IP Australia’s Myriad Guidelines

IP Australia has published its guidelines for examining whether a patent application claims a manner of manufacture under s 18(1)(a) and (1A)(a) in light of the High Court’s ruling in D’Arcy v Myriad.

According to the guidelines, Examiners will find it useful to ask:

  1. What is the substance of the claim (not merely its form)?
  2. Has the substance of the claim been “made” or changed by man, or is “artificial”?
  3. Does the invention have economic utility?
  4. Does the invention as claimed represent a new class of claim?

In deciding whether the claim is for an established class of invention or a new class of claim, it will not necessarily be relevant that patents have previously been granted for similar subject matter. Examiners are directed to take into account whether the Courts have previously considered the type of subject matter and whether it was rejected or not.

Claims to plants and micro-organisms are not to be considered to fall within a new class merely because they are claims for a plant or micro-organism. Apart from claims to nucleic acid molecules, the guidelines indicate that the Commissioner will consider as excluded subject matter:

• cDNA and synthetic nucleic acids

• Probes and primers

• Isolated interfering/inhibitory nucleic acids,

“where they merely replicate genetic information of a naturally occurring organism”. However, such claims may be patentable where the utility of the invention “lies in genetic information that has been ”made” (e.g. non-naturally occuring chimeric nucleic acid). Other types of biological inventions may also ve patentable where they do not merely replicate the genetic information of a natually occurring organism.

The guidelines should appear in the Manual of Practice and Procedure in January 2016.

Gene Patenting Inquiry

The Commonwealth Senate has launched an inquiry into the patenting of genes.

According to the terms of reference:

The impact of the granting of patents in Australia over human and microbial genes and non-coding sequences, proteins, and their derivatives, including those materials in an isolated form, with particular reference to:

(a)     the impact which the granting of patent monopolies over such materials has had, is having, and may have had on:

(i)     the provision and costs of healthcare,

(ii)    the provision of training and accreditation for healthcare professionals,

(iii)   the progress in medical research, and

(iv)   the health and wellbeing of the Australian people;

(b)     identifying measures that would ameliorate any adverse impacts arising from the granting of patents over such materials, including whether the Patents Act 1990 should be amended, in light of the any matters identified by the inquiry; and

(c)     whether the Patents Act 1990 should be amended so as to expressly prohibit the grant of patent monopolies over such materials.

The terms of reference do not say so but, presumably, the inquiry has been triggered by the recent controversy when Genetic Technologies announced it was going to commence enforcing its exclusive licence to patents relating to breast cancer detection.  It would seem, however, that the company rescinded its threat.

The Senate Community Affairs committee is due to report by the last sitting day of 2009.  Written submissions have been sought, however, by 19 March 2009.

Anyone else looking forward to learned consideration of TRIPS art. 27, 30 and 31 after all that hard work that’s been done by the ALRC.  See now ACIP’s review of patentable subject matter (pdf) which includes some notes on the AUSFTA obligations.  Then, of course, there is always Patents Act s 163.