Celsis In Vitro, Inc. v. CellzDirect, Inc., 664 F.3d 922 (Fed. Cir. 2012)
系爭專利有關一種multi-cryopreserved hepatocytes(多凍存肝細胞),是一種肝臟細胞,對於被告CellzDirect對於專利是否顯而易見的爭辯,其中(不同法官採取不同的顯而易見的判斷):
- CAFC首席法官(Chief Judge)Rader認為相關技術為常見,但此件專利涉及的多凍存肝細胞技術卻在此擁擠(crowded art)的技術領域中未見有先前技術(the art was well-known for being unpredictable; that art was a crowded one but there was not one reference to multi-cryopreservation),認為先前技術並未教示(teach away/反向教示)多凍存的技術;
- 但另一法官Gajarsa的意見則是,認為在大多數認同的顯而易見的分析並不同過去最高法院在KSR案的判斷顯而易見的判例(是否產生超出預期的結果?是否有可預期的變化?是否僅解決已知問題?),也就是大多數人仍採用KSR判例前(pre-KSR)的判斷標準,也就是考慮先前技術是否對「多凍存肝細胞」有教示(teaching)、建議(suggestion)或是產生動機(motivation),依此作為判斷顯而易見的依據。
系爭專利為Celsis所有的美國專利US7,604,929,有關以多次冷凍的方式進行保存肝臟細胞的技術(保鮮,可再生),於2010年在地方法院對CellzDirect所販售的多凍存的肝細胞(multi-cryopreserved hepatocyte products)提出專利侵權的初步禁制(preliminary injunction)訴訟。之後上訴到CAFC。
CAFC同意地方法院初步禁制的決定,原因有四,認為專利權人已經實現該專利,而且:
1. 技術是成功的
2. 已經產生無法彌補的傷害
3. 負載的艱辛(balance of hardships)
4. 公眾利益
CAFC法官認定專利有效的理由也就是USPTO審查顯而易見性的準則(再次重申):
(1) the scope and content of the prior art;
(2) the level of ordinary skill in the art;
(3) the differences between the claimed invention and the prior art; and
(4) the objective evidence of nonobviousness
判決中,值得一提的是,CAFC採用地方法院對於「crowded art」中產生不可預期的技術的態度,也就是學術上在肝細胞保存(hepatocyte preservation)已有多年,但是卻未有多凍存(multi-cryopreservation)的任何參考文獻,認定此專利技術為非顯而易見,也就是法院發現專利與先前技術具有重要的區隔(significant distinction between previous research on hepatocyte freezing)。
再是,CAFC採用地方法院認為被告的專家證詞並無說服力(unpersuasive),專家也不能解釋為何先前的文件與研究都顯示經冷凍的肝細胞活力會降低的問題,但系爭專利的多次冷凍的保鮮技術卻因此顯得具有進步性。
系爭專利US7,604,929名稱為Cellular compositions and methods for their preparation,專利範圍即界定多凍存肝細胞的步驟。
專利轉手幾次,最近幾次轉手也與這次有關:
1. 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.
2. The method of claim 1, wherein said density gradient fractionation comprises density centrifugation through polyvinylpyrrolidone-coated colloidal silica particles.
10. A method of investigating in vitro drug metabolism comprising incubating hepatocytes of a multi-cryopreserved hepatocyte preparation in the presence of a xenobiotic, and determining the metabolic fate of the xenobiotic, or the affect of the xenobiotic on the hepatocytes or on an enzyme or metabolic activity thereof, wherein the hepatocytes have been frozen and thawed at least two times, and wherein greater than 70% of the hepatocytes of said preparation are viable 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.
Ron
資料參考:
KSR判例:
http://enpan.blogspot.tw/2009/02/ksr-v-teleflex.html
http://enpan.blogspot.tw/2010/09/ksr-uspto.html
IPWatchDog整篇列舉CAFC2012的進步性相關判決:
http://www.ipwatchdog.com/2013/01/24/cafc-2012-on-the-obviousness-of-chemical-innovations-part-ii/id=33577/
這件案子內容:
http://www.lawupdates.com/commentary/icelsis_in_vitro_inc._v._cellzdirect_inc._ifederal_circuit_disagrees/
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