The promise and perils of strategic publication to create prior art: A response to professor Parchomovsky

Michigan Law Review

Volumn 98, Issue 7, 2000, Pages 2358-2370

  Eisenberg, Rebecca S ^a  

^a NONE

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EID: 0346966898     PISSN: 00262234     EISSN: None     Source Type: Journal    
DOI: 10.2307/1290308     Document Type: Article

References (64)

1. Gideon Parchomovsky, Publish or Perish, 98 MICH. L. REV. 926 (2000).
2. 35 U.S.C. §§ 102-103 (1994 and Supp. 1999).
3. 35 U.S.C. § 102(a) bars issuance of a patent if "the invention was . . . described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent." 35 U.S.C. § 102(b) bars issuance of a patent if "the invention was . . . described in a printed publication in this or a foreign country . . . more than one year prior to the date of the application for patent in the United States."
4. 35 U.S.C. § 102(a) bars issuance of a patent if "the invention was . . . described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent." 35 U.S.C. § 102(b) bars issuance of a patent if "the invention was . . . described in a printed publication in this or a foreign country . . . more than one year prior to the date of the application for patent in the United States."
5. Parchomovsky, supra note 1, at 929.
6. Three subsections of 35 U.S.C. § 102 - §§ 102(a), (e), and (g) - define prior art as of the applicant's invention date. This focus on invention date as the moment for measuring prior art is consistent with a unique feature of the U.S. patent system: the allocation of patent priority to the first person to make an invention (rather than the first to file a patent application - the person who would prevail in most patent systems in the world).
7. Subsection (b) of 35 U.S.C. § 102 defines prior art as of one year prior to the application filing date. This provision has the effect of barring the issuance of a patent to a first inventor who waits too long to get a patent application on file after public disclosure or use of the technology.
8. See 35 U.S.C. §§ 102(a), 103.
9. The procedural device for getting around the reference is known as a "Rule 131 affidavit." See 37 C.F.R. § 1.131 (1999). Rule 131 permits a patent applicant to overcome a patent or printed publication cited as prior art by proving completion of the invention prior to the effective date of the reference.
10. See In re Stryker, 435 F.2d 1340 (C.C.P.A. 1971); In re Stempel, 241 F.2d 755 (C.C.P.A. 1957)
11. See In re Stryker, 435 F.2d 1340 (C.C.P.A. 1971); In re Stempel, 241 F.2d 755 (C.C.P.A. 1957)
12. . 10. If the date of the reference is more than one year prior to the patent applicant's own filing date, the applicant may not use a Rule 131 affidavit to swear behind the reference, see 37 C.F.R. § 1.131(a)(1), and the reference will be available as prior art under 35 U.S.C. § 102(b) (1994 and Supp. 1999).
13. . 10. If the date of the reference is more than one year prior to the patent applicant's own filing date, the applicant may not use a Rule 131 affidavit to swear behind the reference, see 37 C.F.R. § 1.131(a)(1), and the reference will be available as prior art under 35 U.S.C. § 102(b) (1994 and Supp. 1999).
14. See In re Application of Foster, 343 F.2d 980 (C.C.P.A. 1965).
15. 35 U.S.C. § 103.
16. Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538-39 (Fed. Cir. 1983).
17. See 35 U.S.C. § 112 (1994 and Supp. 1999); Gould v. Hellwarth, 472 F.2d 1383 (C.C.P.A. 1973).
18. See 35 U.S.C. § 112 (1994 and Supp. 1999); Gould v. Hellwarth, 472 F.2d 1383 (C.C.P.A. 1973).
19. See Gould v. Schawlow, 363 F.2d 908 (C.C.P.A. 1966).
20. See Seymour v. Osborne, 78 U.S. (11 Wall.) 516 (1870); Rockwell Int'l v. United States, 147 F.3d 1358 (Fed. Cir. 1998); Motorola, Inc. v. Interdigital Tech. Corp., 121 F.3d 1461 (Fed. Cir. 1997).
21. See Seymour v. Osborne, 78 U.S. (11 Wall.) 516 (1870); Rockwell Int'l v. United States, 147 F.3d 1358 (Fed. Cir. 1998); Motorola, Inc. v. Interdigital Tech. Corp., 121 F.3d 1461 (Fed. Cir. 1997).
22. See Seymour v. Osborne, 78 U.S. (11 Wall.) 516 (1870); Rockwell Int'l v. United States, 147 F.3d 1358 (Fed. Cir. 1998); Motorola, Inc. v. Interdigital Tech. Corp., 121 F.3d 1461 (Fed. Cir. 1997).
23. This strategy only works if the patent applicant can also show conception of the invention, or a mental picture of what the invention looks like, as of the filing date. Cf. Amgen v. Chugai, 927 F.2d 1200, 1216-17 (Fed. Cir. 1991) (holding that a patent applicant who made an enabling disclosure of how to clone a gene could thereby establish constructive reduction to practice of the invention, but could not establish conception of the gene as of the filing date when he did not yet know its structure).
