In the wake of a series of cyber attacks against defense contractors, the Cabinet's National Information Security Center published a draft countermeasure. Government contracts will include requirements of confidentiality, organizational response, and the government's information security audit. It also defines national security as "a state where the territory, the people and the governing institutions remain unharmed, peaceful and unperturbed", explicitly targeting domestic, as well as international, concerns.

The Japanese Supreme Court upheld a lower court's decision not to cover "mixed care" under the national health insurance. The patient, however, was able to receive the unapproved care in a separate institution without jeopardizing his covered care. In essence, the Court decision prevents NPI institutions from offering uncovered care. It is not entirely unreasonable.

A subcommittee of MHLW's Health and Science Councils is discussing the legal status of package inserts. Currently they are considered reference material of an approval application and the responsibility remained unclear. Once it is given defined legal status, however, the government will face a greater degree of liability under the product liability legislation.

The district court decision on the Iressa litigation did not find the government liable for the patients' deaths and damages, while holding AstraZeneca liable. This could boost the latest government policy to push for expedited approval without clinical trials, as the manufacturers could face a difficult tradeoff.

A MIC study group published a final report on spectrum auction. The next generation mobile service will be subject to a new spectrum auction process, while resale of auction rights will be prohibited.

MIC is seeking public comments on the revised guidelines on promotional emails. The problem is, as discussed in the working group on this matter, spammers simply ignore laws or guidelines, which are becoming increasingly detailed.

MIC's "Telecommunications Business Dispute Settlement Commission" appears asleep these days. There have only been a formal case of recommendation or two past few years. Others are informal "consultations" at the working level, not much different from the old MPT days.

The Supreme Court struck down the previous JPO practice of not granting extension of a process patent when there is a pre-existing product with the same API and indications. Needless to say, existence of a pioneer product does not allow distribution of a follow-on product and the ruling is only reasonable. The previous JPO practice only benefits the bureaucracy who did not have to consider substantive issues.

Kitamura is "honorably mentioned" (i.e. without payment) as expert in regulatory matters and compliance by an Asian in-house counsel magazine.