CASRIP Newsletter - Fall 1996, Volume 3, Issue 3
Current Developments: Japan
JPO's Proposal for Revised Examination Guidelines
Last August, the Japanese Patent Office (JPO) announced their plan to revise their examination guidelines (Examination Guidelines for Patent and Utility Model in Japan: English Translation available from AIPPI Japan, FAX: 03-3591-1510), and sought comments from the public (the deadline for submitting comments was mid-October). After reviewing the public comments, the JPO plans to adopt the proposal early next year. Once adopted, the JPO will apply the guidelines retroactively to all applications filed on or after July 1, 1995.
The current guidelines were subjected to a major revision in 1993, giving detailed examples of computer program-related inventions with respect to their patentability. Another revision was made in 1994 to clarify issues regarding the sufficient descript ion requirement, comparable to the enablement requirement which is applied to biotechnology inventions. The main goal of the proposed revisions is to catch up with extensive case law developments on the patentability of inventions in these fast moving te chnology fields in Japan and other jurisdictions, particularly in the United States. The proposed revisions concern three chapters of the current guidelines: the definitions of invention and industrial applicability (Japanese Patent Law, Article 29, Paragraph 1); special issues involved with examining computer softw are-related inventions; and special issues involved with examining biotechnology inventions. One major change in the proposed guidelines is to make claims directed at a computer-readable storage medium recording a program patentable. It follows that although the listing of computer programs as such, being a non-statutory invention remained the same, computer programs stored in an IC memory or disk are patentable as long as the process conducted by the program me ets the statutory invention requirement (i.e. a creation of technical idea utilizing laws of nature). In other words, the main purpose of excluding computer programs is to make sure that the laws of nature, mathematical formulas as such, or presentations of information, are excluded from patentability. This change perfectly follows the case law development after In re Alappat in the U.S. Court of Appeals for the Federal Circuit. It also conforms with the guidelines published by the U.S. Patent and Trad emark Office.
For example, the proposal gives an illustration of a third category storage medium claim:
A storage medium containing thereon a computer program for controlling rate of fuel injection for an automobile engine, said computer program is:
a) causing a computer operation to calculate the rate of engine revolutions;
b) causing a computer operation to calculate transition of the rate of engine revolutions; and
c) causing a computer operation to determine the rate of fuel injection in accordance with the rate of engine revolutions and transitions of the rate of engine revolutions.
The proposal concludes that the claim is a statutory invention because: 1) the claim falls within the third category; 2) the subject matter, considered as a whole, is not simply directed at the presentation of information; and 3) step c) corresponds to t he means in the apparatus claim which solves the problem utilizing natural laws.
Another major change is to expand the section dealing with biological inventions by adding more claim examples and clarifying that genes can be defined in terms of functions, physiochemical properties or other characteristics which can distinguish them f rom prior art. Considering the increased significance of genetic engineering, the new guidelines list the section for inventions relating to generic engineering first (the current guidelines begin with the section for micro-organisms and have the section for bioengineering inventions last). Furthermore, the revised guidelines list their preference with respect to how the subject matter is to be defined in claims using examples. For example, a gene may be described by specifying: 1) its base sequence; 2 ) an amino acid sequence of the protein encoded by the gene; 3) a combination of the terms "substitution, deletion or addition" or "hybridize" and functions of the gene, and if necessary, origin or source of the gene in a generic form; or 4) functions, ph ysiochemical properties, origin or source of the gene, or a process for producing the gene. In addition to the categories of subject matter listed in the current guidelines, i.e. genes, vectors, recombinant vectors, transformants, an d fused cells, the proposed guidelines include recombinant protein and monoclonal antibodies.
With respect to the enablement requirement, the proposed guidelines adopt the undue experimentation approach to prevent applicants from claiming an extremely broad scope with few examples disclosed in the specification. In other words, although a gene c an be defined in terms of its function, a claim may be rejected for lack of enablement if the claim scope is too broad compared to the disclosure in the specification. This practice closely parallels the restrictive attitude toward enablement dealing wit h biotechnology inventions held by both the European Patent Office, which attempts to limit the scope of claims issued, and by the U.S. Federal Circuit.
In short, the proposed guidelines indicate the JPO's effort to ensure that their examination standard is harmonized with those used by U.S. PTO and EPO. This definitely makes it easier for U.S. and European applicants to obtain Japanese patents beca use claims and specifications originally filed their national patent offices can be used without extensive change to meet Japanese patentablity requirements.
