What the Harvard Mouse Can Teach Us About Patents 

publication 

Spring 2008 - (NOC: News of Course , published by CAPRA)

NOC: News of Course , published by CAPRA

To understand why a rodent from Massachusetts ended up in the Supreme Court of Canada requires an understanding of some of the fundamental principles of patent law.  A patent, according to Section 42 of the Patent Act, grants "to the patentee and the patentee's legal representatives for the term of the patent, from the granting of the patent, the exclusive right, privilege and liberty of making, constructing and using the invention and selling it to others to be used, subject to adjudication in respect thereof before any court of competent jurisdiction."  So, a patent is granted for an invention, which the Patent Act defines in Section 2 as "any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter."

This definition gives us the four fundamental principles of patent law - invention (or the requirement of inventive ingenuity), novelty (the requirement that it be new), utility (the requirement that it be useful) and subject matter (the term used to describe the phrase "art, process, machine, manufacture or composition of matter").  Before getting into the details, it is important to realize that Canada has two patent regimes.  Patents applied for before October 1, 1989 are under one regime (sometimes called the "Old Act"), while those applied for on and after October 1, 1989 are under the second (sometimes called the "New Act").  The discussion which follows refers only to the New Act, although readers should be aware that there are still Old Act applications pending and Old Act patents which are still in effect.

Invention

The requirement of invention is sometimes stated negatively – the invention must not be obvious.  This is spelled out in Section 28.3 of the Patent Act which provides that the "subject matter defined by a claim in an application for a patent in Canada must be the subject matter that would not have been obvious on the claim date to a person skilled in the art or science to which it pertains, having regard to" the state of the art.  For the purposes of understanding the requirement of invention, it is not important to understand the details of determining the "claim date" or the date at which the state of the art is determined.  The claim date is the earliest date (usually the date of the inventor's first application for a patent) that the inventor is entitled to claim for the invention.  If an invention is not obvious to a skilled person in the field of the invention, in light of what such persons knew or would have known, then it has the requisite inventive ingenuity.

The problem with this requirement is that it is often tempting to look backward from the invention to what was previously known and trace a series of steps that a skilled worker could have followed from what had been known to the invention.  Courts realize this, and are generally cautious of such hindsight analysis.  Often, once an invention has been made it becomes immediately apparent that the solution has been waiting right under everyone's nose for years.  One example is Mandy Haberman and her children's training cup.  Anyone who has tried to help a child graduate from a bottle to a cup realizes that trying to do so in a single step is unwise.  To solve the problem with spills, training cups with caps keep most of the liquid in the cup.  However, in the real world where the parent feeding the child is probably also trying to keep their three-year old from feeding her vegetables to the dog and answer the phone at the same time, a lot of liquid can still be lost by the time that parent realizes that the cup has been tipped on its side.  Mrs. Haberman had the idea of putting a slit valve in the cup opening similar to the valve on the nipple of a baby bottle.  Shortly after her spill-proof cup came to market, the unfortunately named Jackel International launched its "Tommee Tippee" slit valve cup.  Jackel was promptly sued, and attacked the patent as obvious.  While the judge struggled, in the end the vast sums of money Jackel and others had spent trying without success to develop spill-proof cups of their own convinced him that the simple slit valve was not an obvious solution to the problem, and only Mrs. Haberman had seen its possibilities.

Novelty

The second requirement an invention must have to be patentable is that it must be new.  If it can be demonstrated that the invention was "anticipated" because someone had already made the invention and disclosed it in such a way that it became available to the public, then the invention cannot be the subject of a patent.  This comes from the requirement of Section 28.2 of the Patent Act that the "subject matter defined by a claim in an application for a patent in Canada (the "pending application") must not have been disclosed…in such a manner that the subject matter became available to the public in Canada or elsewhere".

The trick of course comes in the comparison, since there are usually some differences between the new and the old versions as different persons made them.  If a compound is old, say AZT in the 1980s, but an inventor appreciates that it may have a new use, say as an antiretroviral drug, it will be possible to obtain a patent for the use of AZT to treat HIV/AIDS but not a patent which claims AZT as a compound.  It is thus important to focus on what the invention is, and determine whether the invention as such is new.  The fact that there may be aspects of the invention that are old does not prove that the invention itself lacks novelty.  It is not uncommon for scientists to assume that, because a compound is old it is not possible to obtain patent protection for an invention that discloses a new application for that compound.  However once the new application for the old compound is published, the ability to obtain patent protection is significantly impaired.

Where the invention is a combination of features, whether it is new must be tested on the combination as a whole and not feature-by-feature.  However, to be a combination, the features must interact to give an effect that did not exist before.  There is an example from the pharmaceutical field that will illustrate this point.  Amoxicillin belongs to a group of antibiotics, which have a structure called a ß-lactam ring.  Clavulanic acid and its salts also have a ß-lactam ring, but despite this their antibiotic effect is trivial and therefore did not come into use as stand-alone antibiotic.  It was eventually discovered that amoxicillin was not effective against some bacteria because they produced lactamase, a chemical that destroyed the amoxicillin before it could kill the bacteria.  Clavulanic acid, while not much of an antibiotic, was discovered to inhibit lactamase and the combination of both amoxicillin and a salt of clavulanic acid was effective against many bacteria that either of them alone could not treat.

On the other hand, if the features that are combined operate independently and produce the same effect in the combination that they did separately, the result is referred to as an aggregation.  An aggregation is considered to be unpatentable because it is obvious to use A to get effect A and also use B to get effect B.  Considerations of invention and novelty often arise together, and sometimes people confuse the two; however, they are distinct requirements.  The difference was colourfully illustrated by Justice Hugesson in the Federal Court of Appeal "...obviousness is an attack on a patent based on its lack of inventiveness.  The attacker says, in effect, "Any fool could have done that."  Anticipation or lack of novelty, on the other hand, in effect assumes that there has been an invention but asserts that it has been disclosed to the public prior to the application for the patent.  The charge is: "Your invention, though clever, was already known."

