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| Title: | 生物相似藥物藥廠專利行為及其對專利制度之啟示
Patenting behavior of biosimilar manufacturers and its enlightenment for patent reform |
| Authors: | 洪英愷
Hung, Ying-Kai |
| Contributors: | 鄭菀瓊
Cheng, Wan-Chiung
洪英愷
Hung, Ying-Kai |
| Keywords: | 生物相似藥物專利
生物製劑專利
專利分析
專利審查
標準必要專利
biosimilar patents
biologic patents
patent analysis
patent examination
standard-essential patent |
| Date: | 2021 |
| Issue Date: | 2021-09-02 18:10:38 (UTC+8) |
| Abstract: | 過去曾有研究揭示生物相似藥物藥廠可能會申請專利以保護其在商業上具有優勢的技術，然而，該專利行為似乎與專利制度的立法初衷背道而馳，現行的專利制度已確立了：先行者合法壟斷、後進者於專利到期後獲利之原則，因此，本研究全面性地探討生物相似藥物的專利行為，並證實其和原專利制度的理念相悖。
透過與傳統化學學名藥相比較，本研究不僅證實生物相似藥的專利行為確實存在，亦發現其數量約佔其各自參照原廠藥物專利數量的 15%。本研究進一步分析了這群專利的類型、專利申請時間、專利申請順序等指標，發現生物相似藥的專利類型主要為製造方法和醫藥用途類型，另外，即使原廠藥物已被核發藥證，生物相似藥物藥廠的專利行為仍持續進行，有趣的是，在製造方法和醫療用途類型中所檢索到的專利，約有三分之一數量可在兩種以上的藥物被檢索到，這意味著該重複被檢索到的專利之技術可應用於多種藥物，最後，本研究嘗試以動態的視覺化圖形描繪本研究發現。
本研究進一步依據專利申請人的申請動機、申請人對該專利技術的認知，和考量生物藥品的技術特性，將檢索到的專利初分成兩種類型：無意義的專利行為和目的性的專利行為。又根據目前的實證研究，雖然尚無法確定生物相似藥的專利行為是否不可避免，其原因可能和生物藥品難以界定的特性，與申請人豎立的專利叢林現象皆息息相關，經本研究討論，生物相似藥專利行為和生物原廠藥物的專利叢林互為複雜的因果關係，最終迫使所有相關利益者、整體社會、病患承擔更多成本。
在不影響現行制度的前提下，應進行專利制度調整和其配套措施。本研究提出了兩種可能的改革方向，第一為提高生物藥品相關的專利審查標準、另一為將至少一種製造方法所涉及到的製造方法專利視為標準必要專利，讓生物相似藥物申請人，能以較為接近化學學名藥的情境進入生物藥品市場。
Previous studies reveal that the bio-generic drug might apply for patents to protect their business-advantage techniques. However, the patenting behavior seems unexpected to the original purpose of the patent system. Patent system has long established the rule that: “pioneer monopolizes; followers gain after the patent expired.” Hence, this study explored the patenting behavior of biosimilars in the United states comprehensively and demonstrated that it is sometimes contrary to the traditional wisdom.
Compared to the conventional chemical generics, the patenting behavior from biosimilars does exist and accounts for about 15% of their individual reference originators. The article further considers the indicators of patent types, filing time, filing order and finds that the favorite types of patent categories filed by biosimilar makers are manufacturing process and medical use. Furthermore, the patenting will not stop even if the originators got approvals. Interestingly, around one-third of the manufacturing methods and medical uses patent categories can be retrievable in more than two drugs, implying that the techniques involved may be applied for multiple drugs. Finally, the article proposes the visualization of the patenting behavior dynamically from biologics and biosimilars.
The article further defines the patenting behavior based on the motivation and cognition of patent applicants into two categories: unintentional patenting behavior and purposeful patenting behavior with consideration of the natural properties of the biologic product. Although it is not clear that whether the patenting behavior from biosimilars is unavoidable, one of the motivations may be related to the patent thicket stacked by originators owing to the hard-to-define characteristic of the biologic product. The complicated reciprocal causation between biosimilar patenting behavior and patent thicket force all stakeholders and the society as a whole (including the patients) to bear more and more costs.
Under the premise of not affecting the existing system, the standards and allocation measures of the patent framework should be adjusted. The investigation proposes two possible suggestions to unwind the problems. The first one is to enhance the criteria of patent examination. Another one is to put the manufacturing process patent as the standards-essential patent to those biosimilar applicants to mimic the scenario of the chemical generics. |
| Reference: | Aaron C. Anselmo et al., Non-invasive delivery strategies for biologics, 18 Nat. Rev. Drug Discov. 19 (2019).
Abbott, ABBOTT COMPLETES SEPARATION OF RESEARCH-BASED PHARMACEUTICALS BUSINESS (Jan. 2, 2013), Abbott, https://www.abbottinvestor.com/news-releases/news-release-details/abbott-completes-separation-research-based-pharmaceuticals/.
Ahmad AL-Sabbagh et al., Development of biosimilars, 45 Seminars in Arthritis and Rheumatism 11 (2016).
AJMC THE CENTER FOR BIOSIMILARS, FDA Approves Coherus’ Pegfilgrastim Biosimilar, Udenyca (Nov. 3, 2018), AJMC THE CENTER FOR BIOSIMILARS, https://www.centerforbiosimilars.com/view/fda-approves-coherus-pegfilgrastim-biosimilar-udenyca.
Alain Beck. Biosimilar, biobetter and next generation therapeutic antibodies, 3 mAbs.107. (2011).
Alastair D. G. Lawson, Antibody-enabled small-molecular drug discovery, 11 Nature Review Drug Discovery 523 (2012).
Albina Khairullina, Ideas-Driven Engogenous Growth and Standard-Essential Patents, (2020), https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3589892.
Alexandra Beumer Sassi et al., Novel Approaches and Strategies For Biologics, Vaccines and Cancer Therapies, Biobetter Biologics, 201 (2015).
