[Ip-health] KEI initial comments on NIH proposed grant of exclusive license on liver cancer treatment to Salubris

Kim Treanor kim.treanor at keionline.org
Tue Aug 8 08:03:24 PDT 2017


KEI initial comments on NIH proposed grant of exclusive license on liver
cancer treatment to Salubris
Kim Treanor on 8 August 2017

On August 8, 2017, Knowledge Ecology International (KEI) submitted comments
on the proposed grant of an exclusive license from the National Institutes
of Health (NIH) and Department of Health and Human Services (HHS) to
Salubris Biotherapuetics, Inc, a corporation headquartered in Guangdong,
China, for an important new technology that could be used to develop
treatments for liver cancer.

Background on NIH proposed license to Salubris for patents on liver cancer

8 August 2017
FMI: Kim Treanor, kim.treanor at keionline.org or +1 (202) 332-2670

The Federal Register notice from the NIH describes Salubris as a company
located in Gaithersburg, Maryland, though it appears that this Gaithersburg
office was opened only in May of 2017. The company is headquartered in
Shenzhen, Guangdong, China, and headed by the billionaire Ye Chenghai, a
former mayor of Shenzhen who is described by Forbes as the 51st richest
person in China as of 2016.

The technology that is the subject of the proposed worldwide exclusive
license is a bispecific, biparatopic antibody-drug conjugate (ADC).
Therapeutic antibodies have revolutionized therapy for cancer and
autoimmune diseases. First monoclonal antibodies were used to target a
single epitope on malignant cells, or harmful protein. Antibodies were then
rendered more potent by conjugating cytotoxic molecules to them. As our
understanding of the immune system is improving, we can now use antibodies
to activate our lymphocytes against tumor cells. Breakthroughs in
recombinant DNA technology and sequencing have enabled scientists to design
multispecific antibodies that can target more than one epitope on the same
or different antigen. This new generation of antibodies are effectively
multi-tools with each Fv performing a different function. For example,
bispecific antibodies can on the one hand bind to receptors overexpressed
on tumor cells and on the other hand can increase internalization (for drug
delivery) or trigger cell death. Some bispecific antibodies, such as BiTEs,
can link effector T-cells to cancer cells.

The considered license describes two paratopes that could be engineered
within one antibody to target liver cancer cells. Not only would this
improve the specificity of the antibody drug conjugate, but it could also
inhibit growth in these cancer cells. Many bispecific antibodies are
already in clinical trials and several are already on the market. The
versatility of these next generation antibodies makes them highly effective
therapeutic agents.

In our comments, KEI asks the NIH and HHS to confirm the term and proposed
royalty on this license, how much money the NIH or federal agencies have
spent to develop the technology, and whether the NIH and other federal
agencies will be subsidizing future development of this drug. The Orphan
Drug Tax Credit can be used to subsidize 50 percent of the cost of
qualifying trials for a liver cancer drug.

KEI also asks what terms will be included in this license to ensure that
the invention is “available to the public on reasonable terms” and what
analysis was undertaken to ensure that “the proposed scope of exclusivity
is not greater than reasonably necessary to provide the incentive for
bringing the invention to practical application”, both required by the
Bayh-Dole Act.

KEI recommends that in any licensing agreement, the licensee agree to
disclose the steps it will take to enable the registration and availability
of the product at an affordable price in every country with a demonstrated
need. As the technology has been developed using taxpayer funds, we also
recommend that any licensee agrees to make the product available to the
public in the U.S. at publicly disclosed prices no higher than the median
price charged in Canada plus the seven countries with the largest GDP,
which have per capita incomes of at least half that of the United States.

KEI also makes recommendations that any licensing agreement include
requirements of transparency in R&D spending, royalties, marketing costs,
and spending on lobbying, and that any licensee agrees to make its
materials and methods known to any generic drug manufacturer seeking
marketing approval for any small molecule and biologic product in any OECD
country or for WHO prequalification.

According to the Centers for Disease Control, “each year in the United
States, about 22,000 men and 9,000 women get liver cancer, and about 16,000
men and 8,000 women die from the disease. The percentage of Americans who
get liver cancer has been rising for several decades.”


Kim Treanor
Knowledge Ecology International
kim.treanor at keionline.org
tel.: +1.202.332.2670

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