Table of contents section one an introduction to intellectual property

- "For the purposes of subsection (1) and sections 80 to 101, an invention pertains to a medicine if the invention is intended or capable of being used for medicine or for the preparation or production of medicine"

F: - Commissioner of Patents refused to grant a patent to Tennessee for a surgical method for joining or bonding surfaces of incisions/wounds in living animal tissue by applying certain compounds

- The discovery that these compounds had an unexpected property of bonding human tissue was new, useful and unobvious, but the compounds itself were old, well known, and used for other applications

- The Commissioner decided that the method did not constitute patentable subject matter under s. 2(d) of the Patent Act in that it is neither an art, or a process within the meaning of the section

- The decision of the Commissioner was affirmed by the Exchequer Court

I: - Can a new use for surgical purposes of a known substance be claimed as an invention and patentable?

J: - No, appeal dismissed…s.41 of the Patent Act governs the application

A: - The scope of the word “process” in s. 2(d) is somewhat circumscribed by the provision of s. 28(3) excluding a “mere scientific principle or abstract theorem.”

- The claims are limited to a method (ie: the process), which in this case is nothing else than a new use for a known substance

- While applicants claim not that they invented the glue, but that they invented the glue for surgical use, the court rejects the argument

- Section 41 of the Act was enacted for the purpose of restricting the scope of patents “relating to substances prepared or produced by chemical processes and intended for food or medicine”

- This necessarily implies that, with respect to such substances, the therapeutic use cannot be claimed by a process claim apart from the substance itself

- Thus a party can't bypass the prohibition of patenting the substance by patenting the use of the substance, so the claim must fail

- The only way you can patent a medical substance thingy is to patent the process for producing it

- While a party can patent processes for, say, tenderising meat or applying herbicide, can't patent for medical procedures because of s.41
- B: if allowed to patent the medical use of the substance, you indirectly patent the medical substance which is not patentable under s.41…can't allow

R: - While s.41 is now repealed (you can now patent drugs), parties still cannot patent a method of medical treatment as distinct from the substance with which you perform the medical treatment for the same policy reasons regarding availability of medical treatments for everybody

- However, recent case law since the 1992 repeal on the status of the ban on patenting methods of medical treatment indicate that the issue may be open to question (ie: case law from Australia)

a) Pro-patent – will encourage research, development, and ingenuity

b) Anti-patent – will drive up costs of future progress by monopolizing good ideas for 20 years

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- The following case holds that a computer program can't be an invention because it is simply a set of algorithms (series of simple steps followed to perform a task) that is a faster but identical intellectual process as that performed by humans

F: - A geologist applied for a patent because he devised a method whereby measurements of soil characteristics from boreholes are recorded on magnetic tapes, transmitted to a computer programmed according to the mathematical formulae set out in the specifications, and converted into charts, graphs or tables in readable form

- ie: obtained data was processed by a computer and displayed in graphical, human-readable form

- P claimed that the usefulness of the invention is not the computer program, but the complex process of transforming the data, which is affected by the computer

- ie: easier and more efficient to find oil and gas, therefore cost-savings and useful

I: - Is a process of a computer transferring scientific data into graphical, readable form an invention forming patentable subject matter?

J: - No, patent denied...P was claiming a monopoly on a computer program which is not an invention

A: - Invention as defined by the Patent Act does not exclude computer programs, but using computer programs to manipulate data is not new

- If the calculations were performed not by computers, but by men, then the subject matter would be mathematical formulae which are not patentable

- Even though the method of calculation by a human (an abstract theorem) would take 150 years, the fact that a computer can do it faster is the same thing

- It is still an idea that is not patentable, and not under s.2 of the Act

- Therefore, the fact that you will use a computer to apply a formulae, does not make an otherwise un-patentable formulae patentable

- Here, a two part test was applied:

a) Determine what has been discovered

b) Apply patent criteria

- After characterising the alleged invention, consider whether the new discovery was merely an operation or process which could be performed mentally

- However, if in creating the useful end result, one does more than merely determine information from calculations, then may be patentable

- Here, Schlumberger contests that calculations are not mental operations but purely mechanical ones that constitute the various steps in the process disclosed by the invention

- If this was correct, it would follow that the mere fact that the use of computers is prescribed to perform the calculations prescribed in the specifications, would have the effect of transforming into patentable subject-matter what would, otherwise, be clearly not patentable

R: - The fact that a computer is or should be used to implement a discovery does not change the nature of the discovery and does not make an otherwise unpatentable formulae patentable

- If the software is connected with a novel means of using hardware, then it can qualify as an invetion

F: - Subject-matter of this application relates to the storage, indexing and retrieval of text data for text processing machines such as printers

- IBM wanted a method for storing memory on a hard drive

- Initial response by Patent Commissioner was this was simply a computer program and not patentable

- IBM claims that their method calls for the physical placement of information in a specific manner and so achieves a physical improvement with respect to the security of data and the speed of access

I: - Was the disclosed method more than simply calculations or a mere scientific principle or abstract theorem and therefore patentable?

