Exclusions to patentability Flashcards
*** Chiron v Murex Diagnostics [1996
Industrial application includes “any kind of industry” in its widest sense (whether or not for profit)
Needs a “useful purpose”
Key terms: Industrial application
- Paez’s Application
Inventions alleged to operate in a manner which is clearly contrary to well-established physical laws, such as perpetual motion machines, are regarded as not having industrial application.
Key terms: Industrial application
Paris Convention, 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 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.”
Key terms: ordre public
TRIPS Article 27(2)
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.
Key terms: ordre public
Patents Act 1977, s 1(3)-(4)
(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.
Key terms: ordre public
EPC, 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;
Key terms: ordre public
- T 315/03 Transgenic animals/HARVARD [2006
Whether it is contrary to morality is judged at the priority date
Key terms: ordre public
- T 19/90 Oncomouse/HARVARD [1990]
The exclusion should reflect the current views of society in relation to morality and technology
“a careful weighing up of the suffering of animals and possible risks to the environment on the one hand, and the invention’s usefulness to mankind on the other.” = BALANCING TEST
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.
Key terms: ordre public, balancing test, animal varieties
- G 1/07 Treatment by surgery/MEDI-PHYSICS [2011]
Each exception must be considered for its purpose to determine whether it should be narrowly interpreted.
Key terms: how to read exclusions
- Aerotel Ltd v Telco Holdings Ltd [2006]
All exceptions should be narrowly construed
Key terms: how to read exclusions
- T 356/93 Plant cells/PLANT GENETIC SYSTEMS [1995] OJ EPO 545
“It is generally accepted that the concept of ‘ordre public’ covers the protection of public security and the physical integrity of individuals as part of society. This concept encompasses also the protection of the environment. Accordingly…inventions the exploitation of which is likely to breach public peace or social order (for example, through acts of terrorism) or the seriously prejudice the environment are to be excluded from patentability as being contrary to ‘ordre public’.
The concept of morality is related to the belief that some behaviour is right and acceptable whereas other behaviour is wrong, this belief being founded on the totality of the accepted norms which are deep routed in a particular culture. For the purposes of the EPC, the culture in question is the culture inherent in European society and civilisation. Accordingly…inventions the exploitation of which is not in conformity with conventionally accepted standards of conduct pertaining to this culture are to be excluded from patentability as being contrary to morality.”
Key terms: ordre public EPO
- Relaxin [1995]
“[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 decide on fundamental ethical questions.” AVOIDING ONCOMOUSE TEST
Key terms: avoidance of the balancing test
- Phillip Grubb et al, Patents for Chemicals, Pharmaceuticals and Biotechnology (suitability of patent officers to decide on morality)
“Patent Officers are, in this respect, simply members of the public, with no special aptitude or training. As long as the criteria for applying EPC, Article 53(a) are as stated in the Guidelines, namely ‘whether it is probable that the public in general would regard the invention as so abhorrent that the grant of patent rights would be inconceivable’ then examiners, as members of the public in general, are as well fitted to judge this as anyone else. But if, as they are required to by the Board of Appeal in the Oncomouse case and by the BPD, examiners are supposed to carry out sophisticated balancing of subjective moral values as part of the examination procedure, then they are wholly incapable of such a task. Are EPO examiners to have courses in moral philosophy or theology? And if so, what variety?”
Key terms: view point on balancing test
- G 2/06 Use of embryos/WARF [2009]
“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.”
Key terms: stem cells
- C-34/10 Greenpeace v Brustle [2012]
1.Article 6(2)(c) means that:
–any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’;
–it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’ within the meaning of Article 6(2)(c) of Directive 98/44.
- The exclusion from patentability concerning the use of human embryos for industrial or commercial purposes set out in Article 6(2)(c) of Directive 98/44 also covers the use of human embryos for purposes of scientific research, only use for therapeutic or diagnostic purposes which is applied to the human embryo and is useful to it being patentable.
- 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.
