This principle [that patents are granted only for 'inventions'], however, has been for the past 30 years the subject of a legal trick played by clever patent attorneys. ... Isolated biological materials, that is, naturally occurring biological materials that have been removed from the natural environment, such as the human body, are no longer regarded as products of nature, but as inventions.While Senator Heffernan's stance on gene patents is well-known, we confess to being surprised by this move. It is perhaps no coincidence, however, that a revived Senate Committee (including Senator Heffernan) inquiring into gene patents is due to report today.
The Bill proposes amendments to subsections 18(1)(a) and 18(1A)(a), which define patentable subject mater by reference to a 'manner of manufacture within the meaning of Section 6 of the Statute of Monopolies', as well as subsection 18(2), which defines express exclusions to patentability, and adds a definition of 'biological materials' in subsection 18(5).
In our view all of the amendments proposed in the Bill are appalling and ill-conceived, and we can only hope that they proceed no further than a reading in the Senate!
Firstly, the Bill proposes to require than an invention be a manner of manufacture within the full meaning, including the proviso, of section 6 of the Statute of Monpolies.
The 'proviso' in question is the original (1623) exclusion for subject matter that is 'contrary to Law', 'mischievous to the State, by raising Prices of Commodoties at home', or 'Hurt of Trade', or 'generally inconvenient'. Many of these exclusions have either been deliberately dropped from the modern patent law, or have been covered in specific provisions of the Act. Reintroducing these outdated concepts is, without doubt, a retrograde step.
The Bill further seeks to add an exclusion from patentability, in subsection (2), for biological materials including their components and derivatives, whether isolated or purified or not and however made, which are identical or substantially identical to such materials as they exist in nature. A new subsection (5) is a 'deeming provision' specifying that biological materials, in section 18, includes DNA, RNA, proteins, cells and fluids. Of course, this is non-limiting, and therefore potentially includes (perhaps unintentionally) much more besides.
As one of our colleagues has pointed out this morning, such a broad exclusion would encompass many of the important developments of the past decades, and which may not have come about without the incentive of patent monopoly, including taxol, insulin, heparin, erythropoietin, vaccines for influenza, tetanus, diptheria, pertussis.
We note that this development cuts across other ongoing activities, including the ACIP Review of Patentable Subject Matter, and IP Australia's ongoing program of patent law reform. In this context it seems doubtful (we hope) that Senator Heffernan's bill will make much progress.