Patent Cases of 2023: Decisions Reshaping Protecting Innovation
In 2023, the landscape of patent law witnessed significant shifts due to landmark rulings in several high-profile cases. These cases set broad precedents that will influence how innovation is protected and commercialized in the future.
1. Enablement
Amgen Inc. v. Sanofi, 143 S. Ct. 771, 215 L.Ed.2d 44 (2023)
In a much-anticipated decision, the Supreme Court addressed a dispute between Amgen and Sanofi over the patentability of PCSK9 inhibitors, a class of cholesterol-lowering drugs. The crux of the case involved the specificity required in a patent application for claiming biologic inventions. Although Amgen described in its specification the amino acid sequences for 26 particular antibodies, Amgen broadly claimed any antibody capable of binding to a specific location on a protein and blocking that protein from raising LDL cholesterol levels. As the Court explained, such functional claiming covered a “vast” number of additional antibodies that Amgen never described, and Amgen provided no method for discovering operable antibodies without extensive trial and error experimentation. Amgen’s two approaches for further antibody discovery were, according to the Court, “little more than two research assignments.” Emphasizing that “the more a party claims . . . the more it must enable,” the Court held that Amgen’s limited disclosure was woefully inadequate to enable the full scope of the claims, particularly given the unpredictable link between an antibody’s amino acid sequence and its function in the body. The Court so found without applying the Federal Circuit’s Wands test regarding undue experimentation, stating simply that the level of experimentation must be “reasonable.” The Court also noted that a specification need not necessarily describe how to make “every single embodiment” within a claimed class. But because Amgen had not described how to make and use the full scope of its broad claims without undue experimentation, the Court affirmed the Federal Circuit’s decision invalidating Amgen’s claims for lack of enablement.
In light of this decision, practitioners drafting claims to a genus that potentially has many species should ensure that the patent application discloses as many examples of species within that genus as possible. As a fallback position, claims directed to several narrower sub-genera may be included in the application, with the specification describing as many examples of species within each sub-genus as is feasible. As part of such a disclosure strategy, practitioners also may consider describing one or more common features, such as structural features, of species within a genus or sub-genus. Finally, it is important to include dependent claims directed to individual species or smaller groups of species that have commercial value.
2. Public Use Bar
Minerva Surgical, Inc. v. Hologic, Inc., 59 F.4th 1371 (Fed. Cir. 2023)
In this case, the Federal Circuit upheld the district court’s summary judgment that the asserted claims were anticipated under the “public use” bar of pre-AIA 35 U.S.C. § 102(b). The invention was directed to a medical device for ablating uterine endometrial tissue. The Federal Circuit agreed that the patented technology was “in public use” because, before the critical date, the patentee disclosed 15 “fully functional” devices over the course of several days at an industry trade show (along with a brochure that provided a detailed description of the devices) and the attendees at the event were not subject to any confidentiality obligations. The Federal Circuit also opined that the technology was “ready for patenting” because the patentee considered the 15 disclosed devices to be fully functional working prototypes. The fact that the surgical devices were not yet FDA approved, or that further refinements needed to be made, did not affect the Federal Circuit’s conclusion that the technology was “ready for patenting.” This case is an important reminder to companies, particularly start-up companies, that before taking a new product to a trade show or disclosing it to potential investors, an appropriate patent application or a confidential agreement must be put in place.
3. IPR Estoppel
Ironburg Inventions Ltd. v. Valve Corp., 64 F.4th 1274 (Fed. Cir. 2023)
Section 315(e)(2) of the Patent Code prevents a petitioner, following a final written decision in an IPR, from asserting in a district court action invalidity grounds that the petitioner “raised or reasonably could have raised” in the petition. As the Federal Circuit explained, the “estoppel applies not just to claims and grounds asserted in the petition and instituted for consideration by the Board, but to all grounds not stated in the petition but which reasonably could have been asserted against the claims included in the petition.” Ironburg specifically addressed the question of what happens when a challenger discovers prior art after filing its petition. The Federal Circuit clarified that the proper standard is the “skilled searcher” standard, i.e.,“an IPR petition ‘reasonably could have raised’ any grounds that ‘a skilled searcher conducting a diligent search reasonably could have been expected to discover.’” The Federal Circuit also clarified that it is the patent owner seeking to impose estoppel that bears the burden to establish that this standard has been met by a preponderance of the evidence.
4. Establishing Article III Standing for an Appeal from an IPR Decision
Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLC, 85 F.4th 1377 (Fed. Cir. 2023)
Although a party does not need Article III standing to file an IPR petition, the party still must have Article III standing to seek review of the Board’s decision in the Federal Circuit. Thus, a petitioner that loses in the PTAB must show on appeal that it suffered an injury in fact based on potential infringement liability. In the Allgenesis case, the Federal Circuit concluded that Allgenesis failed to show injury in fact based on potential infringement liability. The Federal Circuit determined that Allgenesis failed to show that it has concrete plans for future activity that creates a substantial risk of future infringement or that may cause the patentee to assert a claim of infringement. To support its claim of standing, Allgenesis offered a declaration by its Vice President of finance that included information about a completed Phase II trial. However, the declaration did not discuss specific plans to conduct a Phase III trial or to seek U.S. Food and Drug Administration (FDA) approval. Instead, the declaration only contained generic statements that the project was not being abandoned. While Allgenesis’s briefing and oral argument included statements that it is planning to conduct a Phase III trial, the Federal Circuit determined that there was no record supporting such claim. Allgenesis also attempted to rely on its own failed attempts at seeking a settlement from Cloudbreak, but the Federal Circuit concluded that this was insufficient to show a substantial risk of infringement.
Allgenesis’s additional argument was that the Board’s priority decision created an injury in fact. Allgenesis argued that the Board’s determination about the priority date of Cloudbreak’s patent affected Allgenesis’s rights in its pending patent applications. However, the Federal Circuit was unpersuaded and ruled that collateral estoppel will not attach to the examination of pending applications from the PTAB’s non-appealable priority determination.
For life sciences companies working in drug development, declarations in support of Article III standing should contain specific information about ongoing clinical trials leading to drug commercialization, and concrete timelines for future events, including Phase III clinical trials and target dates for FDA submission. If a company cannot provide such information for business purposes or other reasons, it should consider the risks of not having Article III jurisdiction for appeal and whether to proceed with an IPR in the first place.