BPCIA Litigation Roundup (Summer 2016)

AbbVie v. Amgen (adalimumab)  •  Amgen v. Apotex (pegfilgrastim)  •  Amgen v. Hospira (epoetin alfa)  •  Amgen v. Sandoz (filgrastim)  •  Amgen v. Sandoz (pegfilgrastim)  •  Immunex v. Sandoz (etanercept)  •  Janssen v. Celltrion (infliximab)  •  U.S. Biosimilar Litigation News

Below is a brief summary of each of the U.S. patent litigations concerning a proposed or approved biosimilar product. Please also consult our BPCIA Litigation Summary Chart for additional details.

Biosimilars to Neupogen® (filgrastim)

1. Amgen v. Sandoz

  • Accused Product: Zarxio® (filgrastim-sndz)
  • Approval/Launch Status: FDA approved Sandoz’s aBLA on March 6, 2015. Sandoz launched on September 3, 2015.
  • Procedural History and Case Status:
    • District Court (No. 3:14-cv-04741-RS (N.D. Cal.)): On October 24, 2014, Amgen filed a complaint alleging that Sandoz had violated the BPCIA (1) by not providing its application and manufacturing information within 20 days of FDA acceptance as “required” under the first step of the patent dance set forth in subsection (l)(2)(A) of the BPCIA, and (2) by providing a purported notice of commercial marketing under subsection (l)(2)(A) of BPCIA before FDA had approved the application. Amgen asked the court to order Sandoz to follow the pathway set out in the BPCIA. On March 19, 2015, the District Court issued an order ruling in favor of Sandoz that the patent dance steps are not mandatory, and that biosimilar applicants do not have to wait for FDA approval before they can provide sufficient notice of commercial marketing. Amgen appealed.
    • Court of Appeals (No. 15-1499 (Fed. Cir.)): On July 21, 2015, the Federal Circuit, in a split panel decision, ruled: (1) in Sandoz’s favor (affirming the District Court) that the disclosures set forth in subsection (l)(2)(A) of the BPCIA are not mandatory and that the statute allows a biosimilar applicant to choose between either disclosing its subsection (k) application and manufacturing information, or not disclosing such information and instead facing an immediate infringement action from the reference product sponsor; and (b) in Amgen’s favor (reversing the District Court) that a notice of commercial marketing pursuant to subsection (l)(9)(A) of the BPCIA can be given only after FDA approval of the biosimilar product. In light of its interpretation of the “notice of commercial marketing” provision and its ruling in favor of Amgen, the Federal Circuit extended the injunction against Sandoz through September 2, 2015 (180 days after Sandoz received approval and provided an effective post-licensure notice of commercial marketing).
    • Supreme Court (Nos. 15-1039 and 15-1195): On February 16, 2016, Sandoz filed a petition for certiorari, asking the Supreme Court to review the Federal Circuit’s interpretation of the BPCIA’s “notice of commercial marketing” provision. On March 21, 2016, Amgen opposed Sandoz’s petition and also filed a conditional cross-petition for certiorari, challenging the Federal Circuit’s ruling that a biosimilar applicant is not required by the BPCIA to disclose a copy of its aBLA and related manufacturing information. On May 17, 2016, Sandoz opposed the cross-petition, and, later that month, the parties filed reply briefs. Several amicus briefs have been submitted in support of Sandoz. On June 20, 2016, the Supreme Court invited the Solicitor General to weigh in on the issues presented in the two petitions.

Biosimilars to Remicade® (infliximab)

1. Janssen v. Celltrion

  • Accused Product: Inflectra® (infliximab-dyyb)
  • Approval/Launch Status: FDA approved Celltrion’s aBLA on April 5, 2016. On June 6, 2016, Celltrion stipulated that it will not launch its product before September 15, 2016, unless certain criteria are met.
  • Procedural History and Case Status:
    • District Court
      • (Janssen v. Celltrion, No. 15-10698-MLW (D. Mass.)): BPCIA complaint filed March 6, 2015. On May 21, 2016, the District Court denied a motion by Janssen to stay the litigation, but granted Janssen’s motion to amend the protective order to permit it to file a new case against HyClone, the third-party cell culture media supplier for Celltrion’s biosimilar product, based on information produced by Celltrion under the protective order. On August 16, 2016, the District Court began hearing argument on Celltrion’s motion for summary judgment of invalidity of the ’471 patent, as well as other issues. At the hearing, the District Court granted Celltrion’s motion for summary judgment that all claims of the ’471 patent are invalid for obviousness-type double patenting, based on multiple reference patents.
      • (Janssen v. Celltrion, No. 16-11117-MLW (D. Mass.)): Complaint filed June 14, 2016 for infringement of ’083 patent based on cell culture media. Celltrion is moving to dismiss, and the parties have asked the District Court to scheduling briefing for August through October 2016.
      • (Janssen v. HyClone, No. 16-00071-BCW (D. Utah): Complaint filed June 14, 2016 for infringement of ’083 patent based on cell culture media. On August 5, 2016, HyClone moved to dismiss the complaint and stay the litigation.

