Patenting of
human genes and
their uses in
diagnostic tests
Prof Sigrid Sterckx, Ghent University
Dr Julian Cockbain, European Patent Attorney,
Gent and Oxford
Oxford, 24 June 2015
Translation
• Patents can assist translation (getting science into
practice) or it can hinder it.
• Diagnostic tests are a perfect example of both.
• Analyte patents (eg BRCA/Myriad) can hinder
• Platform patents (ie new equipment or way of finding
the analyte) can help. I’m tempted to say PCR, but HCy
is a better example.
• So don’t accept a gung-ho argument on either side to
readily
Monopoly
• Patents (that is monopolies) are a bad thing, a
restraint on free trade
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They are NOT a right
They need to be justified
They need to be in the interests of the society
They must not damage the interests of society
The ‘natural’
• What is out there in nature, is ours freely to use
• Products, phenomena, and laws of nature should
be free to all men, the exclusive property of no-one
• Water, elements, minerals, trees, gravity, relativity,
microbes, and genes
• OTHERWISE further research and development is
stifled – risking lives or even the climate of our planet
• This has been a consistent feature of US Supreme
Court law – the need to avoid patents which inhibit
further discovery or preempt any use of the building
blocks of nature.
Purpose
• The purpose of patents (now) is to encourage
investment in the development of new
technologies
• It was not always so:
• - to avoid loss of technology (Venice)
• - to repay the sovereign’s favorites (UK)
• - to introduce new industry, and taxes and jobs (UK)
• - to keep Ben Franklin happy (US)
Purpose
• Despite screams to the contrary, the purpose was
NEVER to confirm a ‘natural right’ or a ‘human right’
or to ‘reward’ or ‘encourage’ invention
Natural products
• Many, if not most, of our drugs and our diagnostic
tests are, or are founded on, natural products –
peptides, oligonucleotides, lipids, other
biochemicals, and the like
• A very recent example – teixobactin, an antibiotic
from a soil-dwelling bacterium
The balance
• Give a short term (20y) monopoly
• But for ‘inventions’ which meet the requirements,
the standard gatekeepers of novelty, nonobviousness, utility, and sufficiency of disclosure
The gatekeepers aren’t
enough
• For newly found natural materials, e.g. genes or
biochemical markers, the normal gatekeepers are
ineffective – being newly found they meet the
novelty (and usually non-obviousness) hurdles since
those involve comparison with the known
Patent-eligibility
• EPC and 35 USC contain further ‘patent-eligibility’
barriers.
• Art 52(2) EPC – certain things, like ‘discoveries’ and
‘computer programs’ are simply not inventions
• 35 USC 101 requires inventions to fall into particular
categories, e.g. compositions of matter or
processes, to be patent-eligible
USA
• A gene, a DNA molecule, is a ‘composition of
matter’ surely? There can be no doubt that the 35
USC 101 patent-eligibility hurdle is overcome surely?
• Not so – US Supreme Court considers that natural
products, laws and phenomena are open to all, the
property of none. However…
Parke-Davis v Mulford
• A patent for ‘purified’ adrenalin (as compared to
ground up adrenal glands)
• In 1911, SDNY Judge Learned Hand found this ‘for
every practical purpose a new thing commercially
and therapeutically. That was a good ground for a
patent.’
‘Isolated’, ‘purified’,
‘tweaked’
• Thus for a century the practice of many patent
offices was generally (not always) that a natural
product was patent-eligible if claimed in a way it
did not exist in in nature, e.g. ‘an isolated DNA
molecule comprising the sequence TTCCAA…’
• Novobiotic do this with teixobactin: ‘An isolate X,
or an enantiomer, diastereomer, tautomer, or
pharmaceutically-acceptable salt thereof...’
