Below is an excerpt from Hospira's brief (filed on July 6, 2017) in opposition to Amgen's motion for a preliminary injunction regarding Hospira's biosimilar version of the drug Epogen (1:15-cv-00839-RGA). Hospira argues that it has provided Amgen with an effective notice of commercial marketing as set forth in Supreme Court's Sandoz v. Amgen decision on June 12, 2017.
I. NATURE AND STAGE OF PROCEEDINGS
Hospira is seeking FDA approval to market a biosimilar version of Arngen's Epogen (epoetin alfa) product. Amgen has sued Hospira for infringing two expired patents, U.S. Patent Nos. 5,756,349 (the "'349 Patent") and 5,856,298 (the '"298 Patent"). Amgen also has alleged that Hospira violated the Biologics Price Competition and Innovation Act (the "BPCIA") by failing to provide an effective notice of commercial marketing under 42 U.S.C. § 262(l)(8)(A) of the Act.
The BPCIA provides that a BLA applicant shall provide notice of commercial marketing at least 180 days before the date of first commercial marketing. The United States Supreme Court recently held that this notice can be provided before the applicant has FDA approval. Hospira submitted its abbreviated biologics application ('"BLA") on December 16, 2014 and provided its notice of commercial marketing on April 8, 2015 (the ''Notice" or "Hospira's Notice"). Hospira has thus satisfied section 8(A). Hospira' s proposed biosimilar has not been approved to date by the FDA. Amgen originally filed its Motion for a Preliminary Injunction on May 26, [Redacted]. That position was squarely rejected by the Supreme Court's Sandoz v. Amgen decision on June 12, 2017. Now that the Supreme Court has eviscerated Amgen' s first preliminary injunction argument, Amgen has conjured up a new argument to support its request for an injunction based on arguments that were raised for the first time in the present motion and that contradict the clear factual record and Amgen's prior statements. (D.I. 262.)
II. SUMMARY OF ARGUMENT
The Court should deny Amgen's motion. First, Amgen is unlikely to succeed on the merits. The Supreme Court recently confirmed in Sandoz v. Amgen that a BLA applicant may send a notice of commercial marketing prior to obtaining FDA approval, which Hospira undisputedly did on April 8, 2015. There is no basis in the BPCIA or the Supreme Court's Sandoz opinion for the additional requirements Amgen now asks this Court to impose--none of which were raised in Amgen's initial request for a preliminary injunction.
Hospira provided its Notice in April 2015 and never rescinded or withdrew it. Amgen knows that fact so well that it pointedly complained about it in its Second Amended Complaint filed in October 2016 [Redacted] Amgen's reliance on one out-of-context quotation from a letter cannot change Hospira's consistent position in correspondence with Amgen and before this Court and Amgen's acknowledgement of that position. Thus, Amgen's first argument that it will succeed on the merits fails.
Amgen's second argument fails because it has no statutory support. The BPCIA does not require Hospira to provide an additional notice of commercial marketing after it receives and responds to a complete response letter (''CRL"). Amgen's argument rehashes the same rationale that the Supreme Court squarely rejected in Sandoz. Indeed, in rejecting Amgen's argument that notice can only be properly provided after FDA approval because that is when the properties of a biosimilar product can be known, the Court explained that '"nothing in §262(1)(8)(A) turns on the precise status or characteristics of the biosimilar application." Sandoz Inc. v. Amgen Inc., No. 15-1039, slip op. at 17 (U.S. June 12, 2017). Thus, Amgen's motion is completely baseless.
Second, Amgen will not suffer any irreparable harm that is cognizable under the BPCIA. Hospira provided a proper Notice more than 180 days ago and can launch its product upon FDA approval. If Amgen loses any sales to Hospira, that is not cognizable "harm"-that is the intended consequence of the BPCIA, which seeks to get competitive biosimilar products into the hands of consumers in a timely fashion. Moreover, Amgen' s argument ignores crucial facts about the marketplace [Redacted] Amgen also suggests that it will face irreparable harm because it may have more patents waiting in the wings. But no such patents were disclosed to Hospira under the BPCIA exchanges, and Amgen has repeatedly told investors that its last material patent on Epogen expired when the '349 patent expired in May 2015.
Third, the balance of equities favors Hospira, not Amgen. Hospira complied with the BPCIA's notice of commercial marketing requirements. Hospira diligently pursued its BLA, including responding to questions from the FDA. As contemplated by the BPCIA, Hospira should now be permitted to launch its product as soon as it obtains approval. Amgen has had patent protection for Epogen since it was launched in 1989, almost thirty years ago. Now, with the only patents that Amgen thought it could assert against Hospira having expired, Amgen improperly is attempting to use the notice of commercial marketing to eke out another six months of market exclusivity, when the Supreme Court has clearly ruled against this. Granting Amgen further exclusivity by issuing an injunction would be improper and inequitable.
Fourth, the public interest does not favor an injunction. The BPCIA created a framework for biosimilar drug product approval with the potential to save billions of dollars in public health costs. The public interest is greatly served by biosimilar drug competition; the public does not benefit from enjoining competitive biosimilars without any factual or legal basis, particularly following a three-decade run of unfettered market exclusivity.
Finally, if an injunction is granted, the Court should require Amgen to post a significant bond, as required by the Federal Rules and Third Circuit case law. However, the Court should address the amount of a bond if and when the scope and timing of an injunction are determined. If the Court were to require Hospira to send a further notice of commercial marketing, it could potentially keep Hospira from launching its product when it obtains FDA approval. That would cause great financial harm to Hospira. In fact, being prevented from launching for even one day after approval would cause unwarranted and significant harm to Hospira [Redacted]-If, at some point, the Court were to decide to issue an injunction, it should allow the parties to present detailed evidence on the bond amount. ID.
