相关临床试验
11
0 进行中
药物批准
280
批准总数
监管机构
2
监管机构数
成立时间
N/A
已完成
10
90.9%
终止
1
9.1%
- 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.
- Pricing negotiations between the pan-Canadian Pharmaceutical Alliance and Johnson & Johnson for Carvykti, a CAR-T therapy for multiple myeloma, collapsed in September after nearly two years of discussions. - The therapy, approved by Health Canada in February 2023, has a sticker price of $632,455 and showed remarkable results with 33% of heavily pretreated patients remaining alive and progression-free at five years. - Nearly 1,000 Canadian multiple myeloma patients and caregivers have launched a letter-writing campaign urging officials to resume negotiations for the potentially curative treatment. - Multiple myeloma affects 11 Canadians daily, making it the second most common blood cancer, while Carvykti is already publicly reimbursed in 13 countries including Spain, Belgium, and Portugal.
- 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.
