On July 21 the US Court of Appeals for the Federal Circuit ruled in Amgen v Sandoz that biosimilar applicants can opt out of the ‘patent dance’. Courtenay Brinckerhoff of Foley & Lardner considers the decision’s implications for the biosimilars framework and highlights the questions that remain unanswered.
Biopharma parties thinking about challenging a patent via an inter partes review should be aware that there are significant differences between district court and IPR practice, as Tasha Francis and Dorothy Whelan of Fish & Richardson explain.
The judiciary system for the new Unified Patent Court has been the subject of much discussion. As part of a regular column, Paul England, senior associate at law firm Taylor Wessing and who chaired a recent discussion between a panel of experts, examines the issue.
The question of whether using a known drug for treating a known disease, but in a distinct sub-population of patients, can constitute a patentable new invention is key to the development of personalised medicine, says Stephen Smith of Potter Clarkson.
An enormous increase in the number of biotech articles published in Brazil indicates that the area is experiencing strong expansion when considered in the global context, as Gabriel Di Blasi and Marisa Moura Momoli of Di Blasi, Parente & Associados report.
Mexican patent examiners usually reject patents directed to human embryonic stem cells, but applications filed after 2008 may have a greater chance of being approved, as Jasmin Maqueda of Becerril, Coca & Becerril describes.
The proposed Trans-Pacific Partnership seemingly contains a bid by the US to increase standards for compulsory licences above those already in place internationally, say Sandra Kuzmich and Russell Garman of Frommer Lawrence & Haug.
The inter partes review system was set up as a cheaper way of invalidating patents than litigation. Given the high success rate, and the large number of ‘patent trolls’ involved, is it likely that troll activity will be dampened? Steve Coyle, Leslie-Anne Maxwell and Chad Dever of Cantor Colburn investigate.
The Supreme Court’s Limelight decision makes it particularly difficult for the owners of diagnostic method patents to enforce those patents against a third party selling the assay. MaryAnne Armstrong of Birch, Stewart, Kolasch & Birch describes the current situation.
Despite the SPC Regulation having been in existence for decades, applicants are still left to navigate uncertain waters on issues of fundamental importance when it comes to ‘combination’ therapies, as Michael Pears of Potter Clarkson reports.