News & Analysis as of

Disclosure Requirements Patent Infringement Patents

Jones Day

Institution Denied for Failure to Show Disclosure in Provisional Application

Jones Day on

On December 1, 2023, Intelligent Wellhead Systems, Inc. (“Intelligent”) filed a petition for inter partes review (“IPR”) of U.S. Patent No. 11,401,779 (“the ’779 Patent”) (“IPR256”), assigned to Downing Wellhead Equipment,...more

Womble Bond Dickinson

Codifying the Experimental Use Exception? USPTO Seeks Public Input

Womble Bond Dickinson on

The United States Patent and Trademark Office (USPTO) released a Notice on the Federal Register (“the Notice”) today requesting public commentary and input on the current state of the experimental use exception. The USPTO is...more

McDermott Will & Emery

Legal Lens on the Unified Patent Court - May 2024

McDermott Will & Emery on

The Unified Patent Court (UPC) is revolutionizing the way patents are enforced in Europe, and McDermott’s intellectual property team is here to help you navigate this dynamic landscape. Our Legal Lens on the Unified Patent...more

Sunstein LLP

Trial Court Ruling Threatens Patent Portfolio Development

Sunstein LLP on

A recent decision by a San Francisco federal district court judge imperils the way many significant patent portfolios are developed. In Sonos v. Google, Judge William Alsup held that two patents asserted by Sonos against...more

Smart & Biggar

Dexlansoprazole formulation patent invalid and not infringed by Apotex

Smart & Biggar on

On February 7, 2024, the Federal Court dismissed Takeda’s action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations in relation to dexlansoprazole (Takeda’s DEXILANT). Justice Furlanetto...more

Linda Liu & Partners

Donation (Disclosure-Dedication) Doctrine in China’s Patent Litigation

Linda Liu & Partners on

When construing the patent claims to determine patent infringement in China, the principle of equivalence will be applied, that is, the protection scope of a patent right is not only determined by the technical features...more

Fitch, Even, Tabin & Flannery LLP

Federal Circuit Rejects Patentee’s Attempt to Skirt Local Patent Rules in Duplicative Litigation

On September 7, in Arendi S.A.R.L. v. LG Electronics Inc., a Federal Circuit panel affirmed the District of Delaware’s decision dismissing a patent infringement action as duplicative of a co-pending, earlier-filed action. ...more

Foley & Lardner LLP

Does Amgen Have Viable State Law Claims Against Sandoz Arising From The Zarxio Biosimilar Patent Dispute?

Foley & Lardner LLP on

In Sandoz Inc. v. Amgen Inc. (which you can read more about here), the Supreme Court held that 42 USC § 262(l)(9)(C) sets forth the exclusive federal remedy for failing to provide a copy of the biosimilar application to the...more

Burr & Forman

Northern District of California's Revised Patent Local Rules Require Early Disclosure of Damages Information

Burr & Forman on

Last month, the Northern District of California revised its Patent Local Rules by adding requirements for early disclosure of damages information. Because the Northern District of California has been a national driving force...more

Hogan Lovells

Show me the Money: New rules in Northern California call for early disclosure of damages in Patent Litigation

Hogan Lovells on

Recently, the District Court for the Northern District of California updated is Local Patent Rules.  Early disclosure of financial information regarding damages is one change that has attracted some attention. ...more

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

McDonnell Boehnen Hulbert & Berghoff LLP

Federal Circuit Denies En Banc Petition in Amgen v. Sandoz

The Federal Circuit today denied the petitions for rehearing by the panel and rehearing by the en banc Court filed by both parties in Amgen v. Sandoz. Amgen had petitioned for rehearing on the panel's decision that the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen v. Sandoz – Did the Federal Circuit Just Doom the New Biosimilar Approval Pathway?

Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”) in 2009 in an effort to bring biosimilar drug products to market. The goal was for the BPCIA to mimic for biologic drugs the Hatch-Waxman statute...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen v. Sandoz Update -- En Banc Rehearing Petitions Filed

On July 21, 2015, the Federal Circuit decided the Amgen v. Sandoz appeal in a case of first impression regarding the interpretation of the disclosure and notice provisions of the Biologics Price Competition and Innovation Act...more

Robins Kaplan LLP

Trade Secrets, Security, and Cloud Computing: Best Practices Now

Robins Kaplan LLP on

As businesses increasingly store and access confidential information in the cloud, questions arise as to how to safeguard a company’s private data once it becomes part of an external computing network. Standards for...more

Mintz - ML Strategies

Biosimilars, the BPCIA, and Amgen v. Sandoz: The Federal Circuit’s First Attempt To Make Sense of “A Riddle Wrapped in a Mystery...

Mintz - ML Strategies on

On July 21, 2015, the Federal Circuit issued a key decision regarding the meaning of various provisions of the Biologics Price Competition and Innovation Act (BPCIA). See Amgen Inc. v. Sandoz Inc., Fed. Cir. Case No....more

McDonnell Boehnen Hulbert & Berghoff LLP

Federal Circuit Decides Amgen v. Sandoz (in an opinion that will make neither party happy)

In a seriously fractured decision, the Federal Circuit construed the provisions of the Biologics Price Control and Innovation Act (BPCIA) today in Amgen v. Sandoz. In doing so, the Court limited the information available to...more

Patterson Belknap Webb & Tyler LLP

Disclosure Requirements Under the BPCIA

The Biologics Price Competition and Innovation Act (BPCIA) provides for a series of disclosures between a biosimilar applicant and the innovator company, commonly referred to as the “patent dance.” 42 U.S.C. §262(l). While...more

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