Tuesday, September 30, 2008

Patently Silly?

My only experience with patents was rather expensive and nonproductive. I invented a device to draw perpendicular lines on a mammogram for needle-localization purposes, which actually was quite elegant. Sadly, after a $500 patent search, I found that I was about the fifth or sixth person to come up with this design. Sigh.

A fan of this blog (thanks to PACSMan and Jennifer) sent me a link to PatentlySilly, a blog about weird patents that really demonstrates just how clueless the US Patent Office can be. Check out this patent for a water-pipe with a little extra stimulus, as a good example. This gets a patent, but my great idea couldn't. There ain't no justice!

There have been several stories lately about DR Systems suing NovaRad, Emageon, and eRad. I first heard about this from an AuntMinnie post, and there has been further elaboration from PACSMan/Ms. PACS and Spidey.

Now, I should state up front that I have met DR Systems President Dr. Murray Reicher, and I continue to correspond with him on non-PACS matters. (I've never even touched a DR product, for better or worse.) In my dealings with him, Dr. Reicher demonstrates the very highest moral and ethical fibre possible, and I don't think his company would pursue patent-infringement lawsuits if he did not feel completely justified in doing so. But I needed to educate myself in the particulars, as this is a very important situation in the PACS world.

The patent in question can be found at the US Patent Office website. The patent, "Automated system and a method for organizing, presenting, and manipulating medical images," was filed by Wesley Hilton, Dr. Reicher, and Dale Seegmiller on December 30, 1992, and approved September 19, 1995. Here is the abstract:

An automated system for organizing, presenting, and manipulating medical images includes a database in which the medical images are structured into groups, each group including one or more image series, each image series including an ordered sequence of images which illustrate incrementally registered aspects of an anatomical target. Image series are presented in their sequential order either in a monitor presentation format which displays each sequence in its entirety in a single monitor display container or which presents two or more image series, image-by-image, in adjacent presentation areas of a series display container. The system includes a plurality of monitors in which all monitors, save one, produce display containers for image series presentation. One monitor is reserved for displaying a working palette to which images of the image series displayed on the other monitors may be moved. The system activates a monitor in a plurality of monitors in response to movement of a cursor between monitors. An active monitor is indicated by presentation of a control panel. The system also provides heads-up presentation of control panel icons at a cursor location outside of the control panel by sequentially changing the shape of the cursor to the icon shapes for user selection.
Got all that? Here's a drawing from the patent that gives you a vague idea of the approach:

Text not available

Feel free to read the entire patent at your leisure. The Summary continues:

SUMMARY OF THE INVENTION Therefore, it is a primary objective of this invention to provide an automated system for storage, retrieval, and presentation of medical images which is especially adapted for the presentation of medical image sequences and which affords the user with a flexible and responsive set of functions that permit direct manipulation of the modes of image presentation and of the presented images themselves. The invention is embodied in a computer display system which presents images of anatomical structure and the like for examination. The system includes the following combination: a first display container including a first preselected number of substantially rectangular presentation areas in a substantially rectangular array; a second display container including a second preselected number of substantially rectangular presentation areas in a substantially rectangular array; an image database including a plurality of images of anatomical structure, the images being separated into image groups in which: each image group is indexed by a unique group identification; and each image group is partitioned into one or more ordered image series, each ordered image series including a succession of images which illustrate incrementally registered aspects of an anatomical target, each image series being ordered by assignment to each image in the image series of a position in a respective monotonically changing sequence; a mechanism connected to the image database and to the first and second display container and responsive to a group identification for displaying at least two image series of an image group indexed by the patient identification, wherein: each image series is displayed in the order of its respective sequence in a respective display container such that each presentation area of the respective display container includes no more than one image; or, all of the image series are displayed in one display container and each image series is displayed one image at a time in the order of its respective sequence in a respective presentation area of the display container.
This legalese word salad (there is much more) seems to be discussing what we now call hanging protocols, a preset display configuration for various imaging procedures.

