Morality and patentability – stem cell patents in New Zealand
Tuesday 6th January 2009
Stem cell research and patents claiming stem cells are a controversial topic around the world. For example, the Enlarged Board of Appeal of the European Patent Office has recently held public oral proceedings to consider an appeal against the rejection of a patent application directed to primate embryonic stem cells filed by the Wisconsin Alumni Research Foundation.[i]
In addition, stem cell patents held by the Wisconsin Alumni Research Foundation have been challenged in the United States. [ii]
In New Zealand, patent claims that include stem cells within their scope frequently face a “contrary to morality” objection during examination. This objection is raised under the ambit of section 17(1) of the New Zealand Patents Act 1953 which allows a patent application to be refused if “it appears to the Commissioner in the case of any application for a patent that the use of the invention in respect of which the application is made would be contrary to morality”.
Objections under section 17(1) are raised by examiners in New Zealand against claims directed to stem cells, their use, methods to induce stem cells to differentiate and similar subject matter. Objections under section 17(1) are also raised against claims to transformed cells, if the claim does not clearly exclude cells within a human from its scope. In the context of stem cell claims, an objection may be raised under section 17(1) that a claim encompasses human totipotent cells (which may develop into a human) and that the claim is therefore contrary to morality. The Assistant Commissioner of Patents addressed the appropriateness of such objections in the recently published decision, P22/2007.[iii]
The Assistant Commissioner’s decision
Two patent applications are at issue in P22/2007. These are NZ 532170 in the name of the Wisconsin Alumni Research Foundation and NZ 535243 in the name of Wicell Research Institute, Inc. NZ 532170 is directed to an in vitro method for directing the differentiation of primate embryonic stem cells and NZ 535243 is directed to a method for inducing primate stem cells to differentiate. In each case, the application was refused by the examiner under section 17(1) of the Patents Act. Each applicant requested a hearing before the Assistant Commissioner to decide whether refusal on this ground was warranted. These matters were heard together and a number of issues surrounding stem cells and the application of section 17(1) are discussed in the Assistant Commissioner’s decision.
Can totipotent stem cells develop into a human?
The applicants argued that there is no authority to support the examiner’s position that totipotent stem cells are capable of developing into a human. The Assistant Commissioner rejected this argument because the Assistant Commissioner considered that it is well established and generally accepted in the field that totipotent stem cells do have the potential to develop into an entire human body.
The law in New Zealand and the application of section 17
The applicants noted that there is no judicial comment on the meaning of “contrary to morality” in New Zealand. One of the few references to section 17 in a New Zealand case is in Pfizer v Commissioner of Patents,[iv] where O’Regan J said that
“we do not believe that s17 empowers the Commissioner to decline a patent because the patent would be used for an immoral purpose but rather only if the invention for which the patent is sought would be used for such a purpose.”
In addition, section 17 has been referred to as “a little used provision”.[v] There has also been some discussion of section 17 in academic writing [vi] and during the consultation regarding the review of the Patents Act.[vii] Since there is minimal guidance available regarding the application of section 17 in New Zealand, the “morality” position in other jurisdictions was also reviewed by the Assistant Commissioner in P22/2007.
The law in Europe
The Assistant Commissioner reviewed the position in Europe where Article 53(a) of the European Patent Convention excludes “inventions the publication or exploitation of which would be contrary to ‘ordre public’ or morality” from patentability. In addition, there is a specific exclusion to the use of human embryos for industrial or commercial purposes.[viii]
The European Patent Office Examining Division considered and refused European Patent Application No. 96 903 521.1 “Primate embryonic stem cells”.[ix] This refusal was appealed to the EPO Technical Board of Appeal, which declined to decide whether the application was allowable. The application has now been referred to the Enlarged Board of Appeal, and oral proceedings were recently held.
The applicants in New Zealand argued that the European position is not on point because the law being considered is whether claims to primate stem cells violate the prohibition against the commercial exploitation of embryos, not whether methods of producing stem cells are contrary to morality.
The position in the United Kingdom
The UK Patents Act 1977 has both a “contrary to morality” provision and a paragraph analogous to Rule 23d(c).[x] In addition, the UK Intellectual Property Office has issued Examination Guidelines that refuse to allow claims to human stem cells or their use.[xi] However, the applicants submitted that, as in Europe, the stance in the UK is based on the exclusion of the use of human embryos for industrial or commercial purposes, not on a contrary to morality provision such as New Zealand has.
