NEW USE PATENTS RUN RISK OF OPPOSITION
“New or subsequent use of a known product” is amongst the subject matters specifically excluded from the scope of patentable inventions in Pakistan [Sec. 7(4)(d) of the 2000 Ordinance]. Yet regardless of the said legal position prevailing since the 2000 Ordinance went into effect; the fact that mere changing the category of claim to give a specifically excluded subject matter an inventive gloss is not sufficient to evade the prohibition, as well as the well-recognized rule of claims interpretation that ‘a valid claim cannot read on a prior art product’, the Pakistan Patent Office (PK-PO) initially owing to their usual reluctance to accept the new legislative changes and later as a matter of practice developed gradually had consistently allowed patents covering new uses upon changing the semantic form of claims, for instance by dressing Swiss-style use claim format” “Use of compound ‘X’ (known) for the manufacture of a medicament ‘M’ (known) for the treatment of a disease ‘Y’ (new purpose)” to product claim of the format: “A pharmaceutical composition ‘P’ (known) comprising a compound ‘X’ (known) in association with a pharmaceutically acceptable carrier in known ratio (active: inactive) for the treatment of a disease ‘Y’ (new use)”.
This practice of the PK-PO was superficially attractive but it being exceeding the boundaries of statutorily patentable subject matters was not immune from criticism. Consequently, an increasing number of pre-grant opposition by the generic drug manufacturers against patent applications covering ‘new uses’ has forced PK-PO to go over their practices. Per contra their past practices, PK-PO is now taking strong stance against patent applications directly or indirectly related to ‘new uses’ independent of the field of use (that is, medical or non-medical). Until recently a leading French pharmaceutical company as part of their Life Cycle Management (LCM) strategy has attempted to secure still more patents for the selective specific uses of their known drug “X” for the treatment of periventicular leukomlacia; major depressive disorders; sleep disorders in depressed patients etc. which the PK-PO straight away refused to grant. Earlier the company had secured patents covering uses of the same drug for the treatment of – i) generalized anxiety disorder; ii) bipolar disorders.
The recent transition in the PK-PO practice is admittedly a step towards right yet it may be puzzling for the patent owners’ because this carries with it a charge sufficient to expose earlier granted patens to the risk of belated opposition.
Although Pakistan is now at odds with number of countries such as USPTO, EPO, UKIPO and JPO where new uses are patentable but to do so without a legislated override is even too odd. Until the 2000 Ordinance is amended to give protection to the ‘new uses’, the applicant and/or inventors must look into other ways available for reasonable protection such as new dosage forms; fixed dose composition etc. with enhanced pharmacological effect or superior activity, for example, rather than entering the patent stream through red channels.