從Teva Pharmaceutical Industries Ltd. v. AstraZeneca Pharmaceuticals LP案看先前技術對於美國專利新穎性判斷之影響
葉雲卿╱世新大學智慧財產研究所 助理教授
2014.06.17
美國法專利訴訟對於訴訟爭議的專利,是否因為先前技術存在,而喪失新穎性,必須判斷先前技術是否完全揭露申請專利內容,美國最高行政法院有一段經典描述:「That which infringes if later in time, anticipates if earlier…」(註1)。是指若該先前技術在該爭執申請專利之後申請,該先前技術倘會侵害該爭執專利,那麼先前技術已經揭露所有專利技術特徵。後來經美國案例法更進一步修正為「That which literally infringes」,也就是對於比對先前技術特徵,必須文義相同,如果該比對先前技術內容對於專利構成文義侵權,則先前技術已經揭露所有專利技術特徵,則為是否欠缺新穎性的問題;反之,先前技術文字記載如無法讀入(read on)專利,而必須透過「均等論」(註2)(doctrine of equivalents)解釋,這種情況則屬於顯著性而非新穎性的問題(註3)。本文將以Teva Pharmaceutical Industries Ltd. v. AstraZeneca Pharmaceuticals LP將討論在專利訴訟過程中,先前技術對於判斷是否揭露爭執專利特徵。
Teva Pharmaceutical Industries Ltd. v. AstraZeneca Pharmaceuticals LP專利訴訟乙案發生於2008年,本案適用2011年美國專利法(America Invents Act, AIA)修正以前專利法。在AIA修正之前,美國專利法採取先發明主義,其依據其修正前專利法第102條g項2款(註4),如果於發明人發明之前,在美國境內並無其他發明人有相同發明,且該相同發明未經放棄、抑制、隱藏該項發明之情況,則發明人應該取得專利。Teva vs AstraZeneca 該案討論102條g項問題,雖然102條g項AIA修正後被刪除,但本案在判斷先前技術揭露的內容與新穎性是否喪失之判斷,仍具有實益。
案件背景
訴訟當事人本案原告Teva,與被告 AstraZeneca都是專門製造,並銷售藥品的公司。
被控物品:本案被告AstraZeneca是一間製造銷售CRESTOR®的公司,這是一種治療血脂異常(dyslipidemia) 的藥物,該藥物成分之一statins為一種不穩定的化合物,因此必須以穩定配方製備。因此,AstraZeneca以穩定的配方來製備CRESTOR,也為此設計以含有較穩定的磷酸鈣 (tribasic calcium phosphate) 成分放入配方內,該配方同時也包含了交聯羧甲基纖維素鈉 (crospovidone),用來作為崩散劑。
2008年10月,原告Teva在美國賓州的聯邦地方法院( U.S. District Court for the District of Pennsylvania) 起訴,控告AstraZeneca侵害其第’502號專利權。’502申請專利範圍,涉及一種具有穩定Statin配方成分(a stabilizing effective amount(註5))。而被告AstraZeneca所製造、販賣的藥品CRESTOR®因為含有該等具穩定作用的成分,所以CRESTOR®已經落入502專利申請專利範圍,而被控侵權。因此Teva主張AstraZeneca製造、販賣CRESTOR®侵害其502號專利。Teva主張AstraZeneca所販賣CRESTOR®,係利用含amido-group的高分子化合物 (AGCP compound) 或以高分子化合物的amido-group來穩定statin,此種配方落入502號專利之專利申請範圍。另就專利的新穎性,Teva主張在1999年12月1日,針對502號專利之發明,其申請專利範圍,即已經具備有構想 (conception),且已經付諸實施 (reduce to practice)。
依照美國舊專利法,被告主張原告的專利權符合舊專利法102條第g項無效,必須證明有先前發明(prior invention),且該先前發明必須限制於已經完成的發明,(註9)也就是必須具有構想,並付諸實施,且未放棄、抑制、或隱瞞之發明始足當之。因此,本案在地院的審理中,Teva雖未針對AstraZeneca所提出的CRESTOR是否在1999年12月1日前製造爭執,但卻主張即便AstraZeneca很早就開始進行CRESTOR商業化配方之製造,但也不能證明概念(conception)已經形成或是已經付諸實施(reduce to practice)。一審審理過程中,Teva進一步指出,因為並無證據顯示AstraZeneca知道CRESTOR®成分中的聚維酮(crospovidone)的功能,而這種氨基聚合物(amido-group)包含高分子化合物事實上具有穩定藥效的作用。Teva進一步表示,AstraZeneca不了解crospovidone的功能,因此不能證明該使用是一種先前技術。
35 USC Article 102 g (2) before such person’s invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.
“'which would literally infringe if later in time anticipates if earlier.'" Upsher-SmithLabs., Inc. v. Pamlab, L.L.C. (Fed. Cir. 2005) (citations omitted); accord Peters v. Active Mfg. Co. (1889) ("That which infringes, if later, would anticipate, if earlier.").
International Glass Co. v. United States, 408 F. 2d 395 (Ct. Cl. 1969)
The court stated that "conception and reduction to practice require 'contemporaneous recognition and appreciation of the invention represented by [the asserted patent claims].'" D.I. 92 at 21
[T]he inventor need not 'establish that he recognized the invention in the same terms as those recited in the [claims]' as '[t]he invention is not the language of the claims but the subject matter thereby defined.'. . . Rather, the inventor must establish that he recognized and appreciated 'a compound corresponding to the compound defined by the [claims].'D.I. 92 at 21 (citations omitted).
Dow Chemical Co. v. Astro-Valcour, Inc., 267 F.3d 1334 (Fed. Cir. 2001); Mycogen Plant Sciences v. Monsanto Co., 243 F.3d 1316 (Fed. Cir. 2001); and Invitrogen Corp. v. Clontech Laboratories, Inc., 429 F.3d 1052 (Fed. Cir. 2005)
The Federal Circuit stated "'[t]he invention is not the language of the [claim] but the subject matter thereby defined'"(citing Dow Chemical Co. v. Astro-Valcour, Inc., 267 F.3d 1334 (Fed. Cir. 2001)).