16 The “Novelty” Requirements for Gene andGenetically-Modified Organisms Inventions and the Potential
Benefits of a Peer-to-Patent System (*)
Invited Researcher: Thomas Margoni (**)
The paper focuses on the patentability requirements applicable to the case of biotechnological inventions(gene patents and other genetically modified organisms). The paper takes a comparative standpoint andanalyzes North-american, European, and Japanese landscapes. Attention will be also paid to the internal
guidelines followed by the relevant Patent Offices, and their examiners. Particular attention will be paid to the“novelty” requirement, and it will be analyzed also under the more pragmatic aspect of the prior art searches
that relies on public and community participation. The Peer-to-Patent system will be presented in its
fundamental traits in order to identify its potentially beneficial outcomes in terms of quality and efficiency of thepatent granting system.

Ⅰ Introduction
The paper focuses on the patentability
requirements applicable to the case of
biotechnological inventions (gene patents andother genetically modified organisms). The paper
takes a comparative standpoint and analyzes
North-american,
European,andJapaneselandscapes. Attention will be also paid to theinternal guidelines followed by the relevant Patent
Offices, and their examiners. Particular attention
will be paid to the “novelty” requirement, and it
will be analyzed also under the more pragmatic
aspect of the prior art searches that relies on
public and community participation. The
Peer-to-Patent system will be presented in its
fundamental traits in order to identify its
potentially beneficial outcomes in terms of quality
and efficiency of the patent granting system.
Given the technical features of genes, theobjective of this study is to understand what“novelty” in the biotechnological patent systemmeans: If researcher A isolates the DNA fragment
ACTCCATTGA, is research B entitled to file apatent for its complementary strand? Under a purechemical point of view, the complementary strand
is made of a different molecular sequence, making
it potentially a different invention. On the otherside, it could be argued that regardless of thedifferent chemical structures, the substances
above mentioned are two sides of the same coin,as both segments carry the same set of genetic

information. Of course such an example
oversimplifies a very complex situation, and any
given solution will stem from an analysis of all thepatent requirements, and of the specific claimspresent in the application. Nevertheless, throughthe analysis of legislation, case law and Patent
Offices guidelines of relevant jurisdictions, thepresent paper aims at finding analytical answers to
the reported questions, and offer the base for thedevelopment of guidelines and best practices.

Ⅱ Gene Patents
In the field of biotechnological inventions –such as gene patents and other Genetically
Modified Organisms (GMOs) – the novelty
requirement is often analyzed (and sometimes
confused) with the subject-matter one. The“product (or law) of nature” doctrine creates animportant hurdle to the patentability of such typesof inventions, in all those cases where
biotechnological products and processes may bederived from the duplication of compounds foundin living organisms or produced by naturally
occurring animals or plants. If it is accepted thattransgenic plants and animals, modified
micro-organisms and isolated and purified DNA
sequences are the results of human intervention
and therefore patentable subject-matter, they are“new” in the sense of having no previous
existence in the state of the art. However, at thesame time, in a different chemical composition,(*) This is a summary of the report published under the Industrial Property Research Promotion Project FY2011
entrusted by the Japan Patent Office.
(**) Post-Doctoral Fellow, Assistant professor, Faculty of Law, University of Western Ontario, Canada

