This article is written by Tejas Agarwal who is pursuing Certificate Course in Intellectual Property Law and Prosecution from LawSikho.
Patentability of Biotech inventions
Biotechnology patents fall under the ambit of Utility patents. Utility patents are provided for invention or discovery of a new and useful product, manufacturing process, the composition of matter, or process, or new and useful improvement to an existing process. All the applications for patent must fulfil certain patentability criteria namely novelty or newness, inventive step or non-obviousness and utility or industrial usage. These criteria are common in most countries which are signatory to international treaties like Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement, Patent Cooperation Treaty, etc.
According to a report published in the year 2020 by World Intellectual Property Organization (WIPO) (For full report see here), Patents in the field of biotechnology accounts for 2% of the total published patents in the year 2018.
The present case pertains to the patentability of OncoMouse or Harvard Mouse which is a kind of transgenic animal developed by scientists of Harvard College in mid-1980s. It was not the first transgenic mouse to be developed for cancer research but the first one to be patented. Before deep-diving into the case, let us first understand what are transgenic animals?
Transgenic Animals are those animals whose genome has been altered by transfer of a gene or genes from other species or breed for biomedical research. The most common animal used in these experiments are genetically modified rodents, predominately mice.
Harvard College scientists developed a process by which they were able to create transgenic animals by injecting cancer-promoting oncogene into fertilized animal eggs at the one cell development stage and implanting them into a female host animal. The offspring obtained from this female was tested for the presence or absence of the oncogene. Those in which the presence of oncogene was confirmed, were referred to as ‘founder’ mice and were mated again with unaltered mice. The offspring resulting from this process had oncogene and every cell in their body was affected by it, thus named as oncomouse becoming a suitable model for animal carcinogenic research.
The Harvard College even trademarked the name “Onco-Mouse” and now breeds and sells them to experimenters for cancer research.
In 1985, Harvard College (Official applicant was President and Fellows of Harvard College) applied for a patent at the Canadian Intellectual Property Office (‘CIPO’) for inventing a process to create transgenic animals as well as for the end product of the process namely the founder mouse and the oncomouse.
The patent application was titled “Transgenic Animals” and was filed in several countries such as in the United States, in Europe through European Patent Office, New Zealand and Japan. The inventors were Philip Leder and Timothy A. Stewart. The process claim was allowed by the examiner while the product claim was rejected. The appellate commissioner also confirmed the refusal of the product claim. Aggrieved by this decision, the Harvard College appealed to Federal Court, Trial Division but without any success.
They then appealed to the Federal Court of Appeal, where the appeal was heard and allowed. The Federal Court of Appeal directed the Commissioner of Patents to issue patent on the claims made by the applicant. The Court held that oncomouse is the result of both ingenuity and laws of nature and is an invention within the meaning of S.2 of the Patent Act (Canadian Law) (see here)(‘the Act’). Now, aggrieved by this decision, the commissioner of patents then filed an appeal to the Supreme Court of Canada for which leave to appeal was granted on June 14, 2001.
The sole issue raised in this Appeal was whether higher forms of life are inventions as ‘manufacture’ or ‘composition of matter’ within the existing definition of ‘invention’ under S.2 of the Act.
The majority consisting of Bastarache J. joined by L’Heureux-Dubé Gonthier, Iacobucci, and LeBel JJ. sided with the reasoning given by the Commissioner of Patents that higher life forms cannot be patented within the existing definition of ‘invention’ under the Act and legislative action is required to enlarge the subject matter of the patents. The reasons given by the majority for their decision are as follows:-
- The Commissioner of Patents does not have any discretion under S. 40 of the Act to reject a patent application solely on the ground of public policy consideration without contravention of any other provision under the Act. This was the only argument which the majority accepted from the decision of the Federal Court of Appeal.
- The product obtained from the process of making transgenic animals is neither ‘composition of matter’ nor ‘manufacture’ within the meaning of invention under S. 2 of the Act as the current scheme allows only patenting of lower life forms under the term ‘invention’ since they are easier to conceptualize as ‘composition of matter’ or ‘manufacture’ than the higher life forms.
- The Parliament did not intend to include the patenting of higher life forms within the definition of ‘invention’ as it raises unique concerns which can be dealt with only through public debate, balancing competing social interests and intricate legislative drafting.
- The Act does not define “invention” as “anything new and useful made by man” and only inventions which fall within the terms of the act are patentable. The court cannot, and;
- The Plant Breeders’ Rights Act was enacted as a special legislation to protect plant varieties which is a subset of higher life forms, then a similar legislation is required to deal with higher life forms in general and therefore the court is not competent to address the complex issues associated with it.
The decision of the majority was opposed by a strong dissent penned by Binnie J. joined by McLachlin, Major, Arbour JJ. In their dissent, the Hon’ble Justices agreed with the reasoning given by the Federal Court of Appeal and found that the Oncomouse developed by scientists of Harvard college is patentable under the definition of ‘invention’ as it is a product of extraordinary human ingenuity in which every single cell in the animal body was altered by modifying the genetic material not occurring naturally in this form. The reasons given by them are as follows:
- The Commissioner of Patents has no discretion in refusing the patent application on the ground of morality, public interest, public order, or any other ground if all the statutory provisions are fulfilled. The majority also agreed with this interpretation.
- Once the majority acknowledged that the fertilized, genetically modified oncomouse egg is an invention under the Act, it is not correct to conclude that the resulting oncomouse that grows from the egg is not patentable because it not an invention.
