THE COUNTRY OF ORIGIN MARKING OF COSOPT™ Sterile Ophthalmic Solution (dorzolamide hydrochloride-timolol maleate ophthalmic solution)

NY E83145 June 18, 1999 MAR-2-RR:NC:2:238 E83145 CATEGORY: MARKING Jack D. Mlawski, Esq. Galvin & Mlawski 440 Park Avenue South - 9th Floor New York, NY 10016-8067 RE: THE COUNTRY OF ORIGIN MARKING OF COSOPT™ Sterile Ophthalmic Solution (dorzolamide hydrochloride-timolol maleate ophthalmic solution) Dear Mr. Mlawski : This is in response to your letter dated June 4, 1999, on behalf of your client, Merck & Co., Inc., requesting a ruling on whether the proposed marking "Made in France" is an acceptable country of origin marking for imported COSOPT™ Sterile Ophthalmic Solution (dorzolamide hydrochloride-timolol maleate ophthalmic solution). Although a marked sample was not submitted with your letter for review, you have indicated in a telephone conversation with a member of my staff, on June 15, 1999, that the subject product is supplied in an OCUMETER® (a white, opaque, plastic ophthalmic dispenser with a controlled drop tip) which, in turn, is put up in retail packaging. The subject product, COSOPT™ Sterile Ophthalmic Solution (dorzolamide hydrochloride-timolol maleate ophthalmic solution), is an ophthalmological medicament, in the form of a clear, colorless to nearly colorless, slightly viscous solution, containing a combination of two drugs: dorzolamide hydrochloride (a topical carbonic anhydrase inhibitor) and timolol maleate (a topical beta-adrenergic receptor blocking agent), as the active ingredients. It is indicated for the reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension. We note, as evidenced by monographs appearing in the 1999 Physicians’ Desk Reference®, that dorzolamide hydrochloride and timolol maleate are separately available (by prescription) for the treatment of elevated intraocular pressure. We further note that the monograph appearing in the 1999 Physicians’ Desk Reference® for the subject product indcates that, “[T]he combined effect of these two agents (i.e., dorzolamide hydrochloride and timolol maleate) administered as COSOPT™ b.i.d. results in additional intraocular pressure reduction compared to either component administered alone (underscoring added) ... .” You state that dorzolamide hydrochloride will be manufactured in the United States and shipped to France, where it will be combined with French-manufactured timolol maleate. The two-drug combination will then be formulated with various excipients to produce the finished medicament (i.e., COSOPT™ Sterile Ophthalmic Solution (dorzolamide hydrochloride-timolol maleate ophthalmic solution)) for exportation to the United States. The marking statute, section 304, Tariff Act of 1930, as amended (19 U.S.C. §1304), provides that, unless excepted, every article of foreign origin (or its container) imported into the the U.S. shall be marked in a conspicuous place as legibly, indelibly and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the U.S. the English name of the country of origin of the article. The regulations implementing the requirements and exceptions to 19 U.S.C. §1304 are set forth in Part 134, Customs Regulations (19 C.F.R. Part 134). Section 134.1(b), Customs Regulations (19 C.F.R. §134.1(b)), defines the country of origin as “[t]he country of manufacture, production, or growth of any article of foreign origin entering the U.S. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the ‘country of origin’ within the meaning of this part; however, for a good of a NAFTA country, the NAFTA Marking Rules will determine the country of origin.” A substantial transformation occurs when articles lose their identity and become articles having a new name, character or use. United States v. Gibson-Thomsen Co., 27 CCPA 267 at 270 (1940), National Juice Products v. United States, 10 CIT 48, 628 F. Supp. 978 (CIT 1986). In the instant case, we find that the combining of (U.S.-produced) dorzolomide hydrochloride and (French-produced) timolol maleate in France results in a product, COSOPT™Sterile Ophthalmic Solution (dorzolamide hydrochloride-timolol maleate ophthalmic solution), which has an identity and character medicinally distinct from the materials from which it was produced. Therefore, we hold that dorzolomide hydrochloride and timolol maleate undergo a substantial transformation as a result of the operations performed in France, and that the country of origin of COSOPT™ Sterile Ophthalmic Solution (dorzolamide hydrochloride-timolol maleate ophthalmic solution) is France. Since the solution, per se, is, of course, incapable of being marked, it is excepted from being marked (19 C.F.R. Section 134.32(a)). Accordingly, pursuant to 19 C.F.R. Section 134.32(d), receipt of the imported product by the purchaser at retail in a container marked with its (i.e., the solution’s) country of origin will suffice to meet the requirements of 19 U.S.C. §1304. This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. Part 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, contact National Import Specialist Harvey Kuperstein at 212-637-7068. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division