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1 ●exactly the same genetic and functional
information may already exist in nature.
Patents are legal monopolies used in modern
societies to protect and foster inventive activities1 .
The rationale behind such tools is to compensate a
specific individual (the inventor) with a legal (not anatural) time-limited monopoly for her making
public a new, useful and industrially applicableinvention2 .
Patents can be seen as a form of retributionthat the State grants to a specific category ofworkers: the inventors. Patents represent just oneof the form a given societal organization canchoose to use. Depending on the time and place,inventors have been retributed in other forms, notnecessarily indexed to the success of theirinventions. Let's only think at medieval societies
where inventors were usual figures in royal courts,
and where their survival depended from such formof patronage. This model has lasted for centuries,
and certainly we cannot affirm that science andtechnology have not been developed by minds
such as those of Archimedes or Al-Jazari. However,a first major issue with such model is the scientificand technological independence from theconstituted power. Another problem that emerges
clearly, is how to remunerate the inventor only forits successful inventions, those which could bringtechnological or militar advantage, aspects thatsometime concretize with some year of
discrepancy from when the knowledge has been
produced. Such a form of patronage was proper ofmedieval societies, based mostly on local tradeand rural production. It already looked not
appropriate to bigger commercial empires 3 , letalone to industrial form of organization4 .
One of the most striking inventions of theindustrial revolution, together with the steam
engine, has certainly been the limited liability forincorporations5 . Another fundamental step in our
modern societies has been the idea to renderinventors participants of their success, or failure.
The creation of a legal title stating that a given
invention belongs exclusively to its inventor, andthat everybody interested in its use should obtain
permission, is but another model (more in linewith the capitalistic and proto-democraticsocieties emerging during that century) tocompensate a specific task believed to befundamental for the social welfare of a given
human organization. Under this point of view, apatent could be well idealized as a share in one
owns invention's fate.
Nowadays, the situation might look, andactually is, extremely different, and the idea of the●particularly gifted who invents something in its
workshop is far away in time and space from thecurrent market situation. However the legal
framework stratified over the past few centuries,
is in large parts still the same 6 . Requirements
such as novelty, utility and non-obviousness havebeen filled up with specific content by courts andpatent offices, and the eligibility of new products(software), new discoveries (genes), or new
processes (business methods) has been largely
discussed by international assemblies and national
parliaments. However, the Patent Acts around theworld have to a considerable extent looked almost
the same during the past 100 years, and growing7 .
In light of such an apparent contradiction, we willproceed to an analysis of the patentability
requirements for gene-related inventions inselected jurisdictions.
Inventions, to be patentable, needs to refer tofields such as art, process, machine, manufacture,and composition of matter, categories also known
as patentable subject matter 8 . Gene patents
usually take the form of composition of matter,such as in the case of isolated natural sequences ofgenes, or altered natural sequences that result in amore useful compound thanks to the alteration. A
second type, and more recent, structure thatgene-related patent usually take is that of aprocess, or method, such as in the cases ofobtaining a natural sequence for diagnostic or
testing purposes9 .
However, the trail that brought courts andpatent offices to accept such type of claims is very
steep and bumpy. Among the first patents
regarding isolated forms of natural occurring
substances there are U.S. Patent No. 730,176 and753,177, both challenged in the case Parke-Davis v.
H.K. Mulford 10 . What is really important about thiscase, is the view expressed by J. Hand regarding
the patentability of an isolated form of adrenalinewith regard to the novelty requirement. In his
opinion in fact, such isolated form, is a new
substance and not just a compound with a higher
degree of purity, case in which there would be nonovelty11 . J. Hand goes further explaining that thepatent at stake regards a new substance, in fact theclaimed invention regards a composition of matterthat does not include a salt, and no one everisolated a substance which was not in salt form
before 12 . Relevant at our purposes, is that thedistinction between the natural occurring
substance and the isolated one – from a chemical
point of view – is not in degree but in kind13
The step following patentability's recognitionof isolated natural occurring substances, would be
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to recognize patentability of life forms. For such a
decision we have to move forward in time of about
seventy years. The landmark U.S. Supreme Court
case discussing extensively such issue is certainly
Diamond v. Chakrabarty 14 . In 1972 Chakrabarty
applied for a patent regarding a bacterium of aknown genus containing at least two stableenergy-generating plasmids, which could provide
separate hydrocarbon degradative pathways. Suchcharacteristic of breaking-down crude oil was
unknown – at least to the obtained level of
effectiveness – in any natural occurring substance,and especially the bacterium did not have suchability, in its naturally occurring version.
Nevertheless, the Supreme Court in
Chakrabarty tell us that its holding is not tosuggest that § 101 has no limits, or that itembraces every discovery. Therefore, for example,
the laws of nature, physical phenomena, andabstract ideas have been already held notpatentable 15 . In these decisions, for instance, a“new mineral discovered in the earth or a newplant found in the wild are not patentable subject
matter. Likewise, Einstein could not patent hiscelebrated law that E=mc2; nor could Newton
have patented the law of gravity. Such discoveries
are "manifestations of . . . nature, free to all men
and reserved exclusively to none” 16 .
However the present case is different, theCourt points out, as the claim under judgment is
not to an unknown natural phenomenon, but tosomething (manufacture or composition of matter)that does not occur naturally, a man-made productwhich has a “distinctive name, character [and]use.17 " In light of these considerations, the Court
concludes that the respondent's micro-organism
plainly qualifies as patentable subject matter.
The court argues that the invention in Funkis of a different nature. In Funk, the patentee
discovered something that already existed innature (i.e. that some bacteria do not exert
mutually inhibitive effect on each other), and heused such discovery to produce a mixed culture
capable of producing a useful result. In such casethe court held that the patentee discovered only
some of the handiwork of nature, and this was notpatentable18 .
In Chakrabarty, however, the courts believethat the patentee has produced a “new bacteriumwith markedly different characteristics from any
found in nature, and one having the potential forsignificant utility” 19 . Such invention does notcorrespond to something nature has already, but tosomething that the patentee has newly invented,
thus it is patentable subject matter under § 101.

