INVENTIONS, GENES AND NAPOLEONIC VICTORIES
| Citation | (1997) 9 SAcLJ 1 |
| Author | GEORGE WEI |
| Published date | 01 December 1997 |
| Date | 01 December 1997 |
Recent years have seen a growing number of important English decisions concerning the law of patents. Matters touched upon have ranged from the question of what is an invention, to the requirement of novelty, inventive step, industrial applicability, priority dates, sufficiency, interpretation of the scope of the claimed invention, infringement, tie in clauses and so on. A number of these cases are concerned with inventions arising out of recombinant DNA technology and their products. That this is so is hardly surprising given the immense importance of the technology in developing new genetically engineered products and processes. The first of these cases is some seven years old: the decision of the Court of Appeal in Genentech Inc.’s Patent1. More recently, other genetic engineering cases have reached the courts: two of these are concerned with Hepatitis B and C viral infections. Of these, the dispute between Biogen Inc. (Biogen) and Medeva Plc (Medeva) over the patentability of inventions relating to a test kit and vaccine for Hepatitis B infection has given the House of Lords, what may be considered to be, a relatively rare opportunity of clarifying some basic principles in patent law in connection with genetic engineering.2 Issues raised in the House of Lords include: the concept of invention, inventive step, priority date, enabling disclosure and support of patent claims by the description in the specifications filed in support of the application. These concepts, whilst not exhaustive, are pivotal points on which many a patent application will turn, both in the United Kingdom, Europe and also in Singapore as well as in many other jurisdictions. This article seeks to discuss some of these issues in the context of the decision of the House of Lords in the Biogen case and where appropriate to discuss the extent to which the decision will be of relevance to Singapore under the Patents Act 1994.
Biogen, founded in February 1978, by Professor Sir Kenneth Murray and a number of other molecular biologists of international repute, set out as one of their first projects to develop antigens of the Hepatitis B virus (HBV) which, as is well known, is a virus which can cause serious, and potentially fatal, liver disease. The antigens of HBV were sought as they could be used in methods to test people for HBV infection. They could
also be used to develop vaccines against infection. The technology to be employed to develop the antigen was the rapidly developing area of genetic engineering employing recombinant DNA technology. Whilst, many techniques of recombinant DNA technology are well understood today, this does not appear to have been the position in and around 1978 when much of the research and development relevant to the patent claims at hand took place. In order to set the scene for the patent issues that arose, a brief description of recombinant DNA technology will be necessary together with the problems that Biogen faced in employing that technology to produce the HBV antigens. By November of 1978, Professor Murray had produced two of the known HBV antigens in colonies of cultured bacteria, namely HBV surface antigen (HbsAg) and HBV core antigen (HbcAg) in the bacterium E.coli. In the following discussion, Professor Murray and his team are referred to as Biogen.3
Genetic information essentially comprises the chemical instructions or codes that control the make-up of all living matter.4 In the case of human, and many other life forms, genetic information is to be found in chromosomes which are found inside the nucleus of cells. Human beings have a total of 46 chromosomes organised into 23 pairs which can be found in the nucleus of the cells which make up the human body. The nucleus of sex cells, however, only contain 23 chromosomes. This is because the other 23 chromosomes will come from the other parent upon fertilization of the egg by the sperm. Other living cells may have a different number of chromosomes: for example, the fruit fly only has 4 chromosomes in its cells. The genetic information in the chromosomes is organised into genes and in the case of human beings comprises some 100,000 genes. Collectively, the total number of genes are referred to as an organism’s “genome”. The expression, “genotype”, on the other hand, refers to the genetic make up of any individual organism within that class. Each gene is responsible for one specific trait of the organism. Each gene is made up of a chemical substance called “deoxyribonucleic acid” or “DNA” in short. Understanding the DNA sequence and structure of any given gene will help scientists in understanding how that gene works. The knowledge that can be gained from this can then be used in some cases to develop new methods of treatment and diagnosis of certain diseases. For example, the identification
of the gene responsible for controlling the production of insulin can help doctors to identify patients who may have a propensity towards developing the ailment diabetes and it may even be helpful in devising new methods of treatment in the future: for example by “repairing” the defective gene which is responsible for the disease. An understanding of the structure and sequence of the DNA in genes can also be used in areas that are not concerned with genetic diseases. It can also lead to a better understanding of the immune system and how certain viruses and bacterium are able to defeat the immune system resulting in consequential disease. In recent times, for example, the search for a method of diagnosis and treatment of HIV infection and “acquired immune disease syndrome” or “AIDS” has proceeded along this front. Similarly, in the area of hepatitis, a disease caused by a virus which affects the liver, the search for accurate tests for infection and treatment have been very urgent given the serious nature of the disease. Not too surprisingly, genetic engineering has played an important role here as is demonstrated by the Biogen case. If scientists were able to unravel the genetic make up of the virus, the first steps would have been taken down the road which, hopefully, will lead to effective diagnosis and treatment. The Biogen case also demonstrates that even without knowing the precise genetic make up of a virus, it may still be possible, with effort and a degree of luck, to use recombinant DNA technology to manufacture artificial antigens of a virus for use in test kits and vaccines.
