Currently 79 countries are party to the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure.
Deposition of biological materials is necessary to meet the enabling disclosure requirement. Insufficiency of disclosure is a ground for invalidation of a Malaysian patent. It is impossible to sufficiently disclose an invention either directed at or requiring the use of biological materials merely by way of written description. This is addressed by depositing a sample with an international depositary authority (IDA), which will be treated as sufficient for patent purposes.
At the time of writing, Malaysia has yet to accede to the treaty.
Currently, there are no provisions in Malaysian law for deposits of biological materials. When a Malaysian application requires the use of biological material, the Malaysian IP Office (MyIPO) requires execution of a statutory declaration confirming that either a sample will be provided to any requestor or, if a deposit has been made, a declaration authorising the authority to provide a sample will be given.
This requirement has occasionally been interpreted broadly. A declaration is requested at the mere mention of biological materials, regardless of whether that material is needed for performance of the claimed invention.
Amendments to Malaysia’s Patents Act signalling Malaysia’s accession to the treaty have been proposed and are expected to be passed in parliament shortly. A specific provision for deposition of biological materials has been made. Deposition will be a filing date requirement for direct applications and must be made before filing. This will not apply to Patent Cooperation Treaty national phase applications.
Definitions of biotechnological inventions including biological material and processes have been proposed. The definitions are in line with those set out in the European Patent Convention and the EU Directive 98/44/EC.
Although it is the practice of MyIPO to adopt the European approach regarding biotech inventions, allowance of any claim-type largely depends on an individual examiner’s interpretation. It is difficult to be certain of the claim scope permitted for biological materials since there is no guidance and the validity of such claims has not been contested in court. Introduction of definitions for biological terminology will provide clarity and greater certainty.
Regardless of whether a Malaysian International Depositary Authority is established, accession to the treaty is a positive development for local inventors.
The proposed definitions together with accession to the treaty could be advantageous in several ways.
It may become possible to rely on deposited material when referring to DNA and/or amino acid sequences. Sequencing errors can lead to incorrect disclosure of sequences and it would be helpful to rely on the deposited material for “correction” of the error. Applicants could also rely on deposited material as a starting point for broader claim language. A claim directed at a deposited microbial strain could be interpreted to cover mutant strains. It could also be possible for applicants to rely on deposited material to defend patentability.
Although not compulsory, it is beneficial for Malaysia to form an IDA to reduce costs for local inventors. Presently, it is necessary for local inventors to deposit biological materials with foreign IDAs at high costs. The majority of IDAs are located in Europe with only four developing countries hosting IDAs. Dialogue between the Malaysian government and local institutions on the formation of an IDA began in June 2007. Selection of an existing facility for approval as an IDA is expected.
Regardless of whether a Malaysian IDA is established, accession to the treaty is a positive development for local inventors. The treaty provides for recognition of lawful deposits which can be relied upon to assert proprietary rights.
On the other hand, accession to the treaty could be a hindrance to compliance with the Convention on Biological Diversity (CBD). Provisions to recognise traditional knowledge (TK) and genetic resource (GR) documents during substantive examination have been proposed. These provisions require submission of evidence of prior informed consent and certificate of origin during examination and TK and GRs would be recognised as prior art. However, the secrecy surrounding deposits made under the treaty impairs the gathering of data on implementation of the CBD’s GR disclosure requirement, thereby hindering identification of misappropriation.
As can be expected, there are currently a host of uncertainties about the implementation of the provisions of the treaty in Malaysia. It is hoped that the implementing regulations of the proposed amendments to the patents act, a draft of which has yet to be issued, would serve to clarify matters.
Oon Yen Yen is a patent manager at Henry Goh. She can be contacted at: yen@henrygoh.com
Malaysia, patent, Patent Cooperation Treaty, MyIPO, IDAs, filing, application, deposition, DNA, GR, TK, CBD,
