Legal Issues Surrounding the Protection of Intellectual Property Rights in Biotechnologies

With the proliferation of information-based earning in the global economy, business people in general find themselves faced with the problems attendant to protecting and enforcing proprietary economic rights. These developments in the economy have spawned an increased awareness and use of various statutory and common law intellectual property protective schemes by these businesses - the development of the intellectual property statutes in areas such as patents, plant breeders rights and trade marks cannot keep pace with the burgeoning number of issues and strains which these increased and varied uses put on those systems. By the very nature of their work, biotechnology companies find themselves faced with a high percentage of these problems in determining issues of international intellectual property protection.

The first problem faced by biotechnology companies in their encounters with the intellectual property legal system appears at this time to be one of definition. The term "biotechnology" itself has been held by the Federal Court of Canada to be a term of unsettled meaning Astra AB v. Aastra Corp. (1995), 59 C.P.R. (3d) 340). If the definition of that term is unsettled at the judicial level, it flows therefrom that the courts interpreting the rights of biotechnology companies in light of current established statutory regimes and case law might be less likely to adopt a progressive stance with respect to this area of the law, at least until the judicial comfort level with the terminology of the industry has increased and some of these terms gain acknowledged judicial scope.

Companies seeking multi-national protection of particular inventions often end up with 'checkerboard' protection. For example, the Canadian Patent Office has yet to acknowledge the patentability of plants, pointing to the Plant Breeders' Rights Act as the Canadian government's alternative to plant patents. The United States, on the other hand, does allow the patenting of plants. Other countries have no protective scheme whatsoever in place and companies are left to find alternative methods of maintaining control over the exploit of their research. Another situation which might result in companies taking different approaches to patenting or other forms of IP protection are situations where governments have attempted to piggy-back other legislative schemes onto the patent system. An obvious example of this lies in pharmaceuticals, and the Patented Medicines Price Review Board. While a pharmaceutical company may focus on patenting their work in other countries, they may wish to avoid the legislative regime associated with patented medicines in Canada and may therefore end up looking for other alternative methods. In the case of a company with a transgenic animal, statutory protection may not even be available in many countries and other methods of protection such as contracts or the physical control of the breeding of the animal may be necessary to control the invention. It all remains a minefield at this point.

On this point, and of interest to biotechnology companies in the past while has been the public disclosure of the Commissioner of Patents decision rejecting the 'Harvard Mouse' application, rendered against the background of currently heated public debate over how far biotechnology and genetics researchers should be allowed to obtain patent protection for the products of their research. The Harvard Mouse application itself, entitled "TRANSGENIC ANIMALS", dealt with a transgenic mouse which through alteration and breeding was genetically
predisposed such as to be beneficially used in cancer research. The genes in question were identified and produced, and then implanted in a number of mouse embryos and a line of such transgenic mice produced. The Patent Examiner rejected this application on several grounds, including that the Commissioner of Patents was obliged to consider the public interest in
evaluating such a patent application even if it did represent patentable subject matter. The Commissioner of Patents reviewed the rejection of the application by the Examiner, overturning the public policy discretion. 

The first important holding of this decision is that the Commissioner of Patents is bound to examine a patent application solely within the bounds of the Patent Act - there is no residual discretion on public policy grounds. The Commissioner points out in his own written decision that that would imply that he has been conferred with a policy discretion beyond the terms of the Patent Act and an invention could be found to be unpatentable even though it complied with interpretation under the terms of the Act. This provides some positive result for biotechnology companies in this respect insofar as it would appear that so long as their inventions do fit within the scope of patentable subject matter the Patent Office has acknowledged that there is a duty then to grant a patent.

Having stated that the only basis upon which he could refuse to allow the application to go forward was to find it not in compliance with the terms of the Patent Act, the Commissioner goes on to deal with the invention at hand. The 'Harvard mouse' application consisted of two sets of claims - one set dealing with the transgenic mouse itself, and the second set of claims dealing with the method of identification, expression and production of the genes which were implanted into the mice. He cites the obiter commentary in the leading Pioneer Hi-Bred decision of the Supreme Court of Canada which suggests that creations of the reproductive process have never been allowed to form the basis of a patent because they follow the laws of nature, and to that extent do not represent inventive effort. Stepping back from the Supreme Court decision in Pioneer Hi-Bred, the Commissioner goes on to refer more specifically to the decision of the Federal Court of Appeal in that case. He indicates that on the basis of authorities cited therein the Court found that cross-breeding did not equate to 'manufacture' as that term is used in the Patent Act. The Commissioner makes the same distinction here as did the Examiner - the second set of claims dealing with the production of the gene itself did identify patentable subject matter since that portion was all done as a result of work generated and controlled exclusively by the inventors. The first set of claims, with respect to the transgenic mouse containing the genes, however, were not allowable because the process of putting the genes into the new line of mice relied on the processes of nature in reproduction, the processes of nature being
beyond the control of the inventors.

The Harvard mouse patent was widely expected to issue, given its previous favorable treatment by the United States Patent and Trademark Office, thus opening the door for other potential patentees to apply for patent protection for genetically altered plants and animals. While the appeal process in this matter runs its course, potential patentees should avail themselves of existing avenues of alternative protection. Given the Commissioner's statement that there is no residual discretion in that office to refuse to grant patent protection on public policy grounds, it can be expected that some sort of protection will be allowed at some time, dependent upon the particular circumstances of an invention.

Another new item of interest and relevance to biotechnology companies evaluating their options and procedures in intellectual property protection and particularly with respect to patenting are the new Patent Rules having come into effect on October 1, 1996, which strongly parallel the requirements and regulations under the Patent Cooperation Treaty to which Canada is a signatory. Some of the highlights of those new Rules of particular import to agricultural biotechnology players are: 

• a type of Canadian 'provisional' patent application is now available. The filing requirements for same are basic and skeletal in nature, and the applicant has fifteen months from the date of filing this new type of application to 'complete' it;

• under the new Rules requests for examination must be filed within five years of the filing date; and  

• the new Rules include provisions detailing requirements for the deposit of biological material and for the submission of sequence listings for patent applications containing amino acid and nucleotide sequences. There is currently a proposal before the federal government for the deposits of biological material for patenting purposes be commenced.

Significant other detailed changes were made as well.

To say then that parties generally seeking intellectual property protection of their inventions in Canada and abroad, and biotechnology companies in particular, face difficult questions in determining the appropriate protective strategies for their inventions is definitely the case. The availability, accessibility and propriety of various legislative protection measures in various market countries might in certain cases mandate different approaches be taken in different countries with respect to the same invention. Companies working in transgenic plants and animals currently face problems in Canada with respect to the patentability of their inventions and as such plant breeders at this point are still restricted to the use of the Plant Breeders' Rights Act while researchers in the area of transgenic animals await the outcome of the appeals process in the Harvard Mouse case to determine whether or not their inventions will be allowed patent protection within Canada. Biotechnology companies stand to gain in Canada from the new Patent Rules having come into effect this October 1. In any event, the constantly changing legal landscape of intellectual property protection has significant potential effects for age biotech research. Can the law evolve as quickly as the science? We'll see. 

Originally published in Ag-West Biotech News, Winter 1996.

The writer would be pleased to provide more information or specific legal opinion on any of the topics discussed herein.

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