A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Friday, 3 October 2008

Proposals for reform in Japan: Samurai writes

The SPC Blog has a friend in Japan who goes by the name Samurai. Writing on the extension of the patent term in Japan and proposals for change, Samurai has this to say:

"The Patent Term Extension (PTE) regime of Japan may be changed drastically according to the IP Strategic Program (IPSP) 2008 (click here for the original Japanese PDF), composed by the Intellectual Property Strategy Headquarters which is chaired by the Prime Minister of Japan.It contains some interesting proposals.

However, before going further, I would like to begin with explaining the current regime, for the convenience of those who are not familiar with Japan's unique PTE system.The guidance for PTE examination will be found here (pdf) and it basically says that the Japanese Patent Office (JPO) will examine the extension application based on whether 'product' or 'use' in the approval is the first or not. This could mean that you can file multiple extension applications whenever you get an additional Marketing Approval (MA) for the same ingredient for the different 'use' (i.e. an additional indication). Moreover, you could extend plural patents based on a single MA due to lack of such limitation in the legislation. As a result, we are enjoying tremendously generous PTEs. These are the basics of Japan's PTE.

Some entities were not satisfied by this and made a greedy attempt to accomplish the extension for the formulation-altered version of the existing drugs. They were Senju (original; English summary), Roche (original; English summary) and Takeda (original; no English summary) and they all lost their actions before the IP High Court. It has therefore been established case law that the formulation patent is not eligible for the extension. Now they seem to be changing their tactics and have utilized the Cabinet instead of courts. Below is a tentative translation of the excerpt from the IPSP 2008 mentioned above (on page 33 of the Japanese text).

Chapter 2: Protection of IPR

I. Adequate protection of intellectual property

1. Ensuring that the new technologies will be properly protected and supporting the creation of new markets

(2) Fundamental review of the Patent Term Extension system

The additional subjects, such as the allowance process in the Cartagena Protocol on Biosafety or the approval process of using biomaterials derived from iPS cells as well as the innovative drugs which differ in terms of revolutionary formulation technologies including DDS will be investigated. In addition, the comprehensive review of the requirements of the extension, the eligible numbers and frequency of patents and the scope of rights of the extended patent, including way for the overall system, also based on international trends, will be conducted. The study, to begin immediately, and reach its conclusion in fiscal 2008. (Ministry of Economy, Trade and Industry, the concerned agencies).

As you can see, it says that they may consider adding the formulation patent as eligible subject matter -- but it also states they may ban Japan's unique multiple extensions (see the phrase 'international trends') at the same time. Of course, the extension of the formulation patent would not be in line with 'international trends'.

As a concerned person, I'm closely of watching the course of action. As is stated in the IPSP, the review has just been started and the reform plan has not yet been finalized. Since the deadline set by IPSP is March 2009, the public comment procedure which will disclose the details of the reform might be expected some time in the beginning of 2009 or earlier. I will keep you updated whenever the status changes".

The SPC Blog thanks Samurai for his contribution and looks forward to hearing of future developments. The blog will also be pleased to receive comments from readers, since some of the points made by Samurai are quite contentious.

1 comment:

Anonymous said...

I would have thought formulation patents can be used to get EU SPCs. The claims of this patents relate to an "application" of the active ingredient in the sense of Article 1(c). Does anyone disagree?