The current lawsuit against Emageon, eRad, and NovaRad was filed in California, and some details can be found here. I actually paid a few dollars to download the complaint itself, which is a public document. Of the fifty-five pages (they only charge $0.08 per page, with maximum charge of thirty pages or $2.40 per document!), the majority simply reproduce the patent in question, 5,452,416, a.k.a, the '416 patent, and this is followed by a series of definitions of the various terms in the patent which come from a prior case against Fuji. The real complaint is succinctly worded, and repeated for the three defendents:

Emageon/eRAD/NovaRad has infringed at least claims 1 and 6 of the '416 patent through, among other activities, the manufacture, use, importation, sale and/or offer for sale of automated medical imaging and archival systems. Emageon/eRAD/NovaRad has also infringed at least claims 1 and 6 of the '416 patent by knowingly and actively inducing others to infringe, and by contributing to the infringement by others.

Hmmmm... Sounds like contributing to the delinquency of a minor. So, we need to look at Claim 1 and Claim 6 of the patent. Here they are:

is to be limited only 10 include all such viewed in conjunction accompanying drawings We claim 1 A system for a location where 15 structure for button of the including the keyboard to the desired location the left button Any appropriate to its default the A icon in executed by annotating a 20 by reference that the of selecting the anatomical sequence of a 25 annotation list commonly employed The procedure an annotation list in the 30 this icon is and is moved in location At the trackball is depressed list to the box 35 panel For so means including one displaying at least display area areas hi a means for storing an of images of being groups hi which each unage group identification each image group ordered unage including a incrementally target each assignment to numerical changing physician data tables unique group


series in the order of in a respective display container presentation area of the tainer includes no more than one to designation of the monitor mode 5 The system of claim 1 further means for displaying a palette the one or more display monitors play container for presenting a areas in an array and means for selecting an image of an in the at least one reproducing the selected image area of the palette display 6 A method for presenting structure for examination by a method being executed on a having a display for displaying at least one subdivided into a of Text not available

Well, I'm not a patent attorney, but my semi-educated read of these claims suggests that DR has a point. Pretty much any and all PACS displays could be lumped under this description with enough of a fudge-factor. There does seem to be some specificity for what we would now call a hanging protocol, although a quick read makes it sound like the patent just covers a run-of-the-mill display. That's trouble for everyone else, and good news for DR Systems.

I suppose the moot point her is whether or not DR really invented all this, or at least perfected it. The patent was filed in 1992, and granted in 1995. Was there PACS in 1995? Of course. Were there hanging protocols? Not on the systems I used at that time. Were they in development at other shops? I don't know about that. Moreover, should this sort of thing have been patented? Today, it seems self-evident that you should look at PACS more or less as everyone does it, although I certainly have my own personal preferences in that regard. Is the image layout on the screen patentable? Or copyrightable, for that matter? I've jokingly said that I need to patent both breathing and the sun coming up in the morning; think of the fees I could charge! How much credit does the Patent Office receive for deciding that something should receive a patent? What is a patent anyway? From the Patent Office itself comes the official definition:

. . .a property right granted by the Government of the United States of America to an inventor “to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States” for a limited time in exchange for public disclosure of the invention when the patent is granted.

(An invention is) any art or process (way of doing or making things), machine, manufacture, design, or composition of matter, or any new and useful improvement thereof, or any variety of plant, which is or may be patentable under the patent laws of the United States.

You can see that the parameters are pretty nebulous, and an invention is patentable if the USPTO says it is. I guess "breathing" and "sun coming up in the morning" probably won't fly, however. But from Thompson Reuters Scientific comes this list, which is a little more intuitive:

In general a patent will be granted for an invention so long as it:

  • is new or "novel": the invention must never have been made in public in any way, anywhere, before the date on which the application for a patent is filed.
  • involves an inventive or "unobvious" step: this step must not be obvious to others with good knowledge and experience of the subject of the invention.
  • is capable of industrial/useful application: an invention must be capable of being made or used in some kind of industry.
It's the "new" and "unobvious" questions that I cannot answer with respect to the DR programs. The way patent applications are written, chock full of legalese and mumbo jumbo, nothing is obvious. Is the layout of images on a screen obvious, new, and unique? Is the concept of hanging protocols obvious? Was it new and unique in 1992? I'll have to leave that to folks older and wiser than I. I could barely spell PACS back then. But, we do have the reality of the patent granted to DR at that time.

DR has sued other PACS vendors, and several small companies have settled. Supposedly, some larger companies are considering fighting DR Systems, which to my non-legal mind would require invalidation of the DR '416 patent. I'm not sure that would be easy, and I know it would be incredibly expensive. The lawyers always win, don't they?

