Exclusions from patentability Flashcards
What does Article 6 Biotech Directive say?
Article 6
- Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation.
- On the basis of paragraph 1, the following, in particular, shall be considered unpatentable:
(a) processes for cloning human beings;
(b) processes for modifying the germ line genetic identity of human beings;
(c) uses of human embryos for industrial or commercial purposes;
(d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.
Implemented in UK legislation:
Section 1(3) and (4)
Section 3 Schedule A2
Implemented in EPC: Article 53 (and corresponding regulations)
What is the “balancing test”?
Applied to inventions which are immoral/contrary to ordre public (involving animal suffering due to genetic modifications)
According to ‘Oncomouse’, a T-Board of Appeal decision at the EPO, the application of Article 6(2)(d) Biotech Dir is subject to the so-called “balancing test”:
this test requires a careful weighing up of the suffering of the animals and possible risks to the environment on the one hand, and the invention’s usefulness on the other.
How does doc be read re morality?
Whether something is contrary to morality is judged at the priority date;
the excision should reflect the current views of society in relation to morality and technology
what is “germ line” modification?
Human germline engineering is the process by which the genome of an individual is edited in such a way that the change is heritable. This is achieved through genetic alterations within the germinal cells, or the reproductive cells, such as the oocyte and spermatogonium.
What is Article 4 of the Biotech Directive?
Article 4
- The following shall not be patentable-
(a) plant and animal varieties;
(b) essentially biological processes for the production of plants or animals. - Inventions which concern plants or animals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety.
- Paragraph 1(b) shall be without prejudice to the patentability of inventions which concern a microbiological or other technical process or a product obtained by means of such a process.
Implemented in UK:
Section 2 Schedule 2A
Implemented in EPC:
Section 53
What was the purpose behind the “essentially biological processes” exclusion?
From ‘Broccoli/PLANT BIOSCIENCE’:
It must be concluded that the legislator’s intention was to exclude from patentability the kind of plant breeding processes which were the conventional methods for the breeding of plant varieties of that time.
What factors need to be considered in determining if an invention falls within Article 6(2)(c)?
This exclusion relates to uses of human embryos for industrial or commercial purposes.
From ‘Use of embryos/WARF’:
The EPC forbids the patenting of claims directed to products which – as described in the application – at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which the said products are derived, even if the said method is not part of the claims
[Thus, this decision conveys the EPO’s interpretation that the exclusion relates to the invention itself–not the claim.]
From Greenpeace v Brustle:
(1) only use for therapeutic or diagnostic purposes which is applied to the human embryo and is useful to it being patentable
(2)Article 6(2)(c) of Directive 98/44 excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos
From ‘International Stem Cell Corp’:
something is a human embryo only if it does not, in itself, have the capacity of developing in to a human being
What factors do you need to consider when a invention relates to animal varieties?
Animal varieties cannot be patented, but “animal varieties” does not extent to “animals” per se, but limited to sub-species of animals.
As the technical feasibility of invention is not confined to a particular animal variety, transgenic animals do not fall within the exclusion. (from ‘Oncomouse’)
meaning of TRANSGENIC: relating to or denoting an organism that contains genetic material into which DNA from an unrelated organism has been artificially introduced.
what factor needs to be considered when an invention relates to a plant variety?
where a transgenic plant is claimed, but no variety identified, then it can be patented even if the claim covers plant varieties
From Transgenic Plant/NOVARTIS II: Enlarged Board held that patent protection ends where the protection under the UPOV Convention (or under the Community Plant Variety Regulation) begins (and the converse)
[note, to be protected as a plant variety, has to be: Distinct;
Uniform;
Stable; and
New.]
MEANING OF TRANSGENIC: relating to or denoting an organism that contains genetic material into which DNA from an unrelated organism has been artificially introduced.
What is Article 5 of Biotech Directive?
Article 5
- The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions.
- An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.
- The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application.
SUMMARY:
can’t patent: human body at any stage, sequence or partial sequence of its gene
can patent: element produced by means of technical process, even if the structure of that element is identical to that of the natural element found in body (i.e. can patent sequence of gene produced from tech process)
What is the exception re medical methods (UK and EPO)?
Section 4A (methods of treatment or diagnosis)
(1) A patent shall not be granted for the invention of-
(a) a method of treatment of the human or animal body by surgery or therapy, or
(b) a method of diagnosis practised on the human or animal body.
(2) Subsection (1) above does not apply to an invention consisting of a substance or composition for use in any such method.
Article 53(exceptions to patentability)
European patents shall not be granted in respect of-
“(c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.”
What is meant by “surgery”?
factors to consider (from EPO caselaw):
(1) requirement of medical expertise and the health risk involved
(2) degree of invasiveness or the complexity of the operation performed
not surgical: injecting a contrast agent, administering anaesthetic gas
What is meant by “therapy”?
Therapy is not limited to curative medical treatment as opposed to prophylactic medical treatment of disease, which may be preventive or curative
What is meant by “diagnostic methods”?
From ‘Diagnostic methods’ case:
A diagnostic method must include:
(i) the examination phase, involving the collection of data,
(ii) the comparison of these data with standard values,
(iii) the finding of any significant deviation, i.e. a symptom, during the comparison,
(iv) the attribution of the deviation to a particular clinical picture, i.e. the deductive medical or veterinary decision phase (diagnosis for curative purposes stricto sensu).
What is section 1(2) PA 1977?
Section 1(2) of the Patents Act 1977
It is hereby declared that the following (amongst other things) are not inventions for the purposes of this Act, that is to say, anything which consists of-
(a) a discovery, scientific theory or mathematical method;
(b) a literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever;
(c) a scheme, rule or method for performing a mental act, playing a game or doing business, or a program for a computer;
(d) the presentation of information;
but the foregoing provisions shall prevent anything from being treated as an invention for the purposes of the Act to the extent that a patent or application for a patent relates to that thing as such.
Corresponds to Article 52 EPC
