On October 5, 2015, Apotex filed its answer and counterclaims in the ongoing Amgen v. Apotex Neulasta® (pegfilgrastim) litigation.
As we previously reported, Amgen’s complaint alleged that Apotex provided Amgen with an “ineffective” Notice of Commercial Marketing pursuant to 42 U.S.C. § 262(l)(8)(A), because “a subsection (k) applicant may only give effective notice of commercial marketing after FDA has licensed its product” and Apotex’s product “has not yet been licensed by FDA.”
In response, Apotex’s answer includes this interpretation of subsection 262(l)(8)(A):
“Where a biosimilar applicant has provided the reference product sponsor with the required information pursuant to § 262(l)(2)(A), the BPCIA gives such biosimilar applicant the option to either provide the reference product sponsor a Notice of Commercial Marketing under 42 U.S.C. § 262(l)(8)(A) or to face an action under 28 U.S.C. § 2201 for a declaration of patent infringement. Any other interpretation of the BPCIA would render superfluous subsection (l)(9)(B), which states:
If a subsection (k) applicant fails to complete an action required of the subsection (k) applicant under paragraph (3)(B)(ii), paragraph (5), paragraph (6)(C)(i), paragraph (7), or paragraph (8)(A), the reference product sponsor, but not the subsection (k) applicant, may bring an action under section 2201 of title 28 for a declaration of infringement, validity, or enforceability of any patent included in the list described in paragraph (3)(A), including as provided under paragraph (7).
(Emphasis added). Thus, the BPCIA expressly contemplates and provides for the situation where a biosimilar applicant declines to provide a Notice of Commercial Marketing, which triggers a reference product sponsor’s right to bring suit under BPCIA subsection (l)(9)(B).”
Apotex’s interpretation thus seems to be an attempt to parallel the Federal Circuit’s interpretation of subsections 262(l)(2)(A) and 262(l)(8)(A) in Amgen v. Sandoz. There, Sandoz chose not to disclose information to comply with subsection 262(l)(2)(A), and the Court concluded that the 262(l)(8)(A) notice provision was therefore mandatory. Apotex, however, allegedly did comply with paragraph (l)(2)(A) by disclosing its section (k) application and manufacturing information. It is still an open question whether a court will find the subsection 262(l)(8)(A) notice provision optional in circumstances where the parties have complied with subsection 262(l)(2)(A).
Apotex also asserts an antitrust counterclaim. Apotex alleges that Amgen is wrongfully maintaining a monopoly in what Apotex calls the pegfilgrastim market by filing and pursuing sham litigation. Apotex asserts that Amgen’s conduct is harming competition and delaying consumer access to Apotex’s product in three ways: (1) by forcing Apotex to incur substantial expenses defending the patent litigation; (2) by discouraging Apotex from launching its product because of the threat of substantial damages it might owe Amgen; and (3) by deterring downstream customers from buying pegfilgrastim biosimilar products.
We will continue to monitor and report developments in this case.