Commissioner for Patents
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`United States Patent and Trademark Office
`P.O. Box 1450
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`Alexandria, VA 22313-1450
`www.wpto.gov
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`Leslie Morioka, Esq.
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`Patent
`Department
`White & Case LLP
`1155 Avenue of the Americas
`New York, NY 10036-2787
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`In Re: Patent Term Extension
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`for.
`Application
`U.S. Patent No. 6,143,771
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`NOTICE OF FINAL DETERMINATION
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`An application for extension of the patent term of U.S. Patent No. 6,143,771 under
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`35 U.S.C. § 156 was filed in the United States Patent and Trademark Office on May 25, 2005.
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`The application was filed by AstaZeneca AB, the owner of U.S. Patent No. 6,143,771 by virtue
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`of the Assignment to Astra AB by the inventors and by Assignment from Astra AB to
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`AstraZeneca AB. Extension is sought based upon the premarket review under§ 505(b) of the
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`Federal Food, Drug, and Cosmetic Act (FFDCA) ofNEXIUM® LV. esomeprazole sodium for
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`injection.· NEXIUM® I.V. was approved for commercial use and sale by the Food and Drug
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`Administration (FDA) on March 31, 2005.
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`A determination has been made that U.S. Patent No. 6,143,771 is NOT eligible for patent term
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`extension under 35 U.S.C. § 156 based upon the regulatory review period ofNEXIUM® I.V.
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`A single request for reconsideration of this FINAL DETERMINATION O F INELIGIBILITY
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`may be made if filed by the applicant within TWO MONTHS of the mailing date of this letter.
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`The period for response may be extended pursuant to 37 C.F.R. 1.136. See 37 C.F.R. 1.750. A
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`failure to respond to this letter will result in the application papers being placed into the patent
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`file with no further action taken on the application for patent term extension.
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`According to Applicants, the product for which patent term extension is sought is NEXIUM®
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`I.V. (esomeprazole sodium for injection). Applicants admit that a patent term extension for
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`PRILOSEC® (omeprazole) was previously granted for U.S. Patent No. 4,255,431, now expired.
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`Additionally, Applicants admit that patent term extension applications have been filed for
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`NEXIUM® (esomeprazole magnesium) and PRILOSEC® O TC (omeprazole magnesium) for
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`U.S. Patent Nos. 4,738,974 and 5,817,338, respectively. It is noted that an interim extension of 1
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`year has been granted for U.S. Patent No. 4,738,974.
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`The USPTO understands that esomeprazole sodium, the active ingredient ofNEXIUM® I.V., is
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`not the same active ingredient as PRILOSEC® ( omeprazole ), NEXIUM® ( esomeprazole
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`magnesium) or PRILOSEC® O TC ( omeprazole magnesium). The difference between the active
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`in NEXIUM I.V.® and NEXIUM® is a sodium salt and a magnesium salt of the active
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`moiety, esomeprazole, respectively.
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`Under 35 U.S.C. § I 56( a) a term of a patent which claims a product shall be extended if, inter
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`U.S. Patent No. 6,143,771
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`2
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`alia, the product has been subject to a regulatory review period before its commercial
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`marketing or use. In addition, under § 156(a)(5)(A):
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`marketing or use of the product ... is the first the permission for the commercial
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`or use of the product under the provision of law under
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`permitted commercial marketing
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`which such regulatory review period occurred; (Emphasis added)
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`Thus, the determination of eligibility of U.S. Patent No. 6,143,771 turns on the provisions in
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`§ 156(a)(5)(A) that the permission for the co}lllllercial marketing or use is the first permitted
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`commercial marketing or use of the product. The term "product" is defined in 35 U.S.C. § 156(f)
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`(B) Any medical device, food additive or color additive subject to regulation
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`· (f) For purposes of this section:
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`(1) The term "product" means:
`(A) A drug product ...
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`under the Federal Food Drug and Cosmetic Act.
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`(2) The term "drug product" means the active ingredient of-
`(A) A new drug, antibiotic drug, or human biological product ... .including any
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`salt or ester of the active ingredient,
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`as a single entity or in combination with
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`another active ingredient. (Emphasis added.)
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`The terms are similarly defined in the Food Drug and Cosmetic Act (21 C.F.R. 60.3(b)(l0)).
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`21 C.F .R. 60.3(b )(1 0) Human drug product means the active ingredient of a new
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`drug or human biologic product (as those terms are used in the [FD&C] Act and
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`the Public Health Service Act), including any salt or ester of the active ingredient.
