生物制剂 是本所业务分支,下属于 生命科学.
保护快速增长产业的复杂科学
自问世近十年来,《生物制剂价格竞争与创新法案》(BPCIA)为公司寻求美国食品与药品管理局(FDA)批准制造和销售生物仿制药或品牌可替换生物药物创造了条件。《生物制剂价格竞争与创新法案》规定参比药申办方享有12年市场独占权。由于专利可以为品牌产品提供额外的排他性,该法案也为参比药申办方和生物仿制药之间的专利诉讼提供了法定依据。不同于《药品价格竞争和专利期修正案》(Hatch-Waxman Act),BPCIA未要求参比药申办方在类橙皮书中列载专利,但却规定了特殊的诉讼前程序,也被称为“专利舞蹈”,要求确定相关专利及各方对于侵权和有效性的依据。
精通法律、科学、与技术
品牌生物制剂领域专业复杂且不断发展,飞翰律师事务所为客户提供几乎所有与该领域相关的知识产权事务的咨询意见,包括专利申请、尽职调查、专利组合管理和诉讼。我们的团队由业内最富经验的生命科学领域知识产权律师构成,他们对围绕这些复杂分子的相关法律、技术、监管和商业等综合事务以及其如何影响生命科学企业具有深入的了解。
我们帮助处理:
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
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