24. See Brenner v. Manson, 383 U.S. 519, 534-35 (1966); In re Brana, 51 F.3d 1560, 1564 (Fed. Cir. 1995).
25. See Brenner v. Manson, 383 U.S. 519, 534-35 (1966); In re Brana, 51 F.3d 1560, 1564 (Fed. Cir. 1995).
26. See, e.g., In re Schoenwald, 964 F.2d 1122, 1124 (Fed. Cir. 1992) ("[N]o utility need be disclosed for a reference to be anticipatory of a claim to an old compound.").
27. See id.
28. The term "genomics" refers to the study of the DNA of different organisms.
29. The PTO is currently sorting its way through numerous patent applications on DNA sequences that push the limits of the utility requirement in this context. It recently published Revised Interim Utility Examination Guidelines, 64 Fed. Reg. 71440 (Dec. 21, 1999) corrected 65 Fed. Reg. 3425 (Jan. 21, 2000), and Training Materials for patent examiners on how to implement the guidelines with particular attention to examples from genomics and biotechnology. The training materials are available from the PTO website. See Revised Interim Utility Guidelines Training Materials (visited June 16, 2000) http://www.uspto.gov/web/offices/pac/utility/utilityguide.pdf; Revised Interim Written Description Guidelines Training Materials (visited June 16, 2000) http://www.uspto.gov/web/offices/pac/writtendesc.pdf.
30. The PTO is currently sorting its way through numerous patent applications on DNA sequences that push the limits of the utility requirement in this context. It recently published Revised Interim Utility Examination Guidelines, 64 Fed. Reg. 71440 (Dec. 21, 1999) corrected 65 Fed. Reg. 3425 (Jan. 21, 2000), and Training Materials for patent examiners on how to implement the guidelines with particular attention to examples from genomics and biotechnology. The training materials are available from the PTO website. See Revised Interim Utility Guidelines Training Materials (visited June 16, 2000) http://www.uspto.gov/web/offices/pac/utility/utilityguide.pdf; Revised Interim Written Description Guidelines Training Materials (visited June 16, 2000) http://www.uspto.gov/web/offices/pac/writtendesc.pdf.
31. The PTO is currently sorting its way through numerous patent applications on DNA sequences that push the limits of the utility requirement in this context. It recently published Revised Interim Utility Examination Guidelines, 64 Fed. Reg. 71440 (Dec. 21, 1999) corrected 65 Fed. Reg. 3425 (Jan. 21, 2000), and Training Materials for patent examiners on how to implement the guidelines with particular attention to examples from genomics and biotechnology. The training materials are available from the PTO website. See Revised Interim Utility Guidelines Training Materials (visited June 16, 2000) http://www.uspto.gov/web/offices/pac/utility/utilityguide.pdf; Revised Interim Written Description Guidelines Training Materials (visited June 16, 2000) http://www.uspto.gov/web/offices/pac/writtendesc.pdf.
32. See, e.g., Eliot, Marshall, Talks of Public-Private Deal End in Acrimony, 287 SCIENCE 1723 (2000); Justin Gillis, Gene-Mapping Controversy Escalates, WASH. POST, Mar. 7, 2000, at E1; Peter G. Gosselin & Paul Jacobs, Clinton, Blair to Back Access to Genetic Code: The Two Leaders Plan to Issue Joint Statement That Data on Human Genome Should Be Public, Not Private, Property, L.A. TIMES, Mar. 14, 2000, at C1.
33. See, e.g., Eliot, Marshall, Talks of Public-Private Deal End in Acrimony, 287 SCIENCE 1723 (2000); Justin Gillis, Gene-Mapping Controversy Escalates, WASH. POST, Mar. 7, 2000, at E1; Peter G. Gosselin & Paul Jacobs, Clinton, Blair to Back Access to Genetic Code: The Two Leaders Plan to Issue Joint Statement That Data on Human Genome Should Be Public, Not Private, Property, L.A. TIMES, Mar. 14, 2000, at C1.
34. See, e.g., Eliot, Marshall, Talks of Public-Private Deal End in Acrimony, 287 SCIENCE 1723 (2000); Justin Gillis, Gene-Mapping Controversy Escalates, WASH. POST, Mar. 7, 2000, at E1; Peter G. Gosselin & Paul Jacobs, Clinton, Blair to Back Access to Genetic Code: The Two Leaders Plan to Issue Joint Statement That Data on Human Genome Should Be Public, Not Private, Property, L.A. TIMES, Mar. 14, 2000, at C1.
35. The Human Genome Project is an international effort to map and sequence all of the DNA in human cells. In the United States, its principal sponsors are the National Human Genome Research Institute and the Department of Energy. Numerous websites explain the goals and achievements of the Human Genome Project, including http.//www. nhgri.nih.gov/ and http://www.er.doe.gov/.
