大家都知道,專利說明書要揭露完整、清楚、明確,就美國專利而言,要符合專利法第112條的揭露規定。揭露的標準為其主張的專利範圍在申請時讓該發明領域相關技術人員在無須過度實驗下可以據以實施。參考資料之一:http://enpan.blogspot.tw/2013/01/aia35-usc-112.html。
剛剛才出來的CAFC判決(Wyeth v. Abbot Labs)涉及專利明確的問題,此案例特別涉及化學藥物類中的「用途」發明,因為用途發明往往是建構於已知的產品上,因此在描述其用途時,或許容易忽略揭露的義務,總覺得這些應該是公知技術才是。系爭專利為惠式大藥廠(Wyeth)所擁有的美國專利US5,516,781與US5,563,146,專利涉及「使用雷帕黴素的抗生素來治療和預防動脈球囊導管阻塞」的技術,在CAFC判決中法官一致認定不符合美國專利法第112條揭露明確的規定。
先參考US5516781的獨立項:
1. A method of treating restenosis in a mammal resulting from said mammal undergoing a percutaneous transluminal coronary angioplasty procedure which comprises administering an antirestenosis effective amount of rapamycin to said mammal orally, parenterally, intravascularly, intranasally, intrabronchially, transdermally, rectally, or via a vascular stent impregnated with rapamycin.
其中涉及雷帕黴素(rapamycin)的解釋,在說明書「背景技術」中曾有定義為:
『Rapamycin, a macrocyclic triene antibiotic produced by Streptomyces hygroscopicus [U.S. Pat. No. 3,929,992] has been shown... 』
但是Wyeth訴求更廣的解釋,企圖包括大量結構性相似的分子,但說明書卻僅揭露表現必要作用的檢驗成份的單一物種,文中有提到:
The court also found that, while the specification describes assays to ascertain whether a potential rapamycin compound exhibits the recited functional effects, the only species disclosed is sirolimus.
法院認為,其中雷帕黴素(rapamycin)一般有很多種分子,但說明書卻未有足夠的描述,因此也造成需要很多的實驗才可以得到需要的結果。這些都不符合112條的規定。而且在發明提出的時間點的有限知識下並不能瞭解其中化學成份與化學的複雜度,即便Wyeth提出專家證詞說相關技術人員可以根據說明書記載內容可以達成其主張的發明,但卻因為說明書沒有記載足夠的內容達成權利範圍想要的功效,使得專利無法據以實施,被判無效。
以下摘錄上訴者(侵權被告)的意見,並同時獲得CAFC法院認同:
上訴者的爭辯獲得法院同意,其中重點有:
- They argue that the specification is silent on how to structurally modify sirolimus to yield a compound having the recited functional effects.
- Appellees disagree that one of ordinary skill would have known to select only compounds with a molecular weight below 1,200 Daltons.
- Even accepting Wyeth’s molecular weight argument, however, Appellees respond that there are still tens of thousands of potential compounds that requirescreening.
- They emphasize that Wyeth’s own witnesses testified that even minor alterations to the sirolimus molecule could impact its immunosuppressive and antirestenotic properties.
- Appellees argue that one of ordinary skill would thus need, at a minimum, to engage in a laborious iterative process to determine what candidates fall within the claimed genus, and that there is no contrary evidence in the record.
資料參考:Patently-O
資料來源:
http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/12-1223.Opinion.6-24-2013.1.PDF
(updated on June 8, 2017)
Ron
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