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Federal Circuit’s Sandoz v. Amgen Decision Forecloses Early Declaratory Judgment Suits by Biosimilars Applicants

On December 5, in the closely watched Sandoz v. Amgen case, the Federal Circuit held that a biosimilars applicant cannot use the Declaratory Judgment Act to challenge a reference product sponsor's patent prior to filing a...more

Massachusetts Fines Bank for Data Breach

On December 8, a large bank settled with the state of Massachusetts for $825,000 over a data breach that exposed the personal information of at least 260,000 customers. In March 2012, the bank allegedly lost unencrypted...more

Stryker Sues Zimmer For Patent Infringement

Stryker Corp. and Stryker Sales Corp. sued Zimmer, Inc. and Zimmer Surgical, Inc. in the Western District of Michigan on November 21, 2014. In its complaint, Stryker alleges that Zimmer’s “TotalShield Surgical Helmet System“...more

50,000 Reasons for Employees to Think Twice Before Taking Their Employer's Copyright Works and Confidential Information

An ex-employee was recently ordered to pay his former employer AUD50,000 in damages after the Federal Court (Court) held that the employee had infringed copyright and breached his employment agreement and duty of...more

Federal Circuit Rules Against Patent Declaratory Judgment Actions Before Biosimilar Application Is Filed

On December 5, 2014, the Federal Circuit issued its opinion in Sandoz Inc. v. Amgen Inc. et al. In a unanimous panel opinion (Judges Dyk, Taranto and Chen), the Court held that clinical trials initiated to support a possible...more

Celltrion Healthcare Co. v. Kennedy Trust for Rhematology Research (S.D.N.Y. 2014); Hospira Inc. v. Janssen Biotech Inc. (S.D.N.Y....

Earlier this month, Judge Paul Crotty, U.S. District Court Judge for the Southern District of New York handed down rulings in two separate cases related to the biosimilars law (the Biologics Price Competition and Innovation...more

Procedural Missteps Cause Fifth Circuit to Affirm Judgment, Fee Award

M2 Tech., Inc. v. M2 Software, Inc. - In an unpublished decision, the U.S. Court of Appeals for the Fifth Circuit held that a federal district court did not abuse its discretion in issuing a default judgment and fee...more

Federal Circuit Affirms Dismissal in Sandoz v. Amgen under Traditional Jurisdictional Grounds and Declines First Opportunity to...

In the first Federal Circuit case involving the Biologics Price Competition and Innovation Act (“BPCIA” or “Biosimilars Act”), the Court of Appeals for the Federal Circuit affirmed Judge Maxine E. Chesney’s (N.D. Cal.)...more

Patent Ever-Greening: Not So Obvious

Although the Federal Circuit recently affirmed a district court’s decision on patent invalidity based on obviousness-type double patenting, the case provides an impetus to review terminal disclaimer practice within a patent...more

Damages in “Aggravated Breach” Cases

We have written before about the “aggravated breach of contract” theory under N.C. Gen. Stat. § 75-1.1. This theory can make a breach of contract a springboard to treble damages....more

Federal Circuit Finds No Biosimilars Application Means No Case or Controversy for Sandoz

In Sandoz Inc. v. Amgen Inc., the Federal Circuit upheld the district court decision dismissing Sandoz’s declaratory judgment action for lack of jurisdiction. Although this may be the first Federal Circuit decision relating...more

Declaratory Judgment Action Premature: Decision Suggests “Patent Dance” Mandatory for Biosimilar Applicants

Biosimilar applicants and branded biologics have been wondering how the procedures set forth in the Biologics Price Competition and Innovation Act (“BPCIA”) will be implemented since its enactment in 2010. The lack of...more

New York District Court Dismisses Biosimilar Applicant’s Declaratory Judgment Action for Lack of Jurisdiction

In a recent lawsuit between a biosimilar applicant and a patent owner, Judge Paul A. Crotty (S.D.N.Y.) relied on Sandoz Inc. v. Amgen Inc., 3:13-cv-02904-MMC (N.D. Cal. Nov. 12, 2013) to deny declaratory relief for the...more

Federal Circuit Provides Important Guidance in RAND Disputes

On Dec. 4, 2014, the Federal Circuit issued a much-anticipated opinion in Ericsson, Inc. v. D-Link Sys., Inc., Nos. 2013-1625, -1631, -1632, -1633 (Fed. Cir. Dec. 4, 2014). The panel—consisting of Judges Kathleen O'Malley,...more

IP Newsflash - December 2014

Federal Circuit Vacates Lower Court’s Obviousness Finding Based on Incorrect Application of Inherency Doctrine - In Par Pharmaceutical, the Federal Circuit vacated an obviousness ruling by the district court, finding...more

Federal Judge Awards Attorneys’ Fees to Defendant in Dismissed Qui Tam Case, Calls Whistleblower a “Serial Relator”

In November 2013 and this past October, Mintz Levin’s Health Care Qui Tam Update highlighted three separate qui tam False Claims Act (FCA) cases filed by Fox RX, Inc. (Fox), a former Medicare Part D plan sponsor. Fox filed...more

Blog: Beth Israel To Pay $100,000 for Massachusetts Health Information Breach

Beth Israel Deaconess Medical Center (Beth Israel) reached a settlement with the Massachusetts Attorney General’s Office for a data breach in which a physically unsecured laptop was stolen containing personal and protected...more

Federal Circuit Says District Courts Should Freely Grant Stays When CBM Proceeding Instituted

On November 20, 2014, the Federal Circuit issued its decision in Versata Software, Inc. v. Callidus Software, Inc. reversing the district court’s denial of a motion to stay pending a Covered Business Method (“CBM”) review of...more

Storing IP addresses – German referal to the ECJ

(Decision of 28 October 2014, VI ZR 135/13) - The German Federal Supreme Court had to decide whether the Federal Republic of Germany may save the IP address of a visitor to their websites beyond the termination of the...more

State Enforcement Actions Following Class Settlements Addressed By Ninth Circuit

A recent Ninth Circuit decision caught my eye. It addressed whether a state enforcement action can be barred by a class action settlement on the same issue, finding that it was barred in part, to the extent the suit sought...more

District Courts Should Not Nit-PIC

Anti-Cancer, Inc. v. Pfizer, Inc., et al. - Addressing the issue of when it is appropriate to issue sanctions for deficient Preliminary Infringement Contentions (PICs) (under state court procedural rules), the U.S....more

SEC Files Settled Insider Trading Case In District Court

After bringing a series of insider trading cases as administrative proceedings in recent weeks, the Commission returned to its more traditional approach. The agency filed settled insider trading charges against a CEO and...more

Ultramercial Inc. v. Hulu, LLC: Federal Circuit Invites Early Challenges to Subject Matter Eligibility of Software Patents

Earlier this year, in Alice v. CLS Bank, the Supreme Court set out guidelines for determining whether patents claiming software and hardware features are statutorily eligible for patentability under 35 U.S.C. § 101. Following...more

Patent Update for IT and Biotech Companies: New Pieces to the Patent Puzzle

In This Presentation: - PATENT ELIGIBLE SUBJECT MATTER: LIFE IN SOFTWARE/IT AFTER ALICE CORPORATION V. CLS BANK (AND OTHER RECENT 101 DECISIONS) - A Brief History with respect to Software and Biz...more

Versata Software, Inc. v. Callidus Software, Inc. (Fed. Cir. 2014)

The Federal Circuit made it clear earlier today that district courts should freely grant stays in view of Covered Business Method ("CBM") patent reviews instituted by the Patent Trial and Appeal Board ("PTAB"). In Versata...more

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