Allegan Mich., Perrigo Announces that Dexcel`s Settlement with AstraZeneca Allows OTC Omeprazole Launch Following Final FDA Approval, Website of Perrigo, https://investor.perrigo.com/2007-11-01-Perrigo-Announces-that-Dexcels-Settlement-with-AstraZeneca-Allows-OTC-Omeprazole-Launch-Following-Final-FDA-Approval (last visited Apr. 18, 2021).
Ameet Sa.rpatwari et al., The US Biosimilar Market: Stunted Growth and Possible Reforms, 105 Clinical Pharmacology & Therapeutics 95 (2019).
Amgen, Amgen And Allergan’s MAVSITM (bevacizumab-awwb) And KANJINTITM (trastuzumab-anns) Now Available In The United States, Amgen, https://www.amgen.com/newsroom/press-releases/2019/07/amgen-and-allergans-mvasi-bevacizumabawwb-and-kanjinti-trastuzumabanns-now-available-in-the-united-states (last visited Feb. 15, 2021).
Amgen, Amgen Wins Patent Case On Enbrel® (etanercept) (Aug. 9, 2019), Amgen, https://www.amgen.com/newsroom/press-releases/2019/08/amgen-wins-patent-case-on-enbrel-etanercept.
Amgen, FDA Approves Amgen And Allergan`s MVASI™ (bevacizumab-awwb) For The Treatment Of Five Types Of Cancer, Amgen, (Sep. 14, 2017) https://investors.amgen.com/news-releases/news-release-details/fda-approves-amgen-and-allergans-mvasitm-bevacizumab-awwb.
Amgen, FDA Approves Amgen`s RIABNI™ (rituximab-arrx), A Biosimilar To Rituxan® (rituximab) (Dec 17, 2020), Amgen, https://www.amgen.com/newsroom/press-releases/2020/12/fda-approves-amgens-riabni-rituximabarrx-a-biosimilar-to-rituxan-rituximab.
Amgen, FDA Approved AVSOLATM (infliximab-axxq), a Biosimilar to Remicade® (Dec. 6, 2019), Amgen, https://www.amgen.com/stories/2019/12/fda-approves-avsola-infliximab-axxq-a-biosimilar-to-remicade.
Amgen Inc. v. Sandoz, Inc., Case No. 14-cv-04741-RS (N.D. Cal. Mar. 19, 2015).
Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015).
Amgen Inc. v. Apotex Inc., 827 F.3d 1052, 119 U.S.P.Q.2d 1318 (Fed. Cir. 2016).
Amit B.O. et al., Teriflunomide and its mechanism of action in multiple sclerosis, 74 Drugs. 659 (2014).
Ana Plzninc et al., Batch-to-batch N-glycosylation study of infliximab, trastuzumab and bevacizumab, and stability study of bevacizumab, 24 European Journal of Hospital Phamacy 286 (2017).
Ana Santos Rutschman & Julia Barnes-Weise. The COVID-19 Vaccines Patent Waiver: The Wrong Tool For The Right Goal, Bill of Health (2021).
André Frenzel et al., Phage display-derived human antibodies in clinical development and therapy, 8 MAbs. 1183, 1184 (2016).
Andreas Baumann, Early development of therapeutic biologics – pharmacokinetics, 7 Curr Drug Metab 15 (2006)
Andreas Baumann, Preclinical development of therapeutic biologics, 3 Expert Opin. Drug Discov. 290 (2008).
Andrew J. Reason et al., Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products, 27 Biopharm International (2014).
Andrew W. Mulcahy et al., Biosimilar Cost Savings in the United States, 7 Rand. Health Quarterly 5 (2018).
Anurag S. Rathore et al, Approval of biosimilars: a review of unsuccessful regulatory filings, 21 Expert Opinion on Biological Therapy 19 (2021).
Arnold G. Vulto & Orlando A. Jaquez, The process defines the product: what really matters in biosimilar design and production?, 56 Rheumatology 15 (2017).
Arti K. Rai & W. Nicholson Price II, An administrative fix for manufacturing process patent thickets, 39 Nature Biotechnology 21 (2021).
A patent waiver on COVID vaccines is right and fair, 593 Nature 478 (2021).
Bastiaan L. Duivelshof et al., Glycosylation of biosimilars: Recent advances in analytical characterization and clinical implication, 1089 Analytica Chimica Acta 3 (2019).
BIOPROCESS ONLINE, Mylan announces strategic collaboration with Biocon to enter the global generic biologics market (Jun. 30, 2009), BIOPROCESS ONLINE, https://www.bioprocessonline.com/doc/mylan-announces-strategic-collaboration-with-0001.
BioConversationsTM, Biocon’s Landmark Achievement of First USFDA approval of Biosimilar Trastuzumab applauded by all including the Media (Dec. 5, 2017), BioConversationsTM, https://bioconblog.com/2017/12/05/biocons-landmark-achievement-of-first-usfda-approval-for-biosimilar-trastuzumab-applauded-by-all-including-the-media/.
Biogen, Biogen IDEC and Genentech announce restructuring of anti-CD20 collaboration agreement (Oct 21, 2010), Biogen, http://media.biogen.com/news-releases/news-release-details/biogen-idec-and-genentech-announce-restructuring-anti-cd20.
Biogen, BIOGEN IDEC BECOMES BIOGEN (Mar. 23, 2015), Biogen, https://investors.biogen.com/news-releases/news-release-details/biogen-idec-becomes-biogen.
Boehringer Ingelheim, Boehringer Ingelheim Pharmaceuticals, Inc. receives FDA approval for CyltezoTM (adalimumab-adbm), a biosimilar to Humira®, for the treatment of multiple chronic inflammatory diseases (Aug. 29, 2017), Boehringer Ingelheim, https://www.boehringer-ingelheim.us/press-release/boehringer-ingelheim-pharmaceuticals-inc-receives-fda-approval-cyltezo-adalimumab.
