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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 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 Topics • types of intellectual property (IP) • IP rights and business • protecting your biotech innovations 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 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 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 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! 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 Other forms of protection (before we get to patents) • integrated circuit topographies • plant breeders’ rights 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 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) 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? 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 CA Patent No. 2,446,195 “Processes and Apparatus for Extraction of Active Substances and Enriched Extracts from Natural Products” 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 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 Biotech Inventions: What’s patentable? 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 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 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 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 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 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 Questions? Jenna Wilson [email protected] Mee Ling Wong [email protected] Resources • Canadian Intellectual Property Office (cipo.gc.ca) • United States Patent and Trademark Office (www.uspto.gov) • World Intellectual Property Organization (www.wipo.int)