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1

The Myriad Genetic Saga

The Myriad case is a long and complex, yetstill actual one. The last stone in this saga has
been layed down by the Court of Appeal for theFederal Circuit, which with an order of September
13 2011 no. 2010-1406 has denied rehearing of the
Myriad case. The next step will then be up to theSupreme Court.
Such motion for rehearing was filed by bothparties as a consequence of the Court of Appeal for
the Federal Circuit decision of July 29, 2011,
which partially reversed the district court
summary judgment of March 29, 201020 that had
invalidated most of Myriad patents.
During the obvious appeal, the holdings of theDistrict court were reversed in large parts,
although with dissenting opinions on different
points.
Regarding isolated genes, cDNAs and partial
isolated gene sequences, the Court of Appeal for
the Federal Circuit (in a 2 to 1 decision) decided
that such products are §101 compliant, thus
patentable subject matter. For the CAFC
“cleaving” DNA out of chromosomes, is a processthat produces something that does not exists assuch in nature. Isolating is different (after all theprecedent of Park-Davis regarded a new substance,
not just an isolated one, which was believed to bepatentable by J. Hand in its obiter21 ).
It is possible to note how weak certain
passages of the court are, almost sounding as an
ex-post justification of an already taken decision in
the sense of not creating excessive financial harm
to a sector, while maintaining some of theprerogatives of the District Court. Such an implicit
tension is evident in the dissenting opinion, where
it is writes that there is no magic to a chemicalbond which requires the Court to recognize a new
product when such a chemical bond is altered or
broken. What is claimed in the BRCA genes is thegenetic coding material, and that material is thesame, structurally and functionally, in both thenative gene and the isolated form of the gene22 .
The dissenting opinion goes further and adds thatpatent thickets are significant obstacle to the next
generation of innovation in genetic medicine,
multiplex tests and whole-genomic sequencing,
contesting the position of the majority of the
Court on the fact that there are already more than
2,500 gene patents, and invalidating them would
create economic losses. Finally, the dissenting
opinion clarifies that cDNA and DNA sequences as
short as 15 nucleotides should not be patentable.

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2

Myriad Patents in EU

The Myriad saga is an interesting one as itallows us to draw a comparison with the EU, as thepatents have been granted to Myriads also by theEuropean Patent Office. However, as we will see
the European part of the story is much different,
as it will focus on a series of decisions withing thevery same European Patent Office, and not on
court of justice decisions. At this regard isrelevant the different political and administrative
organization of the EU with regard to the USA, andof the fact that the European Patent Office is nopart in the EU organization, but a different andseparate international body. This is not the place
for an analysis of the role of the European Patent
Office in the EU, therefore we will only
incidentally clarify those aspect that could
ingenerate confusion.
The European Patent Office has granted
mainly 4 patents regarding the BRCA genes,
although not before a long and painful way23 . In
fact, after a period of almost 6 years between filingand issuance of the patents, between 2002 and2003 all of them have been opposed following thespecific third party opposition procedures set
forth by art. 99 – 105c of the European Patent
Convention (EPC) 24 . Following this procedure a
specific panel of patent examiners at the European
Patent Office, the Opposition Division (OD),
decides on the oppositions filed by the concerned
third parties on the base of the compliance of the
opposed patent to the European Patent Officerules and to EU legislation. Following thisprocedures, one of the patent has been entirely
revoked (EP699754) while the other three havebeen maintained in narrowed versions. It must be
observed how, apart the variety in the reasons
why these four patents have been either revokedor amended, there are many inconsistencies
connected with the inadequacies in the genesequence, in the prohibitions of extensive
amendments, in relation to the satisfaction ofpatent requirements (such as novelty, inventive
step and industrial application), in addition to theprohibition of granting patent protection to
discoveries, scientific theories and mathematicalmethods, diagnostic methods performed on thehuman body, and inventions contrary to public
morality25 .

