News & Analysis as of

aBLA Patents

Venable LLP

EYLEA® (aflibercept) and Soliris® (eculizumab) IPR Updates

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On December 8, 2023, the PTAB instituted three of Samsung Bioepis’s pending IPRs against Alexion’s Soliris® (eculizumab), IPR2023-00933, IPR2023-00998, and IPR2023-00999. The challenged patents include composition of matter,...more

Venable LLP

Celltrion Completes Application for FDA Approval of CT-P41, Biosimilar of Prolia® / Xgeva®

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On November 30, 2023, Celltrion announced that it filed for an abbreviated Biologics License Application (aBLA) for FDA approval of CT-P41 (denosumab), a proposed biosimilar of Amgen’s Prolia® / Xgeva® (denosumab)...more

Goodwin

Innovent Announces Results of Phase III Trial of Sintilimab and Bevacizumab Combination Therapy In Patients With Advanced Lung...

Goodwin on

Innovent Biologics, Inc. announced the results of the Phase III ORIENT-31 study evaluating sintilimab in combination with BYVASDA (bevacizumab biosimilar) for the treatment of non-squamous non-small cell lung cancer. ...more

Patterson Belknap Webb & Tyler LLP

Hospira Seeks En Banc Review of the Federal Circuit’s “Safe Harbor” Ruling in Amgen v. Hospira

In December, in Amgen v. Hospira, 944 F.3d 1327 (Fed. Cir. 2019), a panel of the Federal Circuit issued the first decision applying the statutory Safe Harbor of 35 U.S.C. § 271(e)(1) to BPCIA patent litigation. ...more

Patterson Belknap Webb & Tyler LLP

Amgen Files New Patent Infringement Suit Over Neupogen Biosimilar

On July 23, 2019, Amgen, maker of the cancer treatment drug Neupogen (filgrastim), filed patent infringement claims in the Southern District of California against Tanvex Biopharma over Tanvex’s proposed filgrastim biosimilar...more

Akin Gump Strauss Hauer & Feld LLP

Prosecution History Estoppel Bars Amgen’s Infringement Claim Under the Doctrine of Equivalents

The Federal Circuit affirmed a district court decision barring Amgen from asserting an infringement claim under the doctrine of equivalents against Coherus Biosciences because Amgen disclaimed all combinations not identified...more

Patterson Belknap Webb & Tyler LLP

Prosecution History Estoppel Bars Amgen’s Doctrine-of-Equivalents Infringement Claim Against Neulasta (Pegfilgrastim) Biosimilar...

Amgen Inc. v. Coherus Biosciences Inc., No. 2018-1993, Slip op. at 6 (Fed. Cir. July 29, 2019) stems from a Biologics Price Competition and Innovation Act action brought by Amgen against Coherus seeking FDA approval to market...more

K&L Gates LLP

Amgen v. Sandoz - New Developments in Biosimilars Litigation

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INTRODUCTION & BACKGROUND - On May 8, 2019 in Amgen, Inc. v. Sandoz International GmbH, the Federal Circuit Court affirmed the district court’s judgment, concluding that the district court correctly construed the claims and...more

Fish & Richardson

Amgen v. Sandoz: Final Judgment of Non-Infringement: Clearance for Biologics Still Being Finalized at the Time of Judgment?

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Decisions in the Amgen v. Sandoz case involving Sandoz’s biosimilar versions of Amgen’s Neupogen® and Neulasta® drugs have provided significant guidance to biosimilar litigants over the years.  ...more

Dechert LLP

Federal Circuit Panel Describes the Doctrine of Equivalents as Applying “Only in Exceptional Cases”

Dechert LLP on

In a patent owner’s declaratory judgment action under the Biologics Price Competition and Innovation Act (“BPCIA”) a Federal Circuit panel in Amgen Inc. v. Sandoz Inc., Appeal No. 2018-1551 (Fed. Cir. May 8, 2019) narrowly...more

Goodwin

Coherus Settles with AbbVie, and Sues Amgen, Over Adalimumab Biosimilars (Updated)

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Coherus announced today that it has executed settlement agreements with AbbVie that grant Coherus global, non-exclusive, royalty-bearing license rights under AbbVie’s intellectual property to commercialize CHS-1420, Coherus’...more

McDonnell Boehnen Hulbert & Berghoff LLP

Senators Ask FTC to Investigate Biosimilar Litigation Settlement Agreement

The high cost of biologic drugs was one of the (if not the) most compelling motivations for Congress to adopt a biosimilar pathway as part of the Affordable Care Act in 2010 (aka "Obamacare"). Passage of the Biologic Price...more

