IP considerations associated with CDx

European
Biotechnology
Nº 4 | Volume 13 | 2014
Big Data & IP
Net work
Companion Diagnostics
IP considerations
associated with CDx
Ramin Ronny Amirsehhi, Amirsehhi Intellectual Property Law; Martinsried
Many pharmaceutical companies are considering a biomarker strategy for their
drugs as advances in diagnostic technologies, the growth of biosimilars, a rising
number of expiring patents, and concerns about profit margins drive them to adjust their approach.
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In the race to discover and develop com
panion diagnostics successfully, many
pharmaceutical companies are partner
ing with biotech companies that are ex
pert in the appropriate diagnostic or tech
nology. Working with a diagnostic part
ner to develop a companion diagnostic,
which ultimately also requires obtaining
market authorisation, complicates the al
ready complex drug development and ap
proval process. An intellectual property
(IP) strategy is part of this complex proc
ess, and plays a key role in the develop
ment and commercialisation of compan
ion diagnostics.
IP strategies for companion diagnos
tics include a deep understanding of type
of discovery, business objectives, patent
eligibility and infringement considera
tions. While it is beyond the scope of this
article to examine all IP considerations
for all major jurisdictions, it is important
to briefly discuss how patent law is evolv
ing in the US and Europe. In this first in
stallment of a series of articles, we look
at types of discovery and US patent eligi
bility issues.
Type of discovery
The strength of patent protection is most
often correlated with the type of discov
ery. Patent claims directed at compounds
are the strongest type of protection. Such
protection could be used to exclude oth
ers from using the compound or novel bio
marker in any type of diagnostic for any
type of drug.
In most cases, biomarkers are known
proteins. A discovery involves their corre
lation with a particular disease and drug
that is under study. This type of discov
ery may result in method-of-treatment
claims, which can be very valuable – es
pecially if such method claims read on a
drug and/or diagnostic label.
Method-of-treatment claims need to
be drafted with both the drug label and
diagnostic label in mind. The labels can
be in general terms or include a specif
ic assay. A claim directed at a specific di
agnostic assay or technology would in
clude limitations associated with how the
presence of the biomarker is determined.
Such claims can be vital in the long run,
as they may extend the exclusivity of the
drug against generics and biosimilars,
since to meet FDA requirements, any ge
neric or biosimilar equivalent would also
be required to include reference to the di
agnostic assay.
The discovery and patenting of new plat
form technologies can also be valuable to a
diagnostic company. It is important to con
sider in advance how a potential competi
tor may attempt to avoid patent infringe
ment while at the same time demonstrat
ing the equivalence of its device to a legal
02.04.2014 16:40:15 Uhr
Nº 4 | Volume 13 | 2014
Big Data & IP
ly marketed device by submitting a 510(k)
premarket submission to the FDA. Therefore, it is important to consider other feasible methods or techniques for measuring the biomarker and include these in the
specification and/or claims.
Discoveries that do not impact labels
are less valuable, and are usually easier to get around. These include, for example, the discovery of specific assay
reagents.
Patent eligibility
By now, most people in the life science
community have become aware of the
US Supreme Court’s decision in Mayo
Collaborative Services vs. Prometheus
Laboratories, Inc. 132 S.Ct. 1289, (2012
–“Mayo” decision), as well as in Association for Molecular Pathology et al. vs.
Myriad Genetics, et al., 133 S.Ct. 2107,
(2013 – “Myriad” decision). It is important to highlight the difference between
these two rulings.
The Mayo decision is entirely independent of the “law of nature“; it is focused on
process claims. The Myriad decision did
not review process claims, and focused on
the genes. There are numerous publications analysing the two decisions. This article will therefore propose strategies for
obtaining claims that relate to diagnostic
methods or biomarkers. It is important to
remember that the following approach-
es are completely applicable only in the
US. For other jurisdictions – such as Europe – different scope of claims may be
obtained. When drafting applications, applicants should therefore consider these
differences and include them in the specification and claims.
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Proposed solutions
According to the Mayo decision, correlations between a biomarker and efficacy
are a natural law, and are therefore not
patentable. The possible approaches in
light of this can be claims 1) directed at
a method of diagnosing a disease by detecting a novel biomarker, 2) use of a specific reagent (as mentioned above, these
types of claims can be easy to circumvent
for competitors and should be considered
carefully), 3) adding a treatment step (the
treatment step can be a particular drug or
therapy), or 4) detecting a combination of
biomarkers.
Genomic DNA is considered a product
of nature, and based on the Myriad decision is therefore not patentable. Possible
strategies for bypassing this roadblock
can be claims directed at cDNA, nonnaturally occurring DNA (such as mutagenized or chemically modified DNA),
synthetic RNA or synthetic proteins (it is
important to avoid using the term “isolated”), as well as their respective probes
and primers. 
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