Exclusions to patentability

These include, in cases of drugs and medicines, adding the following to the “discoveries” exclusion from patent protection:

•  The mere discovery of a new form or new property of a known substance that does not result in the enhancement of the known efficacy of the known substance; and

•  The mere discovery of any new use for a known substance.

However, patent applications involving “new use” and “new forms” of known substances filed after QUAMA have not been examined due to a lack of consensus on how the amendments were to be interpreted and applied in the substantive examination process. The two most common issues raised by the patent community relate to:

•  The interpretation of “mere discovery”, and

•  The definition of “enhancement of the known efficacy” (enhanced efficacy).

A breakthrough in the five-year stand-off came when the Bureau of Patents (BOP) of the IP Office of the Philippines (IPOPHL) issued the new Examination Guidelines for Pharmaceutical Patent Applications Involving Known Substances, which took effect on February 2, 2012. In April and May of this year extensive training for examiners on the implementation thereof was held.

"Under the new guidelines, enhanced efficacy is not limited to therapeutic efficacy. It includes advantageous properties of new forms of known substances, such as bioavailability."

Under the guidelines, “new uses” refer to second (further) medical uses of known substances, while “new forms” are “salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations, and other derivatives of a known substance”.

Mere discovery

BOP adopted the “doctrine of inherency” of the US Patent and Trademark Office (USPTO) in order to filter “mere discovery” through inherency analysis. Consequently, “new forms” and “new uses” would be considered as “mere discoveries”, if found to be inherent.

Under the USPTO patent examination practice, the “doctrine of inherency” allows examiners to rely upon “inherent disclosures” in determining novelty. Its operation necessarily requires comparison of the invention with prior art. Thus, if applied to QUAMA, the determination of whether “new uses” and “new forms” of drugs and medicines are patentable subject matter, requires indispensably the examination of prior art and the determination of novelty.

According to the guidelines, an invention is inherent if it is the “natural result flowing from the explicit disclosure of the prior art”. To be non-inherent then, the invention must not form part of a prior art and hence, effectively comply with the novelty requirement under the IP Code.

Enhanced efficacy

In addition, QUAMA reproduced the “discoveries” amendments into the IP Code’s inventive step provision, introducing “enhancement of the known efficacy of the known substance” (enhanced efficacy) as an inventive step requirement in cases of “new forms” or “new properties” of drugs and medicines.

In an attempt to clarify the ambiguity regarding the assessment of “enhanced efficacy”, QUAMA’s implementing rules and regulations added a subsection to the inventive step provision stating that “the patent examiner may call on representatives of the BFAD (Bureau of Food and Drugs) and/or its delegated experts to provide an expert opinion with regard to significant enhancement of therapeutic efficacy”.

This however caused more confusion, particularly as to the standard to be applied in the assessment of “enhanced efficacy”, and among others, it prompted BOP to declare a status quo with regard to patent applications affected by QUAMA.

Under the new guidelines, “enhanced efficacy” is not limited to therapeutic efficacy. It includes advantageous properties of new forms of known substances, such as bioavailability, stability and solubility, or improved or unexpected properties not found in the original substance, such as lower neurotoxicity and higher potency. As to the role of BFAD and its delegated experts, the guidelines categorically pronounce that their expert opinions are not binding.

The new guidelines are indeed a much-awaited solution to the limbo of QUAMA-related patent applications. Without significantly veering away from the status quo, BOP managed to resolve the standing issue by making the concept of “enhanced efficacy” a qualifying criterion for “non-obviousness” in cases of “new forms” or “new properties” of drugs and medicines.

In effect, the principal test for inventive step would still be “non-obviousness”, as provided for by the IP Code prior to QUAMA, qualified by “enhanced efficacy” provided for by QUAMA.