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A day late and a few million dollars short

Nature Biotechnology volume 27, pages 538–541 (2009)Cite this article

The pitfalls of seeking and obtaining a patent term extension.

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References

  1. Johnson & Johnson Fourth Quarter and Year End 2008 Earnings Meeting (Jan. 20, 2009) <http://files.shareholder.com/downloads/JNJ/531545955x0x264950/c2d48b4a-d107-48ee-b793-0f17ab5033ae/4Q08_WCWeldon_V10_Web.pdf

  2. Pfizer Reports Fourth-Quarter And Full-Year 2008 Results And 2009 Financial Guidance (Jan. 26, 2009) <http://media.pfizer.com/files/investors/presentations/q4performance_january012609.pdf>

  3. AstraZeneca PLC Fourth Quarter and Full Year Results 2008 (Jan. 29, 2009) <http://www.astrazeneca.com/_mshost3690701/content/resources/media/investors/AZN-Q4-2008/q4-results-2008-figures.pdf>

  4. 35 USC §271.

  5. 35 USC §156; 21 CFR §60; Drug Price Competition and Patent Term Restoration Act of 1984, tit. II, Pub. L. No. 98–417, 98 Stat. 1585, 1598 (1984) (as amended Dec. 8, 2003).

  6. 21 USC 355(b).

  7. Electronic Orange Book (FDA, Washington, DC;). <http://www.fda.gov/cder/ob>

  8. 21 USC §355(j); 21 USC §355(b)(2)

  9. 35 USC §156(d)(1).

  10. Online date calculators follow this convention as well. See, e.g. Date Calculator <http://www.timeanddate.com/date/dateadd.html>

  11. USPTO Patent Application Information Retrieval (PAIR) database. <http://portal.uspto.gov/external/portal/pair>

  12. A PTE applicant must identify the filing deadline in its application. 37 CFR §1.740(a)(5).

  13. Manual of Patent Examining Procedure §2753 (July 2008 revision).

  14. See Application Pursuant to 35 USC §156(d)(1) and 37 CFR §1.740 For Extension of Patent Term for US Patent No. 5,196,404. <http://portal.uspto.gov/external/portal/pair>. This PTE applicant apparently read the statute as reciting a two-month deadline based on its identificaiton of February 15, 2001 as the sixtieth day.

  15. Letter from USPTO to FDA for US Patent No. 5,196,404 (Mar. 2, 2001) Notice of Final Determination (Nov. 20, 2001). <http://portal.uspto.gov/external/portal/pair>

  16. Decision Denying Application for Patent Term Extension for US Patent No. 5,196,404 at p. 7, n. 3 (Apr. 26, 2007). <http://portal.uspto.gov/external/portal/pair>

  17. 888 F.2d 826 (Fed. Cir. 1989).

  18. HR 5120, 109th Cong. (2006).

  19. HR 6344, 110th Cong. §4(a)(1) (as passed by House of Representatives, June 23, 2008).

  20. Id. at §4(b)(2)(B)

  21. Cong. Rec. H5811–H5816 (daily ed. Jun. 23, 2008) (statement of Rep. Conyers).

  22. See Application for Extension of the Term of US Patent No. 4,861,779 Under 35 USC §156 (Nov.19, 2002). <http://portal.uspto.gov/external/portal/pair>

  23. Letter from FDA to USPTO [re: US Patent No. 4,861,779] (Jul. 16, 2003). <http://portal.uspto.gov/external/portal/pair>

  24. Order to Show Cause [re: US Patent No. 4,861,779] (April 4, 2008). <http://portal.uspto.gov/external/portal/pair>

  25. See Application for Extension of Patent Term Under 35 USC §156 [re: U.S. Patent No. 5,817,338] (Aug. 19, 2003). <http://portal.uspto.gov/external/portal/pair>. This PTE application was also rejected on other grounds.

  26. Letter from FDA to USPTO [re: US Patent No. 5,817,338] (Oct. 19, 2004). <http://portal.uspto.gov/external/portal/pair>

  27. Letter from USPTO to FDA [re: US Patent No. 5,817,338] (Apr. 1, 2008). <http://portal.uspto.gov/external/portal/pair>

  28. Letter from FDA to USPTO [re: US Patent No. 5,817,338] (Oct. 21, 2008). <http://portal.uspto.gov/external/portal/pair>

  29. Petition to the Director (37 CFR §1.181) [re: US Patent No. 5,817,338] (May 30, 2008). <http://portal.uspto.gov/external/portal/pair>

  30. Denial of Patent Term Extension Application [re: US Patent No. 5,817,338] (Dec. 16, 2008). <http://portal.uspto.gov/external/portal/pair>

  31. See Application for Extension of Patent Term Under 35 USC §156 [re: U.S. Patent No. 5,674,860] (Sept. 19, 2003). <http://portal.uspto.gov/external/portal/pair>. This PTE application was also rejected on other grounds.

  32. Letter from FDA to USPTO [re: US Patent No. 5,674,860] (Dec. 6, 2007). <http://portal.uspto.gov/external/portal/pair>

  33. Notice of Final Determination – Ineligible [re: US Patent No. 5,674,860] (Jun. 13, 2008). <http://portal.uspto.gov/external/portal/pair>

  34. Id. at p. 5.

  35. Request for Reconsideration of Final Determination [re: U.S. Patent No. 5,674,860] (Dec. 16, 2008). <http://portal.uspto.gov/external/portal/pair>

  36. Cf. In re Buspirone Antitrust Litigation, 185 F. Supp. 2d. 340 (improperly listing a patent in the Orange Book associated with potential antitrust liability).

  37. 35 USC §156(c)(1).

  38. 37 CFR §1.775(c).

  39. 35 USC §282.

  40. 37 CFR §1.765(a).

  41. MPEP §2753; 35 USC §156(d)(2)(B).

  42. 35 USC §282.

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  1. Dianna Goldenson is at Darby & Darby, New York, New York, USA. The views expressed in this article are those of the author and do not reflect those of Darby & Darby or any of its clients. dgoldenson@darbylaw.com,

    Dianna Goldenson

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D.G. is employed by Darby & Darby, an intellectual property law firm that represents various pharmaceutical companies that make generic and branded drugs.

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Goldenson, D. A day late and a few million dollars short. Nat Biotechnol 27, 538–541 (2009). https://doi.org/10.1038/nbt0609-538

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