Alice案後,美國聯邦法院已累積許多案件,針對軟體發明之標的如何適用二階段測試法判斷專利標的適格性提高相關細節,同樣亦有若干案件,針對生物科技領域專利標的,如何適用二階段測試法進行闡釋,這些案件對於未來物科技專利之申請具有重要意義。本文將以2015年Sequenom v Ariosa與Rapid Litigation Management Ltd. v. CellzDirect, Inc.二案分析生物科技專利之適格性判斷基準。
2012年美國最高法院在Mayo Collaborative Servs. v. Prometheus Labs., Inc.[1]首度對於生物科技專利適格性之判斷提出意見,並於2014年最高法院在Alice案,提出二階段測試法判斷專利標的適格性,就專利標的涉及「抽象概念」、「自然界之物」、「自然法則」三個司法例外(judicial exceptions)事項提出適格性之判斷標準。
2015年Sequenom v Ariosa案[2],涉及美國專利No.6,258,540之適格性判斷[3],本發明要求保護使用cffDNA的某些方法。該專利指導技術人員採取母體血液樣本,保留非細胞部分,以發明人所發現的遺傳物質,並確定父系遺傳序列作為區分胎兒和母體DNA。本項核心發現,可運用於檢測懷孕初期胎兒遺傳狀況的測試,該測試避免了對母親和胎兒都有潛在危害的危險侵入性技術,然而聯邦上訴法院卻宣告本件專利不適格。
在第1階段之分析,法院認為該技術之專利標的適格,並未指向自然法則(Law of Nature)。法院認為,肝細胞在多次冷凍循環中之存活的能力是一種自然法則,而本項專利之權利範圍非僅僅僅涉及冷凍循環中之存活的能力,而係指向一種新的有用的保存肝細胞的技術。法院進一步解釋,發明人必然發現某種肝細胞在多次凍融循環中存活的能力,但其所主張係一種生產多冷凍保存肝細胞的方法。因此,請求項的撰寫對於專利取得具有重大之影響,倘若發明人主張某一類型之肝細胞可以在多次凍融循環中存活,則因涉及自然界之產物而標的不適格。然而,在本案中,法院認為發明人利用他們的自然發現創造了一種新的以及改進的方法,來保存肝細胞供以後使用,因此並未指向自然界之物或自然法則。
MayoCollaborative Servs. v. Prometheus Labs., Inc.,566 U.S. 66, 132 S. Ct. 1289 (2012).
788 F.3d 1371 (Fed. Cir. 2015),
1. A method for preparing a deoxyribonucleic acid (DNA) fraction from a pregnant human female useful for analyzing a genetic locus involved in a fetal chromosomal aberration, comprising:
a. extracting DNA from a substantially cell-free sample of blood plasma or blood serum of a pregnant human female to obtain extracellular circulatory fetal and maternal DNA fragments;
b. producing a fraction of the DNA extracted in (a) by:
i. size discrimination of extracellular circulatory DNA fragments, and
ii. selectively removing the DNA fragments greater than approximately 500 base pairs, wherein the DNA fraction after (b) comprises a plurality of genetic loci of the extracellular circulatory fetal and maternal DNA; and
c. analyzing a genetic locus in the fraction of DNA produced in (b).
827 F.3d 1042 (Fed. Cir. 2016)
The claim 1 states.“A method of producing a desired preparation of multi-cryopreserved hepatocytes, said hepatocytes being capable of being frozen and thawed at least two times, and in which greater than 70% of the hepatocytes of said preparation are viable after the final thaw, said method comprising:
(A) subjecting hepatocytes that have been frozen and thawed to density gradient fractionation to separate viable hepatocytes from non- viable hepatocytes,
(B) recovering the separated viable hepatocytes, and
(C) cryopreserving the recovered viable hepatocytes to thereby form said desired preparation of hepatocytes without requiring a density gradient step after thawing the hepatocytes for the second time, wherein the hepatocytes are not plated between the first and second cryopreservations, and wherein greater than 70% of the hepatocytes of said preparation are viable after the final thaw.”