[Ip-health] Briefing note on NIH proposed license to Gilead for CD-30 CAR T technology

Kim Treanor kim.treanor at keionline.org
Fri Jan 5 07:04:05 PST 2018

Link to this post on keionline:

On Fri, Jan 5, 2018 at 9:54 AM, Kim Treanor <kim.treanor at keionline.org>

> Briefing note on NIH proposed license to Gilead for CD-30 CAR T technology
> Contact: Kim Treanor 202-332-2670 <(202)%20332-2670>;
> kim.treanor at keionline.org
> January 5, 2018
> The National Institutes of Health (NIH) has proposed an exclusive license
> with Gilead for certain patent applications for inventions that target
> CD-30 proteins and CAR T technologies.
> The proposed license is to Kite, a company Gilead acquired in 2017 for
> $11.9 billion. Gilead and Kite previously registered a CAR T based product,
> Yescarta, a treatment for adults with a certain type of lymphoma. Yescarta
> was also developed using technology invented by and licensed from the NIH
> and was the subject of a separate NIH Cooperative Research and Development
> Agreement (CRADA).
> Yescarta has a list price in the United States of $373,000, plus
> additional costs relating to the treatment. It was recently reported that
> only five patients have received the treatment due to its high cost.
> Knowledge Ecology International (KEI) filed an objection to the exclusive
> license on January 4, 2018.  The objection made the following points.
> It is premature to grant an exclusive license, given the fact that the NIH
> is funding a Phase 1 trial.
> The NIH is currently sponsoring and fully funding a Phase 1 trial with 76
> patients for the technology. KEI objects to the NIH licensing the CD-30 CAR
> T inventions before the NIH or anyone has information about the Phase 1
> trial results. The value of the invention will be much higher if the trial
> is successful, and the NIH could obtain a higher royalty and cash payments
> for the licenses, a shorter term of exclusivity, or a lower price for the
> product, and perhaps no exclusivity at all, if there is more certainty the
> technology will work. Licensing the technology now, just as the Phase 1
> trial begins, eliminates the possibility of a much better license in the
> future.
> 2. If the NIH grants an exclusive license, it should include clear
> safeguards in the license to protect U.S. residents from excessive prices
> and access barriers.
> If the NIH does grant an exclusive license, it needs to have concrete and
> clear safeguards to protect U.S. residents from excessive prices and access
> barriers. KEI proposed five different provisions in the license to address
> this.  They included:
> (a) A clause prohibiting prices that discriminate against U.S. residents,
> when compared to nine other high income countries with large economies,
> (b) An obligation to avoid significant gaps in access in the United States,
> (c) A requirement that the price for this NIH funded invention “not be
> higher than CAR T treatments of similar efficacy, taking into account
> differences in patient populations, if the cumulative revenue per
> indication is less than $300 million.”
> (d) A requirement that ”the price should not increase faster than the rate
> of inflation as measured by the consumer price index, unless the increase
> can be justified by a need to earn a reasonable profit on the risk adjusted
> investments in research and development,” and
> (e) A provision to end the monopoly when the cumulative global revenue for
> the product exceeds $300 million, for any approved FDA indication or $1
> billion for all indications.
> 4. The NIH should protect patients in countries with per capita incomes
> that are less than one third of U.S. per capita income.
> KEI noted the NIH has filed an application in the WIPO PCT to protect the
> invention in 199 countries, including most countries in Sub-Saharan Africa,
> and many countries classified by the United Nations as a least developed
> country.
> KEI asked that the NIH exclude from the exclusive license any country with
> a per capita income that is less than one third the per capita income of
> the United States.
> 5.   The NIH should require transparency with regards to R&D outlays.
> KEI noted, “it is an unnecessary and reason-inhibiting fact that actual
> R&D outlays are often hidden from the public, although speculation about
> R&D costs is used to justify high prices. The NIH can remedy this by
> requiring that companies that license NIH-owned technologies disclose to
> the public the actual R&D costs for commercializing inventions, along with
> all public sector R&D subsidies, such as the Federal R&D and Orphan Drug
> tax credits.”
> --
> Kim Treanor
> Knowledge Ecology International
> kim.treanor at keionline.org
> tel.: +1.202.332.2670 <(202)%20332-2670>

Kim Treanor
Knowledge Ecology International
kim.treanor at keionline.org
tel.: +1.202.332.2670 <(202)%20332-2670>

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