Westwood Pharmaceuticals, Inc. v. Quigg, Not Reported in F.Supp. (1989) 13 U.S.P.Q.

2d 2067

1989 WL 205631 United States District Court, District of Columbia. WESTWOOD PHARMACEUTICALS, INC. Plaintiff, v. Donald J. QUIGG, Commissioner of Patents and Trademarks Defendant. Civ.A. No. 882198. | Nov. 30, 1989. Attorneys and Law Firms Charles E. Van Horn, Fred E. McKelvey, Patent & Trademark Office, Office of the Solicitor, Arlington, Va., for defendant. Peter R. Mathers, Daniel R. Dwyer, Kleinfeld, Kaplan & Becker, Washington, D.C., for plaintiff. Opinion

LacHydrin a prescription drug product having lactic acid as its active ingredient.5 LacHydrin was subject to regulatory review under section 505 of the Federal Food, Drug and Cosmetic Act (FFDCA) as amended.6 In November 1983, Westwood submitted a New Drug Application (NDA) to the FDA pursuant to 21 U.S.C. 355(b). LacHydrin received permission for commercial marketing on April 24, 1985. It was approved for use in the treatment of dry, scaly skin and ichthyosis vulgaris and for the temporary relief of itching associated with such conditions. The period of time during which the FDA reviewed Westwoods NDA is referred to as the regulatory review period. 35 U.S.C. 156(g)(1). In June 1985, Westwood, the authorized agent of the patent owner, filed an application with the PTO for an extension of the term of U.S. Patent 4,105,783 (LacHydrin). The PTO denied Westwoods application for extension on the ground that the drug product LacHydrin was ineligible for extension under 35 U.S.C. 156 because this product was not the first permitted commercial marketing or use of lactic acid under the provision of law (21 U.S.C. 355) under which the regulatory review period occurred. In response, Westwood initiated this action seeking judicial review of the Commissioners decision denying its application for a patent term extension. Because these background facts are not in dispute7 and the sole question is one of statutory interpretation, this case is appropriate for summary judgment pursuant to Fed. R. Civ. Pr. 56.

MEMORANDUM OPINION SPORKIN, District Judge. *1 This case is before the Court on cross motions for summary judgment. Plaintiff in this action is seeking declaratory and injunctive relief.1 Plaintiff is the authorized agent of the holder of a patent covering the use of an FDA-approved drug product, LacHydrin and challenges the denial of its application for a patent term extension2 pursuant to the Drug Price Competition and Patent Restoration Act of 1984 (the Act).3 Title II of the Act, 35 U.S.C. 156 (Supp. II 1984), permits extensions of the patent term for certain drugs subject to the Food and Drug Administrations (FDA) rigorous drug approval procedures. At issue is the proper interpretation of 35 U.S.C. 156(a)(5)(A). Westwood Pharmaceuticals, Inc. (Westwood) contends that the Patent and Trademark Offices (PTO) interpretation is contrary to law. This Court disagrees and affirms the decision of the PTO, granting summary judgment in its favor.

I. BACKGROUND On August 8, 1978, BristolMyers Company was granted U.S. Patent 4,105,783.4 This patent claims the use of

II. DISCUSSION Title II of the Drug Price Competition and Patent Term Restoration Act of 1984 allows for an extension of patent terms for patents that cover human drugs and other products. 35 U.S.C. 156(a). Under this statutory provision, the term of a patent which claims a product, a method of using a product, or a method of manufacturing a product can be extended beyond its originally scheduled expiration date if certain criteria are met. Among the express statutory conditions for granting an extension for patented products that have been subject to FDA regulatory review is that permission for the commercial marketing or use of the product after such regulatory review period [must be] the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred. 35 U.S.C. 156(a)(5)(A). The issue in this case is the proper interpretation of the phrase under which such regulatory review period occurred.

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Westwood Pharmaceuticals, Inc. v. Quigg, Not Reported in F.Supp. (1989) 13 U.S.P.Q.2d 2067

*2 Since 1938, Section 505 of the FFDCA has been the applicable provision of law under which drug products such as LacHydrin have been and continue to be approved. This section of the FFDCA was substantially changed by the Drug Amendments of 1962.8 Westwood argues that the unique standards established by the post1962 version of 505 render it a different provision of law, within the meaning of 156(a)(5)(A), than the pre1962 version. Westwood contends, therefore, that because the approval of LacHydrin was the first approval of a lactic acid product under the effectiveness standards imposed in accordance with the 1962 amendments that it is also the first permitted commercial marketing or use of the product under the provision of law under which [its] regulatory review period occurred. 35 U.S.C. 156(a)(5)(A). Westwood agrees, however, that if lactic acid products had been evaluated for effectiveness by the FDA and approved under post1962 law then the approval granted Westwood to market LacHydrin would not be the first approval under the post1962 version of 505 of the FFDCA. In denying Westwoods application for a patent term extension, the PTO relied on FDA findings that approval of Westwoods NDA did not represent the first permitted commercial marketing or use of the active ingredient, lactic acid, under 505 of the FFDCA and that the FDA had previously approved NDAs for drugs which contain lactic acid, or a salt or ester of lactic acid, as an active ingredient. PTO Decision, at 23. Eight drug products containing lactic acid were the subject of NDAs that had obtained FDA approval pursuant to Section 505 of the FFDCA prior to April 24, 1985. These drug products received approval for commercial marketing prior to the 1962 amendments to the FFDCA and they were not subject to the effectiveness testing required under the 1962 amendments. Id. at 4. In reviewing Westwoods extension application, the Commissioner concluded that the applicable provision of law under which the regulatory review period occurred was Section 505 of FFDCA, 21 U.S.C. 355. Despite the changes in the statute which were brought about by the 1962 Amendments, it was the commissioners view that Section 505 continues to be the provision under which FDA review takes place. Moreover, any differences in the statutory requirements did not affect whether a product approved for commercial marketing or use by the FDA prior to the 1962 Amendments was to be considered approved under the statute as amended. In fact, any approvals obtained prior to the 1962 Amendments are considered to be approved within the meaning of 505 as amended.9