Brian Chen et al., Challenges to Biosimilar Substitution, 318 JAMA Newtwork Open 1186 (2017).
Brian J. Love et al., Determinants of Patent Quality Evidence from Inter Partes Review Proceedings, 90 University of Colorado Law Review 130, 132 table 7 (2019).
Bristol Myers Squibb, Bristol-Myers Squibb Completes Acquistion of ZymoGenetics, Inc. (Oct. 12, 2010), Bristol Myers Squibb, https://news.bms.com/news/details/2010/Bristol-Myers-Squibb-Completes-Acquisition-of- ZymoGenetics-Inc/default.aspx.
Bruno Calo-Fernández & Juan Leonardo Martínez-Hurtado, Biosimilars: Company Strategies to Capture Value from the Biologics Market, 5 Pharmaceuticals 1395 (2012).
Business Standard, Biocon buys Nobex for $5 million (Feb. 6, 2013), Business Standard, https://www.business-standard.com/article/companies/biocon-buys-nobex-for-5-million-106032901137_1.html.
Carlos M Correa, Guidelines for the Examination of Patent Applications relating to Pharmaceuticals, United Nations Development Programme. 9, 10 (2007).
Carmela De Luca & Anastassia Trifonova, Patent disclosure requirements for therapeutic antibody patents, 27 Expert Opinion on Therapeutic Patent 868, 871 (2017).
Chun J. & Hartung H. P., Mechanism of action of oral fingolimod (FTY72) in multiple sclerosis, 33 Clinical Neuropharmacology 91 (2010).
Chie Hoon Song & Jeung-Whan Han, Patent cliff and strategic switch: exploring strategic design possibilities in the pharmaceutical industry, 5 SpringerPlus 2 (2016).
Christopher M. Holman, AbbVie Hopes to Maintain Humira Exclusivity Though Secondary Patents and Regulatory Barriers to Entry, 36 Biotechnology Law Report 12 (2017).
Claudia Mund, In: Duncan Matthews & Herbert Zech, Patenting biosimilars, Research handbook on Intellectual Property and the Life Sciences 1, 2 (2017).
Coherus BIOSCIENCES, Baxter and Coherus BioSciences Announce Collaboration to Develop and Commercialize Biosimilars (Sep. 3, 2013), Coherus BIOSCIENCES, https://investors.coherus.com/news-releases/news-release-details/baxter-and-coherus-biosciences-announce-collaboration-develop.
Courtenay C. Brinckerhoff, Will The Biologic Patent Transparency Act Shrink The Biosimilar Patent Dance Floor? (May 7, 2019), FOLEY & LARDNER LLP, https://www.foley.com/en/insights/publications/2019/05/will-bpta-shrink-patent-dance.
Craig W. Lindsley, New 2016 Data and Statistics for Global Pharmaceutical Products and Projections through 2017, 16 ACS Chemical Neuroscience 1635 (2017).
David Pfister & Massimo Morebidelli, Process for protein PEGylation, 180 Journal of Control Release 135, 136 (2014).
Dean G. Brown & Heike J. Wobst, A Decade of FDA-Approved Drugs (2010-2019): Trends and Future Directions, 64 Journal of Medicinal Chemistry 2312 (2021).
Damian Rolfe et al., Are biosimilars patentable? 26 Expert Opinion on Therapeutic Patent 871 (2016).
Daniel Weinhuch et al., Introduction into Formulation Development of Biologics, Challenges in Protein Product Development. 3 (2018).
Dean Baker & Noriko Chatani, Promoting Good Ideas on Drugs: Are Patents the Best Way?, Center for Economic and Policy Research (2002).
Denis Kent et al., Disruption and maturity: the next phase of biologics (May, 22 2021), QuintilesIMS, https://www.iqvia.com/-/media/iqvia/pdfs/nemea/uk/disruption_and_maturity_the_next_phase_of_biologics.pdf.
Dov Hirsch, The Riddle of the Mysterious Patent Dance Wrapped in an Enigma: Is the Patent Dance of the BPCIA Optional or Mandatory?, 27 Fordham Intellectual Property, Media & Entertainment Law Journal 656, 658 (2017).
David IR Holmes & Ian Zachary, The vascular endothelial growth factor (VEGF): angiogenic factors in health and disease, 6 Genome Biology 209.1 (2005).
Drugs@FDA: FDA-Approved Drugs, U.S. FOOD & DRUG ADMINISTRATION, https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125553 (last visited Feb. 10, 2021).
DRUGBANK, https://go.drugbank.com/ (last visited Feb. 13, 2021).
DRUGBANK, Abiraterone, DRUGBANK, https://go.drugbank.com/drugs/DB05812 (last visited Feb. 16, 2021).
DRUGBANK, Adalimumab, DRUGBANK, https://go.drugbank.com/drugs/DB00051 (last visited Feb. 14, 2021).
DRUGBANK, Apixaban, DRUGBANK, https://go.drugbank.com/drugs/DB06605 (last visited Feb. 16, 2021).
DRUGBANK, Atorvastatin, DRUGBANK, https://go.drugbank.com/drugs/DB01076 (last visited Feb. 16, 2021).
DRUGBANK, Bevacizumab, DRUGBANK, https://go.drugbank.com/drugs/DB00112 (last visited Feb. 14, 2021).
DRUGBANK, Dimethyl fumarate, DRUGBANK, https://go.drugbank.com/drugs/DB08908 (last visited Feb. 16, 2021).
DRUGBANK, Erythropoietin, DRUGBANK, https://go.drugbank.com/drugs/DB00112 (last visited Feb. 14, 2021).
DRUGBANK, Esomeprazole, DRUGBANK, https://go.drugbank.com/drugs/DB00736 (last visited Feb. 16, 2021).
DRUGBANK, Etanerept, DRUGBANK, https://go.drugbank.com/drugs/DB00005 (last visited Feb. 14, 2021).
