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AstraZeneca AB v. Apotex Corp. (Fed. Cir. 2015)

Earlier this month, the Federal Circuit rendered a decision on damages in what may be the last of a long-running series of ANDA cases involving AstraZeneca's Prilosec® (omeprazole) franchise. As set forth in the opinion,...more

Whistleblower Pays Price for Frivolous Suit

On Wednesday of this week, the federal court for the Southern District of New York rejected Fox’s plea to spare it from the $169,000 bill submitted by the white shoe law firm that successfully defended Managed Health Care...more

Otsuka Files Amended Complaint and Motion for TRO/PI for Abilify®, Pointing to Congressional Intent to Argue Broad Exclusivity

As discussed in our April 13, 2015 blog, Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America Pharmaceutical, Inc. (collectively “Otsuka”) had until April 15, 2015...more

Amgen Receives No Help from the FDA -- A Biosimilar Update

Near the end of last month, the U.S. Food and Drug Administration ("FDA") denied a citizen petition filed by Amgen in which it requested that action be taken to ensure that biosimilar applicants comply with the disclosure and...more

Federal Circuit Addresses Damages in the Hatch-Waxman Context

On April 7, 2015, the United States Court of Appeals for the Federal Circuit issued its decision in Astrazeneca AB v. Apotex Corp., No. 2014-1221, affirming an award of a reasonable royalty of 50% in a case arising from the...more

Motions To Stay Pending Resolution Of Rule 12 Motions Is Granted.

Kaavo Inc. v. Cognizant Technology Solutions Corporation, et al, C.A. Nos. 14-1192-LPS-CJB; 14-1193-LPS-CJB, April 9, 2015. Burke, C. J. Defendants’ motions to stay proceedings pending resolution of Rule 13 motions to...more

A New Weapon to Combat Cybersquatting: File Suit against Domain Registrars and Hosting Companies

Cybersquatting, under the Anticybersquatting Consumer Protection Act (ACPA), 15 U.S.C. § 1125(d), is registering, trafficking in, or using an Internet domain name with bad faith intent to profit from the goodwill of a...more

Target’s Consumer Class Action Settlement: A New Way to Resolve Big Data Breach Cases?

Many will recall the 2013 holiday shopping season when Target announced that cyber thieves had accessed and stolen as many as 70 million customer credit and debit card numbers and extracted personal information for another 40...more

FDA Denies Request to Make “Patent Dance” a Prerequisite for Biosimilar Approval

In a decision released on March 25, 2015, FDA denied a Citizen’s Petition that would have effectively made the information and patent exchange described in § 262 of the Biologics Price Competition and Innovation Act (“BPCIA”)...more

Third Party Subpoena Permitted in IPR - Marvell Semiconductor, Inc. v. Intellectual Ventures I LLC

After briefing on the Garmin factors to determine if additional discovery was “necessary in the interest of justice” during an inter partes review (IPR), the Patent Trial and Appeal Board (PTAB or Board) granted the patent...more

Amgen Inc. v. Sandoz Inc.

On March 19, 2015, the United States District Court for the Northern District of California issued its decision in Amgen Inc. v. Sandoz Inc., construing the patent negotiation provisions of the Biologics Price Competition and...more

IP Newsflash - April 2015

DISTRICT COURT CASES - Patent Directed to Online Auction Held Invalid Under § 101 - A district court recently granted a defendant’s motion for judgment on the pleadings, holding that a patent directed to an...more

Threshold Issues: IPR Not Derailed by Unidentified D/B/A Name or Prior ANDA Certification - Metrics, Inc. v. Senju Pharmaceutical...

Addressing threshold jurisdictional issues of a petition for inter partes review (IPR), the U.S. Patent and Trademark Office’s (USPTO) Patent Trial and Appeal Board (PTAB or Board) determined that a d/b/a name does not create...more

California District Court Denies Amgen’s Motion for a Preliminary Injunction on BPCIA

On March 19, Judge Seeborg of the Northern District of California denied Amgen’s motion for a preliminary injunction in Amgen v. Sandoz. Sandoz recently won the first-ever FDA approval for a biosimilar for its product Zarxio,...more

Ambiguity in Court’s Construction Creates Objective Reasonableness of Infringement and Negates Exceptional Case Determination -...

Addressing the award of attorneys’ fees by the district court, the U.S. Court of Appeals for the Federal Circuit reversed the district court’s grant of fees under § 285 and affirmed the district court’s denial of fees under §...more

Strike Two – FDA Rejects Amgen’s Certification Petition for Biosimilar Applicants

In parallel with the district court case where Amgen is asserting that Sandoz has not complied with the BPCIA because they have not provided Amgen with a copy of their biosimilar application, in October 2014 Amgen filed a...more

Target Reaches Preliminary Settlement in Consumer Data Breach Class Action

Last week, a Minnesota federal district court granted a motion for preliminary approval of a settlement of putative consumer class action claims against Target in the wake of a data breach at the retailer over the 2013...more

The $10 Million Target Settlement

In the past two years, there have been a number of lawsuits filed against major corporations as a result of data breaches, including the class action filed against Target following the data breach it suffered in late 2013. ...more

Draeger Medical Systems Files For Declaratory Judgment Against My Health

On March 19, 2015, Draeger Medical Systems, Inc. (“Draeger”) filed a Declaratory Judgment action against My Health, Inc. (“My Health”). The complaint alleges that My Health sent a cease and desist letter to Draeger that...more

The Tyranny of the Judiciary

There has always been a tension between the need for a final arbiter of the law and the inherent power associated with such a role placed in the judicial branch. Jefferson himself was wary of this tendency, writing in a...more

Alert - Biologics Price Competition and Innovation Act (BPCIA) Developments

The Evolving World of Biosimilars - Amgen, Inc. v. Sandoz, Inc. Addressing two new issues in the Biologics Price Competition and Innovation Act (BPCIA), the Northern District of California issued an order, on...more

One More Hurdle Cleared – Amgen’s Preliminary Injunction Motion for Filgrastim is Denied

On March 19, 2015, Judge Seeborg of the United States District Court for the Northern District of California denied Amgen Inc.’s motion for a preliminary injunction in the Amgen v. Sandoz case, thereby removing one more...more

Large Retailer Agrees to Pay $10 Million Related to Data Breach Incident

On March 19, a district court granted preliminary approval in which a large retailer agreed to pay $10 million to settle a class-action action suit related to a 2013 data breach, which resulted in the compromise of at least...more

District Court Rules Against Amgen’s Motion for Preliminary Injunction to Prevent Marketing of Sandoz’s Biosimilar Zarxio

In an order released on March 19, 2015, U.S. District Court Judge Richard Seeborg of the Northern District of California denied Amgen’s motion for judgment on the pleadings as well as its request for a preliminary injunction...more

Gotta Dance? Apparently Not -- A Biosimilar Update

United States District Judge Seeborg of the Northern District of California denied Amgen's motion for a preliminary injunction today in the Amgen v. Sandoz case, thereby paving the way for the marketing of the first...more

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