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U.S. Patentable
Subject Matter Martin Pannall
Partner
Madderns
Brett Lunn
Managing Partner
FB Rice
Derek Minihane
Head of Sound Processors Development
and IP Strategy, Program Manager R&T
Cochlear, Ltd.
Robert Kramer
Special Counsel
Finnegan Henderson Farabow Garrett & Dunner
LLP
* All views expressed are those
of the individual speaker.
OVERVIEW
I. What is patentable in the U.S.
II. Current legal landscape
III. Europe and Australia
IV. Corporate IP, R&D, investment and licensing issues
V. Patentability of emerging technologies
I. What is Patentable in the U.S.
35 U.S.C. § 101 (legislative)
Whoever invents or discovers any new and useful
process, machine, manufacture, or composition of matter,
or any new and useful improvement thereof, may obtain a patent
therefor, subject to the conditions and requirements of this title.
“Part of the storehouse of knowledge of
all men … free to all men and reserved
exclusively to no one.” – Biliski
“[T]he concern ... patent law not inhibit
further discovery by improperly tying up
the future use of these building blocks
of human ingenuity.” - Alice
Judicial exceptions:
• laws of nature
• physical phenomena
• abstract ideas
§101
§102
§103
§112
35 USC §102 (anticipation) - NOVELTY
35 USC §103 (obviousness) - NONOBVIOUSNESS
35 USC §112 (enablement) - WRITTEN DESCRIPTION - particularly point out
and distinctly claim the
subject matter of the invention
In the U.S. • Medical devices are patentable.
• Methods of surgery and medical treatment are patentable.
However, they cannot be asserted against doctors
or the medical facilities where they are associated.
• Diagnostic methods … it depends.
The current test for patentability was set forth in Mayo (2012):
1. determine whether the claim is directed to a judicial exception
to patentability; if so
2. determine whether any element or combination of elements
is sufficient to ensure the claim amounts to
something more than a judicial exception.
law of nature
physical
phenomena
abstract idea
Australia
x Europe
x Canada
x South Korea
x Japan
II. Current Legal Landscape
Mayo Collaborative
Svcs. v.
Prometheus Labs
Supreme
Court
2012
Ineligible
Two prong Mayo test:
1. Determine whether the claim is directed to a judicial exception to patentability.
2. If it is, determine whether any element or combination of elements is sufficient
to ensure the claim amounts to something more than a judicial exception.
‘623 patent, claim 1:
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 administered to said
subject.
Technical problem: drugs for treatment of certain diseases
like Crohn’s are metabolized differently by different people,
making it hard for doctors to determine the proper dose.
Solution: Through research the patentee was able to identify
the effective range for the concentration of the drug after it
had been metabolized, then adjust dosage.
The patent claim: a method for optimizing the quantity of the
drug by: (1) administering the drug, (2) testing the blood for
the metabolite concentration, (3) increasing or decreasing
the dosage based on particular results.
Prior law and thinking in the industry: a law of nature was
patentable as long as the patent also claimed a “machine or
transformation.” Here the Federal Circuit upheld patent
validity because the patent claimed two transformations:
(1) transforming the human body by administering the drug,
and (2) transforming the blood by analyzing it to determine
metabolite levels.
Mayo v. Prometheus (cont’d)
The Supreme Court:
Step 1: the patent simply describes a law of nature.
Step 2: Here the added elements are steps doctors were already doing:
• administering the a drug to a patient (well known)
• determining the resulting metabolite level (well known)
• to be sufficiently transformative (“machine or transformation” test), the patent must claim more
than a well-understood, purely conventional, routine or obvious activity (“pre-solution” or “post-solution”).
[MOT test does not trump the exceptions to patentability.]
In dicta, the Supreme Court:
acknowledges competing industry fears specifically in the field of diagnostic methods that its holding:
(1) reduces the protection for and thus investment in new and valuable diagnostic methods, and
(2) reduces patent thickets that prevented doctors from using “critical scientific data” to provide sound medical
care.
explained that the patent laws balance competing needs across “many different fields of human endeavor,”
that it “hesitate[s] before departing from established general legal rules” to protect … one field [that may risk]
unforeseen results in another,” and it “recognize[s] the role of Congress in crafting more finely tailored rules
where necessary.”
“We need not determine here whether, from a policy perspective, increased protectionfor discoveries of
diagnostic laws of nature is desirable.”
