Exclusions from Patentability Flashcards
What are the general requirements for patentability according to TRIPS Article 27(1)?
Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions whether products or processes, in all fields of technology, provided they are new, involve an inventive step, and are capable of industrial application… patents shall be available and patent right enjoyable without discrimination without discrimination as to the place of invention, the field of technology and whether the products are imported or locally produced
How does the Patents Act 1977 define industrial applicability?
An invention shall be taken to be capable of industrial application if it can be made or used in any industry, including agriculture
How does Article 57 EPC define industrial application?
An invention shall be considered as susceptible to industrial application if it can be made or used in any kind of industry, including agriculture
What does the Biotech Directive 98/44/EC Article 5(3) require in relation to industrial application?
The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application
What does the Paris Convention say about Ordre Public and Morality?
Article 4quater
The grant of a patent shall not be refused and a patent shall not be invalidated on the ground that the sale of patented product or of a product obtained by a means of a patented process is subject to restrictions or limitations resulting from domestic law
What does TRIPS say about Ordre Public and Morality?
Article 27(2) Memebers may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.
What does the Patents Act 1977 say about ordre public?
S1
(3) A patent shall not be granted for an invention the commercial exploitation of which would be contrary to public policy or morality
(4) for the purposes of subsection (3) above, exploitation shall not be regarded as contrary to public policy or morality only if it is prohibited by any law in force in the United Kingdom or any part of it.
What does the EPC say about ordre public?
Article 53(a):
European patents shall not be granted in respect of:
(a) inventions the publication or exploitation of which would be contrary to ordre public or morality, provided that the exploitation shall not be deemed to be contrary merely because it is prohibited by law or regulation in some or all of the contracting states.
When is the relevant date for considering whether something is contrary to morality?
Whether an invention is contrary to morality is considered at the priority date.
T315/03 Transgenic Animals/Harvard [2006] OJ EPO 15
The Exclusions whould reflect the current views of society in relation to morality and technology
T19/90 Oncomouse/Harvard [1990] OJ EPO 476
How should exclusions be considered?
Each exception must be considered for its purpose to determine whether it should be narrowly construed
G1/07 Treatment by surgery/Medi-physics [2011] OJ EPO 134
All Exceptions should be narrowly construed
Aerotel Ltd v Telco Holdings Ltd [2006] EWCA 137
What is the balancing test?
Introduced in T19/90 Oncomouse/Harvard [1990] OJ EPO 476 the balancing test was introduced:
a careful weighing up of the suffering of animals and possible risks to the environment on one hand and the invention’s usefulness to mankind on the other
The EPO tends to avoid using the test as in Relaxin [1995] EPOR 541:
[whether] human genes should be patented is a controversial issue on which many persons have strong opinions, the EPO is not the right institution to decided on fundamental ethical issues
Patent officers are, when it comes to ethical questions, simply members of the public with no special aptitude or training.
What does the Biotech directive say about excluded subject-matter?
Biotech directive 98/44/EC Article 6:
- Inventions shall be considered unpatentable where their commercial exploitation would be contrary to 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
What are 2 key cases concerning patentability of stem cells?
G2/06 Use of Embryos/WARF [2009] OJ EPO 306
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.
C-364/13 International Stem Cell Corp, EU; 2014; 2451 Article 6(2)(c) of the directive must be interpreted as meaning that an unfertilised human ovum whose division and subsequent development have been stimulated by parthenogenesis does not constitute a human embryo within the meaning of that provision if, in light of current scientific knowledge, it does, in itself have the inherent capacity of developing into a human being, this being a matter for the national court to determine.
