Question 1
We have recently been informed about the new opportunity to apply to be part of the ASEAN Patent Examination Co-operation (ASPEC) procedure.
In that respect of:
a) how does it work, and
b) when should we apply (file the ASPEC request form)?
ASPEC is not comparable to PCT, as ASPEC in itself does not issue any examination report or written opinion. ASPEC is merely a co-operation between 8 ASEAN countries namely: Cambodia, Indonesia, Laos, Malaysia, Singapore, Thailand, the Philippines and Vietnam. Once a search and examination report is issued by any of these countries (first IP Office), the applicant may use the report to file an ASPEC Request in another member state (second IP Office), and the report from the first IP Office will be used as a reference. However, the second IP Office is not obliged to adopt any of the findings or conclusions made by the first IP Office. There is no additional fee to file ASPEC Request.
Question 2
When will the member state in which we have filed the ASPEC request, provide the search and examination documents to the other ASPEC member states?
Answer 2
The search and examination report will be issued by the first IP Office, and subsequently during the normal course of patent prosecution the applicant has to submit the ASPEC Request Form together with the report to the second IP Office.
Question 3
What are the advantages or disadvantages of that ASPEC process?
Answer 3
The advantages that are as per the objectives of ASPEC:
- reduced work and faster turnaround time
- better search and examination as some IP Offices might have better access to databases unavailable to the other IP Office.
There is no particular disadvantage that we are able to pin point at the present time.
Question 4
Should we use this process only for certain type of Patent applications or for any type of patent application?
Answer 4
This program can be used for all types of patent applications, which is applicable in the particular member state (e.g. divisional application and utility innovation).
Question 5
Is there any risk?
Answer 5
We are not aware of any risk. In any case, this program is still in its infancy stage, so the actual risk factor (if any) might only surface after some time.
Question 6
What is your current experience with this new ASPEC process?
Answer 6
Please see our concluding remark below.
Question 7
Is there any advantage for the patent applicant e.g. acceleration of the grant procedure, or id the benefit only for the ASPEC Patent Offices?
Answer 7
This program may result in faster prosecution of the patent application, however please bear in mind that the receiving IP Office is not obliged to adopt any of the findings or conclusions reached by the other IP Office.
Question 8
Is there any advantage to file the ASPEC request form in one or other ASPEC member states (faster or more efficient office?).
Answer 8
There is no significant advantage, as the efficiency level of the each ASPEC member states is comparable.
Question 9
In which country(ies) would you advice us to file the ASPEC request form.
Answer 9
No particular preference, as each country has their provision of rules and regulations, and is independent from one another.
Question 10
What is the role of the first IP Office (ASPEC member state) were the ASPC Request Form is filed.
Answer 10
To provide the search and examination report to the applicant, and the applicant will later submit the ASPEC Request Form to the second IP Office.
Question 11
Can we provide the search report and examination report of any corresponding Patent Office e.g. European Patent Office.
Answer 11
Yes you can. However, in this instance the applicant need not file a request for ASPEC, wherein they might just submit the search report to the individual country directly.
CONCLUSION:
The feedback from the Malaysian Patent Office is that an application under ASPEC has not been filed to date. However, the infrastructure is in place to accept such request. We further checked with Singapore Patent Office, and there are only 3 such applications on record. We do not believe there has been significant progress in any of the other ASEAN countries relating to ASPEC process. This program is new and given that the ASEAN countries do not have a sophisticated Search & Examination processing body, we do not anticipate this process to be active at this time. In all likelihood, the Registrar will still await the outcome of corresponding cases in the more matured patent territories like US, EP, JP, KR, AU and GB.
Tuesday
Franchise Agreement
Question 1
Our understanding is that the application to register the franchise will not be made for some time after the pilot operation run by the franchisee has commenced, as the Registry requires proof that the franchise can operate successfully in Malaysia before awarding a franchise license.
We have been proceeded on the following basis:
a) That the letter of intent needs to be submitted and approved before we can make any formal arrangement with the franchisee.
b) That we need to sign a master franchise agreement with the franchisee so that he can start a pilot operation.
c) The franchisee needs to operate said pilot operation for a number of months before we can apply to the registry for a franchise license (so the franchise agreement for the sub franchises would only need to be prepared at this point).
Answer 1
Stage 1 - Approval under Section 54.
