Those with a keen eye trained on the patent reform bill now under consideration in the House of Representatives might universally hold a dim view of fee diversion even if they see first-to-file and the prior user defense through profoundly different lenses. The problem is that the manager's mark for H.R. 1249 as of June 20 includes language that will put the fees paid by patent, trademark and copyright applicants right back into the hands of appropriators, who will have a tough time avoiding the urge to raid the cookie jar in a fiscal environment in which cookies are increasingly...
The U.S. House of Representatives is expecting a vote this week on its patent reform bill, but unlike passage of the Senate bill, the House bill has to deal with a potentially crippling conflict. This conflict was set up by the provision dealing with fees collected by the Patent and Trademark Office, which is on a collision course with the budget-cutting mood in the House. Another difference between the two bills is the inclusion of the prior user defense in the House bill, but I'm going to propose that the real question here is not whether the House and Senate...
FDA reported yesterday a program designed to leverage resources with other nations in an effort to hold flawed products at the border, but the agency's commissioner, Margaret Hamburg, MD, acknowledged on a conference call yesterday that the program might suffer from a lack of cash. (Medical Device Daily)
FDA's Center for Devices and Radiological Health published the results of its analysis of decisions on 510(k) applications between 2006 and 2010 (see the pdf of the report here), including some data from as far back as 2001, and several features jump out to the casual observer. The problem for CDRH managers is that the report suggest a number of stories – several of which the agency fails to tell – that will do nothing to dial down industry's pushback against FDA's more aggressive enforcement/compliance regime. The report is also certain to do nothing to drain the increased pressure on...
