Exclusions to Patentability CONCEPTS

Question 1

TRIPS Article 27(1)

Answer 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 that they are new, involve an inventive step and are capable of industrial application… patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.

Question 2

Patents Act 1977, s 4(1), EPC Article 57

Answer 2

An invention shall be taken to be capable of industrial application if it can be made or used in any kind of industry, including agriculture.

Question 3

Biotech Directive 98/44/EC, Article 5(3)

Answer 3

The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application.

Question 4

Paris Convention Article 4quater

Answer 4

“The grant of a patent shall not be refused and a patent shall not be invalidated on the ground that the sale of the patented product or of a product obtained by means of a patented process is subject to restrictions or limitations resulting from the domestic law.”

Question 5

TRIPS Article 27(2)

Answer 5

Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordrepublic 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.

Question 6

Patents Act 1977, s1 (ordre public)

Answer 6

(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 because it is prohibited by any law in force in the United Kingdom or any part of it.

Question 7

EPC Article 53(a) (ordre public)

Answer 7

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;

Question 8

Section 2(2) of the Landmines Act 1998

Answer 8

“no person shall assist, encourage or induce any other person to engage in any conduct [to develop or produce an anti-personal mine]”

Question 9

Biotech Directive (98/44/EC) Article 6

Answer 9

1. 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.
2. 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

Question 10

TRIPS Article 27(3)(b)

Answer 10

Members may exclude from patentability-

plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes.

However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof….

Question 11

Biotech Directive 98/44/EC Article 4

Answer 11

1. The following shall not be patentable-

(a) plant and animal varieties;
(b) essentially biological processes for the production of plants or animals.

2. 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.
3. 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.

[harmonised into Patents Act 1977 Schedule A2]

Question 12

Biotech Directive 98/44/EC Article 5

Answer 12

1. 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.
2. 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.
3. The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application.

Question 13

Community Plant Varieties Regulation No. 2100 of 1994 (Community plant variety rights);

Plant Varieties Act 1997 (plant breeder’s right).

Answer 13

To be protected a variety has to be:

Distinct;
Uniform;
Stable; and
New.

Question 14

EPC Rule 28(2)

Answer 14

“Under Article53(b), European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process.”

Question 15

TRIPS Article 27(3)(a)

Answer 15

Members may also exclude from patentability:

(a)diagnostic, therapeutic and surgical methods for the treatment of humans or animals…

Question 16

Old EPC / UK approach to methods of treatment

Answer 16

PA Section 4 (industrial application)

(1) Subject to subsection (2) below, an invention shall be taken to be capable of industrial application if it can be made or used in any kind of industry, including agriculture.
(2) An invention of a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body shall not be taken to be capable of industrial application.
(3) Subsection (2) above shall not prevent a product consisting of a substance or composition being treated as capable of industrial application merely because it is invention for use in any such method.

EPC Article 52(4):

“Methods of treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body shall not be regarded as inventions which are susceptible of industrial application…This provision shall not apply to products, in particular substances or compositions, for use in any of these methods”

Question 17

New EPC / UK approach to methods of treatment

Answer 17

PA 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.”

Question 18

First and Second Medical Use

Answer 18

OLD LAW:

Section 2(6)-

“In the case of an invention consisting of a substance or composition for use in a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body, the fact that the substance or composition forms part of the state of the art shall not prevent the invention from being taken to be new if the use of the substance or composition in any such method does not form part of the state of the art.”

NEXT:

EPO allows claiming of known product for manufactire of specified new and inventive medical use (Eisai) - SWISS TYPE CLAIM

NEW LAW:

Patents Act 1977, section 4A(3) and (4):

“(3) In the case of an invention consisting of a substance or composition for use in any such method, the fact that the substance or composition forms part of the state of the art shall not prevent the invention from being taken to be new if the use of the substance or composition in any such method does not form part of the state of the art.

(4) In the case of an invention consisting of a substance or composition for a specific use in any such method, the fact that the substance or composition forms part of the state of the art shall not prevent the invention from being taken to be new if that specific use does not form part of the state of the art.”.

EPC Article 54(4) and (5):

“(4) Paragraph 2 and 3 shall not exclude the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in Article 53(c), provided that its use for any such method is not comprised in the state of art.

(5) Paragraph 2 and 3 shall also not exclude patentability of any substance or composition referred to in paragraph 4 for any specific use in a method referred to in Article 53(c), provided that such use is not comprised in the state of the art.”

NO MORE SWISS CLAIMS.

Question 19

Differences between Swiss and new 2nd use claims

Answer 19

Swiss form:
“use of substance X for the preparation of a medicament (or pharmaceutical composition) for treating indication Y”

EPC 2000 form:
“product X for treating indication Y”

New form has wider scope as it is a PRODUCT claim

Question 20

Excluded things EU: EPC Art. 52(2-3)

Answer 20

(2) The following IN PARTICULAR shall not be regarded as inventions within the meaning of paragraph 1-

(a) a discovery, scientific theory and mathematical method;
(b) aesthetic creations;
(c) a scheme, rule and methods for performing mental acts, playing 	games or doing business, and programs for a computers;
(d) presentations of information.

(3) The provisions of paragraph 2 shall exclude patentability of the subject-matter or activities referred to in that provision only to the extent to which a European patent application or European patent relates to such subject-matter or activities AS SUCH.

Question 21

Excluded things UK: Section 1(2) of the Patents Act 1977

Answer 21

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.

Question 22

Difference in UK / EPO reading of exclusions

Answer 22

The list of ‘non-inventions’ (or subject matter which is not patentable) have common features which they share. Furthermore as the list is only exemplary other things with similar features may also be non-inventions.

T 930/05 Modellieren eines Prozessnetzwerks/XPERT (unpublished*)

“It is idle to pretend that it is easy to reconcile the different cases on these questions, but part of the difficulty, I think, is caused by an unspoken belief that the various excluded matters have something in common. In my view, they do not. They are a heterogeneous collection, some of which (aesthetic creations) have their own form of protection, others of which (discoveries, mathematical methods and scientific theories) have never been accepted as suitable subjects of monopolies on obvious, but different, policy grounds. The problems are really caused by (c) and (d), which, by reason of their exclusion ‘only to the extent that the patent relates to such subject matter… as such’ are remarkably difficult to assess in cases lying near the boundary, particularly as it is difficult to discern an underlying policy.”
Pumfrey J, Halliburton Energy Services v Smith International [2005]