Patents covering microorganisms – new deposit receipt requirements in New Zealand
Published on 15 Sep, 2014
When a claim of a patent covers a micro-organism that is difficult to reproduce or a method that requires the use of such a micro-organism, the patentee may meet the obligation to fully disclose the micro-organism by depositing a sample of the micro-organism in a recognised depositary institution under the Budapest Treaty. The new New Zealand Patents Act that came into force on 14 September 2014, requires that a patent applicant provide the New Zealand Commissioner of Patents with a micro-organism deposit receipt from the depositary institution potentially years before filing their patent application in New Zealand. This impractical requirement would essentially ensure that few, if any, patents would be granted in New Zealand for these micro-organisms or related inventions. The New Zealand Patent Office appears to appreciate the difficulty the change to the Act has precipitated and has informally assured our biotechnology patent attorneys that steps will be taken to remedy the situation. In the meantime, we note that there are avenues available to those who may otherwise fall foul of the new requirements to retain their rights in the invention.
Section 43 of the New Zealand Patents Act 2013 came into force on 14 September 2014 and essentially corresponds to Section 6 of the Australian Patents Act 1990, with the exception of one, notable additional clause, s43(1)(b):
s43 Deposit requirements for micro-organisms
(1) The deposit requirements are satisfied in relation to a micro-organism to which a specification relates if, and only if,-
(a) the micro-organism was, on or before the filing date of the specification, deposited with a prescribed depositary institution in accordance with the rules relating to micro-organisms; and
(b) the applicant for the patent provides to the Commissioner, within the prescribed period, a receipt for the deposit from the prescribed depositary institution; and
(2) For the purposes of subsection (1)(b), the receipt for the deposit must be in the prescribed form (if any).
reg 59 Deposit requirements for micro-organisms
(1) The prescribed period for the purposes of section 43(1)(b) of the Act is 3 months after the date that the micro-organism is deposited with the prescribed depositary institution.
Taken literally, this definition means that an Applicant would need to provide the New Zealand Commissioner of Patents with a deposit receipt potentially years before entering national phase in New Zealand, since Budapest Treaty deposits would generally be made before the corresponding complete application is filed. As such, complying with Section 43 would be difficult to say the least.
Steps are presently being taken at the Intellectual Property Office of New Zealand (IPONZ) to rectify the situation. In the meantime, we advise that there is limited risk to Applicants falling foul of s43 for at least the following three reasons.
1. Section 42 of the new Act (see below) states that the deposit requirements of s43 must be met for an invention thatis a micro-organism. However, if an invention merely involves the use, modification, or cultivation of a micro-organism, then the requirements of s43 need only be satisfied if the micro-organism “is not reasonably available to a person skilled in the relevant art in New Zealand”. In this regard, and in light of s42(4), IPONZ have indicated that a micro-organism deposit made in a prescribed depository institution any time before filing in New Zealand would correlate to that micro-organism being “reasonably available”.
42 Specifications for micro-organisms
(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.
(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 the invention; and
(c) the micro-organism is not reasonably 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.
(4) For the purposes of this section and section 45, a micro-organism may be reasonably available to a person even if it is not so available in New Zealand.
2. For an invention that relates to a micro-organism per se, the provision of Section 147 of the new Act could appropriately be applied because the fact that compliance to reg59 was near impossible, would constitute “exceptional circumstances”.
147 General power of Commissioner to extend time limits in exceptional circumstances
(1) The Commissioner may, in exceptional circumstances, extend a time limit prescribed by these regulations for filing information or a document or for taking a step in respect of a matter. …
(3) The Commissioner may grant the extension even if either or both of the following apply:
(a) the time limit has expired for doing the thing:
(b) the Commissioner has already granted an extension under these regulations. …
3. IPONZ is well aware of the “flaw” associated with reg59, and is adamant that the literal interpretation is not the intended purpose of s43(1)(b) and reg59. Shelston IP has been informed that steps are already being taken to ensure the rights of Applicants will not be adversely affected by reg59, including revisions to the Examiner’s manual that will accompany the new Act. It is our understanding that reg59 will almost certainly be amended in the first round of legislative amendments made to the Act that will likely take place in 2015.
In summary, our advice to Applicants is not to be unduly concerned by what appears to be a drafting error in the new legislation. We fully expect common sense to prevail in this instance with reg59 not being enforced until such time as it is amended to accurately reflect the intended scope of s43.