Abstract：OBJECTIVE To explore and analyze the intellectual property protection system related to the registration of biological products in the United States. METHODS Domestic and foreign documents were consulted, the background of the US "Biologics Price Competition and Innovation Act" was reviewed, the use of the patent dance system in the United States was sorted to resolve various patent disputes. RESULTS The data protection system is parallel to patents. The application for biosimilar drugs is submitted within the 12-year protection period. Before the FDA has not approved it, the patent dance system uses the information exchange process between the biosimilar drug company and the original research company to identify relevant patents and the scope of patent litigation shall be determined through good faith negotiation, minimize the pressure of patent litigation, strive to resolve patent disputes before biosimilars are marketed, and accelerate the listing of biosimilars, so as to improve the availability of medicines to the public. CONCLUSION The particularity of biological products causes the early resolution of patent issues to be more complicated than chemical drugs, and it is not appropriate to use the same model as chemical drugs to resolve disputes.
齐云, 杨悦, 邢花. 美国生物制品注册早期相关知识产权制度研究[J]. 中国药学杂志, 2022, 57(3): 242-248.
QI Yun, YANG Yue, XING Hua. Intellectual Property System Related to Biologics Early Registration in the United States. Chinese Pharmaceutical Journal, 2022, 57(3): 242-248.
ZELENETZ A D, AHMED I, BRAUD E L, et al. NCCN biosimilars white paper: regulatory, scientific, and patient safety perspectives[J]. Natl Compr Canc Netw, 2011,9 (Suppl 4):S1-S22.
FDA.Biosimilar and interchangeable products[EB/OL]. (2017-10-23) [2021-07-22] https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products.
FENG X C,YANG Y. Balance mechanism study between brand-name drugs and generic drugs in american drug review [J]. Chin Pharm J (中国药学杂志),2018,53(11):938-944.
TIMMIS R. The biologics price competition and innovation act: potential problems in the biologic-drug regulatory scheme[J]. J Int Human Rights, 2015, 8(4):26-35.
FDA. Biosimilar development, review, and approval[EB/OL]. (2017-10-20) [2021-7-24]. https://www.fda.gov/drugs/biosimilars/biosimilar-development-review-and-approval.
YAO X F,DING J X. Analysis and strategic choice of biologics data protection system [J]. Intellect Prop(知识产权),2017,192(2):94-98.
FDA.Guidance for industry reference product exclusivity for biological products filed under section 351(a) of the PHS Act [EB/OL]. (2014-08-04)[2020-01-30] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reference-product-exclusivity-biological-products-filed-under-section-351a-phs-act.
YANG L,SONG H L,ZHAO J. Parallel and coexisting research of drug trial data protection and patent protection [J]. Chin J New Drugs(中国新药杂志),2013,22(22):2600-2606,2615.
BIOSIMILARS COUNCIL. FDA Biosimilars Approvals[EB/OL]. (2020-4-23 )[2021-2-12]. https://biosimilarscouncil.org/resource/fda-biosimilars-approvals/.
CHEN Q. Research on conflict between trial data exdusive and patent of drug-from the perspective of drug accessibility[J]. Intellectual Prop(知识产权),2012,(12):56-61.
MARI S. Opportunities and challenges of biosimilars in EU, US and Russia [J]. Sci Focus(科学观察),2018,13(4):40-58.
ZACHARY B.Is FDA doing enough to bring biosimilars to market? experts discuss[EB/OL]. (2019-11-04) [2021-02-21]. https://www.raps.org/news-and-articles/news-articles/2019/11/is-fda-doing-enough-to-bring-biosimilars-to-market.
STACIE R. How 2 recent court cases could impact follow-on biologics strategy[EB/OL]. (2019-07-23) [2021-02-09]. https://www.bioprocessonline.com/doc/how-recent-court-cases-could-impact-follow-on-biologics-strategy-0001.
DOV, HIRSCH. The riddle of the mysterious patent dance wrapped in an enigma: is the patent dance of the BPCIA optional or mandatory?[J]. Ford Intell Prop, Med Entertain Law J,2017,27(3):645-690.
HE Y D. Injunctive relief for patent infringement in the united states [J]. Glob Law Rev(环球法律评论),2009,31(5):124-133.
R0YZMAN I, SHAH K. 10 years of biosimilars: lessons and trends[J]. Nat Rev Drug Dis, 2020, 19(6):375.
ZACHARY B.US supreme court: no six-month wait for biosimilars after FDA approval[EB/OL]. (2017-06-12) [2021-02-22]. https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2017/6/us-supreme-court-no-six-month-wait-for-biosimilars-after-fda-approval.
SUPREME COURT OF THE UNITED STATES.Sandoz Inc. v. amgen inc.[EB/OL]. (2017-06-12) [2021-02-21]. https://www.supremecourt.gov/opinions/16pdf/15-1039_1b8e.pdf.
PATRICH G, DUANE M. Amgen vs. sandoz: who will win over the supreme court?[EB/OL]. (2017-04-26) [2021-02-22]. https://www.bioprocessonline.com/doc/amgen-vs-sandoz-who-will-win-over-the-supreme-court-0001.
FDA. List of licensed biological products with(1) reference product exclusivity and(2) biosimilarity or interchangeability evaluations to date [EB/OL]. (2014-09) [2021-02-07]. https://www.fda.gov/media/105605/download.
BRIAN M J. Biosimilars patent litigation in the EU and the US: a comparative strategic overview[J]. Generics Biosimilars Initiation J,2015, 4(3):113-117.
WIATR C. US biosimilar pathway unlikely to be used[J]. Bio Drugs, 2011, 25(1):63-67.
NMPA. Comments on the implementation measures for the early resolution mechanism of drug patent disputes (Trial) (Draft for Soliciting Comments) [EB/OL]. (2020-09-11) [2020-11-10]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20200911175627186.html.