Shu-Yi Lin Email & Phone Number

Contract review, monitoring up-to-date policy, law and regulation, and reminding relevant obligations and risks.Overseeing more than 300 IP assets worldwide. Patent drafting (healthcare): WO2017115301, WO2018127082, WO2022233318, CN112007031, CN112891308. IP Quality management: set up and updated policies and procedures, drafted/amended SOPs and conducted trainings and audits. The management system covering patent, trademark, trade secret was certified by a third party for… Show more Contract review, monitoring up-to-date policy, law and regulation, and reminding relevant obligations and risks.Overseeing more than 300 IP assets worldwide. Patent drafting (healthcare): WO2017115301, WO2018127082, WO2022233318, CN112007031, CN112891308. IP Quality management: set up and updated policies and procedures, drafted/amended SOPs and conducted trainings and audits. The management system covering patent, trademark, trade secret was certified by a third party for consecutive five years. Show less

Responsibilities1.Competitive analysis: Interpreting and integrating data or knowledge of market, drug price, reimbursement status, clinical studies, pharmacology and patents.2.Partnering and collaborating with internal departments; providing clinical and technical information; contributing to new product development.3.Regulatory affairs: Preparing orphan drug designation and IND/IRB submission.4.IP: Patent prosecution; patent drafting; patent search; freedom to operate… Show more Responsibilities1.Competitive analysis: Interpreting and integrating data or knowledge of market, drug price, reimbursement status, clinical studies, pharmacology and patents.2.Partnering and collaborating with internal departments; providing clinical and technical information; contributing to new product development.3.Regulatory affairs: Preparing orphan drug designation and IND/IRB submission.4.IP: Patent prosecution; patent drafting; patent search; freedom to operate analysis.Achievements1.Competitive analysis for 4 medicinal products and 1 medical device.2.FDA granted orphan drug designation for investigational drug3.4 new patent applications filed and 1 freedom to operate analysis. Show less

1. Regulatory submission in Taiwan for medical imaging device, computer aided detection/triage software, drug eluting catheter, muscle stimulator, olfactory test, tear test, caries detection and surgical instrument.2. Quality System Documentation submission in Taiwan for manufacturers in Korea, USA, Canada, Australia, Germany and India.3. Reimbursement dossier submission in Taiwan for drug eluting catheter.

Taiwan

Responsibilities1.Business development support: providing potential business opportunities by integrating industry research, patent analysis and market research.2.Patent due diligence, including manually reviewing US patent prosecution file history and assignment recordation.3.Patent purchase/license agreement review.4.Patent prosecution in China, Europe, Korea, Japan, Taiwan and USA; global patent firm coordination.5.Patent strategy advice/patent portfolio… Show more Responsibilities1.Business development support: providing potential business opportunities by integrating industry research, patent analysis and market research.2.Patent due diligence, including manually reviewing US patent prosecution file history and assignment recordation.3.Patent purchase/license agreement review.4.Patent prosecution in China, Europe, Korea, Japan, Taiwan and USA; global patent firm coordination.5.Patent strategy advice/patent portfolio management.6.Patent analysis: semiconductor, telecommunication, computer science and medical device.7.Patent mining (medical imaging and mobile health; targets including GE, Siemens and Philips)8.IP report; patent landscaping.Achievements1.Initiated more than 20 patent transaction opportunities, including 3 value drivers targeting on medical imaging products of market leaders.2.Performed due diligence for more than 100 patent portfolios.3.Established automatic solutions to improve standard due diligence process by Microsoft Excel formula/function/vba.4.Assisted more than 100 patents granted. Technical fields involved: semiconductor, computer and telecommunication; the main client is Intellectual Ventures.5.Completed more than 10 IP reports for Agency for Science, Technology and Research (A*STAR), Singapore's lead public sector agency. Technical fields involved: medical device and biotechnology. Show less

Taiwan

Responsibilities1.Patent prosecution2.Patent search and analysis3.Patent invalidation4.Design around advice for generic drug launch

Taiwan

Responsibilities:Patent drafting, patent prosecution and patent maintenance; technical fields involved: pharmaceuticals, biotechnology and chemical engineering.Achievements: More than 200 patents granted. Clients included Johnson & Johnson, Pfizer, Roche, Novartis, Abbott, Merck, Bayer, 3M and BASF etc.

Master Of Science (Ms), Pharmaceutical Sciences

Bachelor Of Science (Bs), Pharmacy