Fallout from Mayo v. Prometheus (2012) (1)
Case Court Description
Association for
Molecular
Pathology v.
Myriad Genetics
Supreme Court
2013 Ineligible
(mixed)
Applies Mayo test to the products of nature exception. Held a naturally occurring DNA segment
is a product of nature and not patent eligible merely because it has been isolated. gDNA is not
patent eligible because the genetic information encoded in BRCA1 and BRCA2 genes were not
created or altered.
cDNA is patent eligible because it is not naturally occurring.
Claims directed to screening methods comparing cancer growth rates to a control group while
itself not patentable (mental step), becomes eligible because the host cells are man-made (by
removal of noncoding regions).
Intema v.
PerkinElmer
Supreme Court
denied certiorari
2013 Ineligible
Ultrasound and biomarkers. It is no longer sufficient under the machine or transformation test
that a claim element adding measuring an ultrasound or assaying blood overcomes the
exception to patentability (here the mental step is measuring two data points being better than
one).
Alice Corp. Pty.
Ltd. v. CLS Bank
Supreme Court
2014 Ineligible
Applies Mayo test to abstract ideas exception to hold unpatentable claims directed to using a
computer to mitigate settlement risk in escrow. Adding a computer (“wholly generic computer
implementation”) to the process no longer makes it patentable. (software and business method
patent)
Univ. of Utah
Research Found.
[Myriad] v Ambry
Genetics
Federal Circuit
2014 Ineligible
In re BRCA1- & BRCA2-Based Hereditary Cancer Test -- breast and ovarian cancer
susceptibility gene. Altered genes (synthetic) are “structurally identical to the ends of DNA
strands found in nature” are not patentable. Patent also claims a method for comparing patient
gene sequences with known sequences to identify alterations to identify differences, held to be
abstract under Step 1 of Alice. Combining non-patent-eligible elements in a claim with a
comparison step is generally patent ineligible
Fallout from Mayo v. Prometheus (2)
Case Court Description
Accenture Global
Services v. Guidewire
Software
Federal Circuit
2013 Ineligible
Component based interface to handle tasks during claim processing
SmartGene v Advanced
Biological Labs. Federal Circuit
2014 Ineligible
Systems, methods and computer program products for guiding the selection of therapeutic
treatment regimens
Cyberfone Systems v.
CNN Interactive Group Federal Circuit
2014 Ineligible Telephone/transaction entry device and system for entering transaction data into database
In re Roslin Institute
(Edinburgh) Federal Circuit
2014 Ineligible Cloned mammals produced by somatic cell nuclear transfer
Digitech Image Techs. v
Electronics for Imaging Federal Circuit
2014 Ineligible Device profiles for use in a digital image processing system
Planet Bingo v VKGS Federal Circuit
2014 Ineligible Storing preselected numbers for use in games of bingo
buySAFE v. Google Federal Circuit
2014 Ineligible Safe Transaction Guaranty
DDR Holdings v.
Hotels.com Federal Circuit
2014 Eligible Expanding commercial opportunities for internet websites.
“A problem specifically arising in the realm
of computer technology where the solution
claimed directs how to manipulate the
computer technology to overcome the
problem.”
“[M]erely recit[ing] the performance of some
business practice known from the pre-
Internet world along with the requirement to
perform it on the Internet.”
Fallout from Mayo v. Prometheus (3)
Case Court Description
Ultramercial v. Hulu Federal Circuit
2014 Ineligible
Payment of intellectual property royalties by interposed sponsor over a telecommunications
network
Fuzzysharp Techs v.
Intel
Federal Circuit
2015 Ineligible
Rule 36 - Visibility Calculations for 3D Computer Graphics
Gametek v. Zynga Federal Circuit
2015 Ineligible Rule 36 - Obtaining advantages and transacting the same in a computer gaming environment
Dietgoal Innovations v.
Bravo Media
Federal Circuit
2015 Ineligible Rule 36 - Computerized meal planning
Freddie Mac v.
Graff/Ross Holdings
Federal Circuit
2015 Ineligible Rule 36 - Securitizing property into separately valued components
Internet Patents Corp. v.
Active Network
Federal Circuit
2015 Ineligible Dynamic tabs for a graphical user interface
In re Webb
Federal Circuit
2015 Ineligible Rule 36 - Poker games with varying position advantage
In re Karpf Federal Circuit
2015 Ineligible Rule 36 - Converting a portion of future retirement payments to current benefits
Retirement Capital
Access Mgmt. v. U.S.
