Sandoz

News & Analysis as of

Teva Standard of Review Becomes Outcome-Determinative in Fed. Circuit Ruling Last Week

Earlier this year in Teva Pharmaceuticals USA v. Sandoz, Inc., 135 S. Ct. 831 (2015), the Supreme Court changed the appellate standard of review for claim construction decisions. The Court held that while claim construction...more

Federal Circuit Tackles Claim Construction Review under New Standard

The More Things Change (Lighting Ballast Control LLC v. Philips Electronics North America), the More They Stay the Same (Teva Pharmaceuticals USA, Inc. v. Sandoz Inc.) - On June 18, 2015, the Federal Circuit handed down...more

Louisiana Appellate Court Overturns Improper Application of “Law of the Case” Doctrine

Today is the day when we will learn whether the Governor of Louisiana will enter the 2016 presidential race. That reminds us of Louisiana’s rather colorful collection of politicians, including Huey Long and Edwin Edwards....more

FDA Approach to Labeling Treats Biosimilars Like Generics

One of the FDA’s recent biosimilar guidance documents has drawn criticism for eliminating labeling information necessary for physicians to make prescribing decisions. The guidance document, titled, “Scientific Considerations...more

Amgen v. Sandoz -- Federal Circuit Oral Argument

The Federal Circuit heard oral arguments in the Amgen v. Sandoz case on Wednesday, June 3, 2015. The three judges on the panel were Judge Newman, Judge Lourie, and Judge Chen. This case is on appeal from the U.S. District...more

Act II: Oral Argument in Amgen v. Sandoz is heard at the Court of Appeals for the Federal Circuit

The Court of Appeals for the Federal Circuit yesterday heard oral arguments on the applicability and interpretation of two key provisions of the Biologics Price Competition and Innovation Act (BPCIA). Briefly, oral argument...more

BIO International Convention 2015 Preview - BIO and Biosimilars

The 2015 BIO International Convention begins in two weeks in Philadelphia. For the past few years, we have provided a series of previews with the goal of making the large amount of information and opportunities available at...more

Motivation to Combine Reviewable for Clear Error - Insite Vision Inc. v. Sandoz, Inc.

Reviewing the district court’s framing of the obviousness inquiry and determination of no motivation to combine for clear error, the U.S. Court of Appeals for the Federal Circuit affirmed the district court’s determination...more

Federal Circuit Review | May 2015

Overly Narrow Statement Of Problem Can Show Reliance On Hindsight - In INSITE VISION INCORPORATED v. SANDOZ, INC., Appeal No. 2014-1065, the Federal Circuit held that enunciating an overly narrow statement of the problem...more

FDA Releases "Final" Guidances for Industry regarding the Biosimilar Approval Pathway

About three years ago, and less than two years after Congress passed and President Obama signed the Biologics Price Competition and Innovation Act (BPCIA) into law, the U.S. Food and Drug Administration issued a series of...more

Federal Circuit Grants Injunction Keeping Sandoz’s Biosimilar Version of Neupogen Off Market Until Appeal Decided

The Federal Circuit yesterday granted Amgen’s motion for a preliminary injunction to keep Sandoz’s biosimilar form of Neupogen off the market until the Court renders its decision on the merits of the appeal. The parties had...more

Petitioners Must Present Sufficient Evidence to Establish Inherency

Last Friday the Patent Trial and Appeal Board (PTAB) denied four Sandoz Inc. petitions for instituting inter partes review (IPR) of U.S. 8,455,524 (IPR2015-00005), U.S. 7,612,102 (IPR2015-00006), U.S. 7,659,290...more

The Soon-to-be Reality of Medicare Part B Reimbursements for Biosimilars

As the country’s largest health insurer, Medicare has immense influence on the health care market. In the wake of the recent approval of Sandoz’s Zarxio (filgrastim-sndz), the first FDA-approved biosimilar, last month the...more

Zarxio®, First BPCIA Approved Biosimilar, Added to Purple Book

In September 2014, the FDA published the first edition of the Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (“Purple Book”), the...more

InSite Vision Inc. v. Sandoz, Inc. (Fed. Cir. 2015)

The Federal Circuit showed once again the importance of a district court's factual findings (and the deference the appellate court gives those findings, particularly when supported by expert testimony), in InSite Vision Inc....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

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

Biosimilars Await Naming Guidance From FDA

Earlier this month, the FDA announced the first approval of a biosimilar product under the Biologics Price Competition and Innovation Act (BPCIA). The new Sandoz product, which will be sold under the trade name Zarxio, is a...more

District Court Denies Amgen's Bid to Block Sale of Blockbuster Biosimilar Drug

On March 19, 2015, Judge Seeborg of the Northern District of California handed a significant victory to Sandoz's efforts to bring the first biosimilar product to market by denying Amgen's partial judgment on the pleadings and...more

$12.6 Million Sandoz ASP Reporting Settlement Raises More Questions Than It Answers

Recently, HHS-OIG announced a first-of-its-kind settlement over pharmaceutical manufacturer reporting of Average Sales Price (ASP). Sandoz, Inc. agreed to pay a civil monetary penalty of $12.64 million for alleged failure to...more

Alert - Biologics Price Competition and Innovation Act (BPCIA) Developments

The Evolving World of Biosimilars - Amgen, Inc. v. Sandoz, Inc. Addressing two new issues in the Biologics Price Competition and Innovation Act (BPCIA), the Northern District of California issued an order, on...more

One More Hurdle Cleared – Amgen’s Preliminary Injunction Motion for Filgrastim is Denied

On March 19, 2015, Judge Seeborg of the United States District Court for the Northern District of California denied Amgen Inc.’s motion for a preliminary injunction in the Amgen v. Sandoz case, thereby removing one more...more

District Court Rules Against Amgen’s Motion for Preliminary Injunction to Prevent Marketing of Sandoz’s Biosimilar Zarxio

In an order released on March 19, 2015, U.S. District Court Judge Richard Seeborg of the Northern District of California denied Amgen’s motion for judgment on the pleadings as well as its request for a preliminary injunction...more

Court Report - March 2015 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Otsuka Pharmaceutical Co., Ltd. v. Sandoz Inc. et al. 1:15-cv-01716; filed March 9, 2015 in the District Court of New...more

The First Biosimilar Application Has Been Approved -- But What About the Patent Issues?

As we reported earlier this week, the U.S. Food and Drug Administration ("FDA") approved the first biosimilar application -- an application by Sandoz to market a biosimilar version of Amgen's NEUPOGEN® (filgrastrim) biologic...more

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