Utility

There are three aspects to utility.  Firstly, is the invention itself useful?  Secondly, even if the invention is useful, does the patent include and claim protection for things that will not work?  Thirdly, does the inventor claim some property for his invention, which the invention does not deliver? 

The requirement of the utility of the invention itself is really quite low – in one case a judge said all that was required was that "the wheels must go round".  It is not necessary that the invention is better, or cheaper than the state of the art, as long as it provides another way of solving the problem.  With a test so low, one might wonder whether any patent application fails on this ground.  The answer is yes, with the perpetual motion machine in its various guises as the leading example.  One Otta filed a patent application for a steam boiler/turbine/generator combination in which "batteries provide 304KW to the heater of a boiler.  The steam pressure drives a turbine of 500HP (373KW).  Part of the torque of the turbine is used to drive an alternator to provide 3-4KW, which is applied to the heater of the boiler while the batteries are switched off.  The remaining output of the turbine (369-370 KW) is applied to a generator."  Had Mr. Otta actually found a way to generate 373 KW of electricity with an input of only 3-4 KW, the coming changes to the Income Tax Act would be the least of the worries for those in the energy trust sector of the economy.

The second type of utility problem is more common.  An inventor discovers that a certain family of chemicals does something useful, and lays claim to every chemical in that family.  If it turns out that some of the family members do not work, claims that include them are invalid.  An example is a patent for the method of froth flotation to separate certain metals from ore.  The key was the discovery that the addition of a xanthate improved the separation.  Every claim of the patent claimed any xanthate.  While a great many xanthates worked exactly as claimed, the most common commercial xanthate known at the time of the patent, cellulose xanthate, did not work at all.  Even though the invention was a huge advance in mineral processing, because the patent for the invention also claimed things that would not work, the patent was held to be invalid.

The third type of utility problem is sometimes called "want of promise" because the inventor in the patent promises things that the invention does not deliver.  In the early years of the 20th century, one Alsop obtained a patent for "a novel process of treating flour to purify the same and increase the nutritive qualities thereof, and to this end resides broadly in subjecting flour to the action of a gaseous medium which will operate to bleach or purify the flour, and cause a reduction in the quantity of carbohydrate contents, and an increase in the quantity of the protein contents thereof."  While the process did bleach the flour, it did not and could not convert carbohydrate into protein.  For this reason, the patent was held to be invalid.

Subject Matter

As noted above, a patent may only be granted for something that can be described as an "art, process, machine, manufacture or composition of matter" or an improvement to one of that list.  Some things are easy – a new process for making a chemical or a new machine for making paper.  Others are more difficult, such as methods of doing business.  In the United States, where the patent legislation has a similar requirement, some business methods have been granted patent protection.  In Canada, the view at the moment is that a business method as such, with nothing more, cannot be the proper subject matter of a patent.  Computer programs also raise special problems.

So, where does this leave life forms and the famous Harvard Mouse in particular?  It is important to be aware that the patent filed by the trustees of Harvard included two broad classes of claims.  One class sought to protect the process of creating a non-human mammal by inserting a certain gene sequence that would make the resulting mammal susceptible to cancer.  Such mammals could then be used to screen compounds for their ability to cause cancer.  The second class of claims sought to protect the non-human mammal with such susceptibility to cancer.  The patent office allowed the first class of claims, but held the second class of claims to be unpatentable.

Before the Harvard Mouse, the Canadian Patent Office had issued patents for lower life forms – usually microorganisms with particular properties.  The Patent Office drew the line on a functional basis – in effect, if the properties of an individual were indistinguishable from the properties of the population as a whole, then the microorganism could be patented provided that all other requirements of patentability were satisfied.  This was an analogy to a chemical where the properties of an individual molecule did not differ from the properties of all those molecules in the aggregate.  The problem the Patent Office had with the claims to the non-human mammal was that each individual was different.  Whether the inserted gene was expressed in any particular mouse was a matter of chance, and even if expressed, the tissue in which the gene was expressed varied from mouse to mouse, again as a matter of chance.  The differences between mouse and mouse were not, as some contended, a matter of fur colour, they related to the very purpose for which the oncomouse had been created.  In effect, the claims as presented were to all winning poker hands.

This is a very simplified consideration of the issues raised by the Harvard Mouse.  The questions were sufficiently complicated that five judges of the Supreme Court of Canada concluded that the non-human mammal could not be patented, while four concluded that it could.  Policy issues going beyond patent law, including the philosophical question of patenting higher life forms were also involved.

Subject matter also has other policy issues and it is often difficult to understand or justify the different outcomes that can result.  For instance, while mechanical and chemical arts can be patented, professional skills, such as methods of medical treatment, cannot be patented.  A mechanic who invents a new method of removing a broken part from a car can patent that method, while a surgeon who invents a new method of removing an infected appendix cannot patent that method of surgery.  A chemist who develops a new synthesis for an old compound can patent that synthesis, while a lawyer who develops a new strategy for saving taxes cannot patent that strategy.  Making these distinctions is not easy, nor is it always easy to understand conclusions such as that the use of AZT to treat HIV/AIDS is not a method of medical treatment.

In a future article we will look at the sections of a patent, the function each of them is expected to serve and how they work together to define the scope of protection.  Not surprisingly, the patent itself has been the subject of change and improvement over the years, and some parts, such as the claims, are of comparatively recent origin.  The object of this series of articles is not to prepare you to qualify as patent agents, but to give you enough understanding to appreciate the impact that patents can have on your jobs.