2014年10月3日 星期五

CIP案被自己母案阻礙的案例 - Santarus v. Par Pharma (Fed. Cir. 2012)

CIP案被自己母案阻礙的案例 -  Santarus v. Par Pharma (Fed. Cir. 2012)

相關討論可參考上篇:http://enpan.blogspot.tw/2014/10/cip.html

Santarus and the University of Missouri v. Par Pharma (Fed. Cir. 2012)

密蘇里大學(University of Missouri)擁有一些formulations of omeprazole proton pump inhibitors (PPIs)的專利,並專屬授權給藥商Santarus。技術有關密蘇里大學醫藥博士Dr. Jeff Phillips發現在上述藥品加上碳酸氫鈉可以較長時間抑制胃酸而使得胃壁可以吸收藥效。

訴訟被告Par Pharmaceutical, Inc取得美國FDA同意販售相關簡化新藥的許可,即便被告已經取得FDA許可,不過仍在上述專利過期之前販賣侵權藥品。但弔詭的是,訴訟在地方法院審理時,判決Par Pharmaceutical, Inc侵權,但是專利範圍卻是因為不符美國專利法第103、112條規定而背叛無法主張專利權(unenforceability),但也沒有因此產生不公平的行為(比如用無效專利提告)。

於是雙方都上訴,不過上訴理由沒有涉及專利侵權的議題,而是專利有效性的議題。

系爭專利:US7399772(Substituted benzimidazole dosage forms and method of using same),從Claim 1可以知道,就是上述密蘇里大學醫藥博士Dr. Jeff Phillips所發現可以抑制胃酸的治療方法。
1. A method for treating an acid-caused gastrointestinal disorder comprising the step of administering to a subject suffering from said disorder a solid pharmaceutical composition comprising:
(a) about 10 mg to about 40 mg of non-enteric coated omeprazole; and
(b) sodium bicarbonate in an amount of 0.2 mEq to 5 mEq per 2 mg omeprazole;
wherein the composition contains no sucralfate, the acid-caused gastrointestinal disorder is selected from the group consisting of duodenal ulcer, gastric ulcer, gastroesophageal reflux disease, and erosive esophagitis, and the sodium bicarbonate is present in the composition in an amount sufficient to substantially prevent or inhibit acid degradation of at least some of the omeprazole by gastric acid upon administration to the subject.

這裡無法深入專利技術,不過討論的議題僅涉及這件專利與其母案的關聯性,在此僅討論其中之一系爭專利US7,399,772(10/641,732):
系爭專利732案為10/068,437(2002,拋棄)的延續案;
437案為09/481,207(2000,US6,489,346)的延續案;
207案為09/183,422(1998,拋棄)的部分延續(CIP)案
422案更為08/680,376(1996,US5,840,737)的CIP案
376案主張1996年1月4日的美國臨時案(60/009,608)的優先權。
這樣看來,這件申請於2003年的系爭專利是延續自1996年的臨時申請案(provisional application)。其中爭議的是有兩次CIP。

從這個Chain of Priority來看,溯及1996年的美國臨時案,最早非臨時案的母案08/680,376(1996,US5,840,737),可以參考此最早母案的Claim 1:
1. A method for treating gastric acid disorders by administering to a patient a single dose of a pharmaceutical composition of omeprazole or lansoprazole in a pharmaceutically acceptable carrier consisting essentially of a bicarbonate salt of a Group IA metal wherein said administering step consists of providing to the patient orally a single dose of an aqueous solution or, suspension of the pharmaceutical composition without requiring further administration of the bicarbonate salt of the Group IA metal.

中間有個獲准專利:US6,489,346,可以參考此案Claim 1:
1. A solid pharmaceutical composition in a dosage form that is not enteric-coated, comprising: active ingredients consisting essentially of:
(a) a non-enteric coated proton pump inhibitor selected from the group consisting of omeprazole, lansoprazole, rabeprazole, esomeprazole, pantoprazole, pariprazole, and leminoprazole, or an enantiomer, isomer, free base, or salt thereof, in an amount of approximately 5 mg to approximately 300 mg; and
(b) at least one buffering agent selected from the group consisting of sodium bicarbonate, potassium bicarbonate, a calcium salt, and a magnesium salt, in an amount of approximately 0.1 mEq to approximately 2.5 mEq per mg of proton pump inhibitor; wherein the dosage form is selected from the group consisting of suspension tablet, chewable tablet, effervescent powder, and effervescent tablet.

這些專利範圍慢慢演變成本例US7399772的範圍產生差異,關鍵就是Chain過程中有兩次CIP案所新增的技術特徵。

在討論專利有效性時,地方法院認為系爭專利US7399772的揭露內容(或說請求項範圍)並未完整揭示於所主張優先權的最早母案US5,840,737,同時也認為有許多先前技術證明系爭專利為顯而易見的技術。(其中討論技術差異的細節可參閱判決原文)

地方法院同時認為系爭專利US7399772已經與最早母案US5,840,737的優先權關係斷線,甚至這件母案US5,840,737也成為系爭專利的先前技術之一。

不過,案件到了CAFC,CAFC卻否決地方法院將上述737作為772的先前技術的判斷,原因是圍繞在一些系爭專利請求項中的負面表示是否充分揭露在原來最初的母案中,顯然CAFC判斷這個揭示方式並未讓系爭專利與原1996年母案斷線,其間的優先權主張仍有效,因此作出否決的判斷。
這個案例因為地院僅根據一個描述未載於母案而判斷系爭專利與母案斷線,這樣過於輕率的決定被CAFC駁回:

決定:


(判決原文對其他系爭專利也有深入的技術討論與比對,此母案成為有些系爭專利的前案,有些卻也不是)

結論:
  1. 上述案例中雖然案件上訴到CAFC作出原來主張的優先權仍有效,最後的討論是一般103議題,但是過程中仍確認了CIP母案可能作為後續案的先前技術之一的可能
  2. 專利案,包括CIP案,每項請求項的優先權是逐項判斷的(claim-by-claim basis)
  3. 審查CIP案的權利範圍時,審查單位應判斷出哪些請求項具有新增技術,哪些都是繼承自母案的技術
  4. CIP案中有關新增技術的請求項會失去與先申請案(母案)的聯繫
  5. 如果CIP案申請日距離母案公開日超過一年,母案可能會成為核駁CIP案的先前技術,甚至CIP案本質已經暗示審查委員可以引用母案作出審查意見
  6. 縱然法官們對於優先權文件是否可為後續案的引用前案的意見有些差異,但仍有一致的態度,目前美國法院主流意見是(In re Chu, 66 F.3d 292 (Fed. Cir. 1995)):
    "Chu is entitled to the benefit of the Doyle patent filing date only if the Doyle patent discloses the subject matter now claimed by Chu. This, however, is admitted by Chu not to be the case. In fact, Chu states that "the invention as now claimed[ ] was not described in the [Doyle] patent." Specifically, Chu concedes that "nothing in Doyle suggests that SCR catalyst be placed inside the bag filter." Therefore, independent claim 1, which includes this limitation, and dependent claims 2, 4, and 14, are not supported by the Doyle patent disclosure. Accordingly, Chu cannot obtain the benefit of the Doyle patent filing date for these claims and the Doyle patent was properly relied on as prior art."

判決原文:
http://www.cafc.uscourts.gov/images/stories/opinions-orders/10-1360.-1380.pdf

Ron

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