Patenting drug delivery technology: tips for formulating practical and effective patent portfolio.

Abstract

Pharmaceutical Patent AnalystVol. 5, No. 2 CommentaryPatenting drug delivery technology: tips for formulating practical and effective patent portfolioTakeshi S KomataniTakeshi S Komatani*Author for correspondence: E-mail Address: tskomatani@shupat.gr.jp SHUSAKU·YAMAMOTO, Osaka, JapanSearch for more papers by this authorPublished Online:18 Feb 2016https://doi.org/10.4155/ppa.15.42AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail View articleKeywords: active pharmaceutical ingredientdrug delivery systemintellectual propertypatentpatent term extensionportfoliosupplementary protection certificatePapers of special note have been highlighted as: •• of considerable interestReferences1 Coelho JF, Ferreira PC, Alves P et al. Drug delivery systems: advanced technologies potentially applicable in personalized treatments. EPMA J. 1(1), 164–209 (2010).Crossref, Medline, Google Scholar2 Mastrobattista E, Hennink WE, Schiffelers RM. Delivery of nucleic acids. Pharm. Res. 24(8), 1561–1563 (2007).Crossref, Medline, CAS, Google Scholar3 Xu L, Anchordoquy T. Drug delivery trends in clinical trials and translational medicine: challenges and opportunities in the delivery of nucleic acid-based therapeutics. J. Pharm. Sci. 100(1), 38–52 (2011).Crossref, Medline, CAS, Google Scholar4 US Code: Title 35 (35 USC) Sec. 101.Google Scholar5 Japanese Patent Act. Article 29(1), main paragraph.Google Scholar6 European Patent Convention Article 53(c).Google Scholar7 European Paten Office. www.epo.org/law-practice/case-law-appeals/recent/t080234eu1.html.Google Scholar8 The Commissioner of Japan Patent Office v. Takeda Pharmaceutical Inc. The Supreme Court of Japan, Heisei 21 (Gyo-Hi) no.324–326, 28 April 2012 (2012). ••These decisions, directed to the patent term extension based on a drug delivery system patent, set out the Japanese Supreme Court's position on what is necessary for obtaining patent term extensions, based on the premise that the drug delivery system patent is ‘valid’.Google Scholar9 Komatani TS. Patent term extension in Japan: challenges still lay ahead even after the 2011 revision. Pharma. Pat. Anal. 2(1), 63–76 (2012).Link, Google Scholar10 Japan Patent Attorneys Association. www.jpaa.or.jp/english/court_decisions/6-PacifCapsuleCase.pdf.Google Scholar11 Regulation (EC) no. 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products.Google Scholar12 Massachusetts Institute of Technology. Case C-431/04 (2006). http://curia.europa.eu/juris/showPdf.jsf?text=&docid=56613&pageIndex=0&doclang=EN&mode=lst&dir=&occ=first&part=1&cid=642888.Google Scholar13 Neurim Pharmaceuticals Ltd. v. The Comptroller General of Patents. Court of Justice of the European Union, C-130/11; 19 July 2012 (2012).Google Scholar14 D'Oca G, Sklan A, Komatani TS. Cases update. Pharm. Pat. Anal. 1(4), 372–374 (2012).Google Scholar15 MPEP section 2750. www.uspto.gov/web/offices/pac/mpep/s2750.html.Google Scholar16 JRC Science & Policy Report, Farid, Reasonable & Non-Discriminatory (FRAND) Licensing Terms (2015). http://is.jrc.ec.europa.eu/pages/ISG/EURIPIDIS/documents/05.FRANDreport.pdf.Google Scholar17 The White House. www.whitehouse.gov/the-press-office/2015/01/20/remarks-president-barack-obama-prepared-delivery-state-union-address.Google ScholarFiguresReferencesRelatedDetails Vol. 5, No. 2 Follow us on social media for the latest updates Metrics Downloaded 64 times History Published online 18 February 2016 Published in print March 2016 Information© Future Science LtdKeywordsactive pharmaceutical ingredientdrug delivery systemintellectual propertypatentpatent term extensionportfoliosupplementary protection certificateDisclaimerThis commentary describes the opinions and observations of the author as a Japanese patent attorney and does not necessarily represent the viewpoints of the author's employers or author's firm. By its nature, the subject article provides the author's general opinion, and necessarily limited discussion of various topics; it does not purport to give specific legal advice or a substitute for legal counsel. As legal advice must be tailored to the specific circumstances of each case, nothing provided herein should be used as a substitute for advice of competent counsel. The author and the author's firm assume no liability for the use or interpretation of information contained herein. The author and the author's firm expressly disclaim all liability in respect of anything done or omitted to be done wholly or partly in reliance of this material.Financial & competing interests disclosureThe author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.PDF download