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FDA withdraws draft guidance for industry: statistical approaches to evaluate analytical similarity

USA - July 18 2018 On June 21, 2018, the Food and Drug Administration (FDA) withdrew its draft Guidance for Industry entitled “Statistical Approaches to Evaluate…

The Supreme Court Permits Recovery of Lost Profits for Foreign Uses

USA - June 25 2018 On June 22, 2018, the U.S. Supreme Court issued a significant decision regarding the recovery of lost profits for foreign uses of a U.S. patented…

Alissa K. Lipton

WesternGeco LLC诉Ion Geophysical Corp.一案中最高法院允许追回境外使用专利的利润损失

USA - June 25 2018 2018年6月22日,美国最高法院发布一项关于追回境外使用美国专利发明之利润损失的重大裁决。具体而言,在WesternGeco LLC 诉 Ion Geophysical Corp…

Alissa K. Lipton

WesternGeco LLC v. Ion Geophysical Corp

USA - June 25 2018 米国最高裁判所は2018年6月22日、米国外で使われた特許発明から生じる逸失利益の賠償を認める判決を言い渡した。. 事件で最高裁は、連邦巡回控訴裁判所(CAFC)の判決を覆し、争点となった法令であるU.S.C. §§ 271(f)(2)…

Alissa K. Lipton

Summary of FDA Guidance on Determining Whether to Submit an ANDA or a 505(b)(2) Application

USA - October 24 2017 On October 13, 2017, the U.S. Food and Drug Administration (FDA) released for comment, by December 12, 2017, draft guidance for industry entitled…