It’s life Jim, but not as we know it

Craig Venter has never been the sort to shy away from controversy. Researchers at the J. Craig Venter Institute have filed a patent application for a minimal set of genes required to sustain life. Such a minimal gene set could be used to create “synthetic” organisms. Unsurprisingly, the patent application has attracted the attention of activists who fear a monopoly in the emerging field of synthetic biology.

Venter’s colleagues used the bacterial pathogen Mycoplasma genitalium, which already has a very small genome, as the starting point for their studies. The team systematically knocked out individual genes to identify non-essential genes based on the organism’s ability to survive without them. The essential gene set was then derived from the total number of genes minus the non-essential genes.

The patent application (US 2007/0122826) claims the minimal gene set and a “free-living organism” containing the gene set. The applicants discuss using an existing bacterium, stripped of its own genes, as a recipient for a synthetically-produced minimal gene set. This would create a “synthetic” organism for which they propose the name Mycoplasma labratorium. Some would argue that it is not a strictly synthetic organism as an existing cell is required. The pending claims are not however limited to use of an existing cell.

The applicants do not demonstrate production of such a “synthetic” organism is in the patent specification, which may impact on the resulting claim scope. However, Venter scientists recently transplanted the genome of M. mycoides into an genome-free M. capricolum recipient cell (Science (2007) 317, 5838, 632-8) which suggests that production of a “synthetic” organism is imminent, if not already done.

The scope of the pending claims is not however, as broad as the activists may fear, in part due to the publication of a similar study, by the same team in 1999. Among other restrictions, the pending claims are limited, for example, to a gene set comprising no more than 450 protein-encoding genes.

Claims in any patent application are also often significantly narrowed during the examination process. It will be interesting to follow examination at the USPTO, which typically applies a fairly strict one sequence per application policy. A corresponding PCT International application has been filed, but the claims have yet to be examined in any patent office

Regardless of the scope of any claims eventually granted, this patent application is sure to stimulate lively debate, and to generate a lot of, and probably not unwelcome, publicity.

New policy on bioprospecting in New Zealand

Bioprospecting: Harnessing Benefits for New Zealand is the latest discussion document from Ministry of Economic Development (MED).

The document outlines the obligations of New Zealand as a party to the Convention on Biological Diversity (CBD). The overarching principle of the CBD is that states have sovereignty over their genetic resources so access to biological resources should be regulated by a nation’s own laws.

As a signatory to the CBD, New Zealand has agreed to provide an access and benefit-sharing system to biological resources.

MED is seeking feedback from New Zealanders who are directly affected by the CBD. MED is holding seminars, hui and reference forums until mid-September. A schedule of venues and dates can be obtained from www.med.govt.nz/bioprospecting.

MED will accept written submissions addressing particular issues and concerns until 12 October 2007.

We attended a public seminar on 31 July 2007 given by MED. The seminar covered the government’s current working definition of bioprospecting. MED acknowledged that access to New Zealand’s biological resources and protection of traditional Maori knowledge is not currently regulated by any legislative framework in New Zealand.

The MED also acknowledged that although the current extent of bioprospecting in New Zealand is unknown, New Zealand is of interest to potential bioprospectors due to our:

• geographic isolation (unique and/or endemic groups of organisms)
• extensive marine environment
• environmental features (geothermal and hydrothermal vent systems).

MED is now working on a comprehensive bioprospecting policy for New Zealand and will consider New Zealanders’ views on bioprospecting and how our bioresources should be protected. MED has not yet decided what will be covered by any bioprospecting regulations or what form those regulations may take.

We will keep our clients updated with progress as we wait and see how New Zealand’s bioprospecting policy shapes up.

If you have an interest in this area or would like to express a particular view, you can file written submissions before the 12 October deadline. Guidelines and suggestions for written submissions are in the discussion document. Please contact us if you need help with preparing your submissions.

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US Supreme Court interprets “obviousness”

The US Supreme Court recently gave a highly anticipated decision in KSR v Teleflex.

Of particular interest was the Court’s analysis of the doctrine that governs combining multiple pieces of prior knowledge to attack the inventiveness of a patent application. Central to this 24-year old doctrine is the requirement for some “teaching, suggestion, or motivation” (TSM) that would lead a skilled person to combine prior knowledge. Application of this doctrine required identifying TSM in separate pieces of prior knowledge that would allow it to be combined.

The Court in KSR rejected a rigid application of the TSM approach. The Court also acknowledged the importance of a common sense approach to identifying a reason that would prompt a skilled person to combine various pieces of prior knowledge.

What does the KSR decision mean in practical terms? It should make it easier for the USPTO to reject patent applications that are seen to be mere combinations that yield a predicable result.

A greater effect may be felt within the mechanical arena than in life sciences, as life science inventions are considered inherently less predictable. As a result, even though a life science invention may be “obvious to try”, such attempts are likely to yield an unpredictable result.

A simple chemical modification is not necessarily obvious where the prior art also says it would be pointless to make that modification. For example, in a recent US Federal Court case Takeda v Alphapharm (June 28, 2007) relating to a new chemical compound, the known parent compound was stated not to be active in the particular disease state. The Court held that the test for obviousness is whether the prior art would have suggested making the specific molecular modifications necessary to achieve the invention. This approach was stated to be consistent with the approach enunciated in KSR.

Similarly, it would be expected that it would be difficult to make out a case of obviousness for a novel gene (where the amino acid sequence is unknown) or for disease-related markers, since their identities would be unpredictable.

Therefore, it is likely that while KSR will have a lesser effect on patentees in the life sciences, we can expect obviousness objections to be based on looser collections of prior art documents. This will result in greater time and expense during the examination phase of patent applications in the US.