The use of computers in the life sciences has continued to grow
and evolve. Current advances include the use of sophisticated
techniques such as multi-variate analysis or machine learning
methods to identify risk factors or diagnose disease. Healthcare
providers are considering how 'big data' may be used to
gain efficiencies and improve patient care. Computers have
also migrated from the desktop to individual portable devices and
the 'internet of things' promises to transform fields such
as agriculture, diagnostics and drug delivery.
While computer-implemented inventions in the life sciences have
great potential, commercial success is far from assured. Obtaining
effective intellectual property protection can be critical.
To be patentable, a claimed invention must be new and inventive
over the prior art, and must be directed to patent eligible subject
matter. What is considered 'patent eligible subject matter'
differs in each jurisdiction. For example, in the United States
"laws of nature, physical phenomena, and abstract ideas"
("ineligible elements") are ineligible for patent
protection. Driving this exclusion is the concern that a patent may
pre-empt an entire field and improperly tie up fundamental concepts
from future use.
Many inventions in the life sciences incorporate ineligible
elements. For example, in the Mayo1 decision the
correlation between a biomarker (thiopurine drug metabolites) and a
particular outcome (therapeutic efficacy and toxicity) was
considered to be an unpatentable "natural law". In Mayo,
the Supreme Court also set forth a two-part test for assessing
whether inventions are patent eligible. First is a law of
nature, natural phenomenon or an abstract idea claimed? If
not, the invention is patent eligible. If so, are there
additional elements that transform the nature of the claim into a
patent-eligible application of otherwise ineligible elements?
Examples of "additional elements" that may be
sufficient to transform a claim into patent eligible subject matter
include the use of specific reagents or analytical techniques, or
incorporating unconventional method steps or elements that are
separate from the natural law itself.
For some inventions, the use of a computer may be considered an
"additional element" for transforming a claim into a
patent eligible subject matter. In the recent Alice
decision2, the Supreme Court revisited the two-step test
in Mayo in the context of a software patent and held that simply
implementing an abstract idea on a computer is not an additional
feature sufficient to 'transform' the claimed abstract idea
into a patent-eligible application. In Alice, the computer
was configured to implement a business method, which was not
considered to improve the operation of either the computer or any
other area of technology. In contrast, a computer-implemented
invention in the life sciences may well be considered to constitute
an improvement in technology and qualify as patent eligible subject
The best strategy for claiming a particular invention will
depend on the nature of invention as well as any expected
commercial activities. Applicants seeking patent protection
in the United States should work with their patent agent to
identify 'additional elements' that may be used transform
the claims into patent eligible subject matter without necessarily
sacrificing commercially relevant claim scope. In practice,
it may also be advisable to file one or more continuation patent
applications in order to obtain claims that incorporate different
'additional elements' in order to obtain the broadest
Compared to the United States, Canada has not yet seen the same
developments with respect to restricting the patentability of laws
of nature, physical phenomena or abstract ideas. For example,
diagnostic methods are generally patentable as long as they do not
include administration or surgical steps and meet all the other
requirements for patentability. However, the law is in a state of
flux and it is possible that Canada may eventually adapt
restrictions similar to those that are evolving in the United
1. Mayo Collaborative Services v. Prometheus Laboratories,
Inc. 566 U.S. (2012) 2 Alice Corp. v. CLS Bank International 573
2. Alice Corp. v. CLS Bank International 573 U.S. (2014)
This article was originally published in the June/July issue of Biotechnology Focus, Volume 18, Number 3, pg 16.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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A recent Saskatchewan Court of Queen's Bench decision allowed a court-appointed receiver to sell and transfer intellectual property rights free and clear of encumbrances, finding that a license to use improvements of an invention was a contractual interest and not a property interest.
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