Intellectual property rights and patentability in medicine

Abstract

[한글]

[영문]

Although there has been many BT related researches and studies conducted, not much consideration was put on the intellectual property rights and patentability in medical industry. Nevertheless, the wide expansion and rapid advancement of medical

inventions and medical industry demand more through review for their intellectual property rights and patentability.

Therefore, this study will first examine the concept of intellectual property and the Korean patent system briefly. Then, the current situation of the medical patent in Korea is introduced and the discussion of the medical patent in the foreign countries will be followed. Finally, the main focus of this thesis, the patentability of medical inventions such as new medicament, medical instruments, medical use and medical treatment process inventions while considering the ethical matters and social consensus issues in the medical industry. Since the patentability of the new medicament and medical instruments is already fully discussed and established in the Korean patent system, this thesis would give just a brief discussion on these two subjects.

The main discussions are that since the patents for treatment process employs the human body as its subject, they lack the industrial applicability; that the exclusion of medical practice from patent subject for the public health is desirable in terms of national economy; and that if it were rational to exclude the

treatment process from the patent subjects, the issue would be how to enforce this rationally and co-purposefully.

More specifically, the provision in the Examination Guideline is unreasonable: that is, the exclusion of medical treatment due to its lack of industrial and the entry of medical use inventions as a type of material claims. There would be several alternative plans for this. First of all, the provision that ‘excludes the

patent for medical treatment process which does not include the treatment process by drugs due to the ethical reason’ should be stipulated on the Korea Patent Act.

Apart from this, another plan would be that the treatment process inventions should be allowed for the patent subject, but in the process of granting the patent, more thorough and specified principles or criteria should be applied: the principles on the Korea Patent Act such as novelty, non-obviousness, and industrial applicability as well as the ethical considerations or ethical principles as discussed in the previous chapter. In order to enforce this effectively, more rational and reasonable examination of claims would be possible in granting the patents for not only the medical industry but also other industries such as BT industry, which may need the ethical consideration as well, by establishing the ethics review committee under the Korea Intellectual Property Office. In addition, the appropriate

protection for the true nature of inventions should be given by allowing expressing the medical use inventions as a type of process claims, not material claims.

However, the most important thing to consider in applying or introducing this is not the government-driven policy establishment but the social consensus because the ethical consideration is necessary in grating the patents in medical industry for its unique characteristics unlike the patent in other areas or fields. In order to accomplish both public interest or goods and industrial development harmoniously, the attitude to consider more carefully is strongly required.