US: LIFE SCIENCES
How to protect patents after Prometheus
James Brady, Jeremy Cubert and Eric Silverman identify the types of patents at risk under the
Mayo v Prometheus decision and how best to defend them under the new law
S
everal types of inventions are particularly at risk in view of the Supreme
Court’s landmark ruling in Mayo v Prometheus, which held that Prometheus’
patent claims directed to a method of determining the proper dosage of the
thiopurine drug in patients did not sufficiently transform the naturally occurring
correlations on which they were based to be patent-eligible subject matter under section 101 of the US patent law.
The ruling has primarily – but not exclusively – put inventions in the biotechnology and medical science areas at risk. Traditionally, the discovery of a broad scientific principle by itself is not patentable subject matter. Einstein’s equation (E=mc2),
Newton’s law, and similar bedrock scientific discoveries are in a special category that
are freely available for all. Under Prometheus, new so-called laws of nature appear
to be accorded similar status. While certain applications of these discoveries are
patentable, the discoveries and principles by themselves are not. What and how
much more is required depends, in part, on the type of invention involved.
Natural correlations
The claims at issue in Prometheus involved a correlation between a biological marker and determining a course of treatment. Under Prometheus, the correlation
between a natural result and an input into a natural system, without more, is a law
of nature and ineligible for patent protection. Thus, any patent claim that recites or
is based on a natural correlation should be analysed to determine if additional elements or steps are or can be recited such that the claim is directed to patent-eligible
subject matter.
Medical diagnostic claims
Medical diagnostic claims typically rely on measuring a biological marker and,
based on the result, determining if a person has a disease. These claims are similar
to natural correlation claims, but do not always include a step for adjusting a treatment or treating a subject. Consider the following hypothetical claim:
“A method of determining if a tumour is malignant, comprising: obtaining a
blood sample; and determining the level of marker A in the blood sample, wherein if the level of marker A is above 2, the tumour is malignant.”
Under Prometheus, such claims are at risk because a correlation between the level
of marker A and malignancy is likely to be considered a law of nature.
Personalised medicine claims
Personalised medicine typically includes methods of identifying the risk of contracting a disease based on an individual’s genetic makeup. Consider the following hypothetical claim:
“A method of determining the likelihood of developing atherosclerosis, comprising: isolating genomic DNA from a tissue sample; determining if the genomic
DNA includes Genetic Mutation B, wherein if Genetic Mutation B is present, the
likelihood of developing atherosclerosis is increased by 50 percent.”
The likelihood of disease based on the presence of the genetic marker is likely to
be considered a law of nature.
Method of treatment claims
Method of treatment claims may be at risk to the extent they rely on a law of nature
to inform the course of treatment. For example, consider the step of treating a
patient with an increased dose of a drug based on measurement of the metabolite in
blood in the claims at issue in Prometheus. If the additional treatment step does not
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One-minute read
On March 20 this year, in a
highly anticipated decision,
the US Supreme Court held
in Mayo Collaborative
Services v Prometheus
Laboratories that patent
claims are not directed to patent-eligible subject matter under 35 USC section 101 if they
encompass nothing more than a newly discovered “law of nature” plus “well-understood,
routine, conventional activity”. The fact that
the law of nature was first discovered by the
patent owner is of no moment under the
Prometheus test. Over the next several years,
lower court decisions and the USPTO will further define these terms. Meanwhile, the patent
community must consider how to reduce risks
going forward. Patent owners need to shore
up patents and applications that are at risk
and develop strategies for meeting the new
test set forth in Prometheus.
US: LIFE SCIENCES
add anything new or non-obvious to the
natural correlation, the claim is at risk
under section 101 as a law of nature.
Hypothetical fix
“A method of treatment comprising administering at least one
chemotherapeutic drug to a patient having a level of marker A above xyz.”
