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.
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.
Section 8 of Canada’s Patented Medicines (Notice of Compliance) Regulations is a unique provision under which an innovator can be liable for a generic’s losses that result from a delay in coming to market, as Gunars Gaikis explains
Which patented drugs are losing their market exclusivity in 2015, and how will their makers cope? LSIPR takes a look at five of the biggest drugs to lose patent protection in the US this year.
As Myriad seems to have thrown in the towel in its fight to protect patents covering its BRCA diagnostic tests, LSIPR asks whether the gene patent’s days are numbered in the US, and takes a look at its fortunes in other jurisdictions.
The most recent Illicit Trade Report states that pharmaceuticals are by far the most numerous counterfeit commodity reported, and the problem is increasing. LSIPR investigates what’s being done about it.
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.
Despite the headwinds facing the industry, a growing number of leading pharmaceutical companies feature on Thomson Reuters’ annual Top 100 Global Innovators list, as Bob Stembridge reports.
Maximising the strength of patent protection should be an important objective of any R&D pharma company. Christine Goddard and Janis Fraser of law firm Fish & Richardson offer their six top tips for success.