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District Court Declines to Lift Stay Even After Patent Trial and Appeal Board Issued Written Decision on CBM Petitions

The district court stayed several consolidated cases pending certain proceedings before the Patent Trial and Appeal Board ("PTAB"). In the order granting the stay, the district court stated: "Upon issuance of a final decision...more

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

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

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

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

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

Order in Amgen v. Sandoz Provides First Judicial Interpretations of the BPCIA Patent Dispute Resolution Provisions

On March 19, 2015, the District Court for Northern District of California (Judge Seeborg), issued an order providing one of the first judicial interpretations of the patent dispute resolution provisions laid out in subsection...more

Defining “Reasonable” in RAND: A Bit of Common Sense

What is RAND? It’s a simple question. Given the ubiquity of the term, one would think that the answer would be clear. After all, standard-setting organizations (“SSOs”) around the world require patent holders to declare their...more

A “Solution” in Search of a Problem? The Innovation Act of 2015 and Trends in Fee-shifting in Patent Litigation

On February 5, 2015, Rep. Robert Goodlatte (R-VA) introduced H.R. 9, entitled the “Innovation Act.” Among other things, the bill would direct courts to award attorneys’ fees and litigation-related expenses to prevailing...more

The First Biosimilar Application Has Been Approved -- But What About the Patent Issues?

As we reported earlier this week, the U.S. Food and Drug Administration ("FDA") approved the first biosimilar application -- an application by Sandoz to market a biosimilar version of Amgen's NEUPOGEN® (filgrastrim) biologic...more

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