Patentable Subject Matter and Exclusions from Patentability in Singapore
Singapore Intellectual Property Blog
I was invited to give a talk recently on patentable subject matter and exclusions from patentability in Singapore.
The talk was presented at a webinar on 8 April 2024, hosted jointly by the Association of Singapore Patent Attorneys (ASPA), CNCPI - Compagnie Nationale des Conseils en Propriété Industrielle (French IP Attorney Association) and the Institute of Patent and Trade Mark Attorneys of Australia (IPTA).
This blog post sets out a transcript of the talk.
Transcript of Talk on Patentable Subject Matter and Exclusions from Patentability in Singapore
Introduction
Good afternoon, ladies and gentlemen.
My name is Chong-Yee, and I am a Singapore Patent Attorney, a Chartered UK Patent Attorney, and a European Patent Attorney.
Today, I will talk about patentable subject matter and exclusions from patentability in Singapore.
What We’ll Cover
We’ll first go through the specific exclusions that are set out in the Singapore Patents Act. These relate primarily to industrial applicability, and I’ll tell you how we get around these exclusions for inventions relating to methods of medical treatment.
Next, I will tell you about a particular section of the Singapore Patents Act that was previously present, but is now deleted. This subsection set out a list of things that were excluded from patentability, and I will consider the consequences of this deletion later on in the talk.
Finally, I will describe how IPOS interprets the Patents Act to effectively deny patentability to classes of inventions it considers to be non-patentable.
Patentable Inventions - Singapore Patents Act 1994
Statutory exclusions first.
Section 13 of the Patents Act sets out a definition of what a patentable invention is, and I’ve put the text of Section 13 on the slide.
“(1) Subject to subsection (2), a patentable invention is one that satisfies the following conditions:
(a) the invention is new;
(b) it involves an inventive step; and
(c) it is capable of industrial application.”
Section 13(1) says that subject to subsection (2), a patentable invention is one that satisfies the conditions of it being new, that it involves an inventive step, and that is capable of industrial application.
Section 13(2) excludes from patentability things the publication of which would be expected to encourage offensive, immoral, or antisocial behaviour.
The interesting point about this is that the Singapore Patents Act, in its current form, does not specifically set out a list of things that are not considered patentable inventions. This is unlike a number of other jurisdictions that I’m aware of where the law actually lists classes of inventions that are not patentable.
For example, Article 53 of the European Patent Convention, and also Section 1(2) of the UK Patents Act contains a list of items which are not patentable.
Industrial Application - Singapore Patents Act 1994
We’ll turn first to the industrial application exclusion. We saw just now that unless something is capable of industrial application, it cannot be patented. This is set out in Section 16.
“(1) Subject to subsection (2), an invention is taken to be capable of industrial application if it can be made or used in any kind of industry, including agriculture.
(2) An invention of a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body is not taken to be capable of industrial application.”
Section 16(1) says that any invention, so long as it may be made, or used in any kind of industry, including agriculture, is capable of industrial application.
This is a very broad statement of what is available in terms of industrial applicability.
Section 16(2), on the other hand, makes clear that if your invention is an invention that relates to a method of treatment of the human or animal body by surgery or therapy, or a method of diagnosis practiced on the human or animal body, this is not to be taken as capable of industrial application.
This way of framing the exclusion is interesting because this was the situation before EPC 2000.
The European Patent Convention and the UK Patents Act used to have a section very similar to Section 16, saying that medical treatment methods, diagnosis methods, are not capable of industrial application.
Since EPC 2000, the laws in those countries and jurisdictions were amended to actually specifically set out the indication that methods of medical treatment are not to be granted patents.
The upshot of all this is that method of medical treatment claims are not available in Singapore. This is in contrast to, for example, as I understand it, Australia, where you can get such claims. Of course, the situation in Europe is very similar to that of Singapore, in that they are not available in Australia.
First Medical Use - Section 16(3) Singapore Patents Act
How do we protect medical inventions?
The first medical use format is available to cover the first medical use of a known compound, and we can claim this in that form. Such claims are anticipated by any prior medical use of a compound.
This is, of course, a legal fiction, as otherwise, a claim to a known substance for a non-medical use is not considered novel.
The format of such a first medical use claim is X for use in a method of treatment of Y. This is similar to the current EPC-2000 medical use claim.
Interestingly, in Singapore, first medical use claims do not need to set out a specific disease or indication.
