BIOTECHNOLOGICAL INVENTIONS

PATENTABILITY
LEGAL AND ETHICAL CONSIDERATIONS

Dr. Rim Ghedira

European Patent Attorney
Janssen Pharmaceutica, Beerse

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A patent is
A right to exclude others from making, using, offering
for sale, selling or importing the patented invention

Reveal Obtain
invention exclusivity

… so that others can learn from it and improve upon it!

Source : European Patent Office – patent teaching kit
A patent is

 State granted exclusive right to prevent another to make,

use, import, sell and offer to sell one’s invention.

 Therefore, imposed limitations:

- specific territory (country-by-country)

- duration: 20 yrs from the filing date

- scope of protection (CLAIMS!)

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Information included in a patent application
Patents accelerate innovation

“The classic patent

system is a balance
between the interests of
society and those of
private business. This
system is not static,
however, as the diffusion
of both technology and
knowledge spurs further
technological innovation,
development and
progress.”

Source: EPO, Scenarios for the

future
Biotechnology

 Merriam-Webster: The manipulation of living organisms or

their components to produce useful usually commercial
products; also : any of various applications of biological
science used in such manipulation

 Examples:
– DNA/RNA
– Yeast
– Bacteria
– Plants
– Animals
– Humans
Science, ethics and patents

 Science brings technical progress

 Patent system gives incentive to invest in science and

provides a reward for providing and publishing inventions and
by providing a monopoly to the party that gets a patent

 Ethics are about what is regarded right or wrong by a

society and may change over time in view of scientific
developments

 The patent system provides an interesting cross over

between all these areas (Art 53 a)
What can be patented?
 Inventions, in all fields of technology, provided that they
are:
– Novel,
– involve an inventive step, and
– susceptible of industrial application.

 An invention is always technical in nature, consisting of a

reproducible technical teaching (isolation, purification,
chracterization, technical effect suggesting a use).

 An invention has to solve a meaningful technical problem

(Art. 56EPC) and it has to be industrially applicable (Art.
57EPC)

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What can be patented?

• Generally, patent laws define what does not qualify as an

invention.

• In Europe, the European Patent Office (EPO) examines

the patentability of a European patent application
according to the laws of the European Patent
Convention (EPC).

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Patentability of Biotech inventions (EPO)

Source : European Patent Office

Patentable inventions - Exclusions Art.52(2) EPC

(1) European patents shall be granted for any inventions, in all

fields of technology, provided that they are new, involve an inventive
step and are susceptible of industrial application.

(2) The following in particular shall not be regarded as inventions

within the meaning of paragraph 1:

(a) discoveries, scientific theories and mathematical methods;

(b) aesthetic creations;

(c) schemes, rules and methods for performing mental acts,

playing games or doing business, and programs for computers;

(d) presentations of information.

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Scientific theories
The theory of relativity
Physical theory of semi conductivity not allowable.However,
new semiconductor devices and processes for manufacturing these
may be patentable

Mathematical methods
A shortcut method of division would not be patentable, but
a calculating machine constructed to operate accordingly may well
be patentable

Aesthetic creations
A diamond may have a particularly beautiful shape (not of
itself patentable) produced by a new technical process (which is
patentable)

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Schemes, rules and methods for performing mental
acts or playing games
Schemes for learning a language, methods of solving
crossword puzzles and games (as an abstract entity defined by
its rules) are not patentable

Methods for doing business

Schemes for organising a commercial or administrative
operation.

Programs for computers

A computer program may be considered as an invention
if the program has the potential, when running on a computer,
to bring a further technical effect which goes beyond the normal
physical interactions between the program and the computer
(program for checking the spelling of words vs program for
controlling an X-ray apparatus)

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 Exceptions to patentability (Art.53 EPC):
European patents shall not be granted in respect of:

(a) inventions the commercial exploitation of which would be

contrary to "ordre public" or morality; such exploitation shall
not be deemed to be so contrary merely because it is prohibited by
law or regulation in some or all of the Contracting States;

(b) plant or animal varieties or essentially biological

processes for the production of plants or animals; this provision
shall not apply to microbiological processes or the products
thereof;

(c) 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, in
particular substances or compositions, for use in any of these
methods.

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Art.53(a)EPC – “contrary to ordre public or
morality”

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Examples
Oncomouse
OncoMouse or Harvard mouse (T19/90 and
T315/03)

 Laboratory mouse that has been genetically modified to

carry a specific gene called an activated oncogene

 The activated oncogene significantly increases the mouse’s

susceptibility to cancer, and thus makes the mouse suitable
for cancer research.

 Patentable?
 Exceptions to patentability (Art.53 EPC):
 European patents shall not be granted in respect of:

(a) inventions the commercial exploitation of which would be

contrary to "ordre public" or morality; such exploitation shall
not be deemed to be so contrary merely because it is prohibited by
law or regulation in some or all of the Contracting States;

(b) plant or animal varieties or essentially biological

processes for the production of plants or animals; this provision
shall not apply to microbiological processes or the products
thereof;

(c) 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, in
particular substances or compositions, for use in any of these
methods.

