Protection of Intellectual Property in Canada George Jackowski, Ph.D., KCTJ October 19 th, 2015 Chairman of NAVA Corp.

PROTECTION OF INTELLECTUAL PROPERTY IN CANADA In Canada like Poland, we do not have any homegrown global multinational pharmaceutical companies We have strong homegrown global generic companies →E.g. Apotex – who are more interested in patent litigation and nullifying patents Many Canadian companies are acquired by global multinational pharmaceutical companies (GMNPC) or license out their technologies to GMNPC’s Many GMNPC’s have offices supporting their local sales people, marketing, clinical support, have limited R&D and manufacturing, and tend to significantly utilize FDA approved Contract Manufacturing Organizations (CMO) 2

PROTECTION OF INTELLECTUAL PROPERTY IN CANADA GMNPC’s have worldwide patents with issued Canadian patents protecting the product, indication, distribution and manufacturing Health Canada is very well respected globally and is recognized for its thoroughness & safety of clinical trials, approval process and oversight – hence Canadian approved pharmaceuticals and therapeutics are accepted worldwide 3

PROTECTION OF INTELLECTUAL PROPERTY IN CANADA The drivers for global commercialization of products are: →US patents & US trademarks →US Federal Drug Administration (FDA) approvals Creating a worldwide market for healthcare products and technologies involves filing intellectual property in: USA, Europe, Japan and Canada (local jurisdiction) 4

PROTECTION OF INTELLECTUAL PROPERTY IN CANADA Patent system is expensive, but is excellent for parties (academics and start-ups) with little access to capital who have great ideas Science behind biotech patents today is less about entirely novel breakthroughs (less than 1%) BREAKTHROUGH PRODUCTS and more about the clever combination and extension of existing ideas INNOVATIVE PRODUCTS Protection for 20 years from date of filing 5

PROTECTION OF INTELLECTUAL PROPERTY IN CANADA Our Patent Strategy: 6 US Provisional Patent Filing PCT Filing – European Search Authority US CIP Filing US Patent Issued Patent Prosecution Highway (PPH) – Expedite Review Process European Patent Issued

7 Thank you Dziękuję bardzo