Very importantly, the format of this claim is not use of X in a method of treatment of Y, because use claims in Singapore are considered method claims, and of course, methods of treatment, of medical treatment, are not patentable in Singapore, because they are not industrially applicable.
Second and Further Uses - European Patent Office Enlarged Board of Appeal G 05/83, John Wyeth’s and Schering’s Applications
In Singapore, second medical use claims are used to protect inventions which relate to the further use of a compound with a already known medical use.
The format of such second medical uses is use of X in the preparation of a medicament for the treatment or prevention of Y. This is what is known as a Swiss-type claim format, and is not identical to the current EPC-2000 medical use format.
If you remember, before EPC-2000, second and further uses in Europe were protected by way of Swiss-type claims.
In Singapore, quite interestingly, the Examiners require the specific medical indication to be set out in the second medical use claim.
For example, a claim in the second medical use format to the treatment of cancer is OK, but the other form of claim, for example, treatment of condition caused by a reduced level of hormone X, that is not considered OK in Singapore.
The good news is that if you discover that there is a new patient subgroup that can be treated, or that you can administer a drug in a particular different manner, or a different dosage regime, those things can confer novelty to a second medical use claim.
Excluded Subject Matter - Under Previous Section 13(2) of the Singapore Patents Act
We will now turn to an exclusion that was present in the Patents Act, but has now been removed.
The Patents Act, when it was enacted, previously contained Section 13(2), and I’ve set out the text of Section 13(2) on the slide, and it declares that these things, in A to D, are not inventions for the purposes of the Act.
“(2) It is hereby declared that the following (among other things) are not inventions for the purposes of this Act, that is to say, anything which consists of —
(a) a discovery, scientific theory or mathematical method;
(b) a literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever;
(c) a scheme, rule or method for performing a mental act, playing a game or doing business, or a program for a computer; or
(d) the presentation of information,
but the foregoing provisions shall prevent anything from being treated as an invention for the purposes of this Act only to the extent that a patent or an application for a patent relates to that thing as such.”
A discovery, for example, mathematical method, a aesthetic creation, such as a literary or dramatic work, or a rule for performing a mental act, playing a game or doing business, a programme for a computer, or the presentation of information.
These things were previously declared by Section 13(2) to be not patentable inventions.
This is similar to Article 53 of the EPC and Section 1.2 of the UK Patents Act.
Singapore Patents Act - No Excluded Subject Matter Provisions
The Patents Act came into force on 23 February 1995, and on 1 January 1996, Section 13(2) was deleted.
So Section 13(2), if you look at it, it was in force only for about 10 months and slightly less than one week.
The reason given by the Minister of Law in Parliament when this was debated was in order to conform the Singapore Patents Act with TRIPS, which is the World Trade Organization Agreement on the Trade-Related Aspects of Intellectual Property Law.
Article 27(3) of TRIPS provides that patents shall be available for any inventions, whether products or processes, in all fields of technology.
The upshot of this is with the deletion of Section 13(2), the Patents Act no longer lists out the things that are not considered patentable inventions.
Arguably, the consequence of this deletion is that we are now able to get patents for previously excluded subject matter, including mathematical methods, business methods, and computer programs.
But is this generally the case?
Non-Statutory Exclusions
Unfortunately, in Singapore, as very often happens, what the government gives with one hand, it takes away with the other. And I’m sure that’s the case in many different countries as well.
Several years after the deletion of Section 13(2), IPOS revised the Examination Guidelines for Patent Applications at IPOS to include sections relating to patentable subject matter.
The specific section that is of interest is Section 8 of the Guidelines.
I urge you to have a look at the Guidelines for Examination because they deal with how Examiners are meant to approach examination.
Very interestingly, it has a lot of discussion on the excluded subject matter provisions.
Sections 8.2 and 8.3 set out some guidance for the Examiners in how to assess whether something is excluded or not.
The Examiners are told first to construe the claims and also to identify the inventive concept behind each claim.
Second, as a primary focus to consider the issues of novelty, inventive step, and industrial applicability.
Then finally, if only if there’s a residual issue that the claims relate to subject matter that is not an invention, then they should raise these excluded subject matter objections.
The only issue is that the Patents Act does not define what an invention is.
“Patentable Subject Matter” - Section 8.5 of Guidelines for Examination
Turning now to Section 8.5, the Examiners are told that objections should only be raised if the actual contribution lies solely in subject matter that is not an invention.
It lists out five categories of things that are not considered inventions, including discoveries.
