의약품발명의 진보성 요건에 대한 기능적 고찰

• 영문명: THE NATURE OF CHEMICAL NON-OBVIOUSNESS: FUNCTIONAL APPROACHIN PHARMACEUTICAL CONTEXT
• 발행기관: 한국정보법학회
• 저자명: 조성훈(Cho, Sunghun)
• 간행물 정보: 『정보법학』제16권 제3호, 383~425쪽, 전체 43쪽
• 주제분류: 법학 > 민법
• 파일형태: PDF
• 발행일자: 2012.12.31

국문 초록

제약 산업은 그 혁신 및 개발 과정에 있어 특허법에 의한 보호가 불가결한 분야로 인식되고 있다. 그러나 과연 특허이론 및 실무가 산업 발전에 적합한 유인체계를 제공하고 있는지 여부에 대하여 의문이 제기되고 있는바, 본 논문에서는, 의약품 발명의 특허요건 판단에 있어 가장 중요한 의미를 가지는 진보성 요건을 중심으로 기존 이론및 실무의 적정성을 검토하였다. (1) 임상실험절차 등 제약 산업에 특유한 규제비용과 (2) 과학발전에 따라 급격한 변화를 겪고 있는 제약 산업의 혁신 과정을 고려해 볼 때, ‘구조적 유사성’과 ‘기대되지 않은 효과’를 기본으로 하는 화학발명 특유의 진보성 판단 구조는 제약 산업의 혁신 과정에 적합한 유인체계를 제공하지 못한다고 판단된다. 그에 대한 대안으로 (1) 혁신서열체계를 바탕으로 한 해당 의약품의 사회적 가치, (2) 개발 및 상품화 과정의 비용과 위험 등을 진보성 판단의 새로운 이차적 고려요소로 도입함이 상당하다고 사료된다.

영문 초록

It is widely accepted that pharmaceutical industry stands among one of the few fields where patent protection is necessary to encourage innovation, with patents taking credit for the discovery and development of valuable new drugs that provide great health benefits to the public. Yet despite these successes, the pharmaceutical industry, along with the patent system for pharmaceuticals, is facing considerable criticism, especially from the perspective of access to drug and proper incentive for R&D. Many solutions are suggested especially from the perspective of implementing legislative or administrative actions. I will focus on, however, the patent law itself, especially the non-obviousness jurisprudence of pharmaceutical patent. In pharmaceutical industry, there are several factors that may cause potential mismatch between technical non-obviousness and pharmaceutical R&D or clinical testing efforts, such as unique regulatory landscapes, recent scientific developments, and changes in innovation patterns. To address this situation, I suggest that, with implementing the FDA’s drug classification system and innovation ranking system, (1) the cost and risk of development and commercialization of invention; and (2) the social value of a drug should be considered as new (or at least supplemental) secondary consideration factors. With above approach, we can achieve wise innovation policy on a case-by-case basis, by fine-tuning tailored degrees of patent protection for different categories of drug products.

목차

Ⅰ. INTRODUCTION

Ⅱ. THE MODERN STANDARD OF NON-OBVIOUSNESS

1. KSR and the Federal Circuit’s TSM Test

2. Common Sense and Hindsight Bias

3. Obvious to try

4. KSR and the Obviousness Jurisprudence of Pharmaceutical Patents

Ⅲ. THE DEVELOPMENT OF CHEMICAL NON-OBVIOUSNESS

1. Structural Similarities and Unexpected Properties

2. In re Papesch (1963)

3. In re Dillon (1990)

4. The Function and Limits of Unexpected Properties

Ⅳ. FUNCTIONAL APPROACH IN PHARMACEUTICAL NON-OBVIOUSNESS

1. Pharmaceutical Research Today

2. Assessment of Current Pharmaceutical R&D

3. Implications on Pharmaceutical Obviousness Jurisprudence

4. Functional Approach in Pharmaceutical Non-obviousness

V. REVIEW OF RECENT CASES

1. New Molecular Entities

2. IMDs: New Chemical Derivatives

3. IMDs: New Pharmaceutical Formulations

4. IMDs: New Combinations of Known Molecular Entities

Ⅵ. THE IMPACT OF KSR IN PHARMACEUTICAL PATENTS

Ⅶ. CONCLUSION

키워드

특허법 제약 특허 진보성(비자명성) 혁신서열체계 Patent Pharmaceutical Patent Non-Obviousness Unexpected Properties Innovation Ranking System