- Miyako Okada-Takagi, Ph.D.
Toyoko Gakuen Women's College,
8-9-18, Todoroki, Setagaya-ku, Tokyo 158, JAPAN
(Email: miyakot@kt.rim.or.jp)

The ability to secure property interests in technological processes, products and know-how encourages development of technology. One factor to evaluate competitiveness in biotechnology is intellectual property law. The laws relating to the protection of biotechnological inventions and related know-how were compared and contrasted in Japan and the United States.

1. Introduction

Biotechnology gives rise to a vast array of new inventions, which can be placed into two categories: products and processes. Products include organisms, and their products, such as drugs, chemicals, monoclonal antibodies. Processes include various ways to make new organisms or to use an organism to make some product.

Biotechnology, as defined in this report, focuses on the industrial use of recombinant DNA, cell fusion, and novel bioprocessing techniques. These techniques will find applications across many industrial sectors including pharmaceuticals, agriculture, specialty chemicals and food additives, environmental applications, commodity chemicals and energy production and bioelectronics. Competitive advantage in areas related to biotechnology depends as much on developments in bioprocess engineering as on innovations in genetics, immunology, and other areas of basic science.

I will look at Japanese biotechnological conditions in companies. Some Japanese companies are very interested in the development of amino acids and high-value compounds by selecting and engineering plant cells to produce secondary metabolites in vat culture. The specialty chemicals industry promises to be a particularly competitive industry as biotechnology develops, because large chemical companies from Japan as well as the United States are hoping to switch from the stagnant commodity chemicals industry into the more profitable specialty chemical industry. Therefore the general chemical and petrochemical firms of Japan are leaning strongly to biotechnology, and some of them are making rapid advances in R&D through their efforts to make biotechnology a key technology for the future.

Japanese companies are expected to be strong competitors in the world because Japanese bioprocess-based companies are known to possess highly developed enzyme technology, a prerequisite for efficient biological production; and some are currently the world's major producers of amino acids. These companies have operating production plants in the USA, and they have strong biotechnology R&D programs in Japan.

The commercialization of biotechnology will require many small, incremental improvements in bioprocess technology, superb quality control, and mass production to progress along the learning curve. As biotechnology development reaches large-scale production stages, well-developed bio-processing skills will be necessary to compete in world product markets. Nowhere is the art of bioprocessing better refined than in Japan. Certainly Japan's expertise in this area will provide competitive strength in many future biotechnology product markets.

There are changes in laws and policies that could improve the US competitive position. These changes include clarification and modification of particular aspects of intellectual property law. The ability to secure a property interest in an invention and to protect related know-how is perceived as providing an extremely important incentive for a private company to spend time and money to carry out research for the commercialization of new processes and products. Without the ability to prevent other companies from taking the results of this effort, many new projects would not be undertaken. The intellectual law most relevant to biotechnology are those dealing with patents.

A US patent gives the inventor the right to exclude all others from making, using, or selling the invention within the United States without the inventor's consent for 17 years. In return, the inventor must make full public disclosure of the invention. The policy behind US patent law is twofold. First, by rewarding successful efforts, a patent provides inventors and their backers with an incentive to spend time and money in R&D. Second, the patent system encourages public disclosure of technical information, which may otherwise have remained secret, so that others are able to use it. The criteria for obtaining and enforcing patents on biotechnological inventions are quite similar in Japan and the US.

2. Patentable subject matter

One of the major patent law questions arising with respect to biotechnology is whether living organisms are patentable subject matter. The inventor of a new microorganism could not be denied a patent solely because the invention was alive. The US Supreme Court ruled to distinguish between unpatentable and patentable subject matter on the basis of "products of nature, whether living or not, and human-made invention" (Diamond v. Chakrabarty, 447 U.S. 310, 1980).

There us some uncertainty in the classification of certain types of biological inventions, for example certain lower organisms could to be classified as plants, animals, or something else. However, virtually any other biotechnological invention would be patentable subject matter. Such inventions would include processes using micro-organisms, recombinant DNA (rDNA) molecules, subcellular units such as plasmids, methods for making these inventions, and biotechnological methods for treating human or animal disease. The US definition of patentable subject matter is very broad, and it seems to be a matter of choosing between multiple options for protecting subject matter by either utility patents or a plant patent.

The Japanese definition of patentable subject matter is essentially coextensive with the definition of the European Patent Convention, excluding processes in the fields of medicine, diagnosis, therapy, and pharmacology in which the human body is an indispensable element. Also certain microbiological inventions could be excluded from patentability in Japan if they are "likely to injure the public health."

In the USA the trade secret route can still be selected in the event that no patent protection is secured, however, in Japan, pending applications are published before it is known whether patenting will be possible, thereby, providing complete and enabling disclosure to the public. Such publication usually occurs 18 months after the application is filed. This situation precludes reliance on trade secrecy once a patent application is filed, which is a considerable disincentive to seek patent protection for certain types of biological inventions, particularly those involving basic genetic procedures and the resulting products.

