미국 특허법에서 Safe Harbor (1)

1년쯤 전에 Merck v. Integra Lifesciences, Inc. 케이스 판결이 있었다. 대법원 판결이었고, case citation은 545 U.S. 193이다.

Lexis로 케이스를 뽑아 봤는데, 그리 길지 않은 의견서(opinion)이다. Antonin Scalia 대법관이 의견서를 썼다. 첫 문단에 케이스를 아주 잘 요약해 놓았다.

This case presents the question whether uses of patented inventions in preclinical research, the results of which are not ultimately included in a submission to the Food and Drug Administration (FDA), are exempted from infringement by 35 U.S.C. 271(e)(1).

35 U.S.C. 271(e)(1)은 미국 특허법에서 이른바 safe harbor 조항이라 불린다. 이 부분도 역시 케이스에서 잘 정리해놓았다. 일반적인 특허법의 원칙은 특허받은 발명을 제조, 사용, 판매하는 것이 특허 침해다.

It is generally an act of patent infringement to “mak[e], us[e], offe[r] to sell, or sel[l] any patented invention . . . during the term of the patent therefor.” 271(a).

여기에 대한 예외규정을 만든 것이 1984년 Drug Price Competition and Patent Term Restoration Act이다. 그 때 271(e)가 만들어졌다.

In 1984, Congress enacted an exemption to this general rule, see Drug Price Competition and Patent Term Restoration Act of 1984, 202, 98 Stat. 1585, as amended, 35 U.S.C. 271(e)(1), which provides:

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913) . . .) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs . . . .”

법 자체가 짧지도 않고 쓰여진 언어 자체를 보면 법보다 더 길게 정의 규정을 만들어야 할 정도로 쓰여져 있다. Merck v. Integra Lifesciences 케이스에서는 가장 마지막 부분이 이슈가 되었다.

“solely for uses unreasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs…”

(계속)

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