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Protecting and commercializing biotechnology

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Canada
May, 2008

Source: Ag-West Bio Inc.
Bio-Bulletin Voume 3 issue 3

On April 17th, over 30 participants attended a seminar on the protection and commercialization of biotechnology. Gowlings Life Sciences Industry Group and Ag-West Bio Inc.. hosted the morning event supporting the development of life science organizations in Saskatchewan.

Gowlings’ Konrad Sechley spoke on patents, stating, “Complex products are covered by potentially hundreds or thousands of patents.” Each component or piece of technology can be covered by many patents. Many options for patenting exist, including: cross-licensing, patent pools, open source, Fair Reasonable Ad Non-Discriminatory (FRAND) terms, and designing around technology. Sechley warned, “The creep of technology in the lab must be dealt with and might require licenses.” Especially in university settings, materials may be shared among researchers between labs and researchers and students may not be aware of contract obligations. Biological Open Source (BiOS) is a framework that enables sharing of patented and non-patented technology by those who agree to the agreed principles. However, new patentable advances return to BiOS. Sechley recommended that designing around patented technology may be the strongest position for most players in the biotechnology sector.

Judy Erratt continued the morning’s session with a presentation on intellectual property (IP) due diligence
audits. IP audits are helpful in ensuring that a company is managing and exploiting its IP in the most effective
manner as well as managing the risk of infringing third party rights.

Thorough due diligence reviews include a listing of inventory, inventorship, ownership, strength of portfolio and freedom to operate. Erratt reminded the participants that “in Canada, an inventor is generally considered to be
the person who conceives the invention and puts it into practice.” Naming incorrect inventors may invalidate a patent application.

The next session focused on changes to American and Canadian patent rules. In the US, requests for continued examination have increased 10-fold in the last five years and appeals have doubled between 2006 and 2007. The result is that the United States Patent and Trademark Office has several options to manage the application process. Decisions are still pending. In Canada, Judy Erratt recommended that even small organizations or universities file under the rules for large entities to ensure issues, such as the inability to transfer or license any right in the invention to an entity that employs 50+ employees, are avoided in the future. On the topic of stem cells, in June 2006, the Canadian Patent Office issued a practice note that animals from any stage of development from fertilized eggs on are “higher life forms” and not patentable. However, this is contrary to recent Supreme Court ruling and the findings will have influence on future stem cell policy. A one-year pilot project to accelerate applications between Canada and the US began in January of this year and may be extended if successful.

Gowling’s Ottawa partner, Jane Clark, completed the morning with a discussion of key copyright issues. Owners and authors have rights; whoever creates the work is the copyright owner unless that person is an employee working in the course of his/her employment. Signed assignments are recommended for contractors. Another issue surrounds moral rights. Authors, even employees, have moral rights, including a right to be associated, a right to remain anonymous and a right to the integrity of the work. The third major issue of copyright is the distinction between existing and future works. Agreements must be signed by the author, dated and witnessed. Clark also noted that attempts to reform Canada’s copyright practices have held up.

Gowlings specializes in business law, intellectual property and advocacy. This year, company representatives are visiting several Canadian centres, sharing legal advice on IP.

 

 

 

 

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