In decisions starting with Bilski (Bilski v.
Kappos, 561 U.S. 593 (2010)), followed by Myriad
(Association for Molecular Pathology v. Myriad Genetics,
Inc., 133 S. Ct. 2107 (2013)) and Mayo (Mayo v.
Prometheus, 132 S. Ct. 1289 (2012)), and finally by
Alice (Alice Corp. Pty. Ltd. v. CLS Bank
Int'l, 134 S. Ct. 2347 (2014)), the U.S. Supreme Court
transformed the issue of patent eligibility, with far-reaching
implications for the pharmaceutical and biotech industries and
their ability to obtain fair protection for the fruits of their
research. Here, we consider the developments of the eligibility
guidelines, how they are applied (including a number of
illustrative examples) and practical implications for the
pharmaceutical and biotechnology industries, including potential
approaches to patent claim drafting.
Initially, in response to Myriad and Mayo, the US
Patent and Trademark Office (USPTO) released a memorandum entitled
"Procedure For Subject Matter Eligibility Analysis Of Claims
Reciting Or Involving Laws Of Nature/Natural Principles, Natural
Phenomena, And/Or Natural Products". This March 2014 Guidance
applied to "claims (i.e., machine, composition, manufacture
and process claims) reciting or involving laws of nature/natural
principles, natural phenomena, and/or natural products".
The issuance of the March 2014 Guidance caused considerable and
understandable concern in the biotechnology and pharmaceutical
industries over exactly what might now be patent eligible. Few had
imagined after the Myriad and Mayo decisions
issued that the USPTO would seek to take the reasoning of those
decisions (which, it had appeared, set a narrow exclusion to
patentability to naturally occurring gene sequences) and
extrapolate it to an extreme that most observers believe was never
intended by the Courts. Section 101 eligibility in the US was
always intended to be a coarse sieve, not a fine filter. The first
months immediately after the issuance of the March 2014 Guidance
saw a sharp rise in eligibility objections.
The USPTO embarked on an exercise in which it held meets with
interested stakeholders, including representatives from the
pharmaceutical and biotechnology industries. In the light of the
feedback that it received, on 16 December 2014 the USPTO published
its 2014 Interim Guidance on Patent Subject Matter Eligibility.
This came into force with immediate effect and replaced the highly
controversial earlier Guidance. It also supplemented the Guidance
issued following the Alice Corp decision concerning
abstract ideas issued earlier in 2014. The new Guidance requires
the examiner to evaluate the claim as a whole. Examples are given
of how the new approach should be applied, using the facts from
previously decided cases including Myriad, Mayo and
Alice. In the following, we discuss this new guidance and
consider the practical implications for the pharmaceutical and
biotechnology industries for the drafting, filing and prosecution
of patent applications in the US directed to natural
products.
It is firstly important to understand is that the December 2014
Guidance is for USPTO examiners to enable them to interpret the key
Myriad, Mayo and Alice decisions. It is not
binding on the US courts. This Guidance sets out a two-part test,
with the second part itself divided into two steps. In step 1, the
examiner must first decide if the claim is related broadly to
patentable subject matter: is the claimed invention a process,
machine or a composition of matter? If not, then the claim is not
eligible subject matter. If it is, then the claim is analysed to
determine if it relates in whole or in part to a judicial exception
to patent-eligibility (step 2A). If not, then the claim satisfies
the requirements of patent eligibility under Section 101. If the
claim is determined to relate in part to a judicial exception, then
the claim is analysed to determine if it recites additional
elements that amount to significantly more than the judicial
exception (step 2B). The analysis will only proceed to step 2B when
the claim is directed to an exception, i.e. when no markedly
different characteristics are shown.
We now consider how these steps are applied by the examiners
through the use of illustrative examples that the USPTO has
provided to its own examiners to assist them in guiding how they
interpret the Interim Guidance of December 2014. We will then
consider the practical implications for users of the patent system
in the US seeking to obtain protections in the pharmaceutical and
biotech fields.
Step 2A appears to be an important improvement for pharmaceutical
and biotechnology companies in the approach to be adopted by
examiners when considering eligibility of natural products when
compared to the March 2014 Guidance. Thus, for example, under the
December 2014 Guidance a combination product as a whole must be
assessed to determine if it is markedly different from a product of
nature. Under the March 2014 Guidance, evaluation of a combination
of natural products was performed by individually comparing each
component part to its naturally occurring form, and the effect of
the combination of the products on, for example, the whole was not
given.
As an example, under the March 2014 Guidance gunpowder was
considered to be a combination of three naturally occurring
products (potassium nitrate, charcoal and sulfur). Each was
considered to be in its 'naturally occurring, unchanged
state' in the mixture and it was not considered to display any
of the exceptions set out in the final step of the March 2014
Guidance (equivalent to step 2B of the December 2014 Guidance). In
the example published with the December 2014 Guidance, the analysis
of gunpowder as a combination holds it to be markedly different
from its naturally-occurring components because gunpowder is
explosive, while the naturally-occurring substances on their own
are not. This functional difference in the combination compared to
the activities of the individual components enables subject matter
eligibility to be acknowledged.
