Protection of Intellectual Property in Canada

George Jackowski, Ph.D., KCTJ

October 19th, 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)

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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

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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)

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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

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PROTECTION OF INTELLECTUAL PROPERTY IN CANADA

Our Patent Strategy:

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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

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Thank you

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