According to the Philippines Intellectual Property Code, the following in relation to pharmaceutical substances are not patent eligible and do not possess inventive step:
- the mere discovery of a new form or new property of a known substance which does not result in the enhancement of the known efficacy of that substance,
- the mere discovery of any new property or new use for a known substance, or
- the mere use of a known process unless such known process results in a new product that employs at least one new reactant.
The Philippines Intellectual Property Code is supplemented by a set of guidelines (QUAMA Guide) for the assessment of patentability of pharmaceutical substances in the Philippines.
Notably, the QUAMA Guide applies the principles of the Doctrine of Inherency in the assessment of patentable subject matter and inventive step. This is in contrast to other jurisdictions which consider the issue of inherency during the assessment of novelty. Specifically, the Doctrine of Inherency is adopted in the Philippines to first assess if the claimed subject matter is a “mere discovery” and therefore not patent eligible. Subject matter that is a natural result that necessarily and inevitably flows from an explicit disclosure of the prior art will be considered inherent and a mere discovery.
Once the claimed subject matter is deemed to be patent eligible, the assessment of novelty and inventive step will proceed. The principles of inherency are also applied in the determination of inventive step.
The application of the Doctrine of Inherency in the assessment of patentable subject matter in the Philippines is summarised for each situation below.
(a) New forms of a known substance
In order to be patent eligible, according to the QUAMA Guide, a new form of a known substance must be non-inherent and show an enhancement in efficacy that is also non-inherent. In other words, enhanced efficacy alone is not sufficient – the enhanced efficacy must be unexpected.
Efficacy may be therapeutic efficacy or any advantageous property such as bioavailability, stability or solubility. Data showing enhanced efficacy must be supported by the description.
Importantly, improved thermodynamic stability and lower hygroscopicity are considered to necessarily and inevitably follow from the known properties attributable to a polymorph and do not contribute to patent eligibility.
(b) New use of a known substance
Medical use claims of a known compound which rely solely on the following features for patentability are considered inherent and unpatentable:
- a new mode of administration of dosage regime,
- a new patient group,
- a new mechanism or technical effect,
- a new advantage to a known use, or
- a new clinical situation for a known treatment.
Similarly, a new medical use of a known compound would be considered inherent and a mere discovery if the new use is directed to a more specific concept of the known medical use, or if the new use inevitably results from closely related pharmacological effects of the known substance.
(c) Use of a known process
A process that is known will be considered to be inherent unless a new product is produced and one new reactant is employed. Newly discovered results of known processes are considered inherent, whether or not the prior art discloses the process by which a known product is made.
- A new form of a known compound must be non-inherent and have an unexpected enhancement in efficacy that is supported by data in the specification.
- A new medical use of a known compound must not rely solely on a new administration mode or dosage regime, patient group, mechanism or technical effect, advantage, or clinical situation for patentability.
- A use of a known process must employ a new reactant and produce a new product.