Bancorp
Federal Circuit
2015 Ineligible Rule 36 - Integrated bank accounts for home ownership (mortgage) payoffs
CMG Financial Svcs v.
Pacific Trust Bank Federal Circuit
2015 Ineligible Rule 36 - Determining a nutritional diet product for a canine or feline animal
Fallout from Mayo v. Prometheus (4)
Joao Bock Transaction
Sys v. J. Henry &
Assoc.
Federal Circuit
2016 Ineligible
Rule 36 - Apparatus for securing banking transactions or wireless or cellular communication
devices
Morales v. Square, Inc. Federal Circuit
2016 Ineligible Rule 36 - Interactive TV system for mass media distribution
Allvoice Devs. v.
Microsoft
Federal Circuit
2015 Ineligible Speech recognition and automatic dictation
OIP Technologies v.
Amazon.com
Federal Circuit
2015 Ineligible Automatic pricing in electronic commerce
Intellectual Ventures I v.
Capital One Bank
Federal Circuit
2015 Ineligible
Administration of financial accounts, and advanced internet interface providing user display
access of customized webpages
Versata Development
Group v. SAP America
Federal Circuit
2015 Ineligible Increasing patient compliance with medical care instructions
Vehicle Intelligence and
Safety v. Mercedes-
Benz
Federal Circuit
2015 Ineligible
Screen equipment operators for impairment, selectively testing operators, and control
equipment if an impairment is detected
Mortgage Grader v. First
Choice Loan Servs Federal Circuit
2016 Ineligible Anonymous shopping of loans from different lenders.
In re Smith Federal Circuit
2016 Ineligible
Method of conducting a wagering game with conventional shuffling and dealing steps using a
standard deck of cards (variation of Black Jack).
Genetic Techs. Ltd. V.
Merial LLC Federal Circuit
8 April 2016
Ineligible
Genetic diagnostic method of detecting a coding region allele by amplifying genomic DNA and
analyzing it. “Detecting an allele” was held to be a mental process step of restating a newly
discovered natural law – the existence of linkage disequilibrium (“like Einstein telling linear
accelerator operators about his basic law and then trusting them to use it where relevant”).
The mental comparison was not possible in 1992 when claimed, until this method was
developed.
Prior art: invasive prenatal procedure for detecting certain birth defects; risky to the fetus
Discovery: paternally-inherited cell-free fetal DNA (cffDNA) is detectable in the plasma
of pregnant women in what was previously considered medical waste.
Claims: The claims are broad and directed to any method of detecting paternally inherited
cffDNA from maternal serum or plasma by amplifying and detecting the cffDNA.
Claim 1: A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample
from a pregnant female, which method comprises amplifying a paternally inherited nucleic acid from the serum or
plasma sample and detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.
• Largely undisputed that the method was novel (§ 102), a breakthrough, and “truly meritorious.”
• There is some disagreement about whether the claims are too broad or indefinite.
Fallout from Mayo v. Prometheus (5): Ariosa v. Sequenom
Ariosa Diagnostics,
Inc. v Sequenom Federal Circuit
2015 Ineligible
A non-invasive prenatal diagnostic method for
detecting certain birth defects.
* Advice given here post Mayo in 2013 was that diagnostics methods are likely still patentable.
Applying Mayo the Federal Circuit held:
(1) claimed method starts with cffDNA a naturally occurring substance (phenomenon)
and ends with detecting a naturally occurring substance;
(2) other steps are merely amplifying (by PCR) or detecting (by probe). They are well understood, conventional
and routine, and cannot transform (MOT test) the natural phenomenon into a patentable invention.
The Federal Circuit made it clear that it believed this outcome was wrong, but required by Mayo.
Judge Newman dissented:
• In Mayo, both the medicinal product and its metabolites were previously known, leaving sparse room
for innovative advance in using this information as a diagnostic dosage tool.
• The Supreme Court nevertheless “recognized … that patent eligibility is not disabled when science is
put to practical use, stating that ‘a new way of using an existing drug’ is patent-eligible under Section 101.”
• In Myriad, the Supreme Court limited its holding to “genes and the information they encode are not
patent eligible … simply because they have been isolated from the surrounding genetic material.”
• Ariosa is distinguishable because the diagnostic method claimed was not known previously,
nor were the “diagnostic knowledge and benefit implemented by the method.”
