[202] Commonly known as the Hatch-Waxman Amendments.

[203] 733 F.2d 858, 221 USPQ 937.

[204] “Congress’ efforts to balance two conflicting policy objectives: to induce brand name pharmaceutical firms to make the investments necessary to research and develop new drug products, while simultaneously enabling competitors to bring cheaper generic copies of those drugs to market” after the patents on them expired - Edwards J. in Abbott Labs v. Young, 920 F.2d 984 (D.C. Cir. 1990).

[205] 35 USC § 271(e)(1).

[206] 35 USC § 271(e). A complication in the procedure was introduced by the extension of the patent term by the Uruguay Round Amendments Act that extended the term of U.S. patents having regard to the question of how to deal with extended patents but limited the remedies for acts carried out during the extended period (mainly to confine the remedies that could be awarded against those who had made substantial investment preparatory to introducing a product after the previously expected expiration date to the award of equitable remuneration to the patentee during the extended period. In DuPont Merck Pharmaceutical Co v. Bristol-Myers Squibb Co., 62 F.3d 1397, 35 USPQ2d 1718 (1995), the Federal Circuit held that the limitation on remedies under the Uruguay Round Amendment Act did not alter the fact that sale of the drug during the extended period would still be an infringement and so the necessary certification was required.

[207] 21 USC § 355(b)(1) and 21 CFR 314.53(c)(2).

[208] Mylan Pharmaceuticals v. Thompson, 60 USPQ2d 1576 (Fed. Cir. 2001).

[209] 21 CFR 314.94(a)(12)(vi).

[210] 21 USC § 355(j)(2)(B)(i).

[211] Eli Lilly and Co. v. Zenith Goldline Pharmaceuticals Inc., 58 USPQ2d 1543 (D. In. 2001).

[212] 21 USC § 355(j)(5)(B)(iv).

[213] Mylan Pharmaceuticals Inc. v. Shalala, 52 USPQ2d 1449 (D. D.C. 2000).

[214] See, for example, actions against Hoechst Marion Roussel, Geneva Pharmaceuticals and Abbott Laboratories CCH Trade Regulation Reporter ¶24, 709. Similar issues arose in In re Cardizem CD Antitrust Litigation, 105 F.Supp. 2d 682 (E.D. Mich. 2000) and In re Terazosin Hydrochloride Antitrust Litig., 2000 U.S. Dist. LEXIS 20477 (S.D. Fla. 2000).

[215] Eli Lilly and Company v. Medtronics, Inc., 496 U.S. 661, 15 USPQ2d 1121 (1990).

[216] 35 USC § 287(c)(1). This amendment was enacted in response to the outcry that ensued when a surgeon who had obtained a patent for “no stitch” cataract surgery tried to license the procedure for $4 per operation. As originally enacted, this amendment does not apply to any patent issued before September 30, 1996. The 1999 reforms amended this so that the provisions now apply only to patents granted on applications having their earliest effective filing date on or after September 30, 1996.