Creating and enforcing patent rights in the fast moving field of personalized medicine.

Abstract

Personalized MedicineVol. 3, No. 1 Special ReportCreating and enforcing patent rights in the fast moving field of personalized medicineDavid S Resnick, Ronald I Eisenstein, J Amelia Feulner & Leena H KarttunenDavid S Resnick† Author for correspondenceSearch for more papers by this author, Ronald I EisensteinSearch for more papers by this author, J Amelia FeulnerSearch for more papers by this author & Leena H KarttunenSearch for more papers by this authorPublished Online:23 Jan 2006https://doi.org/10.2217/17410541.3.1.89AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail View articleKeywords: diagnostic methodearly publicationenforcementinterferenceNixon Peabody LLPoppositionpatentpatenting strategiespetition to make specialBibliography1 Lynch TJ, Bell DW, Sordella R et al.: Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small cell lung cancer to gefitinib. N. Engl. J. Med.350(21), 2129–2139 (2004).Google Scholar2 Paez JG, Janne PA, Lee JC et al.: EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science304(5676), 1497–1500 (2004).Google Scholar3 35 U.S.C. 271(a): Infringement of Patent – Patent Laws.Google Scholar4 Bayer AG v. Housey Pharma., Inc., 128 Fed. Appx. 767 (Fed. Cir. 2005).Google Scholar5 State St. Bank & Trust Co. v. Signature Fin. Group, 149 F.3d 1368 (Fed. Cir. 1998).Google Scholar6 Informatics Act of 2005. H.R. 4208. IH.Google Scholar7 Taylor AL, Ziesche S, Yancy C et al.: Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. N. Engl. J. Med.351(20), 2049–2057 (2004).Google Scholar8 Karttunen LH, Feulner JA, Resnick DS: Patenting Personalized Medicine. J. Biolaw & Bus.9(1) (2006).Google Scholar9 35 U.S.C. §154(d): “The applicants must also give actual notice of the published application to the accused infringer and explain, what acts are regarded as giving rice of provisional right.” Legislative History, Congr. Rec. S14719 (November 17, 1999).Google Scholar10 37 Code of Federal Regulations (CFR) 1.219: Early Publication. Patent Rules, Chapter I. United States Patent and Trademark Office, Department of Commerce, Part 1 – Rules of Practice in Patent Cases.Google Scholar11 37 CFR 1.18(d): Patent Post Allowance (including issue fees), (d) Publication Fee. Fees are according to schedule effective from January 1, 2006.Google Scholar12 MPEP § 1120: Section 1120 of Manual of Patent Examining Procedure (MPEP), 8th edition. US Patent and Trademark Office, Department of Commerce. (August 2001, last revision October 2005).Google Scholar13 37 CFR 1.17(h): Patent Application and Reexamination and Processing fees. Fees are according to schedule effective from January 1, 2006.Google Scholar14 37 CFR 1.102: Advancement of Examination and MPEP 708.02, VIII. Special Examination Procedure for Certain New Applications.Google Scholar101 Genzyme's EGFR Mutation Assay. Genzyme press release September 29, 2005. www.genzymegenetics.com/about/news/GENZ%20PR-092705.aspGoogle Scholar102 Guidance for Industry: Pharmacogenomic Data Submissions. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH). March 2005 www.fda.gov/cder/guidance/index.htmGoogle Scholar103 United States Patent and Trademark Office http://portal.uspto.gov/external/portal/pairGoogle Scholar104 European Patent Office website. Go to “Public File Inspection”. http://my.epoline.org/portal/publicGoogle ScholarFiguresReferencesRelatedDetailsCited ByPharmacogenomics: A New Frontier for the Evergreening of Pharmaceutical DrugsSSRN Electronic Journal Vol. 3, No. 1 Follow us on social media for the latest updates Metrics Downloaded 142 times History Published online 23 January 2006 Published in print February 2006 Information© Future Medicine LtdKeywordsdiagnostic methodearly publicationenforcementinterferenceNixon Peabody LLPoppositionpatentpatenting strategiespetition to make specialDisclaimerThe views in the article represent the current views of the authors only, not Nixon Peabody LLP. The views of the authors are subject to change due to changes in the constantly evolving field of patent law.PDF download