10 After Myriad : The Comparative Study on
Biotechnology Patent Practice (*)
Invited Researcher: WU, Chia-Ying (**)
The substance of the patent system is to protect innovation and facilitate the development of industries.
Since the start of the Human Genome Project, Patent Offices in the U.S., Japan, and Europe have held many
discussions concerning the patentability of DNA sequences. Most Patent Offices have adopted similar standards
for judging the examination of practices related to DNA. In 2013, the U.S Supreme Court rendered a decision inthe Myriad Case that DNA isolated from nature is a product of nature and thus unpatentable subject matter.
This caused a significant change in patent practices. The USPTO revised examination standards twice inMarch and December 2014 and the amendment drafts caused a great deal of discussion throughout the world.
This report discusses the impact of the Myriad Case in the U.S. on examination practices for claims forsubstances, analyzes the criteria for patent eligibility in Europe, Japan, and Taiwan, and proposes a substitutestructure that can be established in order to balance the patent system and public health.

The Myriad Case revolves around thepatentability of two genes, BRCA1 and BRCA2,and their application for examination. BRCA1/2
genes are tumor-suppressor genes and Myriad
obtained patents related to them in 1997 and 1998.
Today, breast cancer is the second highest causeof death after lung cancer among cancers inwomen in the U.S. and the attention to andunderstanding of breast cancer have increased.
The need for early diagnosis in the healthcare
business market is expanding and research anddevelopment as well as patents related to BRCA1and BRCA2 are of particular importance.
Myriad held many patents, including patents
for the BRCA1/2 genes, the methods for using
and isolating these genes, and the method ofexamination for mutation. Myriad imposed strict
licensing conditions on research institutions andothers by requiring them to use the results ofanalysis only for research experiments andprohibiting them from providing the results topatients. Therefore, medical institutions, patients,researchers, and genetic counselors of the Breast
Cancer Prevention Center became considerably
dissatisfied with Myriad, which seemed tomonopolize the research and examination marketof BRCA1/2 genes. In 2009, the Association of
MolecularPathology(AMP)
andmany
researchers and women adopted the American
Civil Liberties Union (ACLU) as theirrepresentative and filed with the U.S. District
Court for the Southern District of New York for adeclaratory judgment to invalidate 15 claims1 in 7
patents held by Myriad. The District Court gave asummary judgment that claims on all genes,including BRCA1/2, or a combination of part ofgenes did not conform to the provisions of 35
U.S.C. § 101 and were not patentable. As thereason, the District Court stated that isolated
BRCA genes listed in the patent specifications
were not markedly different than genes found innature, and that when comparing isolated DNA toDNA in human body, the fundamental features
were completely the same and their genetic codes
were identical as well. With regard to claims
related to cDNA, the District Court also foundthat cDNA was a product of nature since naturally
occurring products, which means genotype DNA,produce mRNA by pre-mRNA splicing.
Myriad eventually filed an appeal with theUnited States Court of Appeals for the Federal
Circuit (CAFC). The CAFC rendered a judgment2
where the court upheld part of the judgment ofthe lower court and reversed another part of said
judgement. The CAFC upheld the part where theDistrict Court judged that claims related to themethod of comparing or analyzing DNA
sequences of BRCA1/2 were invalid but ruled that
product claims related to the isolation of DNA
sequences and method claims for the screening of(*) This is a summary of the report published under the Industrial Property Research Promotion Project FY2014 entrustedby the Japan Patent Office.
(**) Senior Patent Examiner & Section Chief, Taiwan Intellectual Property Office, at our institute over a period of
approximately 5 months from October 15, 2014 through March 14, 2015, as an Invited Researcher for the Fiscal Year2014.
IIP Bulletin 2015 Vol.24● 66 ●

therapeutic substances for potential cancer risks
were patentable. The majority opinion of theCAFC was that isolated DNA sequences arepatentable subject matter because isolated DNA
is produced by chemical method, does not bind toother genes after the isolation, and therefore isdifferent than DNA naturally found in the humanbody. However, the U.S. Supreme Court rendered
the final decision on June 13, 2013 and gave a
different decision from the CAFC on the Claims of
isolated genotype DNA. This decision was also
different from the patent examination practices of
the USPTO related to DNA over the many years.
The Supreme Court judged that products ofnature should be patent ineligible and that said
DNA was unpatentable even if it was isolated
artificially. However, while cDNA has the exon ofnaturally occurring DNA, it is distinguished fromgenotype DNA found in nature, and therefore
cDNA is a patentable subject matter.
The Myriad Case raised disputes over thepatentability of BRCA genes in the countries
other than the U.S., for examples Europe andAustralia. The judgment of the Technical Boardsof Appeal of the European Patent Office in T
1213/053 was as follows: the claims at issue wereobtained by technical means from parts of genesequences, including human BRCA1; according tothe provisions of Rule 23e (2) of the Rules of theEuropean Patent Convention,4 since these probes
are elements isolated from the human body,although their structure and the elements foundin nature are the same, if the gene sequence orelement containing part of the sequence isproduced by technical means, it is a patentablesubject matter. In the lawsuit against Myriad inAustralia, revocation of the patent was sought bya cancer survivor, Yvonne D’Arcy, on the grounds
that the isolated BRCA nucleic acid molecule isactually the same nucleic acid molecule found innature and has the same gene information; andtherefore, it is not patentable under Australian
Patent Law. The first instance Federal Court andthe Full Federal Court, at the second trial, judgedthat the patent in question was valid. Australian
Patent Law considers products of nature as
patentable subject matter. If the court judged thatthe scope of invention that Myriad claimed was
not the coding, information, or sequence ofcharacters, but the chemical substance, thenucleic acid molecule is created artificially; andthe most important point is that there is a further
significant difference between its functions andthose of the nucleic acid molecule found in nature.

