But as I stated in my two posts (here and here) to the MDD Perspectives blog on NIH's finances, spending on heart disease and Alzheimer's relative to NIH spending on cancer is strangely low when you consider the relative burdens these diseases impose on society. Consider that and then read the undated statement at the AA website about NAPA. The legislation “will create a coordinated national plan to overcome the Alzheimer crisis and will ensure the coordination and evaluation of all national efforts in Alzheimer research, clinical care, institutional, and home- and community-based programs and their outcomes,” the statement claims.
The absence of any meaningful commitment by our government (by which I mean our tax dollars) is just a wee bit conspicuous. I can just hear the legendary Clara Peller hollering “where's the beef?” Her feigned outrage over the skimpy portions of beef on burgers was hilarious, but I can just imagine what a member of our nation's electoral elite would say in response.“We're sorry Mrs. Peller, what on earth makes you think a hamburger has to have beef to be a burger? It's called a HAMburger, not a beefburger!”
It's too bad both Mrs. Peller and Dave Thomas, the founder of Wendy's, the fast-food chain that made the dear lady famous, aren't around to ask our elected officials where in heck the money is (Mrs. Peller) and to do something about the absence of any meaningful additional resources for Alzheimer's (Mr. Thomas). This would be funny as screwball comedy but for one thing: Human lives and our nation's economy are at stake. That's not funny, not even a little bit.
It's another example of why the process of making policy, like the process of making sausage, is simply horrible to behold. But as we all know, there's often little or no digestible beef in sausage.[caption id="attachment_578" align="alignleft" width="300" caption="Something's missing!"][/caption]
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 scarce.
The newest iteration of H.R. 1249 includes the language, “there is established in the Treasury a Patent and Trademark Fee Reserve Fund,” which will be filled with the proceeds collected in excess of the amounts appropriated to the U.S. Patent and Trademark Office in a given fiscal year. This new feature of H.R. 1249 provides that the monies in question “shall be made available until expended only for obligation and expenditure by” PTO “to the extent and in the amounts provided in appropriations Acts.”
It's not hard to understand why the House Appropriations Committee wants to avoid the appearance of favoritism, but the conceptual construct underlying the idea of ending diversion of PTO's fees into the Treasury's general fund is that innovation creates job and PTO needs more money to clear the patent backlog, which is presumed to be chock-full of job-creating innovation. Therefore, you have to let PTO keep the fees it collects from inventors if you want intellectual property to play a meaningful role in bringing the economy back to life. I have not heard the argument that the $50 million the Treasury would lose to PTO would be at least offset by an increase in tax revenues, but any such effect might not be felt for a couple of years, which might seem like an eternity to those trying to keep the U.S. government from ending up with the kind of credit rating now enjoyed by Greece and Ireland.
Still, the casual observer has to wonder how many small cuts to the corpus will yield a corpse. First-to-file is not universally popular, and the purportedly offsetting prior user defense is obnoxious to a far greater number. Is there any need for this bill if it allows appropriators to dive into the PTO piggy bank any time they want?
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 can pave over those differences. The real question is whether Congress spent too much time playing with this set of issues and in the process made itself almost entirely irrelevant where patent law is concerned.The two bills differ somewhat on inter partes re-examinations, but it ranks as a small difference compared to some of the things that are typically settled during House-Senate conferences. I understand that the difference between nine and 12 months to conduct such a review is important (not to mention the difference in the threshold for conducting such a review), but there's a saying often heard in this town when House-Senate negotiations are stuck. That saying is: “I'm not impressed with your logic, but I am impressed with your votes.” If inventors end up dismayed with the outcome on the inter partes review discussion, they won't be the first to have a reason to gripe about the goings-on on Capitol Hill.
Allowing PTO to keep the fees it collects looks like the no-brainer of the century, but I'll point out that the brainiacs in the Senate didn't see fit to put that in their bill despite six years of thrashing about on damages, inequitable conduct and a host of other features that have since been addressed by the courts. Fee diversion could kill patent reform in the House this year because the federal budget deficit is at astronomical levels, and the tidy little sum of $50 million the Treasury siphons off from PTO each year now looks like Senator Everett Dirksen's serious money. Device makers might not like the continued abuse of patent (and trademark and copyright) fees, but deficit hawks would say if FDA is getting a haircut, why not PTO?Just as an aside, I'll point out that the Supreme Court has opted to hear Prometheus v. Mayo, a case that will go a long way to determine how much life science companies are willing to plow into molecular diagnostics, presumed to be the sine qua non of personalized medicine. No point in going into the details of that case here, especially since the case has bounced back and forth twice between the Supreme Court and the Court of Appeals for the Federal Circuit, but a win for the Mayo Clinic (Rochester, Minnesota) could have a profound impact on private-sector investment in diagnostics. Yet Congress is mum. To add another record to the file labeled “Department of Redundancy Department,” the Senate bill declares a standard for patent obviousness in language aping the Supreme Court decision in KSR v. Teleflex. Really, was anyone not paying attention? I'm pretty sure PTO gets it, but if you're not sure Senator Leahy, give Mr. Kappos a ring. Why clutter things up with this sort of superfluous junk?
So we have fee diversion as a situation Congress legitimately needs to deal with, along with first-to-file and the prior user defense. A lot of stakeholders (not all) are sympathetic to first-to-file, but the field is perhaps more evenly split on a prior user defense, which is seen as essential to offset the ills inherent to first-to-file. Some see the prior user defense as an abomination, but PTO director David Kappos seems supportive. I'm not going to take a position because I honestly have no idea, but in one of the House hearings earlier this year, the witnesses testified to a one that fee diversion was the most important thing for Congress to address. So if first-to-file needs the prior user defense as a corrective, how important is either or both compared to fee diversion?
If the House bill tanks this week, it may come across as an object lesson in the importance of getting the job done now while you still can rather than waiting long enough for events to take away your options and leave you empty-handed. That's not a bad way to live if you like the taste of bitter pills, but it's not what we pay these 535 people more than $100,000 each to do.
On the other hand, the judges seem to have most of this under control, and who's to say it's a bad thing if not everyone gets to the train station on time? After all, most of us don't want a lot of pointless flailing about by noisy, ill-mannered people on the train ride to work.
Last week, the Advanced Medical Technology Association (AdvaMed; Washington) put on its Superman cape and unveiled a set of policy recommendations that it hopes will preserve America's position as a leader in medical technology innovation.
Dubbed the Competitiveness Agenda (which can be seen in more detail by clicking here), AdvaMed is issuing out a call to arms to the government to not overlook the med-tech industry.
Here's the problem that the med-tech industry is facing. Imagine for one moment that you're on the brink of not being able to pay your mortgage. Slowly and steadily you're getting behind on the bills and you realize that it's going to come to a point that you can no longer pay your mortgage. The first instinct is to call the bank, but the response you would often get is "wait until you're behind in your payments, then we'll see what we can do."
The problem is, you don't want to get behind. You don't want your home to go into foreclosure. You want help now. The same thing exists with the med-tech industry. As it stands now the industry isn't really in dire straits. It's headed that way, due to cumbersome FDA regulations and heavy fees on med-tech companies.
So AdvaMed's policy recommendations are right on time. The federal government has to ask itself if these recommendations are worth implementing now, or if it can stand to afford letting med-tech slip deeper and deeper into a hole that will consume America's top position in innovation.