J: - Yes, patent granted

A: - Patent Board is satisfied that the disclosed method is directed to more than the various calculations to be made and more than a mere scientific or abstract theorem

- It wasn't just the program itself; it was the physical operations associated with the program that were patentable

- Here, IBM was patenting the storage device; patenting the new way of registering/storing data on the storage device, which gave it enough physical embodiment to be

- Board is also of the opinion that the disclosure of the application complies with the requirements of s.2 of the Patent Act and therefore they do not support the rejection of the claims for being directed to non-statutory subject matter

R: - While parties may patent hardware or methods of using hardware, such as new ways of storing data on a storage device that alters the way the computer program functions, computer software that simply uses the hardware to make calculations are not patentable

- ie: using program 'x' on hardware 'y' because it doesn't monopolize program 'x' entirely

- However, in Canada, the use of an algorithm is not patentable unless there is some effect by program 'x' on the way that hardware 'y' functions

- B: this is odd…may be changed in the future, but no recent case law on this…mainly companies use copyright protection rather than patent law to protect their computer programs

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F) LIVING MATTER
- Before Harvard College, the SCC made a decision in Pioneer Hi-Bred where a company wanted to patent a hybrid plant that produced a particular soybean

- The company produced the soybean not by genetic manipulation but by cross-breeding plants in a way that was not possible in nature

- SCC held that the crossbred soybean variety did not meet the disclosure requirements of the Patent Act, as there was no guarantee the process would produce the plant (trial and error needed)

- Shortly after this decision, Parliament passed the Plant Breeders' Rights Act, which gives plants specifically tailored and less onerous requirements in return for a narrower monopoly right than is available under the Patent Act

- While in Pioneer the SCC dodged the issue of patenting living matter by focusing on the disclosure issue (B: a "chicken" decision), the following case tackled the issue head-on…

F: - Harvard researchers developed a process by which it could breed genetically altered mice that would possess a cancer-promoting gene

- In the process, the cancer promoting gene ("oncogene") is injected into fertilized mouse eggs as close as possible to the one-cell stage

- When the mouse grows up, it has kids with the same gene that are used for research

- The school then applied for a patent for the genetically altered mice they called the "oncomouse" as well as a patent for the process by which they created the oncomice (ie: the founder mice and the offspring whose cells are affected by the oncogene)

- The Commissioner of Patents rejected their application to patent the mice on grounds that higher life forms were not inventions under section 2 of the Canadian Patent Act

- In s.2 of the Patent Act, an "invention" is defined as "any new and useful improvement, in an art, process, machine, manufacture or composition of matter"

- However, they allowed the process claims, as it's a way of doing something that will produce the same result every time

- Federal Court agreed; Federal Court of Appeal reversed, holding that the Act allows for patenting a "composition of matter" and that this includes living things since Parliament didn't exclude it

I: - Is the oncomouse, a genetically modified rodent with heightened genetic susceptibility to cancer, an "invention" under s.2? Are the words "manufacture" and "composition of matter", in the context of the Patent Act, sufficiently broad to include higher life forms and the process leading up to them?

J: - No, for Canada in a 5-4 judgment (with strong dissent from Binnie J.)

A: - There are two judgments:

a) Bastarache J. – Majority – Higher life forms not patentable under meaning of "invention"

- B: very delicate judgment by majority based on statutory interpretation, but undertones are completely based on morality on whether it's "right" to patent living things, including humans

- Since the sole question in this appeal is whether the words "manufacture" and "composition of matter", within the context of the Patent Act, are sufficiently broad to include higher life forms, it is irrelevant whether this Court believes that higher life forms such as the oncomouse ought to be patentable

- Bastararche bases conclusion on statutory interpretation, as the words of the Patent Act "are to be read in their entire context and in their grammatical and ordinary sense harmoniously with the scheme of the Act, the object of the Act, and the intention of Parliament"

- Parliament did not define "invention" as "anything new and useful made by man"

- The choice of an exhaustive definition signals a clear intention to exclude certain subject matter as being outside the confines of the Act

- Here, "manufacture" denotes a non-living mechanistic product or industrial process, not a higher life form, so doesn't fit here

- Also, "composition of matter" does not include a higher life form such as the oncomouse because when read along with other words, it implies something non-living

- It may relate to chemical compositions, but a self-reproducing being that transcends the composition of matter it holds can't be patentable

- Therefore, just as "machine" and "manufacture" do not imply a living creature, the words "composition of matter" are best read as not including higher life forms

- While a fertilized egg injected with an oncogene may be a mixture of various ingredients, the body of a mouse does not consist of ingredients or substances that have been combined or mixed together by a person

