Pharmaceutical Industry

News & Analysis as of

FDA Proposes Electronic Distribution of Prescribing Information

Drug manufacturers may no longer be required to distribute prescribing information on paper—with limited exceptions—and instead may have to distribute that same information electronically. The FDA recently issued a proposed...more

Supreme Court Cuts Out a Slice of the Federal Circuit’s De Novo Pie

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

The Supreme Court Clarifies the Standard for Reviewing Fact-finding in Claims Construction

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

Claims Are Construed Relating To Polysorbate Patents

Andrews, J. Claim construction opinion issues. The court considers 17 terms from five patents regarding formulation and device patents relating to polysorbates....more

Product Liability Alert: Failure-To-Warn Suit Against Generic Drug Maker Proceeds Despite Argument of Federal Preemption

On January 20, 2015, the U.S Supreme Court denied cert in Teva v. Superior Court of California, Orange County, refusing to review a California state court ruling allowing patients to proceed with claims that Teva...more

District Court Vacates Insider Trading Guilty Pleas in Misappropriation Case in Light of Landmark Newman Decision

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

FDA Clarifies Orphan Drug Exclusivity Policy Following Court Defeat

On the heels of a loss in federal court last fall, the FDA recently announced a clarification of its policy concerning orphan drug exclusivity. In short, despite a court ruling requiring the FDA to grant orphan drug...more

"Insights Conversations: Life Sciences"

A healthy market for M&A activity, particularly cross-border deals, and a strict regulatory environment are the big factors influencing the health and activities of life sciences companies. Skadden partners John T....more

Supreme Court Orders Federal Circuit To Defer To District Court Factual Findings During Patent Claim Construction: Will Markman...

On January 20, 2015, the U.S. Supreme Court handed down its first patent decision of the current term, rejecting the U.S. Court of Appeals for the Federal Circuit’s long-standing practice of reviewing district court patent...more

Teva Decision Will Be Felt in Future Patent Claim Construction Hearings

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

Teva v. Sandoz (USSC) – Standard for Appellate Review of Claim Construction Rulings

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

HIPAA Violation — Pharmacy Held Liable for Employee’s Misdeeds

Recently, the Indiana Court of Appeals let stand a $1.4 million jury verdict against a national pharmacy chain for its employee pharmacist’s unauthorized disclosure of a customer’s confidential medical records.  Given the...more

Court Report - January 2015 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Tris Pharma Inc. v. Par Pharmaceutical Inc. et al. 1:15-cv-00068; filed January 21, 2015 in the District Court of...more

A Step Forward in Approving Lower-Cost “Generic” Biologic Drugs

A federal advisory panel has helped clear the path for what may be the first biosimilar biologic drug ever approved in the United States. Interestingly, generics of traditional drugs have been available in the U.S. for...more

Supreme Court Changes Standard Of Review For Patent Claim Construction Rulings

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 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

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

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