In the battle for marketing approval of a biosimilar version of Neupogen under the BPCIA, applicant Sandoz stymied Amgen’s chance to join the so-called patent dance. Andrew Williams of McDonnell Boehnen Hulbert & Berghoff ponders the implications.
The FDA could approve the US’s first biosimilar product any day now. But is the country ready for the wave of biosimilar applications that will surely follow, and how quickly can these cut-price drugs come to market? LSIPR reports.
The patentability of human embryonic stem cells is bound up with many ethical considerations, including the viability of the cells used. Laura von Hertzen and Robert Burrows of Bristows discuss the latest legal opinions.
Genetically modified plants, hybrid seeds and plants obtained from such seeds are usually granted patent protection in Mexico as they are not created by ‘essentially biological’ processes, as Fernando Rincón of Becerril, Coca & Becerril reports.
Controversial patents covering a fruit and a vegetable are awaiting their fate at the Enlarged Board of Appeal. LSIPR examines the likelihood of their succeeding.
Existing portfolios should be carefully reviewed and care must be taken in drafting new patent applications to withstand section 101 scrutiny in the US, as Judith Kim, director, and Scott Schaller, of counsel, at Sterne Kessler Goldstein & Fox, describe.
At first glance, it might seem odd for a company to both divide blood plasma and fight the side-effects of cancer treatment. But not for PlasmaTech Biopharmaceuticals, which tells LSIPR about how the company does it and also protects its IP.
Protecting rights related to desirable plant species is a delicate process, says Gabriel Di Blasi.
Earlier this year, the Advocate General of the CJEU opined that stem cells from parthenotes are patentable. Franz-Josef Zimmer and Markus Grammel examine the reasoning behind his opinion.
Who has legal interest in the grant of sanitary registrations for follow-on biologics? José Trigueros examines a recent case in Mexico that could have far-reaching ramifications.