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ANDA Update - Volume 2, Number 2

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

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

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

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

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*

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

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

MAG Aerospace Industries, Inc. v. B/E Aerospace, Inc. (Fed. Cir. 2016) - Equitable Assignor Estoppel Doctrine Expanded by Federal...

Arcane aspects of the law are frequently analogized as constituting "traps for the unwary," and patent law seems to have more than its share of minutiae that fall within that characterization. The equitable principle of...more

FTC Maintains Aggressive Stance Against Pay-for-Delay Deals

A recent complaint filed by the Federal Trade Commission (FTC) indicates that the agency is continuing its aggressive pursuit of agreements between drug manufacturers that delay the entry of generic pharmaceuticals into the...more

German Court orders WhatsApp to provide consumers in Germany with T&Cs in German language

In a press release dated 17 May 2016, the Federation of German Consumer Organizations (Verbraucherzentrale Bundesverband – vzbv) announced that on 8 April 2016, the Court of Appeal Berlin (Kammergericht Berlin; “Court”)...more

President Obama Signs the Defend Trade Secrets Act into Law

On May 11, 2016, the President signed the Defend Trade Secrets Act of 2016 (DTSA) into law, creating the first federal civil remedy for trade secret misappropriation. Last month, the Senate unanimously passed the bill, S....more

FTC Settles Monopolization Charges Stemming from Contract Exclusivity Terms Used by First-to-Market Medical Polymer Maker

The mere possession of monopoly power does not violate federal antitrust laws. The laws only address the anticompetitive acquisition, maintenance, or abuse of that power. The Federal Trade Commission (“FTC”) entered into a...more

Medical Software Company Wins $940 Million in Trade Secret Case

A jury recently awarded Epic Systems Corporation (“Epic”), a medical software company, $940 million in damages in a case against Tata Consultancy Services Limited (“Tata”) involving theft of Epic’s trade secrets and...more

Digital Single Market Strategy Update: Europe Proposes Further Harmonisation of Consumer Protection Laws

The European Commission has published two draft directives on the supply of digital content and the online sale of goods that aim to help harmonise consumer law across Europe. In proposing these new laws, the European Union...more

District Court Grants Motion for Summary Judgment on Laches Defense Where Defendant Could Not Establish Prejudice from Plaintiff's...

The court explained the facts as follows: The defendant, CrestaTech, was founded by Mihai Murgulescu and George Haber in 2005. Its initial products included a receiver for satellite radio and a television platform. CrestaTech...more

Home Depot agrees to settle data breach class action suit for at least $19.5 million and up to $28 million including attorneys’...

Home Depot announced on March 7, 2016, that it is agreeing to settle claims against it for the massive data breach that occurred in 2014, affecting up to 56 million debit and credit card holders for at least $19.5 million,...more

In Daubert Ruling Excluding Both Parties’ Damages Experts, Judge Andrews Rejects FRAND Portfolio Rate as Ceiling on Reasonable...

On February 25, 2016, Judge Richard Andrews granted the parties’ cross-motions to exclude both sides’ damages experts in M2M Solutions LLC v. Motorola Solutions, Inc., C.A. No. 12-33-RGA, Dkt. Nos. 295 and 296 (D. Del. Feb....more

5 Questions About France’s New Health-related Class Action Law

The number of eligible associations and the law’s broad scope could portend a significant number of health-related class actions. A new law, referred to as Loi Santé No. 2016-41 and enacted on 26 January 2016, contains...more

President Obama Signs the Judicial Redress Act (H.R.1428/S.1600)

As part of implementing the EU-US Privacy Shield, on February 24, 2016, President Obama signed the Judicial Redress Act (H.R.1428/S.1600). This law is designed to give EU citizens the right to sue the U.S. government for...more

WSGR Obtains First-of-Its-Kind Precedent on California's Automatic Renewal Law

A host of Silicon Valley companies have been targeted by suits claiming that recurring payments the companies receive for services have been obtained in violation of California's Automatic Renewal Law (ARL), Business and...more

Litigation Watch: Can a Third-Party Vendor Be Left Holding the Bag After a Breach?

Many organizations, particularly those outside of the technology sector, rely heavily on third-parties—including cyber security specialists, lawyers, and public relations firms—to help pick up the pieces after a data breach. ...more

IP Newsflash - February 2016 #2

SUPREME COURT CASES - Post-Complaint Events or Transactions Cannot Cure Prudential Standing Defects - The U.S. Supreme Court denied Alps South’s writ to review the Federal Circuit’s decision that the company lacked...more

Defendants Summary Judgment Motion in In re Cathode Ray Tube Antitrust Litigation May Illuminate Policy Justifications Behind...

Earlier this month, defendants in the In re Cathode Ray Tube Antitrust Litigation moved to challenge the standing of major retailers to pursue damages claims under the Supreme Court’s 1977 Illinois Brick decision. LG...more

Harmonizing B2C Online Sales of Goods and Digital Content in Europe

The European Commission has announced new draft laws that would give consumers new remedies where digital content supplied online is defective or not as described by the seller....more

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