Fallout from Mayo v. Prometheus (5): Ariosa v. Sequenom
Ariosa Diagnostics,
Inc. v Sequenom Federal Circuit
2015 Ineligible
A non-invasive prenatal diagnostic method for detecting certain birth
defects.
Seen as an opportunity to encourage the Supreme Court to limit Mayo, provide further guidance, or identify principles
that might protect meritorious discoveries / inventions in the area of diagnostics.
Some worry that Judge Newman’s dissent will discourage the Supreme Court granting certiorari.
Sequenom petitioned the U.S. Supreme Court in March for a writ of certiorari. The question presented:
Whether a novel method is patent-eligible where:
1. a researcher is the first to discover a natural phenomenon;
2. that unique knowledge motivates him to apply a new combination of known techniques to that discovery;
and
3. he thereby achieves a previously impossible result without preempting other uses of the discovery?
22 Amicus briefs filed so far:
• Federal Circuit Bar Ass’n: must consider the claim as a whole.
• Eli Lilly, Pfizer, Upsher-Smith and Eisai
Exceptions to § 101 are no longer needed and should be reconsidered. When § 101 is considered before other
sections (§§ 102, 103, 112), it is stretched to address issues more appropriately raised in those other sections.
• David Kappos (director of the USPTO (2009-2013)) calls for abolition of § 101.
"We're dealing with a litmus test, an 'I know it when it see it' test," "we're now seeing real chaos”
from the need for thousands of examiners and hundreds of judges trying to apply the standard(s).
Timing: respondent brief due 20 May (+7 days amicus); docketing; 3-12 weeks for cert. decision (<1%; 4 justices);
briefing (45/30/30 days), hearing (Oct. – April), decision (median 83 days after hearing).
Ariosa v. Sequenom (con’t): Supreme Court
Warnings
Not technology based rejections. This is about how the claims
and specification are drafted.
Many of these claims were drafted before cases like Mayo,
Myriad and Ariosa. (broad vs narrow; specificity; preemption)
A carefully drafted patent balances between legal, technical and
commercial needs, including considerations of patentability,
novelty, obviousness and written description. These cases
changed the standards against which the claims and
specification are judged.
There is no reason to believe that the tests / standards are now
final, or for example, that Judge Newman won’t be proven right.
“Given the evolving state of the law, the § 101 analysis should be, and is, a difficult exercise. At their
broadest, the various decisions of the Federal Circuit would likely ring the death-knell for patent protection of
computer-implemented inventions, a result not clearly mandated (at least not yet). On the other hand, to
recognize and articulate the requisite degree of specificity - either in the equipment used or the steps claimed
- that transforms an abstract idea into patent-eligible subject matter is a challenging task. In trying to sort
through the various iterations of the § 101 standard, the court looks to DDR as a benchmark; i.e., the claims
(informed by the specification) must describe a problem and solution rooted in computer technology, and the
solution must be (1) specific enough to preclude the risk of pre-emption, and (2) innovative enough to
"override the routine and conventional” use of the computer.”
In denying Cisco’s motion for summary judgment of invalidity under § 101, the district court denies Cisco’s
attempt to simplify the invention to a pre-computer human counterpart. This does not “make the concept
abstract, as ‘[a]t some level, ‘all inventions … embody, use, reflect, rest upon, or apply laws of nature, natural
phenomena, or abstract ideas.’” Here “[t]he claims as an ordered combination (in light of the specification)
sufficiently delineate ‘how’ the method is performed to ‘improve the functioning of the computer itself,’ thereby
providing an inventive concept. The same specificity suffices to negate the ‘risk [of] disproportionately tying
up the use of the underlying ideas.’” (Quoting Alice and Mayo.)
From DDR Holdings: “A problem specifically arising in the realm of computer technology where the solution
claimed directs how to manipulate the computer technology to overcome the problem.”
SRI Int’l v. Cisco
Systems
D. Delaware
(Robinson)
11 April 2016
Eligible
Monitoring and surveillance of computer networks for intrusion detection.
BMS’s claims are not directed to BMS’s particular composition (in which case Merck presumably would not infringe),
but more broadly to a method of treating cancer. Merck’s product is Pembrolizumab, a “biologic” that has larger, less well
defined molecules than a traditional pharmaceutical.
Claim 1:
A method of treating a metastatic melanoma comprising intravenously administering an effective amount of a
composition comprising a human or humanized anti-PD-1monoclonal antibody and a solubilizer in a solution to a
human with the metastatic melanoma, wherein the administration of the composition treats the metastatic melanoma
in the human.