Patterson Belknap Webb & Tyler LLP

First Decision on Label Carve-Outs for Biosimilars Expected in Enbrel Litigation

As biosimilar litigation between Amgen, the maker of Enbrel® (etanercept), and Sandoz, the maker of biosimilar ErelziTM (etanercept-szzs) heads toward trial before Judge Claire Cecchi in the District of New Jersey, Sandoz is...more

Fish & Richardson

Declaratory Judgment Litigation Brought by Biosimilar Manufacturers

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Courts have begun to shape the contours of the Biologics Price Competition and Innovation Act (“BPCIA”) and the progress of biosimilar litigation, but the use of declaratory judgment actions by biosimilar manufacturers...more

Fish & Richardson

Biosimilars 2017 Year in Review

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Since the passage of the Biologics Price Competition and Innovation Act (BPCIA), 2017 has been the most active year yet for drug manufacturers. Fish attorneys Tasha Francis, Jenny Shmuel, and Brianna Chamberlin addressed the...more

Jones Day

Federal Circuit Rules BPCIA Preempts State Law

Jones Day on

On December 14, 2017, the U.S. Court of Appeals for the Federal Circuit again interpreted the Biologics Price Competition and Innovation Act ("BPCIA"). In Amgen Inc. et al. v. Sandoz Inc., 15-cv-1499 (Fed. Cir. 2017), the...more

Mintz - Intellectual Property Viewpoints

Federal Circuit Rules that BPCIA Preempts State Law Biosimilars Claims

In an opinion issued on December 14, 2017, the United States Court of Appeals for the Federal Circuit held that the 2010 Biologics Price Competition and Innovation Act (“BPCIA”) preempts the use of state law to penalize...more

Perkins Coie

Federal Circuit Rules Out State-Law Remedies for Failure to Participate in the Biosimilars "Patent Dance"

Perkins Coie on

On December 14, the Federal Circuit issued a decision that further clarifies the ground rules for disclosures of product information by manufacturers of biosimilar pharmaceutical products. In particular, the Federal Circuit...more

Jones Day

Federal Circuit Clarifies Probative Value of Patent Dance Statements

Jones Day on

The Situation: The Biologics Price Competition and Innovation Act was considered in a November 2017 decision by the United States Court of Appeals for the Federal Circuit. The Result: The court found that the commercial...more

Fish & Richardson

Federal Circuit Provides Guidance on Probative Value of “Patent Dance” Letters and aBLA Parameters in an Infringement Analysis

Fish & Richardson on

On November 13th, in an opinion drafted by Judge Taranto, the Federal Circuit affirmed the Southern District Court of Florida’s judgment that Apotex’s biosimilar versions of Neulasta® and Neupogen® do not infringe Amgen’s...more

Fish & Richardson

List it or Lose it: The Federal Circuit Weighs in on the Amgen v. Hospira Discovery Dispute

Fish & Richardson on

The Federal Circuit issued its opinion in the Amgen v. Hospira appeal (16-2179) on August 10, 2017, dismissing the appeal for lack of jurisdiction and denying Amgen’s petition for a writ of mandamus. The decision affirmed...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen Inc. v. Hospira, Inc. (Fed. Cir. 2017)

In the third installment of the "Amgen v." trilogy of BPCIA Federal Circuit cases, the Court in Amgen Inc. v. Hospira, Inc. answered a question that had been lingering since the very first case -- can a reference product...more

Fish & Richardson

The Ramifications of Leaving the Patent Dance Floor

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While the Supreme Court held in Amgen v. Sandoz that biosimilar applicants cannot be forced with a federal injunction to provide a copy of their biosimilar application (aBLA) and manufacturing information to the reference...more

Fish & Richardson

The Amgen v. Sandoz Disclosure Disputes Continue

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A theme emerging in biosimilar litigation is when –and how much—discovery is available to reference product sponsors. The Supreme Court in Amgen v. Sandoz grappled with this issue in the spring, as it decided whether...more

King & Spalding

The Age of Competition - The Supreme Court Decides the First BPCIA Case

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In a landmark ruling for the biotech and pharmaceutical industries, a unanimous Supreme Court decided Sandoz Inc. v. Amgen Inc., 582 U.S. ____, Nos. 15-1039, 15-1195 (June 12, 2017), its first biosimilar case governed by the...more

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