Key terms: stem cells
- C-364/13 International Stem Cell Corp
“Article6(2)(c) of Directive must be interpreted as meaning that an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis does not constitute a ‘human embryo’, within the meaning of that provision, if, in the light of current scientific knowledge, it does not, in itself, have the inherent capacity of developing into a human being, this being a matter for the national court to determine.”
Key terms: stem cells
- G 1/98 Transgenic plant/NOVARTIS II [2000]
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)
Where a plant variety is individually claimed it cannot be patented irrespective of how it was made.
This means that a variety is excluded where it was produced by selective breeding or by genetic engineering. But where a transgenic plant is claimed, but no variety identified, then it can be patented even if the claim covers plant varieties.
Key terms: protection of plant varieties
- G 2/07 Broccoli/PLANT BIOSCIENCE [2012]
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. These conventional methods included in particular those (relevant for the present referrals) based on the sexual crossing of plants (i.e. of their whole genomes) deemed suitable for the purpose pursued and on the subsequent selection of the plants having the desired trait(s). The application of technical means or other forms of human intervention in such processes which helped to perform them was already common.
Key terms Essentially biological processes
- G 1/04 Diagnostic methods [2006] (‘defining diagnosis’)
“‘the exclusion from patentability of [medical] methods… seems actually to be based on socio-ethical and public health considerations. Medical and veterinary practitioners should be free to take the actions they consider suited to diagnose illnesses by means of investigative methods. Consequently, the policy appears to be aimed at ensuring that those who carry out diagnostic methods as part of the medical treatment of humans or veterinary treatment of animals are not inhibited by patents.”
Diagnostic methods likewise do not cover all methods related to diagnosis. To determine whether a claim is directed to a diagnostic method within the meaning of Art. 53(c), it must first be established whether all of the necessary phases are included in the claim.
The claim must include method steps relating to all of the following phases:
(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).
…each of the preceding technical method steps relating to phases (i) to (iii) must be performed on a human or animal body.
Key terms: industrial application, diagnostic methods
- G 1/07 Treatment by surgery/MEDI-PHYSICS [2011] (defining ‘surgery’)
This includes that the requirement medical expertise and the health risk involved may not be the only criteria which may be used to determine that a claimed method actually is a “treatment by surgery” within the meaning of Article 53(c) EPC. The referring decision and the President have mentioned the degree of invasiveness or the complexity of the operation performed…Although it appears likely that interventions involving a high degree of complexity and/or high degree of invasiveness would normally also be such as to require professional medical expertise and entail health risks even when carried out with the required care and expertise, the Enlarged Board does not wish to rule from the outset that, depending on circumstances of the individual case under consideration, other criteria could not also determine that a physical intervention on the human or animal body is a “treatment by surgery
Key terms: Surgery
- T 266/07 Magnetic resonance/WARF
Injecting a contrast agent (not surgical) - into the HEART would be though
Key terms: Surgery
- T 992/03 Treatment by surgery/MEDI-PHYSICS
Administering an anaesthetic gas (not surgical)
Key terms: Surgery
- T 1605/07 Blood flow measurement/TRANSONIC
Using a device that removes blood from the body and then puts it back (surgical)
Key terms: Surgery
* T 290/86 Cleaning plaque/ICI [1992] Unilever Limited (Davies’s) Application (1983) RPC 219
“Therapy” not limited to curative medical treatment as opposed to prophylactic medical treatment of disease, which may be preventive or curative.”
Something which has an excepted use which is dissociable from a permitted use will fall into the exclusion.
Key terms: Therapy
T 1075/06 Blood separation system/FENWAL
Treats blood = therapeutic
Key terms: Therapy
- T 24/91 Cornea/THOMPSON [1995]
Removing myopia, hyperopia and astigmatism = therapeutic
Key terms: Therapy
- T 385/09 Cooling animals/LELY ENTERPRISES
Alleviates a feeling of being hot = not therapeutic
Key terms: Therapy
- T 469/94 Perception of fatigue/MIT
Removing fatigue = not therapeutic
Key terms: Therapy
- T 19/86 Pigs II/DUPHAR [1989]
Claim for controlling parasites on pigs rejected at EPO on the grounds it was therapy. It was not an excuse that it was carried out by farmers, it was the same as the treatment carried out by vets.