The Commissioner determined, therefore, that, even if the phrase provision of law used in 156(a)(5)(A) were interpreted as being limited to the post1962 version of 505, the FDA approval of LacHydrin did not represent the first permitted commercial marketing or use of the product10 under the provision of law under which the regulatory review period occurred. Having reached this conclusion, the Commissioner denied Westwoods application for a patent term extension because it failed to meet the requirements of 156(a)(5)(A). *3 The construction of a statute by those charged with its execution should be followed unless there are compelling indications that it is wrong. Red Lion Broadcasting Co. v. FCC, 395 U.S. 367, 381 (1969); see also Federal Election Commission v. Democratic Senatorial Campaign Committee, 459 U.S. 27 (1981) (finding that an agencys construction of a statute it is charged with enforcing is entitled to deference if it is reasonable and not in conflict with the expressed intent of Congress). The Commissioners interpretation of 156(a)(5)(A) is consistent with the statutory language and with the legislative history associated with this provision. The Commissioners decision should be treated with great deference by a reviewing court. Because the Commissioners decision is consistent with the statutory language and it is not arbitrary or capricious nor contrary to law, Camp v. Pitts, 411 U.S. 138 (1973), this Court will not disturb it.11 An appropriate Order accompanies this opinion.

ORDER Upon consideration of plaintiffs and defendants cross-motions for Summary Judgment, the oppositions thereto, the arguments of counsel, and in accordance with the Courts opinion of this date, it is this 30th day of November 1989 hereby ORDERED that plaintiffs motion for summary judgment is denied; it is FURTHER ORDERED that the defendants motion for summary judgment is granted.

Parallel Citations 13 U.S.P.Q.2d 2067

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Westwood Pharmaceuticals, Inc. v. Quigg, Not Reported in F.Supp. (1989) 13 U.S.P.Q.2d 2067

Footnotes
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Plaintiff, Westwood Pharmaceuticals, is a wholly owned subsidiary of BristolMyers Company having its principal place of business in Buffalo, New York and is the exclusive licensee under U.S. Patent 4,105,783 and authorized agent of the patent owner of record. Defendant, Donald J. Quigg, is named in his official capacity as Commissioner of Patents and Trademarks, Department of Commerce. He is referred to throughout as Commissioner. The Court finds, and the parties concur, that subject matter jurisdiction exists pursuant to 28 U.S.C. 1331 (federal question), 1338(a) (relating to patents) and 1361 (mandamus). The relief sought is authorized by 28 U.S.C. 2201 et seq. (declaratory judgment) and 5 U.S.C. 701 et seq. (Administrative Procedure Act). The parties do not dispute that there exists a justiciable controversy between them and that venue is proper in this Court pursuant to 28 U.S.C. 1391(e). See In re Westwood Pharmaceuticals, Docket No. 85E0310 (June 9, 1988) (PTO Decision). The Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. No. 98417, 98 Stat. 1585 (1984), is codified at 35 U.S.C. 156 and provides for patent term extensions in specified cases involving patents related to drug products that must undergo regulatory review by the FDA to be approved for commercial marketing or use in the United States. The protections afforded by the patent are scheduled to expire on May 3, 1994. Although Westwood refers to the active ingredient of its product as ammonium lactate, a salt of lactic acid, Westwood does not dispute the PTOs characterization of lactic acid as an active ingredient of LacHydrin. Plaintiffs Reply Memorandum to Defendants Opposition to Plaintiffs Motion for Summary Judgment, at 2. 21 U.S.C. 355 (1972). There is no genuine issue of as to the material facts in this case. The PTO agreed with Westwoods Statement of Material Facts dated December 7, 1988 with the exception of Westwoods characterization of the active ingredient of the product as ammonium lactate, a salt of lactic acid. Westwood has acquiesced in the PTOs characterization of the active ingredient as lactic acid. See supra note 5. Pub.L. No. 87781, 76 Stat. 780 (October 1962). The Drug Amendments of 1962 modified the FFDCA to require, for the first time, a showing of effectiveness as a precondition for approval of a drug product for commercial marketing. Section 107(c)(2) of the Drug Amendments of 1962 provides: An application filed pursuant to Section 505(b) of the basic Act which was effective within the meaning of that Act on the date immediately preceding the enactment date shall be deemed, as of the enactment date, to be an application approved by the Secretary within the meaning of the basic Act as amended by this Act. Westwood has argued that the approval of LacHydrin under the post1962 provisions of the FFDCA represents the first approval of a new use of the product. This argument is no longer valid because of the determination that product under 35 U.S.C. 156(a)(5) refers to the patented drugs active ingredient and not to the patented drug itself, whether or not it contained previously patented ingredients. Fisons v. Quigg, 8 U.S.P.Q.2d 1491 (D.D.C.1988), affd Fisons v. Quigg, 876 F.2d 99 (Fed. Cir.1989) (agreeing that the new use for which a patent extension is sought must be the first permitted marketing or use of a particular active ingredient, rather than merely the first permitted commercial marketing or use of a particular drug product). While the Court believes that this result is compelled by the present state of the record, this may well be an area that Congress may wish to clarify when it next has the occasion to address this subject.

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