An applicant who wishes to protect an invention which is, or relates to a ‘micro-organism’ should be particularly aware of the repercussions of not entering national phase prior to 13 September 2014. The Patents Act 2013, which comes into force on this date, mandates that, where an invention is a micro-organism, the description requirements can only be met when a micro-organism deposit has been filed.
Until now it was understood that the provisions of the new Act would bring New Zealand into line with its major trading partners and allow for a micro-organism deposit to satisfy the requirements of description, but that it would still be possible to describe the micro-organism in clear enough terms in the specification. In fact we had been advised that the Intellectual Property Office of New Zealand intended to apply the same standard as Australia.
We have now been informed that this is not the case, and that where the invention is to a micro-organism per se, a deposit is required in order for the specification to “disclose the invention in a manner clear enough and complete enough to enable the person skilled in the art to perform the invention” and “describe the best method of performing the invention” (Section 39(1)(a) and (b) of the Patents Act 2013).
Inventions to a Micro-organism per se
Section 42 of the Patents Act 2013 can beviewed in full here. Of particular interest is subsection (1) which states:
“(1) To the extent that an invention is a micro-organism, the complete specification complies with section 39(1)(a) and (b), so far as those paragraphs require a description of the micro-organism, if, and only if, the deposit requirements specified in section 43 are satisfied in relation to the micro-organism."
Thus, according to section 42(1) where an invention is a micro-organism, the requirements of description and best method are only met if a micro-organism deposit is made. This is in contrast to jurisdictions such as Australia, Europe, the United Kingdom and United States which all allow for a micro-organism to be described in clear enough terms in the specification itself.
Exactly how onerous the new condition will be will depend on how broadly the term “micro-organism” is defined. Unfortunately, neither the Act, nor the Budapest Treaty define a micro-organism.
Other jurisdictions interpret “micro-organism” very broadly. For instance the EPO case T0356/93 held that the term “micro-organism” included:
“not only bacteria and yeasts, but also fungi, algae, protozoa and human, animal and plant cells, i.e. all generally unicellular organisms with dimensions beneath the limits of vision which can be propagated and manipulated in a laboratory. Plasmids and viruses are also considered to fall under this definition (cf. Guidelines for Examination, C-IV, 3.5).”
Similarly the IP Australia examination guidelines state:
“The Office interprets the term"micro-organism" (as used in the Act) to include any biological materials accepted for deposit with a prescribed depository institution, for the purposes of the Budapest Treaty, in accordance with the rules relating to micro-organisms. Examples of micro-organisms include bacteria and other procaryotes, fungi including yeast, mushrooms, algae, protozoa, eucaryotic cells, cell lines, hybridomas, viruses, plant tissue cells, spores, seeds and hosts containing materials such as vectors, cell organelles, plasmids, DNA, RNA, genes and chromosomes".
Both of these jurisdictions can justify a broader interpretation, given they do not require a micro-organism deposit. However if such broad definitions are applied in New Zealand, they could potentially lead to some surprising results, especially for applicants via the PCT.
Frequently biological materials falling within one of the definitions above are adequately described in the specification and it would surprise many overseas applicants that a deposit is required. For example plasmids can be perfectly adequately described by way of genetic sequence. However, if plasmids are considered to be a micro-organism (as defined by the European Patent Office), then the description requirements of the Patents Act 2013 can only be met if there is a deposit meeting the requirements of the Act.
Similarly, isolated human cells and cell lines have previously been considered to be adequately described by other means such as particular cell markers, methods of isolation, culturing method or combinations thereof. If either of the broad definitions above are taken, then merely describing a cell or cell line by any of these means will no longer be sufficient to meet therequirements of the Patents Act 2013.
The micro-organism deposit will need to have been filed before or on the filing date of the specification in question, which, in the case of a PCT application the deposit is the international filing date. If no deposit is filed and the invention relates to that microorganism, it will not be possible to claim the microorganism per se under the Patents Act 2013.
For applicants who have already filed their international application and have not filed a micro-organism deposit, itis already too late to meet the requirement of the Patents Act 2013. Therefore in order to obtain protection in New Zealand, such an application must enter national phase in New Zealand prior to 13 September 2014 so the provisions of the Patents Act 1953 apply. Until we get certainty as to what the term micro-organism encompasses, we recommend applying this approach to any application broadly related to a micro-organism, and especially those mentioned in the quotes above be filed before 13 September 2014.
Inventions which involve the use of a micro-organism
The Act treats inventions which involve the use, modification or cultivation of a micro-organism more leniently than those which relate to a micro-organism per se. Section 42(2) and (3) state:
“(2) Subsection (3) applies if—
(a) an invention involves the use, modification, or cultivation of a micro-organism, other than the micro-organism mentioned in subsection (1); and
(b) a person skilled in the relevant art in New Zealand could not reasonably be expected to perform the invention without having a sample of the micro-organism before starting to perform theinvention; and
(c) the micro-organism is notreasonably available to a person skilled in the relevant art in New Zealand.
(3) The complete specification complies with section 39(1)(a) and (b), to the extent that those paragraphs require a description of the micro-organism, if, and only if, the deposit requirements specified in section 43 are satisfied in relation to the micro-organism.”
Thus where an invention involves the use, modification or cultivation of a micro-organism, a deposit is only required if the person skilled in the art could not reasonably be expected to perform the invention without having a sample of the micro-organism and the micro-organism is not publicly available.
The Act requires that a deposit be made to an International Depositary Authority (IDA) in accordance with the rules of the Budapest Treaty. A guide to these rules can be found here.
It is worthy of note that no current New Zealand institutions are listed as IDA and we are not aware of any moves to do so. Accordingly for a New Zealand applicant to make a deposit, it will be necessary to send the organisms to an overseas IDA. The time period for doing so should be taken into account when developing your patent filing strategy.
In addition it will be necessary to provide a deposit receipt within 3 months of the date of receipt of the micro-organism by a depositary institution, and to include within the specification the name of the depositary institution and the file, accession or registration number of the deposit at all time after this period. The specification will also need to contain, at the filing date of the specification, all relevant information on the characteristics of the micro-organism known to the applicant.