This approach assumes that administering the recited drug or drug category
to such patients is novel and non-obvious. As with the natural correlation
claims, reciting the particular instrumentalities used for measuring the biological
marker, such as novel or non-obvious
antibodies, oligo-peptides, or DNA
oligomers also should be considered for
shoring up the hypothetical claim to
meet the new standard of section 101.
Pre-Mayo medical diagnostic claim: “A method
Drug discovery and research tools
of determining if a tumour is malignant, comMethods of identifying new drugs often
prising: obtaining a blood sample; and deterutilise natural phenomena. For example,
mining the level of marker A in the blood samnew antibiotics can be identified by
ple, wherein if the level of marker A is above
applying candidate compounds to bacte2, the tumour is malignant.”
ria growing in media, and new antiPost-Mayo recommended changes: “A method
cancer drugs are identified by evaluating
of treatment comprising administering at
libraries of compounds for their ability
least one chemotherapeutic drug to a patient
to kill cancer cells. Although the drugs
having a level of marker A above xyz.”
and antibiotics may be novel and nonobvious, the drug discovery process
might be considered to involve a mere law of nature.
Method of treatment claims
Best bets
While Prometheus did not specifically address method of
The Prometheus decision stated that the section 101 inquiry treatment claims, method of treatment steps included in natushould preclude “drafting effort[s] designed to monopolize [a] ral correlation or medical diagnostic claims may not always
law of nature”. Otherwise, patent eligibility would “‘depend change a law of nature into patent-eligible subject matter. The
simply on the draftsman’s art’” without addressing the princi- treatment steps themselves should be novel or non-obvious.
ples prohibiting patents preempting laws of nature. Practitioners should consider reciting the use of novel or nonNonetheless, there are strategies that practitioners should con- obvious drugs, routes of administration, end use disease indisider in order to meet the patent-eligibility requirements set cations, treatment regimes, or instruments for administering
forth in Prometheus and maximise patent protection for at the drug.
risk inventions.
Drug discovery and research tools
Natural correlations
Claiming assays and related tools for discovering new drugs is
The Prometheus decision indicated that, while a natural cor- likely to be particularly challenging. Yet even under
relation itself is not patent eligible, a claimed process that inte- Prometheus, such inventions may be patentable if they rely on
grates the correlation “into the process as a whole” by using a “unconventional steps” or materials that restrict “the claims
step, or a combination of steps, that is not “obvious, already to a particular, useful application of the [law of nature]”, as
in use, or purely conventional” may be patent-eligible subject described in the Prometheus decision. Thus, rather than focusmatter. Thus, one key that should be considered in any attempt ing on a newly discovered natural law that makes the drug disto draft patent-eligible claims that include a newly discovered covery tool or assay possible, practitioners should consider
natural correlation is to include a novel step or element in focusing claims on unconventional steps that are informed by
addition to the newly-discovered correlation. As the Court the natural law underlying the tool or assay. For example, a
explains, while “Archimedes [could not] have secured a patent method of screening a library of compounds for a particular
for his famous principle of flotation by claiming a process con- biological activity could recite the particular probes or
sisting of . . . refer[ring] to that principle in order to determine reagents used. Alternatively, a chemical feature of the library
whether an object will float”, claims drawn to a boat designed of compounds could be recited, for example, as: “A method of
to make optimum use of Archimedes’ principle would pre- screening for ABC comprising applying compounds selected
sumably be patent-eligible.
from XYZ with a methyl group at carbon 4 to a cell culture.”
Applying these principles to the above hypothetical claim,
With regard to development activities, the above strategies
practitioners should consider also reciting use of novel or non- can be used to guide R&D efforts to protect the most imporobvious reagents, or devices for measuring blood concentra- tant real-world applications of newly discovered natural laws
tions, such as labelled antibodies, nucleic acid probes, or kits in patent application claims. Consideration should be given to
and systems for measuring and quantifying these reagents. filing multiple patent applications directed to different end
While adding limitations may render a specific claim quite nar- uses of the natural law. In the new first-to-file world under the
row, including additional independent claims directed to vari- America Invents Act, applicants would be wise to resist filing
ous classes and categories of reagents may provide an overall too broadly to cover only the newly discovered law of nature,
broader scope of protection. In addition, amending the claim and instead take the time to think outside the box, attempt to
to recite novel treatment or dosing regimens should also be foresee the future, and disclose and claim actual or future end
considered to avoid Prometheus issues and invalidity under use applications of the natural law.
section 101.
