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Recent US patent legislation: What's new for biotech?

Nature Biotechnology volume 18, pages 229–231 (2000)Cite this article

Abstract

New reforms bring US law closer in line with those of other major countries.

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References

  1. The new legislation was part of Senate Bill 1948, 106th Cong., 1st Sess., which was enacted as part of Public Law No. 106-113 (Nov. 29, 1999).

  2. Under the new law, design applications and provisional applications will not be published.

  3. Under the prior statute, 35 USC §122, patent applications were kept in confidence by the PTO unless the applicant authorized the release of information or the release was “necessary to carry out the provisions of any Act of Congress or in such special circumstances as may be determined by the Commissioner.”

  4. See 35 USC §154(a)(2).

  5. S. 1948 §4502(a), codified at 35 USC §122(b)(1)(A).

  6. Id.

  7. The procedure states that an applicant may certify upon filing that the invention disclosed in the US application “has not and will not be the subject of an application filed in another country, or under a multilateral international agreement, that requires publication of applications 18 months after filing….” S. 1948 §4502(a), to be codified at 35 USC §122(b)(2)(B)(i). The certification can be rescinded “at any time.” If the request is rescinded, the application will be published. S. 1948 §4502(a), codified at 35 USC §122(b)(2)(B)(iv). If an applicant certifies but then subsequently files a non-US application, the applicant will have 45 days to notify the US PTO of the filing, and failure to notify the US PTO “shall result in the application being regarded as abandoned, unless it is shown to the satisfaction of the Director that the delay in submitting the notice was unintentional.” S. 1948 §4502(a), to be codified at 35 USC §122(b)(2)(B)(iii). An application is not published if it is “no longer pending.” Patent applications which are subject to a secrecy order imposed by the US government under 35 USC §181 (on the grounds that publication or disclosure may “be detrimental to national security”) will not be published. S. 1948 §4502(a), to be codified at 35 USC §122(b)(2)(A)(ii).

  8. See S. 1948 §4502(a), codified at 35 USC §122(b)(2)(B)(v).

  9. S. 1948, §4505, codified at 35 USC §102(e). The new law provides that a person will not be entitled to a patent if “(e) The invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effect under this subsection of a national application published under section 122(b) only if the international application designating the United States was published under Article 21(2)(a) of such treaty in the English language ….”

  10. See S. 1948 §4504, codified at 35 USC §154(d)(1)(A).

  11. S. 1948 §4504, codified at 35 USC §154(d)(1)(B).

  12. S. 1948 §4504, codified at 35 USC §154(d)(2).

  13. S. 1948 at §4502(a), codified at 35 USC §122(b)(2)(B)(v).

  14. See generally S. 1948 §4604, to be codified at 35 USC §§311–318.

  15. Under some circumstances, reexamination can be granted on the basis of prior art that was previously before the patent office, e.g., during prosecution of the application or in a prior reexamination. Reexamination may be possible if the significance of the prior art was not appreciated in the prior PTO proceeding. See generally "US Patent and Trademark Office, Guidelines for Reexamination of Cases in View of In Re Portola Packaging,“ 110 F.3d 786, 42 USPQ2d 1295 (Fed. Cir. 1997),” 64 Fed. Reg. 15, 346 (1999).

  16. See, e.g., Custom Accessories, Inc. vs. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 961, 1 USPQ2d 1196, 1200 (Fed. Cir. 1986) (suggesting that the burden of proving a patent is invalid is “made heavier” if the patent has survived reexamination).

  17. S. 1948 §4604(a), codified at 35 USC. §314(b)(3).

  18. S. 1948 §4604(a), codified at 35 USC §315(b).

  19. S. 1948 §4604(a), codified at 35 USC §318.

  20. S. 1948 §4604(a), codified at 35 USC §315(c).

  21. S. 1948 §4402(a), codified at 35 USC §154(b).

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  1. a member and John C. Todaro is an associate at Darby & Darby, P.C., 805 Third Avenue, New York, 10022, NY

    Adda C. Gogoris & John C. Todaro

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  1. Adda C. Gogoris
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Gogoris, A., Todaro, J. Recent US patent legislation: What's new for biotech?. Nat Biotechnol 18, 229–231 (2000). https://doi.org/10.1038/72702

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