Amgen Inc. v. Sanofi, Appeal No. 2020-1074 (Fed. Cir. Feb. 11, 2021)

In this week’s Case of the Week, the Federal Circuit affirmed a district court’s JMOL ruling that asserted claims of two related pharmaceutical patents were invalid because their shared specification did not enable the full scope of the claims. The patents were directed to synthetic antibodies used in high cholesterol treatments that operate by binding to specified amino acids (or “residues”) of enzyme PCSK9, thereby blocking PCSK9 from binding to LDL cholesterol receptors (“LDLR”) and permitting those receptors to remove LDL cholesterol from the bloodstream.

The claims at issue contained dual functional limitations, requiring that a claimed antibody both bind to at least one or two of numerous listed PCSK9 residues (i.e., in ranges from one or two residues to all of them), and that the antibodies block the PCSK9/LDLR interaction. Appellee Sanofi contended that because there are millions of antibody candidates potentially falling within the scope of the claims, and because antibody generation is unpredictable, practicing the full scope of the claims would require substantial trial and error in screening each candidate antibody for the claimed binding and blocking functionalities. Appellant patent owner Amgen contended that in finding the claims not enabled, the district court erred by focusing on the effort required to discover and make every embodiment of the claims, that the patent adequately disclosed the required screening methods, and that the examples provided were sufficiently structurally representative to enable the claims.

Applying the enablement factors from In re Wands, 858 F.2d 731, 736-37 (Fed. Cir. 1988), the Federal Circuit agreed with the district court and Sanofi, finding that the claims were far broader in functional diversity than the disclosed examples, noting, for example, that while the claims covered antibodies that bind to up to sixteen residues, none of Amgen’s examples bind to more than nine of them, and that there were three claimed residues to which none of the example antibodies bind. The Court held that for claims including functional limitations, it was appropriate for the enablement inquiry to focus on the breadth of those requirements, especially where the predictability of the art and guidance from the specification fall short. The Court also re-iterated its prior holdings that “undue experimentation” in such cases can include undue experimentation from identifying, from among many compounds that meet the claims’ structural requirements, those specific compounds that also satisfy the functional limitations.

The Federal Circuit qualified its ruling by noting that it did “not hold that the effort required to exhaust a genus is dispositive,” but that in this case, where the functional limitations were broad and encompassed millions of potential candidates, the disclosed examples were narrow, and the art was unpredictable, judgment of non-enablement was appropriate.

A copy of the opinion can be found here.

ALSO THIS WEEK

Synchronoss Technologies, Inc. v. Dropbox, Inc., Appeal Nos. 2019-2196, -2199 (Fed. Cir. Feb. 12, 2021)

In a second decision on the issue of indefiniteness in one week, the Federal Circuit affirmed a district court ruling that claims for synchronizing data on the Internet were invalid. Some of the terms at issue in this case were phrases incorporating functional language with nonce terms appended to them: “user identifier module”; “authentication module identifying a user coupled to the synchronization system”; “user authenticator module”; “user login authenticator”; “user data flow controller”; and “transaction identifier module.” The district court found each of these terms indefinite. Each of the terms, it concluded, was subject to 35 U.S.C. 112 paragraph 6 because they recited pure functions and means for accomplishing those functions, but failed to supply an associated structure. Other claims were found to recite an impossibility. Specifically, the claims require “generating a [single] digital media file” that itself “compris[es] a directory of digital media files.” Synchronoss’s expert conceded that this is not possible. The Federal Circuit affirmed, adopting the rationale provided by the district court.

A copy of the opinion can be found here.

Mojave Desert Holdings, LLC v. Crocs, Inc., Appeal No. 2020-1167 (Fed. Cir. Feb. 11, 2021)