Case Law Development Generic Manufacturer's Experiments for NIH Approval Infringes Original Manufacturer's Patent Rights March 6 Judgment of Nagoya Dist. Ct.
In Japan, original and general drug manufacturers' debates recently heated up on the issue of whether general drug manufacturers may begin experimentation on drugs which are covered by patents held by original drug manufactures to obtain NIH approval prior to expiration of the patent term. In the United States, the Drug Price Competition and Patent Term Restoration Act (also known as the Hatch-Waxman Act) enables general manufactures to begin experimentation for FDA approval before the expiration of patents during the patent extension period. Patent extensions were permitted only for drugs which were subjected to regulatory review by a federal authority prior to the drug's commercial marketing use. Also, the drug's commercial marketing or use afte r the regulatory review period was the first marketing or use governed by the law under which the regulatory review occurred. When the law was revised to introduce the patent term extension provision, pharmaceutical lobbyists and co nsumer groups fought over two competing goals: restoration of portions of the patent term lost in the premarket regulatory review on one side, and the quick entry of general drug manufacturers into the market to reduce price on the other. Their compromi ze was codified in 35 U.S.C. Section 271 (e). It exempts activities reasonably connected to the development and submission of information under a federal law which regulates the manufacture, use or sale of drugs or veterinary biological products from pat ent infringement.
In Germany, the same debate was settled when the Supreme Court properly interpreted German Patent Act Section 11(2), introduced in 1981 based on a provision of the Community Patent Convention, to provide for an experimental use exception, and set asi de the restrictive approach adopted by old case law. The new definition for the exception of all experimental uses directed to gain knowledge includes activities to gain data for regulatory approval. Thus, regardless of the patent t erm being the extended period or not, activities for obtaining data for regulatory approval are exempted from patent infringement.
When Japanese Patent Law adopted the patent extension provision and harmonized itself with U.S. patent law, no discussion was made with respect to the general drug manufacturer's right to engage in activities to obtain NIH approval. Current case law adopts a restrictive approach closely parallelling old German case law indicating that such activities constitute infringement, rather than falling within the experimental use exception provided in Japanese Patent Law, Article 69. N agoya District Court followed the current case law and found experimentation to obtain data to submit a NIH approval infringes on a patentee's patent. It reasoned that the activities to obtain data for regulatory approval are working the patented invention which does not fall within the meaning of the experimental use exception for the purposes of experiment and research. Accordingly, the court granted a preliminary injunction to stop the defendant's activities.
While the defendant did not appeal because the disputed patent expired soon after the judgment, the issue is far from settled. Many cases filed by original manufacturers against general manufactures are now pending in Japanese courts. It is rumored that the Ministry of Health will soon intervene into this problem. Since the prevention of experiments to submit an approval substantially gives twelve to eighteen months extra time beyond the extended patent term to enable original makers to exclusivel y market their products, this creates a problem of over-protection. As history in the United States and Germany indicate, government initiative through legislation may be necessary to resolve this conflict between original and general manufacturers.
- Toshiko Takenaka
 Japanese Patent Office, Implementation Guidelines for Examination of Industrially Applicable Inventions (Draft) (1996).
 Japanese Patent Office, Implementation Guidelines for Inventions in Specific Field (Draft), Chapter 1. Computer Software Related Inventions (1996).
 Japanese Patent Office, Implementation Guidelines for Inventions in Specific Field (Draft), Chapter 2 Biological Inventions (1996).
 Supra note 2, Implementation Guidelines, 13.
 Supra note 3, Implementation Guidelines, 2.
 35 U.S.C. Section 156.
 This case was discussed by Michael Kern, Current Development: Europe/Germany, 3 CASRIP Newsletter 8 (1996).
 Judgment of Tokyo Dist. Ct. July 10, 1987, Hanrei Jiho (No. 1246) 128. (finding that the defendant's activities to submit an agent for registration necessary to market the product does not fall within the terms "activities for experim entation and research" because the activities did not aim to further develop the technology).
 Judgment of Nagova Dist. Ct. March 6, 1996 (Unpublished Opinion). A summary is reported in Chiteki Zaisanken Hanketsu Sokuho, (May 20, 1996)