LATEST ARTICLES
Austria
Schoenherr Attorneys at Law
Austria's healthcare system got a long-anticipated makeover. After years of small-scale adjustments, a collective amendment – the "Vereinbarungsumsetzungsgesetz 2024"...
Belgium
Altius
For the past five years there has been an ongoing battle between the Belgian Competition Authority ("BCA") and the legislator about the BCA's competence...
Brazil
Koury Lopes Advogados
New Normative Instruction (IN), which comes into force in June, brings a list of equivalent foreign regulatory authorities approved by ANVISA and the requirements for optimized registration of medical devices...
Koury Lopes Advogados
Petições que já tenham sido alvo de avaliação por autoridades passam a tramitar com mais agilidade perante a Anvisa, facilitando a regularização desses produtos...
Canada
Torys LLP
In Palmer v. Teva Canada Limited1, the Ontario Court of Appeal dismissed the plaintiffs' appeal from the lower court's decision denying certification of a proposed product liability class action that claimed damages...
Goodwin Procter LLP
On March 18, 2024, Fresenius Kabi ("Fresenius") and Formycon announced a settlement agreement with Johnson & Johnson regarding FYB202, a proposed ustekinumab biosimilar to STELARA in Europe and Canada.
Smart & Biggar
On February 16, 2024, the Minister of Health tabled the 2022 Annual Report of the Patented Medicine Prices Review Board (PMPRB).
Smart & Biggar
On February 29, 2024, the Minister of Health announced the introduction of Bill C-64, An Act respecting pharmacare (Pharmacare Act), which "proposes the foundational principles...
Smart & Biggar
On February 23, 2024, Health Canada announced that it will expand the information available on the Generic Submissions Under Review (GSUR) list to include the following...
Smart & Biggar
In this article, we provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, and market access) since our March 2023 update.
Smart & Biggar
On March 7, 2024, Health Canada published a Memorandum of Understanding (MOU) with the Competition Bureau (together, Participants) to advance their mutual interests and develop a framework...
China
AnJie Broad Law Firm
《专利法》第七十六条、《药品专利纠纷早期解决机制实施办法（试行）》（简称药品专利纠纷实施办法）和《最高人民法院关于审理申请注
Kangxin
フランスヴァレオクリーニングシステム会社（VALEO SYSTEMES D'ESSUYAGE）と厦门卢卡斯自動車部品有限公司などとの「車ワイパー」に係る発明特許侵害紛争
Denmark
Plesner
The Danish company TÜV SÜD Danmark ApS has been designated as a new notified body for the certification of medical devices.
Germany
Bardehle Pagenberg
Counterclaim for revocation can be combined with central revocation action against the same patent upon request by the parties
India
IndusLaw
Over the past two months, significant strides have been made in reforming marketing practices within the
pharmaceutical industry, alongside efforts to establish fair pricing frameworks for both drugs and medical devices.
Kazakhstan
GRATA International
Как отмечалось нами ранее в предыдущих обзорах нормативно-правового регулирован&
Netherlands
Van Doorne
Last week, the European Commission raided a manufacturer of medical devices for cardiovascular application.
Taylor Wessing
The case law year started well for those interested in supplementary protection certificates ("SPCs") for patents and waivers thereof: on 23 January 2024...
Bär & Karrer
Swiss healthcare regulation is spread over various statutes, ordinances and guidelines, including self-regulatory instruments such as best practice codes and references to international provisions.
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