DNJ: Zydus Pharmaceuticals's ANDA to sell a version of Prevacid does not infringe on Takeda’s patents

No infringement of Takeda patent

There had been an issue about the claim element: “fine granules having an average particle diameter of 400 microns or less.”

Foley had discussed the CAFC decision:


The Federal Circuit first noted that “the claim language [at issue] is not qualified by the word ‘about’ or any other indicator of imprecision,” even though the hardness strength is recited as “about 1 to about 20 kg.”

Turning to the specification, the Federal Circuit noted:

The specification explains that conventional granules of that size “produce a feeling of roughness in the mouth”—one of the very problems the claimed invention purports to solve. …. That clear dividing line between the “fine” granules of 400 μm or less (which avoid a feeling of roughness in the mouth) and “conventional” granules of 400 μm or more (which do not) disappears if the “fine granules” are construed as incorporating a 10% deviation. Thus, there can be little doubt that the narrower construction “most naturally aligns with the patent’s description of the invention.”

Takeda pointed to passages in the specification that refer to a particle size of “about 400 μm or less,” but the Federal Circuit found that those same passages indicate that a smaller particle size is desired.

In the present invention, “fine granules having an average particle diameter of 400 μm or less … have an average particle diameter of about 400 μm or less, in order that roughness is not felt in the mouth. Preferably, the average particle diameter of the fine granules is 300 to 400 μm.

[T]he average particle a [sic] diameter of the included granules must be about 400 μm or less, preferably about 350 μm.

The “fine granules” have an average particle diameter of about 400 μm or less, preferably 350 μm or less. Preferably; the average particle diameter of the fine granules is 300 to 400 μm.

Overall, the Federal Circuit found that “[n]owhere does the specification suggest that an average particle size greater than 400 μm (even within 10% of that figure) could achieve the inventive result of avoiding a feeling of roughness in the mouth.”