1. EPICentre Legal Workshop Series: Biotechnology and IP Presented to: Entrepreneurship Practice & Innovation Centre, September 20, 2016 Presented by: Jenna Wilson & Mee Ling Wong Patent & Trademark Agents Intellectual Property Lawyers

2. Who are we? Jenna Wilson lawyer, patent agent, trademark agent emphasis on software, mechanical, electronics, financial technology, contracts Mee Ling Wong lawyer, patent agent, trademark agent emphasis on biotech, pharmaceuticals, oil & gas

3. Topics types of intellectual property (IP) IP rights and business protecting your biotech innovations

4. What is intellectual property? sets of legal rights protecting intellectual creations—the right to exclude mostly time-limited national/territorial scope (treaties aid in obtaining rights abroad) varying degrees of formal, legal, or practical requirements must be enforced by owner/licensee

5. Why secure IP rights? IP rights can be crucial to your business strategy protect your strengths minimize weaknesses position yourself for opportunities anticipate and neutralize threats source of revenue

6. Copyright protects expressive works original literary (includes computer programs), dramatic, artistic and musical works limited utility for functional or physical innovations balanced against users’ rights rights arise automatically; registration optional but recommended in some cases minimum 50 years of protection

7. Trademarks protect your brand words, sounds, designs, shape, etc. that distinguish the source of goods and services rights can be secured by Federal registration (best option) or protected as unregistered mark (more challenging to enforce) can exist, in theory, in perpetuity stay tuned for EPICentre talk on trademarks!

8. Designs protects ornamental appearance of utilitarian objects in some cases, copyright or patent not available but design registration may be must be secured by examination and registration process max 10 years protection

9. Other forms of protection (before we get to patents) integrated circuit topographies plant breeders’ rights

10. Patents time-limited monopoly to make, construct, use, sell an invention maximum 20-year term inventions are arts, processes, machines, manufactures, compositions of matter, improvements, with some exclusions non-trivial application and examination process must be new, inventive, and useful

11. What can’t you patent? scientific principles and abstract theorems purely natural processes higher life forms (e.g. transgenic animals, plants) application of professional skill, including methods of medical treatment fine arts (e.g. artistic or literary works) forms of energy (e.g. signals)

12. Who can obtain a patent? inventor or inventor’s legal representative assignees, employers, universities understand your university's Tech Transfer Policy: who owns your research?

13. How do you get a patent? prior art search (optional, but a very good idea file application with disclosure, claims, drawings examination process; examiner will allow or refuse, options for appeal application will be published whether you get a patent or not maintenance (renewal) fees

14. CA Patent No. 2,446,195 “Processes and Apparatus for Extraction of Active Substances and Enriched Extracts from Natural Products”

15. When to file a patent? first-to-file system  “race to the patent office”  but be careful not to jump the gun; you must have sufficient description to enable others to understand and make invention novelty requirement best practice - file before first public disclosure grace period in select countries

16. Was the invention disclosed? publicly disclosing your invention before filing a patent application may preclude you from getting patent protection disclosure includes submitting your work to a journal or speaking at a conference, but also includes:  intra- or inter- faculty discussions  thesis defenses (request it be closed!)  weekly or monthly research updates

17. Biotech Inventions: What’s patentable?

18. Mining Your Research for IP – Ex. 1 Jane has discovered a new protein, ABC, which is exclusively expressed in cancerous lung cells Jane has also identified the gene, previously unknown, that encodes the ABC protein by administering an ABC specific antibody, Jane is able to convert cancerous lung cells to normal lung cells

19. Ex.1 – Is there any patentable subject matter? ABC protein (specific amino acid sequence) abc gene (specific nucleotide sequence) antibody specific for ABC protein diagnostic methods for lung cancer (e.g. measuring ABC protein levels or abc gene expression) use of ABC specific antibody for treating lung cancer

20. Mining Your Research for IP – Ex. 2 XYZ is a known protein, which functions as an anti-freeze in fish John has discovered that the addition of XYZ protein to ice cream improves its texture by reducing the formation of ice crystals PEGylated XYZ was found to be more effective than non-modified XYZ in reducing ice crystals in ice cream

21. Ex.2 – Is there any patentable subject matter? PEGylated XYZ (but not XYZ, which is old and known) ice cream comprising XYZ or PEGylated XYZ use of XYZ or PEGylated XYZ for reducing ice crystal formation in ice cream

22. Mining Your Research for IP – Ex. 3 diphenhydramine (e.g. “Benadryl”) is a well known allergy medication effectiveness is attributed to its ability to block the release of histamines Pat has discovered that diphenhydramine does not block the release of histamines, but rather it activates a known enzyme, QRT, that destroys histamines

23. Ex.3 – Is there any patentable subject matter? needs more research first! diphenhydramine and its use for the treatment of allergies and enzyme QRT are old and known discovery of how diphenhydramine actually works in the treatment of allergies is not patentable future research may reveal new uses of diphenhydramine or new compounds that activate QRT

24. Questions? Jenna Wilson jenna.wilson@wilsonlue.com Mee Ling Wong meeling.wong@wilsonlue.com

25. Resources Canadian Intellectual Property Office (cipo.gc.ca)cipo.gc.ca United States Patent and Trademark Office (www.uspto.gov)www.uspto.gov World Intellectual Property Organization (www.wipo.int)www.wipo.int