[The rest of the brief has been omitted--Please see the actual brief if you want to read further]
I. NATURE AND STAGE OF PROCEEDINGS
Hospira is seeking FDA approval to market a biosimilar version of Arngen's Epogen (epoetin alfa) product. Amgen has sued Hospira for infringing two expired patents, U.S. Patent Nos. 5,756,349 (the "'349 Patent") and 5,856,298 (the '"298 Patent"). Amgen also has alleged that Hospira violated the Biologics Price Competition and Innovation Act (the "BPCIA") by failing to provide an effective notice of commercial marketing under 42 U.S.C. § 262(l)(8)(A) of the Act.
The BPCIA provides that a BLA applicant shall provide notice of commercial marketing at least 180 days before the date of first commercial marketing. The United States Supreme Court recently held that this notice can be provided before the applicant has FDA approval. Hospira submitted its abbreviated biologics application ('"BLA") on December 16, 2014 and provided its notice of commercial marketing on April 8, 2015 (the ''Notice" or "Hospira's Notice"). Hospira has thus satisfied section 8(A). Hospira' s proposed biosimilar has not been approved to date by the FDA. Amgen originally filed its Motion for a Preliminary Injunction on May 26, [Redacted]. That position was squarely rejected by the Supreme Court's Sandoz v. Amgen decision on June 12, 2017. Now that the Supreme Court has eviscerated Amgen' s first preliminary injunction argument, Amgen has conjured up a new argument to support its request for an injunction based on arguments that were raised for the first time in the present motion and that contradict the clear factual record and Amgen's prior statements. (D.I. 262.)
II. SUMMARY OF ARGUMENT
The Court should deny Amgen's motion. First, Amgen is unlikely to succeed on the merits. The Supreme Court recently confirmed in Sandoz v. Amgen that a BLA applicant may send a notice of commercial marketing prior to obtaining FDA approval, which Hospira undisputedly did on April 8, 2015. There is no basis in the BPCIA or the Supreme Court's Sandoz opinion for the additional requirements Amgen now asks this Court to impose--none of which were raised in Amgen's initial request for a preliminary injunction.
Hospira provided its Notice in April 2015 and never rescinded or withdrew it. Amgen knows that fact so well that it pointedly complained about it in its Second Amended Complaint filed in October 2016 [Redacted] Amgen's reliance on one out-of-context quotation from a letter cannot change Hospira's consistent position in correspondence with Amgen and before this Court and Amgen's acknowledgement of that position. Thus, Amgen's first argument that it will succeed on the merits fails.
Amgen's second argument fails because it has no statutory support. The BPCIA does not require Hospira to provide an additional notice of commercial marketing after it receives and responds to a complete response letter (''CRL"). Amgen's argument rehashes the same rationale that the Supreme Court squarely rejected in Sandoz. Indeed, in rejecting Amgen's argument that notice can only be properly provided after FDA approval because that is when the properties of a biosimilar product can be known, the Court explained that '"nothing in §262(1)(8)(A) turns on the precise status or characteristics of the biosimilar application." Sandoz Inc. v. Amgen Inc., No. 15-1039, slip op. at 17 (U.S. June 12, 2017). Thus, Amgen's motion is completely baseless.
Second, Amgen will not suffer any irreparable harm that is cognizable under the BPCIA. Hospira provided a proper Notice more than 180 days ago and can launch its product upon FDA approval. If Amgen loses any sales to Hospira, that is not cognizable "harm"-that is the intended consequence of the BPCIA, which seeks to get competitive biosimilar products into the hands of consumers in a timely fashion. Moreover, Amgen' s argument ignores crucial facts about the marketplace [Redacted] Amgen also suggests that it will face irreparable harm because it may have more patents waiting in the wings. But no such patents were disclosed to Hospira under the BPCIA exchanges, and Amgen has repeatedly told investors that its last material patent on Epogen expired when the '349 patent expired in May 2015.
Third, the balance of equities favors Hospira, not Amgen. Hospira complied with the BPCIA's notice of commercial marketing requirements. Hospira diligently pursued its BLA, including responding to questions from the FDA. As contemplated by the BPCIA, Hospira should now be permitted to launch its product as soon as it obtains approval. Amgen has had patent protection for Epogen since it was launched in 1989, almost thirty years ago. Now, with the only patents that Amgen thought it could assert against Hospira having expired, Amgen improperly is attempting to use the notice of commercial marketing to eke out another six months of market exclusivity, when the Supreme Court has clearly ruled against this. Granting Amgen further exclusivity by issuing an injunction would be improper and inequitable.
Fourth, the public interest does not favor an injunction. The BPCIA created a framework for biosimilar drug product approval with the potential to save billions of dollars in public health costs. The public interest is greatly served by biosimilar drug competition; the public does not benefit from enjoining competitive biosimilars without any factual or legal basis, particularly following a three-decade run of unfettered market exclusivity.
Finally, if an injunction is granted, the Court should require Amgen to post a significant bond, as required by the Federal Rules and Third Circuit case law. However, the Court should address the amount of a bond if and when the scope and timing of an injunction are determined. If the Court were to require Hospira to send a further notice of commercial marketing, it could potentially keep Hospira from launching its product when it obtains FDA approval. That would cause great financial harm to Hospira. In fact, being prevented from launching for even one day after approval would cause unwarranted and significant harm to Hospira [Redacted]-If, at some point, the Court were to decide to issue an injunction, it should allow the parties to present detailed evidence on the bond amount. ID.
[The rest of the brief has been omitted--Please see the actual brief if you want to read further]
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