相关临床试验
3
1 进行中
药物批准
1385
批准总数
监管机构
4
监管机构数
成立时间
N/A
进行中（未招募）
1
33.3%
已完成
1
33.3%
终止
1
33.3%
- Canada's Drug Agency (CDA-AMC) has recommended conditional public reimbursement for Yorvipath (palopegteriparatide injection) in adults with chronic hypoparathyroidism inadequately controlled with conventional therapy. - Yorvipath is a parathyroid hormone (PTH) replacement therapy authorized by Health Canada on January 28, 2026, and supported by evidence from the Phase 3 PaTHway trial. - The recommendation marks an important milestone, though final listing decisions rest with participating federal, provincial, and territorial drug plans and hinge on price negotiation. - Clinicians and patient advocates highlight that PTH therapy addresses the underlying hormone deficiency, offering a distinct approach for patients whose disease remains uncontrolled despite calcium and active vitamin D therapy.
- The Supreme Court of Canada ruled 7-2 that methods of medical treatment cannot be patented under Canadian law, reaffirming a half-century precedent. - The Court upheld Janssen's patent for paliperidone palmitate dosing regimens, finding they do not amount to professional medical skill and judgment. - A concurring opinion argued the prohibition is a "relic of another age" and that methods of medical treatment should be assessed under standard patentability criteria. - The decision blocks Pharmascience from marketing a generic version that would infringe Janssen's dosing regimen patent for the schizophrenia drug INVEGA SUSTENNA.
- The Supreme Court of Canada heard arguments in October 2025 regarding the patentability of medical treatment methods in Pharmascience Inc. v Janssen Inc., focusing on Janssen's paliperidone palmitate patent for schizophrenia treatment. - The case centers on whether Janssen's Canadian Patent No. 2,655,335 relating to INVEGA SUSTENNA dosing regimens constitutes an unpatentable method of medical treatment or a patentable medical use. - The Federal Court of Appeal previously ruled that patentability depends on whether the invention requires physician skill and judgment, distinguishing between "how to use" versus "whether to use" the invention. - A Supreme Court decision expected in 2026 will resolve over a decade of uncertainty regarding medical use claims involving dosage ranges and treatment regimens in Canadian patent law.
- The Supreme Court of Canada will hear arguments on October 9, 2025, in Pharmascience Inc. v Janssen Inc., addressing whether patents can validly claim methods of medical treatment, particularly dosing regimens. - The case centers on Janssen's "335 Patent" for a pharmaceutical dosing regimen, which Pharmascience challenges as invalid for claiming an unpatentable method of medical treatment. - Six parties including industry associations and physician groups have submitted arguments, with positions ranging from complete prohibition to full patentability of medical treatment methods. - The Supreme Court's decision could eliminate decades of uncertainty in pharmaceutical patent law or establish new frameworks for determining what constitutes patentable medical treatment methods.
