2016: NIH FOIA office withholds all records related to exclusive license on HER2+ breast cancer treatment technology

(More on government funded inventions here. Other KEI comments on NIH licenses are found here.)

In response to a February request under the Freedom of Information Act (FOIA) for documents related to the grant of an exclusive patent license on a HER2+ breast cancer treatment technology, the National Institutes of Health (NIH) withheld in full all responsive records.

Knowledge Ecology International received a “final response” from an NIH FOIA Officer today, May 3, 2016, via first-class mail, addressing the request for documents related to the prospective grant of an exclusive license to HUIYU Pharmaceuticals Co, Ltd. The license would have allowed HUIYU an exclusive market in China to use an Antibody Drug Conjugate (ADC) technology to treat HER2+ breast cancer. In its public notice of the license, NIH described the technology as follows:

These inventions concern Antibody Drug Conjugates (ADCs). ADCs can demonstrate high efficacy as cancer therapeutics, however, much more can be done to improve their efficacy and safety profile. Site-specific antibody drug conjugation is a promising way to do this.

The scientists at the NIH have identified a fully human monoclonal antibody, m860, that binds to cell surface-associated Her2 with affinity comparable to that of Trastuzumab (Herceptin) but to a different epitope. In addition, the scientist developed a site-specific glycan engineering method to conjugate the antibody to the small molecule drug auristatin F. The ADC prepared though this site-specific approach shows very good stability, cell surface binding activity and also potent specific cell killing activity against Her2 positive cancer cells, including Trastuzumab resistant breast cancer cells. This ADC has the potential to be developed as a targeted therapeutic for Her2-overexpressing cancers.

KEI requested all internal documents, correspondence, and notes related to the licensing process, including records generated by the National Cancer Institute and other NIH agencies and centers; records from the U.S. Department of Health and Human Services (HHS); records from foreign governments, including the government of China; and records created by non-governmental persons and entities. KEI also requested all correspondence and records with the prospective licensee.

The response, dated April 26, 2016, noted that a search of NIH records found “131 pages of responsive records,” all of which NIH has decided to “withhold in their entirety pursuant to Exemptions 4 and 5 of the FOIA” and applicable HHS regulations. Exemption 4 protects confidential business information, while exemption 5 allows agencies to withhold deliberative documents related to the decision or policy-making processes. The NIH also claimed that portions of the records could also be withheld under exemption 3 and 6, related to “documents which are exempt from disclosure by another statute” and private personal information, respectively.