Grand Panel Decision regarding standing to sue and inventive step of pharmaceutical invention

Japan Patent Information Committee
SUEYOSHI, Tsuyoshi

– Nippon Chemiphar and X v. Shionogi and AstraZeneca UK Limited, Judgement of IP High Court, Grand Panel, April 13, 2018, Cases 2016 (Gyo-Ke) 10182 and 10184 –

1  Background

This case is the appeal against the JPO’s Invalidation Trial No. 2015-80095 in connection with JP Pat. No. 2,648,897 (the “ ’897 Patent”). The ’897 Patent covers new compounds covering the active ingredient of Crestor®, one of the most popular drugs for treatment of hyperlipimedia.  Shionogi was the patentee. AstraZeneca UK Limited (“AstraZeneca”) was the registered exclusive licenses.

X initiated the Invalidation Trial against the ’897 Patent on March 31, 2015, the last date of the period in which the Japanese Patent Act prior to the amendment of 2014 was effective (the “Patent Act prior to the 2014 amendment”). Under the Patent Act prior to the 2014 amendment, any party could initiate an invalidation action (Note: On and after April 1, 2015, a party can initiate an invalidation trial against the patent only when he/she has interest in a patent.

In the course of the invalidation trial, Nippon Chemiphar intervened on the X’s side, and Astra Zeneca intervened on the Shionogi’s side. The JPO dismissed the request of X and maintained the ’897 Patent.  Each of Nippon Chemiphar and X filed an appeal with the IP High Court.

In the proceeding in the IP High Court, the ’897 Patent expired. However, Nippon Chemiphar and X pursued the court proceeding.

The original panel merged the two cases, and transferred to the Grand Panel.

This case is the 12^th case of the Grand Panel since establishment of the IP High Court and start of the Grand Panel system.  The Grand Panel system was introduced for the purpose of showing a reliable rule and a unified judgment in the high court level, because IP disputes can cause impact on business activities and industrial economy.

2  Issues

This case has the following two issues:
(i) standing to sue in the IP High Court stage after expiration of the patent;
(ii) finding of an invention in a prior art document when only a general formula of compounds is disclosed with a huge number of options (subordinated concepts; specific compounds in this case) without indication for a specific option(s).

3  Judgment

3.1  Standing to sue

The IP High Court affirmed the standing to sue of Nippon Chemiphar and X.

The IP High Court judged that the standing to sue in an appeal against a JPO’s decision is not lost even after expiration of a patent, except for under special circumstances where risks of claim of damages and unjustified enrichment as well as criminal penalty are completely extinguished.

In obiter dicta, the IP High Court judged that the reasoning above can be applied to cases under Patent Act with 2014 amendment, under which a party can initiate an invalidation trial only when he/she has interest in the patent.

3.2  Finding of a prior art invention having a huge number of options

The IP High Court judged that a specific option cannot be found as prior art invention under the circumstances of this case.

The reasoning of the IP High Court is as follows.
– An invention in a prior art document should be a specific technical idea which can be derived from the document.
– When compounds are described as a general formula with a huge number of options in a prior art document, a technical idea of a specific option (compound) cannot be derived from the document, except for under the special circumstances where a specific option should be selected with priority.

4  Takeaways

This judgement became final and binding.

The issue of the standing to sue after expiration of a patent has been rarely discussed in the court cases. This judgement settled this issue.  Under this judgment, the standing to sue will be hardly denied; a potential infringer can pursue an appeal in the IP High Court without his/her specific embodiments.

The finding manner of a prior art invention disclosed as a general formula fits with the traditional and current practice in the chemical field. This judgement can also support the concept of selection invention.  In addition, the reasoning of this judgment can cause impact on amendment from an upper concept to a subordinated concept among a large number of options, although this judgment is related to the inventive steps.

In the general reasoning of the inventive steps, the judgment reaffirms the traditional “weight-together” approach (under which many factors are weighted together) in assessment of inventive steps, rather than problem-solution like approach in which a problem, which precisely reflects a difference between a claimed invention and a closest prior art, is emphasized.   This may cause theoretical discussion in the framework of the inventive steps.