PHARMA PATENTS
terms of numerical value, but comparative data showing the efficacy of the new form with that of a known substance, eg, activity of the new form, relevant results of experimental assays, clinical or pre-clinical test data, etc. A reasonable correlation should be demonstrated between the efficacy claimed and the data provided.
Second or further medical use
Te term “new use” will refer to second, or further, medical uses of known compounds. Second medical use of known substances or compositions may be covered by patent protection if it satisfies the eligibility standard requirement on “mere discoveries”, that is, inherency. Since method of treatment claims are non-allowable, second, or further, medical use claims should be draſted as Swiss-type claims.
Claiming medical indications
Section 22.3 of the IP Code excludes methods of treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body. Some examples of the assessment guidelines to be applied are:
• Methods of treatment that are not within the scope of the terms “therapy” and “surgery” are not excluded from patentability.
Enhancement of known efficacy
It is in the determination of inventive step of a patent application involving a new form or new property of a known substance that the matter of enhancement of known efficacy shall be considered. An expanded definition of efficacy is provided by the guidelines. Tat is, efficacy may refer to the “therapeutic efficacy” or to any of the “advantageous properties” exhibited by the new form of the known substance. Enhancement of efficacy may refer to improved or unexpected properties of known pharmaceutical substances such as increased bioavailability, lower neurotoxicity, or higher potency, which are not found in the original pharmaceutical substance. Enhanced efficacy may also be proven by factors such as fewer side-effects, wider spectrum of activity, reduction in treatment time, etc.
To show enhancement of the known efficacy, applicants are therefore required to demonstrate that the claimed new form of the known substance exhibits an “unexpected” or “improved” result that is not restricted solely in its therapeutic advantages. Necessarily, significant differences in efficacy between the new form or new property and the known substance or prior art have to be presented and substantiated, not necessarily in
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• Pain, fatigue and addiction: the relief of pain is regarded as therapeutic. Reducing fatigue is not comparable with the relief of pain, and could be considered as non-therapeutic. Methods to stop addiction or withdrawal symptoms are considered as therapeutic methods.
First medical use
First medical use may be claimed for a known substance the pharmacological properties of which are not disclosed in the prior art. In this case, the technical teaching would be the novel and inventive purpose of the known substance. Te concept of “first medical use” can be applied only to claims relating to known substances or compositions for use in therapy, surgery or diagnosis as referred to in Section 22.3 of the IP Code.
Second medical use
Within the context of the QUAMA provision, the concept of “second (further) medical use” can be applied only to claims relating to the subsequent use of known substances or compositions for the preparation of a medicament intended for therapy, surgery or diagnosis as referred to in Section 22.3 of the IP Code. Claims relating to the use of a substance for the manufacture of a medicament are permitted where the novelty is derived from the new pharmaceutical use, and not from the product.
World Intellectual Property Review Annual 2012 63
If an application includes “method of treatment” claims, these claims may be re-draſted into second medical use claim format (Swiss-type). Tis shall not constitute new matter and thus may be submitted any time during the examination stage. n
Editha R. Hechanova is the president and chief executive of Hechanova & Co, Inc. She can be contacted at:
editharh@hechanova.com.ph
Fe Belen Bello is a patent executive at Hechanova & Co, Inc. She can be contacted at
belen.bello@
hechanova.com.ph
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