Merck & Co. v. Kessler

80 F.3d 1543, 38 U.S.P.Q. 2d (BNA) 1347, 1996 U.S. App. LEXIS 6296
CourtCourt of Appeals for the Federal Circuit
DecidedApril 4, 1996
DocketNos. 96-1068, 96-1105 and 96-1107
StatusPublished
Cited by55 cases

This text of 80 F.3d 1543 (Merck & Co. v. Kessler) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Merck & Co. v. Kessler, 80 F.3d 1543, 38 U.S.P.Q. 2d (BNA) 1347, 1996 U.S. App. LEXIS 6296 (Fed. Cir. 1996).

Opinion

NIES, Senior Circuit Judge.

These appeals raise the question of whether there are limitations to the application of a patent restoration extension, granted pursuant to the Hatch-Waxman Act (35 U.S.C. § 156), to the term of the patent calculated as 20 years from fifing under the Uruguay Round Agreements Act (URAA) (35 U.S.C. § 154). The district court held that all patents in force on June 8, 1995, including patents in force only because of a Hatch-Wax-man extension, were entitled to add the time of the Hatch-Waxman extension to the new term afforded by the URAA. We affirm-in-part and reverse-in-part.

I.

Two statutes are at issue in this case. The Drug, Price Competition and Patent Term Restoration Act, codified in part at 35 U.S.C. § 1561, (also known as the Hatch-Waxman Act), provides generally for a limited extension of the term of a patent, inter alia, for a drug as to which marketing was held up during the patent term by the process of obtaining Food and Drag Administration (FDA) approval (hereinafter “restoration extension”). Each of the drug patents in suit received a two-year RESTORATION extension at a time when the term of the patent was 17 years from date of issuance. The second statute is the URAA, 35 U.S.C. § 154 (1995), which provides an alternative calculation of the term for patents in force on June 8,1995, namely, 20 years from fifing of the patent application. For patents that were prosecuted to issuance in less than three years, URAA effects an extension of its term, that is, the difference between 17 years from issuance and 20 years from filing. Each of the patents in suit was in force on June 8, 1995.

The first of these statutes, the HatchWaxman Act, which passed in 1984, eliminated the pre-1984 requirement that a company seeking to market a generic version of a patented drug had to conduct its own testing program. Instead, the Hatch-Waxman Act permits the generic producer of the fully tested drag to rely on the safety and efficacy data of a prior applicant, frequently the holder of a patent on the product. 21 U.S.C. § 355<j)(7)(B); H.R.Rep. No. 857, 98th Cong.2d Sess. Pt. 1, at 16-17 (1984). Thus, the marketing of generic versions of an FDA-approved drug is expedited. In ex[1547]*1547change, the Hatch-Waxman Act provides the holders of patents on approved patented products with an extended term of protection under the patent to compensate for the delay in obtaining FDA approval. This restoration period does not recover the full time lost from the patent term due to FDA’s premark-et approval process but merely “ameliorates the loss incurred when patent terms tick away while the patented product is awaiting [FDA’s] regulatory approval for marketing.” Unimed, Inc. v. Quigg, 888 F.2d 826, 829, 12 USPQ2d 1644, 1647 (Fed.Cir.1989). Regardless of the time so lost, if a patent was issued and testing began before the 1984 enactment of the Hatch-Waxman Act, the total extension period may not exceed two years, 35 U.S.C. § 156(g)(6)(C); otherwise the restoration period is limited to no more than five years. Id. at § 156(g)(6)(B). Further, the effective patent term including the restoration period may not exceed 14 years following FDA approval of the new drug. Id. at § 156(c)(3).

Another overall limitation is that the term of the patent may be given only one RESTORATION extension. Id. at § 156(a)(2). If the term of the patent has received such an extension, the patent may not be given another restoration extension even for another drug covered by the patent whose marketing also is delayed by reasons of FDA procedures. Finally, the restoration period of the patent does not extend to all products protected by the patent but only to the product on which the extension was based. Id. at § 156(b)(1). A restoration extension is made known to the public by the issuance of a certificate by the PTO stating the number of days that the term is extended. Id. at § 156(e)(1); 37 C.F.R. § 1.780.

The FDA has major administrative responsibilities under the Hatch-Waxman Act. A generic drug manufacturer is not guilty of infringement by filing an application for approval of marketing (an ANDA) if the generic company does not seek approval to engage in the commercial manufacture, use, or sale of the drug before the expiration of the patent. On the other hand, a patent owner is entitled to notice, and it is an act of infringement for purposes of a declaratory judgment action, for a generic manufacturer to file an ANDA for use prior to the patent expiration date on the basis of alleged invalidity or noninfringement of the patent. The statute requires the FDA to publish the expiration date, and a patent owner must be given notice by the applicant of an ANDA seeking use before the expiration of the patent.2

The second statute, the URAA, was enacted in 1994. The purpose of the URAA was not to extend patent terms, although it has that effect in some cases, but to harmonize the term provision of United States patent law with that of our leading trading partners which grant a patent term of 20 years from the date of filing of the patent application. Prior to June 8, 1995, U.S. patents had an expiration date under 35 U.S.C. § 154 measured as 17 years from the date the patent issued, except where terminal disclaimers were filed. Amended section 154(a) now reads:

Subject to the payment of fees under this title, such grant shall be for a term beginning on the date on which the patent issues and ending 20 years from the date on which the application for the patent was filed in the United States or, if the application contains a specific reference to an earlier filed application or applications under section 120, 121, or 365(c) of this title, from the date on which the earliest such application was filed.

35 U.S.C. § 154(a)(2) (1994).

For certain patents which were issued and for pending applications which were filed pri- or to June 8, 1995, a transitional provision preserves a guaranteed 17-year term, if it is longer than 20 years from filing, by the following provision:

The term of a patent that is in force on or that results from an application filed before the date that is 6 months after the date of the enactment of the Uruguay [1548]*1548Round Agreements Act shall be the greater of the 20-year term as provided in subsection (1), or 17 years from grant, subject to any terminal disclaimers.

Id. at § 154(c)(1).

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Cite This Page — Counsel Stack

Bluebook (online)
80 F.3d 1543, 38 U.S.P.Q. 2d (BNA) 1347, 1996 U.S. App. LEXIS 6296, Counsel Stack Legal Research, https://law.counselstack.com/opinion/merck-co-v-kessler-cafc-1996.