Intellectual Property in the Life Sciences Industry: How to - PowerPoint PPT Presentation

CHOATE.COM Intellectual Property in the Life Sciences Industry: How to Identify and Manage Patent Risks Medmarc Webinar April 24, 2019 CHOATE HALL & STEWART LLP

Overview  Patent Primer – What patents do (and don’t)  Risks associated with Third Party patents – Freedom to operate – Scenarios: competitors, partners, targets, and others  Risks in your patent portfolio – Coverage of your product – Coverage of competitor product  Managing patent risk – A few simple steps you can take right now Choate Hall & Stewart LLP | Two International Place, Boston, MA 02110 T T 617-248-5000 F 617-248-4000 | choate.com 2

Overview  Patent Primer  Risks associated with Third Party patents  Risks in your patent portfolio  Managing patent risk Choate Hall & Stewart LLP | Two International Place, Boston, MA 02110 T T 617-248-5000 F 617-248-4000 | choate.com 3

Patent Primer  What a patent does (and does not) – Anatomy of a patent o Specification / Drawings o Claims – A right to exclude, not a right to practice Choate Hall & Stewart LLP | Two International Place, Boston, MA 02110 T T 617-248-5000 F 617-248-4000 | choate.com 4

Patent Primer  What a patent does (and does not) – Anatomy of a patent o Specification / Drawings o Claims – A right to exclude, not a right to practice  Where it works – US – International Choate Hall & Stewart LLP | Two International Place, Boston, MA 02110 T T 617-248-5000 F 617-248-4000 | choate.com 5

Patent Primer  What a patent does (and does not) – Anatomy of a patent o Specification / Drawings o Claims – A right to exclude, not a right to practice  Where it works – US – International  Patent life cycle – Obtaining a patent – Challenging a patent Choate Hall & Stewart LLP | Two International Place, Boston, MA 02110 T T 617-248-5000 F 617-248-4000 | choate.com 6

Patent Primer  Patent life cycle – Obtaining a patent o Preparation o Filing and prosecution o Issuance and maintenance – Challenging a patent o Post-grant proceedings before the USPTO o Challenges in District Court Choate Hall & Stewart LLP | Two International Place, Boston, MA 02110 T T 617-248-5000 F 617-248-4000 | choate.com 7

Patent Primer  Patents are assets – Often, a company’s only assets – Can be bought/sold or licensed  Patents are business tools – Can be used in a variety of transactions – Can be used for offense or defense (or both) Choate Hall & Stewart LLP | Two International Place, Boston, MA 02110 T T 617-248-5000 F 617-248-4000 | choate.com 8

Overview  Patent Primer  Risks associated with Third Party patents  Risks in your patent portfolio  Managing Patent Risk Choate Hall & Stewart LLP | Two International Place, Boston, MA 02110 T T 617-248-5000 F 617-248-4000 | choate.com 9

3 rd Party Patents  Right to exclude – Freedom to operate  Scenarios: – Competitors – Targets – Partners (e.g., co-developers, customers, CROs / universities) o Issues with ownership – Other third parties Choate Hall & Stewart LLP | Two International Place, Boston, MA 02110 T T 617-248-5000 F 617-248-4000 | choate.com 10

3 rd Party Patents Patents held by competitors  Different competitors may pursue different strategies – May depend on product / business plan / budget  Aware of potentially problematic patents? – Design around – License – Challenge (PGR / IPR)  Pending applications – changing claim scope – Risk level may change throughout prosecution Choate Hall & Stewart LLP | Two International Place, Boston, MA 02110 T T 617-248-5000 F 617-248-4000 | choate.com 11

3 rd Party Patents Patents held by targets  Acquisition of an existing portfolio  Diligence is key – Adequate patent coverage of target technology? – Fit with your patent strategy?  Freedom to Operate Choate Hall & Stewart LLP | Two International Place, Boston, MA 02110 T T 617-248-5000 F 617-248-4000 | choate.com 12

3 rd Party Patents Patents held by partners  CROs / CMOs – Proper conveyance of ownership of IP critical – Most common: Assignment  Universities / Medical Centers – Different types of relationships: License, Co-development, – Conveyance of existing and/or future IP – Most common: License Choate Hall & Stewart LLP | Two International Place, Boston, MA 02110 T T 617-248-5000 F 617-248-4000 | choate.com 13

3 rd Party Patents Patents held by NPEs  Special case – Cost of litigation vs. settling  If you receive a letter from a suspected NPE, call counsel Choate Hall & Stewart LLP | Two International Place, Boston, MA 02110 T T 617-248-5000 F 617-248-4000 | choate.com 14

Overview  Patent Primer  Risks associated with Third Party patents  Risks in your patent portfolio  Managing Patent Risk Choate Hall & Stewart LLP | Two International Place, Boston, MA 02110 T T 617-248-5000 F 617-248-4000 | choate.com 15

Risks in your patent portfolio  Coverage of your product – Current claim scope – Match with business objectives? – Issued v. pending claims – Mistakes can be costly and tough to fix  Inventorship  Assignment / ownership issues Choate Hall & Stewart LLP | Two International Place, Boston, MA 02110 T T 617-248-5000 F 617-248-4000 | choate.com 16

Risks in your patent portfolio  Coverage of (potential) competitor product – Overall strategy? – Monitoring of competitor activities – Current claim scope – Issued v. pending claims Choate Hall & Stewart LLP | Two International Place, Boston, MA 02110 T T 617-248-5000 F 617-248-4000 | choate.com 17

Overview  Patent Primer  Risks associated with Third Party patents  Risks in your patent portfolio  Managing Patent Risk Choate Hall & Stewart LLP | Two International Place, Boston, MA 02110 T T 617-248-5000 F 617-248-4000 | choate.com 18

Managing Patent Risk  Develop and implement patent strategy – Internal communication is key (R&D / BD / Legal) – Review and monitor regularly  Role of IP counsel – IP counsel not just for patent prosecution – Communication is key – Regular check-ins – involve R&D / BD Choate Hall & Stewart LLP | Two International Place, Boston, MA 02110 T T 617-248-5000 F 617-248-4000 | choate.com 19

Managing Patent Risk Competitor / other 3 rd party letter  – Do not ignore! – Do not respond – Call counsel  Insurance – Defense Insurance o Defend against charge of infringement of 3rd party IP – Abatement Insurance o Enforce your IP rights Choate Hall & Stewart LLP | Two International Place, Boston, MA 02110 T T 617-248-5000 F 617-248-4000 | choate.com 20

Questions? Alexander D. Augst Choate, Hall & Stewart LLP 617.248.5120 aaugst@choate.com Choate Hall & Stewart LLP | Two International Place, Boston, MA 02110 T T 617-248-5000 F 617-248-4000 | choate.com 21