Sandoz

News & Analysis as of

Both Parties Seek En Banc Intervention in Amgen v. Sandoz

Last month, a divided panel of the Federal Circuit issued a split decision in Amgen v. Sandoz (summary; opinion). Amgen (in which Patterson Belknap represented one of the amici supporting Amgen) is the court’s first decision...more

Is Patentability Smothered by the “All Encompassing” Prior Art Reference?

Patent owners may welcome the Allergan, Inc. v. Sandoz, Inc. decision earlier this month when the Federal Circuit affirmed the validity of five patents relating to the pharmaceutical formulation Lumingan ® .01%. The Federal...more

Riddle Me This: The Federal Circuit Provides a Measure of Clarity to the Enigmatic Biosimilar Approval Pathway

In Amgen Inc. v. Sandoz Inc. (No. 2015-1499), a fractured panel of the Federal Circuit Court of Appeals recently decided two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009...more

Spectrum Pharms., Inc. v. Burwell

Case Name: Spectrum Pharms., Inc. v. Burwell, Civ. No. 15-631 (RCL), 2015 U.S. Dist. LEXIS 73218 (D.D.C. May 27, 2015) (Lamberth, J.) - Drug Product and Patent(s)-in-Suit: Fusilev® (levoleucovorin); N/A - Nature of...more

Identifying the likely beneficiaries of an emerging biosimilars market

Financial analysts have predicted that over the next five years, biosimilars will be a $10 billion market, so it is understandable why considerable attention and investment is being made in this space. However, while there is...more

Insite Vision Inc. v. Sandoz, Inc.

Case Name: Insite Vision Inc. v. Sandoz, Inc., 783 F.3d 853 (Fed. Cir. Apr. 9, 2015) (Circuit Judges Prost, Newman, and Linn presiding; Opinion by Linn, J.) (Appeal from D.N.J., Cooper, J.) - Drug Product and...more

Federal Circuit Confirms Both New Biosimilar Bring-to-Market Procedural Option and Additional Six-Month Exclusivity Period for...

On July 21, 2015, brand-name biologics companies and companies developing biosimilars received a split in a significant decision with industry-wide ramifications in the high-stakes battle about how and when biosimilar...more

BPCIA Statute: Patent Dance Is Optional, But Opting Out Has Consequences

The Federal Circuit issued a ruling on July 21, 2015 in the Amgen Inc. et al. v. Sandoz Inc., Case No. 2015-1499, appeal after hearing oral arguments on June 3, 2015. See BPCIA: A “Choose Your Own Adventure” Statute?...more

"Don't Stop the Dance"[*] -- The Dissents-in-Part from Amgen v. Sandoz

As we have been reporting this week, the Federal Circuit handed down its decision in Amgen Inc. v. Sandoz Inc. -- a case of first impression relating to the Biologics Price Competition and Innovation Act ("BPCIA") for...more

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

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

Biosimilars Can Sit Out Patent Dance, But May Have To Wait Out Second Exclusivity Period

In Amgen v. Sandoz, Fed. Cir., No. 15-1499 (July 21, 2015), a divided panel of the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that...more

Federal Circuit Delays Sandoz Biosimilar Launch

In a closely-watched case between Amgen and Sandoz regarding the first biosimilar approved (Zarxio), the Federal Circuit interpreted key Biologics Price Competition and Innovation Act (BPCIA) provisions regarding Sandoz's...more

Federal Circuit Interprets Biosimilars Law in Amgen v. Sandoz

In a seriously fractured decision, the Federal Circuit construed the provisions of the Biologics Price Control and Innovation Act (BPCIA or Act) in Amgen Inc. et al. v. Sandoz Inc. In doing so, the court limited the...more

Federal Circuit Interprets BPCIA for First Time

The U.S. Court of Appeals for the Federal Circuit today decided issues of first impression relating to the statutory interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). In a split decision in...more

Federal Circuit Issues Its First Decision Interpreting BPCIA

The courts must “say what the law is,” even when that law, as Judge Lourie described the BPCIA, is “a riddle wrapped in a mystery inside an enigma.” Today, in Amgen Inc. v. Sandoz Inc., No. 2015-1499 (Fed. Cir. July 23,...more

Alert: Fractured Federal Circuit Provides Guidance on Biosimilars Patent Dance

Both Sides Come Away with Wins in Amgen v. Sandoz - Yesterday, in Amgen, Inc. v. Sandoz, Inc., the Federal Circuit construed multiple provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). ...more

Product-by-Process Claims: A Jurisdictional Overview

The Supreme Court of Japan has issued a decision which made significant changes to how product-by-process claims are handled by the Japanese Patent Office. The decision makes Japanese law on product-by-process claims similar...more

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

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