Devising a Patent Strategy to Protect the IP of Biologics in Light of ambiguities, Loopholes and Pitfalls in the Regulatory Scheme

Abstract

Pharmaceutical Patent AnalystVol. 2, No. 2 EditorialDevising a patent strategy to protect the IP of biologics in light of ambiguities, loopholes and pitfalls in the regulatory schemeBenjamin C Hsing & Sapna W PallaBenjamin C Hsing* Author for correspondenceKaye Scholer LLP, 425 Park Avenue, New York, NY 10022–3598, USA. Search for more papers by this authorEmail the corresponding author at benjamin.hsing@kayescholer.com & Sapna W PallaKaye Scholer LLP, 425 Park Avenue, New York, NY 10022–3598, USASearch for more papers by this authorPublished Online:26 Feb 2013https://doi.org/10.4155/ppa.13.8AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit View articleKeywords: biologicsbiosimilarsexclusivitypatent strategypreliminary injunctionPapers of special note have been highlighted as: ▪ of interestReferences1 42 U.S.C. §262.Google Scholar2 42 U.S.C. §262(l)(2).Google Scholar3 42 U.S.C. §262(l)(3)(A).Google Scholar4 42 U.S.C. §262(l)(3)(B).Google Scholar5 42 U.S.C. §262(l)(3)(B).Google Scholar6 42 U.S.C. §262(l)(3)(C).Google Scholar7 42 U.S.C. §262(l)(4)(A)–(4)(B).Google Scholar8 42 U.S.C. §262(l)(6)(A).Google Scholar9 42 U.S.C. §262(l)(5)(A).Google Scholar10 42 U.S.C. §262(l)(5)(B)(i).Google Scholar11 42 U.S.C. §262(l)(5)(A)(ii).Google Scholar12 42 U.S.C. §262(l)(6)(B).Google Scholar13 42 U.S.C. §262(l)(3), (4) or 5(B).Google Scholar14 42 U.S.C. §262(l)(9)(A).Google Scholar15 35 U.S.C. §271(e)(2)(C).▪ This section states that it “shall be an act of infringement to submit … (i) with respect to a patent that is identified in the list of patents described in section 351(l)(3) of the Public Health Service Act (including as provided under section 351(l)(7) of such Act), an application seeking approval of a biological product, or (ii) if the applicant for the application fails to provide the application and information required under section 351(l)(2)(A) of such Act, an application seeking approval of a biological product for a patent that could be identified pursuant to section 351(l)(3)(A)(i) of such Act…”Google Scholar16 42 U.S.C. §262(l)(8)(A).Google Scholar17 42 U.S.C. §262(l)(8)(B).Google Scholar18 35 U.S.C. §271(e)(4).Google Scholar19 42 U.S.C. §262(k)(6).▪ A biosimilar is deemed to be ‘interchangeable’, if it ‘may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product’. 42 U.S.C. §262(i)(3).Google Scholar20 42 U.S.C. §262(k)(6)(A).Google Scholar21 42 U.S.C. §262(k)(6)(B).▪ A ‘final court decision’ means a final decision of the appellate court.Google Scholar22 42 U.S.C. §262(k)(7)(A).Google Scholar23 42 U.S.C. §262(k)(7)(B).Google ScholarFiguresReferencesRelatedDetails Vol. 2, No. 2 Follow us on social media for the latest updates Metrics Downloaded 137 times History Published online 26 February 2013 Published in print March 2013 Information© Future Science LtdKeywordsbiologicsbiosimilarsexclusivitypatent strategypreliminary injunctionFinancial & competing interests disclosureThe authors have 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