18 December 2015Jurisdiction reportsOon Yen Yen

The Budapest Treaty: on its way to Malaysia?

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.

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