Neither Australia nor the United States have “contrary to morality” provisions in its legislation, although the Australian Patent Examiners’ Manual does include a section regarding the examination of patent claims directed to stem cells.[xii] The Singapore Patents Act includes a section that excludes from patentability “an invention the publication or exploitation of which would be generally expected to encourage offensive, immoral or antisocial behaviour.” Patents equivalent to NZ 532170 and 535423 have been granted in the United States and Singapore.
The gist of the applicants’ argument is that the law as applied in foreign jurisdictions is not applicable to the situation in New Zealand as the legislation and its application is different.
Is the claimed invention contrary to morality?
The applicants then referred to the definitions of both “morality” (conformity to the rules of right conduct; moral or virtuous conduct) and “contrary” (opposite in nature or character, diametrically opposed, mutually opposed; opposite in direction or position) and submitted that the Assistant
Commissioner needed to determine whether using the methods claimed in NZ 532170 and 535423 is “diametrically opposed to behaviour which New Zealand society believes to be right conduct, that belief being deeply rooted in our culture.”
The Assistant Commissioner agreed that this is the appropriate question and accepted that there is no “deeply rooted” belief against stem cell research amongst the New Zealand population as a whole, while conceding that there is widespread debate on the issue.
In addition, the Assistant Commissioner noted that any moral and legal issues relating to the use of these methods are dealt with by legislation other than the Patents Act. For example, stem cells derived from an embryo are excluded from the definition of “embryo” in section 5 of the Human Assisted Reproductive Technologies (HART) Act 2004. Section 16 of the HART Act provides that research in the HART area must be approved by the Ethics Committee on Assisted Reproductive Technology. The New Zealand Public Health and Disability Act 2000 provides a Health and Disability Ethics Committee that includes human embryonic stem cell research in its jurisdiction and the 2006 Ministry of Health Guidelines for using cells from human embryonic stem cell lines for research contain a number of strict conditions and requirements that must be met before research on embryonic stem cells can be performed.
The Assistant Commissioner therefore considered that stem cell research, even if totipotent cells are involved, is not viewed by the government to be inherently contrary to morality and is clearly allowed provided certain conditions are met. The Assistant Commissioner held that “it is not appropriate for the Intellectual Property Office of New Zealand to act as a further arbiter of morality in cases such as this”.
In addition, the Assistant Commissioner noted that there is precedent from the Intellectual Property Office of New Zealand in the form of previously granted patents for methods involving the treatment of embryonic stem cells. Since it is well-settled law that the benefit of the doubt must be given to the patentee, the Assistant Commissioner held that the two applications should proceed to acceptance.
Intellectual Property Office of New Zealand practice regarding section 17(1)
The P22/2007 decision was publicly released on 14 May 2008. Although the Assistant Commissioner makes some strong statements regarding the application of section 17(1), the Assistant Commissioner’s decision does not set a binding precedent for other pending applications. On 13 May 2008, the Intellectual Property Office of New Zealand released a Practice Note regarding raising section 17(1) objections during examination.[xiii] As a general guide, the Note lists subject matter that may attract an objection under section 17(1) including claims directed to
“human beings, processes which give rise to human beings and biological processes for their production; methods of cloning human beings; totipotent human stem cells; human embryos and processes requiring their use; placental and umbilical cord tissues and processes requiring the use of placental and umbilical cord tissues; transformed host cells within a human and other cells and tissues within a human”.
The guidelines state that the Intellectual Property Office of New Zealand will “continue to raise objections under s17(1) where it appears that the use of the invention would be contrary to morality for New Zealand society as a whole or for a significant section of the community, including Māori.” In determining whether an invention is contrary to morality, the Intellectual Property Office of New Zealand states that it will take into account “concerns of interest groups, evidence including appropriate public polls and research, corresponding foreign legislation, case law and guidelines.” In other words, the Intellectual Property Office of New Zealand may consult with non-government parties in order to arrive at an informed decision. It appears that the new guidelines broaden the circumstances in which an invention may be objected to as contrary to morality because the opinion of only a section of the New Zealand community may be considered in some cases.
