In 1980, the US Supreme Court held that patents could be issued for "anything under the sun made by the hand of man."   Since then, the US Patent and Trademark Office (USPTO) has granted numerous patents for genetically engineered organisms, including higher life forms, such as the onco-mouse, a transgenic animal predisposed to develop certain types of cancer. The USPTO announced in 1987 that it would reject any patent claim "including within its scope a human being."   An agreement reached last week by Congressional lawmakers would codify this policy and would specifically bar the USPTO from issuing patents for human organisms. The Weldon Amendment on Patent Applications was introduced as part of an appropriations bill in July and was approved in the US House of Representatives.   The amendment sought to bar all patent claims on the human organism.   However, following negotiations between the House and the Senate, clarifying language was approved for inclusion with the amendment.   As a result, patents will be banned for genetically engineered human embryos, foetuses and human beings, but will still be permitted for genes, cells, tissue and other biological products and for procedures or methods for creating biological products.   The amendment would allow patents related to stem cell therapy and would leave the USPTO free to deal with borderline and new issues as they arise. By comparison, the Supreme Court of Canada, in a 5-4 split decision, ruled last year that higher life forms, human or otherwise, are not patentable in Canada because they do not fall within the definition of "invention" under the Patent Act (see Harvard College v Canada (Commissioner of Patents), [2002] 4 SCR 45, 2002 SCC 76). For links to news stories, see: http://makeashorterlink.com/?G3D2217B6; http://makeashorterlink.com/?D285427B6; or http://www.concordmonitor.com/stories/news/other2003/patent_2003.shtml. For the full text of the "Harvard Mouse" SCC judgment, visit: http://www.canlii.org/ca/cas/scc/2002/2002scc76.html. Summary by: Clare McCurley For further information about the patenting of life forms, contact Gervas Wall (gwall@dww.com) or Kathryn Schubert (kschubert@dww.com).

E-TIPS® ISSUE

03 12 04

Disclaimer: This Newsletter is intended to provide readers with general information on legal developments in the areas of e-commerce, information technology and intellectual property. It is not intended to be a complete statement of the law, nor is it intended to provide legal advice. No person should act or rely upon the information contained in this newsletter without seeking legal advice.

E-TIPS is a registered trade-mark of Deeth Williams Wall LLP.