第一炮來自美國。道氏化學(Dow)與杜邦(DuPont)兩個美國化工產業的龍頭企業,宣布將進行對等合併(Merger of Equals),之後會再分割成三家各自專注於農業、材料科學以及特殊化學品的上市公司。到了今年二月,中國化工集團收購了瑞士農化與種子公司先正達(Syngenta),成為中國企業史上規模最大的海外併購案。最後,今年九月中,換成德國化工大廠拜耳(Bayer)買下美國的基改種子公司孟山都(Monsanto)。
As an alternative to paragraph 1, a Party shall instead adopt or maintain a system other than judicial proceedings that precludes, based upon patent-related information submitted to the marketing approval authority by a patent holder or the applicant for marketing approval, or based on direct coordination between the marketing approval authority and the patent office, the issuance of marketing approval to any third person seeking to market a pharmaceutical product subject to a patent claiming that product, unless by consent or acquiescence of the patent holder.
因為第二項起頭為”As an alternative to paragraph 1”,故會員國可就第一項或第二項之規範擇一遵守。其次,”a system other than judicial proceedings”表示第二項要求非司法制度,故其應期待以行政手段處理。另”precludes … the issuance of marketing approval”用語表示第二項僅要求「核發」(issuance)的防止,而未禁止會員國審查許可證申請。
If a Party permits, as a condition of approving the marketing of a pharmaceutical product, persons, other than the person originally submitting the safety and efficacy information, to rely on evidence or information concerning the safety and efficacy of a product that was previously approved, such as evidence of prior marketing approval by the Party or in another territory, that Party shall provide:
a system to provide notice to a patent holder or to allow for a patent holder to be notified prior to the marketing of such a pharmaceutical product, that such other person is seeking to market that product during the term of an applicable patent claiming the approved product or its approved method of use;
第a款要求通知專利權人有關學名藥廠申請許可證之訊息。”prior to the marketing of such a pharmaceutical product”用語表示,通知的時間最晚在學名藥廠開始行銷之前,亦即在第一項制度中,學名藥廠獲頒許可證之權利不受通知規範之影響;否則第a款會使用”prior to the issuance of marketing approval”。此觀點亦可為第二項規範所支持。因為如果第一項亦要求停止核發許可證,則第二項之規定將形同虛設。
再者,第a款對適格的專利權人身分亦有限制。原藥廠必須有涵蓋學名藥藥物或使用方法之專利,才得享有專利連結制度之優惠。”claiming the approved product”用語表示相關請求項必須有所有的學名藥成分的技術特徵,包括有效成分(active ingredient)、和劑型所需要的成分。如果僅是請求有效成分的專利,則不是合格的專利;否則第a款用語會是”an applicable patent claiming an active ingredient of the approved product”。另一類專利為”an applicable patent claiming … its approved method of use”,乃醫療方法專利,而屬我國專利法不予專利之標的,故我國專利連結制度無須考慮此類專利。
適格的專利權人將根據第b款有尋求第c款所給予的救濟手段。第b款內容為:
adequate time and opportunity for such a patent holder to seek, prior to the marketing of an allegedly infringing product, available remedies in subparagraph (c); and
“seek … available remedies”用語代表專利權人僅有請求救濟之權利,但未必能取得其所期望的救濟內容。至於”adequate time and opportunity”的要求應配合”prior to the marketing of an allegedly infringing product”來看,只要在學名藥廠開始行銷之前提供救濟程序即可。亦即,第b款並非要求停止核發許可證。
最後,第c款規定救濟手段,其內容為:
procedures, such as judicial or administrative proceedings, and expeditious remedies, such as preliminary injunctions or equivalent effective provisional measures, for the timely resolution of disputes concerning the validity or infringement of an applicable patent claiming an approved pharmaceutical product or its approved method of use.
至於全球豪華汽車的銷售量,BMW集團的銷售量達224萬輛,成長6.1%,該集團旗下的BMW品牌汽車銷售量達190萬輛位居第一,Benz汽車的銷售量187輛拿下亞軍,第三名是Audi汽車的180萬輛,第四名是豐田的Lexus汽車的65.2萬輛,中國大陸吉利集團的Volvo汽車銷售量有50.3萬輛穩坐第五名,英國的Jaguar Land Rover品牌的銷售量達48.7萬輛,GM集團的Cadillac凱迪拉克汽車的27.7萬輛,Porsche汽車的22.5萬輛。還有第九名的Nissan旗下Infiniti品牌汽車的21.5萬輛,以及第十名的Honda集團旗下的Acura品牌汽車的20.6萬輛。