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Patent Safe Harbor Applies to Supplemental New Drug Applications

On May 13, 2015, the Federal Circuit confirmed in Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. that the safe harbor provisions of 35 U.S.C. § 271(e)(1) can shield post-FDA approval activities from liability for...more

IP Dispute Resolution Review Newsletter, Spring 2015

In This Issue: - The New “Clear Error” Standard of Review in Patent Infringement Mediation - Trademark Trial Appeal Board Decisions Now Have Preclusive Effect - Engaging Panelists for Neutral Analysis Provides...more

IP Newsflash - May 2015 #3

FEDERAL CIRCUIT CASES - Federal Circuit Reverses Summary Judgment of Noninfringement Under § 271(e)(1) for Consideration of Certain Post-FDA-Submission Activities, But Expresses Skepticism About Infringement...more

PTAB Clarifies Protocol for Expanded Post-Grant Panels

Today the Patent Trial and Appeal Board (“Board”) posted on its website Revision 14 of its Standard Operating Procedure 1 (SOP 1). SOP 1 covers the assignment of Administrative Patent Judges to merits panels, interlocutory...more

USPTO Implements Quick Fixes to AIA Review Rules

On March 27, 2015, the director of the U.S. Patent and Trademark Office (PTO) announced several quick fixes in response to public comments on proposed revisions to the rules for inter partes review (IPR), post grant review...more

Another Step Towards the Implementation of the “Unitary Patent Package”

The Court of Justice of the European Union on 5 May 2015, in cases C-146/13 and C-147/13, has followed Advocate General Yves Bot’s opinion and dismissed, as expected, the Kingdom of Spain’s actions against the Regulations...more

Board Clarifies When Expanded Panel Can Consider an IPR Issue

In the aftermath of the decision by an expanded panel of PTAB judges in Target Corp. v. Destination Maternity Corp. (deciding, in a 4-3 decision, that both joinder of issues and joinder of parties is allowed in inter partes...more

Amgen Prevails on Temporarily Excluding Zarxio® From Market

After an unsuccessful attempt to obtain a preliminary injunction against Sandoz Inc.’s (“Sandoz”) Zarxio® in the District Court for the Northern District of California, Amgen Inc. (“Amgen”) has prevailed before the Federal...more

Federal Circuit Keeps Sandoz Biosimilar Off the Market for Now

The Federal Circuit is set to hear oral arguments in Amgen v. Sandoz on June 3, but in the meantime has granted Amgen’s motion for a preliminary injunction to keep Sandoz’ biosimilar version of Neupogen® off the market until...more

PTO Revival Rulings Are Not Subject to Collateral Attacks by Third Parties - Exela Pharma Sciences, LLC v. Lee

Addressing whether third parties have the right to challenge a patent revival ruling by the U.S. Patent and Trademark Office (PTO) under the Administrative Procedure Act (APA), the U.S. Court of Appeals for the Federal...more

ITC Section 337 Update - May 2015

ALJ Lord Recommends 12 Month Delayed Relief Based On Public Interest If Commission Finds Violation Of Section 337 In 910 – On April 10, 2015, ALJ Lord issued the public version of the Initial Determination on Violation and...more

SCOTUS Opts Not To Remand Case Raising Preclusion Question Answered in B&B Hardware

On April 27, the Supreme Court surprisingly denied certiorari in Escamilla v. M2 Tech., Inc., U.S., No. 14-1012 rather than remanding the case for further consideration in light of the High Court's recent decision in B&B...more

“Indirect” Common Inventorship Not Sufficient To Support Priority Claim Under 35 U.S.C. §120

The PTAB recently took up the issue of whether, in a family of patents and applications, a later patent in the family is entitled to the benefit of the filing date of an earlier-filed application in the family where the later...more

Trademark Review | April 2015

The Supreme Court Rules TTAB Findings May Have Preclusive Effect in Later Federal Court Proceedings - B&B and Hargis have long contested each other’s rights in the mark "SEALTIGHT" for fasteners. B&B was the first to...more

Federal Circuit Patent Updates - April 2015

Biosig Instruments, Inc. v. Nautilus, Inc. (No. 2012-1289, 4/27/15) (Newman, Schall, Wallach) - April 27, 2015 11:12 AM. Wallach, J. On remand from the Supreme Court, reversing district court summary judgment...more

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

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

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