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IP High Court Case Summary:2015 (Ne) 10080:

Doctrine of equivalents was not applied by the first and fifth requirements in the case of chemical substance.

February 24, 2016, the Intellectual Property High Court (IP High Court) denied applying doctrine of equivalents in this case of chemical substance (Crystal). Then, District Court decision was affirmed (no infringement).

<Invention>

The title of the invention at issue is “Crystal of Pitavastatin Calcium Salt”. Claim-1 is “Crystal of a compound of the formula ( 1 ) :

which contains from 7 to 13% of water and which shows, in its X-ray powder diffraction as measured by using CuK a-radiation, peaks at diffraction angle (2θ) of 4.96°, 6.72°, 9.08°, 10.40°, 10.88°, 13.20°, 13.60°, 13.96°, 18.32°, 20.68°,21.52°,23.64°,24.12° and 27.00°, and a peak having a relative intensity of more than 25% (as 100% at a diffraction angle (2θ) of 20.68°) at a diffraction angle (2θ) of 30.16°, excepting for the crystals having melting point of 95 °C by the differential scanning calorimetry.”

Defendant was manufacturing the medicine which has “Crystal of Pitavastatin Calcium Salt”. However, the diffraction angles (2θ) are different from the claimed crystal at 14 peaks out of 15 peaks. The plaintiff (patentee) sued the defendant for a patent infringement.

<Tokyo District Court Decision> 2014 (Wa) 5187

District Court decided that the defendant’s medicine does not belong to the claim because the defendant’s diffraction angles (2θ) are different from the claimed crystal by 14 peaks out of 15 peaks. (No literal infringement)

<IP High Court Decision> 2015 (Ne) 10080

IP High Court considered applying the doctrine of equivalents to this case. There are five requirements for the doctrine for equivalents, and all the five requirements must be satisfied for applying the doctrine of equivalents.

As for the first requirement, IP High Court discussed if the diffraction angle (2θ) is non-essential part or not. Then, IP High Court decided that it is not non-essential part because the diffraction angle (2θ) at peak is an important element to differentiate the claimed crystal from the other crystals. Therefore, the first requirement is not satisfied.

As for the fifth requirement, IP High Court discussed if patentee intentionally excluded the different diffraction angles (2θ) from the claim during the filing procedures. Then, IP High Court decided that patentee intentionally excluded the different diffraction angles (2θ) from the claim because diffraction angles were added to the claim by the amendment against the examiner’s reason for refusal. Therefore, the fifth requirement is not satisfied.

Accordingly, IP High Court denied applying the doctrine of equivalents to this case. Then, IP High Court decided there is no infringement.

<Comments>

This precedent is important because the doctrine of equivalent is discussed between the different crystals in terms of the diffraction angles (2θ) at peak.

Moreover, This precedent suggests that the diffraction angle (2θ) at peak can be an essential part of the invention, which can be one of the counterargument against the infringement based on the doctrine of equivalent.

http://www.ip.courts.go.jp/app/files/hanrei_jp/690/085690_hanrei.pdf