Cinq décisions d’intérêt en matière de protection de la propriété intellectuelle dans le domaine pharmaceutique en 2020 : lorsque les traités commerciaux internationaux s’invitent dans le débat
Bibliographic record
Abstract
RESUME Le present article passe en revue la jurisprudence marquante concernant, entre autres, les brevets pharmaceutiques pour l’annee 2020, avec un regard sur certains regimes implantes par le Canada en vertu de traites internationaux. Les decisions commentees portent sur le regime des certificats de protection supplementaire (CPS), l’interpretation d’ingredients medicinaux et de combinaison d’ingredients medicinaux, ainsi que la classification des adjuvants. Il est aussi question du regime de la protection des donnees, de l’exclusivite de marche accorde aux brevetes, de l’interpretation de drogue innovante et d’element chimique nouveau, de la comparaison directe ou indirecte d’une drogue generique a une drogue innovante, des etudes sous-jacentes sur la biodisponibilite ainsi que des enantiomeres et les composes racemiques. Enfin, les facteurs obligatoires et complementaires a la disposition du Conseil d’examen du prix des medicaments brevetes en matiere de surveillance et de controle des prix des medicaments brevetes sur le marche canadien sont analyses. Un parallele est effectue entre chaque decision commentee et divers traites internationaux, notamment l’Accord economique et commercial global entre le Canada et l’Union europeenne, l’Accord de libre-echange nord-americain, l’Accord sur les aspects des droits de propriete intellectuelle qui touchent au commerce et l’Accord entre le Canada, les Etats-Unis d’Amerique et les Etats-Unis mexicains. ABSTRACT This article reviews leading case law concerning, among other matters, pharmaceutical patents for the year 2020, with a look at some of the regimes implemented by Canada under international treaties. Annotated decisions deal with the Certificates of Supplementary Protection (CSP) regime, the interpretation of medicinal ingredients and combinations of medicinal ingredients, and the classifi cation of adjuvants. Also discussed are the data protection regime, market exclusivity granted to patentees, the interpretation of innovative drug and new chemical entity, the direct or indirect comparison of a generic drug to an innovative drug, the underlying bioavailability studies, as well as enantiomers and racemic compounds. Finally, the mandatory and additional factors available to the Patented Medicine Prices Review Board in monitoring and controlling the prices of patented drugs on the Canadian market are analyzed. A parallel is drawn between each commented decision and various international treaties, including the Canada-European Union Comprehensive Economic and Trade Agreement (CETA), the North American Free Trade Agreement (NAFTA), the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and the Agreement between Canada, the United States of America, and the United Mexican States (CUSMA).
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.006 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.003 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.002 | 0.005 |
| Insufficient payload (model declined to judge) | 0.007 | 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; both teacher heads agree on what is shown here.
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".