Therapeutic methods are un-patentable in most countries of the world, however in some; these methods can be protected through a special drafting called “second medical use format or Swiss style”.
Such drafting however, is not always accepted when it is mentioned dosage regimens, which are interpreted as un-patentable therapeutic treatment characteristics.
The Law of Industrial Property in Mexico, considers that therapeutic methods are not inventions; therefore protection to the same through a patent cannot be given.
Although it is not explicitly stated by the Law, in practice claims drafted into second medical use format are accepted and protected.
Nonetheless, the second medical use drafting can also be objected when a dosage regimen is defined therein.
A dosage regimen is understood as the administration design of a drug, considering its formulation, route of administration, dosing interval and duration of treatment.
Also, said dosage regimen is modified taking other variables such as patient age and health status, among others.
Consider the following example of second-medical-use drafting:
“The use of a compound X for the manufacture of a medicament for the treatment of a disease Y in a patient in need thereof, wherein the medicament is administrable every 24 hours”.
Usually, the previous wording would be accepted without problems till the words “in need thereof”, however the phrase “every 24 hours” is a regular schedule indicating every when the medication or drug should be administered.
Patent examiners reject said schedule by considering it a therapeutic method feature, which is not protectable under the patent law framework.
Thus, the wording of the second medical use claims should be carefully reviewed and dosage regimen expressions that would be inevitably objected in the technical examination should be deleted.
It can be cited as examples of dosage regimen expressions: every 8 hours, before bedtime, before meals, and in general all those indicating at what specific intervals drugs or medications should be administered.
For all the above, it is important that patent attorneys advise their clients that dosage regimen expressions are not considered second medical use technical characteristics by the examiners, on the contrary, they fall within the patentability exceptions; and therefore they advice the removal of such expressions by means of which the issuance of objections shall be avoided during the technical examination.