Using the above strategies, inventors, patent managers, and
their representatives can avoid traps under the new law and
shore up their discoveries and pending patent portfolios. An
Medical diagnostic claims
Under Prometheus, the issue of patent-eligible subject matter additional challenge, however, is correcting issued patents that
is highly suspect for medical diagnostic claims such as the are now at increased risk of invalidity.
hypothetical claim above. Strategies that should be considered
include converting medical diagnostic claims into treatment Shield existing patents
claims directed to a patient population having the characteris- While patent applications are pending, consideration should
tics indicated by the biological marker. Thus, the hypothetical be given to amending the applications or filing divisional and
claim example above could be amended as follows:
continuations-in-part containing claims that use the above
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US: LIFE SCIENCES
Software and other inventions
Claims directed to software may also be at risk
under Prometheus. For example, in Smartgene v
Advanced Biological Laboratories (DDC, March
30 2012), the United States District Court for the
District of Columbia found the following claim
to be patent ineligible subject matter under
Prometheus:
“A method for guiding the selection of a
therapeutic treatment regimen for a patient
with a known disease or medical condition,
said method comprising: (a) providing patient
information to a computing device comprising: a first knowledge base comprising a plurality of different therapeutic treatment regimens for said disease or medical condition; a
second knowledge base comprising a plurality of expert rules for evaluating and selecting a therapeutic treatment regimen for said
disease or medical condition; a third knowledge base comprising advisory information
useful for the treatment of a patient with different constituents of said different therapeutic treatment regimens; and (b) generat-
ing in said computing device a ranked listing
of available therapeutic treatment regimens
for said patient; and (c) generating in said
computing device advisory information for
one or more therapeutic treatment regimens
in said ranked listing based on said patient
information and said expert rules.”
According to the court, “the patents-in-dispute do no more than describe just such an
abstract mental process engaged in routinely,
either entirely within a physician’s mind, or
potentially aided by other resources in the
treatment of patients”.
For non-medical inventions, practitioners
should avoid reciting claim language that could
be analogised to a law of nature and preemption of an abstract idea. As with claims in the
medical field, specific process steps can be
used in place of generalised steps that do not
recite structural elements. Thus, instead of
reciting “a computer for processing data generated in step 1”, a claim may recite how the
steps taken by the computer process the data.
USPTO guidance
In a March 21 2012 letter to the Patent
Examining Corps, the USPTO said: “Examiners
must continue to ensure that claims, particularly process claims, are not directed to an exception to eligibility such that the claim amounts
to a monopoly on the law of nature, natural
phenomenon, or abstract idea itself. In addition,
to be patent-eligible, a claim that includes an
exception should include other elements or
combination of elements such that, in practice,
the claimed product or process amounts to significantly more than a law of nature, a natural
phenomenon, or an abstract idea with conventional steps specified at a high level of generality appended thereto.”
When drafting claims in medical or nonmedical areas of technology, it has now become
important to identify the additional elements
beyond what the patent office or a court might
consider a law of nature or abstract idea, and
be prepared to argue the significance of the
additional step or feature.
strategies. Consideration also should be given to drafting a described in the USPTO’s Manual of Patent Examination
range of claims – from broad claims closer to the bare natural Procedure, stating that the applicant believes the original
law, without overstepping the Prometheus line, to sets of patent to be wholly or partially invalid by reason of, for examdependent claims with lower risk of overstepping Prometheus, ple, the patentee’s claiming more or less than the patentee had
ultimately to narrow claims directed to the most marketable the right to claim. This can raise potential issues in subsequent
end use applications of the natural law. In litigation, not all litigation. Such issues can be minimised by following correct
these claims need be asserted, but the broader claims can add procedures and obtaining reissue patents that pass section 101
potential value particularly in licensing, and the narrower muster where the original patent did not. Reissue applications
claims provide a hedge against invalidity.
