`
`Mailed: July 28, 2005
`
`Leslie Morioka, Esq.
`Patent Department
`White & Case LLP
`1155 Avenue of the Americas
`New York, NY 10036-2787
`
`Commissioner for Patents
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`www.uspto.gov
`
`In Re: Patent Term Extension
`Application for
`U.S. Patent No. 6,143,771
`
`NOTICE OF FINAL DETERMINATION
`An application for extension of the patent term of U.S. Patent No. 6,143,771 under
`35 U.S.C. § 156 was filed in the United States Patent and Trademark Office on May 25, 2005.
`The application was filed by AstaZeneca AB, the owner of U.S. Patent No. 6,143,771 by virtue
`of the Assignment to Astra AB by the inventors and by Assignment from Astra AB to
`AstraZeneca AB. Extension is sought based upon the premarket review under § 505(b) of the
`Federal Food, Drug, and Cosmetic Act (FFDCA) of NEXIUM® I.V. esomeprazole sodium for
`injection. NEXIUM® I.V. was approved for commercial use and sale by the Food and Drug
`Administration (FDA) on March 31, 2005.
`
`A determination has been made that U.S. Patent No. 6,143,771 is NOT eligible for patent term
`extension under 35 U.S.C. § 156 based upon the regulatory review period of NEXIUM® I.V.
`
`A single request for reconsideration of this FINAL DETERMINATION OF INELIGIBILITY
`may be made if filed by the applicant within TWO MONTHS of the mailing date of this letter.
`The period for response may be extended pursuant to 37 C.F.R. 1.136. See 37 C.F.R. 1.750. A
`failure to respond to this letter will result in the application papers being placed into the patent
`file with no further action taken on the application for patent term extension.
`
`According to Applicants, the product for which patent term extension is sought is NEXIUM®
`I.V. (esomeprazole sodium for injection). Applicants admit that a patent term extension for
`PRILOSEC® (omeprazole) was previously granted for U.S. Patent No. 4,255,431, now expired.
`Additionally, Applicants admit that patent term extension applications have been filed for
`NEXIUM® (esomeprazole magnesium) and PRILOSEC® OTC (omeprazole magnesium) for
`U.S. Patent Nos. 4,738,974 and 5,817,338, respectively. It is noted that an interim extension of 1
`year has been granted for U.S. Patent No. 4,738,974.
`
`The USPTO understands that esomeprazole sodium, the active ingredient of NEXIUM® I.V., is
`not the same active ingredient as PRILOSEC® (omeprazole), NEXIUM® (esomeprazole
`magnesium) or PRILOSEC® OTC (omeprazole magnesium). The difference between the active
`ingredient in NEXIUM I.V.® and NEXIUM® is a sodium salt and a magnesium salt of the active
`moiety, esomeprazole, respectively.
`
`Under 35 U.S.C. § 156(a) a term of a patent which claims a product shall be extended if, inter
`
`
`
`U.S. Patent No. 6,143,771
`
`2
`
`alia, the product has been subject to a regulatory review period before its commercial
`marketing or use. In addition, under § 156(a)(5)(A):
`
`the permission for the commercial marketing or use of the product . . . is the first
`permitted commercial marketing or use of the product under the provision of law under
`which such regulatory review period occurred; (Emphasis added)
`
`Thus, the determination of eligibility of U.S. Patent No. 6,143,771 turns on the provisions in
`§ 156(a)(5)(A) that the permission for the commercial marketing or use is the first permitted
`commercial marketing or use of the product. The term "product" is defined in 35 U.S.C. § 156(f)
`as follows:
`
`(f) For purposes of this section:
` (1) The term "product" means:
`(A) A drug product . . .
`(B) Any medical device, food additive or color additive subject to regulation
`under the Federal Food Drug and Cosmetic Act.
` (2) The term "drug product" means the active ingredient of -
`(A) A new drug, antibiotic drug, or human biological product . . . .including any
`salt or ester of the active ingredient, as a single entity or in combination with
`another active ingredient. (Emphasis added.)
`
`The terms are similarly defined in the Food Drug and Cosmetic Act (21 C.F.R. 60.3(b)(10)).
`
`21 C.F.R. 60.3(b)(10) Human drug product means the active ingredient of a new
`drug or human biologic product (as those terms are used in the [FD&C] Act and
`the Public Health Service Act), including any salt or ester of the active ingredient,
`as a single entity or in combination with another active ingredient. (Emphasis
`added).
