{"id":25672,"date":"2022-09-19T06:47:00","date_gmt":"2022-09-19T06:47:00","guid":{"rendered":"https:\/\/sagaciousresearch.com\/blog\/?p=25672"},"modified":"2025-01-02T11:00:58","modified_gmt":"2025-01-02T11:00:58","slug":"performing-third-party-ip-review-on-a-drug-for-different-markets-case-study","status":"publish","type":"post","link":"https:\/\/sagaciousresearch.com\/blog\/performing-third-party-ip-review-on-a-drug-for-different-markets-case-study","title":{"rendered":"Performing Third-Party IP Review on a Drug for Different Markets: A Case Study"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"25672\" class=\"elementor elementor-25672\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1aadc5b4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1aadc5b4\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-9cb9044\" data-id=\"9cb9044\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4bb2462c elementor-widget elementor-widget-text-editor\" data-id=\"4bb2462c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\n<p>Entities owning patent portfolios are often involved in <a href=\"https:\/\/sagaciousresearch.com\/blog\/how-to-conduct-effective-patent-licensing-studies-in-life-sciences-domain\/\">licensing<\/a>, acquisition, and partnership activities with investors, R&amp;D groups, or start-up accelerators. Such business transactions require thorough due diligence and third-party expert\u2019s opinion to determine the profitability scope for investing\/partnering party or licensee. Portfolio owners sometimes take the first step in the IP reviewfor effective negotiations with the potential investors\/licensees and to forecast extension to newer markets. However, many businesses reach out to an expert third party for professional IP review and recommendations.<\/p>\n\n\n\n<p>The following case study explains how our IP review services helped a pharmaceutical company get the necessary details on possible threats, market competition, and additional suggestions for strengthening its IP.<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_85 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a32cf6e3d4db\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a32cf6e3d4db\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/sagaciousresearch.com\/blog\/performing-third-party-ip-review-on-a-drug-for-different-markets-case-study\/#IP_Review_and_its_Significance\" >IP Review and its Significance<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/sagaciousresearch.com\/blog\/performing-third-party-ip-review-on-a-drug-for-different-markets-case-study\/#Significance_of_IP_Review\" >Significance of IP Review<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/sagaciousresearch.com\/blog\/performing-third-party-ip-review-on-a-drug-for-different-markets-case-study\/#Case_Study\" >Case Study<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/sagaciousresearch.com\/blog\/performing-third-party-ip-review-on-a-drug-for-different-markets-case-study\/#Final_Thoughts\" >Final Thoughts<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"IP_Review_and_its_Significance\"><\/span>IP Review and its Significance<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>A product in a portfolio predicted to succeed in one market may face different roadblocks in other markets. These challenges may be more on the regulatory and policy front. In such scenarios, a third-party opinion is helpful for portfolio owners as well as parties seeking to invest, license, acquire, etc., based on the IP owned by the business. The review involves an assessment of the entity\u2019s IP, possible edge over existing technology or products, upcoming opportunities according to the IP\u2019s current state and predicted market, potential competition, and risks involved.<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"800\" height=\"301\" src=\"https:\/\/sagaciousresearch.com\/blog\/wp-content\/uploads\/2022\/09\/pic-1.png\" alt=\"benefits-thorough-ip-review\" class=\"wp-image-25762\" srcset=\"https:\/\/sagaciousresearch.com\/blog\/wp-content\/uploads\/2022\/09\/pic-1.png 800w, https:\/\/sagaciousresearch.com\/blog\/wp-content\/uploads\/2022\/09\/pic-1-300x113.png 300w, https:\/\/sagaciousresearch.com\/blog\/wp-content\/uploads\/2022\/09\/pic-1-768x289.png 768w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><figcaption class=\"wp-element-caption\"><strong>Figure 1: Benefits of a Thorough IP Review<\/strong><\/figcaption><\/figure>\n<\/div>\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Significance_of_IP_Review\"><\/span>Significance of IP Review<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>IP review, a part of due diligence, enables businesses to save costs, avoid risks, and more importantly, capitalize on opportunities that would otherwise be missed. The assessment can either be general or specific.<\/p>\n\n\n\n<p>General-purpose IP review helps big companies, start-ups and individuals not only identify opportunities, development needs, and risks but also evaluate and safeguard their IP assets. On the other hand, specific-purpose IP review is generally narrower in scope. One can determine the nature and extent of such an IP review by the objective or upcoming event for which the assessment is to be conducted.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Case_Study\"><\/span>Case Study<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Sagacious IP conducted an IP review for a client on a drug useful for treating a type of arthritis. The client was keen to know how its drug fared compared to other drugs in the market, concerning strengths, challenges, opportunities, and impact. Furthermore, the client was interested in information about exclusivities and patent term extensions in three different jurisdictions and wanted an overall opinion and recommendations based on the findings.<\/p>\n\n\n\n<p>Sagacious IP first performed a quick validity check on the patent portfolio to validate the claims and legal status of the portfolio. Subsequently, our team provided a detailed analysis of each patent in the client\u2019s portfolio to see if the formulation at the current stage could be implemented according to the patents\u2019 claims or solutions disclosed, existing applications, and potential applications in the future. The analysis was not restricted to patent search but also involved researching and identifying clinical and regulatory data for the drug formulations. Later, we compared the client\u2019s product with other known drugs used for treating the same conditions.