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Patent Amendment (Human Genes and Biological Materials) Bill 2010 [No. 2]

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Patent Amendment (Human Genes

and Biological Materials) Bill 2010

 

Explanatory Memorandum

 

 

Outline

 

Section 18 of the Patents Act 1990 provides the patentability criteria for the grant of a valid patent monopoly.

 

The primary criterion of patentability according to section 18(1)(a) and section 18(1A)(a) is that the invention so far as claimed is “a manner of manufacture within the meaning of section 6 of the Statute of Monopolies.”

 

Section 18(1) and section 18(1A) are subject to the subject matter prohibitions provided in section 18(2).

 

Section 18(2) provides that “human beings, and the biological processes for their generation, are not patentable inventions.”

 

Thus while section 18(1)(a) and section 18(1A)(a) mandate that patent eligible subject matter must be a manner of manufacture within the meaning of section 6 of the Statute of Monopolies , if that subject matter falls within the prohibition provided in 18(2) it is ineligible for the grant of a patent monopoly regardless.

 

This means that unless the subject matter of a patent is a “patentable invention” it is ineligible for the grant of a valid patent monopoly.

 

History

 

It has long been accepted that natural phenomena are not patentable inventions. This is because the elucidation of a natural phenomenon such as the discovery of a naturally occurring thing, while adding to the storehouse of human knowledge, does not transform it into a product of humankind. Discoveries are therefore excluded from patentability, while inventions, provided they do not fall within the prohibition in section 18(2), are not.

 

This distinction is in keeping with the original intent of the English Parliament, which in 1623 passed the Statute of Monopolies. Under section 1 of the Statute of Monopolies all monopolies except those expressed exempted were “utterly void and of none effect.” Section 6 of the Statute of Monopolies, being one of the express exceptions, provided that “manners of new manufacture” could be the subject of “Letters Patent and Grants of Privilege” provided they were not “not contrary to the Law, nor mischievous to the State, by raising Prices of Commodities at home, or Hurt of Trade, or generally inconvenient”.

 

This distinction between invention and discovery has thus been an accepted part of English patent law for hundreds of years and was received law by the Australian colonies. After Federation the Australian parliament maintained that distinction in the Patents Act, 1903. Likewise, successive Australian parliaments followed suit in the Patents Act, 1952 and the Patents Act, 1990.

 

That said it was felt necessary, with the passage of the Patents Act, 1990, for certain subject matter to be expressly excluded from patentability as provided by section 18(2). This express exclusion, however, was not intended to neutralise or render redundant the proviso contained within section 6 of the Statute of Monopolies and referred to in section 18(1)(a) and section 18(1A)(a). Rather, it was inserted into the Patents Act, 1990 so as to avoid the possibility, which biotechnology enables, of patent monopolies being granted for inventions which would transgress socially acceptable norms. Thus it is for this reason, and only for this reason, that “human beings, and the biological processes for their generation” are not eligible for the grant of patent monopolies.

 

Purpose of the Bill

 

The purpose of this Bill is to advance medical and scientific research and the diagnosis, treatment and cure of human illness and disease by enabling doctors, clinicians and medical and scientific researchers to gain free and unfettered access to biological materials, however made, that are identical or substantially identical to such materials as they exist in nature.

 

These biological materials even if they have been isolated, purified or synthetically made have not been transformed from products of nature into products of humankind.

 

Thus the Bill (a) reinforces the applicability of the proviso in section 6 of the Statute of Monopolies within the meaning of section 18(1)(a) and section 18(1A)(a), (b) reinforces the applicability of the distinction between discovery and invention and (c) applies that distinction by expressly excluding from patentability, biological materials which are identical or substantially identical to such materials as they exist in nature, however made.

 

The amendments proposed in the Bill therefore:

 

1)     amend subsection 18(1)(a) and subsection 18(1A)(a) by (i) inserting the word “full” before the word “meaning” and (ii) inserting the words “including the proviso” after the word “meaning”; and

2)     amend subsection 18(2) by adding, as another category of subject matter to be expressly excluded from patentability, “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.”

 

3)     insert after section 18(4) the definition of “biological materials” to mean “includes DNA, RNA, proteins, cells and fluids.”