“8.5 An objection should be raised if the actual contribution lies solely in subject matter that is not an “invention”… (for example, if the actual contribution falls within any of the areas described in sub-sections i, ii, iii, iv or v of this Section in this Chapter).”
i. Discoveries - including isolated or purified material or microorganism from nature
ii. Scientific Theories and Mathematical Methods
iii. Aesthetic creations: literary, dramatic, musical or artistic works
iv. Schemes, rules or methods for performing a mental act, playing a game or doing business
v. Presentation of information”
Very interestingly, in the section on discoveries, the IPOS Examiners are told to raise objections that claims to isolated or purified material from nature, including microorganisms, these are not considered to be inventions.
We will get objections to claims to a purified DNA sequence, for example, or an isolated microorganism. Scientific theories and mathematical methods are not considered inventions. Aesthetic creations, schemes, rules, or methods for performing a mental act, et cetera, doing business and the presentation of information.
The keen-eyed among you will immediately spot that these categories are exactly the same or almost exactly the same as those previously set out in Section 13.2.
The even more keen-eyed of you will spot that this list does not specifically mention computer programs. These are actually dealt with within the schemes, rules, or methods for performing a mental act under (iv).
Computer Implemented Inventions - Section 8.6 et seq of Guidelines for Examination
Section 8.6 tells you how IPOS deals with computer-implemented inventions.
The Examiners are told to consider whether a computer, the computer that’s in the claim, is an actual contribution.
The question to be asked is whether it is integral to the invention.
Where the claim is to a computer that implements a business method, the Examiners have to consider whether the technical features of the computers, for example, servers, databases, user devices, interact with the steps of the business method to a material extent and in such a manner as to address a specific problem.
If so, then the claim can pass that test.
Material extent appears to require that the working of the overall combination of the hardware or software in the computer actually confers an additional benefit over and above the standard operation of the hardware or software in order to solve a technical problem.
If you’re interested in artificial intelligence and machine learning, Sections 8.22 and 8.27 deal in detail with these subjects.
Again, I urge you to have a look at the Guidelines for Examination if you’re interested in this.
Enforceability of Provisions: Guidelines…not law
Now we come to the question of whether these provisions that are set out in the guidelines are actually enforceable.
The first thing to remember is that these are guidelines. They are not law. They’re not even case law developed by the courts.
And IPOS acknowledges this because in the preamble to the guidelines, it says that these guidelines are based on IPOS’s interpretation of the currently applicable law and practice of patents.
IPOS also tells us that these guidelines should not be used as legal requirements or to be considered as a conclusive view of the law.
Indeed, at Section 8.8 of the guidelines, which is the preamble to the list of things that it considers not inventions, IPOS tells you that these lists only provide guidance as to the subject matter not considered to be inventions. It gives you some idea of why IPOS has picked out these items as being non-inventions.
IPOS says that it’s all in view of the public policy considerations and in order to maintain consistency with international patent norms.
Conclusion
Where does this leave us?
Well, we saw just now that despite the industrial applicability requirement, first and second medical use claims may be used to protect medical inventions.
The Guidelines for Examination set out a number of things that are not considered, that IPOS doesn’t consider to be inventions.
But I think that it’s fair to say that there’s no statutory basis as such for these exclusions that are set out by IPOS in the guidelines.
If you consider the two reasons given by IPOS for these exclusions, the first one is that it’s a matter of public policy, but arguably such public policy should really be considered by Parliament. If Parliament decides that certain things should not be considered inventions, they should pass laws to exclude them from patentability.
For example, like they did in Section 13.2.
The second rationale given by IPOS for these exclusions is to conform with international norms. But then the question becomes which country should be considered.
We saw earlier that in Australia, methods of medical treatment are available, but in Singapore, they are not considered industrially applicable. In the United States, for example, you can apparently get claims to business methods, but in Singapore, they are said to be excluded from patentability because they are not inventions in the guidelines.
I think the upshot of this is that it is unfortunately not very clear whether there is a specific basis for these exclusions that are set out in the guidelines.
Unfortunately, we will receive objections as we prosecute claims to inventions that rely on the guidelines.
I think the first thing to do is to consider arguing against the objections using the reasoning I gave earlier, the fact that there is no statutory basis. If IPOS persists and the application is refused, perhaps consider challenging this before the courts.
I’ve set out in this slide the number of resources that you can go and have a look at, including the Guidelines for Examination, as well as practice directions and the text of the Act and Rules.
I’ve come to the end of the talk. I hope you found this talk interesting, and I’m happy to answer any questions in either the Q&A or a follow-up by email.
Thank you.