The rulemaking is supposed to formalize the Patent Trial and Appeal Board process, which has been in an interim status since a Supreme Court decision, giving manufacturers more ability to request oversight of the decisions.
A new proposed rule describes when and how parties can request Director Reviews of the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) proceedings, as well as when the PTO Director may initiate a review, but still highlights the rareness of success using the process.
PTO has received 328 complaint requests for Director Review under an interim process as of 1 April. Of the 316...
Divisional patents remain a major barrier to market entry for generics in Europe, heard attendees to Medicines for Europe’s legal affairs conference in Dublin earlier this month.
US Federal Trade Commission says the policy would enhance its ability to detect reverse payment settlements between pharmaceutical companies that raise antitrust concerns.
Industry groups say the initiative will undermine innovation and the competitiveness of European companies, impeding Europe's ability to tackle future crises effectively.
More legal action in India that has the Bolar exception provision at its crux with Roche, in this instance warding off a local drug maker in the Evrysdi patent infringement case.
Finding the right way to measure outcomes is just one of the difficulties involved in conducting clinical trials of potential new therapies for loss of hearing, which can have a number of different causes.
Johnson & Johnson plans to shift 340B price concessions on Stelara and Xarelto to rebates for some hospitals beginning in October, allowing for more company oversight of claims.
MSN Laboratories will be unable to move forward with any potential ‘at-risk’ launch for its generic version of Novartis’ Entresto blockbuster in the US for now after the originator won a stay of the firm’s ANDA approval pending appeal from the US Court of Appeals for the District of Columbia Circuit.
