CLA-2-98:OT:RR:NC:N3:138
Javier Gonzalez
Biohaven Pharmaceuticals Inc.
215 Church Street
New Haven, CT 06510
RE: The tariff classification of BHV-1300 and BHV-1310 from China
Dear Mr. Gonzalez:
In your letter dated June 24, 2025, you requested a tariff classification ruling on BHV-1300 and BHV-1310.
This ruling request was submitted by Kirti Jadeja, Global Trade Advisory, Deloitte Tax LLP.
BHV-1300 IgG is a bispecific extracellular IgG degrader currently being tested for its efficacy in the
treatment of Graves’ Disease. It has an innovative mechanism for degrading and depleting pathogenic IgG in
chronic and acute conditions rather than inhibition. In your letter, you indicated the BHV-1300 will be
imported for investigational research and drug development purposes to conduct Phase 1 through Phase 3
clinical trials. The BHV-1300 will be imported as the BHV-1300 drug product and BHV-1300 Active
Pharmaceutical Ingredient (API). Biohaven Pharmaceuticals, Inc. (“Biohaven”) has an approved IND from
the FDA for BHV-1300 to support the execution of early stage clinical trials for drug development. The
BHV-1300 drug product will be used in Phase 1 clinical trial through Phase 3 clinical trial studies to test for
efficacy in treating Graves’ Disease, and other IgG mediated diseases. The BHV-1300 API will be
formulated into the drug product for testing or for use in toxicology studies to evaluate safety and efficacy in
disease treatment in living organisms.
BHV-1310 IgG is also a targeted extracellular protein degrader being tested against multiple autoimmune
indications and, in particular, Myasthenia Gravis, or Graves’ Disease. These are bispecific molecules that
target pathologic circulating proteins and direct them to the liver (or other organ systems) for degradation by
the endosomal/lysosomal pathway. In your letter, you indicated the BHV-1310 will be imported for
investigational research and drug development purposes to conduct Phase 1 clinical trials and toxicology
studies to evaluate the safety and efficacy in disease treatments. Biohaven has an approved IND from the
FDA for BHV-1310 to support the commencement of clinical trials. The BHV-1310 will be imported as the
BHV-1310 drug product and BHV-1310 API. The BHV-1310 drug product will be used to conduct Phase 1
clinical trials, and the BHV-1310 API will be used in toxicology studies to evaluate the safety and efficacy in
disease treatment in living organisms.
The BHV-1300 and BHV-1310 will be imported in four different forms as follows:
1. API in powder form.
2. Sterile drug product solution in glass vials.
3. Single use Prefilled Syringe (“PFS”) assembled into an auto-injector device (includes the drug
product solution).
4. PFS without the auto-injector device (includes the drug product solution).
You inquired about whether the imported BHV-1300 and BHV-1310 qualifies for duty free treatment as a
prototype under subheading 9817.85.01, Harmonized Tariff Schedule of the United States (HTSUS), which
provides for “Prototypes to be used exclusively for development, testing, product evaluation, or quality
control purposes.” You indicated that Biohaven will import the BHV-1300 and BHV-1310 for further drug
development in limited non-commercial quantities in accordance with industry practice solely to conduct
FDA clinical trials and toxicology studies. You further indicate that Biohaven will not incorporate BHV-1300
and BHV-1310 into other products that will be sold and any remaining BHV-1300 and BHV-1310 will be
disposed of in accordance with applicable regulations. Finally, you state that BHV-1300 and BHV-1310 are
not subject to any of the restrictions detailed in paragraph (c) of U.S. Note 7 to Chapter 98, HTSUS.
Based on the information presented, we find that BHV-1300 and BHV-1310, imported in four different
forms, qualifies for duty free treatment as a prototype under subheading 9817.85.01, HTSUS, provided that
all of the conditions delineated in U.S. Note 7, Chapter 98, Subchapter XVII, Harmonized Tariff Schedule of
the United States, (HTSUS) are satisfied.
The applicable subheading for the subject merchandise will be 9817.85.01, HTSUS, which provides for
“Prototypes to be used exclusively for development, testing, product evaluation, or quality control purposes.”
The rate of duty will be free.
Please note a statistical classification in chapters 1-97 for subheading 9817.85.01, HTSUS, is also required.
Statistical Note 1 to Subchapter XVII of Chapter 98, HTSUS, states, in pertinent part:
For statistical reporting of merchandise under subheading [ ] …9817.85.01, …:
(a) Report the 8-digit number (or 10-digit number, if any) found in this subchapter in addition to the 10-digit
number appearing in chapters 1-97 which would be applicable but for the provisions of this subchapter;
We note that the request did not seek a determination as to the statistical classification in chapters 1-97 for
subheading 9817.85.01, HTSUS; as such, this ruling does not address this issue.
The tariffs and additional duties cited above are current as of this ruling’s issuance. Duty rates are provided
for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying
duty rates are provided at https://hts.usitc.gov/.
The holding set forth above applies only to the specific factual situation and merchandise description as
identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations
(CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the
information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and
complete in every material respect. In the event that the facts are modified in any way, or if the goods do not
conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and
Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2.
Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic
verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection
Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents
filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact
National Import Specialist Judy Lee at [email protected].
Sincerely,
(for)
James Forkan
Acting Director
National Commodity Specialist Division