Patentable, statutory or patent-eligible subject-matter is subject-matters which is susceptible of patent protection. The laws or patent practices of many countries provide exclusion of certain subject-matter, from patentability, even if the invention is novel and non-obvious. The patentability of methods of treatment is a notably contested subject matter worldwide as Article 27 of the World Trade Organisation’s Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement provides flexibility to its Member States by giving them liberty to decide whether patents may be granted to “diagnostic, therapeutic and surgical methods for the treatment of humans or animals.”
Following on from our previous article on the patentabily of “use” claims (http://iphouse.vn/best-practice-guide-for-filing-a-patent-application-in-vietnam-part-vi-use-claims/), this piece provides an overview of the current status with respect to the patentability of methods of treatment (including prevention or diagnosis of disease) under law and practice in Vietnam.
1. Worldwide jurisdictions
Methods of treatment are not allowed in most countries if claimed as such, the most notable exception to this being the United States and Australia.
In the United States, provided the method of treatment fulfills the requirements of patentability, such method is patent eligible.
Likewise, in Australia, the Patents Act does not specifically exclude methods of treatment from patentability. With that being said, the patentability of method of treatment claims in Australia is quite clear that method of treatment claims relate to patentable subject-matter.
However, it is noteworthy that the patentability of methods of treatment is not permissible mostly worldwide.
In Europe, European patents shall not be granted in respect of “methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body […]”(Art. 53(c) of EPC), although the EPO patent laws make clear that the products, substances and compositions used in these methods remain patentable (“[…] this provision shall not apply to products, in particular substances or compositions, for use in any of these methods”).
Likewise, in Japan, according to the Japan Patent Office (JPO), methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body fall outside the scope of “industrially applicable inventions” and are therefore unpatentable.
Article 25 of Chinese Patent Law specifically excludes diagnostic methods from patentability (“Patent rights shall not be granted for any of the following: […] methods for the diagnosis or treatment of diseases”)
Canada also prohibits obtaining a patent for a method that provides a practical therapeutic effect, such as curing, preventing or ameliorating an ailment or pathological condition, or treating a physical abnormality or deformity, such as by physiotherapy or surgery.
2. Vietnam jurisdiction with respect to methods of prevention, diagnosis or treatment of disease
- Article 59 of the Law on Intellectual Property Law
Methods of treatments shall be excluded from patentability in accordance with Article 59.7 of the Law on Intellectual Property Law in Vietnam, i.e “Patent rights shall not be granted for any of the following: […] Methods of disease prevention, diagnosis and treatment for humans or animals.”
In the light of the above, methods of treatments as such (including prevention or diagnosis of disease) are excluded from patentability.
The followings are examples which shall be regarded as methods of treatment and are therefore unpatentable:
- methods of treatment by surgery, methods of treatment by pharmaceutical or psychotherapeutic therapy;
- methods of acupuncture, anesthesia, manipulation, massage, scraping therapy, qigong, hypnosis, medicated bath, air bath, sunbath, forest bath, and nursing care for the purpose of treatment;
- methods of stimulating or irradiating a human or animal body by radiation of electricity, magnetism, sound, light, or heat etc. for the purpose of treatment;
- methods of coating, freezing, or diathermy etc. for the purpose of treatment;
- methods of immunization for prevention of diseases;
- methods auxiliary to a surgery treatment and/or pharmaceutical therapy, such as method of processing cells, tissues, or organs of subject which shall subsequently be returned to the subject, method of hemodialysis, method of monitoring level of anesthesia, method of taking medicines, method of injecting medicines, or method of applying medicines externally;
- methods of fertilization, contraception, increasing number of sperms, adosculation, or embryonic transfer etc. for the purpose of treatment;
- methods of cosmetic surgery, stretching limbs, losing weight, or increasing height for the purpose of treatment;
- methods of treating human or animal wounds, such as method of disinfecting or bandaging a wound; and
- other methods such as method of artificial respiration and method of supplying oxygen for the purpose of treatment.
In a case a method possibly for both treatment and non-treatment purposes, unless it is stated clearly in the specification that the method only serves the non-treatment purpose, it shall be considered nonpatentable (For futher details on this regard, see Art 126.96.36.199 of the Examination Guidelines for Patent and Utility Model in Vietnam).
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