Administrative Agency Intellectual Property Civil Remedies

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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

District Court Lifts Stay After Covered Business Method Review Is Dismissed Because Federal Circuit Would Not Have Jurisdiction to...

Plaintiff GT Nexus, Inc. ("GT Nexus") filed a declaratory judgment action against Inttra, Inc. ("Inttra") seeking a declaration that four of Inttra's patents ("patents-in-suit") were invalid and have not been infringed....more

Don't Underestimate the Importance of TTAB Proceedings

A recent U.S. Supreme Court decision, B&B Hardware, Inc. v. Hargis Industries, Inc., heightens the importance of often-neglected trademark conflict administrative proceedings in the Trademark Trial and Appeal Board....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

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

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

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

Supreme Court Holds That TTAB Rulings Can Have Preclusive Effect in Court

On Tuesday, the Supreme Court issued its decision in B&B Hardware v. Hargis Industries, ruling that decisions of the Trademark Trial and Appeal Board (TTAB) on “likelihood of confusion” in trademark opposition proceedings can...more

Supreme Court: An Administrative Ruling on Confusion Can Be the Last Word in Trademark Litigation

Trademark disputes often focus on whether two marks create a “likelihood of confusion” with one another. That issue can come up before a court considering trademark infringement; before the Trademark Trial and Appeal Board...more

Supreme Court Seals Tight a TTAB Decision

In a recent case that will raise the stakes for companies involved in contentious administrative trademark proceedings, the U.S. Supreme Court held that the administrative tribunal, the Trademark Trial and Appeal Board...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

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

POM Wonderful: The New Prescription for False Advertising

The ability of private parties to pursue mislabelling claims depends on whether allowing such claims to proceed would conflict with the purpose and intent of federal labelling laws and implementing regulations, such as those...more

District Court Action Dismissed Without Prejudice Does Not Bar Filing of IPR Petition - Nautique Boat Co., Inc. v. Malibu Boats,...

Addressing whether a district court action dismissed without prejudice bars a filing of an inter partes review (IPR) petition under 35 U.S.C. § 315(a)(1), the U.S. Patent and Trademark Office’s (PTO) Patent Trial and Appeal...more

Sandoz Inc. v. Amgen Inc.,

Case Name: Sandoz Inc. v. Amgen Inc., No. 2014-1693, 2014 U.S. App. LEXIS 22903 (Fed. Cir. Dec. 5, 2014) (Circuit Judges Dyk, Taranto, and Chen presiding; Opinion by Taranto, J.) (appeal from N.D. Cal, Chesney, J.) (A...more

No Declaratory Jurisdiction Without Biosimilarity Application on File with FDA - Sandoz Inc. v. Amgen Inc.

Avoiding an interpretation of the Biologics Price Competition and Innovation Act (BPCIA), the U.S. Court of Appeals for the Federal Circuit invoked traditional case or controversy principles to affirm the dismissal of a...more

Federal Circuit Review | January 2015

RAND Commitment Relevant to Damages - In ERICSSON, INC. v. D-LINK SYSTEMS, INC., Appeal Nos. 2013-1625, -1631, -1632, and -1633, the Federal Circuit affirmed-in-part and reversed-in-part the district court’s judgment...more

Canada Begins Border Enforcement for Counterfeits

On January 1, 2015, the Government of Canada declared into force new border controls designed to prevent counterfeit and copyright infringing goods from entering and exiting Canada. The new border controls empower officers of...more

"No Clinically Meaningful Differences": The First Accepted Biosimilar Application Has Been Recommend for FDA Approval

Last week, at their January 7, 2015 meeting, the FDA's Oncologic Drugs Advisory Committee ("ODAC") recommended the approval of Sandoz's biosimilar filgrastim application to market a version of Amgen's NEUPOGEN® biologic drug....more

ITC Issues Its First Stay of a CDO - In the matter of Certain Digital Models, Digital Data, and Treatment Plans for Use in Making...

For the first time the U.S. International Trade Commission (U.S. ITC) issued a stay of a cease and desist order (CDO) issued at the conclusion of an investigation under § 337 of the Tariff Act. In the matter of Certain...more

Rubber Hits the Road: Rust-Oleum Trademark Case Leaves TTAB for Minnesota Federal Court

Lately we’ve been discussing more and more the difference between the right to register a trademark and the right to use a trademark. In many trademark disputes the perfect forum for an amicable resolution is the Trademark...more

Justice Department and Patent Office Issue “Policy Statement” Regarding Remedies for Standards-Essential Patents

In a statement likely to be influential with courts, the U.S. Department of Justice (DOJ) and the Patent and Trademark Office (PTO) on January 9 issued a joint Policy Statement urging limitations on remedies for infringement...more

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