One of the package’s most important steps is to follow decisions in the landmark cases of Association for Molecular Pathology v Myriad Genetics, from the US, and Australia’s D'Arcy v Myriad Genetics by clarifying that Singapore believes isolating DNA in nature does not constitute an invention.
The changes are fourfold and concern:
Isolated products found in nature: IPOS aims to change Chapter 8 of the Examination Guidelines to clarify the difference between inventions and discoveries of isolated products found in nature. While isolated or purified materials or microorganisms found in nature are a discovery, if a new use of isolated or purified material or microorganism is found, then the new use can be claimed as an invention. Another example of an invention is a new use of a modified material or microorganism.
New mechanisms to increase transparency and clarity: a formal process for third-party observations before patent grant on issues such as prior art and a reexamination option after grant. The existing regime only has an informal process for sharing third-party observations with examiners and no mechanism for reexamination.
Patent grace period broadened: certain disclosures are excluded from forming part of the state of the art as long as a patent application is filed within 12 months from disclosure. The disclosures include: information relating to the invention was obtained unlawfully, invention was displayed at an international exhibition, the inventor publishes the invention before a learned society or the inventor discloses the information.
Patent Rules: to allow an examiner to raise an objection under the supplementary examination route where the invention in the claims does not constitute an invention.
The IPOS consultation ended on August 15. The changes to grace periods are expected to come in the fourth quarter of this year, while other proposed changes may be implemented in 2018.
“These changes are motivated by the desire to enhance the quality of Singapore patents and to boost the public confidence level in the Singapore patent regime,” says Lim Siau Wen, director of IP at Drew & Napier.
“While such proposed amendments will effectively make it more difficult to obtain and/or maintain a granted patent in Singapore, we believe the overall result will be an improvement to the overall strength and reputation of a granted Singapore patent,” says Andy Leck, managing principal at Baker McKenzie Wong & Leow.
Modelling on other countries
Singapore has modelled the changes on practices in jurisdictions such as the US. “A number of the proposed changes such as third-party observations and reexamination after patent grant have been practised in other jurisdictions such as Europe, the United States or Australia,” says Lim. “The introduction of such procedures in Singapore is therefore similar to the established practices of other jurisdictions.”
“The proposed amendment on the isolated products from nature appears to be following the approach taken by the Supreme Court of the United States in the landmark case, Association for Molecular Pathology v Myriad Genetics,” Leck explains. “The Supreme Court held that simply isolating DNA which does not exist alone in nature cannot be patented, but that complementary DNA (cDNA) is patentable as it was a new use of the isolated/purified DNA. Notably, this position was echoed by the High Court of Australia in D'Arcy v Myriad Genetics.”
“Whether biotechnology inventions constitute patentable subject matter is an ongoing debate and dialogue between countries, inventors and academics,” says Abe Sun, a local principal at Baker McKenzie Wong & Leow. He observes that the controversy can partly be explained by divergent views on a range of issues, including the nature of biotechnology, the future of the nascent biotechnology industry and how the patents system should encourage innovation while giving due respect to ethical issues.
“The controversy of biotechnology inventions is evident from the divergence between the US and European Patent Office approach, with the former not considering isolated genetic material to be patentable subject matter,” says Sun. “Notably, the proposed changes indicate that Singapore has preferred the US approach.”
Grace period
Though a grace period will be in place for Singapore, patentees need to be careful about the confidentiality of their inventions as there is a lack of uniformity in grace periods or even the existence of grace periods across jurisdictions.
“The proposed extension of the grace period to 12 months, and the expanded scope on the patents grace period to disregard disclosure of the subject matter by the inventor, appear to be similar to the approach taken in the US,” says Sun. “It is possible that the motivation for this change might have been the Trans-Pacific Partnership (TPP) Agreement, which sought to harmonise the grace period to a common duration of 12 months. However, this harmonisation was never fully ratified given that the US has backed away from the TPP.”
“Insofar as the broadening of the scope of the grace period is concerned, patentees should be mindful that not all jurisdictions have broad or even grace period provisions and therefore it remains important to maintain the confidentiality of their inventions before filing a patent application for the same,” says Lim.
A $4 billion investment plan for the sector between 2016 and 2020 is a sign of the government faith in biotechnology as a growth pillar. It explains why IP practitioners are behind IPOS's move to strengthen the patent examination process and clarify its stance on patentability.