In this judgment of the Federal Court of Australia,
it is noted that the U.S. Supreme Court found in
Association for Molecular Pathology v. Myriad
Genetics, Inc. that the isolated nucleic acidmolecule is patent ineligible; however, this is theexception for patentability of a product of nature
under the doctrine of binding precedents of theU.S. Patent Act and it is different from Australian
Patent Law; therefore it is impossible to argue
the issue by comparing these judgments. D’Arcy
was dissatisfied with the judgment and appealed
to the Australian High Court. The High Court willhold a hearing for this Case for one to two days inApril 2015. We will have to keep an eye on it inthe future.
After the Examination Guidelines werepublished in March 2014, the USPTO reviewed
various opinions and then published the 2014
Interim Guidance on Patent Subject Matter
Eligibility5 on December 16, 2014. It stated that
this Interim Guidance was a substitute for theGuidance for Determining Subject Matter
Eligibility of Claims Reciting or Involving Laws ofNature, Natural Phenomena, & Natural Products
published in March 2014. This Interim Guidancecontinues to review patent eligibility not only ofDNA subjects, but also of all products of nature;
however, the standard for judging patenteligibility was relaxed from those in theMemorandum published in March. This Interim
Guidance defines the meaning of “directed to6 a
judicial exception” and the definition of “markedlydifferent” is relaxed. The change is made at thispoint where if the subject matter recited in theclaim is markedly different in its structure,function, and/or other characteristics, the subject
matter is markedly different than products foundin nature. An important and simple analysis
method was added to this Interim Guidance,
called streamlined eligibility analysis. As long as
the claim passes the analysis, it is not necessary
toimplement
themarkedlydifferent
characteristics analysis and the claim can bedirectly approved as patentable subject matter.
Examples are focused on claims related tonature-based products. Claims related tobiotechnology are judged using the second
analysis step (step 2B or part 2 Mayo test)7 on
whether the claim recites the additional elements
or whether the element is sufficient to present
that the difference of the claimed invention is“significantly more” than judicial exception;
however, this report analyzed that the number ofthe claims in question here is very small andapplications for most of these processes are made● 67 ●IIP Bulletin 2015 Vol.24

for method of analysis. In cases of biotechnology
claims, the patentability of most of them are
judged in the first analysis step in practice.
Since 1995, the strictness of examination
guidelines for the patentability of genes haschanged many times in the U.S. After 1995, manybiotechnology companies alleged that the utility
requirements were too strict and it was therefore
difficult for new biotechnology companies to raise
the funds necessary for research and development.
Therefore, the utility requirements were relaxed.
However, examination requirements based on the1995 Utility Examination Guidelines were toorelaxed despite fast progress in biotechnology.
Therefore, the Utility Examination Guidelines
were published in 2001 based on external
opinions on gene patents. The Guidelines defined
new standards for utility and presented aThree-pronged test: specific, 8 substantial, 9 andcredible.10 Later, the judgment of the CAFC in In
Re Fisher11 confirmed the USPTO’s policy for therevision of guidelines. However, the U.S.
Supreme Court rendered its decision in theMyriad Case on June 13, 2013 that DNA isolated
from nature is unpatentable subject matter.
Therefore, the guidance published in 2014 applied
the interpretation of said Supreme Court
judgment on patent eligibility not only to DNA,but also to all products of nature. This changed
the conventional examination standards forbiotechnology drastically. If patentability is denied
only on the grounds that the claim is not markedly
different than the substance found in nature, thescope may include chemicals, microorganisms,cells, antibiotics, antibodies, and other elements.
This examination standard of the U.S. is very
distinctive internationally. Under the patentexamination standards in Europe, Japan, andTaiwan, if the claim relates to biological materials
found in nature, the patentability of the claim will
not be refused on the grounds that it is obtained
or isolated by man-made technical means. On theother hand, judgments after the U.S. Supreme
Court in the Myraid Case, such as the judgmentof the CAFC in In re Roslin Inst. 12 or In Re
BRCA1- And BRCA2-Based Hereditary Cancer
Test Patent Litigation13 (Myriad II), embody thespirit of the U.S. Supreme Court judgment andboth cloned sheep and DNA segments that are
created by somatic cell nuclear transfer (SCNT)
technology were found to be unpatentable subject
matters since they were not markedly different
than equivalent substances found in nature.
Therefore, we must continue to watch the future
development of practices in the U.S.