<\/p>\n\n\n\n<p>The impact of the drug formulations was assessed by identifying key problems they were solving, and an overall summary with our findings and recommendations was provided at each step. Further, a detailed table was prepared with information on \u2013 data exclusivities, PTE, <a href=\"https:\/\/www.cancer.gov\/publications\/dictionaries\/cancer-terms\/def\/orphan-drug-designation\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">orphan drug<\/a> status, and accelerated examinations in jurisdictions of interest. This was crucial for the client to re-evaluate market readiness before stepping into new markets.<\/p>\n\n\n\n<p>Unlike other searches and analysis, IP review provides summaries and recommendations for clients\u2019 specific questions regarding managing and negotiating their IP with businesses. In this case, Sagacious IP specifically provided suggestions to the client on:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Possible IP threats.<\/li>\n\n\n\n<li>Market competition \u2013 based on factors such as clinical data, scaling up, and side effects.<\/li>\n\n\n\n<li>Jurisdiction with the most favorable opportunities as per regulations and market.<\/li>\n\n\n\n<li>Additional suggestions on strengthening IP such as opting for PCT Article 19 or Article 34 amendments within the prescribed timelines, and opting for voluntary amendment.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Final_Thoughts\"><\/span>Final Thoughts<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Sagacious IP provided the client with an overall third-party IP review with answers to specific queries pertaining to market advantage, IP competition, jurisdiction-based opportunities, and challenges. The client utilized this review as a due diligence\/first-level IP audit study at various legal and regulatory proceedings for its portfolio across strategic decisions in different jurisdictions.<\/p>\n\n\n\n<p>Sagacious IP offers various patent portfolio-related services, such as <a href=\"https:\/\/sagaciousresearch.com\/patent-due-diligence\">patent due diligence<\/a>, to enable sound business decision-making. Our team of IP professionals specializes in several domains to help our clients in different sectors help overcome challenges regarding their IP. Please visit the service page to know more.<\/p>\n\n\n\n<p>&#8211; Devika Saini (Life Sciences and Chemistry) and the Editorial Team<\/p>\n\n\n\n<p><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6ef9d64 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6ef9d64\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-8ebded8\" data-id=\"8ebded8\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-8c46c6d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"8c46c6d\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-ad36015\" data-id=\"ad36015\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-0f64745 elementor-widget elementor-widget-heading\" data-id=\"0f64745\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Having Queries? 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for='input_203_17'>Country<span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_select'><select name='input_17' id='input_203_17' class='large gfield_select'    aria-required=\"true\" aria-invalid=\"false\" ><option value='' >Please Select Country<\/option><option value='United States' >United States<\/option><option value='Canada' >Canada<\/option><option value='United Kingdom' >United Kingdom<\/option><option value='China' >China<\/option><option value='India' >India<\/option><option value='North Korea' >North Korea<\/option><option value='South korea' >South korea<\/option><option value='United Arab Emirates' >United Arab Emirates<\/option><option value='Afghanistan' >Afghanistan<\/option><option value='Albania' >Albania<\/option><option value='Algeria' >Algeria<\/option><option value='Andorra' >Andorra<\/option><option value='Angola' >Angola<\/option><option value='Antigua and Barbuda' >Antigua and Barbuda<\/option><option value='Argentina' >Argentina<\/option><option value='Armenia' >Armenia<\/option><option value='Australia' >Australia<\/option><option value='Austria' >Austria<\/option><option value='Azerbaijan' >Azerbaijan<\/option><option value='The Bahamas' >The Bahamas<\/option><option value='Bahrain' >Bahrain<\/option><option value='Bangladesh' >Bangladesh<\/option><option value='Barbados' >Barbados<\/option><option value='Belarus' >Belarus<\/option><option value='Belgium' >Belgium<\/option><option value='Belize' >Belize<\/option><option value='Benin' >Benin<\/option><option value='Bhutan' >Bhutan<\/option><option value='Bolivia' >Bolivia<\/option><option value='Bosnia and Herzegovina' >Bosnia and Herzegovina<\/option><option value='Botswana' >Botswana<\/option><option value='Brazil' >Brazil<\/option><option value='Brunei' >Brunei<\/option><option value='Bulgaria' >Bulgaria<\/option><option value='Burkina Faso' >Burkina Faso<\/option><option value='Burundi' >Burundi<\/option><option value='Cabo Verde' >Cabo Verde<\/option><option value='Cambodia' >Cambodia<\/option><option value='Cameroon' >Cameroon<\/option><option value='Central African Republic' >Central African Republic<\/option><option value='Chad' >Chad<\/option><option value='Chile' >Chile<\/option><option value='Colombia' >Colombia<\/option><option value='Comoros' >Comoros<\/option><option value='Congo' >Congo<\/option><option value='Costa Rica' >Costa Rica<\/option><option value='C\u00f4te d\u2019Ivoire' >C\u00f4te d\u2019Ivoire<\/option><option value='Croatia' >Croatia<\/option><option value='Cuba' >Cuba<\/option><option value='Cyprus' >Cyprus<\/option><option value='Czech Republic' >Czech Republic<\/option><option value='Denmark' >Denmark<\/option><option value='Djibouti' >Djibouti<\/option><option value='Dominica' >Dominica<\/option><option value='Dominican Republic' >Dominican Republic<\/option><option value='East Timor (Timor-Leste)' >East Timor 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