Biotechnology and Pharmaceutical product perspective.

In many cases we often find that although researchers consider their research as complete, we take the view that the research is incomplete to justify the patent claims filed. This article proposes to discuss the requirements of one aspect of patentability.

One of the three legal requirements to obtain a patent is that there must be “industrial applicability” in the research results (the other two being – “novelty” and “inventive step”). Now what is meant by the term “industrial applicability”? This article will attempt to explain this term in relation to patent applications in the field of biotechnology and pharmaceutical compounds.

The Malaysian Patents Act 1983 expressly states that “discoveries, scientific theories” are not patentable. For example identifying a strain of naturally existing bacteria, or a phytochemical are mere discoveries. Therefore research findings which are merely discoveries are not patentable. But application of the discovery in an industrially applicable manner or use of the discovery in an industrially applicable manner is patentable. To give a simple illustration – The fact of first knowing that different metals have different coefficients of expansion when subjected to heat is merely a discovery. The researcher has discovered what is already in nature. There is no inventive step, nor is there suggestion of any practical use of the discovery. However, if the discovery is used to produce a thermostatic switch, the latter is patentable. The claims of the patent would be directed to a product and/or method of construction of a thermostatic metal switch, and the method of use thereof.

If a chemical compound present in nature is discovered, but its use is not known, then there is no industrially applicable “invention”. However if a use of the naturally occurring compound is known, then there is an invention.

In a recent case in UK, [Eli Lilly v Human Genome [2008] EWHC 1903 (Pat)] Lilly applied to revoke European patent (UK) 0939804 of HGS. The patent disclosed the nucleotide and amino acid sequence of a novel member of the TNF ligand superfamily which it called Neutrokine-a. The opposition Division of the European Patent Office revoked the patent as being obvious and constituting a claim to an arbitrary member of the TNF ligand superfamilywithout a known function. (The decision is under appeal).

Lilly had alleged that the subject matter of the patent is not capable industrial application. It contended that the specification consists simply of sequence information for a polypeptide with broad, unspecific and inherently speculative statements about its biological activity. The invention failed to properly to characterise the polypeptide, its function or any therapeutic or diagnostic utility for it. The judge, Kitchen J, believe that if these allegations were true, then ALL the claims were invalid.

The requirements of the law that a claimed invention be susceptible of industrial application are essentially directed at ensuring the disclosed invention has a real practical application. In the case of biotechnology inventions, the position is not often so straightforward. These may be concerned with biological material, including gene sequences, bacteria and proteins found in nature. A gene, bacteria or protein sequence, once identified and isolated, may be relatively easy to reproduce. It may also be supposed that since it is sequence from a living organism it will have a function. However, it is quite possible that although the sequence is known, its function is not – or is at least not well understood.

Kitchen J considered the cases – in the UK, in the EPO and from the US courts.

Among other principles he concluded that the patent description (as addressed to a person skilled in the art) must disclose a practical way of exploiting the invention in at least one field of industrial activity (ie. manufacturing, extracting and processing activities). This requirement will not be satisfied if what is described is merely an interesting research result that might yield a yet to be identified industrial application. The purpose of granting a patent is not to reserve an unexplored field of research for the applicant. A patent is not a hunting licence.

In the field of biotechnology, if a substance is disclosed and its function is essential for human health, then the identification of the substance having that function will immediately suggest a practical application. If, on the other hand, the function of that substance is not known or is incompletely understood, and no disease has been identified which is attributable to an excess or a deficiency of it, and no other practical use is suggested for it, then the requirement of industrial applicability is not satisfied.

Using the claimed invention to find out more about its own activities is not in itself on industrial application. Further it is no bar to patentability that the invention has been found by homology studies using bioinformatics technologies.

The Court found that the claimed inventions of Neutrokine-a, were not susceptible of industrial application at the date of the patent. The Patent was held invalid for lack of industrial applicability and insufficiency. Whatever the merit of the discovery of Neutrokine-a, the specification contains no more than speculation about how it might be useful. It does not teach the persons skilled in the art how to solve any technical problem and its teachings as to the range of applications of Neutrokine-a are implausible.

In Malaysia, the law is the same as above. Mere discovery of bacteria, gene sequence or a novel composition is alone not sufficient to obtain a patent. The inventor must show a practical use / application of the product. The invention need not be commercially viable.

Practice Tips

1. Show practical application of compound (or composition or complex). If compound A is mixed with compound B, then it can not be assumed mixture of A and B will give combined results of A & B. It is preferable to show actual worked examples, than to depend on arguments that the mixture is useful. On the other hand if the mixture of A & B gives predicable or expectable results of A and B, and no more or no less, then there is no inventive step or unobviousness.
2. After “discovery” find at least one industrial use or applicability for the “product” or “process”.

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[IP Advisory service from KASS (Issue 102/2008)]