2017年2月16日 星期四

封閉式連接詞影響侵權主張 - Shire Development v. Watson Pharma (Fed. Cir. 2017)

封閉式連接詞影響侵權主張 - Shire Development v. Watson Pharma (Fed. Cir. 2017)

原告/被上訴人:SHIRE DEVELOPMENT, LLC, etc.
被告/上訴人:WATSON PHARMACEUTICALS, INC. etc.
系爭專利:US6,773,720

本案緣起原告Shire以系爭專利提出侵權告訴,認為被告Watson的新藥(ANDA)侵犯專利權。

系爭專利關於口服藥物的的成份,如請求項1描述,主要元件為「內部親脂基質(inner lipophilic matrix)」與「外親水基質(outer hydrophilic matrix)」,另可有「excipients」。其中內部為親脂性元件(lipophilic),外層親水性元件(hydrophilic)是可以聯想到「口服藥」需要與水相溶的概念。
1. Controlled-release oral pharmaceutical compositions containing as an active ingredient 5-amino-salicylic acid, comprising:
a) an inner lipophilic matrix consisting of substances selected from the group consisting of unsaturated and/or hydrogenated fatty acid, salts, esters or amides thereof, fatty acid mono-, di- or triglycerids, waxes, ceramides, and cholesterol derivatives with melting points below 90° C., and wherein the active ingredient is dispersed both in said the lipophilic matrix and in the hydrophilic matrix;
b) an outer hydrophilic matrix wherein the lipophilic matrix is dispersed, and said outer hydrophilic matrix consists of compounds selected from the group consisting of polymers or copolymers of acrylic or methacrylic acid, alkylvinyl polymers, hydroxyalkyl celluloses, carboxyalkyl celluloses, polysaccharides, dextrins, pectins, starches and derivatives, alginic acid, and natural or synthetic gums;
c) optionally other excipients;
wherein the active ingredient is present in an amount of 80 to 95% by weight of the total composition, and wherein the active ingredient is dispersed both in the lipophilic matrix and in the hydrophilic matrix.
地院階段:
地方法院否決被告提出專利無效(無法據以實施)的主張,並認為Watson侵權成立。案件經上訴,並甚至到了最高法院,再發回重審。(經查,相同的當事人在2014, 2015都有法院判決)

系爭專利請求項1中的主要元件採用了封閉式連接詞「consisting of」,其中各成份又有各種可能的組合(or用語),在過去的法院判決中也認定為「Markush group」的寫法。

法院解釋專利範圍:
"consisting of"是個強烈封閉式的用語(但也曾有例外,所以法院態度還算保留):


例外案例:


Markush為選擇式用語:


法院考慮各種用語與可能性是讓我們更清楚、更客觀地看案子。對於本案,被告侵權產品經分析後,有以下成份:


地院認為被告侵權物並沒有完全與系爭專利範圍一致,但因為被告侵權物都有如親水、親脂等成份,仍判侵權成立。

CAFC階段:
案件到CAFC,法院準確地討論到口服藥物吞嚥時的情況,考慮到專利範圍「封閉連接詞」的使用造成的專利範圍的限制,甚至不能包括說明書有列舉的其他成份。


"And we decline to impose such a requirement, which would in effect equate the scope of a Markush group’s “consisting of” language with either “comprising” or “consisting essentially of language."

即便原告有很好的解釋,但是都被這個"consisting of"用語打敗。


最後,CAFC認為侵權不成立,發回重審。

判決文:http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/16-1785.Opinion.2-8-2017.1.PDF
(備份:https://app.box.com/s/mpn0pexfr8h6890t908dvpa74xqvx2j4

資訊來源:
http://patentlyo.com/patent/2017/02/consisting-provides-infringement.html

Ron

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