Big Molecule Watch

1) Amgen v. Sandoz

• Accused Product: Zarxio® (filgrastim-sndz) [EP 2006]
• 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. Meanwhile, the litigation on the merits is proceeding in the district court, which has scheduled a jury trial for March 26, 2018.
  • 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. Several amicus briefs were filed in support of Sandoz. On May 17, 2016, Sandoz opposed the cross-petition, and, later that month, the parties filed reply briefs. On December 7, 2016, at the Court’s invitation, the Acting Solicitor General filed a brief that recommended granting both cert petitions and generally supported Sandoz’s interpretation of the BPCIA provisions at issue. On January 13, 2017, the Supreme Court granted both cert petitions, and on April 26, 2017, held oral argument. A decision is expect by late June.

2) Amgen v. Apotex

• Accused Product: Grastofil™ (filgrastim)
• Approval/Launch Status: Not licensed. FDA accepted Apotex’s aBLA in February 2015.
• Procedural History and Case Status:
  • District Court (No. 15-62081-JIC (S.D. Fla.)): BPCIA complaint filed October 2, 2015. In November 2015, the case was consolidated into the Amgen v. Apotex pegfilgrastim litigation, where the district court entered judgment of non-infringement with respect to Apotex’s filgrastim and pegfilgrastim products. Amgen has appealed. See the summary below of the Amgen v. Apotex pegfilgratim litigation for more details.
  • Court of Appeals (No. 17-1010 Fed. Cir.): See the summary below of the Amgen v. Apotex pegfilgratim litigation for more details.

1) Amgen v. Sandoz

• Accused Product: LA-EP2006 (pegfilgrastim)
• Approval/Launch Status: Not licensed. FDA accepted Sandoz’s aBLA in November 2015. In July 2016, the FDA issued a Complete Response letter. Sandoz has represented that it will need to refile its aBLA to include data from a PK study and does not expect to submit the data to FDA until 2018.
• Procedural History and Case Status:
  • District Court
    • (No. 16-1276-SRC-CLW (D.N.J.)): On March 4, 2016, Amgen filed a complaint against Sandoz seeking a declaratory judgment that Sandoz violated the BPCIA by attempting to unilaterally waive steps of the patent dance. Sandoz later restarted the patent dance negotiations, and this complaint was dismissed.
    • (No. 3:16-cv-02581-RS (N.D. Cal.)): BPCIA complaint filed on May 13, 2016. The case is being coordinated for discovery and trial with the Amgen v. Sandoz filgrastim matter.

2) Amgen v. Apotex

• Accused Product: Lapelga™ (pegfilgrastim)
• Approval/Launch Status: Not licensed. FDA accepted Apotex’s aBLA in December 2014. Apotex is enjoined by the district court from launching its product until 180 days after it provides an effective, post-licensure notice of commercial marketing.
• Procedural History and Case Status:
  • District Court (No. 15-61631-JIC (S.D. Fla.)): BPCIA complaint filed August 6, 2015. In November 2015, the Amgen v. Apotex filgrastim litigation (discussed above) was consolidated into this case. On December 10, 2016, the district court preliminarily enjoined Apotex from launching its pegfilgrastim biosimilar product until 180 days after it provides a post-licensure notice of commercial marketing. After holding a bench trial in July 2016, the district court (1) granted Amgen’s motion for judgment on partial findings with respect to each of Apotex’s invalidity defenses except for non-enablement, (2) entered judgment of non-infringement in Apotex’s favor, and (3) reserved judgment on Apotex’s non-enablement defense by dismissing Apotex’s invalidity counterclaim without prejudice. 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. Apotex filed a petition for certiorari.
    • (No. 17-1010 Fed. Cir.): On October 3, 2016, Amgen filed a notice of appeal to the Federal Circuit from the District Court’s judgment of non-infringement. The parties have completed briefing and are awaiting an oral argument date.
  • Supreme Court (No. 16-332): On September 9, 2016, Apotex filed a petition for certiorari, asking the Supreme Court to review the Federal Circuit’s application of its Amgen v. Sandoz decision to Apotex, as well as its interpretation of the BPCIA’s “notice of commercial marketing” provision. The Biosimilars Council and Mylan filed amicus briefs in support of Apotex. Briefing on the petition concluded on November 21, 2016. On December 12, 2016, the Supreme Court denied Apotex’ petition.

3) Amgen v. Coherus

• Accused Product: CHS-1701 (pegfilgrastim)
• Approval/Launch Status: Not licensed. FDA accepted Coherus’s aBLA in October 2016.
• Procedural History and Case Status:
  • District Court (No. 17-546-LPS-CJB (D. Del.)): BPCIA complaint filed May 10, 2017. Amgen alleges infringement of one patent. Coherus’s answer is due June 1, 2017.