DRUGBANK, Filgrastim, DRUGBANK, https://go.drugbank.com/drugs/DB00099 (last visited Feb. 14, 2021).
DRUGBANK, Fingolimod, DRUGBANK, https://go.drugbank.com/drugs/DB08868 (last visited Feb. 16, 2021).
DRUGBANK, Infliximab, DRUGBANK, https://go.drugbank.com/drugs/DB00065 (last visited Feb. 14, 2021).
DRUGBANK, Paliperidone, DRUGBANK, https://go.drugbank.com/drugs/DB01267 (last visited Feb. 16, 2021).
DRUGBANK, Pegfilgrastim, DRUGBANK, https://go.drugbank.com/drugs/DB00019 (last visited Feb. 15, 2021).
DRUGBANK, Pregabalin, DRUGBANK, https://go.drugbank.com/drugs/DB00230 (last visited Feb. 16, 2021).
DRUGBANK, Rituximab, DRUGBANK, https://go.drugbank.com/drugs/DB00073 (last visited Feb. 15, 2021).
DRUGBANK, Trastuzumab, DRUGBANK, https://go.drugbank.com/drugs/DB00112 (last visited Feb. 14, 2021).
DRUGBANK, Teriflunomide, DRUGBANK, https://go.drugbank.com/drugs/DB08880 (last visited Feb. 16, 2021).
Drug.com, Eticovo FDA Approval History, Drug.com, https://www.drugs.com/history/eticovo.html (last visited Feb. 14, 2021).
Elena Vyacheslavna Litvinova et al., Formation of patent strategy at all stages of biosimilar development and Implementation, 11 Research Journal of Pharmacy and Technology 3081, 3084 (2018).
Edd Fleming & Philip Ma, Drug life-cycle technologies, 1 Nature Review Drug Discovery 752 (2002).
Emily Waltz, It’s Official: Biologics Are Pharma’s Darlings, 32 Nature Biotechnology 117 (2014).
Ernst R. Berndt et al, Authorized Generic Drugs, Price Competition, And Consumer’s Welfare, 26 Health Affairs 797 (2007).
Erwin A. Blackston et al., The Economics of Biosimilars, 6 American Health & Drug Benefits 470, 471 (2013).
Ester Caffarel-Salvador et al., Oral delivery of biologics using drug-device combinations, 36 Curr. Opin. Pharmacol. 8 (2017).
European Medicines Agency, Guideline on similar biological medicinal products (May 22, 2021), European Medicines Agency, https://www.ema.europa.eu/en/similar-biological-medicinal-products.
Eva Rahman Kabir et al., The Breakthrough of Biosimilars: A Twist in the Narrative of Biological Therapy, 9 Biomolecules 21 (2019).
Evelien Moorkens et al., An overview of patents on the therapeutic monoclonal antibodies in Europe: are they a hurdle to biosimilar market entry?, 12 mAbs. 3 (2020).
Feng-Chi Chen & Pin-Shen Lee, Inter Partes Review: Patent Killer No More?, 37 Trends in Biotechnology 681, 682 (2019).
Florian Scotté & Vincent Launay-Vacher, Colony stimulating factors (CSF) biosimilars, Progress?, 7 Targeted Oncology 19, 20 (2012).
Fritiz Lahrtz, How to successfully patent therapeutic antibodies, 20 Journal of Biomolecular Screening 486, 487 (2015).
FUJIFILM, Mylan and Fujifilm Kyowa Kirin Biologics Announce U.S. FDA Approval of Hulio® (adalimumab-fkjp) (Jul. 9, 2020), FUJIFILM, https://www.fujifilm.com/mm/en/news/hq/5183.
GaBi Generics and Biosimilars Initiative, Biosimilar approvals and launches in the US (Feb 26, 2021), GaBi Generics and Biosimilars Initiative, https://www.gabionline.net/Biosimilars/General/Biosimilar-approvals-and-launches-in-the-US.
Genentech, ABOUT US, Genentech, https://www.gene.com/about-us (last visited Feb. 14, 2021).
Gianluca Trifirò, Interchangeability of biosimilar and biological reference product: updated regulatory positions and pre- and post-marketing evidence, 18 Expert Review of Clinical Immunology 311 (2018).
GOOGLE PATENTS, https://www.google.com/?tbm=pts (last visited Mar. 16, 2021).
Gordon Tullock, Rent Seeking and Tax Reform, 6 Contemporary Economic Policy 37(1988).
Guohua An, Concept of Pharmacologic Target-Mediated Drug Disposition (TMDD) IN Large-Molecule and Small-Molecule Compounds, 60 J. Clin. Pharmacol. 149, 150 (2020).
Guro L. Goll & Tore K. Kvien, An Opportunity Missed: Biosimilars in the United States, 72 Arthritis Rheumatology 1046 (2020).
Heinz Mueller, Patenting of Biosimilars?, 2 Intel. Prop. Rights 1 (2014).
Henry Grabowski et al, Data exclusivity for biologics, 10 Nature Reviews Drug Discovery 15 (2011).
Hey A., History and Practice: Antibodies Infectious Disease, 3 Microbiology Spectrum 8 (2014).
Hong Wan, An overall comparison of small molecules and large biologics in ADME testing, 4 ADMET & DMPK journal 4, 16 (2016).
HoUng Kim et al., The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases, 80 Drugs 102 (2020).
Horizon, Horizon Pharma Announces Agreement to Acquire U.S. Right to VIMOVO(R) and Provides 2014 Guidance (Nov. 19, 2013), Horizon, https://ir.horizontherapeutics.com/news-releases/news-release-details/horizon-pharma-announces-agreement-acquire-us-rights-vimovor-and.
Horizon, Horizon Pharma plc Files Patent Infringement Lawsuit Against Watson Laboratories, Inc. for filing and ANDA Against PENNSAID(R) 2R (Dec. 24, 2014), Horizon, https://ir.horizontherapeutics.com/news-releases/news-release-details/horizon-pharma-plc-files-patent-infringement-lawsuit-against.