In some respects, the birth of modern genetic engineering techniques can be traced back to the discovery by Watson and Crick in 1953 of the basic double helix, “ladder” like structure of the nucleic acids that go to make up genes. This discovery gave scientists an understanding of the molecular structure of DNA. DNA is a complex molecule. The “arms” of the ladder comprise alternating phosphate and deoxyribose sugars. The “steps” in the ladder comprise a sequence or chain of nucleotides made of chemical bases from adenine (A), guanine (G), cytosine (C) and thymine (G). Each “step” or base along one arm of the ladder bonds with another “step” or base on the complementary arm of the ladder to form a pair: A always pairs with T and C with G. Each gene is made of a strand of DNA which may comprise many base pairs. It is this sequence of base pairs in each gene which is basically the genetic code for whatever that gene is supposed to encode for. Essentially, each gene encodes for the production of a certain protein. Each protein is comprised of a number of amino acids. All in there are 20 amino acids which can combine together to form all the many different proteins that go to make up an organism. Since the amino acids in the chain are linked together by peptide bonds, proteins are also referred to as “polypeptides.”
How then does the DNA of a gene encode for and produce the desired protein? In brief, the procedure, which involves another chemical called “ribonucleic acid” or “RNA”, appears to be as follows. Consider a cell in the pancreas that is responsible for production of insulin. The gene in the
cell that encodes for insulin splits apart down the ladder of base pairs into 2 strands. At this point, an enzyme called RNA polymerase moves along one of the strands and builds up a RNA strand which is complementary to the DNA strand. RNA is also made up of 4 bases. These are adenine (A), guanine (G), cytosine (C) and Uracil (U). These are the same as in the case of DNA with the exception that thymine (T) is replaced in RNA by uracil (U). This process of building up the equivalent or complementary strand of RNA is referred to as “transcription”. The complementary strand of RNA once produced moves outside of the nucleus and into the body (cytoplasm) of the cell and for this reason, this type of RNA is also referred to as messenger RNA or “mRNA”. Once the mRNA leaves the nucleus, protein synthesis begins. A particle called a “ribosome” moves along the strand of mRNA and builds up the sequence of amino acids that collectively make up the desired protein. Proteins, as noted earlier, are made of sequences of amino acids. The code for any given amino acid comprises a sequence of three nucleotides. Thus, for example, the sequence, A A G in mRNA, will encode for the production of the amino acid lysine. In this way the genetic code may be described as a “triplet code”, with each triplet encoding for a particular amino acid. Each triplet is called a “codon”. To complete the picture, the actual synthesis of the protein involves another type of RNA called transfer RNA or tRNA. Each tRNA molecule is connected with an amino acid and has the ability to “carry” that amino acid to the ribosome-mRNA complex for protein synthesis.
In humans, there are about three billion base pairs in the genome, with individual genes being made up of several thousand base pairs. It is to be noted, however, that not all of the genetic information is...
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