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« In re Dinsmore (Fed. Cir. 2014) | Main | Braintree Laboratories, Inc. v. Novel Laboratories, Inc. (Fed. Cir. 2014) »

June 11, 2014


As one of the 350 or so people who watched the Forum online, I cannot emphasize too strongly the importance of providing detailed and legally supported comments on the Guidance together with suggested further examples. I am aware of considerable efforts in the field of natural products, but believe that more is needed for diagnostic and other processes.

The paper on this blog a few days ago was produced in answer to the invitation for comments and has been submitted to USPTO. Insofar as it advocates a narrow interpretation of Myriad, it advocates substantial re-writing of the Guidance.

There are two unfortunate aspects of the feedback process. The first is the absence of any indication as to what in the guidance is being re-thought. For example the Amazonic acid example which contradicts a position expressly conceded in Myriad is clearly untenable and an immediate indication that it will be withdrawn or substantially modified would save much unnecessary effort within our profession. The second is failure to publish comments as they are received, which inevitable creates avoidable duplication and stifles useful debate.

Feedback works best when the path is short and responsive. "Thanks, but could do more" might be said at this time.


Do you really think that engagement and thoughtful debate is what is being sought with the government mechanism?

I think the bar is substantially lower: notice and availability to provide comments is the goal.

While your heightened goal makes more sense (to me), "making sense" is not a necessary condition for government processes ;-)

@ sceptical

All we can do is to provide the best comments we can, to play it straight and objectively and hope we are listened to. As Maggie Thatcher famously said, there is no alternative.

Even if we are not listened to, it is our duty to make the effort. If we do, and the results are less than hoped then at least we will know we have done our best. We will have the satisfaction of having made the attempt. Cynicism and apathy will foreseeably achieve nothing.

My brother cynicism disagrees with you. My brother apathy just doesn't care.

I like to temper effort (just a bit) with fruit of that effort, and leave the happy "well we tried" windmill tilting to others. But that's just me, as to benefits of such windmill actions are, well,...

"Even if we are not listened to, it is our duty to make the effort." I totally agree with you Paul. We need to let them hear our voices and concerns.

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