Midyear Banking Review
If I won my case, why do I need to worry about an appeal?
In recent days, the U.S. Food and Drug Administration (FDA) has issued multiple policy documents relating to software and digital health. Two of them relate to software-based medical devices: draft guidance for predetermined...more
On 9 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Acceptance Review for De Novo Classification Requests." ...more
In our first two Device Modernization series posts, we discussed FDA’s 510(k) modernization efforts and the proposed De Novo regulation. FDA has also had a heavy hand in legislative efforts to retool oversight of laboratory...more
On January 7, 2019, FDA Commissioner Scott Gottlieb announced significant updates to the FDA’s pilot Software Pre-Certification Program, sometimes referred to more broadly as a Digital Health Pre-Certification Program...more
Last week the Food and Drug Administration (FDA) issued a proposed set of new regulations to further define and update the De Novo review process. Although De Novo review has been available for two decades, for the past 20...more
Background: The Increasing Regulation of Medical Devices Subject to 510(k) Clearance - The U.S. Food and Drug Administration's (FDA's) 510(k) premarket clearance pathway is the road to commercialization for thousands of...more
This is the third installment of our year-in-review series covering major developments at FDA. While the previous two installments, pertain to FDA actions on drugs and biologics, this post will address developments related...more
Case Name: Shire Development, LLC v. Watson Pharms., Inc., 787 F.3d 1359 (Fed. Cir. June 3, 2015) (Circuit Judges Prost, Chen, and Hughes presiding; Opinion by Hughes, J.) (Appeal from S.D. Fla., Middlebrooks, J.) - Drug...more
In its January 2015 decision, Teva Pharms. USA, Inc. v. Sandoz, Inc., the Supreme Court held that the ultimate construction of a patent claim term is a question of law, subject to de novo appellate review, but that the...more
FEDERAL CIRCUIT CASES - CAFC: If (No Factual Findings), Then (No Deference) - Two days ago, on remand from the U.S. Supreme Court, the Federal Circuit in Shire v. Watson again affirmed its reversal of the...more
Case Name: Teva Pharms USA, Inc. v. Sandoz, Inc., No. 10-13-854, 135 S. Ct. 831 (Mar. 20, 2012) (Breyer, J. delivered opinion of the Court, in which Roberts, C.J., and Scalia, Kennedy, Ginsburg, Sotomayor, and Kagan, JJ.,...more
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...more
More Deference to District Courts in Claim Construction - In TEVA PHARMACEUTICALS USA, INC. v. SANDOZ, INC., No. 13-854, the Supreme Court held that factual findings underpinning claim construction rulings are reviewed...more
In a 7–2 decision penned by Justice Breyer, the Supreme Court of the United States overturned the de novo standard as the sole standard of review issues arising in claim construction. Teva Pharmaceuticals USA v. Sandoz,...more
The Supreme Court recently handed down its 7-2 opinion in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. The case involved a Federal Circuit review of a district court’s determination that Teva’s patent claims were not...more
On January 26, 2015, the Supreme Court granted certiorari, vacated, and remanded Shire Development LLC v. Watson Pharmaceuticals, Inc., to the Federal Circuit “for further consideration in light of Teva Pharmaceuticals USA,...more
Recently, the Supreme Court changed the standard of review the Federal Circuit must use when reviewing district court claim construction decisions in patent cases. Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 574 U.S. ___...more
On January 20, 2015, the Supreme Court issued its long-awaited decision on the standard of review of factual findings by the trial court in construing patent claims. The Court ruled that factual findings in the context of...more
On January 21, 2015, the Supreme Court decided a narrow but important issue of appellate jurisdiction in cases that have been consolidated for pretrial proceedings by the Judicial Panel on Multidistrict Litigation. A...more
On January 20, 2015, the Supreme Court issued its opinion in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. (Case No. 13-854), which changed the level of deference the Federal Circuit must show to district court claim...more
On Jan. 20, 2015, the U.S. Supreme Court issued a decision setting forth a new standard for appellate review of a district court’s claim construction ruling. Teva Pharmas. USA, Inc. v. Sandoz, Inc., No. 13-854, slip op., 574...more
In Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., the Supreme Court revised the standard of review used by the Federal Circuit for nearly twenty years in reviewing claim construction rulings, replacing a de novo standard...more
This week, in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., the Supreme Court held that the Federal Circuit must apply a deferential “clear error” standard of review to any finding of fact underlying a district court’s...more
On January 20, 2015, the Supreme Court issued a 7-2 decision in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., No. 13-854, 574 U.S.__ (2015), holding that the Federal Circuit must apply a "clear error" standard when...more
Supreme Court Building #3It has escaped almost no one's notice that the Supreme Court has spent the past decade or so being much more involved in patent law than in preceding twenty years. Evident but perhaps less discussed...more