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Procedure before the EPO

 European patent application was filed and initially refused in

1989 among other things on the grounds that the EPC
excludes patentability of animals per se

 The decision was appealed BoA held that animal varieties

were excluded of patentability, while animals (as such)
were not excluded from patentability. The Examining
Division then granted the patent in 1992

 At this time, Rule 28 EPC was not codified yet….

Procedure before the EPO
 The EPO decided that the exclusion on patenting animal
varieties did not constitute a ban on patenting animals as
such. It concluded further that the oncomouse was not an
animal variety, and so did not fall within that exclusion

 the EPO developed a utilitarian balancing test aiming at

assessing the potential benefits of a claimed invention
against negative aspects. In this case:

the suffering of the oncomice vs. the expected medical

benefits to humanity

 EPO concluded that the usefulness of the oncomouse in

furthering cancer research satisfied the likelihood of
substantial medical benefit, and outweighed moral concerns
about suffering caused to the animal
Rule 28 EPC "ordre public" or morality
 At that time, Rule 28 EPC was not codified yet….

 Rule 28EPC: European patents shall not be granted in

respect of biotechnological inventions which, in particular,
concern the following :
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 (cf. Harvard Mouse).
Tomatoes and Broccoli
A plant variety??

 Exceptions to patentability (Article 53):

- a. inventions the commercial exploitation of which would

be contrary to "ordre public" or morality

- b. plant or animal varieties or essentially biological

processes for the production of plants or animals
(not: microbiological processes or the products
thereof)

- c. methods for treatment of the human or animal body

by surgery or therapy and diagnostic methods practised on
the human or animal body.
The patents of G2/07 and G1/08

 EP1 069 819 concerns a method for deriving broccoli with

enhanced glucosinolate levels

 EP1 211 926 concerns a method for breeding tomatoes with

reduced water content

 Broccoli: included the use of molecular markers, which

assisted in the selection of plants comprising the desired traits,
and the use of double haploid breeding lines, which are the
product of a technical process

 Tomato: a step was included which required leaving the

tomatoes on the vine past normal ripening, to assess which
plants had the desired characteristics

 Patentable?
 Decision
 A non-microbiological process for the production of plants which
contains or consists of the steps of sexually crossing the whole
genomes of plants and of subsequently selecting plants is in
principle excluded from patentability as being "essentially
biological" within the meaning of Article 53(b) EPC.
 Such a process does not escape the exclusion … merely because
it contains, as a further step … a step of a technical nature which
serves to enable or assist the performance of the steps of
sexually crossing the whole genomes of plants or of subsequently
selecting plants.
 If, however, such a process contains … an additional step of a
technical nature, which step by itself introduces a trait into the
genome or modifies a trait in the genome of the plant produced,
so that the introduction or modification of that trait is not the
result of the mixing of the genes of the plants chosen for sexual
crossing, then the process is not excluded from patentability
under Article 53(b) EPC.
Decision
 Not patentable is a process for obtaining plants based on
sexual crossing and selection, irrespective of what other
steps are included in the claim…
 Unless: an additional step of a technical nature, which step
by itself introduces a trait into the genome or modifies a
trait in the genome of the plant produced

What about the plants??

 G2/12 (tomato II)
 G2/13 (broccoli II)
 European Patent Office has declared that plants or seeds
obtained through conventional breeding methods are
patentable subject matter (still need to be new and
inventive!!)
Politics

 The European Parliament adopted a resolution asking the

European Commission to look into the patentability of
products of essentially biological processes

 This resulted, on 3 November 2016, in the Commission

adopting a Notice on certain articles of the Biotech Directive
(2016/C 411/03), in which the Commission took a different
view from that of the Enlarged Board

 the Commission has concluded that animals and plants

derived from essentially biological processes should not be
patentable.
Harmonization required
 European Patent Office amended rules 27 and 28 EPC
(amendment by decision of the Administrative Council
OJ EPO 2017, A56, in force as of 01st July 2017):

 Rule 27(b)EPC: biotechnological inventions are patentable

if they concern:
without prejudice to Rule 28, paragraph 2, plants or
animals if the technical feasibility of the invention is not
confined to a particular plant or animal variety;

 Rule 28(2)EPC: European patents shall not be granted in

respect of biotechnological inventions
Under Article 53(b), European patents shall not be granted
in respect of plants or animals exclusively obtained by
means of an essentially biological process.
Harmonization – what about amended EPC?

 EP2753168, entitled “New pepper plants and fruits with

improved nutritional value”, in the name of Syngenta rejected
in view of amended Rules 27 and 28 EPC (T1063/18).

 Syngenta appealed the decision of the Examining Division and

during the Oral Proceedings, the Board of Appeal decided that
amended Rule 28(2) EPC was in conflict with Article 53(b)
EPC.

plant or animal varieties or essentially biological processes for

the production of plants (Art.53)
vs
plants or animals exclusively obtained by means of an
essentially biological process (Rule 28(2))
Harmonization – what about amended EPC?

 Article 164(2) EPC stipulates that in such cases, the Articles

shall prevail over the Rules.

