The decision by the U.S. Supreme Court that isolated DNA having the same sequence as naturally-occurring DNA is not patentable subject matter is inconsistent with the position of the European Patent Office and Japanese law.
On June 13, 2013, in Association for Molecular Pathology v. Myriad Genetics Inc., the U.S. Supreme Court held that claims to isolated DNA having the same sequence as naturally-occurring DNA was not patent eligible because such DNA was not “markedly different from any found in nature”. On the other hand cDNA (DNA from which introns had been removed) is “different” from what was found in nature and so is patent-eligible. The Supreme Court noted that Myriad had made a medical breakthrough in identifying the location and hence the “typical” structure of the BRCA1 and BRCA2 genes, but “groundbreaking, innovative or even brilliant discovery does not by itself satisfy the §101 inquiry.” Discovery and invention are not the same.
Rejecting the majority view in the decision from the Court of Appeals for the Federal Circuit that the breaking of covalent bonds in order to isolate a fragment of DNA rendered it a non-naturally occurring molecule, the Supreme Court noted “Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes which result from the isolation of a particular section of DNA. Instead the claims understandably focus on the genetic information encoded in the BRCA 1 and BRCA2 genes”.
The Supreme Court also rejected the view that because the USPTO had granted gene patents for many years, their validity should now be upheld.
This is contrary to the law in Europe. As described in Relaxin/Howard Florey Research Institute (1995 OJ EPO 388), the EPO had granted a patent in which claim 1 reads as follows: “A DNA fragment encoding human H2-preprorelaxin, said H2-preprorelaxin having the amino acid sequence set out in Figure 2”. The patent was opposed by the Green Party of the European Parliament on the grounds that what was claimed was a discovery rather than an invention and that the grant of a patent for a human gene offends morality or public order.
Evidence showed that genomic DNA coding for H2 preprorelaxin contained introns which caused the natural material to contain additional amino acids that were not present in the amino acid sequence set out in Figure 2. The Opposition Division, however, indicated that it would not base its decision on this difference and that its decision would be the same “even if genomic DNA sequences encoding human relaxin were included in the scope of the claims”. Since evidence showed that prior to the invention the existence of the form of relaxin specified in the claim was unknown, and as the EPO guidelines permit novelty to be recognized for a natural substance which has been isolated for the first time if it had no previously recognized existence, the Opposition Division concluded that the claim had novelty. The Opposition Division also dismissed arguments that the “invention” claimed was a mere “discovery” as being incompatible with long standing European practice in respect of the patentability of other natural substances as set out in the guidelines.
Patents for genes are still being upheld.
In Japan, the guidelines for biotechnology inventions include the following with respect to “novel” genes:
In principle genes should be defined by means of the amino acids sequence for which they code if that amino acid sequence is novel. In exceptional cases, genes may be able to be defined by a combination of function and physical properties such as molecular weight, physical and chemical properties or origin if for some reason the actual nucleotides sequence of the gene or its amino acid sequence can not be determined. The guidelines also give some guidance as to when new genetic inventions may be regarded as involving an inventive step. In principle the guidelines indicate that where a gene codes for a known protein (even if the amino acid sequence of the protein is not known) there may not be an inventive step unless there was some reason why the amino acid sequence could not have been determined or the DNA being claimed has some advantage over other DNA coding for the same protein (although in this case presumably the DNA would have to be defined by its nucleotide sequence).
In Australia, the Federal Court upheld Myriad’s Australian patent 686004 on the BRCA1 gene. The appeal of this decision is now before the Full Federal Court and the decision is anxiously awaited.