Court: Step 1: the activation of the body’s suppressed immune system by enabling T cells is a natural phenomenon.”
Step 2: “administering a drug” is the only other step, similar to Mayo. But it is “a complicated factual
determination that the court could better resolve after discovery.
Watch this progress as Ariosa sits at the Supreme Court.
Bristol Myers Squibb
Co. v. Merck & Co.
D. Delaware
(Sleet)
17 March 2016
29 March 2016
Denied motions to
dismiss
Methods of treating cancer by administering anti-PD-1 antibodies that enable T
cells to activate the body’s natural immune system (suppressed by the cancer)
and remove cancer cells.
Case Court / Date Description Historical Event
Mackay Radio
Supreme Court
1939 Eligible
“While a scientific truth, or the mathematical expression of it,
is not patentable invention, a novel and useful structure
created with the aid of knowledge of scientific truth may be.”
1952 Patent Act
1953 – DNA double helix model
1968 USPTO Guidelines suggest that
computer software can be patentable.
Gottschalk v.
Benson
Supreme Court
1972 Ineligible
Mathematical algorithm is an abstract idea, to patent it would
preempt the formula, even if previously unknown.
1975 – method for producing
monoclonal antibodies
Parker v. Flook Supreme Court
1978 Ineligible
Cannot simply add non-inventive (well understood method)
post-solution step with a new algorithm.
1970s (late) – insulin (by inserting
foreign genes into an organism)
In re Freeman
In re Walker
In re Abele
CCPA
1978-82 Eligible
(mixed)
Don’t focus on point of novelty (§ 102); something more than
the algorithm has to be claimed (algorithm applied to
physical structure or that limits the process step).
1977 – first full DNA genome
sequencing
1981 – invention of the scanning
tunneling microscope
Diamond v.
Chakrabarty
Diamond v. Diehr
Supreme Court
1980-81 Eligible
Broad interpretation of § 101: “anything under the sun made
by man.” Invention as a whole “transform[s] or reduce[s] an
article to a different state or thing.”
Diehr: “claims must be considered as a whole. It is
inappropriate to dissect the claims into old and new elements
and then to ignore the presence of the old elements in the
analysis”
Historical context for Mayo
Case Court / Date Description Historical Event
1983
Congress creates the U.S. Court of Appeals for the Federal
Circuit to standardize patent law.
Federal Circuit interprets Freeman, Walker, Abele after
Diamond v. Diehr as the Machine or Transformation test
(MOT).
In re Alappat Supreme Court
1994 Eligible
Relaxes MOT where there is a general purpose computer:
“a process, machine, manufacture, or composition of matter
employing a law of nature, natural phenomenon, or
abstract idea is patentable subject matter even though a
law of nature, natural phenomenon, or abstract idea would
not, by itself, be entitled to such protection.”
1989 – scanning tunneling microscope
first used to manipulate individual atoms
1990 – Human Genome Project launched
[estimated cost = USD $3.8B]
1994 – genetically modified tomatoes
State Street Bank
v. Signature
Financial Group
Supreme Court
1998 Eligible
Claimed invention (business method) involved a practical
application that produces a useful, concrete, tangible result.
Claims must still satisfy §§ 102, 103 and 112.
1997 – eukaryotic genome of bakers
yeast unraveled
1998 – first human embryonic cell lines
2001 – first draft of human genome
2003 – first pharmacogenomic (PGx)
medical diagnostic product introduced
(AmpliChip CYP 450)
Bilski v. Kappos Supreme Court
2010
Ineligible
Claimed process is patent-eligible under the machine-or-
transformation test only if: (1) tied to a particular machine or
apparatus, or (2) it transforms a particular article into a
different state or thing. (The ‘useful, concrete, tangible
result’ inquiry from State Street Bank is no longer
sufficient.)
2011 – America Invents Act (AIA)
prohibits patentability for human
organisms (undefined).
Mayo Collaborative
Svcs. v.
Prometheus Labs
Supreme Court
2012
Ineligible
Two step test used today.
Ends MOT as exclusive test.
2011 – value of HGP in economic activity
estimated at USD $796B (Battelle
Memorial Institute).
1980-2010 (~30 years)
In Research Corp. Techs. v. Microsoft (2010), CJ Rader described § 101 as
a “coarse eligibility filter,” which in Ultramerical I (2011) & II (2013), he
contrasts to the substantive conditions of patentability (novelty,
nonobviousness, adequate disclosure).
