USA Trends and Developments Contributed by: Ed Haug, Andrew Wasson and Wan Chieh (Jenny) Lee, Haug Partners LLP
as chemical genus patents, or formulation plat - form patents. Innovators should also consider having a strategic plan ahead of time should a generic applicant challenge an Orange Book patent, either through a delisting counterclaim during litigation or otherwise through the FDA’s dispute mechanism. Wands factors remain as a key test for enablement post-Amgen The specification of a patent is required to pro - vide “a written description of the invention, and of the manner and process of making and using it... as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same...” (35 USC Section 112(a)). This requirement is com - monly referred to as the enablement require - ment. Although the Supreme Court does not often hear patent cases, it revisited the enable - ment requirement last year in Amgen v Sanofi in the context of patent claims that broadly cov - ered all antibodies that functionally meet certain binding requirements (antibodies that (i) bind to specific amino acid residues on PCSK9, and (ii) block PCSK9 from binding to LDL receptors) (Amgen Inc. v Sanofi, 598 US 594, 143 S. Ct. 1243 (2023)). The Supreme Court unanimously affirmed invalidity of these broad functional anti - body claims for failure to meet the enablement requirement for the full scope of the claim. The Court in Amgen reiterated that “[i]f a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class”, or simply, “[t]he more one claims, the more one must enable.” The claims in dispute in Amgen potentially encompass a vast number (at least millions) of antibodies. The specification described 26 antibodies and provided a step-
by-step “roadmap” for how to identify additional antibodies within the scope of the claim. The Court analogised disclosure of the “roadmap” to a combination lock with 100 tumblers, each of which can be set to 20 different positions, and require significant amounts of trial-and-error to discover the successful combinations. The Supreme Court considered this type of disclo - sure to be no more than “a hunting license” for “random trial-and-error discovery”, which is not enablement. The Supreme Court’s holding in Amgen suggests that broad functional claims are more suscepti - ble to invalidity challenges for lacking enable - ment. Since the Amgen decision, the Court of Appeals for the Federal Circuit has invalidated broad genus claims in four out of five deci - sions applying the enablement standard under Amgen. In these post-Amgen decisions, the Federal Circuit extended the analysis of Amgen beyond antibody technologies and reinforced use of the Wands factors for evaluating the ena - blement requirement. The first decision from the Court of Appeals for the Federal Circuit that applied the enablement standard post-Amgen is In re Starett, which is a non-precedential decision arising from the Patent Trial and Appeal Board (“the Board”) affirming rejections by an examiner of pend - ing claims before the United States Patent and Trademark Office (USPTO) (In re Starett, 2023 US App LEXIS 14231 (Fed Cir 2023)). The claims at issue in Starett are related to methods and machines for maintaining augmented telepathic data that includes data structures representing categories of biological signals in a body such as “Nervous System” and “Sensory System”. The specification disclosed a broad and abstract organisational structure used to accomplish the maintenance of augmented telepathic data, but
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