Fixing the legal framework for pharmaceutical research

Science

Volumn 327, Issue 5969, 2010, Pages 1083-1084

  Knowles, Sherry M ^a  

^a GLAXOSMITHKLINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG DEVELOPMENT; INDUSTRIAL INVESTMENT; INDUSTRIAL REGULATION; INNOVATION; PHARMACEUTICAL INDUSTRY; RESEARCH AND DEVELOPMENT; RESEARCH PROGRAM;

CLINICAL RESEARCH; COURT; DECISION MAKING; DRUG INDUSTRY; ENVIRONMENT; FOOD AND DRUG ADMINISTRATION; INVESTMENT; LAW; PRIORITY JOURNAL; SHORT SURVEY; THEORY; ARTICLE; DRUG APPROVAL; LEGAL ASPECT; MEDICAL RESEARCH; PATENT; UNITED STATES;

DRUG; GENERIC DRUG;

BIOMEDICAL RESEARCH; DRUG APPROVAL; DRUG INDUSTRY; DRUGS, GENERIC; INTELLECTUAL PROPERTY; PATENTS AS TOPIC; PHARMACEUTICAL PREPARATIONS; UNITED STATES;

EID: 77649229487     PISSN: 00368075     EISSN: 10959203     Source Type: Journal    
DOI: 10.1126/science.1184188     Document Type: Short Survey

References (43)

1. J., A. DiMasi, H. G. Grabowski, Manag. Decis. Econ. 28, 469 (2007).
2. J. A. DiMasi, Pharmacoeconomics 20 (Suppl 3), 1 (2002).
3. J. A. DiMasi, R. W. Hansen, H. G. Grabowski, J. Health Econ. 22, 151 (2003).
4. J. A. DiMasi, R. W. Hansen, H. G. Grabowski, L. Lasagna, J. Health Econ. 10, 107 (1991).
5. The Drug Price Competition and Patent Term Restoration Act of 1984, 21 U.S. Code (U.S.C.) § 355.
6. U.S.C. S 355§(C)(3)(E)(ii).
7. This 5-year term is often referred to as a "data exclusivity period" but may be considered a forced data-sharing requirement.
8. M. J. Higgins, S. J. Graham, Science 326, 370 (2009).
9. If a generic company files an abbreviated new drug application during the 5-year period and certifies that a listed innovator patent is invalid or not infringed, the FDA will stay approval of the generic drug for 30 months during patent litigation, up to a cap of 7.5 years. See (32).
10. The cost to generic companies of demonstrating bioequivalence typically pales in comparison to the cost to innovator companies of collecting preclinical and clinical safety and efficacy data.
11. U.S. Const, amend. V.
12. In Ruckelshaus v. Monsanto Company (33), the U.S. Supreme Court held that a federal law that allows companies to rely on innovator pesticide data to get approval for a generic version 10 years after first approval is not a taking of property, as Monsanto was aware of the law when it submitted its innovator data for pesticide approval. However, in the post-Monsanto case of Palazollo v. Rhode Island (34), the Supreme Court held that takings claims cannot be defeated merely because the legislature has amended a statute to give prospective notice of some new limitation on property. Hence, HatchWaxman is not insulated from takings claims involving patents issued after that statute was passed, and the economic impact of the outdated law supports compensation.
13. Contents and term of patent; provisional rights, 35 U.S.C. §154.
14. As one example, U.S. Patent No. 6, 637, 447 covering the "Beerella" an umbrella that snaps onto a beer bottle has 18 years of useful patent life, whereas U.S. Patent No. 6, 713, 485 on a metastatic breast cancer therapy has 13.5 years of useful life.
15. If a court makes a ruling prospective only, it appears to cross the line into the policy-making function reserved for the political branches. See (35).
16. KSR Inn Co. v. Teleflex, Inc., 550 U.S. 398 (2007).
17. Amgen v. Chugai Pharmaceuticals Co., 927 F. 2d 1200, 1208-1209 (Fed. Cir.), cert, denied 502 U.S. 856 (1999).
18. In so holding, the Supreme Court overruled the prior "teaching, suggesting, motivation" test for obviousness that required that a reference itself contain the motivation to combine it with a second reference (36).
19. In the mid-1990s, the CAFC issued the landmark decisions of In re Deuel (37), and Regents of the Univ. of Cal. v. Eli Lilly & Co. (38). Deuel ruled that "knowledge of a protein does not give one a conception of a particular DNA encoding it." In the Lilly case, the court held that one cannot obtain a patent on cDNA simply by providing a probe and explaining how to use the probe to isolate cDNA, even if the protein encoded by the cDNA is known. Rather, the applicant must disclose the sequence of the DNA to get a claim to the DNA. Years later, the CAFC was compelled to overrule Deuel because the Supreme Court referred to that case with disfavor in its 2007 KSR opinion (16). The court held that a gene was not patentable to Amgen because its protein was known, even though the patent application was filed only 3 years after the Deuel decision. See (39).
20. -545 F.3d 943 (Fed. Cir 2008); cert granted 556 U.S. 1 (1 June 2009).
21. The oral argument was heard 9 November 2009, with a written decision expected soon.
22. -35 U.S.C. §101.
23. Bilski pertains to a method for hedging risk in commodity trading. The decision being appealed holds that an innovation is patentable only if it involves a "machine or transformation."
24. -35 U.S.C. §112.
25. Ariad Pharms., Inc. v. Eli Lilly & Co., 560 F.3d 1366 (Fed. Cir. 2009);
26. U.S. Patent No. 6, 410, 516 (filed 5 June 1995);
27. Ariad Pharms.. Inc. v. EIi Lilly & Co., No. 2008-11248, 2009 WL 2573004 (Fed. Gr. 21 August 2009).
28. CAFC heard full-court oral argument in Ariad v. Lilly on 7 December 2009, with a decision due shortly. See also (40).
29. Consolidated Fruit-Jar Co. v. Wright, 84 U.S. 92, 96 (1876).
30. Patlex Corp. v. Mossinghoff, 758 F.2d 594, 599 (Fed. Cir. 1985).
31. J. N. Bunch, Tex. Law Rev. 83, 1747 (2005).
32. D. R. Cahoy, Am. Bus. Law. J. 41, 1 (2003).
33. The current congressional debate about whether to impose a data exclusivity requirement for follow on biologics focuses on 12 to 14.5 years. S. 1695 and H. 1548.
34. -21 U.S.C. §355 (j)(5)(B)(iii)
35. Ruckelshaus v. Monsanto Company, 467 U.S. 986; 1005 (1984) [citing (41)].
36. Palazollo v. Rhode Island, 533 U.S. 606, 626-630 (2001).
37. Harper v. Va. Dep't of Taxation, 509 U.S. 86, 97(1993).
38. In re Grabiak, 769 F. 2d 729 (Fed. Cir. 1985).
39. In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995).
40. Regents of the Univ. of Cal. v. Eli Lillys, Co., 119 F.3d 1559 (Fed. Cir. 1997).
41. In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009).
42. Brief for Glaxo Smith Kline as Amicus Curiae Supporting Defendant-Appellant Eli Lilly & Company, No.2008-1248 (Fed. Cir. 19 November 2009) (en banc).
43. PruneYard Shopping Ctr. v. Robins, 447 U.S. 74, 83 (1980).