Depending on who's talking, the U.S. patent system may, or may not, be in dire need of reform. In a Senate Judiciary subcommittee hearing Wednesday on the bipartisan STRONGER Patents Act, Sen. Chris Coons (D-Del.) stressed the need to undo the precedent set by the Supreme Court's 13-year-old eBay decision that weakened injunctive relief in infringement cases and to resolve some of the unintended consequences of the 2011 America Invents Act (AIA).
April is not yet complete, but two items of interest already bear noting. One of these is perhaps the most important patent case to be heard by the Supreme Court in a long time, at least where life sciences are concerned. The other is of broader but no less intense interest to device makers. Myriad at SCOTUS Leading off is the April 15 hearing of the Myriad case at the Supreme Court, a hearing during which Justice Elena Kagan remarked that the Patent and Trademark Office is "very patent-happy." Of all the comments signaling a jurist's likely vote, this was...
The Supreme Court decision in Mayo v. Prometheus and the Court’s remand of Myriad have provoked a lot of angst on the part of those in the life sciences. Still, the degree to which these cases might prove cataclysmic is tough to forecast, and those who think Chicken Little is overdoing it have some basis for skepticism. So in the spirit of Prometheus and Epimetheus, the sibling Greek deities whose names translate respectively as forethought and afterthought, let’s examine the prospects for patents in this strange new world. First, let’s ask Epimetheus about the Supreme Court decision in KSR v....
We who scribble for a living find it easy to go off on those who do not, and today's bulls-eye is on the patent reform bill recently signed into law, the America Invents Act of 2011. One of the interesting things about H.R. 1249 is that it puts some of the fees collected by the U.S. Patent and Trademark Office in an escrow for Congress to decide whether to release to PTO. I've asked a number of people around Washington whether they think Congress can resist the temptation to write PTO an IOU and just keep the money, and almost...
The title of this posting pretty much says it all, but I'm paid to tap out words on my keyboard. So here we go. Remember FDA's draft guidance on when to file a 510(k)? Among the things it stipulates is that if a manufacturer makes a change that requires a new 510(k) filing, the manufacturer cannot cite any predicates other than those that were already cited in that device's filing. So what's a device maker to do? Cite every potential predicate it can. Why? You have to ask? Yes, yes, FDA wants to cut down on the use of...
In the world of diagnostic and therapeutic devices, 2011 has already been a busy year, but a third of the year remains. There are still numerous developments that will trigger cheer and jeers, depending on where you sit. This is not an exhaustive list of things that could arise in the last half of this year, but these are all pretty big, and a lot of people will be watching carefully. FDA meeting on IOM 510(k) report: FDA recently invited all interested parties to talk about the recommendations made recently by the Institute of Medicine regarding the 510(k) device clearance...
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...
Now that the U.S. House of Representatives has voted down a higher debt ceiling for the U.S. government, Congress can go back the drawing board on deciding how many Medicare spending cuts the voters and stakeholders can stomach, but as always, there are pockets of concern within the larger picture. The picture for device makers is somewhat complicated in part because the Medicare Part B “doc fix” is a $30 billion-a-year overhang that will be tough to resolve, not just because of the positions taken up on each side of Capitol Hill. On the Senate side, Kent Conrad (D-North...
(For those who wonder whether Congress will ever pass a patent reform bill, we offer the following with a tip o' the hat to Edgar Allan Poe....) Once upon a mid-day dreary, While I pondered dazed and bleary, O'er forgotten writs of Federal Circuit law and patent lore. Yes, I nodded, nearly napping, But then came a nagging tapping. Some optimist was gently rapping, Rapping at my office door. "'Tis some fool," I think I muttered, "Waxing over writs of yore, Only this, and nothing more." Ah, distinctly I remember, It was back in some December, When each separate Senate...