can be used to add dependent claims as a possible hedge
Owners of issued patents with claims reciting laws of against invalidity of an independent claim, and multiple reisnature should consider filing a reissue application in the sue applications can be filed based on a single issued patent,
USPTO. Reissue patent applications are filed post-grant to giving the patentee the opportunity to cover a multitude of
correct an error in an issued patent where the error renders the individual end uses of the law of nature. Of course, each
patent wholly or partially invalid or inoperable.
amendment, dependent claim, or additional end use must find
While patent reexamination proceedings only address support in the initial disclosure of the original patent. No new
issues of novelty and non obviousness, section 101 issues aris- matter is permitted.
ing under Prometheus can be corrected in reissue proceedings.
By filing a reissue application, the patentee essentially surren- After AIA
ders the original patent. This can take place any time before Supplemental Examination under the AIA should be considthe original patent expires, unless the reissue application seeks ered as another option after implementation of the new rules
to broaden the originally issued claims – in such cases, the reis- on September 16 this year. While Supplemental Examination is
sue application must be filed within two years of grant of the generally for the purpose of avoiding findings of inequitable
patent. Patentees should consider docketing
conduct by submitting new information to
all issued patents for review 18 months after
the USPTO, the proposed rules explicitly
grant, so that sufficient time is available to
encompass section 101 as well. The rules are
fully consider reissue strategies. Although
not yet finalised, and issues remain as to
most reissue applications filed to correct secwhether the USPTO will consider citation to
tion 101 problems are likely to add claim
a patent claim term(s) and the Prometheus
elements and thus be narrowing reissues,
decision “items of information” sufficient to
there will likely remain in many cases
satisfy a request for Supplemental
Why Prometheus will have little effect
opportunities to obtain broader claims that
Examination. If so, then the end result could
on Myriad, March 2012
survive under Prometheus. Furthermore,
be very favourable for some patent owners,
Prometheus patents shot down by
where one claim element is broadened, and
for instance in cases where the USPTO issues
Supreme Court, March 2012
another element is narrowed, the overall
a
certificate stating that the item of informaWhat the Prometheus ruling means for
claim may not consitute a broadening reistion does not raise any substantially new
life sciences, Mar 2012
sue.
question of patentability. If, on the other
Reaction: what the Supreme Court’s
questions mean for Prometheus,
Applications for reissue patents must
hand, the patentee seeks to amend or add
December 2011
include a reissue oath or declaration as
claims, then a simple reissue application
On managingip.com
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US: LIFE SCIENCES
should be considered as a more cost-effective strategy. Under
the newly proposed rules, if a Supplemental Examination proceeding concludes with a USPTO finding that any new item of
information raised a substantial new question of patentability,
the patent next proceeds to ex parte reexamination, which
entails relatively high fees under the proposed rules.
The Prometheus decision altered the scope of patent eligibility under US patent law. The full effect of the decision will
not be clear for some time. Furthermore, the Federal Circuit
will soon reconsider additional aspects of patent eligibility in
a controversial biotechnology case which the Supreme Court
remanded in the wake of Prometheus (Ass’n for Molecular
Pathology v Myriad Genetics, Fed Cir 2011; US March 26
2012). While Prometheus inhibits patent protection for certain
types of inventions, significant protection is still available
where strategies for maximising protection are fully taken into
account.
James
Brady
Jeremy
Cubert
Eric
Silverman
© 2012 James Brady, Jeremy Cubert and Eric Silverman. Brady and
Cubert are partners and Silverman is an associate with Dickstein
Shapiro in Washington DC
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