`
`In Pfizer, Inc. v. Dr. Reddy’s Labs., 359 F.3d 1361, 69 USPQ2d (BNA) 2016 (Fed. Cir. 2004),
`the Federal Circuit provided guidance on what constitutes a “product” for purposes of FDA
`regulatory review. The court found that the approved product is the active ingredient of
`NORVASC®, amlodipine, not amlodipine besylate per se, because test data for both amlodipine
`besylate and amlodipine maleate had been submitted to the Food and Drug Administration, and
`also because, as stated by the court:
`
`We conclude that the active ingredient is amlodipine, and that it is the same whether
`administered as the besylate salt or the maleate salt. The statutory definition of "drug
`product" is met by amlodipine and its salts. Dr. Reddy's is proposing to market the "drug
`product," as defined in 35 U.S.C. §156(f), for the same approved uses. The statute
`foresaw variation in the salt or ester of an active ingredient, and guarded against the very
`loophole now urged. See 35 U.S.C. §156(f); 21 U.S.C. §355(j)(5)(D)(i) and (v). As
`
`
`
`U.S. Patent No. 6,143,771
`
`Page 3
`
`several amici curiae point out, the Hatch-Waxman Act established a balance whereby the
`patent term extension is offset by facilitating generic entry when the extended term
`expires, yet preserving the innovation incentive. Whether or not this bargain achieved
`"perfect symmetry" -- Dr. Reddy's argues that it was not intended to do so, but was
`designed to favor the generics -- the text of the statute shows that it was not intended to
`be defeated by simply changing the salt. None of the aspects offered to the district court
`or on this appeal suggests a statutory intent to provide the generic producer with access to
`the pioneer's approved uses and data while barring extension of patent coverage of the
`drug product whose approvals and data are provided. To the contrary, as we have
`discussed, the Hatch-Waxman Act foresaw and averted the potential loophole of a change
`in the salt of the active ingredient. (Emphasis added.)
`
`The court in Pfizer did not discuss Glaxo Operations UK Ltd. v. Quigg, 706 F. Supp. 1224, 10
`USPQ 2d 1100 (E.D. Va. 1989); aff’d., 894 F.2d 392, 13 USPQ2d 1628 (Fed. Cir. 1990),
`although the Pfizer district court acknowledged the law of the federal circuit articulated in Glaxo.
`In Glaxo, much like Pfizer, there was a new member (cefurozime axetil) of the same active
`moiety as two previously approved salts (two sodium salts of cefuroxime). In Glaxo, the court
`found that since the new member (cefurozime axetil) was neither a salt nor an ester of a
`previously approved product, the new ester could support a patent term extension. Eligibility for
`patent term extension must be consistent with the rights derived from a patent term extension.
`Accordingly, if the rights derived from the extension of a patent based upon the regulatory
`approval of a salt encompass other compounds within the same active moiety, then extension
`based upon subsequent approvals of other compounds within the same active moiety must be
`barred. As Pfizer suggests this result, Glaxo must be treated as overruled, and the application for
`patent term extension dismissed since the active moiety in NEXIUM I.V.® is esomeprazole,
`which was previously approved in NEXIUM® and hence does not constitute the first commercial
`marketing or use.
`
`In view of the above, the term of U.S. Patent No. 6,143,771 is NOT eligible for extension under
`35 U.S.C. § 156 based upon the approval of the product NEXIUM® I.V. and the application for
`patent term extension, filed May 25, 2005, is dismissed.
`
`
`
`U.S. Patent No. 6,143,771
`
`Page 4
`
`Any correspondence with respect to this matter should be addressed as follows:
`By mail:
`Mail Stop Patent Ext.
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`(571) 273-7755
`By FAX:
`Telephone inquiries related to this determination should be directed to Mary C. Till at (571) 272-
`7755. E-mail inquiries should be directed to Mary.Till@uspto.gov.
`
`/s/
`__________________________________
`Karin Ferriter
`Senior Legal Advisor
`Office of Patent Legal Administration
`Office of the Deputy Assistant Commissioner
` for Patent Policy and Projects
`
`cc:
`
`Office of Regulatory Policy
`HFD - 13
`5600 Fishers Lane
`Rockville, MD 20857
`Attention: Claudia Grillo
`
`RE: NEXIUM® I.V.