Key terms: Diagnostic methods
- T 290/86 Thenoyl peroxide/ROUSSEL-UCLAF [1992]
Where an invention has both a medical effect and cosmetic effect it is still excluded from patentability.
Key terms: Dual effects
- T 774/89 Leistungsförderer bei Tieren/BAYER
Suggests that a disclaimer of medical use may be permitted
Key terms: Dual effects
T 144/83 Appetite suppressant/DU PONT [1986]
Suggests that a disclaimer of medical use may be permitted, but only where two functions may be distinguished, such as in weight loss.
Key terms: Dual effects
- G 05/83 Eisai/Second medical indication [1985]
A claim to the method of use of a known substance could not be patented, a claim to the use of a product for the manufacture of a medicament for a specified new and inventive medical use could be permitted.
SWISS CLAIMS ALLOWED
Key terms: second medical use EPO
- Wyeth’ Application [1985]
“[the approach of the EPO] to the novelty of Swiss type use of claim directed to a second, or subsequent, therapeutic use is equally possible under the corresponding provisions of the 1977 Act”.
AFFIRMS SWISS CLAIMS IN UK LAW
Key terms: second medical use UK
G 6/99 MOBIL OIL/BAYER/Friction reducing additives [1990]
[a claim is patentable] if [a technical feature of a product] has not been previously made available to the public by any means as set out in Article 54(2) EPC, then the claimed invention is novel, even though such technical effect may have inherently taken place in the course of carrying out what has previously been made available to the public.
Key terms: Mobile Oil Claims
- Warner-Lambert Company v Actavis [2015]
“How does one tell whether a manufacturer is using the manufacturing process of the claim, and therefore rendering himself liable for patent infringement? The answer must be when he manufactures [the drug] when he knows or foresees that users will intentionally administer it for [particular the indication].”
Difficult issues:
First: a manufacturer who had been supplying the medicine in question from before the priority date and whose sales subsequently increased without the manufacturer having done anything to bring that about.
Second: a defendant has taken all the steps open to him to avoid his medicine being prescribed for the new use, yet those steps are, due to the structure of the marketplace, insufficient to stop it happening.
Key terms: infringement
- Halliburton Energy Services v Smith International [2005]
“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.”
Key terms: UK approach to excluded subject matter
- T 930/05 Modellieren eines Prozessnetzwerks/XPERT
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.
Key terms: EPO approach to excluded subject matter
- T 154/04 Estimating sales activity/DUNS LICENSING ASSOCIATES [2008]
Whether something falls within the excluded subject matter or not is independent from other questions of patentability.
It does not require any knowledge of the prior art or common general knowledge and so can be determined in the abstract.
This means it can be examined first before considering novelty, inventive step or industrial applicability.
Key terms: EPO approach to excluded subject matter
- Aerotel [2007]
Step 1) properly construe the claim;
Step 2) identify the actual contribution;
Step 3) ask whether it falls solely within the excluded subject matter;
Step 4) check whether the actual or alleged contribution is actually technical in nature.
CONFIRMED IN HTC v Apple [2013] EWCA
Key terms: EPO approach to excluded subject matter
- Genetech Inc’s Patent [1985]
“It is trite law that you cannot patent a discovery, but if on the basis of that discovery you can tell people how it can be usefully employed, then a patentable invention may result. This in my view would be the case, even though once you have made the discovery, the way in which it can be usefully employed is obvious enough”
Key terms: Discovery, scientific theory, mathematical methods
- T 59/93 Displayed graphic objects/IBM
Mathematical methods as such would be excluded from patentability by Article 52(2)(a) in conjunction with (3) EPC. However, clearly, the claim does not relate to a mathematical method as such; it does not define any formula according to which the calculations should be performed. Rather, the calculating steps mentioned are only means, or tools, used within the overall method claimed, for entering a rotation angle value into a draw graphic system.
