Types of Protectable Inventions
Q: Can a Patent be obtained to cover any type of invention, including software, business methods and medical procedures?
A: The Patent Law was enacted in 2016 and the government eventually issued the much-anticipated Patent examination guidelines in 2019. The current Law differs from its predecessor in that it does not recognise the patentability of various types of subject matter, such as business methods, computer programs per se, new uses for existing products and new forms of existing compounds.
Article 4(c)(3) of the Patent Law excludes the patentability of business methods. Such patentability can, however, be recognised if the computer-implemented business method has technical character through technical means, as further explained by Annex 3, section 2.4 of the technical guidelines.
Article 4(d) of the Patent Law also excludes the patentability of computer programs. However, computer-implemented inventions are patentable, as described in Annex 3, section 2.1 of the technical guidelines. A computer-implemented invention is an invention that is realised using a medium such as a computer: one or more features of the invention are fully or partly realised by a computer program. The distinguishing feature of a computer-implemented invention is a program feature. A computer program is considered an invention if it involves a technical means such as a computer, server, phone, censors or devices, and when run on a computer, it produces a further technical feature outside normal physical interactions between the computer program (software) and the computer. Computer-implemented inventions can be categorised as process inventions (which include methods) and product inventions (which include systems, devices, computer programs, computer-readable storage media, or a combination of these).
Furthermore, article 4(f)(1) of the Patent Law excludes the patentability of new uses of existing products. This also excludes patentability of second or further medical use, which was previously patentable under the former Patent Law (the previous Patent Law was Law No. 14 Year 2001 on Patents). The Swiss-type second medical use format (previously used as an alternative for method-of-treatment claims that were otherwise not patentable under the previous Patent law) is no longer patentable under the current legislation. Several exceptions are discussed in Annex 1, section 5.2 of the technical guidelines, such as new uses for existing products being patentable when the protection of claims is directed to compound X with the feature of disease Y as a limiting or distinguishing feature. In cases of this kind, the claim protection is intended to allow a pharmaceutical industry body to produce a drug X that is indicated to treat only disease Y. The disease feature must be completely novel and inventive, must not involve the same action mechanism as the prior art and must be supported by clinical trial data, in vivo testing or in vitro testing in the description. The dosing regimen, administration time or frequency, patient group and action mechanism of the drug cannot be the distinguishing feature in product-for-new-use claims. An example of a patentable claim would be ‘compound X for use in treating allergy’, where the prior art indicated compound X for use as a pesticide.
Article 4(f)(2) of the Patent Law excludes the patentability of new forms of existing compounds. Based on Annex 1, section 5.3 of the technical guidelines, new forms include chemical chirality such as enantiomers or diastereomers, crystal forms, solvate forms, hydrate forms, salts, prodrugs and metabolites of existing compounds. Patentability can be acknowledged for new forms that result in meaningful e;cacy improvement, which is further explained in Annex 1, section 2 of the technical guidelines. Meaningful efficacy improvement may include increased bioavailability, improvement in stability, increased solubility, decreased toxicity, improvement in safety, improvement in potency, broader activity spectrum, decreased production cost or decreased treatment period. The meaningful e;cacy improvement should be supported by experimental data.
Article 9 of the Patent Law also further excludes the patentability of methods of examination, treatment, medication or surgery applied to humans or animals. This is further explained in Annex 1, section 6 of the technical guidelines. In vitro, ex vivo and in silico methods of examination or diagnosis are still patentable under this law. Non-therapeutic methods of treatment, such as cosmetic treatments, diet or other non-health-related treatments, are still patentable. In vivo methods of examination, therapeutic methods of treatment, methods of surgery and methods of medication applied to humans or animals are not patentable.
Also excluded in Article 9 of the Patent Law are living organisms. An exception is made for microorganisms such as yeast, fungi, bacteria and actinomycetes. An exception also applies to human cells and plant cells. Embryos, seeds, parts of plants, tissues, organs, transgenic plants and genetically altered animals are not recognised as patentable. New strains should be described specifically and the difference from known strains from the same species should be described for the novelty to be acknowledged. A novel microorganism with a different taxonomy is acknowledged as inventive. In relation to living organisms, patentability for essential biological processes for producing plants or animals is also excluded. Non-biological processes or microbiological processes are, however, patentable. Non-essential biological processes are biological processes that need human intervention, such as plant tissue isolation methods. Microbiological processes are biological processes that include microorganisms, such as fermentation. Artijcial insemination, cross-pollination and other processes that can occur naturally without human intervention are not patentable.
Nucleotides such as DNA, cDNA, primers, genes, vectors or transformants are patentable. Patentable nucleotides are nucleotides in the form of isolated nucleotides. Genes can be characterised by a polynucleotide sequence, an amino acid sequence or a mutation code. Vectors can be characterised by DNA sequence, DNA restriction map, molecular weight and number of base pairs. Transformants can be characterised by one host cell and the introduced gene (sequence). The novelty of gene sequences is examined with basic local alignment search tool (BLAST) searches (used in bioinformatics) or National Center for Biotechnology information databases. Gene sequences are acknowledged as inventive when the se’uence activity is different, at least qualitatively.
Patent Ownership
Q: Who owns the Patent on an invention made by a company employee, an independent contractor, multiple inventors or a joint venture? How is Patent ownership officially recorded and transferred?
A: According to article 12 of the Patent Law, the ownership of a Patent on an invention made by an employee during their work with a company typically belongs to the employer, unless there is a contract stating otherwise. In the case of an independent contractor, the patent ownership typically belongs to the contractor unless there is an agreement stating otherwise. If multiple inventors or joint ventures are involved, they can jointly own the patent unless there is an agreement specifying how ownership is to be allocated.
Should you need more information regarding scope and ownership of Patents in Indonesia, please do not hesitate to contact us via [email protected].
