Patentability Of Nucleic Acids / Microorganisms In Malaysia

Question 1a
We are aware that section 13, of the Malaysian Patent Act lists non-patentable inventions. Among these are plant or animal varieties or essentially biological processes for the production of plants or animals other than man-made living microorganisms, microbiological processes, and the products of such microorganism processes.
Our question is: Would isolated microorganisms (which are isolated from natural sources) and not subjected to any gene transfer or recombinant manipulation be considered man-made organisms and therefore patentable subject matter?

Answer 1a
Yes. Isolated microorganisms (which are isolated from natural sources) and not subjected to any gene transfer or recombinant manipulation can be considered man-made organisms and is patentable only if it is new, involves and inventive step and is industrially applicable. It can be considered as a patentable subject matter only if there is a specific use for it. It is not patentable if there is no specific use for the said subject and if it is obvious to the person skilled in the art.

Question 1b
Would microbiological processes include processes that are conducted using such isolated microorganisms that are not genetically manipulated or otherwise structurally modified; and are the products of these processes patentable? On the matter, I assume the product would have to be novel in any case, and perhaps the inclusion of this in the statute doesn't make sense unless it means a product-by-process claim.

Answer 1b
Yes, with the assumption that the product is novel, microbiological processes which includes processes that are conducted using isolated microorganisms that are not genetically manipulated or structurally modified is patentable through a product by process claim.

Question 2
As far as we know, there is no statutory prohibition against patenting purified nucleic acid molecules. Please let me know whether this is correct. As you know, there is some argument that such molecules are products of nature. So the question is would unmodified nucleic acid molecules which are simply purified and isolated from nature be statutorily patentable subject matter?

Answer 2
Yes unmodified nucleic acid molecules, which are simply purified and isolated from nature, is statutorily a patentable subject matter as long as there is a specific applicability.

Question 3
If the answer to question 2 is yes, in general, what level of claim scope is permitted? I enclose claim 1 of U.S. issued patent 7,553,954 and you will see that the claim provides a genus defined either by hybridization at high stringency or 90% or greater identity to a specific sequence. SEQ ID NO: 7979 is indeed a natural sequence.

Answer 3
The Malaysian Patents Act 1983 is silent on the level of claim scope, to be permitted. However, if such a situation arises, it will be judged based on the following:-
(a) by the person skilled in the art or
(b) based on a doctrine of equivalent.
In any case, Section 13(1) (b) of the Malaysian Patents Act 1983 is equivalent to Article 53(b) of the European Patent Convention.
We provide herewith Article 53(b) of the European Patent Convention, which is equivalent to Section 13(1) (b) of the Malaysian Patents Act 1983.
Article 53

Exceptions to patentability (visit www.epo.org/patents)
European patents shall not be granted in respect of:
(b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision does not apply to microbiological processes or the products thereof.
We provide herewith a doctrine of equivalent in the United Kingdom for a situation wherein a level of claim scope is discussed.
Catnic Components Ltd V Hill & Smith Ltd
Catnic Components had a patent for a lintel, used to provide structural support over a door or window opening in a brick wall. Part of the specification required a bar to "extend vertically". Hill created a virtually identical invention that had a bar that extended at an upwards slant, only 6 degrees from being completely vertical. Despite the difference the device worked entirely in the same way as Catnic's invention.
Catnic sued for patent infringement. At trial, the judge held there was an infringement under the “pith and marrow” doctrine. The Court of Appeal overturned the ruling as although it held that the "vertical" requirement was an exact and essential element of the patent, the effect did not change. The court affirmed the use of purposive construction to patent interpretation and found an infringement.

Question 4
What kind of utility requirements are there for nucleic acid sequences? The sequences in claim 1 of the '954 patent are simply expression sequence tags not associated with any particular function other than as a tool for retrieval of full-length genes. Would this qualify as adequate utility under your law?

Answer 4
Utility test requires that it is useful and new to mankind generally. Apart from this, there are no specific requirement or thresholds. In any case if such matter arises, similar to our answer of Question 3, it will be based on any available EP/U.S precedent, as it was never tested in Malaysia.
Under US patent law, DNA sequences are considered chemical compounds by USPTO and are patentable as compositions of matter. In its Utility Examination Guidelines, the USPTO explained that isolated and purified DNA molecule that has the same sequence as a naturally occurring gene is different from the naturally occurring compound as it is processed through purifying steps that separate the gene from other molecules naturally associated with it and hence eligible for patent protection.
In addition, a prediction of utility with the following establishment is allowed in the U.S:-
(a) a factual basis for the prediction;
(b) an articulable line of reasoning from the factual basis to the prediction; and
(c) made proper disclosure.
The European Patent Office differs in espect of utility or usefulness criteria, which stipulates that for patentability, inventor has to show its industrial application for grant of a patent.
However, the answers as mentioned above were never tested in Malaysia. It is merely guidelines in which if such situation arises in Malaysia, the above options would be established.

Question 5
I assume that claim 8 of '954 is not considered a "plant variety" prohibited by section 13.

Answer 5
Yes. Claim 8 of the ‘954 patent is not considered a “plant variety” prohibited by Section 13(1)(b) of the Malaysian Patents Act 1983 as it is classified as a man-made process.

Question 6
Similar questions arise with respect to claim 1 of U.S. 7,491,806. This too is a naturally occurring sequence, which differs from nature only by being isolated, but it clearly has a useful function.

Answer 6
In such a situation, wherein a naturally occurring sequence, which differs from nature only by being isolated, and if it clearly has a useful function is considered a patentable subject matter.

Question 7
Please take a look at claim 1 of U.S. 7,485,715. I believe this is intended to cover cDNA, although by its wording it would cover isolated genetic sequences as well. Assuming that the claim were worded so that it was clear than only cDNA was included (as cDNA does not occur in nature), would your answers be any different?

Answer 7
Our answer remains the same if only cDNA was included as cDNA is a man made process wherein cDNA is DNA synthesized from a mature mRNA template in a reaction catalyzed by the enzyme reverse transcriptase. Therefore, it is considered a patentable subject matter if and only if there is a specific use.

Question 8
Please look at claim 4 of U.S. 7,084,331. This is a claim format similar to question 1 above - a naturally occurring organism. Would this be patentable? Similar questions apply to claim 1 of U.S. 7,534,612.

Answer 8
Yes. Our answer to this question for claim 4 of U.S 7,084,331 is similar to our answer in question 1 as it is patentable only if there is a specific use for it. It is not patentable if there is no specific use for the said subject and if it is obvious to the person skilled in the art. The same applies to claim 1 of U.S 7,534,612.

Question 9
Please also look at claim 1 of U.S. 7,084,331. This is directed to a modified plant, but it is only modified by introducing a naturally occurring organism. Is this patentable subject matter?

Answer 9
Yes. It is a patentable subject matter as the plant is modified by introducing a naturally occurring organism which is considered as a man made process.

We trust that we have answered some of your questions about patentability of nucleic acids/microorganisms in Malaysia.