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) 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) 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? 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 Steve Zweig Joe Hage “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 “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 Innocent Nweze Dr. Patrick Druggan Marc Samson NEAL H. WRIGHT Gary Baker 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 NEAL H. WRIGHT Steve Zweig NEAL H. WRIGHT Burrell (Bo) Clawson 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 Brian Newman Jing Wang John Aceti Joe Hage Marked as spam  Posted by Asked on March 1, 2016 1:12 pm 42 views |
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