將新產品推向市場,對生命科學領域的企業尤其充滿挑戰,因為通常得經歷一連串嚴格的測試和法規的遵循,從實驗室到上架是一條漫長且風險重重之路。要能存活且保有競爭力,企業的營運計劃必須包含全面以及先發制人的智財策略,期能符合投資者的期待,和市場的需求。
當智權律師和專業同仁與致力開創救生和改善生活產品的創新者共事時,我們親眼目睹了謹慎周嚴及全面的智財資產保護是如何發揮作用的,特別是在行使權利時,讓競爭對手無法越雷池一步,或是得以捍衛自己,反擊侵權的指控。我們汲取在訴訟、申請、和諮詢方面的實務經驗,運用科學及工程背景和全方位聚焦智財的法律敏銳度,讓客戶維持營運,進而持續有突破性的科學新發現和啟發性的技術應用。
熟悉法律、科學、與技術
Finnegan在舉凡專利,商標,著作權,或營業秘密有關的智財議題上為客戶提供諮詢。我們的業務由經驗豐富的律師和專業人士擔綱,他們對生命科學產業引領創新之企業所面臨複雜的法律、技術、法規、和營運的議題皆有深入的理解。
我們透過以下的協助提供服務:
透過法律、技術、與策略上的全方位經驗保護創新
我們在生命科學業務的律師及專家有250位之多,致力於滿足客戶所有智財上的需求。他們多數具有相關科學領域的碩博士學位,例如 : 生物學、化學、生物化學、醫學、藥學、生醫工程、或電子工程,其中多人擁有豐富的研究和/或產業經驗,也有許多人在加入Finnegan之前在業界或大學中已有相當的資歷,或是曾在美國專利商標局擔任過審查委員。
大約十年前施行的《生物製劑價格競爭和創新法案》(BPCIA)為公司尋求美國食品藥物監督管理局(FDA),批准生產和銷售生物仿製藥或可互換版本的品牌生物製品打開了大門。
Finnegan飛翰與生技先驅廠商合作,開發和執行成功的智權策略,包括為突破性的進步取得專利,以訴訟方式行使專利權,以及當他人指控侵權或所有權主張時作辯護。
Success in Abbreviated New Drug Application (ANDA) litigation in the U.S. often begins months or even years before a case is filed. Whether you are anticipating receipt of a Paragraph IV notice letter or still in late-stage clinical trials, it is never too early to start preparation.
消費者得以使用越來越多,價位上負擔得起,提供個人健康和生活方式指標與詳細信息的可攜式裝置。在連接日益緊密的世界中,此類信息對於協助醫療保健專業人員提供更高層次的照護無比珍貴。
Finnegan飛翰具有法律經驗和技術專長,可以幫助客戶解決在開發,保護,和商業化醫療設備與診斷發明中出現的諸多問題。
即使在研發上投入數十億美元,只有很少數的藥物能通過進入市場所需的臨床試驗和嚴格的監管許可。對於投入鉅資研發的公司而言,關鍵在於公司必須保護新藥和療法潛在賦予的智慧財產權。
In a rare rehearing proceeding, successfully represented petitioner Incyte in an inter partes review (IPR) challenging the validity of Concert’s patent before the Patent Trial and Appeal Board (PTAB). Continued representation of appellee Incyte before the Federal Circuit and secured a unanimous affirmance of the PTAB’s obviousness determination.
IPR2017-01256, PTAB, Judges Fitzpatrick, Hulse, Yang, Smith, Franklin
19-2011, Fed. Cir., Judges Hughs, Linn, Stark
1:23-cv-00756, D. Del., Judge Williams
2:23-cv-00094, 2:23-cv-02364, D.N.J., Judges Cecchi, Padin, Wettre
1:21-cv-01610, D. Del., Judges Andrews, Hall
IPR2022-01200, PGR2022-00051, PTAB, Judges Newman, Snedden, Wisz
22-2232, Fed. Cir.
Represented Intuitive Surgical Operations on appeals from petitions for inter partes review (IPR) filed by Auris Health, Inc.
21-1473, -1732, -1733, Fed. Cir., Judges Prost, Dyk, Reyna
IPR2019-01173, -01533, -01547, PTAB, Judges Franklin, Hulse, Jenks, Worth, Yang
Workshop
Life Sciences Workshop: Updates and Key Trends in Pharmaceutical and Biotechnology IP Law
May 2, 2024
Cambridge
INCONTESTABLE® Blog
April 19, 2024
Workshop
Life Sciences Workshop: Updates and Key Trends in Pharmaceutical and Biotechnology IP Law
May 2, 2024
Cambridge
Media Mention
Women in Business Law Americas Awards 2024: Three Finnegan Attorneys Shortlisted
April 7, 2024
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