- Moreover, "matter" captures only one aspect of a higher life form, generally regarded as possessing qualities and characteristics that transcend the particular genetic material of which it is composed

- Therefore, this argument would say that the initially injected egg is an invention, but then changes and is no longer an invention

- Higher life forms cannot be conceptualized as mere "compositions of matter" within the context or scheme of the Patent Act

- Since patenting higher life forms would involve a radical departure from the traditional patent regime, and since the patentability of such life forms is a highly contentious matter that raises a number of extremely complex issues, clear and unequivocal legislation is required for higher life forms to be patentable

- The fact that reproduction doesn't guarantee exactly the same mouse is troubling

- Also concerned with infringement, as individuals would infringe when mice have sex

- Patenting of higher life forms raises unique concerns not addressed by the scheme of the Act…indication that Parliament never intended the definition of "invention" to extend to this type of subject matter

- Require Parliament to engage in public debate, a balancing of competing social interests, and intricate legislative drafting

- B: Majority believes it's clear that Parliament didn't have living things in mind during drafting, and reading it in would be "legislating from the bench" when it's addressing issues that Parliament would rather debate

- Although the Patent Act is designed to advance research and development and encourage broader economic activity, a product of human ingenuity must fall within the terms of the Act in order for it to be patentable

- Subsequent legislation, Plant Breeders' Rights Act is of significance to the interpretation of the Patent Act and the issue of its applicability to higher life forms

- In response to Pioneer Hi-Bred, Parliament passes special legislation that gives special consideration to plants in exchange for less protection than under the Patent Act

- In majority's view, this is recognition of Parliament viewing problems with patenting plants, and it knew of the problems of patenting animals at the same time

- Therefore, if a special legislative scheme was needed to protect plant varieties, a subset of higher life forms, a similar scheme may also be necessary to deal with the patenting of higher life forms in general (such as genetically-modified mice here)

- The distinction between lower and higher life forms, though not explicit in the Patent Act, is nonetheless defensible on the basis of the common sense differences between the two

- ie: lower life unicellular organisms = yeast (chemicals that are living)

- It is now accepted in Canada that lower life forms are patentable but this does not necessarily lead to the conclusion that higher life forms are patentable

- It is easier to conceptualize a lower life form as a "composition of matter" or "manufacture" than it is to conceptualize a higher life form in these terms

- B: Majority can't draw a logical distinction between patenting a mouse and not patenting human cells, which would open up a whole host of moral issues that Parliament should address

- Patentable micro-organisms are formed in such large numbers that any measurable quantity will possess uniform properties and characteristics

- The same can't be said for plants and animal, which can't be perfectly reproduceable

- Therefore, it is far easier to analogize a micro-organism to a chemical compound or another inanimate object than it is to analogize an animal to an inanimate object

b) Dissent – Binnie J. – Can't read in limitations into definition of an "invention" in the Act

- Key question is whether it is an invention under the act – this shouldn't be a policy debate

- The extraordinary scientific achievement of altering every single cell in the body of an animal which does not in this altered form exist in nature, by human modification of the genetic material of which it is composed, is an inventive "composition of matter" within s. 2

- The fertilized, genetically altered oncomouse egg is an invention under the Patent Act, and there is no basis in the statutory text to conclude that the resulting oncomouse, that grows from the patented egg, is not itself patentable because it is not an invention

- The context and scheme of the Patent Act reinforce the expansive sense of the words "composition of matter" to render the oncomouse patentable

- While Parliament did not contemplate the oncomouse in 1869 when it enacted the definition of "invention", it did not contemplate moon rockets, antibiotics, telephones, e-mail or hand-held computers either

- B: Act says you can patent basically anything, majority reads in restrictions that aren't there, and a higher/lower life form distinction doesn't make any sense

- The intent that can properly be attributed to Parliament, based on the language it used and the context of patent legislation generally, is that it considered it to be in the public interest to encourage new and useful inventions without knowing what such inventions would turn out to be and to that end inventors who disclosed their work should be rewarded for their ingenuity

- The oncomouse is also patented in jurisdictions that cover USA Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain, Sweden and the United Kingdom

- Therefore, the Commissioner's approach to this case sounds a highly discordant note

- The massive private sector investment in biotechnological research is exactly the sort of research and innovation that the Patent Act was intended to promote

- Healthcare is the major beneficiary of biotechnology

- At the same time, vast amounts of money must be found to finance biomedical research

- The Patent Act embodies the public policy that those who directly benefit from an invention should be asked, through the patent system, to pay for it, at least in part

- While as a matter of law there can be no patent on a human being, the Patent Act does not distinguish, in its definition of "invention", between "lower" and "higher" life forms

- None of the proposed dividing lines between "lower" and "higher" life forms arise from the text of the Patent Act

