Intellectual Property Administrative Agency Civil Procedure

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Otsuka’s Orphan Drug Exclusivity Claims: FDA Rips Off the Band-Aid Early

On April 20, 2015, FDA filed a brief in Opposition to Plaintiff’s Motion for Temporary Restraining Order (“TRO”) or Preliminary Injunction (“PI”), addressed how Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical...more

Amgen v. Sandoz BPCIA Dispute Heads to the Federal Circuit

After a series of preliminary skirmishes, the first full-fledged litigation under the Biologics Price Reduction and Innovation Act is Amgen’s lawsuit against Sandoz concerning Sandoz’s Zarxio, a biosimilar version of Amgen’s...more

Benefits of Showing Discovery as “Routine” Instead of “Additional”

The PTAB issued an order granting in part a request for discovery by an IPR petitioner. IPR2014-00727 - C&D Zodiac, Inc. v. B/E Aerospace, Inc. ...more

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

Senju Pharm. Co., Ltd. v. Metrics, Inc.

Case Name: Senju Pharm. Co., Ltd. v. Metrics, Inc., Civ. No. 14-3962-JBS/KMW, 2015 U.S. Dist. LEXIS 41504 (D.N.J. Mar. 31, 2015) (Simandle, J.) ....more

30 Months of IPR Practice – By the Numbers

UntitledWelcome to Volume 9 of our IPR-PGR Report. After 30 months of IPR practice, some trends are taking shape. Overall, the percentage of petitions put into trial has gradually decreased, down to 76% this quarter, from a...more

Texas eMediaLaw Legislative Update: 2015

It’s Spring in Texas which means one of two things – the bluebonnets are out and in odd years, our legislature is back at work. One makes me grateful to be in Texas and the other only meets every other year. Here are a few...more

Supreme Court Holds that TTAB Decisions May Have Preclusive Effect, Raising Stakes for Trademark Agency Proceedings

On March 24, the US Supreme Court issued a decision that is likely to raise the stakes of proceedings before the Trademark Trial and Appeal Board (TTAB). In B&B Hardware, Inc.v. Hargis Industries, Inc., No. 13-352 (March 24,...more

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

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

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 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

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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