About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline
LOG IN
LOG IN

20 Legal Med. Q. 1 (1996)
Nucleic Acid Sequences and Other Naturally Occurring Products: Are They Patentable in Canada

handle is hein.journals/medquar11 and id is 5 raw text is: Nucleic Acid Sequences And Other Naturally Occurring Products: Are They Patentable In Canada? Eileen McMahon A patent system is not a means of safeguarding the public interest. It is primarily a commercial and industrial tool that encourages innovation divorced from social and ethical concerns.1 1.0 Introduction. In recent years, there has been a dramatic increase in the number of patent applications filed in Canada for biotechnology inventions.2 Certain of these applications include claims to naturally occurring products, such as genetic sequences or proteins, which have been isolated and purified.3 In Canada, the US and Europe, there has been extensive debate about whether such claims are patentable.4 It is worthwhile to examine Canadian law with respect to the patentability of naturally occurring products, such as genetic sequences and proteins, which have been isolated and purified. This paper has four parts. The first part outlines the controversy which surrounded patent applications in the US by the National Institutes of Health (NIH) to patent partial human gene sequences (expressed se- quence tags or ESTs). The second part examines the definition of invention in Canada's Patent Acts and discusses whether naturally occurring products, such as genetic sequences, may be considered discover- ies or inventions pursuant to the Act, and whether they meet the requirements of inventive- ness under Canada's patent law. The third part reviews the requirements of novelty, utility and reproducibility under Canada's Patent Act and discusses generally whether naturally occurring products which have been isolated and purified meet those requirements. In each of these sections, reference is made to how the same issues have been addressed in the US and Europe. The fourth part offers some suggestions for drafting claims to these products in Canada. 2.0 NIH Patent Applications. NIH filed patent applications for ESTs with the US Patent Office in June 1991.6 The patent applications arose from Eileen McMahon, Deeth Williams Wall, Toronto, Ontario, Canada. The author would like to thank Tom Digby of Visible Genetics Inc for his help in the initial preparation of this article, and Michelle Marsellus of Deeth Williams Wall for her help in revising this paper. research conducted by NIH as part of the Human Genome Project, a collaborative effort by NIH and the Department of Defence to create a detailed map of human DNA.7 NIH stated at the time that it was making the applications to enable it to license its technology to industry.8 Numerous persons have since commented on whether the genetic sequences, as disclosed in the NIH applications, meet the legal requirements for patentable subject matter in the US.9 The claims in the NIH patent applications were all product claims. The claims extended to enriched or isolated ESTs, or parts of them having at least 15 base pairs, or allelic variations or complementary sequences of them, and to entire genes containing ESTs or allelic variations.1o Thus, in addition to the partial DNA sequences the NIH had discovered, NIH claimed the full genes to which the sequences correspond. NIH claimed that the full genes could be readily obtained from the partial sequence information.II On August 20 1992, the US Patent and Trademark Office provided NIH with a first Office Action with respect to the application. The action was 33 pages in length, and rejected all 34 of the claims in the application for reasons including that: 1 the claims were vague, indefinite, misdescriptive, incomplete, inaccurate and incomprehensible; 2 the claims lacked patentable utility; 3 the claims were anticipated by certain art (ie, the claims lacked novelty); 4 the claims were obvious in view of certain art,12 and, 5 the application failed to provide an enabling disclosure. 13 The NIH responded to this action, but did not make its response public.14 In the end, many of the claims were rejected. In February 1994, however, the new director of the NIH, Dr Harold Varmus, decided not to appeal the rejections and to withdraw the remaining claims, on the basis that to pursue the patents would be inconsistent with the NIH's primary role as a research institution.15,16 Since then, a number of private companies have filed patent applications in the US for gene sequences of their LEGAL MEDICAL QUARTERLY/VOL 20 1996/PART 1/1

What Is HeinOnline?

HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.



Short-term subscription options include 24 hours, 48 hours, or 1 week to HeinOnline.

Purchase Access

Contact us for annual subscription options:

Contact Us

Already a HeinOnline Subscriber?

Log In

profiles profiles most