Ⅲ Japan
We do not have any record of similar BRCA
patents, either filed or issued, in Japan.
●

However, this does not exempt us from trying
to answer the question of whether isolated DNA
sequences or methods of comparison can beconsidered “highly advanced creation of technicalideas by which a law of nature is utilized” 26 . The
point is obviously a bit speculative, and the answerof course would strongly depend on the specificdrafting of any given claim. At this regard theJapanese Patent Office guidelines reveals
particularly helpful.
1

Novelty in Gene Patents

Most of the case law we have observed – thus
mostly U.S. – argue the patentability of genes interms of subject matter. However, as the analysis
in Bergy 1979, the decisions of the EPO, and witheven more clarity JPO guidelines indicate, maybe
the correct way to decide about the patentability ofgene related inventions needs to revolve aroundthe other requirements, especially novelty andnon-obviousness.
At this regard it will be very interesting to
see what the Supreme Court will decided in the
Myriad case, and some similar cases that regard
diagnosis methods.
2

Novelty in Japan

Regarding the novelty requirement inbiotechnological invention, the Japanese Patent
Office Guidelines are once more very clear, andoffer a series of cases and examples to clarify thesituation. So for example if a protein as an isolated
and purified single substance is known, arecombinant protein specified by a process of
production is not novel if it results identical as achemical substance to the former27 . However, incase where a “recombinant process inevitably
leads to a different product, for example in its
sugar chain or the like, due to the difference of thehost cells, even though the recombinant protein
has the same amino acid sequence as the publicly
known one, a claimed invention concerning therecombinant protein specified by a process of
production is novel” 28 .
The clarity of the Patent Office Guidelines
guidelines is admirable, and is functional to an
efficient system. However Patent Offices
guidelines are but one part of the more general
patent system, together to, at least, Courts andParliaments. Therefore, even in the lessproblematic jurisdiction here analyzed, theultimate question cannot be avoided. Can genes be
4 ●IIP Bulletin 2012 Vol.21

protected as chemical compounds?

Ⅳ How to Reconcile
Positions

Opposing

A possible way to recompose such dichotomy
is called purpose-bound patents. There is no magic
behind such concept, which resembles undermany aspects the original protection offered bypatents. Inventions regarding a specific genecovering a specific claimed use, do not protect fora third party using the invention in a manner notcovered by the function claimed, or in a way
different from that used by the claimed invention.
At this regard of particular interest is decision
C-428/08Monsanto Tech LLC of the European
Court of Justice. In such decision the European
Court of Justice had the opportunity to clarify inparticular the meaning of art. 9 Directive
98/44EC29 .

Ⅴ Novelty and the Role
Community: Peer-to-PatentofPeer-to-Patent is a project aiming at asignificant increase in the quality, accountability
and public participation of the patent system. It
implements a methodology that is paradigmatic of
our times and technological evolution: theparticipation of experts on a volunteer basis, whooffer their help and expertise to improve theoverall effectiveness of a fundamental public
function, through web-based technologies. As wehave seen at the beginning of this paper, such is infact the goal of a patent system: Inventors file a
detailed description of the fruit of theirinventiveness, completely disclosing it publicly, so
as the whole society can benefit from theknowledge produced. The trade-off for such a
public disclosure (in contrast of keeping it secret),is the legal sanctioned monopoly that the society
recognizes to the make, sell, and use of suchtechnology for 20 years. This bargain, that has
represented for decades a well balanced trade-off
between chocking interests (private benefit
versus public access), allowed for a terrificevolution of the technological sector in the past
centuries, granting scientific and economic
independence to inventors, and a fast andwidespread diffusion of the latest scientificdiscoveries.

