by Dennis Crouch
A number of petitions are pending before the Supreme Court raising interesting patent issues, although none have been granted certiorari thus far.
Leading Eligibility Case: In next week’s long conference (Sept 26), the court will consider what I see as the current leading case of CareDx Inc. v. Natera, Inc., No. 22-1066. The case focuses on the question of whether the patent covering a new biologic diagnostic method was properly invalidated as directed to a natural phenomenon.
The CareDx invention relates to early noninvasive detection of organ transplant failure — an important and longstanding issue in the field. The detection method involves identifying DNA fragments from the transplant within the bloodstream, a challenge that had stumped scientists for over a decade. Although various scientists had proposed mechanisms for using this information, the evidence shows more than a decade of failed ideas, and at least one article reported that the process is “difficult and impractical.” The breakthrough came when Stanford researchers successfully applied high-throughput multiplex sequencing (“shotgun sequencing”) to detect single nucleotide polymorphisms (SNPs) unique to donor organs. Of potential importance, the Stanford researchers did not create these new sequencing techniques, but they were the first to take advantage of them in this particular context and identified particular thresholds in crafting a method that works in this situation. The claims were invalidated by the district court, and that judgment affirmed on appeal.
Another Natural Law Case: A second well written natural phenom petition was recently filed in ChromaDex, Inc. v. Elysium Health, Inc., No. 23-245. The patent in that case claims a dietary supplement of nicotinamide riboside (“NR”) that increases the production of nicotinamide adenine dinucleotide (“NAD+”) — this one was crated by folks at Dartmouth. I have written previously that the Supreme Court’s product of nature in Myriad is hard to square with the two-step abstract idea / law of nature cases of Alice & Mayo. In its decision, the Federal Circuit concluded that the two-step approach is inapplicable in the natural phenomenon case — thus omitting consideration of any inventive concept going beyond the excluded portion. The Hail Mary case of Killian v. Vidal, No. 22-1220, argues that the judge made eligibility exceptions represent a Fifth Amendment taking, a due process violation, and represents an ultra vires action.
IPR Estoppel: A second important case awaiting the late-September conference is Ingenio, Inc. v. Click-to-Call Technologies LP, No. 22-873, focusing on the scope of IPR estoppel under 35 USC 315(e). The case asks whether the Federal Circuit erroneously extended IPR estoppel under 35 U.S.C. § 315(e) to all grounds that reasonably could have been raised in the petition. They focus on the the statutory language that, under their reading, applies the reasonably-could-have modifier in a much narrower context. To wit, petitioner argues that estoppel only applies to issues that could have been raised after the petition was granted– that petitioner “reasonably could have raised during that inter partes review.”
Favorite Pending Case – Inventorship: My favorite pending case is HIP, Inc. v. Hormel Foods Corporation, No. 23-185. HIP argues that the Federal Circuit’s decision improperly heightens the standard for joint inventorship by focusing on quantity rather than substance of inventive contributions. HIP contends any original contribution included in a claim, even if partial, warrants joint inventor status under 35 U.S.C. § 116. In the case, a HIP engineer provided suggestions to Hormel on implementing a pre-cooked bacon method. HIP’s suggestion (using an infrared oven for the preheating step) made its way into the claims, the court concluded it was not significant enough to warrant joint inventorship. For me, the case is largely about the strong presumption that the listed inventors are correct.
Additional Pending Petitions: Two more pending petitions. In Personalized Media Communication, LLC v. Apple Inc., No. 23-230, the patentee PMC argues that the court improperly applied prosecution laches to render its patents entirely unenforceable. PMC argues that under cases such as SCA Hygiene, a patentee’s compliance with statutory deadlines precludes equity from stepping in via laches. I believe that PMC owns the most pre-GATT patents that are still within their patent term. Yes, even more than Gill Hyatt. Finally, in Salazar v. AT&T Mobility LLC, No. 23-241, the petitioner argues that the Federal Circuit acted improperly by issuing an unforeseeably narrow claim construction on appeal. Back in 1995 when these applications were filed, Apple had just released an updated Newton that included Graffiti handwriting recognition software from Palm.
Conclusion: The Supreme Court has not yet granted certiorari on any of these patent law petitions, but their treatment of these issues will provide valuable guidance. Cases like HIP v. Hormel and ChromaDex v. Elysium give the Court opportunities to clarify murky areas of the law around joint inventorship and patent eligibility. Meanwhile, petitions in Ingenio v. Click-To-Call and PMC v. Apple deal with critical procedural issues tied to post-issuance review and prosecution laches. The next few weeks may prove pivotal as the Court considers which of these issues merit its attention.
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