Bibliographic record
Abstract
In 2013 and 2015, the Supreme Court of the United States (US)1 and Australian High Court,2 respectively, rejected the patentability of isolated genes.3 Subsequently, in March 2016 a case in the Federal Court of Canada involving the Children’s Hospital of Eastern Ontario’s (CHEO) challenge to patents on genes related to Long QT syndrome was settled. The settlement provided a licence to CHEO to test for the syndrome. A primary driver of the litigation in all three jurisdictions, was the broader ethical issues posed by such patents, including, the potential healthcare implications of such patents. The European Union adopted tailored legislation to deal with biotechnology patents in 1998, including gene patents. Again, in Europe, a primary concern underlying the drafting of the Directive was the ethical issues posed by biotechnological patents.4 Nonetheless, despite ethical issues driving challenges to, and debates on changes of patent law in such contexts, in practice ethical issues are given limited consideration within patent law cases in each of these jurisdictions. Using gene patents as a case study, this article argues patent law in these jurisdictions, has failed to engage with the broader ethical issues (including potential healthcare implications) of biotechnological patents in any meaningful way. In effect, a marginalisation of ethical issues is evident within patent law. The only exception to this is Canada, where solutions outside patent law, via licensing, have been devised to deliver access to technologies under patent, focusing on the public health issues at stake. The article argues that unless and until we adopt fundamental institutional change within patent law to address broader ethical issues inherent in the grant of patents, it behoves us to take seriously and devise appropriately, solutions outside patent law to address such ethical issues including potential healthcare implications posed by patent use. For such reasons, at a practical level, the solution offered by tailored licensing approaches in the Canadian context, although not without some potential shortcomings, is arguably a preferable solution in the short term. Such licensing approaches should be taken seriously in other jurisdictions.
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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 | 0.046 | 0.057 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.002 | 0.001 |
| Science and technology studies | 0.016 | 0.112 |
| Scholarly communication | 0.018 | 0.016 |
| Open science | 0.002 | 0.012 |
| Research integrity | 0.025 | 0.017 |
| Insufficient payload (model declined to judge) | 0.004 | 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".