First, the letter of intent is submitted to the Registry of Franchises (ROF). In theory, the letter of intent should be filed and approved before offering the franchisor franchise for sale in Malaysia or to Malaysians. This is to ensure that the franchise is not against Malaysian public interests. We should receive a preliminary approval, approval with conditions or rejection in 1 to 3 months, for convenience we shall term this the “Section 54 approval”. You are correct that you should not make any formal arrangements with the franchisee prior to receiving official Section 54 approval.
Please take note that the Section 54 approval does not give the franchisor or the franchisee the permission to commence operations for a trial period. The Master Franchise Agreement should be prepared at this point.
Stage 2 – Application to Register the Master Franchise Agreement.
In the application stage, the ROF will examine the master franchise agreement in detail. As it was highlighted you in our earlier letters, the registry in Malaysia has set out strict rules in registering a franchise agreement.
In relation to your understanding that “the franchisee needs to operate said pilot operation for a number of months before we can apply to the registry for a franchise license (so the franchise agreement for the sub franchises would only need to be prepared at this point.”
This understanding is not quite accurate. At the time of application at this stage, the ROF does not require any proof to indicate that the franchise is operating successfully in Malaysia. The ROF requires evidence of use of the trademark, which can be from any country or countries. The franchisor also can show evidence of use of the trademark in Malaysia, if the franchisor has been using the mark in Malaysia. “Use” here covers direct use by the franchisor itself or use by other third parties via legal agreements. As advised in our earlier letters, the more extensive the evidence of use of the trademark, the greater the popularity of the trademark, the more convincing the application will be to the ROF, as the Registrar is more likely to conclude that Malaysia will benefit from the franchise.
Stage 3 – Registration of Sub-Franchises.
Under the Master Franchise Agreement, it is critical to ascertain whether the franchisee has the right to sub-franchise the franchisor franchise to a third party, at the franchisee own expense – in this case the franchisee would be the Master Franchisee. In this case, he would be treated as a franchisor and he have to register his agreements with every individual sub-franchisor.
If the franchisee does not have the right to sub-franchise, he would be an ordinary Franchisee.
Our understanding is that the application to register the franchise will not be made for some time after the pilot operation run by the franchisee has commenced, as the Registry requires proof that the franchise can operate successfully in Malaysia before awarding a franchise license.
We have been proceeded on the following basis:
a) That the letter of intent needs to be submitted and approved before we can make any formal arrangement with the franchisee.
b) That we need to sign a master franchise agreement with the franchisee so that he can start a pilot operation.
c) The franchisee needs to operate said pilot operation for a number of months before we can apply to the registry for a franchise license (so the franchise agreement for the sub franchises would only need to be prepared at this point).
Answer 1
Stage 1 - Approval under Section 54.
First, the letter of intent is submitted to the Registry of Franchises (ROF). In theory, the letter of intent should be filed and approved before offering the franchisor franchise for sale in Malaysia or to Malaysians. This is to ensure that the franchise is not against Malaysian public interests. We should receive a preliminary approval, approval with conditions or rejection in 1 to 3 months, for convenience we shall term this the “Section 54 approval”. You are correct that you should not make any formal arrangements with the franchisee prior to receiving official Section 54 approval.
Please take note that the Section 54 approval does not give the franchisor or the franchisee the permission to commence operations for a trial period. The Master Franchise Agreement should be prepared at this point.
Stage 2 – Application to Register the Master Franchise Agreement.
In the application stage, the ROF will examine the master franchise agreement in detail. As it was highlighted you in our earlier letters, the registry in Malaysia has set out strict rules in registering a franchise agreement.
In relation to your understanding that “the franchisee needs to operate said pilot operation for a number of months before we can apply to the registry for a franchise license (so the franchise agreement for the sub franchises would only need to be prepared at this point.”
This understanding is not quite accurate. At the time of application at this stage, the ROF does not require any proof to indicate that the franchise is operating successfully in Malaysia. The ROF requires evidence of use of the trademark, which can be from any country or countries. The franchisor also can show evidence of use of the trademark in Malaysia, if the franchisor has been using the mark in Malaysia. “Use” here covers direct use by the franchisor itself or use by other third parties via legal agreements. As advised in our earlier letters, the more extensive the evidence of use of the trademark, the greater the popularity of the trademark, the more convincing the application will be to the ROF, as the Registrar is more likely to conclude that Malaysia will benefit from the franchise.
Stage 3 – Registration of Sub-Franchises.
Under the Master Franchise Agreement, it is critical to ascertain whether the franchisee has the right to sub-franchise the franchisor franchise to a third party, at the franchisee own expense – in this case the franchisee would be the Master Franchisee. In this case, he would be treated as a franchisor and he have to register his agreements with every individual sub-franchisor.