Howard Lee, Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars? 16 AAPS Journal 25 (2014).
Huy X. Ngo & Sylvie Garneau-Tsodikova, Where are the drugs of the future, 9 Medicinal Chemistry Communications 758, (2018).
In re Humira (Adalimumab) Antitrust Litig., No. 19 CV 1873, 43-44 (N.D. Ill. Jun. 8, 2020).
Irene Munk Pedersen et al., The chimeric anti-CD20 antibody rituximab induces apoptosis in B-cell chronic lymphocytic leukemia cells through a p38 mitogen activated protein-kinase-dependent mechanism, 99 Blood 1314, 1315 (2002).
James Bessan, Patent Thickets: Strategic Patenting of Complex Technologies, 1 (2004).
James Smeeding et al, Biosimilars: Considerations for Payers, 44 (2019).
Jan Krauß & David Kuttenkeuler, When to file for a patent? The scientist’s perspective, 60 New Biotechnology 126, 127 (2021).
Jane F. Djung, Insufficient Mechanisms for Orange Book Corrections and FDA’s Ministerial Role: A Need for Reform Note, 47 Connecticut L.aw Review 232 (2014).
Jeffery. R. Gargano & Zachary D. Miller, Taking Advantage of the New Purple Book Patent Requirements for Biologics (Apr. 26, 2021) Morgan Lewis, https://www.morganlewis.com/pubs/2021/04/taking-advantage-of-the-new-purple-book-patent-requirements-for-biologics.
Jeffery Wu & Claire Wan-Chiung Cheng. Into the Woods: A Biologic Patent Thicket Analysis, 19 Chicago-Kent Journal of Intellectual Property 130 (2020).
Jeanne C. Fromer, Dynamic Patent Dsiclosure, 69, Vanderbilt Law Reiew 1715, 1716 (2016).
Jennifer Honek, Preclinical research in drug development, 26 Med. Writing 6,7 (2017).
Jihene Elloumi et al., Monoclonal Antibodies as Cancer Therapeutics, 6 Recent Patent on. Biotechnology 45 (2012).
Jinoos Yazdany, Failure to Launch: Biosimilar Sales Continue to Fall Flat in the United States, 72 Arthritis Rheumatology 870 (2020).
John RP Tesser et al, Biosimilars and the extrapolation of indications for inflammatory conditions, 11 Biologics 5 (2017).
Johnson & Johnson, Janssen Products, LP Modifies Prescribing Information For PROCRIT® (Epoetin alfa) In Chronic Kidney Disease, Johnson & Johnson, https://www.jnj.com/media-center/press-releases/janssen-products-lp-modifies-prescribing-information-for-procrit-epoetin-alfa-in-chronic- kidney-disease.
Johnson & Johnson, Johnson & Johnson Announces Completion of Merger with Centocor, Inc. (Oct. 6, 1999), Johnson & Johnson, https://johnsonandjohnson.gcs-web.com/news-releases/news-release-details/johnson-johnson-announces-completion-merger-centocor-inc/.
John George, Remicade marker Centocor Ortho Biotech changing name (Jun. 22, 2011), PHILADELPHIA BUSINESS JOURNAL, https://www.bizjournals.com/philadelphia/blog/john-george/2011/06/remicade-maker-centocor-ortho-biotech.html.
John W. Cook et al, Academic oncology clinician’s understanding of biosimilars and information needed before prescribing, 11 Therapeutic Advances in Medical Oncology 8 (2019).
Jonathan J. Darrow, The Patentability of Enantiomers: Implications for the Pharmaceutical Industry, 2 Stanford Technology Law Review 46 (2007).
Jonathan J. Darrow et al., Will inter partes review speed US generic drug entry?, 35 Nature Biotechnology 1139, 1140 (2017).
Jorge L. Contreras, Is Biopharma Ready For The Standards Wars?, 7 Texas A&M Journal of Property Law 80 (2020).
Juatao Lou et al., Biomakers for Hepatocellular Carcinoma, 9 Biomark. Cancer 1 (2017).
Kristin H. Kain, Anti-angiogenic drugs to treat human disease: an interview with Napoleone Ferrara, 2 Disease Model & Mechanisms 324, 325 (2009).
László Gulácsi et al., Biosimilars for the management of rheumatoid arthritis: economic consideration, 11 Expert Review of Clinical Immunology 45 (2015).
Laura Magazzini et al., Patent Disclosure and R&D competition in Pharmaceuticals, 18 Econ. Innov. New Technol. 7 (2009).
Lei Diao & Bernd Meibohm, Pharmacokinetics and pharmacokinetic-pharmacodynamic correlations of therapeutic peptides, 52 Clin. Pharmacokinet. 856, 857 (2013).
Lim Jeong Yeo, Samsung Biologics no longer a holding company of Samsung Bioepis (Apr. 5, 2019), The Korea Herald, http://www.koreaherald.com/view.php?ud=20190405000694.
Lim Jeong Yeo, Samsung Biologics gains FDA approval for Humira biosimilar (Jul. 24, 2019).
Lisa Urquhart, Top companies and drugs by sales in 2020, 20 Nature Review Drug Discovery 253 (2021).
Louise C. Druedahl et al., A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual property and abbreviated approval pathways, 38 Nature Biotechnology 1254 (2020).
Luca Falzone et al., Evolution of Cancer Pharmacological Treatments at the Turn of the Third Millennium, 9 Front. Pharmacol. 9 (2018).
Lutz Heinemann et al., An Overview of Current Regulatory Requirements for Approval of Biosimilar Insulin, 17 Diabetes Technol. Ther. 511, 512 (2015).
Lynne A. Bui et al., Key Considerations in The Preclinical Development Of Biosimilars, 20 Drug Discovery Today 3, 4 (2015).
K.C. Nicolaou, Advancing the drug discovery and development process, 53 Angewandte Chemie International Edition in Engish. 9285 (2014).
