Baseball Bats and Chocolate Chip Cookies: The Judicial Treatment of DNA in the Myriad Genetics Litigation
Bibliographic record
Abstract
In June 2013, the U.S. Supreme Court rendered a controversial ruling that naturally occurring DNA segments are "products of nature" and therefore not patentable subject matter.At this intersection between science and law, in litigation of crucial importance to patients, science, and multibillion-dollar biotech enterprises, the appellate judges sidestepped genetics and engaged in a war of metaphors from diamonds to chocolate chip cookies.This case is not an outlier.Apprehensive judges and juries in both Canada and the United States find many convenient excuses to avoid coming to grips with the underlying science in patent cases.But this is simply not acceptable.Legal rulings must be, and must seem to be, well grounded, as a matter of both law and science.The legitimacy of court decisions in the eyes of the stakeholders and the broader public depends on it.T he face of the biotechnology industry changed dramatically with the U.S. Supreme Court's decision in Association for Molecular Pathology et al. v. Myriad Genetics, Inc. et al. (133 S. Ct. 2107) (S.Ct. 2013) (Myriad USSC).As of June 2013, naturally occurring DNA segments are "products of nature" and therefore not patentable subject matter in the United States.The Supreme Court's brief opinion overturned more than 30 years of U.S. Patent and Trademark Office practice and outraged the thousands of patent holders and their attorneys who had relied for years on the validity of their issued gene patents.Instead, Justice Thomas for the unanimous court adopted what many scientists have argued all along: that DNA's unique function and importance derives not from its status as a "composition of matter" but from its status as a carrier of information.In the Myriad Genetics case, the utility of the claimed BRCA1 and BRCA2 genes and related mutations in identifying women with an increased risk of breast and ovarian cancers stemmed from the genetic information they contained.Myriad had merely discovered the genes' precise location and sequences.And this, the Supreme Court held, was insufficient coin to purchase a 20-year patent monopoly.At the same time, Myriad's claims to BRCA1 complementary DNA (cDNA) were upheld on the basis that cDNA is not naturally occurring.Justice Thomas wrote that "the lab technician
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.003 | 0.003 |
| Science and technology studies | 0.002 | 0.006 |
| Scholarly communication | 0.003 | 0.004 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.007 | 0.005 |
| Insufficient payload (model declined to judge) | 0.002 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".