1) Janssen v. Celltrion

• Accused Product: Inflectra® (infliximab-dyyb) [CT-P13]
• Approval/Launch Status: FDA approved Celltrion’s aBLA on April 5, 2016. Celltrion and Hospira launched in late 2016.
• 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. In August 2016, 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. On September 26, 2016, the District Court entered partial final judgment of invalidity with respect to the ’471 patent, and Janssen has appealed to the Federal Circuit. The defendants moved for summary judgment of non-infringement of the ’083 patent, the sole remaining patent-in-suit. On December 22, 2016, the district court denied the summary judgment motion as to Celltrion, but requested additional briefing with respect to Hospira. On February 22, 2017, Celltrion moved to dismiss for lack of standing to bring the suit, a motion which the parties recently completed briefing. On March 3, 2017, the court issued a memorandum and order providing guidance regarding the standards for determining damages in the litigation. The original jury trial date of February 13, 2017 has been postponed.
    • (Janssen v. Celltrion, No. 16-11117-MLW (D. Mass.)): Complaint filed June 14, 2016 for infringement of ’083 patent based on cell culture media. This action is consolidated into the 15-10698 action.
    • (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. This case has been stayed pending resolution of the D. Mass. cases.
  • Court of Appeals:(No. 17-1120 Fed. Cir.): On October 24, 2016, Janssen filed a notice of appeal to the Federal Circuit from the District Court’s partial final judgment of invalidity with respect to the ’471 patent, based on double patenting. The parties completed briefing in April 2017. This appeal is being treated as a companion case for oral argument purposes with Janssen’s related appeal (No. 17-1257) from an ex parte reexamination ruling by the USPTO that the ’471 patent’s claims are unpatentable for double patenting. Briefing is scheduled to conclude in that appeal on June 6, 2017.

2) Janssen v. Samsung Bioepis

• Accused Product: Renflexis® (infliximab-abda) [SB2]
• Approval/Launch Status: FDA approved Samsung Bioepis’s aBLA on April 21, 2017, but Samsung Bioepis has not yet launched.
• Procedural History and Case Status:
  • District Court
    • (No. 17-3524-MCA-SCM (D.N.J.)): BPCIA complaint filed May 17, 2017. Janssen’s complaint alleges infringement of three patents, including the ’083 patent, which is also in suit in the Janssen v. Celltrion case. Janssen also alleges that Samsung Bioepis violated the BPCIA (1) by refusing to produce its aBLA or engage in the patent dance, and (2) by providing a purported “notice of commercial marketing” prior to receiving FDA approval.

1) Amgen v. Hospira

• Accused Product: Retacrit™ (epoetin alfa)
• Approval/Launch Status: Not licensed. In October 2015, FDA issued a Complete Response letter. In December 2016, Hospira resubmitted its aBLA.  On May 25, 2017, the FDA’s Oncologic Drugs Advisory Committee recommended approval of the product across all indications.
• 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. On October 3, 2016, the District Court issued an order granting-in-part and denying-in-part a motion by Amgen to amend its complaint. On May 12, 2017, Hospira moved for summary judgment of non-infringement. 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. The parties completed briefing the appeal in November 2016, and the Federal Circuit held oral argument on April 3, 2017.

1) Immunex v. Sandoz

• Accused Product: Erelzi® (etanercept-szzs) [GP2015]
• Approval/Launch Status: FDA approved Sandoz’s aBLA on August 30, 2016. Sandoz has agreed not to launch its biosimilar until a time point that has not been publicly disclosed.
• 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.

1) AbbVie v. Amgen

• Accused Product: Amjevita® (adalimumab-atto) [ABP 501]
• Approval/Launch Status: FDA approved Amgen’s aBLA on September 23, 2016. Amgen has indicated that it is unlikely to launch its biosimilar before 2018, given the pace of the ongoing litigation.
• Procedural History and Case Status:
  • District Court (No. 16-666-SLR (D. Del.)): BPCIA complaint filed August 4, 2016. AbbVie is asserting 10 patents as part of the first wave litigation but, according to its complaint, has identified 51 other patents that it could assert against Amgen in a second wave litigation. A 20-day bench trial is scheduled for November 4, 2019.

1) Genentech v. Amgen

• Although there is no pending patent litigation yet, on February 15, 2017, Genentech filed a complaint for declaratory judgment against Amgen in the District of Delaware (C.A. No. 17-165) alleging certain violations of the patent dance provisions of the BPCIA following FDA’s acceptance of Amgen’s aBLA. On March 1, 2017, the court dismissed Genentech’s complaint without prejudice. On April 17, 2017, Amgen represented that “the parties are now moving through the ‘patent dance’ as contemplated under the BPCIA.”