Kengo Daidoji et al., Effects of new formulation strategy on life cycle management in the US pharmaceutical industry, 10 Journal of Generic Medicines 172, 178 (2013).
Kresse Georg-Burkhard, Biosimilars-Science, status, and strategic perspective, 72 European Journal of Pharmaceutics and Biopharmaceutics 480 (2009).
Kristina M. Lybecker, Essay: When Patents Aren’t Enough: Why Biologics Necessitate Data Exclusivity Protection, 40 William Mitchell Law Review 1430, 1431(2014).
László Hajba et al., On the glycosylation aspects of biosimilarity. 23 Drug Discovery Today 619 (2018).
Malgorzata Kesik-Brodacka, Progress in biopharmaceutical development, Biotechnol. Appl. Biochem. 306 (2017)
Makurvet Favour Danladi. Biologics vs. small molecules : Drug costs and patient access, 9 Medicine in Drug Discovery 2 (2021).
Marcus Holgersson et al., Entrepreneurial patent management in pharmaceutical stratups, 21 Drug Discovery Today 1043 (2016).
Maria Corena-McLeod, Comparative Pharmacology of Risperidone and Paliperidone, 15 Drugs in R.&D 164 (2015).
Martin Schiestl et al., Acceptable changes in quality attributes of glycosylated biopharmaceuticals, 29 Nature Biotechnology 300 (2011).
McCamish M et al., Toward interchangeable biologics, 97 Clinical Pharmacology & Therapeutics 216 (2015).
Merck Merck Announces US Launch of ONTRUZANT® (trastuzumab-dttb), a Biosimilar of Herceptin® (trastuzumab), Merck, https://www.businesswire.com/news/home/20200415005021/en/Merck-Announces-US-Launch-of-ONTRUZANT%C2%AE-trastuzumab-dttb-a-Biosimilar-of-Herceptin%C2%AE-trastuzumab.
Michael B Bracken, Why animal studies are often poor predictors of human reaction to exposure, 101 Journal of the Royal Society of Medicine 121 (2008).
Michael Gibney, Pfizer complains to FDA about J&J, Amgen Comments on biosimilar products (Sep. 4, 2018), S&P Global Market Intelligence, https://www.spglobal.com/marketintelligence/en/news-insights/latest-news-headlines/pfizer-complains-to-fda-about-j-j-amgen-comments-on-biosimilar-products-46275504.
Michael Sarshad, Major lessons learned from Zarxio’s US launch: the start of a biosimilar revolution, 6 GaBi Generics and Biosimilars Initiative (2017).
Michele Boldrin & David K Levine, Rent-seeking and innovation, 51 J. Monet. Econ. 128 (2004).
Michele K. Dougherty et al., Perspective on the Current State of the Biosimilar Regulatory Pathway in the United States, 103 Clinical Pharmacology & Therapeutics 37 (2018).
Mike Z. ZHai et al., Why Are Biosimilars Not Living up to Their Promise in the US?, 21 AMA Journal of Ethnic 669 (2019).
Mylan, U.S. FDA Approves Mylan and Biocon`s Fulphila™ (pegfilgrastim-jmdb), the First Biosimilar to Neulasta® (Jun. 4, 2018), Mylan, https://investor.mylan.com/news-releases/news-release-details/us-fda-approves-mylan-and-biocons-fulphilatm-pegfilgrastim-jmdb.
Nataša Škalko-Basnet, Biologic: the role of delivery system in improved therapy, 8 Biol. Targets Ther. 108 (2014).
Novartis, Sandoz receives US FDA approval for long-acting oncology supportive care biosimilar Ziextenzo™ (pegfilgrastim-bmez) Novartis (Nov. 5, 2019), Novartis, https://www.novartis.com/news/media-releases/sandoz-receives-us-fda-approval-long-acting-oncology-supportive-care-biosimilar-ziextenzo-pegfilgrastim-bmez.
Palak K. Patel et al., Biologics and biosimilars, 26 Journal of Dermatological Treatment 299, 300 (2015).
Paul Declerck et al., The Language of Biosimilars: Clarification, Definitions, and Regulatory Aspects, 77 Drugs 671, 672 (2017).
Pfizer, FDA Approves Inflectra™ (Biosimilar Inflizmab), The First U.S. Biosimilar Monoclonal Antibody, For All Eligible Indications (Apr. 5, 2016), Pfizer, https://www.pfizer.com/news/press-release/press-release-detail/fda_approves_inflectra_biosimilar_infliximab_the_first_u_s_biosimilar_monoclonal_antibody_for_all_eligible_indications.
Pfizer, FDA APPROVES NEW PFIZER BIOSIMILAR (Dec 13, 2017), Pfizer, https://www.pfizer.com/news/press-release/press-release-detail/fda_approves_new_pfizer_biosimilar; See Dan Stanton, Pfizer: ‘No plans to launch second approved Remicade biosimilar in US’ (Dec. 14, 2017), BioPharma, https://www.biopharma-reporter.com/Article/2017/12/14/Pfizer-No-plans-to-launch-second-infliximab-biosimilar-in-US.
Pfizer, FDA APPROVES PFIZER’S BIOSIMILAR, ABRILADA™ (ADALIMUMAB-AFZB) FOR MULTIPLE INFLAMMATORY CONDITION, Pfizer, (Nov. 18, 2019), https://www.pfizer.com/news/press-release/press-release-detail/fda_approves_pfizer_s_biosimilar_abrilada_adalimumab_afzb_for_multiple_inflammatory_conditions.
Pfizer, NIVESTYMTM, a biosimilar to Neupogen® (filgrastim), is Pfizer’s fourth biosimilar to be approved by the FDA (Jul. 20, 2018), Pfizer, https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_pfizer_s_biosimilar_nivestym_filgrastim_aafi-0.