Key terms: mathematical methods
- T 1194/97 Data structure product/PHILIPS [2000]
‘The significance of the distinction between functional data and cognitive information content in relation to technical effect and character may be illustrated by the fact that in the present context complete loss of the cognitive content resulting in a humanly meaningless picture like “snow” on a television screen has no effect on the technical working of the system, while loss of functional data will impair the technical operation and in the limit bring the system to a complete halt.’
Key terms: presentation of information
- T 163/85 Colour television signal/BBC [1990]
The presentation of information would cover the moving pictures on a television, but not the signal which leads to the creation of the picture itself.
Key terms: presentation of information
Pension Benefit System
Broke the EPO away from the UK’s ‘contribution’ approach in Aerotel and established the ‘character’ or ‘any hardware approach’ for apparatus claims
Hitachi
Expanded the any hardware approach to method claims. Kicks contribution to the novelty and inventive step assessments. Writing using a pen and paper is ‘technical’ under this assessment.
Difference between UK and EPO on exclusions
At EPO technical character can be conferred on a non technical activity by way of technical means of implementation
President’s reference
Cup case illustrating difference beteeen the UK and EPO approaches to excluded subject matter
HTC v Apple [2013] EWCA
Whichever route for assessment (
UK or EPO) is used the result should be the same
Biotech Directive Art. 5(1)
Human body and simple discovery of its elements including sequence or partial sequence of a gene cannot constitute a patentable discovery.
Relaxin
Technical processes used to isolate a known substance in the body mean the isolated sibstance is patentable
IBM / Computer programs
Potential technical effect of computer program prevents it being ‘as such’
Aerotel
Exclusion for a program is not just to a set of abstract instructions but real programs in operable form.
Symbian v Comptroller General of Patents
Program which results in solving of technical problems outside and inside the computer are patentable. Includes making the computer more reliable by solving crashes due to eg conflicting library calls
Halliburton energy services appn
Computer program itself can be claimed if the contribution is technical in nature
AT&T Signposts
1 - Technical effect on process outside computer
2 - At architecture level
3 - Computer operates in new way
4 - A better computer
5 - Problem overcome not just circumvented
- Human Genome Sciences v Eli Lilly
Potential use must be ‘reasonably credible’ or ‘plausible’ not just ‘speculative’
- G 2/08 Dosage regime/ABBOTT RESPIRATORY [2010]
No more Swiss Claims
T1780/12 University of Texas Board of Regents/CANCER TREATMENT [2014]
New form has different scope of protection from Swiss form
The new claim format is a purpose-limited product claim, whereas the old format was a purpose-limited process claim, requiring in addition the manufacture of a medicament. The board acknowledged that the scopes of these two types of claim overlap, but found that they were not the same.
Warner-Lambert v Generics [2016] EWCA
I recognise, as I recognised in Warner-Lambert CoA, that the case where a manufacturer foresees use for the patented treatment, but takes all reasonable steps within his power to prevent it happening, represented a hard case. However, I do not think the answer is to adopt a test of purely subjective intention. Indeed I detected in Mr Speck’s submissions on this occasion a recognition that a purely subjective test is not correct and that the mental element needs to be judged objectively.
I think the debate in this case has been distorted by reference to notions of subjective intention. I have no doubt that an objective approach is necessary. From an objective standpoint one would normally regard a person to intend what he knows or can reasonably foresee as the consequences of his actions. That is the test which I formulated in Warner-Lambert CoA.
If that is the basic test to be adopted, what is sufficient to negative the existence of intention? In my judgment the absence of the patented indication from the label cannot conceivably be sufficient to negative the intention. Mr Speck recognised that there could be objective factual circumstances where the absence of a label identifying the patented indication did not negative intention, for example a manufacturer who proposes to sell far more of the drug than the market for the non-patented indication could bear.
Viewed in this way I think the answer becomes clear. The intention will be negatived where the manufacturer has taken all reasonable steps within his power to prevent the consequences occurring. In such circumstances his true objective is a lawful one, and one would be entitled to say that the foreseen consequences were not intended, but were an unintended incident of his otherwise lawful activity…
