Update in Amgen v. Apotex: Amgen’s Answer to Apotex’s Counterclaims

On October 29, 2015, Amgen filed its answer to Apotex’s counterclaims in the Amgen v. Apotex Neulasta® (pegfilgrastim) litigation.

As background, 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.”

Apotex, in response, alleged that the BPCIA, particularly subsection (l)(9)(B), expressly contemplated the situation at hand, where the biosimilar applicant has complied with subsection (l)(2)(A) by disclosing its section (k) application and manufacturing information but declines to provide Notice of Commercial Marketing. Apotex also asserted antitrust and patent misuse counterclaims.

In its answer, Amgen “specifically denies that § 262(l)(9)(B) permits a biosimilar application to ‘elect not to provide … a notice of commercial marketing,’” and asserts an affirmative defense that Apotex’s counterclaims regarding the interpretation of subsection (l)(8)(A) “fail to state a claim for which relief can be granted because they are merely defenses directed at an element of Amgen’s claims, and are not proper counterclaims.”

Amgen also asserts affirmative defenses that Apotex’s antitrust and patent misuse counterclaims fail to state claims for which relief can be granted, and that Apotex has waived or should be estopped from asserting any unenforceability defenses with regard to the ‘138 patent because Apotex allegedly failed to assert that the ‘138 patent is unenforceable in its detailed statement. Amgen’s waiver and estoppel defenses are intriguing because Amgen appears to be proposing that detailed statements in the BPCIA context have greater substantive requirements than in the Hatch-Waxman context. In Hatch-Waxman cases, it is common practice for defendants to pursue non-infringement, invalidity and unenforceability defenses in litigation that were not raised in the defendants’ detailed statements (for example, in light of facts learned through discovery). The BPCIA’s language in subsection (l)(3)(B) setting forth the required contents of a detailed statement is quite similar to the corresponding provision of the Hatch-Waxman Act (21 U.S.C. § 355(j)(2)(B)), so Amgen might be contending that there is something special about BPCIA procedures that limits section (k) applicants to pursuing only the defenses they raised in their detailed statements.

Finally, Amgen asserts an affirmative defense that Apotex is estopped from claiming that the action is a sham litigation or baseless because, according to Amgen:

This action was commenced pursuant to 42 U.S.C. § 262(l)(4)(A) and (6)(A), after Apotex—by its own admission—engaged in good-faith negotiations with Amgen and, ultimately, agreed that the ’138 patent shall be the subject of an action for patent infringement. (Apotex’s Answer ¶¶ 12, 51.) Apotex agreed to the inclusion of the ’138 patent despite having a statutorily permitted option not to agree. See 42 U.S.C. § 262(l)(4)(B), (5).

We will continue to monitor and report developments in this case.