[Ip-health] DeLauro and Colins on March-In, and reasonable terms earlier this year

Ma Gagnon MarcAndreGagnon at cunet.carleton.ca
Wed Dec 14 08:22:44 PST 2016

Not really.
Bayh-Dole Act allows March-In rights all drugs that received NIH funding.
The referenced Health Affairs article says:
"The 478 drugs in our sample were associated with $132.7 billion in prescription drug sales in 2006. Drugs with public-sector patents accounted for 2.5 percent of these sales, while drugs whose applications cited federally funded research and development or government publications accounted for 27 percent."
Because the numbers go back to 2006 and because drug companies have been significantly externalizing R&D with public and academic partners since that date, the number today is certainly higher than 27%.
All the best,

Marc-André Gagnon, PhD
Visiting Professor, University of Ottawa 
e-mail: ma_gagnon at carleton.ca 
Twitter: @MA_Gagnon 
Ottawa Centre for Health Law, Policy and Ethics
57 Louis-Pasteur
Ottawa, ON (Canada)
K1N 6N5

-----Original Message-----
From: Ip-health [mailto:ip-health-bounces at lists.keionline.org] On Behalf Of Peter Pitts
Sent: December-14-16 10:25 AM
To: Jamie Love
Cc: Ip-health
Subject: Re: [Ip-health] DeLauro and Colins on March-In, and reasonable terms earlier this year

To this point, according to an article in Health Affairs, "… drugs with public-sector patents accounted for only 2.5 percent of US prescription drug spending."
On Dec 14, 2016, at 10:17 AM, Jamie Love wrote:

> https://www.gpo.gov/fdsys/pkg/CHRG-114hhrg21343/pdf/CHRG-114hhrg21343.
> pdf
> From this hearing:
> --------------
> DRUG COSTS Ms. DELAURO. Taxpayers provide more than about 
> $30,000,000,000 annually for NIH’s research. Dr. Collins, you have 
> said that NIH conducts the basic science that ‘‘fosters innovation, 
> ultimately leads to effective ways to treat complex medical 
> conditions.’’ And yet, in so many cases, taxpayer-funded research 
> leads to drugs that are sold back to the taxpayers at exorbitant prices.
> Example. UCLA led to a patent for Xtandi, a drug to treat prostate 26 
> cancer. The drug now costs patients $129,000. The same costs patients 
> in other countries about a third of that amount.
> Look, I realize the pharmaceutical companies invest their resources. 
> They bring a new drug to market. They should profit from that 
> innovation. But what I want to know is why U.S. taxpayers are getting 
> gouged for drugs that wouldn’t exist without the significant investment of U.S. taxpayers.
> Can you better explain why U.S. taxpayers are paying for biomedical 
> research on the front end and paying exorbitant prices at the back 
> end? And I will just say that 50 of my colleagues and myself have sent 
> a letter to you and to Secretary Burwell, requesting that the NIH and 
> HHS assert March-in rights when taxpayer-funded research leads to a 
> patented product that is not available to the public on reasonable terms.
> What are reasonable terms? A drug shouldn’t cost $129,000 for people 
> to get access to it.
> Dr. COLLINS. Well, I know this is a topic of great interest, and well 
> it should be. And certainly, my heart goes out, as all of us do, to 
> patients who are in need of a therapeutic which is outside of their 
> financial means to be able to gain access to, and that really ought to 
> be the thing that drives us trying to come up with better solutions.
> I would say with regard to March-in rights, we read the letter carefully.
> You saw the response from Secretary Burwell. NIH does, in fact, have 
> the ability to march in if reasonable terms are not being met and if 
> we have intellectual property that is attached to that particular product.
> Ms. DELAURO. What is a reasonable term?
> Dr. COLLINS. Well, that is very much where it gets down to the 
> nitty-gritty, doesn’t it? And we have looked at that situation several 
> times in the past, and have not felt like we reached reasonable terms. 
> But we are totally open to considering that on a case-by-case basis, 
> and we will be glad to do that with other products that are brought 
> forward for our consideration. We get it that this is a serious issue.
> Ms. DELAURO. And let us have further conversation. And I have gone 
> over my time. I thank you, Mr. Chairman.
> ​=================
> Later in the same hearing, DeLauro says that a va​ccine for Zika 
> should be affordable, relevant since the NIH and the Army are 
> licensing Zika vaccine patents.
> ​=================​
> ​Ms. DELAURO. I would like to continue this conversation to look at 
> breast cancer particularly. And I might just ask you to take a look at 
> the Wall Street Journal this week. Bristol, and this is Bristol-Myers 
> Squibb bets against Precision Medicine. I would ask you to take a look 
> at it and tell us, you know, what Bristol-Myers Squibb is thinking 
> about or talking about when we are trying to move in this direction.
> Ah, I have got 4 seconds left. La-da-da. All I will just say is, and 
> this is to Dr. Fauci, if, one, I want to make sure that any vaccine 
> that we deal with for Zika is going to be available and affordable for 
> people. This is this reasonable terms issue. But secondly, I will just 
> offer my view. I think it is critical for us to deal with supplemental 
> emergency resources in order to address this issue and this problem. 
> You are right. I will tell you that 46 we are now sending blood 
> products to Puerto Rico in response to a Zika outbreak. What happens 
> when we are looking at a blood supply that is potentially going to be 
> difficult or people are not going to understand the safety of a blood 
> supply with regard to Zika, and what kind of problems that is going to cause here in the U.S.?
> And let me just tell you, American women are not going to—they are 
> going to be outraged if we are not doing something about them and 
> about their ability to be pregnant and to bring a child to term. So 
> thank you for the great work that you are doing in this area. I have 
> another question, but that is okay. [Laughter.]
> Mr. COLE. Well, I am not sure that was a question, but it was——
> Ms. DELAURO. Genetically modified mosquitoes. Are they—is it— 
> genetically modified mosquitoes? Mr. COLE. I am going to ask the 
> gentlelady to take that one for the record. Ms. DELAURO. Okay. All 
> right. Thank you. ​
> --
> James Love.  Knowledge Ecology International 
> http://www.keionline.org/donate.html
> KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
> +41.76.413.6584, twitter.com/jamie_love
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