Sandoz

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Biosimilars: Supreme Court Calls for Solicitor General’s Views in Amgen v. Sandoz

On Monday, June 20, 2016, the Supreme Court deferred a decision on the certiorari petitions filed by both parties from the Federal Circuit’s decision in Amgen v. Sandoz, 794 F.3d 1347 (2015), and instead called for the views...more

Supreme Court Defers Certiorari Decision In Amgen Sandoz Biosimilar Patent Dance Dispute

On June 20, 2016, instead of deciding whether to grant certiorari in the biosimilar patent dance dispute between Amgen and Sandoz, the Supreme Court invited the Solicitor General “to file a brief in this case expressing the...more

Supreme Court asks SG for views on Sandoz, Amgen petitions: Analysis and Next Steps

As we posted on June 20, the Supreme Court has invited the Solicitor General to file briefs regarding the Sandoz v. Amgen and Amgen v. Sandoz petitions for certiorari. Below we provide further analysis and commentary on the...more

Supreme Court asks the SG to Weigh in on Sandoz v. Amgen and Amgen v. Sandoz Petitions

On June 20, 2016, the Supreme Court invited the Solicitor General to file briefs regarding the Sandoz v. Amgen and Amgen v. Sandoz petitions for certiorari...more

Amgen v. Sandoz: Reply Briefs Submitted to Supreme Court

As we previously reported, on February 16, 2016, Sandoz petitioned the United States Supreme Court for a writ of certiorari regarding the Federal Circuit’s interpretation of the BPCIA’s “notice of commercial marketing”...more

FDA Announces Advisory Committee Meeting on Sandoz’s Etanercept Biosimilar

We previously reported on Sandoz’s aBLA for a biosimilar of Amgen’s ENBREL (etanercept) and the related BPCIA litigation. The FDA’s Arthritis Advisory Committee announced this morning that it will hold a public advisory...more

MBHB Snippets: A review of developments in Intellectual Property Law - Volume 14, Issue 2 (Spring 2016)

Pre-AIA and Post-AIA Issues Presented by the On-Sale Bar - The “on-sale” bar to patentability refers to a sale or offer for sale of an invention that can invalidate the patent for that invention. The...more

Standing Alone – The Current Status of the BPCIA’s Notice of Commercial Marketing

In March 2015, the FDA approved the first biosimilar application, which was for a follow-on biologic drug of Amgen’s reference product NEUPOGEN® (filgrastim). Yet, before the applicant, Sandoz, could launch its biosimilar...more

BIO International Convention 2016 Preview

BIO and Biosimilars - The 2016 BIO International Convention begins next week in San Francisco. This convention has become an important destination for all organizations working in the biotechnology space, but the large...more

Court Report - May 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Ventana Medical Systems, Inc. v. Hologic, Inc. 3:16-cv-02703; filed May 18, 2016 in the Northern District of...more

Patient and Provider Groups Urge FDA to Institute Meaningful and Memorable Names for Biosimilars

A coalition of patient and provider groups sent an open letter to Leah Christl, FDA’s associate director for therapeutic biologics and biosimilars, urging FDA to use meaningful names for biosimilars instead of random ones. ...more

Amgen v. Sandoz: Sandoz’s Opposition to Amgen’s Conditional Cross-Petition for Certiorari

As we covered in a previous post, following the Federal Circuit’s decision in Amgen v. Sandoz, Sandoz filed a petition for a writ of certiorari asking the Supreme Court to review the Federal Circuit’s interpretation of the...more

FDA Issues Interim Response to UAW’s Citizen Petition on Biosimilar Labeling

As we previously reported, UAW Retiree Medical Benefits Trust and affiliated funds filed a Citizen Petition on November 2, 2015 asking FDA to adopt a “same labeling” approach for biosimilar labeling. On May 19, 2016, FDA...more

Analysis of Amgen’s complaint against Sandoz in pegfilgrastim litigation

As we reported earlier, Amgen recently filed suit under the BPCIA against Sandoz and Lek Pharmaceuticals in the Northern District of California. Amgen alleges that Sandoz’s submission of an aBLA for its pegfilgrastim product...more

Amgen And Sandoz Do The Biosimilar Patent Dance Over Neulasta

Amgen Inc. has filed a complaint under the Biologics Price Competition and Innovation Act (BPCIA), asserting that a biosimilar application filed by Sandoz Inc. seeking approval of a biosimilar version of Neulasta® infringes...more

Amgen Hedges Its Bets With Cross-Petition For Certiorari Of Biosimilar Decision

Although Amgen originally did not petition the Supreme Court for certiorari to review the first Federal Circuit decision interpreting the BPCIA framework for resolving biosimilar patent disputes, Amgen now has filed a...more

Update on Enbrel Biosimilar and Related US Litigation

Amgen’s Enbrel (etanercept), a blockbuster biologic treatment for a number of autoimmune diseases, including rheumatoid arthritis and psoriasis, has been an attractive target for biosimilar makers. Sandoz, the maker of...more

FDA Guidance for Biosimilar Labeling Largely Stays with Generic Model

On Thursday, FDA released draft guidance clarifying its position on labeling biosimilar products. While the guidance addresses some of the concerns raised by physicians and industry, FDA’s guidance mostly continues to treat...more

Novartis FCPA Enforcement Action, Part I

The philosopher George Santayana is usually best remembered for the pithy saying, ‘Those who cannot remember the past are condemned to repeat it.” Santayana was an essayist, poet, professor and novelist. According to...more

Amgen files Declaratory Judgment Action against Sandoz over NEULASTA® Biosimilar

Last Friday, Amgen filed a declaratory judgment action in the District Court for New Jersey against Sandoz, in the latest iteration of biosimilar litigation between the parties (see complaint). Amgen's and Sandoz's actions...more

Amgen Launches Enbrel Biosimilar Patent Litigation

Although Sandoz’ application for FDA approval to market a biosimilar version of ENBREL® (etanercept) has yet to be approved, Amgen has brought suit under the Patent Act and Biologics Price Competition and Innovation Act...more

Sandoz Asks Supreme Court To Reverse Biosimilar Decision

On February 16, 2016, Sandoz, Inc. filed a petition for writ of certiorari to the Supreme Court, asking the Court to overturn the Federal Circuit decision that interpreted the “patent dance” provisions of the Biologics Price...more

Sandoz Petitions for Certiorari over 180-day Notice Provision in BPCIA

As reported on February 17, 2016 in IP Law360, Sandoz has petitioned the U.S. Supreme Court for certiorari to review the Federal Circuit's decision that reversed the District Court in Amgen v. Sandoz. In its decision, two...more

Biosimilar Law May Head to the Supreme Court

Sandoz is seeking U.S. Supreme Court review of the Federal Circuit’s first ruling related to biosimilars, interpreting the Biologics Price Competition and Innovation Act (“BPCIA”)....more

FDA Panel Shows Strong Support for a Remicade Biosimilar

The Food and Drug Administration’s (FDAs) Arthritis Advisory Committee gave a thumbs up to a biosimilar copy of Johnson & Johnson’s Remicade product, an inflammation blocker used in the treatment of rheumatoid arthritis, on...more

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