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Tag Archives: FDA

U.S. Supreme Court Allows Early Notice For Biosimilars

Posted in Patent Law

In SANDOZ INC. v. AMGEN INC. et al., the United States Supreme Court in a unanimous opinion ruled that biosimilar makers can give their required 180-day statutory notice of sales before their products win approval by the United States Food and Drug Administration (“FDA”).  In short, the Court held a biosimilar maker “may provide notice… Continue Reading

SUPREME COURT: PATENT CLAIM CONSTRUCTION – TWO STANDARDS OF REVIEW

Posted in Patent Law

The Supreme Court recently decided a patent case involving a significant procedural issue.  In Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831 (1/20/15), the question before the Court was whether the Federal Circuit Court of Appeals should review a district court’s factfindings in its claim construction decision under a de novo or a… Continue Reading