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Intellectual Property | BIO
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layout--hero-section -rgnWidth100 paneHero"><div class="section-inner"><div class="act-pane__content row"><div class="act-pane__region layout__region layout__region--col-1 col-lg-12 col-md-12 col-sm-12"><div class="mc-cardHero act-component -styleLanding -titleOnly -skinBlue -titleOnly -btnskinTeal -btnoutlineButtonDefaultInvert"><div class="mc-cardHero__rgnInner act-component-inner" style="background-image:url(/sites/default/files/2021-07/banner-default.png)"><div class="mc-cardHero__rgnMain"><div class="mc-cardHero__backLink" ><a class="af-link" href="/policy" aria-label="Policy" >Policy</a></div><h1 class="mc-cardHero__title" ><div class="af-text">Intellectual Property</div></h1></div><div class="mc-cardHero__rgnShare"><div class="mc-a2aShare act-component -popLeft -skinLight"><div class="mc-a2aShare__rgnInner act-component-inner"><div class="mc-a2aShare__shareButton jsShareTrigger"><a><i class="fas fa-share-alt"></i></a></div><div class="mc-a2aShare__shareFlyout jsShareFlyout"><div 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href="/policy/international/global-markets-trade">Global Markets & Trade</a><a class="dropdown-item menuL2 " id="h5i8BW" href="/policy/international/multilateral-organizations">Multilateral Organizations</a><a class="dropdown-item menuL2 " id="n1FZro" href="/policy/international/bio-launches-call-biotechnology-stories">BIO launches call for biotechnology stories</a></div></li><li class="nav-item dropdown"><a class="nav-link dropdown-toggle menuL1 " href="/policy/intellectual-property" id="d2freq" data-toggle="dropdown" aria-haspopup="true" aria-expanded="false">Intellectual Property</a><div class="dropdown-menu" aria-labelledby="d2freq"><a class="dropdown-item menuL2 " id="aiy6jH" href="/policy/intellectual-property">Overview</a><a class="dropdown-item menuL2 " id="lJT0nA" href="/policy/intellectual-property/patents">Patents</a><a class="dropdown-item menuL2 " id="zcrSzh" href="/policy/intellectual-property/regulatory-data-protection">Regulatory Data Protection</a><a class="dropdown-item menuL2 " id="jEQ6BK" href="/policy/intellectual-property/technology-transfer">Technology Transfer</a></div></li></ul></div></div></div></nav></div></div></div></div></div></div></div></div></div></div></div></div></div></div><div class="act-layout act-pane layout layout--bs-columns layout--top -rgnWidth100 paneTop"><div class="section-inner"><div class="act-pane__content row"><div class="act-pane__region layout__region layout__region--col-1 col-lg-12 col-md-12 col-sm-12"></div></div></div></div><div class="act-layout act-pane layout layout--bs-columns layout--body -rgnWidth100 paneBody"><div class="section-inner"><div class="act-pane__content row"><div class="act-pane__region layout__region layout__region--col-1 col-lg-12 col-md-12 col-sm-12"><div class="mc-contentBasic act-component"><div class="mc-contentBasic__rgnInner act-component-inner"><div class="oc-compoList act-component"><div class="oc-compoList__rgnInner act-component-inner"><div class="oc-compoList__rgnSection"><div class="oc-widgetPane act-pane -rgnWidth80"><div class="oc-widgetPane__rgnInner section-inner act-pane-inner"><div class="act-pane__content"><div class="oc-widgetPane__rgnList row"><div class="oc-widgetPane__rgnCell rowFirst rowLast col-lg-12 col-md-12 col-sm-12"><div class="mc-contentBasic act-component"><div class="mc-contentBasic__rgnInner act-component-inner"><div class="mc-contentBasic__body" ><div class="af-text"><p>Intellectual property is the lifeblood of the biotechnology industry. Strong patents, and an efficient, predictable, and objective patent system, are critical to ensuring a steady stream of capital to biotechnology companies developing innovative medicines, alternative energy sources, insect- and drought-resistant crops, and a wide range of other innovative biotechnologies that are helping to feed, fuel, and heal our planet. This quintessentially-American industry leads the world in innovation, providing the United States with a global competitive advantage and spurring economic growth and the creation of high-paying jobs here at home.