Diamond v. Chakrabarty
• In its famous 1980 decision which opened the
floodgates to the patenting of lifeforms in the US,
the 1950s comment that anything under the sun
made by man should be patent-eligible was
repeated. From then interpretation of 35 USC 101
changed little (and genetics based medicine
developed hugely) until three Supreme Court
decisions from 2012, 2013 and 2014
The trio
• Mayo v. Prometheus – dose-optimising diagnostic
tests (2012)
• AMP v. Myriad – isolated human DNA (2013)
• Alice v. CLS – financial transaction risk mitigation
(2014)
• (OK, and In re Bilski (2010) – business methods)
The development?
• Diamond v. Chakrabarty – arguably novelty, i.e. a
difference, over the natural is enough. A ‘marked’
difference was clearly enough.
• Mayo v. Prometheus – combining the natural with the
conventional was not enough, there needs to be an
inventive concept.
• AMP v.Myriad – Novelty was not enough, there had to
be an inventive act
• Alice v. CLS – Simply combining the excluded natural
with a conventional component would eviscerate the
excusion of the natural making patent-eligibility
dependent on the patent attorney’s drafting skill
The result
• Isolated, extracted, etc naturally occuring genetic
fragments and other materials (e.g. teixobactin) are
not patent-eligible in the US. cDNA is, but it isn’t
clear why given the references to acts of invention
and inventive concepts
• Most recently, the US Patent Office and courts have
been vigorously applying the position laid out in
Mayo, AMP and Alice, e.g. the rejection by the
CAFC of a patent to a dianostic test for paternal
DNA in maternal blood on 12 June 2015 in Ariosa v
Sequenom (plus Ox Uni)
Europe
• Europe went the other way.
• The exclusion of ‘discoveries’ is rendered at least
partly toothless since Art 52(3) EPC restricts the
exclusion to the specified thing (discovery,
computer program, etc) ‘as such’ and since the
‘Computers’ Technical Board of Appeal of the EPO
(3.5.01) has had its way…
Art 52(2)/(3) per 3.5.01
• (a) a discovery is not a discovery as such if it has a
technologial effect when in use, e.g. a gene when
it is operating as part of a protein producing
exercise.
• (b) a discovery is not a discovery as such if it is
claimed in combination with anything else (or
uncombined etc), e.g. as a plant, it is uprooted.
European Biotech
Directive
• The ‘anything added or removed’ approach of
3.5.01 was also set in stone, to the delight of
industry, in Art 5 of the Biotech Directive which
effectively adopted the position of the EPO
Examination Guidelines. Elements isolated from the
human body are patent-eligible even if they are
identical to the elements as they existed in the
body – human genes are patent-eligible as long as
the patent attorney drafts the claim properly – the
teixobactin claims mentioned earlier are OK.
Europe is following the now-discredited Judge
Learned Hand.
Relaxin
• Before the Directive came into force, the EPO
Opposition Division in Relaxin/HOWARD FLOREY had
applied the EPO Guidelines to uphold the patent
(to DNA encoding a human protein, and to
synthetic versions of that protein). On appeal, the
Appeal Board simply followed the Directive which
followed the Guidelines… See T-272/95
Australia
• In passing, essentially the same claims as in AMP v
Myriad were found valid by the Australian appeal
court last year – the isolated DNA was a manner of
manufacture in line with long established Australian
case law. The supreme court (Federal Court of
Australia Full Court) agreed to hear the appeal and
did so on 16-17 June 2015. Result awaited late this
year, but to my mind likely to go Myriad’s way. DN
suspects the full length gene claims might fail for
lack of material benefit.
A way out?
• If a computer program is not an invention, can the same
program become an invention simply by being put on a
standard disc?
• If a gene sequence or a plant or mineral as it occurs in
nature is a discovery, does it cease to be a discovery
when it is put into a standard environment under which it
can be studied?
• Art 52(1) EPC reserves patents for ‘inventions’ and the
EPC does not state that anything that passes the prior art
based ‘inventive step’ test of Art 56 is an invention.
• We need to learn from the Supreme Court with its
‘preemption concern that undergirds [its 35 USC] 101
jurisprudence’ (Justice Thomas, Alice v CLS)
THE END
• Thanks for listening
• Julian.cockbane@btopenworld.com
• Sigrid.sterckx@ugent.be