Ⅵ Final Remarks
In this report, focusing on patentability

IIP Bulletin 2012 Vol.21●

requirements applicableto biotechnologicalinventions, North America, Europe and theJapanese landscapes are analyzed.
Particular attention is paid to “novelty”
requirement which is considered by keeping
watch on the Examination Guidelines.
In context with novelty, the fundamental traitsof the Peer to Patent system is presented to identify
its potentially beneficial outcomes in terms of
quality and efficiency of the patent granting system.
It is hoped that the analysis of this report willoffer the base for the development of examination
guidelines and the best practices.
1

For a history of patent and technological evolution see
Pottage A., Sherman B., Figures of Invention: A
History of Modern Patent Law, Oxford University
Press, 2010.
2
The formal requirements for patent protections aredifferent but somehow comparable across the world.
This is connected to the many international
agreements signed with the aim of harmonization ofpatent law, see infra fn. 9.
3
See for example the Venetian Statute on Industrial
Brevets, Venice (1474) available at:
http://www.copyrighthistory.org/cgi-bin/kleioc/0010/ex
ec/showThumb/%22i_1474%22/start/%22yes%22#
last visited Feb, 2012.
4
See inter alia Boldrin M., Levine D., Against
Intellectual Monopoly, Cambridge University Press,
2008; Perry M., From Pasteur to Monsanto:
Approaches to Patenting Life in Canada, in GendreauY., ed., An emerging intellectual property paradigm –Perspectives form Canada, Ch. 4, Edward Elgar, 2008.
5
See Margoni T., Perry M., Legal Consequences of
Packet Inspection, in Berntzen L., ed, Cyberlaws: The
Second International Conference on Technical and Legal
Aspects of the e-Society (International Academy
Research and Industry Association, 2011) 18-21.
6
The still in force Paris Convention for the Protectionof Industrial Property was first signed in 1883.
7
In addition to the Paris Convention, the Patent
Cooperation Treaty, the Patent Law Treaty, the The
Agreement on Trade Related Aspects of Intellectual
Property Rights (TRIPS), or the Convention on the
Unification of Certain Points of Substantive Law on
Patents for Invention have played a fundamental rolein the harmonization of international patent law.
8
See for example Canadian Patent Act, RSC 1985, c P-4
s; and U.S. Patent Law 35 U.S.C. § 101 (2007).
9
See for example the Myriad patent that will beanalyzed infra in this paper.
10
Parke-Davis & Co. v. H.K. Mulford & Co., 189 F. 95(C.C.S.D.N.Y. 1911).
11
Ibid. at 103.
12
Ibid. at 103.
13
Ibid. at 104
14
Diamond v. Chakrabarty, 447 U.S. 303 (1980).
15
See Parker v. Flook, 437 U.S. 584 (1978); Gottschalk v.
Benson, 409 U.S. 63, 67 (1972); Funk Brothers Seed
Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948);
O'Reilly v. Morse, 56 U.S. 62, 112-121 (1854); Le Roy

5 ●

16

17

18
19
20

21

22

23

24

25
26

27
28
29

v. Tatham, 55 U.S. 156, 175 (1853).
See. Chackrabarty 447 U. S. 303; See also FunkBrothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127.
See Chacrabarty at page 447 U. S. 310 (citing
Hartranft v. Wiegmann, 121 U. S. 609, 121 U. S. 615(1887)).
Cfr. Funk.
Cfr. Chakrabarty.
See Association for Molecular Pathology v. U.S. Patent
and Trademark Office, 94 USPQ2d 1683 (S.D.N.Y.
March 29, 2010).
See Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95(C.C.S.D.N.Y. 1911).
See Association for Molecular Pathology et al. v.
Myriad Genetics, Inc et al. (Case No 2010-1406,
Decided July 29, 2011).
In particular EP699754, EP705902, EP705903 (thethree filed in 1995 and issued in 2001), and EP0785216(filed in 1996 and issued in 2003).
Convention on the Grant of European Patents(European Patent Convention) of 5 October 1973 asrevised by the Act revising Article 63 EPC of 17
December 1991 and the Act revising the EPC of 29
November 2000.
See arts. 52 and 53 EPC.
See art. 2(1) Japanese Patent Act (Act No. 121 of
1959).
Ibid part. VII, chapter 2, paragraph 1.3.2 (Novelty).
Ibid part. VII, chapter 2, paragraph 1.3.2 (Novelty).
See Directive 98/44/EC of the European Parliamentand of the Council of 6 July 1998 on the legal
protection of biotechnological inventions, in L213, 30
July 1998, pp. 13–21.

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