Why Does AMP Want to Bite the Hand That Feeds It?

Let’s be honest: AMP’s gripe with current gene-patenting rules has nothing to do with patenting genes or with its desire to exempt certain labs from infringement claims.

Full-text access for registered users only. Existing users login here.
New to GenomeWeb? Register here quickly for free access.

This debate is essentially

This debate is essentially pointless in the context of a regulatory environment that is a far more severe block to innovation than any IP. Ask yourself this question. How many FDA-approved tests for NEW analytes and especially multiplexed analytes have been approved in the past few years? The majority of newly cleared devices on the market today are "me-too" because of the extreme financial impediment imposed by a de novo filing. How many more Flu Dx do we really need?

Totally in agreement there.

Totally in agreement there. But to me the two go hand-in-hand: Retaining an inventor-friendly IP foundation would encourage researchers to feel more comfortable shouldering the financial risk of developing novel tests and submitting them to FDA review. Ensuring that innovators maintain adequate rights over their inventions or discoveries and convincing FDA to ease the regulatory burden may not on their own spawn a new Season of Discovery, but it's surely a step in the right direction.

Agree klakhman. Both IP (not

Agree klakhman. Both IP (not just gene patents) and FDA continue to be impediments to rapid development of novel MolDx. Improvements in either area would be "a step in the right direction"!

The last paragraph citing the

The last paragraph citing the defibrillator actually illustrate the difference between gene patents and device patents. What if there was a patent stating that heartbeats are initiated by electrical impulses and we thus claim that all technologies that supply an exogenous current to the heart for therapeutic purposes are covered. This would allow the patent holder to severely limit the development of defibrillators. Defibrillators need to be patentable devices; heart biology upon which the device works is not patentable as it is not an invention.

Patents need to be confined to man-made inventions not the underlying biology, chemistry or physics that the invention exploits. By all means, patent diagnostic tools and procedures; don't patent the biology that makes the invention worthwhile.

You have a valid point:

You have a valid point: today's $B, decade-long FDA approval process requires massive private investment, best motivated by the lure of long periods of patent exclusivity.

Yet let's look hard at this capital demand side. The FDA's ponderous approval process saves lives, but at what opportunity cost? As we evaluate comparative effectiveness of treatments and procedures, let's do some evaluations of the system itself! With automation, bureaucratic reform, and open-mindedness, including developing standards to share clinical trial expenses and results internationally, we could slash years of time and large factors off the cost of demonstrating safety and effectiveness. In today's fertile climate, each such reduction will multiply the number of companies that can participate and the drug and device candidates that can be considered. The reductions compound -- e.g. less cost means less need for gene patents, less opportunity for companies to rest on their laurels, and more freedom for new test development as AMP proposes. This will dramatically increase the rate of medical progress and ultimately save millions of lives.