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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

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

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

ITC Section 337 Update - March 2015

Commission Files Brief In 833 Investigation Appeal Regarding Digital Models Qualifying As “Articles” – On February 18, 2015, the International Trade Commission filed its brief in an appeal to the Federal Circuit of the...more

Design Patent Case Digest: Robinson v. JoeyBra LLC

Decision Date: May 8, 2013 and June 3, 2014 Court: W.D. Virginia - Patent: D448,541 - Holding: Plaintiff’s motion for reconsideration of order denying preliminary injunction - DENIED. Defendant’s motion for...more

In re BRCA1- and BRCA2-based Hereditary Cancer Test Patent Litigation (Fed. Cir. 2014)

In a decision that will surprise no one (written by Judge Dyk, which made the conclusions foregone from the first page of the opinion), the Federal Circuit today affirmed the Utah District Court's decision denying Myriad...more

Judge Griesa declines to revisit Federal Circuit’s finding that a license and settlement agreement is “clear on its face.”

Endo Pharmaceuticals, Inc. v. Roxane Laboratories, Inc. Case Number: 1:13-cv-03288-TPG - Defendant Roxane Laboratories, Inc. (“Roxane”) was sued by Endo Pharmaceuticals, Inc. (“Endo”) when Endo learned that...more

Federal Circuit Hears Arguments in Other Myriad Gene Patents Case

On October 6, 2014, the Federal Circuit heard oral arguments in a case involving the claims of the Myriad gene patents that were not invalidated by the Supreme Court’s 2013 decision. The Federal Circuit is reviewing the...more

District Court Denies Preliminary Injunction Where Plaintiffs Could Not Show Irreparable Harm Because Defendant Is Large and Well...

Plaintiff Hill-Rom Company, Inc. ("Hill-Rom") filed a motion for a preliminary injunction against General Electric Company ("GE"). The district court began its discussion by noting that "[t]he Federal Circuit has said that...more

Mylan Pharms., Inc. v. FDA (N.D.W.V.)

Mylan filed a complaint on April 25, 2014, challenging a letter decision by the FDA, addressing the marketing exclusivity eligibility of celecoxib Abbreviated New Drug Application applicants. Mylan then filed a motion for...more

Defendant Who Defeated Preliminary Injunction And Obtained Dismissal For Failure To Prosecute Is Not A "Prevailing Party" In...

The "prevailing party" in a patent case is entitled to attorney fees from the losing side under 35 U.S.C. 285. However what constitutes a "prevailing party" sometimes can be difficult to determine. Judge Moon recently held...more

Federal Circuit Grants Emergency Stay of Preliminary Injunction for Critical Medical Products

Edwards Lifesciences AG v. CoreValve, Inc. - Less than one week after a district court granted a preliminary injunction, banning some U.S. sales of some of CoreValve’s heart valve system, the U.S. Court of Appeals for...more

Patent Owner Practicing the Patent Not Necessary to Secure Preliminary Injunction

Trebro Mfg., Inc. v. FireFly Equipment, LLC - Addressing whether a plaintiff that does not practice the asserted patent and did not itself invent the patent was entitled to a preliminary injunction against a...more

Practical Reasons to Obtain an Opinion of Patent Counsel

The Federal Circuit and Congress have in recent years made it more difficult for plaintiffs to recover enhanced damages in patent infringement suits. This may have caused companies to erroneously assume that seeking an...more

Edwards Secures Preliminary Injunction Against Medtronic

On April 11, 2014, according to a press release, the U.S. District Court for the District of Delaware issued a preliminary injunction barring Medtronic, Inc. from selling its CoreValve TAVI product to most new customers in...more

Myriad Appeals Adverse Preliminary Injunction Decision

On March 13, Myriad Genetics filed a Notice of (interlocutory) Appeal with the Federal Circuit. Myriad is seeking to have the Court review and reverse the District Court's denial of the company's preliminary jnjunction...more

District Court Doubts Patent Eligibility of Myriad BRCA Claims

In a decision issued March 10, 2014, Judge Shelby of the U.S. District Court for the District of Utah denied Myriad’s motion for a preliminary injunction against Ambry Genetics Corp. While Ambry had challenged the validity of...more

Utah Judge Denies Myriad's Preliminary Injunction Motion

In a 106-page opinion, U.S. District Court Judge Robert J. Shelby on Monday denied Myriad Genetics motion for preliminary injunction in Myriad Genetics v. Ambry Genetics. Characteristic of its aggressive defense of its...more

Preliminary Injunction in Myriad v. Ambry and Gene-by Gene: Myriad Replies

Not to be outdone by defendants Ambry Genetics and Gene-by-Gene's 109-page brief in opposition to Myriad's Preliminary Injunction Motion, Myriad has now filed a Reply Brief weighing in at 140 pages (page limits in briefs...more

Business Litigation Report -- September 2013

In This Issue: ..Private Antitrust Litigation in the UK ..First Decision by PTO Under America Invents Act Invalidates Business Method Patent ..September 2013: Bankruptcy & Restructuring Litigation...more

IP Update, Vol. 16, No. 9, September 2013

Patents/Preliminary Injunction: Preliminary Injunction Ordered Based on Appellate Claim Construction Aria Diagnostics, Inc. v. Sequenom, Inc. - Addressing a preliminary injunction filed by a defendant in a...more

Activision TV Obtains Preliminary Injunction Against Nebraska Attorney General: Court Permits Law Firm to Represent Activision in...

Activision TV, Inc. ("Activision") filed a patent infringement action against Pinnacle Bancorp, Inc. ("Pinnacle"). Counsel for Activision, Farney Daniels, had previously sent letters to companies throughout the United States...more

Defendants' Response to Myriad's Preliminary Injunction Motions - Myriad Genetics v. Ambry Genetics Corp. and Myriad Genetics v....

Last month, Ambry Genetics and Gene By Gene responded to Myriad's motion for preliminary injunction in a 109 page brief that sets out its invalidity case as well as the basis for its antitrust counterclaims. Supported by...more

Myriad Preliminary Injunction Hearing to Be Held September 11, 2013

The hearing on Myriad’s motion for a preliminary injunction against Ambry Genetics is scheduled for September 11, 2013, before Judge Robert A. Shelby at the U.S. District Court for the Central District of Utah....more

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