2014年12月23日 星期二

開放式專利範圍與可實施性間的問題 - Promega v. Life Tech. (Fed. Cir. 2014)案例討論



此案例討論關於專利請求項使用開放式連接詞,如comprising, including等,的解釋範圍,是否可以讓專利權人解釋專利範圍時,讓權利範圍均等到發明完成時還不瞭解的部分?
答案除了要看說明書實施例、發明完成時的知識水平、專利答辯時的禁反言、無須過度實驗的範圍外,答案也在幾個案例中,涵蓋到至少與專利範圍相稱的專利說明書所載的知識水平上。在本案中,至少不能涵蓋到不可預知的技術上。(patentlyo.com)

PROMEGA CORPORATION是個生技公司,經營生物銀行;這兩間公司有不少訴訟爭議,LIFE TECHNOLOGIES CORPORATION也是一間生技公司,產品涉及生物檢測、幹細胞、基因檢測,也有跟運動健身有關生活科學軟硬體設備。
http://worldwide.promega.com/

https://www.lifetechnologies.com/


案例討論:
此案例涉及美國專利法第271條專利侵權的規定中,第(f)段,如果有未經授權的產品的全部或一部分使用了某美國專利,則涉及侵權;未經授權而提供製造或使用時,若不是非侵權用途,即便是在國外組合,仍是涉及侵權。
35 U.S.C. 271, Infringement of patent
271(f)
(1) Whoever without authority supplies or causes to be supplied in or from the United States all or a substantial portion of the components of a patented invention, where such components are uncombined in whole or in part, in such manner as to actively induce the combination of such components outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer.
(2) Whoever without authority supplies or causes to be supplied in or from the United States any component of a patented invention that is especially made or especially adapted for use in the invention and not a staple article or commodity of commerce suitable for substantial noninfringing use, where such component is uncombined in whole or in part, knowing that such component is so made or adapted and intending that such component will be combined outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer.


系爭專利的技術關於一種每種基因獨特的STR基因座(Loci),是在染色體上的位置點,這個STR基因座可以作為識別基因的"指紋"(DNA fingerprint),可以作為罪證、醫療用途。要作為基因識別用途時,這個STR Loci要先被放大,放大的方式就是同時複製多個DNA,講來簡單,過程中卻關於許多不確定的因素(無法預測),似乎要碰點運氣。結果,這次系爭專利也不是解決這個問題,而是提出一個成功可以複製的特例。

不過,這件專利技巧性地採用開放式連接詞「comprising」 ,使得專利範圍解釋包括了已經證實可以成功放大STR基因座的方式外,又可能包括別種組合(combination),甚至可以解釋到其他尚不瞭解的的領域。

系爭專利:US5,843,660、US6,221,598、US6,479,235、US7,008,771,以及另一件Tautz專利(RE 37,984

US6,221,598
23. A kit for simultaneously analyzing short tandem repeat sequences in a set of short tandem repeat loci from one or more DNA samples, comprising:
a single container containing oligonucleotide primers for each locus in a set of short tandem repeat loci which can be co-amplified, comprising HUMCSF1PO, HUMTPOX, and HUMTH01.

RE 37,984(這是本次唯一被判專利有效以及侵權成立的專利)
42. A kit for analyzing polymorphism in at least one locus in an DNA sample, comprising:
a) at least one vessel containing a mixture of primers constituting between 1 and 50 of said primer pairs;
b) a vessel containing a polymerizing enzyme suitable for performing a primer-directed polymerase chain reaction;
c) a vessel containing the deoxynucleotide triphosphates adenosine, guanine, cytosine and thymidine;
d) a vessel containing a buffer solution for performing a polymerase chain reaction;
e) a vessel containing a template DNA comprising i) a simple or cryptically simple nucleotide sequence having a repeat motif length of 3 to 10 nucleotides and ii) nucleotide sequences flanking said simple or cryptically simple nucleotide sequence that are effective for annealing at least one pair of said primers, for assaying positive performance of the method.

專利權人PROMEGA對LIFE TECH提出侵權告訴,雖兩家之間有專利授權合約,但是專利權人認為本次訴訟不在該合約的授權範圍內。在地院階段雖被挑戰專利因為不可實施而無效,但是地院認為專利有效,但對於專利侵權議題,則判定侵權不成立,於是兩邊都上訴CAFC,一是為專利無效不成立,另一是為了侵權不成立。

可實施性:
專利可實施性(enablement)規定於35 U.S.C.§112(1):
The specification shall contain a written description of the invention, and the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same. 


法院給的解釋:

地方法院從請求項使用"comprising"來看,認為這個開放式連接詞讓專利範圍可以包括為引述的基因座(loci)。"all of the asserted [open loci set] claims allow for unrecited loci."

不過,上訴至CAFC階段,CAFC法官對可實施性的看法認為,雖然請求項採用了開放式的專利範圍,卻是寫在「body/limitation」的部分,不是在「preamble」,不是寫在每個地方都可以解讀該項為開放式的專利範圍。而且也不能因此涵蓋到無法預期的的元件,可參考以上598案的claim 23,這樣的寫法僅是界定一個可以達成效果的引物,無法涵蓋其他未知。加上專利權人在專利審查階段時不斷地強調與先前技術的差異就在專利所評估採用的基因座,顯然排除了專利說明書以外的可能性。

辯論過程中,專利權人PROMEGA強調專利範圍的廣度,而且認為在沒有過度實驗下涵蓋被告LIFE TECH的作法,反而讓法官在解讀專利範圍時產生了模糊的疑慮,加上說明書經此一辯,讓法官認為專利說明書並未揭露完整內容,也就是不涵蓋專利權人認為可以涵蓋的部分,使得相關技術人員實施時並無依據,專利範圍也沒有清楚的邊界。被認定不符112可實施性的揭露要件

本案例另一個侵權成立的討論就在此省略。

結論:
(1)四件系爭專利因為不符美國專利法第112條可實施要件的規定而認定無效
(2)證據顯示對另一件Tautz專利的侵權成立
(3)本次訴訟的標的不在前述授權合約中
(4)重新計算賠償金

發回地院重審。

判決原文:
http://www.cafc.uscourts.gov/images/stories/opinions-orders/13-1011.Opinion.12-11-2014.1.PDF

資料參考:
http://patentlyo.com/patent/2014/12/promega-enablement-elements.html

Ron

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