology Act 1990. The Act prohibits the creation, keeping and use of human embryos outside the human body without a licence from the relevant authority, but the prohibition only applies to human embryos caught under the statutory definition of "embryo". The Human Fertilisation and Embryology Bill proposes to update this definition to take account of technological developments in the field since its enactment in 1990. The Bill also introduces a separate term "human admixed embryos" for embryos created by combining human and animal DNA and cells. In addition to examining the proposed new defiinitions of "embryo" and "human admixed embryos", this article considers why the definitions of embryos are critical to the regulation of the field and the concerns relating to the wording of the current definition.
DO YOU WANT BIOLOGICAL OR ESSENTIALLY BIOLOGICAL VEGETABLES?
SVEN J.R. BOSTYN
The current Enlarged Board of Appeal referral (G 2/07) is to resolve the claimed contradiction between Article 53(b) EPC and Rule 23b(5) EPC1973 regarding the non-patentability of essentially biological processes for the production of plants, which is said to be found in the use of the wording "essentially biological" in Article 53(b) EPC versus the wording in Rule 23b(5) EPC1973 defining essentially biological as being a process which "consists entirely of natural phenomena such as crossing or selection". In the view of the author, there is no contradiction between these two provisions. The wording "essentially biological process" refers to a process which is in essence and in nature biological. A process which contains non biological steps does not consist entirely of biological phenomena, and cannot be deemed to be in nature biological. Hence such process is not essentially biological. Whether such process is novel, inventive or sufficiently disclosed is obviously an entirely different matter to resolve. The standard applied in earlier case law (e.g., T 320/87), referring to an evaluation to be made between the level of human intervention and the effect on the end-result, is not sufficiently objective to provide an acceptable degree of legal certainty. The solution proposed in this article is also in conformity with developments in case law in other fields of technology, such as for instance computer implemented inventions, where complicated and subjective evaluations as to whether subject matter is patentable subject matter is objectively resolved by emphasizing more on patentability requirements of novelty, inventive step and sufficiency of disclosure.
ON THE OTHER HAND: IS THIS THE LAST WORD ON PATENTING ENANTIOMERS?
STUART JACKSON, BRIAN WHITEHEAD and RICHARD KEMPNER
The Court of Appeal has overruled the decision of the Patents Court in Generics v Lunbeck, in which it held invalid Lundbeck's patent for a single enantiomer of citaloprom ("escitalopram"). Citalopran was widely sold as the racemate because of the difficulty of resolving it. Kitchin J held a claim to a method of obtaining escitalopram valid, but held the product claims to be invalid for insufficiency because only one process for making the product was disclosed. The Court of Appeal disagreed on the question of sufficiency, ruling that the principle of Biogen insufficiency was not of general applicability, and that the disclosure of one method of making a novel and inventive product was sufficient. Accordingly the claim to escitalopram mode by any method was valid. A patentee who has a product claim granted therefore gets more than he has invented: that product made by any method, and all uses of the product, including those he had not thought of. A chemist would be surprised that an enantiomer long known and used as half of the racemate could be inventive. The strange result arises because of the finding that the claim to escitalopram was not obvious, even though a chemist would have known that resolution would eventually be achieved by one or other standard method. This can be seen as a consequence of the more patentee friendly test for obviousness originated in Saint-Gobain v Fusion Provida.
MONSANTO PUTS BIOTECH DIRECTIVE UNDER THE SPOTLIGHT
The scope of potent claims directed to DNA molecules under EU Directive 98/44/EC (the Biotech Directive) is to be considered by the European Court of Justice. A referral has been made by the District Court of the Hague in the case of Monsanto vs Cefetra and the State of Argentina as to the meaning of Article 9 of the Directive. This specifies that the protection conferred by a patent for a product containing genetic information extends to all material, in which the product is incorporated and in which the genetic information is contained and performs its function. Monsanto brought an action in the Netherlands for infringement of their European patent EP 0546090. The patent covers an enzyme and DNA encoding it, which confers resistance to the herbicide glyphosate in plants expressing it. The defendant Cefetra imported into the Netherlands meal prepared from soy plants with the patented gene. Monsanto were able to show that DNA molecules covered by the patent could be detected in this meal. Cefetra argued there was no infringement because Article 9 requires the DNA to perform its function in the product and the meal was not a living material in which this could happen. Monsanto on the other hand argued it was suficient that DNA has exercised its function or could do again in the future. The ECJ will consider which of these two interpretations is correct. The Decision on this points will have very important implications for the scope of gene patents across Europe.
PATENTS — INFRINGEMENT ACTION
Gareth Morgan reviews the decision of the UK High Court in relating to the import of soya meal produced from beans of plants resistant to herbicide glyphosate. This decision is one a number of parallel actions taken by Monsanto relating to the import of soya meal from Argentina and provides an interesting contract to the issues raised in the District Court of the Hague, see above.
PATENTS - SPC REGULATIONS
A Recent decision of the UKIPO has potentially opened the door to the allocation of the SPC Regulations to a greater number of products. it has achieved this by reducing the time between patent filing and product marketing that would result in the grant of an SPC with meaningful duration.
AUSTRALIA -1P - Ownership of Research-based inventions NEW ZEALAND - Stem Cells - The Human Tissue Act 2008 UNITED KINGDOM - Pharmaceuticals - Clinical Trials - MHRA Seraxot investigation - 'Standard' Clinical Trials Agreements - Tax - Protecting Foreign Profits UNITED STATES - Patents - Infringement - UC v Dakocytomation California
A PRACTICAL GUIDE TO DRAFTING PATENTS