Ironically, DR Systems has itself been sued by GE for patent infringement. A suit filed by GE in the US District Court of the Eastern District of New York on 10/16/2006 notes:

DR Systems has been and now is directly infringing and indirectly infringing, by way of inducement and contribution, the '674 Patent in this district and elsewher in the US by making, using, selling, and offering for sale image and information management systems for hospitals and medical imaging centers that practice one or more claims of the '674 Patent. The infringing systems include the Catapult Technologist QC Workstation, Advanced Windows Catapult, The Dominator, Web Dominator, The Instant Reporter, Web Ambassador, CD Ambassador, The Communicator, and/or Guardian Archive.

DR Systems' actions have damaged GE in an amount to be determined at trial and have caused and will continue to cause GE irreparable injury for which GE has no adequate remedy at law.

Sounds kind of familiar, doesn't it? Here we go again...

GE's Patent 6,633,674 was filed November 25, 1999, and issued October 14, 2003. Here is Claim 1:

1. A picture archiving and communication system comprising:
an input device configured to receive uncompressed medical image data files including a descriptive header and image data, and to convert each of the uncompressed image data files to a hybrid compressed data file including uncompressed descriptive header data, compression header, and compressed image data;
a data file server coupled to the input device for storing the hybrid compressed image data files;
a client system coupled to the server, the client system being configured to receive the hybrid compressed data files and to uncompress the image data for output; and
a database accessible by the file server for referencing the hybrid compressed data files.
The rest of the claims have more to do with compression. Here again, a semi-educated read makes it sound like GE has patented PACS, doesn't it? I didn't go through all the court documents (even at $0.08 per page, the cost adds up, you know!) but the suit was eventually dropped "with prejudice."

I think the bottom line here is that the Patent Office granted a lot of patents for PACS and related technologies, almost certainly without completely understanding all the vagarities and implications of what they were approving. I'm sure I don't grasp it all, and I really doubt that anyone does. DR's suits based on Patent '416 seem to me to have some validity, based on the existence of the patent itself. As I noted above, the lawyers win no matter what.

Addendum: Aunt Minnie's Brian Casey has written about this topic as well, and has gone more in depth about the claims of the initial patent.


Anonymous said...

You can think of the GE patent suit as a counter suit. DR sues GE, GE looks through its patents and finds something for which to take legal action against DR. Whoever has the deepest pockets and the most lawyers wins. Faced with the cost of fighting GE in a coounter suit, DR is likely to back down and just pick on the little vendors. The GE suit may not have nuch merit, but probably no more so than the DR suit. Note that GE did not take legal action against any other vendor besides DR, so it is clearly in response to DR's attempted extortion.

Anonymous said...

Thanks anonymous. I was wondering why GE had escaped (McKesson settled and Siemens is being sued). I keep hearing about "ethical" DR Systems. Sorry, I'm not buying it. This is legal extortion, and it inhibits innovation. Even more important is the fact that this RAISES PRICES for customers. Yes, the PACS buyers are paying for DR's greed and selfishness. If you don't like it, spurn DR Systems. Make them pay a price for this type of bad behavior.

BTW: the budding revolt against DR could not have been possible prior to the existence of blogs.

Anonymous said...

Two other comments: if a PACS customer tweaks or otherwise customizes a system purchased from anyone other than DR, does that make said customer liable to a DR suit?

Second, the fact that DR is so facile with courts and lawyers might prompt me to reconsider any relationship I may currently have or could have in the future with that company. One must always wonder, "will I, the DR customer, be next?" Suppose there is a dispute over payments, or perhaps DR dosen't approve of my relationship with another vendor.

If DR is a bully, are DR's customers not vulnerable to the same type of legal intimidation?

Anonymous said...

There may be change in the air.

David Clunie said...

It is an interesting exercise to establish exactly when certain PACS concepts became known to the community, and a very interesting document in that respect is the MDIS RFP, which describes the features that the military required in what became the Siemens Gammasonics/Lockheed Martin/Loral/GE PACS that was eventually used in both military and civilian sites and became the first version of Centricity.

Here is a link to a summary in my blog of some of the features of the MDIS RFP, as well as a link to the MDIS RFP document itself, dated 28 March 1990.