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 methods of diagnosis or treatment of disease in general (http://iphouse.vn/best-practice-guide-for-filing-a-patent-application-in-vietnam-part-viii-patentability-of-methods-of-treatment/), this piece in particular provides guidelines with respect to methods for non-diagnosis/non-treatment purposes and avoiding the exclusion of the methods from patent protection under Article 59 of the Law on Intellectual Property Law, therefore, to a certain extent open, a floor for inventions of question to be patentable in Vietnam.
1. Vietnam jurisdiction with respect to methods of diagnosis or treatment of disease
- Article 59 of the Law on Intellectual Property Law
Generally, methods of diagnosis or treatment of disease shall be excluded from patentability in accordance with Article 59.7 of the Law on Intellectual Property Law in Vietnam. The Article states:
“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, surgery, therapy and diagnostic methods shall basically be excluded from patentability. However, it should be noteworthy that instruments or apparatus for implementing diagnostic methods or treatment, or substances or materials used in such methods, do constitute patentable subject matter provided that such subject-matters fulfill the requirements of patentability.
It should also be noted there is still exception to this exclusion being methods served for non-treatment or non-diagnosis purposes, and can therefore be patentable.
2. Methods for diagnosis and non-diagnosis purposes and the patentability thereof
Methods for diagnosis purposes
In accordance with the Examination Guidelines for patent in Vietnam (Art 220.127.116.11(a)), it phrases “Diagnostic Methods”/”Methods for diagnosis purposes” refer to the processes of identifying, studying and determining the cause or focus of diseases on living human or animal bodies.
Where a method involving diagnosis of a disease complies with the following two requirements, it is a diagnostic method and shall not be granted a patent:
(i) it is practiced on a living human or animal body; and
(ii) its immediate purpose is to obtain the diagnostic result of a disease or health condition.
If an invention, as disclosed in the description, is practiced on samples in vitro, but its immediate purpose is to obtain the diagnostic result of a disease or health condition for the same subject, no patent shall be granted for such invention.
If a method includes diagnostic steps, or testing steps if no diagnostic steps, and the diagnostic result of a disease or health condition can be reached immediately based on the diagnostic or test data thus obtained according to the medical knowledge in the prior art and the disclosure of the application, the method can subsequently be regarded as satisfying the requirement (ii) above.
The following are examples of diagnostic methods to which no patent shall be granted:
- method of measuring blood pressure,
- method of taking pulse,
- method of health diagnosis,
- X-ray diagnostic method,
- ultrasonic diagnostic method,
- gastrointestinal radiography diagnostic method,
- endoscopy diagnostic method,
- isotope tracing diagnostic method and infrared noninvasive diagnostic method,
- method of evaluating the risk of suffering diseases,
- method of predicting the therapeutic efficacy for diseases, and
- gene screening diagnostic method.
Methods for non-diagnosis purposes
The following are examples of methods for diagnosis purposes to which a patent can be granted:
(i) method of pathological anatomy practiced on a dead human or animal body;
(ii) method whose immediate purpose is only to obtain information from the living human or animal body as an intermediate result rather than to obtain the diagnostic result or health condition, or method of processing such information (e.g., parameters of physique and body, physiological parameters or other parameters); and
(ii) method whose immediate purpose is only to treat or test the body tissues, body fluids or excrements that have been removed from the human or animal body in order to obtain information as an intermediate result rather than to obtain the diagnostic result or health condition, or method of processing such information.
In respect of the items (ii) and (iii) above, it should be noteworthy that only if the diagnostic result of a disease and health condition can not be reached immediately based upon the obtained information per se in light of the medical knowledge in the prior art and the disclosure of the application, the information can be regarded as an intermediate result.
3. Methods for treatment and non-treatment purposes and the patentability thereof
Methods for treatment purposes
“Methods of treatment for diseases” or “methods for treatment purposes” refer to the processes of intercepting, relieving or eliminating the cause or focus of diseases so that the living human or animal bodies may recover or gain health or relieve pain.
Methods of treatment for diseases include the ones which serve treatment purpose or which are of treatment nature, prophylactic methods and methods of immunization.
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.
Methods for non-treatment purposes
The followings are examples which shall be regarded as methods for non-treatment purposes and are therefore patentable:
- methods of making artificial limbs or other prostheses, and methods of measurement in making such artificial limbs or prostheses, say, a method of making dental prosthesis, including the step of making tooth mould in the oral cavity of the patient and the step of making dental prosthesis outside the oral cavity (Note: although the ultimate aim is for treatment, the main purpose of the method is to make suitable dental prosthesis);
- methods of stockbreeding by treating animal bodies by a non-surgery means to change their growing trait, such as methods of applying certain electromagnetic stimulation to live lambs in order to accelerate their growth speed, improving the quality of mutton or increase the output of wool;
- methods of butchering animals;
- methods of treating dead human or animal bodies, such as methods of anatomy, beautification, antisepsis, or making specimen;
- methods of purely cosmetic nature, i.e., methods of cosmetic nature which are not invasive to human body or do not produce wounds, including methods of deodorization, protection, decoration or beautification for non-treatment purpose practiced partially on such directly visible parts as skin, hair, nail, and teeth externals;
- methods for making a human or animal not in a diseased state feel comfortable or pleased, or methods for supplying oxygen, negative oxygen ions or moisture under a special condition such as for diving or for shielding from toxic gas; and
- methods of killing or eliminating bacteria, viruses, lice, or fleas on a human or animal body (on the skin or in the hair, excluding wounds and infected sites).
NOTE: For a method possibly for both treatment purpose and non-treatment purpose, unless it is clearly stated that the method serves non-treatment purpose, no patent shall be granted.
4. Methods of surgery
“Methods of surgery” refer to the methods of traumatic or invasive treatment such as incision, resection, stitching, and tattooing practiced on living human or animal bodies with the aid of instruments. Such methods are not be patent eligible. However, a method of surgery practiced on a dead human or animal body may be patentable in so far as it does not violate Article 8.1 of the Law on Intellectual Property.
Methods of surgery are catigorized into two types: one for the purpose of treatment and the other for the purpose of non-treatment.
A method of surgery for the purpose of treatment belongs to methods of treatment for diseases, for which no patent shall be granted in accordance with the Article 59.7 of the Law on Intellectual Property Law.
A method of surgery for the purpose of non-treatment purpose does not fulfill the requirements for industrial applicability as it is in fact practiced on living human or animal bodies, and shall therefore be unpatentable.
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