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Federal Trade Commission Continues to Put a Spotlight on Pharmaceutical Patent Agreements

机译:联邦贸易委员会继续关注药品专利协议

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摘要

The Federal Trade Commission (FTC) recently demonstrated that it is becoming more proactive in its efforts to scrutinize the competitive effects of pharmaceutical industry agreements regarding patents. First, as Barbara H. Wootton and Matthew Shultz of Arnold & Porter LLP point out, the FTC announced that it was proposing to amend the Hart-Scott-Rodino (HSR) premerger notification rules to broaden the types of exclusive patent rights transfers, in the pharmaceutical industry only, that are report-able under the HSR Act. Second, the FTC also announced that it moved for leave to file an amicus brief with U.S. District Court in New Jersey for In re Effexor XR Antitrust Litigation, arguing that a branded company's commitment not to launch an authorized generic in competition with a generic company as part of a patent settlement constitutes a "payment" for delayed generic entry under the Third Circuit's recent decision in In re K-Dur Antitrust Litigation which adopted the FTC's position on the standard for antitrust review of pharmaceutical patent settlements.
机译:联邦贸易委员会(FTC)最近表明,它在审查制药业有关专利的协议的竞争效果方面正变得更加积极主动。首先,正如Arnold&Porter LLP的Barbara H. Wootton和Matthew Shultz指出的那样,FTC宣布,它打算修改Hart-Scott-Rodino(HSR)合并前通知规则,以扩大专有专利权转让的类型,仅适用于制药行业,并且必须根据《 HSR法案》进行报告。其次,联邦贸易委员会(FTC)还宣布,其已向新泽西州美国地方法院提出了关于In Effexor XR反托拉斯诉讼的法庭裁决书,理由是品牌公司承诺不与非专利药公司竞争推出授权的非专利药。根据第三巡回法院最近在In Re K-Dur反托拉斯诉讼中的决定,专利解决方案的一部分构成了延迟通用仿制药的“支付”,该决定采纳了FTC对药品专利和解的反托拉斯审查标准的立场。

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