Déjà Vu All Over Again

PACSman: I was reading about yet another patent that got issued in the PACS world last week and starting thinking to myself what Yogi Berra once said: “This is like deja vu all over again.” This time a patent was issued for archives…or more specifically one that "provides for the management of clinical data using a scalable solution based on clinical business rules that logically or physically segments shared storage infrastructures.” Whatever you call it, it has me wondering what the heck is going on in DC?

Now I do not want to take away anything from any company who applies for a patent - after all, it is their right to apply for and even be granted one - but in the nearly seven years it took from the patent file date to the patent issue date it seems like an entire cottage industry sprang up around what they have patented. This seems to be endemic to our industry, a situation I have seen time and again.

Medical imaging companies have been issued patents for workstation hanging protocols, creating CD’s with embedded DICOM viewers, and now archive management. Normally this isn’t a problem if it’s something that isn’t used as part of the day-to-day operations of a PACS. The problem is most of these so called utility patents are. A utility patent is issued for the invention of a new and useful process, machine, manufacture, or composition of matter, or a new and useful improvement thereof, and generally permits its owner to exclude others from making, using, or selling the “invention” they got a patent on. In the case of many of these medical imaging patents that is tantamount to someone putting a patent on middle C of the piano, having seven years worth of music written around it, and then charging every author whose song hits middle C in it. The more you hit it, the more you pay…for the next 20 years. What sadder still is that 90% of all patents issued in the past few years by the USPTO have been design patents, those that address medical imaging.

Once a patent is issued getting it rescinded is virtually impossible. And what happens next? If typical, the patent holder sends notification to all companies who are using similar (or identical) technologies that might infringe on the patent letting them know that they may be in violation of patent infringement and will need to negotiate a licensing arrangement with them. And who ultimately pays for this? The end user.

Can you fight it? Of course you can and many of the majors have. But for many of the smaller vendors the risk of losing a patent infringement case and having to not only pay their own legal fees but that of the patent holder, plus back licenses, more often than not exceeds the value of just settling and paying the licensing fees up front.

Is this wrong? Legally no. Morally and ethically though it can be considered a gray area. Companies that apply for a patent typically have to state that a patent is pending, yet most patent applications aren’t published until at least 18 months after the filing date of the application. In the healthcare field, that length of time is an eternity - and that’s just to find out that it’s been filed.

After the patent application has been published, a member of the public may request a copy of the application file, but getting this was not an easy process. It wasn’t until late 2004 that the U.S. Patent and Trade Office (USPTO) made patent searches available via the Net, using the USPTO’s Public PAIR (Patent Application and Information Retrieval) system. Unfortunately, until the patent was actually granted, you had to know a fair amount of information about the patent to be able to search for it. This put an unfair burden of responsibility on companies who may have developed technology that was similar but perhaps not identical to that which was under review for a patent. You also never knew if the patent was going to be granted, sent back for revision, etc., until it happens, so why hold up the development of a product for three, five, or seven years or longer on a maybe? It’s also not until after the patent is issued that the application and all correspondence leading up to issuance of the patent are made available in the Files Information Unit for inspection by anyone, copies of of which may be purchased from the Office.

One source said each year nearly 50,000 patents are issued - 137 per day - yet the number of patent reviewers isn’t nearly enough to cover the number of patents being applied for, let alone granted. This creates a situation where patents are issued years after they are filed, allowing a cottage industry to spring up in the interim. If the 50,000 number is indeed correct (I’ve seen numbers anywhere from 20,000-50,000 bantered about on various sites, including the USPTO’s website), this means 350,000 patents were approved before the most recent one in medical imaging was. Even if only 20K patents per year were approved, that still leaves 140,000 who got their Golden Wonka ticket ahead of the latest medical imaging winner. And as Billy Shakespeare said about that in Act 1 of Hamlet: “Something is rotten in the state of Denmark”- or at least in Washington, DC.

The problem as I see it is fourfold. First there are not enough patent reviewers to act in a timely fashion. Seven years is way too long to take to get a patent approved. By the end of seven years, PACS is usually in the third generation of products…and so many systems have been put into place that any retroactive licensing will cause an undue financial burden on companies.

Second, and most importantly, patents are being issued by reviewers who, in my opinion, really either do not know or do not understand the medical imaging community. Adding a DICOM viewer to a CD that contains DICOM images isn’t - or at least shouldn’t have been - patentable. Both DICOM images and DICOM viewers existed separately well before this “patent” was granted. How hard can it be to add software like a viewer to a CD? Not rocket science by any means and not patentable either. And hanging protocols? People have been arranging icons since Windows 3.0 introduced the concept of a Graphical User Interface (GUI) way back in 1990. What makes this special besides this being used in medical imaging? It’s the same concept applied slightly differently. Now, admitted, I am oversimplifying what no doubt is considered a much more complex process by the patent owners, but hopefully you catch my drift here. I need to read the current archive patent a few times before it sinks in, but I’m sure I can distill it to a few simple points of relevancy and commonality as well.

Third, there needs to be a way of letting companies know in plain English when a patent has been filed, what it encompasses, and if their any technologies being in the industry impinges or infringes on it. This should be the responsibility of either the USPTO or the patent applicant, not the end user to figure out, sorta like a guy who gets ambushed on Maury - “You ARE the father…”

Fourth, patents shouldn’t be retroactive to the file date. Penalizing companies for a patent they might not have even known about just isn’t right again in my opinion.

Bottom line - we need to take a closer look at the way patents are issued. We can’t change the way things work overnight, but the input we provide just might make a difference and keep this industry from tripping all over itself as it is now…

Yogi summed up the situation best: "If you can't imitate him, don't copy him." There ya go….