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`as a single entitv or in combination with another active ingredient
`(Emphasis
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`In Pfizer. Inc. v. Dr. Reddy's Labs., 359 F.3d 1361, 69 USPQ2d (BNA) 2016 (Fed. Cir. 2004),
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`the Federal Circuit provided guidance on what constitutes a "product" for purposes of FDA
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`regulatory review. The court found that the approved product is the active ingredient of
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`NO RV ASC®, amlodipine, not amlodipine besylate per se, because test data for both amlodipine
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`besylate and amlodipine maleate had been submitted to the Food and Drug Administration, and
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`also because, as stated by the court:
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`We conclude that the active ingredient is amlodipine, and that it is the same whether
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`administered as the besylate salt or the maleate salt. The statutory definition of "drug
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`product" is met by amlodipine and its salts. Dr. Reddy's is proposing to market the "drug
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`product," as defined in 35 U.S.C. §156(f), for the same approved uses. The statute
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`foresaw variation in the salt or ester of an active ingredient, and guarded against the very
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`loophole now urged. See 35 U.S.C. §156(f); 21 U.S.C. §355G)(5)(D)(i) and (v). As
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`U.S. Patent No. 6,143,771
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`Page 3
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`amici curiae point out, the Hatch-Waxman Act established a balance whereby the
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`several
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`patent term extension is offset by facilitating generic entry when the extended term
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`expires, yet preserving the innovation incentive. Whether or not this bargain achieved
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`"perfect symmetry"--Dr. Reddy's argues that it was not intended to do so, but was
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`designed to favor the generics --the text of the statute shows that it was not intended to
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`be defeated by sirriply changing the salt. None of the aspects offered to the district court
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`or on this appeal suggests a statutory intent to provide the generic producer with access to
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`the pioneer's approved uses and data while barring extension of patent coverage of the
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`drug product whose approvals and data are provided. To the contrary, as we have
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`discussed, the Hatch-Waxman Act foresaw and averted the potential loophole of a change
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`in the salt of the active ingredient. (Emphasis added.)
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`UK Ltd. v. Quigg, 706 F. Supp. 1224, 10 The court in Pfizer did not discuss Glaxo Operations
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`USPQ 2d 1100 (E.D. Va. 1989); affd., 894 F.2d 392, 13 USPQ2d 1628 (Fed. Cir. 1990),
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`although the Pfizer district court acknowledged the law of the federal circuit articulated in Glaxo.
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`In Glaxo, much like Pfizer, there was a new member (cefurozime axetil) of the same active
`In Glaxo, the court
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`moiety as two previously approved salts (two sodium salts of cefuroxime).
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`found that since the new member ( cefurozime axetil) was neither a salt nor an ester of a ·
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`. previously approved product, the new ester could support a patent term extension. Eligibility· for
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`patent term extension must be consistent with the rights derived from a patent term extension.
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`Accordingly, if the rights derived from the extension of a patent based upon the regulatory
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`approval of a salt encompass other compounds within the same active moiety, then extension
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`based upon subsequent approvals of other compounds within the same active moiety must be.
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`barred. As Pfizer suggests this result, Glaxo must be treated as overruled, and the application for
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`patent term extension dismissed since the active moiety in NEXIUM I.V.® is esomeprazole,
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`which was previously approved in NEXIUM® and hence does not constitute the first commercial
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`marketing or use.
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`In view of the above, the term of U.S. Patent No. 6,143,771 is NOT eligible for extension under
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`35 U.S.C. § 156 based upon the approval of the product NEXIUM® I.V. and the application for
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`patent term extension, filed May 25, 2005, is dismissed.
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`,.
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`U.S. Patent No. 6,143,771
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`Page4
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`Any correspondence with respect to this matter should be addressed as follows:
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`By mail:
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`Mail Stop Patent Ext.
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`Commissioner for Patents
`P.O. Box 1450
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`Alexandria, VA 2231.3-1450
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`By FAX:
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`(571) 273-7755
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`Telephone inquiries related to this determination should be directed to Mary C. Till at (571) 272-
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`7755. E-mail inquiries should be directed to Mary.Till@uspto.gov.
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`Senior Legal Advisor
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`Office of Patent Legal Administration
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`Offi ce of the Deputy Assistant Commissioner
`for Patent Policy and Projects
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`cc: Office of Regulatory Policy
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`HFD - 13
`5600 Fishers Lane
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`Rockville, MD 20857
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`Attention: Claudia Grillo
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`RE: NEXIUM® I.V.