</p></div></div></div></div></div></div></div></div></div></div><div class="oc-compoList__rgnSection"><div class="oc-widgetPane act-pane -rgnWidth90"><div class="oc-widgetPane__rgnInner section-inner act-pane-inner"><div class="act-pane__content"><div class="oc-widgetPane__rgnList row"><div class="oc-widgetPane__rgnCell rowFirst rowLast col-lg-12 col-md-12 col-sm-12"><div class="embedEventSectionPane"><div class="oc-widgetPane act-pane -rgnWidth80"><div class="oc-widgetPane__rgnInner section-inner act-pane-inner"><div class="act-pane__content"><div class="oc-widgetPane__rgnList row"><div class="oc-widgetPane__rgnCell rowFirst col-lg-12 col-md-12 col-sm-12"><div class="mc-cardMediaSide act-component -mediaImage -imageLeft -btnsolidButtonDefaultInvert -btnskinBlue -heightFixed"><div class="mc-cardMediaSide__rgnInner act-component-inner"><div class="mc-cardMediaSide__rgnMain row"><div class="col-lg-6 col-md-12 col-sm-12"><div class="mc-cardMediaSide__rgnMedia"><div class="mc-cardMediaSide__image" ><img src="/sites/default/files/styles/bio_media_side_card_auto/public/2019-12/webinar.JPG?itok=A4h3_F94" alt="Webinar" class="af-image"></div></div></div><div class="col-lg-6 col-md-12 col-sm-12"><div class="mc-cardMediaSide__rgnContent"><div class="mc-cardMediaSide__info"><div class="mc-cardMediaSide__title" ><div class="af-text">Navigating Parallel BPCIA and PTAB Proceedings – Recent Developments and Strategic Consideration</div></div><div class="mc-cardMediaSide__description" ><div class="af-text"><p><strong>Wednesday, January 26, 1:00 pm EDT</strong></p><p>This panel will discuss recent developments in BPCIA litigation, PTAB practice, and potential legislative and policy reforms that may be on the horizon.</p></div></div></div><div class="mc-cardMediaSide__ctaLink"><a class="af-link solidButtonDefaultInvert -skinBlue " href="https://www.bio.org/ip-webinar-series" aria-label="Learn More">Learn More</a></div></div></div></div></div></div></div><div class="oc-widgetPane__rgnCell rowLast col-lg-12 col-md-12 col-sm-12"><div class="mc-cardMediaSide act-component -mediaImage -imageRight -btnsolidButtonDefaultInvert -btnskinBlue -heightFixed"><div class="mc-cardMediaSide__rgnInner act-component-inner"><div class="mc-cardMediaSide__rgnMain row"><div class="col-lg-6 col-md-12 col-sm-12"><div class="mc-cardMediaSide__rgnContent"><div class="mc-cardMediaSide__info"><div class="mc-cardMediaSide__title" ><div class="af-text">Explore What's New in Biotech IP</div></div><div class="mc-cardMediaSide__description" ><div class="af-text"><p><strong>Biotech Intellectual Property Law in Focus</strong> is a new webinar series offering timely, relevant insights into the latest issues in the biotech intellectual property sector. This focused webinar series will cover what's new and important in the biotech IP landscape today, featuring expert perspective and information you can put into practice the very next day. </p></div></div></div><div class="mc-cardMediaSide__ctaLink"><a class="af-link solidButtonDefaultInvert -skinBlue " href="https://www.bio.org/ip-webinar-series" aria-label="Learn More">Learn More</a></div></div></div><div class="col-lg-6 col-md-12 col-sm-12"><div class="mc-cardMediaSide__rgnMedia"><div class="mc-cardMediaSide__image" ><img src="/sites/default/files/styles/bio_media_side_card_auto/public/2020-08/244925_BIO_IPCC_Web_555x364%5B10%5D_0.jpg?itok=eZmvbfn9" alt="IPCC_Webinar-Series-MSC" class="af-image"></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div><div class="oc-compoList__rgnSection"><div class="oc-widgetPane act-pane -rgnWidth80"><div class="oc-widgetPane__rgnInner section-inner act-pane-inner"><div class="act-pane__content"><div class="oc-widgetPane__rgnList row"><div class="oc-widgetPane__rgnCell rowFirst rowLast col-lg-12 col-md-12 col-sm-12"><div class="mc-cardMediaSide act-component -mediaImage -imageRight -heightFixed -btnskinPurple -btnsolidButtonDefault"><div class="mc-cardMediaSide__rgnInner act-component-inner"><div class="mc-cardMediaSide__rgnMain row"><div class="col-lg-7 col-md-12 col-sm-12"><div class="mc-cardMediaSide__rgnContent"><div class="mc-cardMediaSide__info"><div class="mc-cardMediaSide__title" ><div class="af-text">IP Attaché Program</div></div><div class="mc-cardMediaSide__description" ><div class="af-text"><p>BIO works with the United States Patent and Trademark Office’s (USPTO) <a href="https://www.uspto.gov/ipattache" target="_blank">IP attaché