If the franchisee does not have the right to sub-franchise, he would be an ordinary Franchisee.
Power Of Attorney For Patent Renewal In Malaysia
Question 1
If our client does not wish to have a renewal certificate, is it necessary to ask for a Power of Attorney?
Answer 1
Please be advised that even though your client may not require the Renewal Certificate, we are still required to submit the Power Of Attorney to the Intellectual Property Corporation of Malaysia (MyIPO), which serves as an authorization from the client for our firm to pay the annuities on their behalf as well as confirmation that the payment will be accepted and recorded by the MyIPO.
If our client does not wish to have a renewal certificate, is it necessary to ask for a Power of Attorney?
Answer 1
Please be advised that even though your client may not require the Renewal Certificate, we are still required to submit the Power Of Attorney to the Intellectual Property Corporation of Malaysia (MyIPO), which serves as an authorization from the client for our firm to pay the annuities on their behalf as well as confirmation that the payment will be accepted and recorded by the MyIPO.
Thursday
Patent Protection, Enforcement And Court System In Malaysia
PROTECTION
Question 1
What is the term of protection of a patent in Malaysia?
Answer 1
In Malaysia, a Patent last for twenty (20) years counted from the date of filing.
Question 2
Is it possible to extent the lifetime of a patent?
Answer 2
No.
ENFORCEMENT
Question 1
What are the types of patent enforcement action are available in Malaysia?
Answer 1
§ Ex-parte injunctions (Anton Piller Orders and Mareva Injunctions);
§ Interlocutory injunction;
§ Permanent Injunction;
§ Damages and
§ Delivery up of the infringing goods by the defendant.
Question 2
How can the patent owner most effectively make his point to stop an infringement?
Answer 2
Obtain an injunction.
Question 3
Are protective orders available in Malaysia?
Answer 3
Yes.
Question 4
Does the Malaysian patent law require the patent owner to send a cease and desist letter to an alleged infringer before a court action can be taken against him?
Answer 4
No.
Question 5
Is it possible to seek a preliminary injunction? If so, how long would this action take?
Answer 5
Possible. Time frame for an inter parte is between 2 – 4 months. If ex parte, than it would be heard urgently in a week or two.
Question 6
Is it possible to seek seizures / inspections of suspect goods?
Answer 6
Yes.
Question 7
How long would a patent infringement / patent invalidation case take? At typically what cost?
Answer 7
1. Infringement action duration 24 – 36 months.
2. Invalidation action duration 24 – 36 months.
3. Typical cost – this can vary according to complexity of case, whether it is contested and seniority of person handling the case.
Question 8
How are damages / royalties assessed?
Answer 8
Plaintiff’s loss of profits or defendant’s account of profits.
Question 9
Can the alleged infringer sue for damages if the patent owner fails to prove infringement in court of Malaysia?
Answer 9
Yes. Only for a claim for costs.
COURT SYSTEM
Question 1
Briefly describe any cases of patent invalidation or patent infringement in Malaysia?
Answer 1
MyIPO has until now not allowed a third party to inspect and to obtain copies of any documents other than the granted patent specification themselves, unless there is written consent from the patent owner. The stand taken by MyIPO is that any communication between the applicant and MyIPO, other than the granted specification, should remain confidential, even after grant of the patent.
In this case, the applicant submitted that the written consent from the patent owner would only required for pending patent applications, as the same were confidential but not for granted patents. The fact that the patent has been duly granted shows that the element of confidentiality no longer exists and therefore a third party should be entitled to inspect the file at the Registry and to obtain the case history and any relevant extract. It was also argued that if Parliament intended to restrict public access only to the granted specification, then the said restriction would have been specified in the Patents Act.
On principles of statutory interpretation, it was submitted that if a statute is clear and unambiguous, a literal interpretation should be taken of the words in the statute. In this case section 34(1) clearly provides that a patent file can be inspected and extracts can be obtained as soon as the patent application proceeds to grant.
Based on these submissions the Court granted the application.
This is a positive development as far as the Malaysian patent regime is concerned, as in any litigation concerning the granted patent; the prosecution history can now be brought up to show whether concessions were made by the applicant to MyIPO, which will be a factor taken into account by the court in construing the claims.
Question 2
How efficient are the courts in disposing IP litigation cases in Malaysia?
Answer 2
Reasonably efficient.
