Promoting generic drug availability: Reforming the Hatch-Waxman Act to prevent unnecessary delays to consumers

St. John's Law Review, Spring 2001 by Giles, Laura

31 Reid, supra note 2, at 309; see also Mylan Pharm., Inc. v. Shalala, 81 F. Supp. 2d 30, 32 (D.D.C. 2000); H.R. REP. No. 98-857, 98th Cong., 2d Sess., pt. 1, at 14, 15 (1984), reprinted in 1984 U.S.C.C.A.N. 2647, 2648.

32 Since the enactment of the Act, the generic drug industry's prescription drug market share has increased from nineteen percent in 1984 to forty-three percent in 1996. See Engelberg, supra note 21, at 389-90; Lewis, supra note 26, at 365-66; Stolberg & Gerth, supra note 1, at 15.

33 See Findlay, supra note 6, at 229. Some important aspects of the generic drug approval process include acquiring the active ingredient, developing a formulation, testing the product, and setting standards.

34 See 21 U.S.C. 355(j) (1994) (discussing the application and approval process for abbreviated new drug applications).

35 Id. 355(jX2)(Mi) (explaining that a listed drug has already been approved for safety and effectiveness).

36 Id 355(j)(2)(A)(ii).

37 See 21 U.S.C. 355()(2)(A)(iii) (1994) (stating that new drugs will be administered in the same manner with the same dosage and strength).

38 Id. 355()(2)(A)(iv). A drug is considered bio-equivalent under ANDA if: (i) the rate and extent of absorption of the drug do not show a significant difference from the rate and extent of absorption of the listed drug when administered at the same... dose ... ; or (ii) the extent of absorption of the drug does not show a significant difference from the extent of absorption of the listed drug when administered at the same. .. dose . . . and the difference from the listed drug in the rate of absorption of the drug is intentional....

Id. This is only a "safe harbor," and a company may prove bioequivalence in other ways. See Schering Corp. v. FDA, 51 F.3d 390, 399 (3d Cir. 1995) ("The mere fact that Congress made the establishment of bioequivalence mandatory in the Act does not evidence an intent to limit the established testing practices of the FDA."); Schering Corp. v. Sullivan, 782 F. Supp. 645, 648-49 (D.D.C. 1992) ("There is simply no indication that the enumerated showings are the exclusive means for establishing bioequivalence.").

39 21 U.S.C. 355(j)(2)(A)(vii). Patent infringement will be discussed in detail in Part LD. of this Note.

40 See Findlay, supra note 6, at 229. Legal battles that a generic company may face are discussed thoroughly in the next section of this Note.

41 See Molzon, supra note 27, at 277-78. The generic drug approval process can be conducted at a "fraction of the cost of a large clinical study" that the pioneer company must go through. Id.

42 See 21 U.S.C. 355(j)(4XB)(iv); see also Mylan Pharm., Inc, v. Shalala, 81 F. Supp. 2d 30, 32-33 (D.D.C. 2000) (discussing the 180-day exclusivity period).

43 21 U.S.C. 355(j)(5)(B)(iv). For a further discussion see John F. Resek, Comment, Biovail v. Hoechst Aktiengesellschaft, Inc.: An Analysis Under the Sherman Act and the Noerr-Pennington Doctrine, 10 FORDHAM INTELL. PROP. MEDIA & ENT. L.J. 571, 573 (2000).

44 On the day of the ruling against Eli Lilly in determining the patent period of Prozac. Eli Lilly's stock plunged thirty-one percent, a loss of more than $35 billion in market value. See Ruling Speeds Generic Process; Eli Lilly Shares Drop; Pharmaceutical Co. Loses $35 Billion in Market Value, DALLAS MORNING NEWS, Aug. 10, 2000, at 101). Analysts estimate that Eli Lilly will lose about $1 billion a year in revenue once the generic is available. See Sharon Bernstein, Ruling Could Help Speed Cheaper Generic Prozac; Pharmaceuticals: Eli Lilly is Stung by a Court Decision That Could Mean the Loss of $1 Billion of Revenue a Year, L.A. TIMES, Aug. 10, 2000, at Cl. "Three months after Naprosene (R) went off-patent, its manufacturer, Syntax, lost 75% of its market to the generic brand." Mossinghoff, supra note 7, at 191.