The emergence of a medical exception from patentability in the 20th century
Bibliographic record
Abstract
Many patent law dilemmas arise from a failure to understand technologies as embedded in broader social, economic and political realities and to contextually analyze these legal phenomena. This narrowness leads to poor legal development, of which the modern medical exception from patentability is one example. Judges have difficulty interpreting it, patentees do not understand its purpose and it does not protect the important medical technologies to which the public would like access. This thesis applies a legal pluralist analysis to examine the emergence of the medical methods exception in order to understand why it was created and legislated. It starts by examining the origins of the exception in the caselaw, and the informal, concurrent norm established by the emerging medical profession in the early 20th century. It then proceeds to examine why the medical profession might have sought and enforced a norm prohibiting its members from patenting, and concludes that this arose from the need of the medical profession to distance itself from the patent law. As a result, professionalizing physicians established an internal normative order that mimicked and in many cases replaced the effect of the formal law. The thesis then proceeds to examine how the form of the informal norm evolved in the period between WWI and WWII, finding that the profession’s norm transformed and broke down concurrently with its efforts to achieve external legitimacy through legislation. That breakdown arose from factors which included growing labour mobility, greater understanding of the benefits of patents, and a growing role of science and industry in medicine that threatened the profession’s access to valuable medical innovation. The thesis concludes with a study of a current case (Myriad Genetics) that applies the thesis’ theoretical framework to a present dispute over the role the law should play in regulating genetic diagnostic tests.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.008 | 0.010 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.002 | 0.001 |
| Science and technology studies | 0.006 | 0.046 |
| Scholarly communication | 0.008 | 0.007 |
| Open science | 0.001 | 0.004 |
| Research integrity | 0.004 | 0.006 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
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".