The Supreme Courtroom and Patent Safety for Medical Diagnostics: A Nearer Have a look at CareDx and Stanford U v. Eurofins

by Dennis Crouch

The just lately filed petition for certiorari in CareDx and Stanford College v. Eurofins Viracor, Inc. (Supreme Courtroom 2023) gives a chance to look at the patent eligibility doctrine within the context of an essential well being diagnostics innovation. The innovations at situation relate to early detection of organ transplant failure, which clearly maintain important potential to avoid wasting lives and cut back reliance on invasive exploratory surgical procedures. The detection methodology entails figuring out DNA fragments from the transplant throughout the bloodstream, a problem that had stumped scientists for over a decade.  Though varied scientists had proposed mechanisms for utilizing this info, the proof reveals greater than a decade of failed concepts, and a minimum of one article reported that the method is “tough and impractical.”  The breakthrough got here when Stanford researchers efficiently utilized high-throughput multiplex sequencing (“shotgun sequencing”) to detect single nucleotide polymorphisms (SNPs) distinctive to donor organs.  Of potential significance, the Stanford researchers didn’t create these new sequencing strategies, however they have been the primary to make the most of them on this explicit context and, because the declare language beneath reveals, the scientists focuses on creating thresholds as a part of a way that significantly work on this scenario.

Three patents are central to this case: U.S. Patent Nos. 8,703,652, 9,845,497, and 10,329,607. Declare 1 of the ‘607 patent exemplifies the claimed methodology, which incorporates the next steps:

  1. Offering a plasma pattern from the recipient;
  2. extracting cell-free DNA from the pattern;
  3. performing “selective amplification” of goal DNA sequences, whereby that amplification “amplifies a plurality of genomic areas comprising a minimum of 1,000 [SNPs]” utilizing PCR;
  4. performing “excessive throughput sequencing” comprising a “sequencing-by-synthesis response” with an error charge of lower than 1.5%;
  5. offering sequences comprising “a minimum of 1,000 [SNPs]”; and
  6. quantifying the proportion of donor-derived DNA, utilizing distinguishing biomarkers drawn from these a minimum of 1,000 SNPs, and whereby the donor’s cell-free DNA contains a minimum of 0.03% of the full within the pattern.

The Infringement Lawsuit: The Delaware District Courtroom initially denied defendants’ motions to dismiss and for abstract judgment of ineligibility. Nevertheless, Chief Choose Connolly later reconsidered the abstract judgment movement and finally dominated that the claims have been ineligible below the two-step evaluation set forth in Mayo Collaborative Companies v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012). The Federal Circuit affirmed this choice.

The petition to the Supreme Courtroom raises the next easy query: Is a brand new and helpful methodology for measuring a pure phenomenon, which improves upon prior strategies for measuring the identical phenomenon, eligible for patent safety below Part 101? The petition emphasizes the significance of this case in comparison with Tropp and Interactive Wearables, and it underscores the necessity for the Supreme Courtroom to assessment its utility of eligibility exceptions to medical diagnostics.

This case has probably important implications for US patent regulation doctrine in addition to potential affect on funding in medical diagnostics. We’ll be following the case carefully and speaking extra about its potential results.