Apotex Inc v The Government of the United States of America: Will Barriers to Jurisdiction Inhibit an Emerging Trend?
Notice bibliographique
Résumé
In a recent investor–State case brought against the United States under the North American Free Trade Agreement (NAFTA),4 the Tribunal upheld the Respondent’s preliminary objections to jurisdiction. The Decision in Apotex Inc v The Government of the United States of America sheds further light on the precise meaning of the term ‘investment’ under NAFTA and confirms that investors must surmount a high jurisdictional threshold in order to bring claims before a NAFTA tribunal. That said, the fact that the Claimant chose to bring its claims before a NAFTA tribunal at all confirms an emerging trend of intellectual property and pharmaceutical claims being brought to investor–State tribunals. Whether this decision will inhibit that trend is the subject of this case note. Apotex Inc is a Canadian company that develops and manufactures generic drugs, including solid oral dosage forms such as capsules and tablets.5 Apotex claimed that it was subject to mistreatment by the United States as it endeavoured to bring generic versions of anti-depressant and anti-cholesterol drugs to market in that country. From a regulatory standpoint, Apotex’s endeavour began with the filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA), establishing that the generic drug is the equivalent to the patented brand name drug.6 Once a patent expires (or is deemed invalid by a court), the first-filed ADNA applicant is eligible to benefit from an exclusive 180-day sales period during which only it can sell the drug in the US market.7 Apotex filed ANDAs for two drugs and then applied for declaratory judgments from the US Federal Courts which it hoped would trigger the 180-day exclusivity period for its commercial benefit. The ensuing litigation was complex and not wholly pertinent to this case note. In sum, the FDA and then the US Federal Courts held that Apotex could only trigger the 180-day exclusivity period by filing its ANDAs and then obtaining declaratory judgments on the merits against the existing patent holder that its patent was invalid or would not be infringed by the drug for which the applicant sought approval.8 Apotex argued in its NAFTA claim that the US regulatory agency and judicial decisions pertaining to its ANDAs were a misapplication of longstanding principles of US law, and in particular that these decisions were ‘arbitrary’, ‘capricious’, and ‘unjust’—and therefore amounted to a breach of the NAFTA.9
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,001 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».