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Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
March 2016
Your Diagnostic Is Not Patentable
6 min reading time

Gavin Bogle, an intellectual property lawyer I met at PEDS2040 surprised me when he said, “At this point, diagnostics are really not patentable.”

I recorded his 5-minute answer at http://medgroup.biz/not-patentable

Gavin: Under “The Mayo Clinic v. Prometheus,” the Supreme Court of the United States said the use of a diagnostic to alter the treatment regime a doctor would use was not patentable.

Joe: Say I have a blood pressure cuff to measure vitals. Not patentable?

Gavin: Well, the cuff itself might be patentable. The machine you have might be. But [you can’t patent the diagnosis, the way to interpret the results].

I think about in-vitro diagnostics where you [attempt to] discover the relationship between an analyte and a disease. And that relationship is not patentable. Even if it’s new and novel and not obvious.

I am simplifying here, you have to understand – but anything that doesn’t provide a significant transformation, other than applying intellectual thought to it, is not patentable.

Joe: Have you, since Prometheus, seen a shift in the amount of investor or entrepreneurial energy in diagnostic innovation?

Gavin: If there hasn’t been, there certainly will be.

Joe: What did Prometheus do as a result of this loss?

Gavin: They have lots of diagnostic tests and most hospitals and purchasers want to buy the test rather than make it themselves so there’s always going to be a marketplace.

Joe: I recall you said, “At this point, marketing is a better defense than a patent for the diagnostic space.”

Gavin: Well, except for the example you use where you have a machine that you build, and it’s a new, a novel, and unobvious machine that does something that nobody else does, I can imagine there are lots of ways of patenting that machine. It’s the intellectual input that’s not patentable.

Some would say the intellectual input is the real heart of these inventions but patent law is going the other way.

Gavin’s complete response and transcription at http://medgroup.biz/not-patentable

For today’s discussion, have other companies been adversely affected by Prometheus? How are they responding?

And do you agree with Gavin? Do you believe we’ll see investors and entrepreneurs shift away from medical device development as a result?

+++++

BAD EHRs (and bad LinkedIn)
Grousing here. I spent a few hours on last week’s announcement, “Bad EHRs” but LinkedIn’s announcement platform went down for a week.

It was a good one too: http://medgroup.biz/bad-EHRs

Better late than never and another reason to have you register at http://medgroup.biz/MDG-SITE so I can reach you if LinkedIn breaks groups irreparably in the future.

+++++

MEET PAST AND PRESENT CDRH and FDA officials in Rockville, MD (March 15-17)
From FDAnews, see http://medgroup.biz/quality-congress

Now in its 13th year, the Medical Device Quality Congress is a must-attend event for medical device and diagnostics professionals. Pick experts’ brains, absorb their knowledge, and develop invaluable contacts.

Save 20% with Medical Devices Group code MDQC20 at http://medgroup.biz/quality-congress

+++++

PUBLISH YOU?
There’s a new peer reviewed journal launching in April called Telehealth and Medicine Today.

See http://medgroup.biz/tel-health-med

My friend Tory Cenaj asked if we have group members interested in being published. Her audience is hospitals and medical research centers, payers and health economists, healthcare providers, researchers, innovators, and medical directors. Another segment of readers are in biopharm, biotech, and device companies; and IT/IS and academicians.

So if you’d like to publish for a digital health and telemedicine readership, visit http://medgroup.biz/tel-health-med

You can also visit the site to get your free subscription.

Good luck, Tory!

+++++

Make it a great week.

Joe Hage
Medical Devices Group Leader


Steve Zweig
Patent Attorney
Although patents and trademarks are tricky, they can be done. My advice here is to consider Kenny Roger’s song, “The Gambler”, and consider getting expert help for important matters.

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Part 2 of 2:

“Since then, I had a trademark registration rejected on the basis of probable confusion with an existing mark. Meanwhile, there was no possibility for confusion by any cognizant person or monkey. It truly seems the ‘intellect’ is being removed from the entire IP arena, doesn’t it?”

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
A member wrote me privately (Part 1 of 2),

“I’ve been stymied by the USPTO again and again.

They repeatedly denied my patent on something that was clearly patentable over a period of six years of trying.

I finally filed an appeal under a special program designed to get patents granted and they had my case in their office under consideration on the date of a six-month filing deadline.

Months later I received their response, in which they not only said my appeal would take longer to review than their program allowed time for (therefore it had NOT even been reviewed)…but also that my application had timed out (said six month deadline) and that therefore I had abandoned it.

My only option would have been to pay them (more) to revive the application, the strength of which they had already pared down to almost nothing.

Gary Baker
Managing Director of the Quine IP Law Group
To answer your question, Sean, U.S. patent 7,149,756 is not to A natural correlation, but a narrowly focused method of using any number of correlations. Sorry to say, there is also a special exclusion from patent eligibility for similar “expert systems”. Someone wanting to invalidate the ‘756 patent might allege is in purely mental, and an expert system similar to the claims invalidated in Smartgene (see – http://law.justia.com/cases/federal/appellate-courts/cafc/13-1186/13-1186-2014-01-24.html )

Innocent Nweze
Chairman & CEO at Cleobrothers Energy & Environmental Systems (CEE Systems)
hmm… Significant!

