Pharmaceutical Manufacturers

News & Analysis as of

Supreme Court Calls for Greater Deference to District Court Claim Construction

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

Alert: U.S. Supreme Court Revises Standard for Appellate Review of Patent Claim Construction Decisions

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

What's Next? Some Consequences of the Teva v. Sandoz Decision

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

Patent Claim Construction Now Subject to Hybrid Review

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 of issues arising in claim construction. Teva Pharmaceuticals USA v. Sandoz,...more

Supreme Court Clarified Standard of Review for Patent Claim Construction – Subsidiary Factual Findings are to be Reviewed for...

In a recent case, Teva Pharmaceuticals USA, Inc. Et Al. V. Sandoz, Inc. Et Al., the Supreme Court of the United States clarified that subsidiary issues of fact determined by a District Court during patent claim construction...more

Generic Drug Manufacturers to Face Failure-to-Warn Claims in California

On January 20, 2015, the Supreme Court declined to hear an appeal involving failure-to-warn claims against generic pharmaceutical manufacturers. Teva Pharms. USA Inc. v. Super. Ct., No. 13-956, 2015 WL 231967 (U.S. Jan. 20,...more

Supreme Court Calls for Some Deference in Claim Construction Standard of Review

On January 20, 2015, the Supreme Court issued its decision in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., finding that the Federal Rules of Civil Procedure call for some deference in the claim construction standard of...more

Supreme Court ends Fed Circuit’s lone reign over claim construction (some of the time at least)

Just like an older sibling forced to share with a new younger brother or sister, we are all likely familiar with authority stepping in and forcing us to share our previously unchecked power or benefits with others. That’s...more

Intellectual Property Alert: Supreme Court Overturns De Novo Review of Patent Claim Construction

On Tuesday, in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., the Supreme Court reversed long-standing Federal Circuit precedent under which patent claim construction was reviewed wholly de novo. Specifically, the Court held...more

Novartis and Qualcomm Form Digital Health Investment Company

Novartis Pharmaceuticals has announced it has formed a joint investment company with Qualcomm Ventures, the venture investment group of Qualcomm....more

Supreme Court Endorses De Novo Review of Claim Construction, But Holds that Subsidiary Facts Underlying Claim Construction are...

Background: Patent claim construction findings are a key aspect to patent infringement cases. Previously, the Federal Circuit reviewed the entire claim construction issue, including any subsidiary facts, de novo....more

Supreme Court Starts 2015 Off with Focus on Facts Shaping Intellectual Property Disputes

The U.S. Supreme Court kicked 2015 off with an intellectual property bang, issuing two important rulings earlier this week. Both decisions focus on the facts underpinning intellectual property disputes—who decides them and...more

In Teva Pharmaceuticals USA, Inc. And Hana Financial, Inc., The Supreme Court Issues Two IP Decisions – One Deferring To Trial...

This week, the Court rendered two IP opinions in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., No. 13-854 (argued October 15, 2014) and Hana Financial, Inc. v. Hana Bank, No. 13-1211 (argued December 3, 2014) . Teva...more

De Novo Review of Claim Construction No Longer the De Facto Standard

On January 20, the U.S. Supreme Court, in Teva Pharmaceuticals USA, Inc. v. Sandoz, rejected the de novo review standard applied by the U.S. Court of Appeals for the Federal Circuit when reviewing all claim construction...more

Electronic Distribution of Prescribing Information for Prescription Drugs & Biologicals

The FDA published a proposed rule on December 18, 2014 that would require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or...more

Supreme Court Alters Claim Construction Review Standard in Patent Litigation

The Court creates a hybrid standard of review. On January 20, in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., the U.S. Supreme Court altered the U.S. Court of Appeals for the Federal Circuit’s longstanding de novo...more

Supreme Court's Dual Standard of Review for Claim Construction Creates a Potential Grab Bag For Patent Litigants

The United States Supreme Court clarified yet another important standard in patent law by mandating that the Federal Circuit apply clear error review when reviewing subsidiary factfindings in patent claim construction. Teva...more

Teva v. Sandoz: The Dissent

The recent history of Supreme Court patent cases has made the dissent a seemingly endangered species, the Court consistently deciding important patent cases by 9-0 votes and, at best, garnering concurring opinions for...more

FDA One Step Closer to New Direct-To-Consumer Television Ad Requirements

Last February, the Food and Drug Administration (FDA) asked for public feedback on a proposed research study related to prescription drug television advertisements. In a notice published in the Federal Register on January 13,...more

Speed of Pharmaceutical Innovation at Stake in N.Y. Antitrust Lawsuit

A pharmaceutical firm’s ability to efficiently produce and promote a better treatment for Alzheimer’s disease lies at the center of an antitrust lawsuit pending before the U.S. Court of Appeals for the Second Circuit. In...more

U.S. Supreme Court Delivers Important Ruling in Teva v. Sandoz Case

The U.S. Supreme Court recently held that the U.S. Court of Appeals for the Federal Circuit, which has nationwide jurisdiction for patent cases, must give deference to a district court’s factual findings in claim construction...more

Supreme Court Gives District Courts More Power in Patent Claim Construction

On January 20, 2015, in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., the Supreme Court reallocated power between federal district courts and the Federal Circuit in the patent claim construction process.  For many years,...more

U.S. Supreme Court Modifies Federal Circuit's Standard of Review for Claim Construction in Teva v. Sandoz

On January 20, 2015, resolving a long debated issue, the U.S. Supreme Court set aside the Federal Circuit’s de novo review of every aspect of a lower court’s claim construction decision, rejecting that form of review where...more

Supreme Court Changes Appellate Standard of Review for Claim Construction Rulings in Patent Cases

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

Supreme Court Refines the Federal Circuit’s Standard of Review for Claim Construction

The Federal Circuit’s high rate of reversal of district court claim constructions is well documented. The de novo standard of review applied by the Federal Circuit to all aspects of claim construction has played a large part...more

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