IIP Bulletin 2015 Vol.24

The impact of the judgment of the U.S.
Supreme Court in the Myriad Case can be foundin the changes between 2013 when the judgmentin the Myriad Case was rendered and 2014 whenBRCA1/2 diagnosis and examination products
were available at only two companies, Myriad andthe UCLA Diagnostic Molecular Pathology
Laboratory. Now, however, 16 biotechnology
companies at least can provide relevant diagnoses.
From the perspective of general citizens, there is
no doubt that the range of selection in the market
increased and it reduced the costs for diagnosis.
With regard to the right infringement lawsuits
between Myriad and other biotechnology
companies, Myriad reached a reconciliation withthe last defendant company, GeneDX, byFebruary 16, 2015; however, the impact of theSupreme Court’s decision in the Myriad Case has
just begun. For example, this year (2015), a U.S.
scientist discovered a new antibiotic, teixobactin,in unclean soil. This antibiotic was discovered innature and therefore it seems to be unpatentable
under the new examination guidelines of the U.S.
RNAi technology is used for the research anddevelopment of medical treatments to suppress
the formation of oncogene by using molecules andhas significant effects, unlike conventional
medical treatment. RNAi itself is a nucleic acidmolecule segment and it was judged by the CARC
in In re BRCA1- and BRCA2-based Hereditary
Cancer Test Patent Litigation (Myriad II) (Fed. Cir.
2014) that any DNA has a complementary
property and all of applications of any DNA weredeveloped based on the complementary property.
Primers or probes used for diagnosis are includedin them and the judgment considers that RNAi,
nucleic acid molecule segments, and otherelements are also applications of thecomplementary property. Therefore, it may
become very difficult to find that nucleic acidmolecule segments are patentable subjectmatters.
In order to reduce the negative impact on
public health by limiting DNA patents in thebiotechnology industry, relevant examination
guidelines were revised after the judgment of theU.S. Supreme Court in the Myriad Case in 2013
and the U.S. government adopted a different
policy than other countries. In other words, DNA
and patent subject matters that are not markedly
different than products of nature are excluded
from patentable subject matters. I wonder if thispolicy can be adopted by other countries under
Civil Law. Based on the current situation, othercountries have not adopted the policy. The patent● 68 ●

practices in the U.S. are fundamentally different
than in other countries in regards to the following
points: the scope of “exceptions to testing andresearch” of the patent is particularly small andthe scope of DNA patents approved by the U.S. isconsiderably large. Moreover, the U.S. is acountry under Common Law and changes inpractical method by judgments is much fasterthan the amendment of acts in countries underCivil Law. Countries under Civil Law, including
Taiwan, should continue to watch the progress ofpatent practices in the U.S. and their impact andshould examine them for their future patent
policies.

that the recited or disclosed invention is currently
available for such use.
11421 F.3d 1365 (Fed. Cir. 2005).
12Appeal No. 2013-1407 (Fed. Cir. May 8, 2014).
13
No. 2014-1361, -1366 (Fed. Cir. Dec. 17, 2014).

1(1) U.S. Patent 5,747,282 (282 patent): Claims 1, 2, 5, 6,and 7; (2) U.S. Patent 5,837,492 (492 patent): Claims 1, 6,and 7; (3) U.S. Patent 5,693,473 (473 patent): Claim 1;(4) U.S. Patent 5,709,999 (999 patent): Claim 1; (5) U.S.
Patent 5,710,001 (001 patent): Claim 1; (6) U.S. Patent
5,753,441 (447 patent): Claim 1; and (7) U.S. Patent
6,033,857 (857 patent): Claims 1 and 2.
2653 F. 3d 1329 (Fed. Cir. 2011).
3
Refer to the following website for the judgment of theTechnical Boards of Appeal of the European Patent Officein T 1213/05 on September 27, 2007, see the following
website:http://www.epo.org/law-practice/case-law-appeals/recent/t051213eu1.html
4Provisions of Rule 23e(2) of the Rules of the European
Patent Convention 1973: An element isolated from thehuman body or otherwise produced by means of atechnical 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 ofa natural element.
5
https://www.federalregister.gov/articles/2014/12/16/2014-29
414/2014-interim-guidance-on-patent-subject-matter-eligibili
ty6
2014 Interim Guidance on Patent Subject Matter
Eligibility, page 11.
72014 Interim Guidance on Patent Subject Matter
Eligibility, page 21-25.
8
The Guidelines required that the description for utility
must be specific. For example, if the utility of theinvention is described for a medical diagnosis, thedescription does not fulfill the requirements of a specificutility. The specific utility of specifying a disease by
medical diagnosis must be defined or it cannot fulfill therequirements of specific utility.
9The Guidelines indicated that the invention is substantial
only if it is used in the real world. For example, a newprotein can be isolated in general academic research;however, if it is not clear how it is used in the “real world,”
the description in the specifications cannot fulfill therequirements of substantial utility.
10The cases where an assertion does not conform to theutility standards of credibility are those cases where thelogic underlying the assertion is seriously flawed orwhere a person of ordinary skill in the art would accept● 69 ●IIP Bulletin 2015 Vol.24