- Whether to carve out a subject-matter exception for "higher life forms", and how "higher life form" is to be defined, is a policy matter for Parliament

- As to the contention that growth from a single fertilized cell to the complete mouse has nothing to do with the inventors and everything to do with the "laws of nature", it must be said that the "laws of nature" are an essential part of working of many and probably most patented invention

- Pharmaceutical drugs utilize the normal bodily processes and functions of animals and humans and are not on that account regarded as less patentable

- Additionally, even if the animal doesn't perfectly reproduce every time, dissent doesn't care, as the invention is the gene and the gene will be present in each reproduced mouse

- Adoption of the Plant Breeders' Rights Act in 1990 does not mean that the subject matter of patents excludes plants and, by extension, other "higher" life forms such as seeds and animals

- It cannot be said that the two Acts are inconsistent

- Animals continue to be used in laboratories for scientific research whether patented or not

- With respect to the commodification of human life, the patentability of humans is precluded by law and the broadest claim here specifically excepts humans from the scope of transgenic mammals

- While the drawing of the line is on patenting human beings and everybody agrees on this, any creature other than a human should be patentable as long as it is the product of some human manipulation and thus an "invention" under s.2 of the Act

- Therefore, neither the Commissioner of Patents nor the courts have the authority to declare a moratorium on "higher" life patents until Parliament chooses to act

R: - In contrast to most other jurisdictions, the majority holds that living organisims are not patentable under the Patent Act because it does not fit the definition of an "invention" under s.2 and would lead the way to patenting other higher-life forms, such as humans

- Didn't say you can't patent the gene, as you can patent something found in nature if you find a new use for it

- Can also patent something in nature that you find and then do something to

- Therefore, an individual modified cell appears to be patentable, but you can't patent living organisms

- Q: if you patent the cell, does this lead to the conclusion that any creature/organism holding the patented cell is infringing patent protection? See the next case…
Monsanto Canada Inc. v. Schmeiser (2004 SCC)…Valid patent over a cell or gene, not higher life forms

F: - Monsanto is the licensee and owner, respectively, of a patent that discloses the invention of chimeric genes that confer tolerance to glyphosate herbicides such as Roundup and cells containing those genes

- Canola containing the patented genes and cells is marketed under the trade name "Roundup Ready Canola" and has "Canola police" monitoring the country

- Farmer Schmeiser grows canola commercially in Saskatchewan

- S never purchased "Roundup Ready" canola nor obtained a licence to plant it

- He also had knowledge of this resistance because he tested it

- After killing the non-modified Canola, he collected the resistant Canola, actively planted the resistant seed, and grew a whole bunch of Roundup Ready Canola

- Since Monsanto didn't licence the genetically modified Canola to Schmeiser, they were afraid that they would lose their monopoly over their crop

- After Canola police tested Schmeiser's 1998 canola crop revealed that 95-98% was Roundup Ready Canola, big evil Monsanto brought an action against Schmeiser for patent infringement

- Note: not under the Plant Breeders' Rights Act, but action under the Patent Act

- Monsanto made a bunch of patent claims, including a chimeric gene, an expression vector, a plant transformation vector, various species of plant cells, and a method of regenerating the resistant plant

- TJ found the patent to be valid and allowed the action, concluding that the appellants knew or ought to have known that they saved and planted seed containing the patented gene and cell and that they sold the resulting crop also containing the patented gene and cell

- The Federal Court of Appeal affirmed the decision but made no finding on patent validity

I: - Are the plants and seeds that Monsanto claims a patent over unpatentable "higher life forms"?

J: - No, for Monsanto…patent is valid

A: - Schmeiser argues that the subject matter claimed in the patent (ie: a gene or a method of rengerating a glyphosate-resistant plan) is unpatentable

- SCC disagrees, because they claim Monsanto only patented the cell, not the plant

- While acknowledging that Monsanto claims protection only over a gene and a cell, Schmeiser contends that the result of extending such protection is to restrict use of a plant and a seed

- Basically, he says SCC should follow Harvard Mouse were plants and seeds were found to be unpatentable "higher life forms"

- However, SCC claims there's a difference between patenting a gene/cell and patenting a mammal

- Therefore, not inconsistent with Harvard Mouse

- Also, in obiter, both majority and dissent in Harvard Mouse noted that a fertilized, genetically altered oncomouse egg would be patentable subject matter, regardless of its ultimate anticipated development into a mouse

- Therefore, Schmeiser failed to discharge its onus that the patent is invalid

- Whether or not patent protection for the gene and the cell extends to activities involving the plant is not relevant to the patent’s validity

R: - While animals and plants are not patentable, it is possible to patent a genetically modified cell whose purpose it is to form part of an animal or a plant
- See later section on "infringement" for a bigger and more difficult issue of whether Schmeiser actually infringed Monsanto's valid patent/invention

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