Dr. Young ? RE: Patents & Stem Cells

[larwatson]

In drafting a position paper in support of ESC research I'm finding the issue of "commercialization" of the stem cell lines (that are currently being made available by the administration) as a potentially devastating issue for the opposition to use in its arsenal against ESC research.

In your opinion, given the economics of the research field, is it feasible to have legislation that (1) lifts limits on available sources to "surplus" in vitro embryos, but (2) prohibits the patenting of the stem cell lines exacted from those embryos? To be clear...the prohibition on patents would only pertain to the stem cell lines and embryos themselves...not the derivative therapies developed therefrom.

[Wise Young]

larwatson,

I am afraid that any position paper that calls for preventing patenting of stem cell lines may muddy the water for the following reasons. There are currently no limits on derivation of human stem cells from any source (that I am aware of) by private organizations or companies. The limit is only on NIH funding of any research that results in death or harm of a human embryo or fetus. This prohibition has incorporated into the Health and Human Services Appropriation bills for most of the past decade. President Bush has partially lifted this prohibition by allowing NIH funds to be used for research utilizing human stem cell lines derived before August 9, 2001. This source is currently not sufficient for therapeutic purposes.

If patenting of stem cells lines were prohibited, you will end up driving all companies out of the market. Why would you want to do this? With this restriction, no company will even consider invest in deriving and characterizing these stem cells. This will essential drive all companies such as Geron and other companies out.

The prolife groups will probably strongly support any legislation that bans embryonic stem cell patents but these groups will continue to insist that NIH does not lift its ban on funding of human embryonic stem cell research. It is bad enough that there are no federal funds going into the derivation of new embryonic stem cell lines for therapeutic purposes. To shut off industry funding would close off this source of stem cells.

Wise.

[larwatson]

Wise,

It is clear from your response that you believe that by eliminating patents on stem cell lines private companies may very well decide to back off on advancing research funds. Given the current marketplace your answer makes sense. However, I am trying to look beyond the current status quo and foresee what the future could look like if we get federal legislation cleaned up.

The point I'm trying to make, and obviously am failing miserably in doing so is this:

Assuming:

(1) we get the ban lifted on the use of the "surplus" embryos (which think is possible);

(2) we get the NIH to follow congresses lead and make PUBLIC funds available for
research; and

(3) public funds are used to derive stem cell lines.....

Answer:

Does it not follow that these stem cell lines

(1) derived from "surplus" in-vitro embryos;

(2) which are not owned (ie not the property)of anyone; and

(3) are funded by the public

should be considered public domain?

And as public domain these stem cell lines should be

(1) made available at no cost for use by ANY research entity...private or public...to develop therapies from; and

(2) it will be these therapies that will be patented and be the source of profit for any researcher or private company?


By having this type of system in place the public is saying that these embryos are a precious public resource. As a public resource we are willing to invest public dollars in order to enhance the use of those resources by deriving stem cell lines to be made available to both public and private entities at no or little cost. Through the investment of public dollars in this way we can ensure the integrity of the use of the embryos as a precious life giving resource, ease the regulatory burden on the researchers, free up the stem cell lines from legal battles over licenses and other property issues, lower the cost of therapies made available to the public, and encourage additional private and public investment by ensuring profitability from those therapies that are eventually brought into the marketplace.

Wise,

Counter-arguments, additions and subtractions are welcome. I just want to make sure that I'm thinking through all of the issues and truly understand all of the concerns before completing my first draft for review and critique. I'm quite certain my above model is a bit simplistic...that's why I am so glad you and the other researchers are here.

[Wise Young]

larwatson,

I see. I am not sure that there will be a need for legislation to implement what you have described. NIH can do several things:

1. It can decide to patent the stem cell lines itself and then issue licenses for the stem cells to one or more companies that show that they have the ability to develop them further.

2. It can allow investigators who derived the stem cells to patent the cell lines. In general, the policy of the NIH has been to allow investigators to patent the results of their research.

3. They can put it into the public domain and not allow anybody to patent the cell line itself but allow use patents on the cell lines.

The third option seems to be quite a reasonable one.

Wise.

[larwatson]

Wise,

Great Info!!! The examples you provide are exactly the type of well reasoned and balanced response that I hoped you could (and quite obviously did) provide for our argument.

I love it when reason is on your side...only unreasonable minds are left to disagree. This is going to be fun.

[Wise Young]

Larwatson,

There is precedent on the third option. In the case of the Human Genome Project, the NIH and other federal agencies that funded the project adopted a policy to put the sequences were put into the public domain as quickly as possible. However, companies can utilize the information to develop uses for the genes that they can then apply for use patents.

Please note the difference between this approach and preventing companies from patenting stem cell lines. It is essentially setting the government up as a potential competitor in developing intellectual property and putting it into the public domain before the companies can patent the sequences. This resulted in a race betweeen the public and private sector to get the sequences first.

Depending on the point of view, this may be good or bad. For companies who have not invested into the sequencing of the human genome or deriving human stem cells, it is a good thing because they will have access to the data. However, for the comapnies who have invested significantly into either, they have lost the rationale for investing in such efforts. The result is the termination now of almost all industry investment into the effort.

Wise.

[larwatson]

Originally posted by Wise Young:

Larwatson,

Please note the difference between this approach and preventing companies from patenting stem cell lines. It is essentially setting the government up as a potential competitor in developing intellectual property and putting it into the public domain before the companies can patent the sequences. This resulted in a race betweeen the public and private sector to get the sequences first.

However, for the companies who have invested significantly into either, they have lost the rationale for investing in such efforts. The result is the termination now of almost all industry investment into the effort.

Wise.

Wise,

I would agree with your first part...it will create competition. I respectfully disagree with your second part. If those companies who have already invested are now in a race...this mechanism will only spur them on to ensure they can protect that investment which they have already made.

I have to tell you...I'm loving the concept that the government through the NIH can act as a venture capitalist and create a competitive environment that will serve to create efficiencies in finding a cure.

Regardless, as you asked in another thread, can't we reach a compromise? My answer is that we don't have to compromise to reach a common ground on this issue, but its going to require all of us (Christians and others) to think outside the boxes we often put ourselves in...including the private sector.