Pfizer, FDA APPROVES PFIZER’S ONCOLOGY SUPPORTIVE CARE BIOSIMILAR, NYVEPRIA™ (PEGFILGRASTIM-APGF (Jun. 11, 2020), Pfizer, https://investors.pfizer.com/investor-news/press-release-details/2020/FDA-Approves-Pfizers-Oncology-Supportive-Care-Biosimilar-NYVEPRIA-pegfilgrastim-apgf/default.aspx.
Pfizer, FOR CERTAIN CANCERS AND AUTOIMMUNE CONDITIONS (Jul. 23, 2019), Pfizer, https://www.pfizer.com/news/press-release/press-release-detail/fda_approves_pfizer_s_biosimilar_ruxience_rituximab_pvvr_for_certain_cancers_and_autoimmune_conditions.
Pfizer, PFIZER’S BIOSIMILAR RETACRIT® (EPOETIN ALFA-EPBX) APPROVED BY U.S. FDA, Pfizer, https://www.pfizer.com/news/press-release/press-release-detail/pfizer_s_biosimilar_retacrit_epoetin_alfa_epbx_approved_by_u_s_fda.
Pfizer, PFIZER RECEIVES U.S. FDA APPROVAL FOR ITS ONCOLOGY BIOSIMILAR, ZIRABEV™ (BEVACIZUMAB-BVZR), Pfizer, (Jun. 28, 2019), https://www.pfizer.com/news/press-release/press-release-detail/pfizer_receives_u_s_fda_approval_for_its_oncology_biosimilar_zirabev_bevacizumab_bvzr.
Pfizer, U.S. FDA APPROVES PFIZER’S ONCOLOGY BIOSIMILAR TRAZIMERA™ (TRASTUZUMAB-QYYP), A BIOSIMILAR TO HERCEPTIN®1 (Mar. 11, 2019), Pfizer, https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_pfizer_s_oncology_biosimilar_trazimera_trastuzumab_qyyp_a_biosimilar_to_herceptin_1.
Ping Li et al., Drugs for Autoimmune Inflammatory Disease: From Small Molecule compounds to Anti-TNF Biologics, 12 Front. Pharmacol. 8 (2017).
Price W. Nicholson & Arti K. Rai., Are trade secrets delaying biosimilars?, 348 Science 188, 189 (2015).
Rahul Vijh, Understanding Danages Calculation in SEP litigation (Jan. 30, 2021), https://www.ipwatchdog.com/2021/01/30/understanding-damages-calculation-sep-litigation/id=129501/.
Rajendra K. Bera, Standard-Essential Patents (SEPs) and “fair, reasonable and non-discriminatory” (FRAND) licensing, 1 (2018), https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2557390.
Reed F. Beall et al., Comparing Onset of Biosimilar Versus Generics Competition in the United States, 108 Clinical Pharmacology & Therapeutics 1308 (2020).
Research group of Jón Tryggvi Njarðarson at the university of Arizona, Top Pharmaceuticals Poster, The research group of Jón Tryggvi Njarðarson at the university of Arizona, https://njardarson.lab.arizona.edu/content/top-pharmaceuticals-poster (last visited Feb. 13, 2021).
Richard Markus et al., Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community, 31 BioDrug 176 (2017).
Richard G. Fran et al, Biosimilar Competition Early Learning (Mar. 2021), Working paper 28460, National Bureau of Economic Research, http://www.nber.org/papers/w28460.
Ritbika Kulatbila, BPCIA Update: Entropy Is the Price of an Ordered Framework, 33 BERKELEY TECH. L.J. 1277, 1278 (2018).
Robin Feldman, May your drug price be evergreen, 5 Journal of Law and the Biosciences 590 (2018).
Ronald Evens & Kenneth Kaitin, The Evolution Of Biotechnology And Its Impact On Health Care, 34 Health Aff. 213, 214 (2015).
Ryan Vacca, Patent Reform and Best Mode : a Signal to the Patent Office or a Step Toward Eliminations?, 75 Albany Law Review 288 (2012).
Samsung Bioepis, Samsung Bioepis Announces RENFLEXIS™(infliximab-abda) Now Available in the United States (Jul. 24, 2017), Samsung Bioepis, https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=24.
Sandoz, FDA approves first biosimilar ZarxioTM (filgrastim-sndz) from Sandoz (Mar. 6, 2015), Sandoz, https://www.sandoz.com/news/media-releases/fda-approves-first-biosimilar-zarxiotm-filgrastim-sndz-sandoz.
Sandoz, FDA approves Sandoz ErelziTM to treat multiple inflammatory disease (Aug. 30, 2016), Sandoz, https://www.sandoz.com/news/media-releases/fda-approves-sandoz-erelzitm-treat-multiple-inflammatory-diseases.
Sandoz, The Sandoz Brand, Sandoz, https://www.sandoz.com/about-us/who-we-are/sandoz-brand (last visited Feb. 14, 2021).
Sandoz, Sandoz receives US FDA approval for biosimilar Hyrimoz™ (adalimumab-adaz) (Oct. 31, 2018), Sandoz, https://www.sandoz.com/news/media-releases/sandoz-receives-us-fda-approval-biosimilar-hyrimoz-adalimumab-adaz.
Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664, 198 L. Ed. 2d 114 (2017).
Sandra Prior et al, Maintaining “standards” for biosimilar monoclonal antibodies, 39 Nature Biotechnology 276 (2021).
Scherer, F. M. The unusual importance of drug patent, The pharmaceutical industry, Handbook of Health Economics, 1318 (2010).
Sohn Ji young, Celltrion to seek US approval for Truxima, Herzuma (May 2, 2017).
Stacie Ropka et al., Opinion: Purple Book Patent Listings Are Only a First Step (May 8, 2021), AJMC THE CENTER FOR BIOSIMILARS, https://www.centerforbiosimilars.com/view/opinion-purple-book-patent-listings-are-only-a-first-step.
Stanton Mehr, Can Biosimilars Be Protected By Patent? (Aug. 15, 2017), BIOSIMILARS REVIEW & REPORT, https://biosimilarsrr.com/2017/08/15/can-biosimilars-be-protected-by-patent/.