 It remains to be seen what the next step of the legislator will

be and whether or not a change of Art. 53(b) EPC is looming.
In the meantime, the agricultural sector is yet again up for a
period of legal uncertainty when it comes to plant patents in
Europe.
Human Embryo
Human embryo
 Rule 28 EPC: Exceptions to patentability for biotechnological
inventions:

(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.
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Embryonic stem cells

• Wisconsin Alumni Research Foundation (WARF) claims a cell

culture comprising primate embryonic cells capable of
proliferation in vitro

• The patent claimed cell cultures comprising embryonic stem

cells rather than claiming embryos per se.

• These cell cultures could at that time only be prepared by a

method which necessarily involved the destruction of
human embryos from which they were derived

• Patentable given exclusion on uses of human embryos for

industrial or commercial purposes?

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Decision

Interpretation of Article 53 and Rule 28 of the EPC, has been

considered in 2008 by the Enlarged Board of Appeal in
Decision G 2/06:
“A claim directed to a product which at the filing date of the
application could be exclusively obtained by a method
which necessarily involved the destruction of human
embryos from which the said product is derived is excluded
from patentability under Rule 28(c), even if said method is
not part of the claim (see G 2/06). The point in time at which
such destruction takes place is irrelevant (T 2221/10).

• Therefore, this cell culture not considered patentable

• Not a decision on the general patentability of stem cells

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Treatment by surgery
Surgery??

 Exceptions to patentability (Article 53):

a. inventions the commercial exploitation of which would be

contrary to "ordre public" or morality

b. plant or animal varieties or essentially biological

processes for the production of plants or animals (not:
microbiological processes or the products thereof)

c. methods for treatment of the human or animal

body by surgery or therapy and diagnostic methods
practiced on the human or animal body.
G1/07

 patent application included several independent claims to an

MRI method involving a step of "administering" a certain
imaging agent.

 The primary focus of the method was not to treat the patient
but to obtain images.
– method certainly was intended for use in providing images to a surgeon
during an operation.

 excluded from patentability is a method that has an invasive

step involving a substantial physical intervention on the body
that requires

– professional medical expertise to be carried out and

– entails a substantial health risk even when carried out with the required
professional care and expertise
G1/07 Conclusion

• Allowable should be the kinds of safe and routine invasive

techniques, at least when performed on uncritical parts of
the body, that are commonly carried out in commercial
settings such as cosmetic salons and beauty parlors.

• Claims to methods that define the operation of a device,

even if subsequent to a surgical procedure (e.g., methods
defining the operation of a pacemaker) can be patentable, if
novel and inventive.

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Diagnostic method/metabolites
Mayo v. Prometheus Laboratories

• Mayo Collaborative Services is a for-profit diagnostic testing

lab
• Prometheus is a specialty pharmaceutical and diagnostics
company

• The patents concern the use of thiopurine drugs in the

treatment of autoimmune diseases, different people
metabolize these drugs differently making it difficult to dose

• Prometheus is the exclusive licensee of the patents

• Mayo bought and used Prometheus kits until 2004, when it

decided to offer its own diagnostic test
Relevant claim

A method of optimizing therapeutic efficacy for treatment of

an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said
immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having said

immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8×108
red blood cells indicates a need to increase the amount of said drug
subsequently administered to said subject and

wherein the level of 6-thioguanine greater than about 400 pmol per
8×108 red blood cells indicates a need to decrease the amount of said
drug subsequently ad ministered to said subject.
Proceedings

 The district court rejected Mayo’s claims by noting that

Prometheus’ patents claimed natural phenomena that could
not be patented

 The court of appeals for the federal circuit reversed and

found the claims to be patentable.

 The U.S. Supreme Court subsequently reviewed the case

Supreme court ruling

• The court called the correlation between the naturally-

produced metabolites and therapeutic efficacy and toxicity
to be an unpatentable "natural law“

• Because methods for making such determinations were well

known in the art, this step simply tells doctors to engage in
well-understood, routine, conventional activity previously
engaged in by scientists in the field. Such activity is
normally not sufficient to transform an unpatentable law of
nature into a patent-eligible application of such a law

• claims were not patent eligible subject matter

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Mayo v. Prometheus Laboratories

• Mayo Collaborative Services is a for-profit diagnostic testing

lab
• Prometheus is a specialty pharmaceutical and diagnostics
company

• The patents concern the use of thiopurine drugs in the

treatment of autoimmune diseases, different people
metabolize these drugs differently making it difficult to dose

• Prometheus is the exclusive licensee of the patents

• Mayo bought and used Prometheus kits until 2004, when it

decided to offer its own diagnostic test
What do you think? Should you (or a company) be
able to get a ‘monopoly’ on: a human gene, an
animal, a plant, a virus etc. etc.

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Summary

 Patents are an important commercial asset for the biotech

industry

 There will always be a gray zone in relation to patentable

inventions, and new cases will be sure to come

 Science is evolving, the ethical framework is constantly

shifting and legislation is not always able to keep up

 For now, a short summary could read:

– Patenting humans: we say NO

– Patenting animals: we say NO unless….
– Patenting plants: we say maybe….
– Patenting bacteria and virusses: we say YES
Thank you

[email protected]
May 05, 2020