Question 3
Are the judges technically qualified?
Answer 3
No.
Question 4
Do the courts rely on precedent cases decided in foreign countries?
Answer 4
Yes, United Kingdom and Australia.
Question 5
How are foreigners treated by the courts in Malaysia?
Answer 5
Same as locals.
Question 6
What is the time frame for a patent invalidation / patent infringement suit to be decided?
Answer 6
2 – 4 years.
Question 7
What step(s) must be taken to appeal a court decision in Malaysia?
Answer 7
A notice of appeal is filed within 30 days from the date of the decision at the Court of Appeal.
Question 1
What is the term of protection of a patent in Malaysia?
Answer 1
In Malaysia, a Patent last for twenty (20) years counted from the date of filing.
Question 2
Is it possible to extent the lifetime of a patent?
Answer 2
No.
ENFORCEMENT
Question 1
What are the types of patent enforcement action are available in Malaysia?
Answer 1
§ Ex-parte injunctions (Anton Piller Orders and Mareva Injunctions);
§ Interlocutory injunction;
§ Permanent Injunction;
§ Damages and
§ Delivery up of the infringing goods by the defendant.
Question 2
How can the patent owner most effectively make his point to stop an infringement?
Answer 2
Obtain an injunction.
Question 3
Are protective orders available in Malaysia?
Answer 3
Yes.
Question 4
Does the Malaysian patent law require the patent owner to send a cease and desist letter to an alleged infringer before a court action can be taken against him?
Answer 4
No.
Question 5
Is it possible to seek a preliminary injunction? If so, how long would this action take?
Answer 5
Possible. Time frame for an inter parte is between 2 – 4 months. If ex parte, than it would be heard urgently in a week or two.
Question 6
Is it possible to seek seizures / inspections of suspect goods?
Answer 6
Yes.
Question 7
How long would a patent infringement / patent invalidation case take? At typically what cost?
Answer 7
1. Infringement action duration 24 – 36 months.
2. Invalidation action duration 24 – 36 months.
3. Typical cost – this can vary according to complexity of case, whether it is contested and seniority of person handling the case.
Question 8
How are damages / royalties assessed?
Answer 8
Plaintiff’s loss of profits or defendant’s account of profits.
Question 9
Can the alleged infringer sue for damages if the patent owner fails to prove infringement in court of Malaysia?
Answer 9
Yes. Only for a claim for costs.
COURT SYSTEM
Question 1
Briefly describe any cases of patent invalidation or patent infringement in Malaysia?
Answer 1
MyIPO has until now not allowed a third party to inspect and to obtain copies of any documents other than the granted patent specification themselves, unless there is written consent from the patent owner. The stand taken by MyIPO is that any communication between the applicant and MyIPO, other than the granted specification, should remain confidential, even after grant of the patent.
In this case, the applicant submitted that the written consent from the patent owner would only required for pending patent applications, as the same were confidential but not for granted patents. The fact that the patent has been duly granted shows that the element of confidentiality no longer exists and therefore a third party should be entitled to inspect the file at the Registry and to obtain the case history and any relevant extract. It was also argued that if Parliament intended to restrict public access only to the granted specification, then the said restriction would have been specified in the Patents Act.
On principles of statutory interpretation, it was submitted that if a statute is clear and unambiguous, a literal interpretation should be taken of the words in the statute. In this case section 34(1) clearly provides that a patent file can be inspected and extracts can be obtained as soon as the patent application proceeds to grant.
Based on these submissions the Court granted the application.
This is a positive development as far as the Malaysian patent regime is concerned, as in any litigation concerning the granted patent; the prosecution history can now be brought up to show whether concessions were made by the applicant to MyIPO, which will be a factor taken into account by the court in construing the claims.
Question 2
How efficient are the courts in disposing IP litigation cases in Malaysia?
Answer 2
Reasonably efficient.
Question 3
Are the judges technically qualified?
Answer 3
No.
Question 4
Do the courts rely on precedent cases decided in foreign countries?
Answer 4
Yes, United Kingdom and Australia.
Question 5
How are foreigners treated by the courts in Malaysia?
Answer 5
Same as locals.
Question 6
What is the time frame for a patent invalidation / patent infringement suit to be decided?
Answer 6
2 – 4 years.
Question 7
What step(s) must be taken to appeal a court decision in Malaysia?
Answer 7
A notice of appeal is filed within 30 days from the date of the decision at the Court of Appeal.
Tuesday
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.
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.
Subscribe to:
Posts (Atom)