UK experimental use exemptions: Part 2—the Bolar exemption
In the second of a four-part series, Sophie Topham of Marks & Clerk explains the rules around the exemption for studies, tests, and trials required for generic and biosimilar medicines.
UK experimental use exemptions: part 1—the original
In the first of a four-part series, Sophie Topham of Marks & Clerk explores how experimental use provides life sciences products with essential relief from patent infringement
The curious case of Wuhan’s Institute of Virology and remdesivir
Changes to China’s patent laws and a filing by a Wuhan lab involving Gilead’s remdesivir have set up an interesting patent race, says Thomas Moga of Dykema.
Got a patent, now where to validate?
For smaller companies and universities, deciding where to validate a pharma patent can be difficult. Sarah Kostiuk-Smith of Mewburn Ellis looks at the options within the European Patent Convention countries.
Second medical use: a regulatory perspective
Under close scrutiny by regulators, the rules around second medical use patents vary from country to country, explains Jackie Mulryne of Arnold & Porter.
Pricing, patents and the PMPRB in Canada
Micheline Gravelle and Iris Cheung of Bereskin & Parr provide an update on the final version of guidelines issued by Canada’s federal drug price regulator—and its likely implications.
Will the EU’s SPC manufacturing waiver weaken European pharma’s IP?
Despite dire warnings by the US Chamber of Commerce, the impact of the EU’s SPC waiver won’t be known for years, says Paul Williams of Lewis Silkin.
Medicinal cannabis: what next for Brazil?
Tensions between public use, drug laws and regulators make IP around Cannabis a complex situation, explains Ludmila Kawakami and Ana Paula D. C. Couto of Di Blasi, Parente & Associados.
Pharma: A Mexican tradeoff
While providing benefits to Mexico’s biologics system, the USMCA may also increase costs for citizens, argues Margarita Guerrero Gonzalez of Uhthoff, Gomez Vega & Uhthoff.
Secondary patents: Moscow mewl
An intervention by Russia’s IP ombudsman seeks to solve the validity issue over secondary patents, but is it needed, asks Maxim Sobolev of Rouse.