program</a>, which strives to improve Intellectual property (IP) systems internationally for the benefit of U.S. stakeholders. IP attachés are posted at U.S. missions around the world to address IP issues arising in their assigned regions. </p></div></div></div><div class="mc-cardMediaSide__ctaLink"><a class="af-link -skinPurple solidButtonDefault " href="https://www.uspto.gov/learning-and-resources/ip-policy/intellectual-property-attach-program/find-attach" aria-label="Find an attaché in your region">Find an attaché in your region</a></div></div></div><div class="col-lg-5 col-md-12 col-sm-12"><div class="mc-cardMediaSide__rgnMedia"><div class="mc-cardMediaSide__image" ><img src="/sites/default/files/styles/bio_media_side_card_auto/public/2019-11/MSC_USPTO.png?itok=re3ITBZ0" alt="USPTO" class="af-image"></div></div></div></div></div></div></div></div></div></div></div></div><div class="oc-compoList__rgnSection"><div class="oc-widgetPane act-pane -rgnWidth80"><div class="oc-widgetPane__rgnInner section-inner act-pane-inner"><div class="act-pane__content"><div class="oc-widgetPane__rgnList row"><div class="oc-widgetPane__rgnCell rowFirst rowLast col-lg-12 col-md-12 col-sm-12"><div class="mc-contentBasic act-component"><div class="mc-contentBasic__rgnInner act-component-inner"><div class="mc-contentBasic__body" ><div class="af-text"><div class="oc-itemList act-pane -linkBelow -headerLarge"><div class="oc-itemList__rgnInner section-inner act-pane-inner"><div class="act-pane__titleWrapper"><div class="act-pane__title" ><div class="af-text">Amicus Briefs</div></div></div><div class="act-pane__header"><div class="act-pane__moreLink" ><a class="af-link" href="/amicus-briefs" aria-label="Browse all Amicus Briefs" >Browse all Amicus Briefs</a></div></div><div class="act-pane__content"><div class="oc-itemList__rgnList"><div class="mc-teaserBasic act-component -fontMedium -textOnly"><div class="mc-teaserBasic__rgnInner act-component-inner"><div class="mc-teaserBasic__rgnMain"><div class="mc-teaserBasic__titleLink" ><a class="af-link" href="/amicus-briefs/bio-files-amicus-brief-california-supreme-court-continuing-gilead-tenofovir-cases" aria-label="BIO Files Amicus Brief in California Supreme Court in Continuing Gilead Tenofovir Cases" >BIO Files Amicus Brief in California Supreme Court in Continuing Gilead Tenofovir Cases</a></div><div class="mc-teaserBasic__summary" ><div class="af-text">November 4, 2024</div></div><div class="mc-teaserBasic__description" ><div class="af-text">BIO filed an amicus brief in the Supreme Court of the State of California, encouraging its review of the lower court decision in the Gilead Tenofovir Cases.The Court of Appeal decision operates from a misunderstanding of the drug development and FDA approval processes, particularly failing to see…</div></div></div></div></div><div class="mc-teaserBasic act-component -fontMedium -textOnly"><div class="mc-teaserBasic__rgnInner act-component-inner"><div class="mc-teaserBasic__rgnMain"><div class="mc-teaserBasic__titleLink" ><a class="af-link" href="/amicus-briefs/bio-files-amicus-brief-continuing-effort-preserve-fdas-expert-scientific-authority" aria-label="BIO Files Amicus Brief in Continuing Effort to Preserve FDA’s Expert, Scientific Authority on Drug Approvals" >BIO Files Amicus Brief in Continuing Effort to Preserve FDA’s Expert, Scientific Authority on Drug Approvals</a></div><div class="mc-teaserBasic__summary" ><div class="af-text">October 12, 2023</div></div><div class="mc-teaserBasic__description" ><div class="af-text">BIO filed an amicus brief in a continuing effort to challenge courts' decisions that undermine FDA authority and hinder patient access to medications.The brief was filed in the Supreme Court of the United States (SCOTUS), following the August 2023 ruling of the U.S. Court of Appeals for the Fifth…</div></div></div></div></div><div class="mc-teaserBasic act-component -fontMedium -textOnly"><div class="mc-teaserBasic__rgnInner act-component-inner"><div class="mc-teaserBasic__rgnMain"><div class="mc-teaserBasic__titleLink" ><a class="af-link" href="/amicus-briefs/bio-files-amicus-brief-supporting-reversal-court-decision-regarding-sec-regulations" aria-label="BIO Files Amicus Brief Supporting Reversal of Court Decision Regarding SEC Regulations on Proxy Advisory Firms" >BIO Files Amicus Brief Supporting