Biosimilars to Neulasta® (pegfilgrastim)

1. Amgen v. Apotex

  • Accused Product: Pegfilgrastim
  • Approval/Launch Status: Not licensed. FDA accepted Apotex’s aBLA in December 2014.
  • Procedural History and Case Status:
    • District Court (No. 15-61631-JIC (S.D. Fla.)): BPCIA complaint filed August 6, 2015. On December 10, 2016, the district court preliminarily enjoined Apotex from launching its biosimilar product until 180 days after it provides a post-licensure notice of commercial marketing. The district court completed a trial in July 2016. On July 18, 2016, the district court granted Amgen’s motion for judgment on partial findings with respect to each of Apotex’s invalidity defenses except for non-enablement, which, like infringement, remains an open issue. The patent-in-suit is also the subject of a pending IPR petition.
    • Court of Appeals (No. 16-1308 (Fed. Cir.)): Apotex appealed from the district court’s grant of a preliminary injunction. On July 5, 2016, the Federal Circuit affirmed the district court’s ruling, and, on August 11, 2016, issued its mandate.

2. Amgen v. Sandoz

  • Accused Product: LA-EP2006 (pegfilgrastim)
  • Approval/Launch Status: Not licensed. FDA accepted Sandoz’s aBLA on or around November 18, 2015. In July 2016, the FDA issued a Complete Response letter.
  • Procedural History and Case Status:
    • District Court
      • (No. 16-1276-SRC-CLW (D.N.J.)): On March 4, 2016, Amgen filed a complaint seeking a declaration that Sandoz violated the patent dance procedures outlined in the BPCIA. On July 22, 2016, the district court dismissed the complaint.
      • (No. 3:16-cv-02581-RS (N.D. Cal.)): BPCIA complaint filed on May 13, 2016. An Initial Case Management Conference is set for September 15, 2016.

Biosimilars to Epogen® and Procrit® (epoetin alfa)

1. Amgen v. Hospira

  • Accused Product: Retacrit® (epoetin alfa)
  • Approval/Launch Status: Not licensed. In October 2015, FDA issued a Complete Response letter. According to Hospira’s parent Pfizer’s August 11, 2016 quarterly report, it is “working diligently to address the content of the letter.”
  • Procedural History and Case Status:
    • District Court (No. 15-839-RGA (D. Del.)): BPCIA complaint filed September 18, 2015. In May 2016, the District Court denied Amgen’s motion to compel Hospira to produce manufacturing information and correspondence with FDA, finding that Amgen had not shown that the information sought was relevant to the charges of infringement of the asserted patents. On August 5, 2016, the District Court denied a motion by Hospira to dismiss count I of Amgen’s complaint regarding Hospira’s alleged failure to comply with the BPCIA’s notice of commercial marketing provision. A five-day jury trial is set for September 18, 2017.
    • Court of Appeals (No. 16-2179 (Fed. Cir.)): Amgen appealed from the denial of its motion to compel. On August 12, 2016, the Federal Circuit denied a motion by Hospira to dismiss Amgen’s appeal and ordered the parties to address both the merits of the discovery dispute and the issue of jurisdiction in their briefs.

Biosimilars to Enbrel® (etanercept)

1. Immunex v. Sandoz

  • Accused Product: GP2015 (etanercept)
  • Approval/Launch Status: Not licensed. FDA accepted Sandoz’s aBLA on or around October 2, 2015. On July 13, 2016, an FDA advisory committee voted to recommend approval.
  • Procedural History and Case Status:
    • District Court (No. 16-01118-CCC-JBC (D.N.J.)): BPCIA complaint filed February 26, 2016. On August 11, 2016, the District Court entered a scheduling order and a consent preliminary injunction that enjoins Sandoz from making, using, importing, offering to sell, or selling its product, “except as allowed by 35 U.S.C. § 271(e)(1).” A trial is set for April 17, 2018.

Biosimilars to Humira® (adalimumab)

1. AbbVie v. Amgen

  • Accused Product: ABP 501 (adalimumab)
  • Approval/Launch Status: Not licensed. FDA accepted Amgen’s aBLA on or around January 25, 2016. On July 12, 2016, an FDA advisory panel voted to recommend approval.
  • Procedural History and Case Status:
    • District Court (No. 16-666-SLR (D. Del.)): BPCIA complaint filed August 4, 2016.
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