Biotechnology, research and intellectual property law andrew j allen

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An objective approach

Merely finding new knowledge is not sufficient for a patent. Novelty is one requirement but is not to be mistaken for an inventive step. Not every advance upon the prior art will have been achieved by the taking of an inventive step. Only those inventions that embody an inventive step are patentable. How the invention was developed is therefore relevant to this issue.

Biotechnology has combined science and industry with the effect that scientific advances will result from business decisions that guide research effort and supply resources. Mere business decisions will not earn patent protection but where those decisions result in programmes of research that contribute real advances in knowledge patent rewards are warranted. In Genentech it was held that the patent for human tissue plasminogen activator protein produced by recombinant DNA techniques was invalid because the product was known and the steps taken to produce it were obvious. If the alleged invention is stated at a general level, it is likely to coincide with prior art and appear to be obvious. Yet any invention can be stated at a level of particularity which will appear to reveal something not previously known. As Mustill LJ observed, 'the way in which the question about obviousness is put, will often, if not always, dictate the answer'.114 In this context, the precise configuration of the sought-after genes and the expression vectors created could not have been known before the work was done. These products were novel. However, the general nature of the route taken to find these products was obvious. This illustrates how the test for inventive step is clearly distinct from the test for novelty. A line of cases in the USA has illustrated the problems that can arise from an overly objective approach to the question of inventiveness. These cases involve the question of whether a known amino acid sequence rendered a corresponding DNA sequence obvious. Following the disclosure of partial amino acid sequences from human insulin-like growth factors in scientific journals, the US Patent Office rejected patent applications that claimed the human DNA and RNA sequences that encoded those proteins. This decision was based upon the fact that a general method for isolating a gene for which a partial amino acid sequence is known, using a short probe constructed by putting together DNA bases that encode part of that amino acid sequence, was known in the prior art. A Federal Circuit court overturned this decision on the basis of the degeneracy of the genetic code.115 The redundancy or degeneracy of the genetic code means that, with very few exceptions, it is possible to have several nucleotide sequences which correspond to a given amino acid sequence. The court held that because many different sequences of DNA could potentially code for the same amino acid sequence, the actual DNA claimed by the patentee was not obvious. The patentability of DNA sequences derived from known amino acid sequence information is not precluded in the USA by obviousness.116 This is because novel chemicals are generally not presumed obvious unless structurally similar to a known compound. The amino acid sequence and the corresponding DNA sequence are sufficiently different chemical molecules that knowledge of the former does not enable conception of the latter.

Discovering the DNA sequence of a gene is also an addition to the stock of human knowledge because the precise sequence of bases was not previously known. However, to assert that this alone is enough for patentability is to assimilate the test for obviousness with that for novelty. In the words of Mustill LJ, something more is required. Unfortunately, the enunciation of just what this something extra is has eluded precise definition.

A subjective approach

With the change in the way that research is conducted, many inventive steps will be the result of planned research programmes undertaken on the basis of careful management decisions involving cost-benefit analyses. Mere business decisions will not earn patent rewards. In Genentech v Wellcome117 the research team had identified a target for research, a route to achieve that target, and decided to bear the risk of failure. The achievement of the target was described as 'excellence in the field of management',118 but was held to involve no invention and was therefore unpatentable. However, the nature of the biotechnology industry, in which product development is a planned exercise involving accountants and managers, should not be a bar to gaining patents for the results of the work. As was recognised by Lord Hoffmann in Biogen:

The fact that a given experimental strategy was adopted for commercial reasons, because the anticipated rewards seemed to justify the necessary expenditure, is no reason why that strategy should not involve an inventive step. An inventor need not pursue his experiments untouched by thoughts of gain. Most patents are the result of research programmes undertaken on the basis of hard-headed cost-benefit analysis.119

In Ancare the Court of Appeal stated the test to be whether the alleged inventive step was 'something that could be done or was at least worth trying'.120 This approach indicates that some consideration should be given to the likelihood of success of a proposed course of development. The assessment of a probability of success invites a court to set a threshold level of probability above which a method would be held to be obvious to try. This type of test is vulnerable to yielding inconsistent results. For example, the Biogen success was held to result from a method that was obvious to try by the English Court of Appeal,121 while the European Technical Board of Appeal held that the same invention was not obvious.122 The English Court of Appeal held Biogen's patent obvious because the route taken was known even though the state of the art suggested the chances of success were low. The European Technical Board of Appeal focussed instead on the objective achievement, the fact that Biogen had overcome scientific uncertainty, and held that while the method may have been known as a possible method to try, it did not offer a reasonable expectation of success.123

Uncertainty is a continuous variable. It ranges from zero to one hundred percent. This fact may have influenced the English Court of Appeal's decision to revoke Biogen's patent on the ground of obviousness.124 As the probability of the success of a method for solving a problem approaches one hundred, it becomes an obvious method to try. The success of a method that is reasonable to try may add new knowledge to the state of the art, but little that can be called inventive. Yet, only a scintilla of invention is enough for a patent.125 The New Zealand Court of Appeal has said that the element of inventiveness necessary to resist an attack on the ground of obviousness was not high.126 Analysis of the likelihood of success of a particular path of research, as a measure of whether an inventive step was achieved, invites the criticism that a patent is earned for mere 'skilful exertion of time and effort'.127

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