Intellectual Property Administrative Agency

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Analysis: The Supreme Court’s B&B Hardware Decision Could Have a Significant Impact on Trademark Infringement Disputes

On March 24, 2015, the U.S. Supreme Court held that, under certain circumstances, rulings by the U.S. Patent and Trademark Office’s Trademark Trial and Appeal Board (TTAB) on the core issue of “likelihood of confusion” in...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

Section 337’s Potential for Defending Biologics Market Share Against Biosimilars

Enforcement of biologic patents at the United States International Trade Commission under Section 337 provides certainty and tactical advantages to patent holders that are unavailable in district court under the BPCIA. For...more

Live Testimony for Fact Witness Can Be Appropriate at IPR Oral Hearing

With the Patent Office considering changes to inter partes review practice to potentially increase the use of live testimony at oral hearings, it is worth reviewing the first case in which the Board allowed such live...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

Stricter Standing for Inter Partes Review?

Neither the statutes nor the regulations governing Inter Partes Review (IPR) require the party challenging the patent to have been charged with infringement, or even to establish any interest in practicing the claimed subject...more

Why Trademark Owners Should Care about the B&B Hardware Decision

On March 24, 2015, the Supreme Court decided the case of B&B Hardware v. Hargis Indus. This case represented a long-standing trademark battle brought in both federal court and before the Trademark Trial and Appeal Board...more

New procedures available for invalidating patents before the USPTO

Business executives have long struggled with whether to defend a patent infringement suit in court, try to settle the dispute for less than the cost/risk of defending it, or seek to deal with the problem patent by requesting...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

Reporting Hydraulic Fracturing Chemicals - New BLM Rules and EPA Study Spotlight FracFocus

In the past ten days, the federal government has articulated different views on the utility and effectiveness of FracFocus, a website used by many operators to report the chemicals used to fracture their wells. In its final...more

NLRB Report Targets Unlawful Employer Handbook Rules

On March 18, the National Labor Relations Board's Office of the General Counsel (OGC) published a Report Concerning Employer Rules that discusses a variety of employee handbook rules addressed by the board in recent cases....more

Supreme Court’s B&B Hardware ruling creates the potential for court deference to the TTAB — but will it happen?

Did TTAB proceedings — until now considered a relatively obscure branch of IP litigation, conducted before an administrative body of which most attorneys are blissfully unaware — just assume greater importance? That seems...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

Navigating Protective Order and Prosecution Bar Issues in BPCIA Litigation

Protective orders preventing litigation counsel from participating in the prosecution of litigation-related patents are commonplace. The Biologics Price Competition and Innovation Act (“BPCIA”), for example, provides a...more

Exela Pharma Sciences LLC v. Lee (Fed. Cir. 2015)

Late last month, the Federal Circuit handed Exela Pharma Sciences its latest defeat in litigation relating to its ANDA filing on Cadence Pharmaceuticals' injectable acetaminophen-based drug Ofirmev®, in Exela Pharma Sciences...more

FDA Regulatory and Compliance Monthly Recap – March 2015

In This Issue: - FDA issues guidance on meetings between agency and sponsors to promote consistency and effectiveness - FDA approves Novartis’ Zarxio as the first biosimilar in the U.S., clearing the drug for...more

DEFENSES AGAINST FOIA: Non-Profit Planned Parenthood Succeeds In Keeping Operations Manual Secret

When inquiring minds want to know, non-profit organizations now have a stronger response.  Last year, we posed the question: Can a non-profit maintain trade secrets and other confidential commercial information? The First...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

Board to Parties: “Call Me” - FLIR Systems, Inc. v. Leak Surveys, Inc.

In an order issued after a post-conference call order, the U.S. Patent and Trademark Office’s (USPTO) Patent Trial and Appeal Board (PTAB or Board) denied patent owner’s request to file a motion seeking sanctions, suggesting...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

PTAB Issues Rare Grant of Rehearing and Clarifies Scope of Joinder - Target Corp. v. Destination Maternity Corp.

In a rare decision granting a petitioner’s request for rehearing, a twice-expanded panel of the Patent Trial and Appeal Board (PTAB or Board) reversed its earlier decisions denying institution of the inter partes review (IPR)...more

PTAB is Revising the AIA rules

On March 27, 2015, U.S. Patent and Trademark Office (“USPTO”) Director Michelle Lee announced on the agency’s website that a three-phase rule change for improving Patent Trial and Appeal Board (“PTAB”) trial proceedings is in...more

Real Parties in Interest Really Matter - GEA Process Engineering, Inc. v. Steuben Foods, Inc.

Citing the petitioner’s failure to identify all real parties in interest (RPIs), the U.S. Patent and Trademark Office’s (USPTO) Patent Trial and Appeal Board (PTAB or Board) vacated earlier decisions on institution and...more

European Generics and Biosimilars – Legal Trends and More Discussed at 11th Annual Legal Affairs Forum – Part Two of Two

On the second day of the 11th Annual Legal Affairs Forum held by the European Generic and Biosimilar Medicines Association, additional exclusivity and intellectual property concerns were covered, including key case updates...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

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