Stephen A. Merrill et al., Seven Criteria for Evaluating the Patent System, A Patent System for the 21st Century, Washington, DC: The National Academies Press, 41. (2004).
SureChEMBL, https://www.surechembl.org/search/ (last visited Mar. 13, 2021).
Teva, Teva and Celltrion Healthcare Announce the Launch of TRUXIMA® (rituximab-abbs) Injection for Rheumatoid Arthritis, the Only Biosimilar to Rituxan® (rituximab) Available in the United States for This Indication (May 4, 2020), Teva, https://www.businesswire.com/news/home/20200504005064/en/Teva-and-Celltrion-Healthcare-Announce-the-Launch-of-TRUXIMA%C2%AE-rituximab-abbs-Injection-for-Rheumatoid-Arthritis-the-Only-Biosimilar-to-Rituxan%C2%AE-rituximab-Available-in-the-United-States-for-This-Indication.
Teva Pharms. USA, Inc. v. U.S. Food & Drug Admin., No. 20-808 (BAH), 2020 WL 7828788, (D.D.C. 2020).
Thomas Morrow, Defining The Difference What Makes Biologics Unique, 1 Biotechnology Healthcare 1 (2004).
Tony Hagen, The Difference Between an Interchangeable Biosimilar and One That Isn’t (May 5 2021), AJMC THE CENTER FOR BIOSIMILARS, https://www.centerforbiosimilars.com/view/the-difference-between-an-interchangeable-biosimilar-and-one-that-isn-t.
U.S. DEPARTMENT OF JUSTICE AND THE FEREDAL TRADE COMMISION, ANTITRUST ENFORCEMENT AND INTERLLECTUAL PROPERTY RIGHTS: Promoting Innovation and Competition, 36 (2007).
U.S. Food & Drug Administration, Biosimilar and Interchangeable Products, U.S. FOOD & DRUG ADMINISTRATION, https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products#reference (last visited Feb. 10, 2021).
U.S. Food & Drug Administration, Considerations in Demonstrating Interchangeability with a Reference Product Guidance for Industry (May 13, 2019), U.S. FOOD & DRUG ADMINISTRATION, https://www.fda.gov/media/124907/download.
U.S. Food & Drug Administration, Drug Approval Package: YONSA (abiraterone acetate), U.S. FDA, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210308Orig1s000TOC.cfm (last visited Apr. 18, 2021).
U.S. Food & Drug Administration, Drug@FDA: FDA-Approved Drugs, U.S. FOOD & DRUG ADMINISTRATION, https://www.accessdata.fda.gov/scripts/cder/daf/ (last visited Feb. 13, 2021).
U.S. Food & Drug Administration, Investigational New Drug (IND) Application, U.S. FOOD & DRUG ADMINISTRATION, https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application (May 23, 2021).
U.S. Food & Drug Administration, Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, U.S. FOOD & DRUG ADMINISTRATION, https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm (last visited Feb. 13, 2021).
U.S. Food & Drug Administration, Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings Institution on the release of the FDA’s Biosimilars Action Plan (Jul. 18, 2018), U.S. FOOD & DRUG ADMINISTRATION, https://www.fda.gov/news-events/press-announcements/remarks-fda-commissioner-scott-gottlieb-md-prepared-delivery-brookings-institution-release-fdas.
U.S. Food & Drug Administration, Paragraph IV Patent Certification (Apr. 6 2021), U.S. FDA, https://www.fda.gov/media/133240/download.
U.S. Food & Drug Administration, What Are “Biologics” Questions and Answers, U.S. FOOD & DRUG ADMINISTRATION, https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/what-are-biologics-questions-and-answers (last visited Feb. 10, 2021).
U.S. FOOD & DRUG ADMINISTRATION, https://www.fda.gov/drugs/biosimilars/biosimilar-product-information (last visited Feb. 13, 2021).
U.S. Patent No 5,649,904.
U.S. Patent No 8,492,551.
U.S. Patent No. 9,458,168.
U.S. Patent No. 10,444,250.
U.S. Patent No. 20,020,111,475.
U.S. Patent No. 20,030,096,400.
U.S. Patent No.20,120,328,626.
U.S. Patent No. 20,040,076,626.
U.S. Patent No. 20,070,093,418.
U.S. Patent No. 20,160,096,892.
U.S. Patent No. 20,170,028,063.
U.S. Patent No. 20,180,230,180.
Xiao Feng Le et al., HER2-targeting Antibodies Modulate the Cyclin-dependent Kinase Inhibitor p27Kip1 via Multiple Signaling Pathways, 4 Cell Cycle 88 (2004).
Wallflowers: biosimilars don’t dance - they go to the PTAB, LEXOLOGY, https://www.lexology.com/library/detail.aspx?g=25b6df6f-2092-4074-a7d7-e9f867316faa (Last visvited: Jun. 25, 2021).
W. Nicholson Price & Arti K. Rai, Manufacturing Barriers to Biologics Competition and Innovation, 101 Lowa Law Review 1051 (2016).
Yaniv Heled, The Biologics Price Competition and Innovation Act 10--A Stocktaking, 7 TEXAS A&M J. PROP. L. 87, 100 (2021).
Yasser R. & Jonathan E. R., Abiraterone acetate: oral androgen biosynthesis inhibitor for treatment of castration-resistant prostate cancer, 6 Drug Design, Development and Therapy 15 (2012)
Zorzal P. B. et al., Sufficiency of disclosure and genus claims for protection of biological sequences: a comparative study among the patent offices in Brazil, Europe and the United States, 3 Biotechnology Research and Innovation, 97, 98 (2019). |
| Description: | 碩士
國立政治大學
科技管理與智慧財產研究所
106364201 |
| Source URI: | http://thesis.lib.nccu.edu.tw/record/#G0106364201 |
| Data Type: | thesis |
| DOI: | 10.6814/NCCU202101494 |
| Appears in Collections: | [科技管理與智慧財產研究所] 學位論文
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