Patentability of a product or process requires novelty, inventive step and industrial utility.  Relevant to genomics, the following are not considered patentable under the Philippine Intellectual Property Code (“IP Code”):

“22.1. Discoveries, …

x x x

22.3 Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body. This provision shall not apply to products and composition for use in any of these methods;

22.4. Plant varieties or animal breeds or essentially biological process for the production of plants or animals. This provision shall not apply to micro-organisms and non-biological and microbiological processes.

x x x

22.6. Anything which is contrary to public order or morality. (Sec. 8, R.A. No. 165a)” [Emphasis supplied]

 

The Revised Implementing Rules for Patents, Utility Models and Industrial Designs list down matter excluded from patent protection as follows:

“Rule 202. Non-patentable Inventions. – The following shall be excluded from patent protection:

(a) Discoveries, …

x x x

(f) Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body. This provision shall not apply to products and compositions for use in any of these methods;

(g) Plant varieties or animal breeds or essentially biological process for the production of plants and animals. This provision shall not apply to microorganisms and non-biological and microbiological processes;

x x x

(i) Anything which is contrary to public order, health, welfare, or morality, or process for cloning or modifying the germ line genetic identity of humans or animals or uses of the human embryo.” [Emphasis supplied]

 

With respect to “discoveries”, the 2017 Manual for Patent Examination Practice states that “[i]f a person finds out a new property of a known material or article, that is a mere discovery and therefore not patentable. If however a person puts that property to practical use, an invention has been made which may be patentable… To find a substance freely occurring in nature is also mere discovery and therefore not patentable. However, if a substance found in nature has first to be isolated from its surroundings and a process for obtaining it is developed, that process is patentable”. [Emphasis supplied]

Micro-organisms and microbiological processes are not excluded from patentability.  The 2017 Manual for Patent Examination defines “microorganisms” and “microbiological process” as follows:

“The term “microbiological process” is to be interpreted as covering not only industrial processes using micro-organisms but also processes for producing new micro-organisms, e.g. by genetic engineering. The product of a microbiological process may also be patentable per se (product claim). A micro-organism can also be protected per se (Sec.22.4, 2nd sentence). The term micro-organism in general includes not only bacteria and yeasts, but also fungi, algae, protozoa and human, and possibly animal and plant cells, i.e. all generally unicellular organisms with dimensions beneath the limits of vision which can be propagated and manipulated in a laboratory, including plasmids and viruses.” [Emphasis supplied]

“Biological material” is defined in the 2017 Manual for Patent Examination as follows:

“The term “biological material” can be considered to mean any material containing genetic information and capable of self-reproducing or of being reproduced in a biological system. It includes both micro-organisms and seeds.” [Emphasis supplied]

The Revised Implementing Rules and Regulations for Patents, Utility Models and Industrial Designs provides the culture deposit requirements for applications relating to biological materials and microorganisms, in order for the invention to be considered as fully disclosed.

Although methods of treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body are not patentable, the exclusion does not apply to products and compositions for use in any of these methods.  Patents may also be granted “for surgical, therapeutic or diagnostic instruments or apparatus for use in such methods”.

Diagnostic methods are defined in the Revised Guidelines on the Examination of Pharmaceutical Applications Involving Known Substances as follows:

“Diagnosis is defined as the determination of the nature of a medical condition, usually by investigating its history, aetiology and symptoms and by applying tests. It includes a negative finding that a particular condition can be ruled out, as well as a positive identification of a disease...” [Emphasis supplied]

Non-patentable diagnostic methods are delimited in the 2017 Manual of Patent Examination Procedure and the Revised Guidelines on the Examination of Pharmaceutical Applications Involving Known Substances as follows:

“Diagnostic methods likewise do not cover all methods related to diagnosis. Methods for obtaining information only (data, physical quantities) from the living human or animal body may not necessarily excluded by Sec.22.3, if the information obtained merely provides intermediate results which on their own do not enable a decision to be made on the treatment necessary. Examples of such methods include X-ray investigations, NMR studies, and blood pressure measurements.” [Emphasis supplied]

Further, excluded treatment or diagnostic methods are those carried on in the living human or animal body, thus:

“A treatment or diagnostic method, to be excluded, would generally have to be carried out on the living human or animal body. A treatment of or diagnostic method practiced on a dead human or animal body would therefore not be excluded from patentability by virtue of Sec. Sec 22.3. Treatment of body tissues or fluids after they have been removed from the human or animal body, or diagnostic methods applied thereon, are not excluded from patentability in so far as these tissues or fluids are not returned to the same body. Thus the treatment of blood for storage in a blood bank or diagnostic testing of blood samples is not excluded, whereas a treatment of blood by dialysis with the blood being returned to the same body would be excluded.” [Emphasis supplied]

The Revised Implementing Rules for Patents, Utility Models and Industrial Designs also proscribes patentability of processes “for cloning or modifying the germ line genetic identity of humans or animals or uses of the human embryo”.

The foregoing considerations are in addition to the regular requirements for patentability.  Hence, application of genomics to inventions for treatment and diagnosis of COVID-19 need to be carefully studied bearing these limitations in mind.