Patenting drug products: Anticipating Hatch-Waxman issues during the claims drafting process

Food and Drug Law Journal

Volumn 54, Issue 2, 1999, Pages 245-253

  Mahn, Terry G ^a  

^a Fish & Richardson PC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG; NEW DRUG; ORPHAN DRUG;

CONFERENCE PAPER; DRUG APPROVAL; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG MARKETING; FOOD AND DRUG ADMINISTRATION; LAW SUIT; PATENT;

EID: 0032775274     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (62)

1. Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (codified at 15 U.S.C. §§ 68b-68c, 70b (1994); 21 U.S.C. §§ 301 note, 355, 360cc (1994); 28 U.S.C. § 2201 (1994); 35 U.S.C. §§ 156, 271, 282 (1994)).
2. See 21 C.F.R. § 314.94(a)(12) (1998).
3. See 35 U.S.C. § 156.
4. See 21 U.S.C. § 355(c)(1).
5. "Drafting" is the act of preparing the written patent application filing, including the claims and specifications. "Prosecution" is the iterative process involving the PTO examiner and the drafter (and can include office appeals) required to arrive at an issuable patent.
6. 35 U.S.C. §§ 101, 102, 103 (Supp. IV 1998) (respectively).
7. 21 U.S.C. § 355(b)(1).
8. Id. § 355(b)(1)(F); 21 C.F.R. § 314.53.
9. Elyse Tanouye & Robert Langreth, Times Up: With Patents Expiring on Big Prescriptions, Drug Industry Quakes, WALL ST. J., Aug. 12, 1997, at A1.
10. See 21 U.S.C. § 355(c)(3)(D).
11. See H.R. REP. No. 857, pt. 1, 98th Cong., 2d Sess. 15 (1989).
12. 21 U.S.C. § 355(c)(3)(D).
13. 35 U.S.C. § 271.
14. Id. § 156(b).
15. Other limitations not listed are that the term must not have expired before an extension request; the maximum extension cannot exceed five years; and the remaining term plus extension may not exceed 14 years. See 35 U.S.C. § 156.
16. 35 U.S.C. § 156(a)(2).
17. Id. § 156(c)(4).
18. Id. § 156(a)(5).
19. Id. § 156(b).
20. See 21 C.F.R. § 314.94(a)(5)(I). There is some latitude in what FDA considers to be the "same" active ingredient. For instance, the drug Ranitidine hydrochloride exists in two crystalline forms; Glaxo Wellcome uses form two as the active ingredient in Zantac®, whereas various generic drug manufacturers have had abbreviated new drug applications (ANDAs) approved using form one. See also Food & Drug Admin., Policy Statement for the Development of New Stereoisomeric Drugs (May 1, 1992).
21. Although FDA considers the term active ingredient to mean "new active moiety" for the purpose of five-year marketing exclusivity, the courts have not agreed with this interpretation for the purpose of patent term extension. See Glaxo Operations UK Ltd. v. Quigg, 894 F.2d 392 (Fed. Cir. 1990).
22. 35 U.S.C. § 156(c)(4).
23. 35 U.S.C. § 156(b) limits extensions for product patents to the "use approved for the product" and for method of use patents to uses "claimed by the patent and approved for the product."
24. Id. § 121; 37 C.F.R. §§ 1.141, 1.142 (1998).
25. 37 C.F.R. §§ 1.141, 1.142.
26. U.S. DEP'T OF COMMERCE, PATENT & TRADEMARK OFFICE, MANUAL OF PATENT EXAMINING PROCEDURE § 803 (7th ed. 1997).
27. See 37 C.F.R. § 1.16.
28. An example of this situation is where a patented compound is found to be much more effective for its intended use when formulated with a controlled release patent. Here, the inactive ingredient patent (i.e., the controlled release) is the blocking patent to generic competition.
29. 109 F.3d 756 (Fed. Cir. 1997).
30. 60 Fed. Reg. 25,619 (May 12, 1995).
31. 35 U.S.C. § 156(d)(1).
32. 37 C.F.R. § 1.720(f).
33. See Fish & Richardson, P.C., Orphan Product Designation: Another Useful Tool to Preserve Marketing Exclusivity (visited Mar. 27, 1999) 〈www.fr.com/reg/intfiles/orproduct.html〉.
34. Id.
35. Pub. L. No. 97-414, 96 Stat. 2049 (1983) (codified at 21 U.S.C. §§ 360aa et seq.).
