Jazz’s REMS patent appears to cover only a method of distributing Xyrem not a method of using the drug and if so should be delisted from FDA’s Orange Book, FTC argues in Jazz infringement suit against Avadel, which had itself sued FDA seeking release from patent certification requirement.
The US Federal Trade Commission suggests that Jazz Pharmaceuticals plc improperly listed its patent on a system for distributing Xyrem (sodium oxybate) in the US Food and Drug Administration’s “Orange Book” because the patent does not claim the drug itself or a method of using it.
The FTC filed an amicus brief in Jazz’s infringement suit against Avadel Pharmaceuticals plc in the US District Court...
Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.
A Duke-Margolis working group is developing ideas to enable non-profit firms to seek US FDA approval for new indications for off-patent medicines. The former acting commissioner thinks citizen petitions might be the fastest route.
Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?
At Medicines for Europe’s legal affairs conference last month, divisional patents were once again a major subject of discussion. Attendees heard fresh details of how patentee games are preventing generics from hitting the market and restricting wider access to major medicines.
The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?
The importance of generic and biosimilar medicines is being recognized by the UK government for the first time. However, Mark Samuels, CEO of Medicines UK, the trade body representing the off-patent industry, says companies are still face multiple hurdles in the market.
The UK drug regulator is collecting data to establish whether patients who are hospitalized for acute pancreatitis after taking a GLP-1 drug have a genetic predisposition to this side effect. If a “clear link” is found, the MHRA would consider regulatory action.