Dr. Patrick Druggan
Head of Regulatory Affairs at The Binding Site
Neil, the issue is whether or not “septicemia” is patentable, not whether diagnostic software is.

Marc Samson
Professional of Life Sciences & Healthcare Biz. 20+ yrs International Management, Sales, Marketing, R&D, Manufacturing.
I was not aware of that and it somewhat surprised me at first but it makes perfect sense. It is consistent with the fact that one cannot patent a mathematical formula describing a natural phenomenon which I was well aware off.

NEAL H. WRIGHT
Director, Owner, President CEO at AlphaBioSource STAT-CAPA NHW Consulting
The early ID and treatment is lifesaving as Septicemia quickly leads to toxic shock and multi-organ failures and has a high mortality rate. As you cannot use the instrument without the diagnostic software and vice versa it would seem that the diagnostic software would be patented with the instrument as a system.

Gary Baker
Managing Director of the Quine IP Law Group
In the video, Gavin speaks well on his feet.

Yes, natural correlations are not patentable. But, as he suggests, the correlations can be a part of a claim that also includes an inventive way to use the correlation, particularly if combined with an device uniquely tailored to using the correlation.

NEAL H. WRIGHT
Director, Owner, President CEO at AlphaBioSource STAT-CAPA NHW Consulting
Another example for us to consider is a company took an existing technology that is used in Bioresearch and previously had absolutely no medical or medical diagnostic applications. They modified this instrument and developed custom reagent medias so that from a sterile collected blood specimen they can detect the very earliest stages of Septicemia blood infection within a few hours as opposed to several days to a week by traditional blood culture methods. Not only can they detect extremely minute fentamolar amounts of infectious agents but they can by this instrument and its unique software provide a very specific very accurate diagnostic of what genus and species the infectious bacterium is. This early diagnostic would not be possible without the highly developed diagnostic software that is the instrument operating system. Septicemia with early detection and pathogen ID guides the choice of antimicrobial agents and allows early treatment saving lives.

NEAL H. WRIGHT
Director, Owner, President CEO at AlphaBioSource STAT-CAPA NHW Consulting
If for example an Neurological cell signalling device is designed and it can measure the velocity of neuron receptors binding to a labeled Proteonomic disease specific bio-probe molecules for a number of individual Neuropathologic diseases. Along with this system an interpretive diagnostic software is developed to analyse the data of the diagnostic test. To go further lets say that the software diagnostics analysis can clearly predict Alzheimers and or other Neuropathological diseases by examining the difference in neuronal receptor binding. In that case the diagnostic cannot be made without the instrumentation and diagnostic reagents and the diagnostic software. It would seem that major investment the developer has made in the diagnostic software would be patentable or afforded some protection for the high costs involved in its innovation.

Steve Zweig
Patent Attorney
I am a patent attorney. Although certainly the Supreme Court is making life a bit more complicated than usual for the computer software and biotech (e.g. medical diagnostics) industries, it is not correct to say that medical diagnostics are not patentable. Medical diagnostics patents are still issuing constantly.

NEAL H. WRIGHT
Director, Owner, President CEO at AlphaBioSource STAT-CAPA NHW Consulting
It would seem that possibly the non-patent-ability may not always apply to the diagnostic mechanism such as unique interpretive software versus the clearly patentable measuring device.

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
I think the proper headline (as a long time medical device designer) is “Medical Diagnoses are Not Patentable.”

Even with that definition, there are already companies like IBM, Raytheon and Annai Systems who would argue that “big data AI analysis” of hundreds to thousands or millions of “measurements” and outputting meaningful information for diagnosis is something that is becoming relevant. These companies are investing a lot in the systems to take “diagnosis data” and crunch it for diagnosis clues.

Dr. Patrick Druggan
Head of Regulatory Affairs at The Binding Site
The judgement was made in 2012. It is specific to companion diagnostics. The medical device is patentable. The issue here is whether an analyte is patentable, not the technology or the device. There is more protection in the device than the analyte as the device can be improved over time, while an analyte is fixed.

Brian Newman
Consultant General and Vascular Surgeon
Very helpful advice.

Jing Wang
—
Can I say: the tests zelf are not patentable but the reagents components are patentable? quite confusing in diagnostics world.

John Aceti
Inventor & Entrepreneur & Business Model Designer: Bringing New Products to the World
Joe – thanks for capturing this information – clearly there is a lot we need to learn, and be cognizant of, when we invent and write claims in this fast growing area of personalized medicine.

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
And for your reference:
https://en.wikipedia.org/wiki/Mayo_Collaborative_Servs._v._Prometheus_Labs.,_Inc.

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Posted by Joe Hage
Asked on March 1, 2016 1:12 pm
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