The Practice Note contradicts the Assistant Commissioner’s approach in P22/2007, where he agreed that the correct question to consider is whether the claimed invention is “diametrically opposed to behaviour which New Zealand society believes to be right conduct, that belief being deeply rooted in our culture.” That is, what should be considered is the belief of New Zealand society as a whole. The Assistant Commissioner also clearly indicated that, at least in relation to inventions encompassing stem cells, it is not the role of the Intellectual Property Office of New Zealand to judge these issues when there are adequate provisions elsewhere for monitoring and approving various forms of stem cell research.
The Practice Note also indicates that the Intellectual Property Office of New Zealand considers it is appropriate to refer to the documentation produced during the review of the Patents Act and the content of the recently introduced Patents Bill itself in determining whether to raise an objection under section 17(1).[xiv] The Patents Bill does include some specific exclusions to patentability as discussed below. However, using the Patents Bill to guide decisions made under the present legislation is a questionable approach because the Patents Bill has not yet been considered or passed by Parliament.
The Patents Bill – exclusions to patentability
The Patents Bill was introduced into Parliament on 9 July 2008, but has not yet begun its progression through the House of Representatives. Clause 14(1) of the Patents Bill excludes from patentability inventions the commercial exploitation of which would be contrary to public order or morality. This is similar to section 17(1) of the present Act. However, clause 14(3) adds a new feature in that the Commissioner may seek advice from the Māori advisory committee (newly established by the Patents Bill [xv] ) or any person that the Commissioner considers appropriate. The explanatory note accompanying the Patents Bill describes the role of the Māori advisory committee as:
“to advise the Commissioner in relation to patent applications for inventions involving traditional knowledge or indigenous plants and animals…to provide advice that can be used by the Commissioner to determine whether such inventions are novel, or involve an inventive step, or whether the commercial exploitation of such inventions would be contrary to Māori values.”
In addition to the morality clause (clause 14), the Patents Bill specifically excludes from patentability human beings and biological processes for their generation, inventions of methods of treatment of human beings by surgery or therapy, inventions of methods of diagnosis practised on human beings, and plant varieties.
The Bill still has to progress through Select Committee review. It is possible that these provisions will change during this process.
The P22/2007 decision and the May 2008 guidelines issued by the Intellectual Property Office of New Zealand provide conflicting messages about the application of section 17(1). The position on the patentability of stem cells, and of other contentious subject matter, will hopefully become clearer as the new Patents Bill progresses through the Parliamentary process.
This article was published in Patent World, November 2008.
[i ] European Patent Application No. 96903521.1. back to text
[ii ] US 5,843,780 (primate embryonic stem cells); US 6,200,806 and US 7,029,913 (human embryonic stem cells). back to text
[iii ] Wisconsin Alumni Research Foundation and Wicell Research Institute Inc, Decision of the Assistant Commissioner, P22/2007. back to text
[iv ] Pfizer v Commissioner of Patents  1 NZLR 362 (CA) back to text
[v ] Paul Sumpter, Intellectual Property Law; Principles in Practice, 2006 back to text
[vi ] See, for example, Libby Beadle, Selling the stem cell short? An assessment of the patentability of the results of human stem cell research in New Zealand. 2004. Canterbury Law Review [Vol 10], p 1-35. back to text
[vii ] CAB Min (03) 11/5; Hon Judith Tizard, Cabinet Paper: Review of the Patents Act 1953 Stage 3: Part 1 (2003). back to text
[viii ] Rule 23d(c). back to text
[ix ] Re Application by Wisconsin Alumni Research Foundation, T 1374/04-EPO (21 April 2006). back to text
[x ] United Kingdom Patents Act 1977, section 1(3), 1(4) and paragraph 3(d) of Schedule A2. back to text
[xi ] Guidelines for Patent Applications Relating to Biotechnological Inventions in the UK Intellectual Property Office (September 2006). back to text
[xii ] Australian Patent Manual of Practice and Procedures, National – Patentable Subject Matter, 22.214.171.124 (1 May 2007). A human totipotent stem cell and methods or processes of obtaining human totipotent cells are not patentable under s18(2) of the Australian Patents Act 1990, which is an exclusion to the patentability of human beings and biological processes for their generation. back to text
[xiii ] Raising objections under section 17(1) – contrary to morality. Intellectual Property Office Newsletter, 13 May 2008. back to text
[xiv ] Patents Bill 235-1 (2008), Government Bill. back to text
[xv ] There is already a Māori advisory committee for trade marks. back to text