Reversal of Court Decision Regarding SEC Regulations on Proxy Advisory Firms</a></div><div class="mc-teaserBasic__summary" ><div class="af-text">June 27, 2023</div></div><div class="mc-teaserBasic__description" ><div class="af-text">BIO filed an amicus brief in the U.S. Court of Appeals for the Sixth Circuit, seeking the reversal of a lower court's ruling that would set aside the 2022 rescission of the Securities and Exchange Commission (SEC) 2020 Rule regulating proxy advisory firms.Proxy advisory firms are firms that provide…</div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div><div class="oc-compoList__rgnSection"><div class="oc-widgetPane act-pane -rgnWidth80"><div class="oc-widgetPane__rgnInner section-inner act-pane-inner"><div class="act-pane__content"><div class="oc-widgetPane__rgnList row"><div class="oc-widgetPane__rgnCell rowFirst rowLast col-lg-12 col-md-12 col-sm-12"><div class="mc-contentBasic act-component"><div class="mc-contentBasic__rgnInner act-component-inner"><div class="mc-contentBasic__body" ><div class="af-text"><div class="oc-itemList act-pane -linkBelow -headerLarge"><div class="oc-itemList__rgnInner section-inner act-pane-inner"><div class="act-pane__titleWrapper"><div class="act-pane__title" ><div class="af-text">Press Releases</div></div></div><div class="act-pane__header"><div class="act-pane__moreLink" ><a class="af-link" href="/press-releases" aria-label="Browse all Press Releases" >Browse all Press Releases</a></div></div><div class="act-pane__content"><div class="oc-itemList__rgnList"><div class="mc-teaserBasic act-component -fontMedium -textOnly"><div class="mc-teaserBasic__rgnInner act-component-inner"><div class="mc-teaserBasic__rgnMain"><div class="mc-teaserBasic__titleLink" ><a class="af-link" href="/press-release/wto-13th-ministerial-conference-outcome-positive-ip-future-biotech-industry" aria-label="WTO 13th Ministerial Conference outcome "positive" for IP, future of biotech industry " >WTO 13th Ministerial Conference outcome "positive" for IP, future of biotech industry </a></div><div class="mc-teaserBasic__summary" ><div class="af-text">March 1, 2024</div></div><div class="mc-teaserBasic__description" ><div class="af-text">Following the conclusion of the WTO 13th Ministerial Conference in Abu Dhabi, John Murphy -- BIO's Chief Policy Officer -- made the following statement: “We are encouraged that WTO Members did not agree to extend an intellectual property waiver to Covid-19 therapeutics at the WTO 13th…</div></div></div></div></div><div class="mc-teaserBasic act-component -fontMedium -textOnly"><div class="mc-teaserBasic__rgnInner act-component-inner"><div class="mc-teaserBasic__rgnMain"><div class="mc-teaserBasic__titleLink" ><a class="af-link" href="/press-release/using-march-price-control-mechanism-dangerous-precedent-set" aria-label="Using March-In as a Price Control Mechanism Is a “Dangerous Precedent To Set”" >Using March-In as a Price Control Mechanism Is a “Dangerous Precedent To Set”</a></div><div class="mc-teaserBasic__summary" ><div class="af-text">December 7, 2023</div></div><div class="mc-teaserBasic__description" ><div class="af-text">The White House just announced plans to use Bayh-Dole “march-in rights” to step in and license patent rights of drugs “developed with federal funding” to other manufacturers when the price of the drug is deemed too high. BIO's Chief Advocacy Officer, Nick Shipley, made the following statement: …</div></div></div></div></div><div class="mc-teaserBasic act-component -fontMedium -textOnly"><div class="mc-teaserBasic__rgnInner act-component-inner"><div class="mc-teaserBasic__rgnMain"><div class="mc-teaserBasic__titleLink" ><a class="af-link" href="/press-release/new-usitc-report-shows-no-credible-evidence-supporting-trips-waiver-expansion" aria-label="New USITC report shows "no credible evidence" supporting a TRIPs waiver expansion" >New USITC report shows "no credible evidence" supporting a TRIPs waiver expansion</a></div><div class="mc-teaserBasic__summary" ><div class="af-text">October 17, 2023</div></div><div class="mc-teaserBasic__description" ><div class="af-text">The United States International Trade Commission (USITC) today released its “COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities” report. 