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 treatment
8 August 2017
FMI: Kim Treanor, firstname.lastname@example.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.”