36. The Bermuda rules derive their name from an agreement entered into at the International Strategy Meeting on Human Genome Sequencing held in Bermuda in 1996. See David R. Bentley, Genomic Sequence Information Should Be Released Immediately and Freely in the Public Domain, 274 SCIENCE 533 (1996). The Bermuda rules have been criticized as promoting public disclosure of data that have not been checked for accuracy. See Mark D. Adams & J. Craig Venter, Should Non-Peer-Reviewed Raw DNA Sequence Data Release Be Forced on the Scientific Community?, 274 SCIENCE 534 (1996).
37. The Bermuda rules derive their name from an agreement entered into at the International Strategy Meeting on Human Genome Sequencing held in Bermuda in 1996. See David R. Bentley, Genomic Sequence Information Should Be Released Immediately and Freely in the Public Domain, 274 SCIENCE 533 (1996). The Bermuda rules have been criticized as promoting public disclosure of data that have not been checked for accuracy. See Mark D. Adams & J. Craig Venter, Should Non-Peer-Reviewed Raw DNA Sequence Data Release Be Forced on the Scientific Community?, 274 SCIENCE 534 (1996).
38. This goal is manifest in the National Human Genome Research Institute's Policy on Availability and Patenting of Human Genomic DNA Sequence Produced by NHGRI Pilot Projects (visited June 19, 2000) http://www.nhgri.nih.gov/Grant_info/funding/statements/RFA/intellectual- property.html: In NHGRI's opinion, raw human genomic DNA sequence, in the absence of additional demonstrated biological information, lacks demonstrated specific utility and therefore is an inappropriate material for patent filing. NIH is concerned that patent applications on large blocks of primary human genomic DNA sequence could have a chilling effect on the development of future inventions of useful products . . . . The grantees are reminded that the grantee institution is required to disclose each subject invention to the Federal Agency providing research funds within two months after the inventor discloses it in writing to grantee institution personnel responsible for patent matters. NHGRI will monitor grantee activity in this area to learn whether or not attempts are being made to patent large blocks of primary human genomic DNA sequence.
39. An expressed sequence tag or EST is a DNA sequence corresponding to a fragment of a gene, sufficient in length to make it unlikely that the same fragment occurs anywhere else in the genome. ESTs are created through a process that identifies only the small fraction of the genome of an organism that its cells are actually using (or "expressing") to produce proteins. The focus on expressed genes and the limitation to partial sequences permits the rapid creation of a database that tags those portions of the genome that are particularly likely to have biological (and commercial) importance. See Mark D. Adams, et al., Complementary DNA Sequencing: Expressed Sequence Tags and Human Genome Project, 252 SCIENCE 1651 (1991).
40. See Rebecca S. Eisenberg, Intellectual Property at the Public-Private Divide: The Case of Large-Scale cDNA Sequencing, 3 U. CHI. L. SCH. ROUNDTABLE 557 (1996).
41. Although the issue is not entirely free from doubt, it now seems unlikely that publication of an EST in the prior art would make the corresponding full-length gene obvious as that standard has been applied to patent claims to DNA sequences. See In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995);
42. In re Bell, 991 F.2d 781 (Fed. Cir. 1993).
43. Most of the members of the SNP Consortium are pharmaceutical firms. For a description of the SNP Consortium and its objectives, see The SNP Consortium, Ltd., The SNP Consortium - Full Genome Representative SNP Map Program Summary (visited June 18, 2000) http://snp.cshl.org/about/program/html.
44. See Eliot Marshall, Drug Firms to Create Public Database of Genetic Mutations, 284 SCIENCE 406 (1999); Eliot Marshall, Human Genome Project: 'Playing Chicken' Over Gene Markers, 278 SCIENCE 2046 (1977).
45. See Eliot Marshall, Drug Firms to Create Public Database of Genetic Mutations, 284 SCIENCE 406 (1999); Eliot Marshall, Human Genome Project: 'Playing Chicken' Over Gene Markers, 278 SCIENCE 2046 (1977).
46. See 35 U.S.C. § 157 (1994 and Supp. 1999).
47. The SNP Consortium, Ltd., supra note 30 (visited June 18, 2000) (emphasis added).
48. The Patent Law Amendments Act of 1984, Pub. L. No. 98-622, 98 Stat. 3383 (1984).
49. See 35 U.S.C. § 157(a)(1) (1994 and Supp. 1999).
50. See 35 U.S.C. § 157(a)(3) (1994 and Supp. 1999).
51. See 35 U.S.C. § 157(c) (1994 and Supp. 1999).
52. The basis for asserting prior art status for a SIR as of its filing date is the language of § 102(e) of the Patent Act, which precludes issuance of a patent on an invention that was "described in a patent granted on an application for patent by another filed in the United States before the invention thereof by the applicant for patent." U.S.C. § 102(e). For an analysis of whether prior art status as of its filing date is among the "attributes" of a patent to which a SIR is entitled, see DONALD S. CHISUM, CHISUM ON PATENTS § 3.07[2] (2000).