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Reg. 40439, Docket No. PTO-P-2024-0003" >BIO Comments to the USPTO’s MAY 10, 2024 Proposed Rulemaking on Terminal Disclaimer Practice, 89 Fed. Reg. 40439, Docket No. PTO-P-2024-0003</a></div><div class="mc-teaserBasic__summary" ><div class="af-text">May 10, 2024</div></div><div class="mc-teaserBasic__description" ><div class="af-text">BIO submitted these comments in response to the United States Patent and Trademark Office’s May 10, 2024, Notice of Proposed Rulemaking regarding Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting. </div></div></div></div></div><div class="mc-teaserBasic act-component -fontMedium -textOnly"><div class="mc-teaserBasic__rgnInner act-component-inner"><div class="mc-teaserBasic__rgnMain"><div class="mc-teaserBasic__titleLink" ><a class="af-link" href="/letters-testimony-comments/comments-biotechnology-innovation-organization-bio-uspto-february-13" aria-label="Comments of the Biotechnology Innovation Organization (BIO) to The USPTO February 13, 2024 Inventorship Guidance for AI-Assisted Inventions, 89 FR 10043" >Comments of the Biotechnology Innovation Organization (BIO) to The USPTO February 13, 2024 Inventorship Guidance for AI-Assisted Inventions, 89 FR 10043</a></div><div class="mc-teaserBasic__summary" ><div class="af-text">May 15, 2024</div></div><div class="mc-teaserBasic__description" ><div class="af-text">On behalf of its member organizations, Biotechnology Innovation Organization (“BIO”) respectfully submits this Comment in response to the United States Patent and Trademark Office’s (the “Patent Office” or “PTO”) February 13, 2024 Request for Comments. 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BIO is the…</div></div></div></div></div><div class="mc-teaserBasic act-component -fontMedium -textOnly"><div class="mc-teaserBasic__rgnInner act-component-inner"><div class="mc-teaserBasic__rgnMain"><div class="mc-teaserBasic__titleLink" ><a class="af-link" href="/letters-testimony-comments/joint-statement-pharmaceutical-trade-bodies-wto-trips-waiver-and" aria-label="Joint statement from pharmaceutical trade bodies on the WTO TRIPS Waiver and upcoming WTO 13th Ministerial Conference " >Joint statement from pharmaceutical trade bodies on the WTO TRIPS Waiver and upcoming WTO 13th Ministerial Conference </a></div><div class="mc-teaserBasic__summary" ><div class="af-text">February 23, 2024</div></div><div class="mc-teaserBasic__description" ><div class="af-text">The meeting of global trade ministers at the World Trade Organization’s 13th Ministerial Conference in Abu Dhabi offers an important opportunity to build on and strengthen the open and rules-based international trading system to support better health outcomes for people across the world and help…</div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div><div class="oc-compoList__rgnSection"><div class="oc-widgetPane act-pane -rgnWidth80"><div class="oc-widgetPane__rgnInner section-inner act-pane-inner"><div class="act-pane__content"><div class="oc-widgetPane__rgnList row"><div class="oc-widgetPane__rgnCell rowFirst rowLast col-lg-12 col-md-12 col-sm-12"><div class="embedGeneralSectionPane"><div class="oc-widgetPane act-pane -rgnWidth100"><div class="oc-widgetPane__rgnInner section-inner act-pane-inner"><div class="act-pane__content"><div class="oc-widgetPane__rgnList row"><div class="oc-widgetPane__rgnCell rowFirst rowLast col-lg-12 col-md-12 col-sm-12"><div class="mc-cardMediaSide act-component -mediaImage -imageLeft -heightFixed -btnskinPurple -btnsolidButtonDefault"><div class="mc-cardMediaSide__rgnInner act-component-inner"><div class="mc-cardMediaSide__rgnMain row"><div class="col-lg-6 col-md-12 col-sm-12"><div class="mc-cardMediaSide__rgnMedia"><div class="mc-cardMediaSide__image" ><img src="/sites/default/files/styles/bio_media_side_card_auto/public/2024-03/bio-action-patient-advocacy-alliances-2.png?itok=OEy7dzQ9" alt="Become an Advocate for Biotechnology" class="af-image"></div></div></div><div class="col-lg-6 col-md-12 col-sm-12"><div class="mc-cardMediaSide__rgnContent"><div class="mc-cardMediaSide__info"><div class="mc-cardMediaSide__title" ><div class="af-text">Become an Advocate for Biotechnology</div></div><div class="mc-cardMediaSide__description" ><div class="af-text"><p>Sign-up to join BIOAction, BIO's grassroots advocacy program. 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