An ANDA Specification that Directly Addresses Issues of Infringement Controls the Infringement Inquiry
In Par Pharmaceutical, Inc. v. Eagle Pharmaceticals, Inc. Appeal No. 22-145, the Federal Circuit held that an ANDA was held not to infringe asserted claims because the ANDA specifies pH ranges that fall outside of those recited in the asserted claims.
Par Pharmaceutical has two patents relating to Vasostrict, which is an injection product used to treat patients with critically low blood pressure. The claims of both patents require a composition having a pH between 3.65 and 3.94. In 2018, Eagle Pharmaceuticals filed an abbreviated new drug application (ANDA) to make and sell a generic version of Vasostrict. Eagle’s ANDA specifies a pH range between 3.35 and 3.64 when released for distribution and a pH range between 3.4 and 3.6 during the drug’s shelf life.
Par sued Eagle alleging that Eagle’s ANDA filing was an act of infringement under 35 U.S.C. § 271(e)(2). Par noted that Eagle’s ANDA seeks authority to release products for distribution with a pH just 0.01 beneath the claimed range, and contended “real-world” evidence shows the pH of Eagle’s drug increases over time. Thus, Par argued, Eagle’s proposed product would inevitably drift upward into the claimed range. The district court disagreed, noting the ANDA requires Eagle’s product to maintain a pH between 3.4 and 3.6 during the drug’s shelf life. After a bench trial, the district court found no infringement under § 271(e). Par appealed.
The Federal Circuit affirmed. It noted that when an ANDA defines a proposed generic drug in a manner that directly addresses the issue of infringement, the ANDA controls the infringement inquiry. Here, the court held, the pH ranges in the ANDA “directly and unambiguously” address the pH range of Eagle’s proposed product. Because those pH ranges are outside the claimed range, the court affirmed the finding of no infringement.
(Pharmaceuticals, ANDA, 35 U.S.C. § 271(e)(2); Prepared by Alistair McIntyre)
Section 101 Jurisprudence Still Sound Post-Dobbs.
In Re Killian, Appeal No. 21-2113, the Federal Circuit held that section 101 jurisprudence is still sound post-Dobbs.
Killian applied for a patent related to a system and method “for determining eligibility for Social Security Disability Insurance [SSDI] benefits through a computer network.” The examiner found that the claims were directed to an abstract idea of “determining eligibility for social security disability insurance . . . benefits” and lacked additional elements amounting to significantly more than the abstract idea because the additional elements were simply generic recitations of generic computer functionalities. The Patent Trial and Appeal Board (“Board”) affirmed the rejection of all pending claims under 35 U.S.C. § 101. Killian appealed and the Federal Circuit affirmed the Board’s decision.
On appeal, Killian argued that Dobbs v. Jackson Women’s Health Organization, 142 S. Ct. 2228 (2022), undermined the Supreme Court’s § 101 jurisprudence. Killian asserted that because Alice, Mayo, Bilski, Parker, and Benson were “mere policy preferences,” they were constitutionally unsound post-Dobbs. Killian also argued that the Alice/Mayo analysis is so vague that the Board’s decision holding a claim patent ineligible is arbitrary and capricious under the Administrative Procedure Act. The Federal Circuit disagreed and walked through the contrary prior jurisprudence in the field. The Federal Circuit also noted its own judicial limitations, which prevented it from addressing many of the issues Killian raised.
On the substance of Killian’s claims, the Federal Circuit agreed with the Board and found that the claims are directed to “collection of information, comprehending the meaning of that collected information, and indication of the results, all on a generic computer network operating in its normal, expected manner.” The Federal Circuit stated that steps that “can be performed in the human mind, or by a human using a pen and paper” are unpatentable abstract mental processes, and implementing these abstract mental processes “on a generic computer does not save the claims from being directed to an abstract idea.” The Federal Circuit further pointed out that the application’s specification suggests “nothing technical exists in the nature of these steps” by stating that the invention “frees up assigned staff to perform more traditional duties.”
(Software & Information Technology, Patentability; Prepared by Mary Bao)
IPR estoppel “under an unusual set of facts”
In Click-To-Call Technologies Lp v. Ingenio, Inc., Dba Keen, Ether, Thryv, Inc. Appeal No. 22-1016, the Federal Circuit held that Ingenio’s IPR petition was partially instituted before SAS (overruling the practice of partial institutions), and a final written decision was issued after SAS. IPR estoppel applied to a claim that was not addressed in a final written decision because the invalidity ground reasonably could have been brought, and petitioner chose not to seek remand in view of SAS.
Click-to-call sued Ingenio for patent infringement. Ingenio filed an IPR petition challenging the asserted claims. The Board partially instituted IPR on certain claims based on the Dezonno reference, but refused to consider grounds based on the Freeman refence. Because Ingenio challenged claim 27 based only on Freeman, that claim was not part of the final written decision. After the IPR concluded, Ingenio filed a motion for summary judgment of invalidity in the District Court, asserting claim 27 was invalid in view of Dezonno. Click-to-call argued that Ingenio was precluded due to IPR estoppel. The District Court granted summary judgment of invalidity.
The Federal Circuit reversed. The Federal Circuit held that Ingenio’s reliance on Dezonno for other claims evidenced its awareness of Dezonno, and therefore it “reasonably could have raised” Dezonno as a ground of invalidity against claim 27 in the IPR. The Federal Circuit also rejected Ingenio’s argument that IPR estoppel could not apply because claim 27 was not part of the Board’s final written decision. Due to the unusual facts of this case, Claim 27 was included in Ingenio’s petition but the Board failed to include claim 27 in its final written decision due to a legal error of partial institution, which was later corrected in SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348 (2018). The IPR proceeding was still pending when SAS issued and Ingenio could have sought remand to address claim 27, but chose not to. “Ingenio’s choice to leave unremedied the Board’s mistake does not shield it from estoppel as to a claim it included in its IPR petition.“
(IPR Estoppel, Issue Preclusion, IPR Partial Institution, Prepared by Joshua Loader)