53. The effectiveness of a SIR as prior art as of its filing date is limited to § 102(e), which may be avoided by a patent applicant who can prove an earlier invention date. Once a SIR is published, it becomes effective as prior art under § 102(b), which prevents the issuance of a patent on an invention that was "described in a printed publication . . . more than one year prior to the date of the application for patent . . . ." A rival who files a patent application within a year of the publication date of the SIR may thus avoid the prior art effect of the SIR by swearing behind its filing date. See supra notes 5-11 and accompanying text.
54. See J. Craig Venter, Clinton and Blair Shouldn't Destroy Our Research, WALL ST. J., Mar. 21, 2000, at A26.
55. CELERA CORP., Celera Compiles DNA Sequence Covering 90% of the Human Genome (visited Jan. 10, 2000) http://www.pecorporation.com/press/prccorp011000.html.
56. See Eliot Marshall, Talks of Public-Private Deal End in Acrimony, 287 SCIENCE 1723 (2000).
57. Suppose, for example, that two rivals, Public University and Private Company, each sequence different portions of the same gene. Suppose further that the patent system offers more generous protection for full-length genes than for gene fragments. (Although the matter is not free from doubt, this appears to be consistent with the position of the PTO as reflected in recently disclosed training materials for patent examiners in applying the written description and utility guidelines. See Revised Interim Utility Guidelines Training Materials, supra note 22; Revised Interim Written Description Guidelines Training Materials, supra note 22.) If Public University freely discloses its portion of the gene in Genbank, Private Company might add that information to the partial sequence it already has, quickly complete the sequence for the full-length gene, and file a patent application that it could not have filed without the Public University disclosure.
58. Suppose, for example, that two rivals, Public University and Private Company, each sequence different portions of the same gene. Suppose further that the patent system offers more generous protection for full-length genes than for gene fragments. (Although the matter is not free from doubt, this appears to be consistent with the position of the PTO as reflected in recently disclosed training materials for patent examiners in applying the written description and utility guidelines. See Revised Interim Utility Guidelines Training Materials, supra note 22; Revised Interim Written Description Guidelines Training Materials, supra note 22.) If Public University freely discloses its portion of the gene in Genbank, Private Company might add that information to the partial sequence it already has, quickly complete the sequence for the full-length gene, and file a patent application that it could not have filed without the Public University disclosure.
59. Pharmacogenomics involves the use of genetic markers to predict drug responses in individual patients on the basis of genetic differences. For a discussion of the use of SNPs in pharmacogenomics, see SNPs in Pharmocogenetics (visited May 23, 2000) http://www.snps. com/pharm.html.
60. For a discussion of the use of SNPs to find genes associated with susceptibility to disease, see Leslie Roberts, SNP Mappers Confront Reality and Find it Daunting, 287 SCIENCE 1898 (2000).
61. See Parchomovsky, supra note 1, at 937.
62. Henry Grabowski and John Vernon have studied the change in price of brand name and generic drugs for drugs going off patent during the years 1984-1991. They found that two years after the first entry of a competing generic product, the price of generic products was on average 35-38% of the price of the corresponding brand name product, and the market share of the generics averaged 45-59%, with generic products enjoying higher market shares in more recent years. See Henry Grabowski & John Vernon, Longer Patents for Increased Generic Competition in the U.S.: The Waxman-Hatch Act After One Decade, 10 PHARMACOECONOMICS 110 (Supp. 2, 1996).
63. For a somewhat dated analysis of the costs of pharmaceutical research and development, see U.S. CONGRESS, OFFICE OF TECHNOLOGY ASSESSMENT, OTA-H-522, PHARMACEUTICAL R&D: COSTS, RISKS AND REWARDS 47-72 (1993).
64. Parchomovsky acknowledges in a footnote that "the payoff of the competing firms from publication may be much lower than the duopoly profit," Parchomovsky, supra note 1, at 937 n.37, but nonetheless he retains this counterfactual assumption as the basis for quantifying the payoff structure in his model.