By 2014 (post Alice), in Ultramerical III Judge Mayer described § 101 as a
“primal filter” that must be addressed as a threshold issue similar to
jurisdiction, at the start of litigation.
Blurring lines between §§ 101, 102, 103 and 112.
§101
§102
§103
§112
35 USC §102 (anticipation) - NOVELTY
35 USC §103 (obviousness) - NONOBVIOUSNESS
35 USC §112 (enablement) - WRITTEN DESCRIPTION
?
?
?
Predictions (mine only)
• Congress is unlikely to change the landscape to protect medical diagnostic patents in any short
term.
• The Supreme Court decision in Ariosa is at least a year away, and is unlikely to get rid of § 101
or the judicial exceptions (it already responded to this in Mayo). It will likely remain a primal
filter.
• The Supreme Court is unlikely to differentiate between the role of various sections of 35 U.S.C.
• Airosa v. Sequenom is a good case for providing additional clarification about protection for a
newly discovered natural phenomena incorporated into a novel method to achieve a previously
impossible result, narrowly drafted (to limit preemption).
• Claims to previously understood natural phenomena using known methods, even if newly
discovered are unlikely to be patentable – in a manner very similar to post -Alice computer,
internet and business method patents.
• DDR Holdings may present a possible solution.
• USPTO has said it will not provide further [substantive] guidance until there is a final,
unappealable decision in Ariosa v. Sequenom. (Last guidance July 2015.)
III. Patentability (Europe)
In general, in Europe medical devices are patentable.
Methods of medical treatment (humans or animals) and diagnostic methods are not
patentable (Article 52(4) EPC) subject to numerous qualifications.
Discoveries, scientific theories and mathematical models are not patentable (Article
52(2)(a)-(d)). Mere discovery is unpatentable as it has no direct technical effect, and
thus is not an invention. But if it is put to practical use or has a technical effect, it may
be patentable.
Medical uses for known substances are patenable (Article 52(4)).
* Other warning:
Unlike Australia and the U.S., novelty in Europe is strict … there is no grace period.
Patentability (Australia)
Patentability (Australia)
D’Arcy v. Myriad Genetics Inc [2015] HCA 35
Three product claims, claiming “an isolated nucleic acid” that codes for a mutant / polymorphic BRCA 1 polypeptide listed
in particular tables set forth in the patent. The lower court construed these claims as directed to a class of chemical
compounds, upholding their validity.
The High Court instead looked past the form of the claims to the substance of the invention, and held that the essential
element of the claimed invention was the existence of the information stored in the relevant sequences, the discovery of
the correlation between a change in probability of malignancy and the existence of a naturally-occuring nucleotide
sequences. The High Court recognized that human action was required to isolate the mutations in the nucleic acid, but it
was not appropriate for the judiciary to extend the meaning of “manner of manufacture” from Section 18(1)(a) of the Patent
Acts 1990 (Cth) through s 6 of Statute of Monopolies, to monopolize application of “long-established methods for the
isolation and amplification of specific nucleotide fragments to the isolation and amplification of a patient's naturally
occurring BRCA1 gene.” The High Court required that an “artificial state of affairs” be linked to the claimed inventive
concept, the utility or economic significance, and not just be a step along the way.
The decision did not challenge 27 other claims in the patent directed to application of the discovery, such as probes,
vectors, diagnostic methods, and methods of producing .
IP Australia more recently issued Examination Guidelines taking a narrow interpretation of patentable subject matter from
Myriad, and including as unpatentable cDNA (unlike the U.S.), synthetic nucleic acids, probes, primers and isolated
interfering/inhibitory nucleic acids, which in their artificial form merely replicate the genetic information of a naturally
occurring organism.
IV. Corporate IP, R&D, investment and licensing issues
1. What to do with your future patent filings.
• More strategy before filing.
• number of patent filings, number of claims, type and breadth of
claims; timing.
2. What to do with your existing patents / portfolios
(limited by existing specification); continuations.
3. What to do with your intended technology research and investment.
4. How this plays into commercialisation and licensing efforts.
• freedom to operate, enforceability, litigation
• fund raising
• portfolio analysis, and licensing
V. Patentability of emerging technologies
• Human 2.0 / bioprinting / gene editing
(example: CRISPR-Cas9)
• Software in medical devices and services /
patient information security
• Big data used in medical care
• More about personalised medicine /
companion diagnostics / theranostics
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