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

Jamie Love james.love at keionline.org
Wed Dec 14 08:39:38 PST 2016

Peter Pitts makes a good point, in my opinion. Under current reporting
practices, only a small number of newly registered drugs show government
rights.   There is probably significant under reporting, but the statute
itself narrows the governments rights to a smaller set of patents that
those that undoubtedly benefited from government funding of the research.
That said, when the rights exist, as they do for drugs like Xtandi, Vimpat,
Folotyn, or Velcade, the federal government is not doing anything to
protect the public.

But on a related note, if few patents with government rights are found in
the Orange Book, maybe the Bayh-Dole Act is not the great engine for
innovation its promoters claim it is.


On Wed, Dec 14, 2016 at 4:24 PM, Peter Pitts <ppitts at cmpi.org> wrote:

> 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:
> WEDNESDAY, MARCH 16, 2016.
> --------------
> 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 <(202)%20332-2670>, US Mobile: +1.202.361.3040
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James Love.  Knowledge Ecology International
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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