Is the De Minimis Difference Principle Enough to Win a Case for Patent Infringement?


There is no explicit rule in Turkish Law governing the de minimis principle. There have also not been any settled precedents in the Turkish High Court to shed any direct light on this small but important legal principal.

However, there have been several infringement actions in the IP courts where the Patentee has alleged that a product differing from the Patent’s scope of protection with trifling, de minimis differences, may still infringe the Patent. The Turkish IP Court’s approach to such allegations has so far, not been promising for Patentees.

In one action, the pharmaceutical Patent claimed that a tablet which included an active agent of 30% to 80% of the total tablet weight. As a result of an inspection of the marketing authorisation dossiers it was determined that the product had an active ingredient of 28.18% of the total tablet weight. Although it was alleged that the de minimis difference should not be enough for the defendant to avoid infringement of the Patent when possible deviations such as the active ingredient and tablet weight are considered.

The Court resolved that, as the Patent did not protect the active agent itself but a formulation including 30-80% API of active ingredient, any formulation not having active ingredient within this range will be outside of the scope of the Patent.

On the other hand, the Court also considered a possible 5% deviation in the weight of the tablets and its effect on infringement claims. It concluded that the active ingredient percentage will not be affected as the deviation will occur in the total weight of the tablet, not in the amount of the active ingredient.

Similarly, in another infringement action, it was determined that the disputed product included 80,32% and 80.997% of the active ingredient as part of the total tablet weight, whereas the Patent protected tablets with an active ingredient of 30% to 80% of the total weight.

The Patentee claimed that the generic product was excluded from the scope of the Patent protection with a 0.3% deviation of the active ingredient which meant the product fell outside the scope of the Patent. However, as a result of an expert examination, the Court concluded that the percentage of the active ingredient would not be affected by a deviation in the total weight. In conclusion, a minor difference from the Patent’s scope of protection sufficed to exclude the generic product from any infringement.

Whilst the Court and the technical experts only considered the deviation in the total weight of the tablet which are compressed from a homogeneous powder mixture, the percentage of all ingredients will be the same no matter the weight of the tablet.

In this respect, the approach of the Turkish IP Courts to products that are slightly different from a Patent’s detailed scope is quite rigid and they are quite reluctant to consider prosecuting infringing products due to formula deviations. Unfortunately, this hinders a satisfactory de minimis evaluation in Turkish IP Law at present

 

Share