生物藥品 業務的一部分 生命科學.
約十年前施行的《生物藥品價格競爭和創新法》(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相似藥或可互換版本的品牌生物製品打開了大門。BPCIA為原開發藥廠提供了12年的市場獨占權,也為原開發藥廠與生物相似藥之製藥廠間的專利訴訟提供了法律依據,因為專利可以為品牌產品提供額外的排他性。與《Hatch-Waxman法》不同,BPCIA不需要原開發藥廠在橘皮書上列出專利。取而代之的是,明確規定了特有的訴訟前程序,有時稱之為“專利舞蹈”,要求確認相關專利以及當事人宣稱侵權和有效的依據。
了解法律,科學,和技術
Finnegan飛翰就與生物藥品有關之複雜且不斷發展的所有智財議題為客戶提供諮詢,包括專利申請,盡職調查,組合管理,和訴訟案件。我們的團隊由具有生命科學背景之經驗豐富的智財律師組成,他們對圍繞這些合成分子之複雜難懂的法律,技術,法規和業務議題,以及這些議題如何影響生命科學企業之運作皆有深入的了解。
我們協助的項目有:
保護創新之全面的法律,技術,和策略經驗
我們的生命科學業務由250多位律師和專業人士組成,致力於滿足客戶對於智財權服務的需求。多數擁有與生物學,化學,生物化學,醫學,藥理學,或生醫工程等相關學科的高階學位。大多具有紮實的研究和/或產業經驗,許多人在產業或大學任職,或在美國專利商標局擔任審查委員後加入Finnegan飛翰。
2:23-cv-00094, 2:23-cv-02364, D.N.J., Judges Cecchi, Padin, Wettre
IPR2022-01200, PGR2022-00051, PTAB, Judges Newman, Snedden, Wisz
22-2232, Fed. Cir.
PGR2022-00037, PTAB, Judges Newman, Obermann, Worth
IPR2022-00738, -00739, -00796, PTAB, Judges Cotta, Wisz, Worth
1:21-cv-10954, D. Mass., Judge Burroughs
1:21-cv-02258, 1:21-cv-02899, N.D. Ill., Judge Lee
1:21-cv-01736, 1:23-cv-00554, D. Del., Judge Andrews
Conference
2nd Annual Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities
March 20, 2024
Boston
Webinar
February 15, 2024
Webinar
Webinar
Navigating Your Life Sciences Opposition: Tips for Best Practice When You Are Opposing or Opposed
December 12, 2023
Webinar
Webinar
November 28, 2023
Webinar
Conference
3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA
October 10-26, 2023
Virtual
Press Release
Finnegan Continues to Hold Top-Tier LMG Life Sciences 2022 Rankings
September 22, 2022
Press Release
Finnegan Celebrates Two Wins at the 2020 LMG Life Sciences Awards and Top Honors in the Rankings
October 5, 2020
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