PHARMA PATENTS
On February 15, 2012, the Intellectual Property Office of the Philippines (IPPHL) published on its website its Examination Guidelines for Pharmaceutical Patent Applications Involving Known Substances. Tese guidelines were issued pursuant to the amendments in the patent law and its implementing rules and regulations, brought about by Republic Act No. 9502, the Universally Accessible Cheaper and Quality Medicines Act of 2008 (QUAMA). Te aim of this act is to promote and ensure access to affordable quality drugs and medicines for all, pursuant to the state’s policy of protecting public health.
To achieve this goal, the QUAMA also introduced amendments to the patent law which were highly criticised by pharmaceutical companies as limiting the patentability of certain chemical forms unless increased efficacy was demonstrated. Tese amendments were reflected in Section 22, which defined non-patentable inventions as:
• Te 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;
• Te mere discovery of any property or new use for a known substance; and
• Te mere use of a known process unless such known process results in a new product that employs at least one new reactant.
Tese formulations were repeated in Section 26 on inventive step. Te guidelines then aim to provide an explanation on the best manner of assessing a patent application against the patent eligibility standard and the patentability criterion of inventive step, by adopting the principle, or doctrine, of inherency, underscoring the IPPHL’s goal of granting patents only when applications for drugs or medicines involving known substances do not fall within the list of non-patentable inventions, while meeting the criteria of novelty, inventive step and industrial applicability.
Tese amendments are material during a non- patentable subject matter inquiry, and the assessment of inventive step requirements for drugs and medicines.
Doctrine of inherency
Te guidelines state that the term “mere discovery” shall be subjected to inherency analysis in order to remove any ambiguity; this gives a more definitive methodology for patent examiners. An examiner’s
62 World Intellectual Property Review Annual 2012
enquiries on non-patentable subject matter shall be guided by the following principles:
• In general, a limitation or the entire invention is inherent and in the public domain if it is the “natural result flowing from” the explicit disclosure of the prior art (4.1.1 of the guidelines);
• To establish inherency, a person of ordinary skill in the art is not required to recognise the inherent disclosure in the prior art (4.1.2); and
• An inventor’s discovery of scientific principles does not entitle him to remove prior art from public domain (4.1.3).
In the first two abovementioned cases, a new form or property of a known substance inherent in the known substance would be considered as “mere discovery”, and so would not be a patentable subject matter. Likewise, in the last case, for a use of a known process which does not employ at least one new reactant and does not result in a new product, such use would be inherent in the known process or would be a “mere use”, and hence not patentable.
www.worldipreview.com
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