3. Novelty

The crucial element of patentability for most biological inventions is whether the fact that the substance was in some way changed from the naturally occurring substance by human invention. For example, although genes and regulatory sequences may be obtained from natural sources, it is the removal of the DNA sequences from their natural habitat and their joining to other DNA sequences that provides the human-made requirement.

As to the second question, it should be noted that U.S. and Japanese laws, in contrast to the laws of most European countries, provide a grace period between the date of any publication by the inventor relating to the invention and the filing of a patent application. This grace period is generally viewed as favorable to the rapid dissemination of new scientific knowledge, because knowledge pertaining to an invention can be published without filing for a patent. The grace period is 1 year in the U.S. and 6 months in Japan. Most European countries require the patent application to have been filed before the invention is disclosed. This requirement is known as "absolute novelty", discussed below.

Consider the following types of possible disclosure by an inventor: 1. Delivering a paper at a conference orally only; 2. Delivering a paper at a conference, both orally and with a disseminated written text; 3. Submitting a paper for publication; 4. Delivering an abstract prior to a conference to the conference promoting organization.

Discussing with colleagues by telephone, letter or in person would not bar patentability all over the world. Cases 3 and 4 would normally not bar a patent because the disclosure were limited to the members contacted, not disseminated to members of the public (e.g., conference attendees) prior to the actual date the patent application was filed. Under the US law, items 1,3,4 would not bar patentability. Item 2 will become a statutory bar 1 year after the paper is disseminated in some tangible form, assuming the disclosure was enabling. Under the Japanese law, items 3 and 4 would not bar patentability, and items 1 and 2 would bar patentability after 6 months. Under the European law, items 1 and 2 would prevent the granting of a patent if they occurred before the earliest effective filing date (e.g., before a US or a Japanese applicant filed a patent application in their countries ).

Because of the different approaches with respect to novelty, the US patent law provides a competitive advantage in that scientific information can be quickly disseminated in the US without forgoing patent rights, within a year. This advantage is qualified if the inventor also wishes to file abroad in which case they cannot publicly disclose the invention until the priority application is filed. The case of Cohen-Boyar patent on rDNA techniques is a well-known example of a case in which the inventors were able to obtain a US patent, even though they had published papers about the techniques, but were unable to file for a European patent because of the absolute novelty requirement in Europe. I believe a grace period should be in effect everywhere.

The US and Japanese laws require the patent application to be filed by the inventor. If two different applicants happen to have the same invention, the patent will be issued to the one who invented it first. Hence, this system is called a "first-to-invent" system. The European law, in contrast to US and Japanese laws, permits someone other than the inventor (e.g., the employer) to file the patent application. If there are two applications for the same invention, the patent will be issued to the applicant who filed first. European countries thus have what is called a "first-to-file" system.

4. Utility

The Japanese system excludes method inventions in the field of therapeutic or diagnostic treatment of humans, as not being part of "industry". Thus certain types of biological inventions will not be patentable in Japan, although patent protection can be obtained for them in the US. However, patent protection is not precluded for the materials that are used in the excluded methods or the products of those methods.

Japan appears to be moving in the direction of providing significant patent protection for biotechnology products and processes. However one possible obstacle is that Japan has strict health and safety guidelines regarding genetic research, which may bar patenting of genetically manipulated organisms viewed as hazardous.

5. Enforcement

Patent infringement is defined as the unauthorized making, using, or selling of any patented invention within the country. No liability for infringement exists prior to the date the patent is issued. Enforcement of patents claiming biological inventions involves unique problems, for example:

A very serious problem for processes is knowing whether an infringer is using the patent. If an nonpatented product can be made by many different processes, the owner of a patent on one of those processes may have no way of knowing whether a product made by a competitor has been made by a different process or not.

Strains of micro-organisms can be altered through mutation and other modification techniques to produce different organisms that possess the same basic characteristics to the protected organism. For this reason, processes using such organisms are likely to be held as trade secrets unless the process is truly a major advance.

The patented process may be used in other countries to make the same products, which can then be imported into the US and compete with the product made by the owner of the US process patent. Although Japan would define this action as infringement of that process patent, the US does not. If the owner of the patent can prove that the foreign activity infringes the US process patent and that importation of the product would injure an efficiently conducted US industry, the product can be excluded from the US. This point is the major difference between these two countries in the patent infringement. That is, the U.S. does not grant extraterritorial effect to process patents. Otherwise the US and Japan define patent infringement in similar ways.

Proving the identity of the patented micro-organism can also be difficult problem for the present state of this technology. The technology is still sufficiently undeveloped that much room exists for honest differences of opinion among experts. Most questions of infringement will probably turn out to be a battle between the respective parties' expert witnesses, until more objective criteria are established.

References

Aizawa, H. Biotechnology And Patent Law, Kobundo Press (1994).
Bent, SA et al. Intellectual Property Rights, In Biotechnology Worldwide, Stockton Press (1987).
OTA, New Developments In Biotechnology: Patenting Life. US Congress OTA (1988).
President's Council. On Competitiveness - Report On National Biotechnology Policy. Memorandum For The President (1991)