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Supreme Court: Biosimilar Applicants May Provide Commercial Marketing Notice Before FDA Approval

by Jones Day on

On June 12, 2017, the U.S. Supreme Court decided two important questions under the Biologics Price Competition and Innovation Act ("BPCIA"), which provides an abbreviated pathway for the approval of generic biologics: (i) the...more

Amgen v. Sandoz: The Supreme Court’s First Biosimilars Ruling

In a unanimous decision issued on June 12, 2017, the Supreme Court for the first time interpreted key provisions of the 2010 Biologics Price Competition and Innovation Act (“BPCIA”). See Sandoz Inc. v. Amgen Inc., No. 15-1195...more

You Don’t Have to Dance the Patent Dance (Except Maybe in California)

Supreme Court Decides BPCIA “Patent Dance” Questions - The 2009 Biologics Price Competition & Innovation Act (BPCIA) provides an orderly process for manufacturers of generic biological drugs (called “biosimilars”) to...more

Supreme Court Permits Biosimilar Drugs to Be Marketed Sooner

by Snell & Wilmer on

On June 12, 2017, in Sandoz Inc. v. Amgen Inc., the United States Supreme Court unanimously held that a drug manufacturer may give a required 180-day notice of its intent to market a biosimilar drug before receiving FDA...more

SCOTUS Simplifies Market Entry Process for Biosimilar Products

by Jackson Walker on

Yesterday’s unanimous ruling by the U.S. Supreme Court in Sandoz v. Amgen injects much needed certainty into a difficult statute and streamlines the process for biosimilar products to enter the marketplace following FDA...more

Yet another Target settlement highlights data breach costs

by Thompson Coburn LLP on

In what appears to be the closing act of the saga that is the Target data breach, on May 23 the retailer announced it had reached a settlement agreement with a coalition of 47 states’ attorneys general. Pursuant to the...more

Shareholder Dismisses Case with Prejudice that Sought to Block Amendment to Intel Stock Plan

As we noted here, a shareholder of Intel sought a preliminary and permanent injunction and any other appropriate relief with respect to a stockholder vote to approve the amendment and restatement of Intel’s 2006 equity...more

ROADBLOCK IN PLACE: Court Grants Limited Preliminary Injunction in Waymo v. Uber

Imagine preparing for that big meeting on your way to work, while you ride along in your car—without the need for a driver. What sounds like it might be out of a sci-fi movie, may actually be the not-so-distant future. Such...more

Shareholder Seeks to Block Amendment to Intel Stock Plan

A shareholder of Intel Corporation has filed a complaint in the United States District Court for the Southern District of New York. The shareholder seeks a preliminary and permanent injunction and any other appropriate relief...more

Another Shot Across The Virtual Bow

This post is a follow-up to my post a couple weeks ago regarding the Zenimax v. Oculus case. As expected, Zenimax filed its motion for an injunction on February 23. The motion itself pulls no punches. It directly and...more

2016’s Top Patent and Trade Secret Developments for Chemistry and Nanotechnology

While 2016 saw several significant IP developments regarding the USPTO claim construction standard and the standard of review of USPTO decisions, the following three developments may have the greatest impact on how in-house...more

Smith & Nephew, Arthrex Settled Suture Anchor Patent Dispute Before Trial

by Knobbe Martens on

On February 14, 2017, U.S. District Judge Michael Mosman of the United States District Court, District of Oregon granted a Joint Stipulated Motion for Dismissal with Prejudice submitted by Plaintiffs Smith & Nephew, Inc. and...more

Innovative Salad Restaurant Agrees to Make Website and Mobile App Accessible

by Seyfarth Shaw LLP on

Seyfarth Synopsis: New website and mobile app accessibility settlement agreement requires WCAG 2.0 AA conformance, training, and feedback mechanism. Being named one of the most innovative companies of 2016 doesn’t make...more

Supreme Court to Consider Biologics Price Competition and Innovation Act

On Friday, Jan. 13, the Supreme Court granted the appellant’s petition and the respondent’s cross-petition for a writ of certiorari in Sandoz Inc. v. Amgen Inc. This is the first time the Court will construe the Biologics...more

Supreme Court Grants Cert in Amgen v. Sandoz

On January 13, 2017, the Supreme Court granted Sandoz’s petition for certiorari and Amgen’s cross-petition in Amgen v. Sandoz, case nos. 15-1039 and 15-1195. The two cases were consolidated, and an hour was allotted for oral...more

Teva FCPA Enforcement Action-Part I

by Thomas Fox on

Just when you were thinking things could not get any bigger after the Odebrecht/Braskem Foreign Corrupt Practices Act (FCPA) enforcement action, the Department of Justice (DOJ) and Securities and Exchange Commission (SEC)...more

Federal Circuit Review | October 2016

by Knobbe Martens on

Withdrawal of Claims During Prosecution Can Trigger Prosecution History Estoppel In UCB, Inc. v. Yeda Research and Development Co., Ltd., Appeal No. 2015-1957, the Federal Circuit held that prosecution estoppel can apply even...more

ANDA Update - Volume 2, Number 2

by McDermott Will & Emery on

180-Day Notice Period for Biosimilar Approval Is Always Mandatory and Enforceable by Injunction - Amgen Inc., v. Apotex Inc., (Fed. Cir. July 5, 2016) - A year after analyzing the patent dance and notice...more

Janssen Seeks Injunction Against Remicade Biosimilar Based On Cell Culture Patent

by Foley & Lardner LLP on

In a complaint filed June 14, 2016, Janssen Biotech Inc. seeks a preliminary injunction that would bar Celltrion and Hospira from selling the biosimilar version of Remicade® (infliximab) that received FDA approval April 2016,...more

How to Prepare for Theft of Company Information

by Dorsey & Whitney LLP on

Companies should take three steps now to ensure use of the Defend Trade Secrets Act. In May, President Barack Obama signed into law the Defend Trade Secrets Act that creates a federal civil cause of action for the...more

Federal Circuit Backs Amgen on Key Provision of Biosimilars Statute

The Federal Circuit on Tuesday ruled that the 180-day notice of commercial marketing provision of the Biologics Price Competition and Innovation Act (BPCIA) is a requirement for all biosimilar applicants regardless of whether...more

Federal Circuit Invites FDA's Early Licensure of Biosimilars to Encourage Pre-Launch Resolution of Patent Disputes

by Foley Hoag LLP on

In its July 5, 2016 decision in Amgen v. Apotex, the Federal Circuit interpreted the Biologics Price Competition and Innovation Act (BPCIA) for the second time. The Court reiterated that the BPCIA requires a biosimilar...more

Federal Circuit Rules on Biosimilar Notice Requirement

by Knobbe Martens on

Biosimilar Applicants Must Provide Notice of Commercial Launch: What You Need To Know - Case Background - In an opinion released today in Amgen v. Apotex, the Federal Circuit held biosimilar applicants who...more

Ask the Public Adjustor: Covering Life with Wisdom*

by Pullman & Comley, LLC on

I’ll come right out and admit it: I was a crasher at last night’s party. Though they helped me bluff my way in, every stitch of clothing I wore was borrowed, and the limo … it’s a long story, but let’s just say Uber. Then I...more

Most-Favored Licensee Entitled to Refund of 99 Percent of Lump Sum Royalty

by McDermott Will & Emery on

The US Court of Appeals for the Fifth Circuit ruled that a most-favored licensee clause allowed a licensee that paid a lump sum of $70 million to be entitled to a refund when a subsequent licensee paid a lump sum of only...more

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