36. 21 U.S.C. § 355(c)(1).
37. Independent device claims in a patent claiming the drug or formulation, on the other hand, are probably not extendable, although there is little guidance from the PTO, FDA, or the courts on this issue.
38. 21 U.S.C. § 355(b)(1)(F); 21 C.F.R. § 314.53.
39. FOOD & DRUG ADMIN., CTR. FOR DRUG EVALUATION & RESEARCH, APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS (CCH 18th ed. 1998).
40. See 21 U.S.C. § 355(b)(2)(A); 21 C.F.R. § 314.50.
41. See id. § 355(j); 21 C.F.R. 314.94(a).
42. See 21 C.F.R. § 314.94(a)(12)(i)(A).
43. 21 U.S.C. § 355(j)(2)(A)(vii); 21 C.F.R. § 314.95(a).
44. 21 U.S.C. § 355(j)(4)(B)(iii); 21 C.F.R. § 314.95(f). By FDA and PTO practice, statutory notification can be accomplished by sending to any one of several addresses on file at each agency. If sent to a "listed address," an NDA holder's claim that notice was sent to the wrong address is not likely to prevail once the 45-day period has run.
45. 21 U.S.C. § 355(j); 21 C.F.R. § 314.95(f).
46. See 59 Fed. Reg. 50,338, 50,345 (Oct. 3, 1994).
47. Unlike the situations in the United States, Canadian law permits the Ministry of Health to audit Canada's "Orange Book" and remove ineligible patents from the list. But see Pfizer v. Food & Drug Admin., 753 F. Supp. 771 (D. Md. 1990) (where FDA rejected an Orange Book filing because the dosage described in the product was different than that of the referenced drug).
48. 21 C.F.R. § 314.53(b).
49. Id.
50. The term "active ingredient" is defined under FDA regulations to include: those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specific activity or effect A component does not have to be present in the final drug product. See Ben Venue Labs. v. Novartis Pharm. Corp., 10 F. Supp. 2d 446 (D.N.J. 1998). 21 C.F.R. § 210.3(b)(7). This definition appears to contemplate intermediate drug compounds provided they are "present" in the drug product.
51. Id. § 314.94(a)(12)(vii).
52. Id. § 314.94(a)(12).
53. Id. § 314.53(b).
54. Under 35 U.S.C. § 271(e)(2)(A), the submission of a generic application for a "drug" or use claimed in a patent is considered to be an act of infringement if a paragraph IV certification, described above, is included.
55. 753 F. Supp. 771 (D. Md. 1990).
56. The statutory definition of the term "drug" and its legislative history support a construction of the term to mean "drug product" including drug/device combinations. Before 1990, the term "drug" was defined in the statute as follows: The term "drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animal; and (D) articles intended for use as a component of any article specified in clauses (A), (B), and (C) of this paragraph; but does not include devices or their components, parts, or accessories. 21 U.S.C. § 321(g)(1) (1990) (emphasis added). The final clause was removed from the definition in the Safe Medical Devices Act of 1990 to "permit an approval of a drug/device combination" under an NDA. Pub. L. No. 101-629, § 16(b), 104 Stat. 4511, 4536. As a result, the definition of drug now implicitly includes devices as "articles intended for use as a component" of a drug. See 21 U.S.C. § 321(g)(1) (Supp. III 1997). Accordingly, patents listed in the Orange Book for an approved drug/device combination can be the subject of an action for infringement under 35 U.S.C. § 271(e)(2)(A).
57. 21 C.F.R. § 314.3(b).
58. See 35 U.S.C. §271 (e)(2).
59. Pub. L. No. 98-417, § 106, 98 Stat. 1597 (codified in 28 U.S.C. § 2201(b) (1997)).
60. 110 F.2d 1562 (Fed. Cir. 1997).
61. Id. at 1571.
62. 35 U.S.C. § 271(e)(2)(A) does not extend to the related claims, but a court would have jurisdiction to hear such claims under the Declaratory Judgment Act (see 28 U.S.C. § 2201) and other patent statutes (e.g., 35 U.S.C. § 271 (g)).