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-1400 and BHV-1420 from China
Dear Mr. Gonzalez:
In your letter dated April 8, 2026, you requested a tariff classification ruling on BHV-1400 and
BHV-1420. This ruling request was submitted by Kirti Jadeja, Deloitte Tax LLP.
BHV-1400 is an engineered bifunctional antibody conjugate designed to selectively recognize and degrade
circulating pathogenic Gd-IgA1 for the treatment of IgA nephropathy autoimmune diseases, specifically for
Berger’s disease. In your letter, you indicated that the BHV-1400 will be imported for investigational
research and drug development purposes to conduct Phase 1 through Phase 3 clinical trials. The BHV-1400
will be imported as the BHV-1400 drug product and BHV-1400 Active Pharmaceutical Ingredient (API).
Biohaven Pharmaceuticals, Inc. (“Biohaven”) has an approved IND from the FDA to support the execution of
early-stage clinical trials for drug development. The BHV-1400 drug product will be used in Phase 1 through
Phase 3 clinical trial studies to test for efficacy in treating IgA nephropathy (IGAN), and other IgA
autoimmune diseases. The BHV-1400 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.
The BHV-1400 will be imported in four different forms as follows:
API in solution.
Sterile drug product in glass vials.
Single use Prefilled Syringe (PFS) assembled into auto-injector device.
PFS without the auto-injector device.
BHV-1420 is a targeted bifunctional degrader of anti-PLA2R autoantibodies that is being tested against
multiple autoimmune diseases, specifically for the treatment of Idiopathic Membranous Nephropathy
(“IMN”). In your letter, you indicated that the BHV-1420 will be imported for investigational research and
drug development purposes to conduct Phase 1 through Phase 3 clinical trials. The BHV-1420 will be
imported as the BHV-1420 drug product and BHV-1420 API. Biohaven has an approved IND from the FDA
to support the execution of early stage clinical trials for drug development. The BHV-1420 drug product will
be used in Phase 1 through Phase 3 clinical trial studies to test for efficacy in treating autoimmune diseases.
The BHV-1420 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.
The BHV-1420 will be imported in two different forms as follows:
API in solution.
Sterile drug product in glass vials.
You inquired about whether the imported BHV-1400 and BHV-1420 qualifies for duty free treatment as
prototypes 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-1400 and BHV-1420 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-1400
and BHV-1420 into other products that will be sold and any remaining BHV-1400 and BHV-1420 will be
disposed of in accordance with applicable regulations. Finally, you state that BHV-1400 and BHV-1420 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-1400 and BHV-1420, imported in various forms,
qualifies for duty free treatment as prototypes under subheading 9817.85.01, HTSUS, provided that all of the
conditions delineated in U.S. Note 7, Chapter 98, Subchapter XVII, HTSUS are satisfied.
The applicable subheading for the BHV-1400 and BHV-1420 will be 9817.85.01, HTSUS, which provides
for “Prototypes to be used exclusively for development, testing, product evaluation, or quality control
purposes.” The general 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. You also submitted a ruling
request for BHV-1450 which will be issued separately under ruling N360524.
The 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/.
This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or other
charges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and other
duties as provided for in Subchapter III to Chapter 99, HTSUS. Thus, for example, in addition to the
classification stated above, the merchandise covered by this ruling may also need to be reported with either
the Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisions
covering exceptions to such tariffs.
For further information to assist with the importation process, please refer to the frequently updated Cargo
Systems Messaging Service (CSMS) messages at
https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and the Trade Remedies page at
https://www.cbp.gov/trade/programs-administration/trade-remedies.
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 P. Forkan
Director
National Commodity Specialist Division