Beruflich Dokumente
Kultur Dokumente
Day 3
Purpose of Patent
Case summary: Harvard College applied for a patent on an invention entitled "transgenic animals", which consisted
of a way of breeding genetically altered mice that would be especially susceptible to cancer, and thus useful in
medical research. The patent was to cover both the "process" for producing these mice or any similar animals; and
the "product" - the mice (or other animals) themselves. The patent authorities allowed the patent on the process
but disallowed it on the transgenic animals themselves, finding that a higher life form is not a "manufacture" or
"composition of matter", which is what this kind of patent is supposed to cover.
Harvard College researchers developed a process by which they could create transgenic animals whose genomes
are altered by a cancer-promoting gene (called an activated oncogene). The researchers injected the oncogene
into fertilized mouse eggs close to the one-cell stage and implanted them into a female host mouse where they
developed to term. The resulting offspring were then tested for the presence or absence of the oncogene. Those
with the gene are referred to as founder mice and are mated with unaltered mice. Offspring that contain the
oncogene and have every cell in their body affected (including germ cells and somatic cells) by it are referred to as
oncomice. Oncomice are useful for carcinogenic studies as they are more susceptible to carcinogens. Such mice
can be given material suspected of being a carcinogen and if tumours develop, it is an indication that the material
is carcinogenic.
Initial Patent Application and Trial
In 1985, the President and Fellows of Harvard College applied for a patent for an invention called transgenic
animals. In particular, they applied for a process patent for the process by which they created the mice as well as
a product patent for the end product of the process, namely the founder mice and the oncomice, offspring
whose cells are affected by the gene. These patent claims also extend to all non-human mammals whose genomes
have been altered in a similar manner. .
In March 1993, the Patent Examiner rejected the product claims (Claims 1 to 12) on the grounds that higher life
forms were outside the definition of invention in section 2 of the Canadian Patent Act and are therefore not
patentable subject matter. The process claims (Claims 13 to 26) were allowed.
Supreme Court Ruling
The court found in favour of the government, ruling that higher life forms are not patentable. The sole question
before the court was whether the words manufacture or composition of matter, in the context of the Patent
Act, are broad enough to encompass higher life forms such as the oncomouse. The court found that they are not.
Bastarache J. stated that the determination of the patentability of higher life forms such as the oncomouse is
beyond the authority of the court and would be a massive change in the current patent regime. The majority
indicated that as there are significant public policy concerns at play, Parliament is best suited to address this issue.
are explained further in the articles on the Mayo and Alice cases.) Under this test the State Street patent would be
invalid.
Alice specifically holds that a generic computer implementation of an abstract idea is patent ineligible. In Alice, the
Supreme Court held that a software-related invention on an existing business procedure could not be saved from
patent ineligibility and be made patent eligible simply by saying, "Do it with a computer." Instead, it would be
necessary to implement the procedure in an inventive manner
In one of these district court decisions, Federal Circuit Judge Bryson, sitting by designation as a district judge, spoke
of these business method patents as uninventive and mere "aspirational" recitations of "methods for performing a
commonplace business function" without any description of "any novel manner of performing that function" other
than saying "do it with a computer":
In short, such patents, although frequently dressed up in the argot of invention, simply describe a problem,
announce purely functional steps that purport to solve the problem, and recite standard computer operations to
perform some of those steps. The principal flaw in these patents is that they do not contain an "inventive concept"
that solves practical problems and ensures that the patent is directed to something "significantly more than" the
ineligible abstract idea itself. As such, they represent little more than functional descriptions of objectives, rather
than inventive solutions. In addition, because they describe the claimed methods in functional terms, they
preempt any subsequent specific solutions to the problem at issue.
c) Industrial Applicability
Section 27. Industrial Applicability. - An invention that can be produced and used in any industry shall be
industrially applicable. (n)
d) Enablement/Sufficient disclosure
Section 35. Disclosure and Description of the Invention. - 35.1. Disclosure. - The application shall disclose the
invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art. Where
the application concerns a microbiological process or the product thereof and involves the use of a micro-organism
which cannot be sufficiently disclosed in the application in such a way as to enable the invention to be carried out
by a person skilled in the art, and such material is not available to the public, the application shall be
supplemented by a deposit of such material with an international depository institution.
35.2. Description. - The Regulations shall prescribe the contents of the description and the order of presentation.
(Sec. 14, R.A. No. 165a)
e) Patentable Subject Matter
Section 22. Non-Patentable Inventions. - The following shall be excluded from patent protection:
22.1. Discoveries, scientific theories and mathematical methods;
22.2. Schemes, rules and methods of performing mental acts, playing games or doing business, and programs for
computers;
22.3. Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced
on the human or animal body. This provision shall not apply to products and composition for use in any of these
methods;