The Federal Circuit reversed the PTAB’s decision refusing to substitute Mojave Desert Holdings, LLC for its predecessor in interest U.S.A. Dawgs, Inc. under Rule 43(b). In response to Crocs, Inc.’s allegations of patent infringement, U.S.A. Dawgs instituted an inter partes review of the patent at issue. During the inter partes review, U.S.A. Dawgs filed for bankruptcy and assigned all of its assets and rights to Mojave through a second entity, U.S.A. Dawgs Holdings, LLC. But the assignment to the holding company did not specifically mention the inter partes review. Consequently, the PTAB denied Mojave’s motion on two grounds: (1) Mojave was not able to prove it was a real party in interest; and (2) the motion was untimely. On appeal, the Court rejected both grounds. The Court reversed the PTAB’s refusal to recognize Mojave as a real party in interest because otherwise it “would create a situation in which the assets [of Mojave] remained potentially liable for infringement, but [Mojave] would have lost the right to challenge patent validity.” The Court held that “the transfer of all assets on its face included the rights in the Board proceeding.” Second, the Court rejected Crocs’ argument that Mojave’s motion was untimely under 37 C.F.R. § 41.8(a) because Mojave waited nearly a year after the assignment before filing the motion to substitute. The Court rejected this argument as well, holding that 37 C.F.R. § 41.8(a) does not permit the PTAB “to ignore a transfer of interest in an inter partes reexamination that has been assigned to a successor-in-interest.” The Court further held that the proper standard for the substitution was Rule 43(b), under which Mojave’s substitution was timely. Accordingly, the Court reversed the PTAB and granted Mojave’s motion to substitute.

Infinity Computer Products, Inc. v. OKI Data Americas, Inc., Appeal No. 2020-1189 (Fed. Cir. Feb. 10, 2021)

In an appeal from a district court’s final judgment of invalidity, the Federal Circuit affirmed, holding Infinity’s asserted patent claims indefinite. The patent at issue was generally directed to a system for “using a fax machine as a printer or scanner for a personal computer.” The issue of indefiniteness revolved around the connection between the fax machine and the computer, which the claims referred to as a “passive link.” During prosecution, Infinity took contradictory positions regarding the scope of the “passive link,” where it ends, and where the “computer” begins. The term itself was used in neither the patent specification nor the parent application. Rather, Infinity first included this term during patent prosecution in an attempt to distinguish prior art. Subsequently, to overcome an ex parte reexamination, Infinity took a contradictory position about the scope of the “passive link” in successfully overcoming reexamination. The district court found the term indefinite, finding that Infinity had taken “materially inconsistent positions” regarding where the “passive link” ended and where the “computer” began. The Federal Circuit affirmed, explaining that holding Infinity to both positions taken during prosecution would result in a “flat contradiction,” and such contradiction would “leave[ ] an ordinarily skilled artisan without reasonable certainty as to where the passive link ends and where the computer begins.”

A copy of the opinion can be found here.

cxLoyalty, Inc. v. Maritz Holdings Inc., Appeal Nos. 2020-1307, -1309 (Fed. Cir. Feb. 8, 2021)

In an appeal from a CBM decision, the Federal Circuit reviewed patent eligibility for patent claims directed to a computerized system and method allowing customers to redeem loyalty points without need for human intervention. The Patent Trial & Appeal Board (PTAB) found the claims to be unpatentable under 35 U.S.C. § 101.  The Federal Circuit reviewed de novo under the two step framework articulated by the Supreme Court in Alice. The Court first agreed with the PTAB that the claims failed step one because they were addressed to an abstract idea, namely, the transfer of information relating to a long-standing commercial practice. The Court also agreed that the claims failed step two of the Alice framework because they merely recite generic and conventional computer components, and functionality for carrying out the abstract idea. The Federal Circuit also rejected patent owner’s threshold argument that the challenger had failed to satisfy its burden of demonstrating that the claims were eligible for CBM review, noting that the PTAB’s decision on that point was non-appealable under the Supreme Court’s Thryv decision.

A copy of the opinion can be found here.

Chudik v. Hirshfeld, Appeal No. 2020-1833 (Fed. Cir. Feb. 8, 2021)

In an appeal from a summary judgement decision by the district court upholding a petition decision by the U.S. Patent Office, the Court reviewed whether a patentee is entitled to C-delay patent term adjustment for the time period between the filing of a notice of appeal and the Examiner re-opening prosecution. The Court concluded that the patentee is not entitled to C-delay patent term adjustment because Section 154(b)(1)(C)(iii) requires that the patent issue under a Board decision that reversed the Examiner or a court decision that reversed the Board. For these reasons, the Court affirmed the summary judgement decision by the district court.

The opinion noted that patentee may obtain B-delay patent term adjustment for the time period between the filing of a notice of appeal and the Examiner re-opening prosecution, provided that the patentee did not file for a request for continued examination (RCE) prior to the notice of appeal. Here, an RCE was filed prior to the filing of the notice of appeal, and all parties agreed that B-delay patent term adjustment was not available due to that.

A copy of the opinion can be found here.