- The intention of the parliament can be gathered from the language and background of the patent legislation. The argument that the parliament could not have anticipated patenting of higher life forms is absurd because they could not have anticipated other inventions in 1869 also such as moon rockets, telephones, antibiotics, email, at the time of drafting the Act, so why not genetic engineering of higher life forms.
- The line drawn by the commissioner of patents with regard to ‘lower’ & ‘higher’ life forms does not have any statutory backing as the expression ‘composition of matter’ is an open-ended term used in the definition of ‘invention’ under the Act. It is a policy matter for the parliament to distinguish between the two life forms and to carve out a subject matter exception would be outside the jurisdiction of the Commissioner of Patents as well as the court.
- The enactment of the Plant Breeder’s Act does not mean exclusion of plants or other higher life forms for that matter from the subject matter of patents as the rights available under the Plant Breeders’ Act is different in various aspects from those given under the Patents Act. There is no inconsistency between the rights conferred by the two Acts.
- The oncomouse was already patented in other foreign jurisdictions having similar intellectual property legislations. The United States Patents Act contains a similar expression ‘composition of matter’ under which the oncomouse was patented in 1988. Similarly, it was also patented in major European Union countries namely Germany, France, Italy, Ireland, Portugal, Spain, etc., United Kingdom and Japan to name a few. New Zealand granted patent for a transgenic animal susceptible to HIV infection.
- The contention that the growth of a complete mouse from a single fertilized cell has nothing to do with the inventors and involves only ‘laws of nature’ is fallacious as ‘laws of nature have an essential role in most patented inventions. Inventions such as these cannot be brought into existence without reliance on ‘laws of nature’ in general and therefore cannot become unpatentable.
- It is a general phenomenon that regulation follows rather than precedes the invention. The claims made by the applicant specifically excludes human from the scope of transgenic mammals. As regards other concerns like environmental, moral, humanitarian, etc., associated with such scientific accomplishments it is for the parliament to consider and has little to do with the patent system.
Finally, in the year 2002, the Supreme Court of Canada passed the judgement in the above case with a majority of 5-4 and allowed the appeal filed by the Commissioner of Patents regarding the product claim. The process claim was not in issue as it was already allowed by the commissioner of patents. (For Full decision see here). The patent application was amended to omit ‘composition of matter’ claims on the transgenic animals. The patent was finally granted to Harvard College on 7th October, 2003 on these amended claims for a period of 17 years from the date of grant of patent i.e. till 7th October, 2020.
The Harvard College filed identical patent applications in other countries for patenting the Oncomouse and evidently all the countries granted them patent in which the application was filed.
- In the United States, the application was filed in 1984 and the patent was granted in the year 1988. The patent term expired on 12th April, 2005. Ironically, the definition of ‘invention’ used in the Canadian Patents Act was essentially taken from the United States Patent Act of 1793 and while the US Patent Office granted the patent both for the product as well as for the process involved in inventing transgenic animals without the need of bringing a legislative amendment, the Canadian Patent office refused to grant a product patent on similar grounds.
- The European Patent Office (‘EPO’) also granted the patent to Harvard College in the year 1992 with an anticipated expiry on 24th June, 2005. Despite having exceptions under Article 53 of the European Patent Convention (‘EPC’) with regard to inventions, the publication or exploitation of which would be contrary to ordre public or morality [Article 53(a)] and exclusion of patents on animal varieties or essential biological processes for the production of animals[Article 53(b)], the EPO concluded that the oncomouse is not contrary to public policy and also not an animal variety, therefore does not fall within these exceptions.
It developed a utilitarian balance test by accessing the suffering caused to the oncomouse against the potential medical benefit to humanity. EPO concluded that the usefulness of the oncomouse satisfied the potential medical benefit to humanity and outweighed moral concerns about sufferings caused to the mouse.
However, after the patent was granted in the year 1992 it was opposed by several 3rd parties on the basis of Article 53(a) of EPC as being contrary to ordre public or morality. After lengthy opposition proceedings, the EPO finally revoked the patent on 16th August, 2006 for failure to pay fees and to file translations of the amended claims under Rule 58(5) of EPC, 1973.
In the year 1873, microbiologist Louis Pasteur patented a new yeast-making method at the French Patent Office. Today we know it as Pasteurisation and is one of the most commercially exploited patents in modern times. Many modern luxuries which are generally taken for granted are product of the advancement in the field of biotechnology that might not have been available to public without patents. A great example of this can be seen in the process of vaccine development for the ongoing covid-19 virus. The field of biotechnology was at the forefront of this whole pandemic and everyone was eagerly waiting for a cure to be invented or discovered as soon as possible.
Patenting non-human life forms will always involve various concerns like ethics, environmental issue, morality, animal rights, etc. which are required to be balanced by the policymakers at the early stage and by the patent office or the courts at the time of hearing different cases. Biotechnology is a fast-changing field where the law always tries to catch up with the existing issue but by the time it addresses the issue, there is a new issue which needs to be taken into consideration. In such situations, the law must be made more accommodating to help the adjudicators in resolving the issues in a more proactive manner rather than making new rules for every single issue which arise with changing times.
- Full text of Supreme Court of Canada decision available at https://scc-csc.lexum.com/scc-csc/scc-csc/en/item/2019/index.do
- European Patent Office (EPO) – can be accessed at https://www.epo.org/law-practice/legal-texts.html
- Klein Carly. (2019) ‘The Complications Around Patenting Biotechnology’, Labiotech.eu [online]. Available at https://www.labiotech.eu/in-depth/biotechnology-patents-intellectual-property/
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