Another example where there has been a change in approach to
combinations is seen in the example of a claim to a "beverage
composition comprising pomelo juice and an effective amount of an
added preservative". There is no naturally occurring
counterpart to the claimed combination, so the combination is
compared to the individual components as they occur in nature (Step
1: YES). Because of its "slower spoiling," the properties
of the claimed combination are considered markedly different from
the properties of the juice by itself in nature. (Step 2: NO). This
is true regardless of whether the preservative is a natural product
or a non-natural product. In the examples under the March 2014
Guidance, the composition comprising pomelo juice and another
natural product (vitamin E) was considered patent ineligible as
both were considered to be naturally occurring products which were
unchanged in the combination, emphasising the importance of this
change in approach resulting from considering the claim as a whole
to determine if it is markedly different from a product of
nature.
Another improvement in Step 2A is how Examiners should approach
claims directed to or comprising isolated or purified natural
products. Under the new Interim Guidance, such a product may be
eligible if there is a resultant change in characteristics
sufficient to show a marked difference from the natural
counterpart. Differences that are exemplified include a change in
the biological or pharmacological functions or activities, chemical
or physical properties, changes in phenotype, or changes in
structure and form, whether chemical, genetic or physical. Purified
products were considered ineligible under the March 2014
Guidelines.
One example given together with the December 2015 Guidance is
directed to a method claim reciting "a method of treating
breast or colon cancer, comprising administering an effective
amount of purified amazonic acid to a patient suffering from breast
or colon cancer" is patent eligible under the new guidelines.
The claim does not even require an analysis of "markedly
different" because the claim is focused on a process of
practically applying the product to treat a particular disease.
Under the previous guidelines, such a claim was typically rejected
as patent ineligible unless it also recited a dosage and/or a time
period of administration. However it is to be noted that the
analysis still considers that isolated purified amazonic acid is
not patent eligible, despite the fact that the details of the
example state that micrograms of the isolated compound are
effective whereas a patient would have to ingest several tonnes of
leaves to achieve the same effect, this is still considered to lack
subject matter eligibility as the analysis argues that it is not
'markedly different' from the 'naturally occurring
product in its natural state'.
For a claim that does not recite something "markedly
different" from the natural counterpart (Step 2B), the Interim
Guidance does not depart significantly from the March 2014
Guidance. The claim must be analysed to determine if elements other
than those related to a judicial exception amount to something
significantly more than the exception itself. The Interim Guidance
provides examples of what is and is not considered
"significantly more".
This is further emphasised by the example of 'purified
Antibiotic L'. Under the Interim Guidance, a claim to this is
deemed patent eligible. The different result is rationalised on the
grounds that in the specification's definition of purified
Antibiotic L, the claim is limited to Antibiotic L in the form of
tetrahedral crystals or having a high-mannose N-glycan on residue
49. Thus, the claim does not encompass naturally occurring
Antibiotic L (which forms hexagonal-pyramidal crystals, and has a
bacillosamine N-glycan on residue 49).
An example of genetically modified bacterium illustrates that a
naturally occurring product that is unchanged from its natural
state ('A stable energy-generating plasmid, which provides a
hydrocarbon degradative pathway) does not have markedly different
characteristics and hence is not patent eligible: there is no
information to suggest that they are markedly different from
naturally-occurring energy-generating plasmids. However, a claim
that incorporates changes in biological function between the
claimed product and its natural counterpart ('A bacterium from
the genus Pseudomonas containing therein at least two stable
energy-generating plasmids, each of said plasmids providing a
separate hydrocarbon degradative pathway') can demonstrate
markedly different characteristics and hence be patent eligible:
the bacterium comprising at least two plasmids is able to provide
at least two hydrocarbon degradative pathways, compared to the
naturally occurring counterpart that only has one, and hence is
markedly different.
The public was invited by the USPTO to submit written comments up
to 90 days from publication of the Interim Guidance in the Federal
Register (a deadline of around 16 March 2015). This resulted in the
issuance of further Guidance in July 2015. However, this did not
address any issues relating to natural phenomena at all and was
restricted to clarification of the guidance for abstract
ideas.
The first months immediately after the issuance of the March 2014
Guidance saw a sharp rise in eligibility objections. Since the
issuance of the December 2014 Guidelines, while the number of
eligibility objections is still considerably higher than it was
prior to the introduction of either sets of guidelines following
Myriad and Mayo the impression of practitioners is that the number
of eligibility objections has fallen. After all the clamour and the
resultant partial retreat by the USPTO in the revised Interim
Guidance, it is to be hoped that the promised 'balanced'
approach is indeed starting to be seen in practice.
Time, of course, will tell and in the meantime we will be watching
closely to determine how things develop and then devising the best
strategies to adopt in this fast changing environment. However, we
certainly advise at this stage that new applications in the US
should include broader claims than might have been feared were
allowable only a few months ago. It will be important,
nevertheless, to ensure that fallback positions are included with
specific limitations that may assist in overcoming any objections
of lack of eligibility, e.g. specific crystal structures that are
not found in nature, methods of treatment comprising specific
dosage regimes, humanized antibodies and non-naturally occurring
DNA sequences.
This article was originally published in MedNous.
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.