Patentability and subject matter exclusions

As with many other major patent jurisdictions around the world, the majority of items excluded from patentability in Malaysia affect the life sciences industry. Examples of excluded subject matter relevant to the life sciences industry are:

(a)  Discoveries and scientific theories;

(b)  Plant or animal varieties or essentially biological processes for the production of plants or animals;

(c)  [not relevant]; and

(d)  Methods of treatment of human or animal body by surgery or therapy, and diagnostic methods practised on the human or animal body.

Interpretation and application of sections 13(1)(a) and 13(1)(b) by the Malaysian Intellectual Property Office (MyIPO) have largely followed the provisions on biotechnological inventions introduced in the European Patent Convention (EPC) 2000 and the EU guidelines for the legal protection of such inventions, in Directive 98/44/EC.

For discoveries—section 13(1)(a)—although it is not possible to pursue patent protection in Malaysia for discovery of a new species, MyIPO accepts claims directed at the composition and/or formulation of an extract obtained from the new species, provided the composition/extract fulfils patentability requirements.

For section 13(1)(b), exceptions are made for manmade living microorganisms as well as microbiological processes and products resulting from such processes. Also, as in the EU, Malaysia has provided for a sui generis system of protection for new plant varieties, ie, the Protection of New Plant Varieties Act 2004, in force since October 2008.

In practice, it has been observed that MyIPO’s interpretation and application of section 13(1)(b) in respect of animal varieties is identical to those of EPC 2000 and the 98/44/EC directive.

Treatment and diagnosis

Of interest to the pharmaceutical and medical sectors is that MyIPO has been guided by the provisions in the EPC 2000 when interpreting and applying the provisions of section 13(1)(d) to methods of treatment and diagnosis. Chapter IV, point 3.5 of MyIPO’s Guidelines for Patent Examination (October 2011) expands on the interpretation of subject matter considered within section 13(1)(d) and which is therefore exempted from patent protection.

Section 13(1)(d) excludes only methods of treatment by surgery or therapy. Hence, all methods of treatment which are non-therapeutic in nature are not exempt from patent protection. This includes cosmetic methods such as application of substances to the human body for cosmetic purposes (eg, methods practised on human hair such as perming, waving, straightening, etc) and/or methods practised on the human or animal body to promote growth (eg, methods practised to improve commercial yield).

MyIPO also considers methods of measuring or recording characteristics of the human or animal body not exempt from patent protection, provided such methods are of a technical and not essentially biological character that can be applied industrially. For example, various methods of diagnostic scanning, and of taking measurements of the human or animal body for the manufacture of prosthetic limbs or orthodontic prosthetics are acceptable subject matter.

Methods of diagnosis performed on a live human or animal body that involves obtaining information that produces only intermediate results, which on their own do not enable a treatment decision to be made, are also not exempt from patent protection.

To be excluded under section 13(1)(d), a treatment or diagnostic method must be carried out on a live human or animal body. Treatment of fluids or tissues removed from a human or animal body are also not exempt from patent protection, provided said fluid or tissues are not returned to the human or animal body, ie, in vitro methods are allowable and in vivo methods excluded.

"As in the EU, Malaysia has provided for a sui generis system of protection for new plant varieties, ie, the Protection of New Plant Varieties Act 2004."

Like the European Patent Office, MyIPO takes the view that “treatment by therapy” implies curing of a disease or malfunction of the human or animal body. Thus, on that score, MyIPO considers prophylactic methods (eg, immunisation protocols) as subject matter exempted from patent protection in Malaysia.

As per EPC provisions, products or apparatus used in methods of treatment or diagnosis are not exempt from patent protection in Malaysia, ie, claims directed towards surgical, therapeutic or diagnostic equipment are allowable. Following this line of thought, claims directed at substances or compositions used in methods of treatment or diagnosis of the human or animal body are equally patentable.

Although classic “method of treatment” claims are not allowable in Malaysia, it remains possible to pursue patent protection for such subject matter as MyIPO allows for the granting of certain types of purpose-limited products, purpose-limited process or purpose-limited use claims, ie, first or second medical use claims.

Oon Yen Yen is a patent manager at  Henry Goh. She can be contacted at:  yen@henrygoh.com