The U.S. Supreme Court's decisions in Molecular
Pathology v. Myriad Genetics, Inc. (Myriad) and
Mayo Collaborative Services v. Prometheus Laboratories
(Prometheus), and its subsequent interpretations of 35
U.S.C. §101, have sparked tremendous controversy in the
biotech industry. Similarly, the USPTO's interpretation of the
Supreme Court's rulings as represented in its Guidance
has not been without controversy. In last month's issue of
IP Buzz,
we summarized and highlighted the key points of the guide. In
this month's article, we will discuss the guide's potential
implications for inventors and legal service providers.
As touched upon in last month's article, the USPTO's
Guidance in view of Myriad and
Prometheus has been received with mixed reviews from the
biotech and legal professions. On one hand, professionals
appreciate that the USPTO was placed in a difficult position and
the prompt issuance of a Guidance to instruct examiners on
claims comprising natural products and/or natural laws.
Proponents believe that the Guidance will be refined
as the USPTO has made it clear that it is willing to accept
feedback from the community.
However, proponents for the Guidance seem to be in the
minority, with many biotech and legal professionals criticizing the
USPTO's interpretation of the Supreme Court's
rulings. Critics contend that the Guidance in effect
goes beyond what the Supreme Court actually ruled in the recent
patent eligibility cases. They point out that the Supreme
Court limited the scope of its decisions and cautioned against
over-interpretation, while the Guidance appears to be less
measured and contrary to the Office's previous practices.
For instance, there are many previously issued patents pertaining
to isolated enzymes, chemicals, naturally occurring antibiotics,
and other "products of nature." However, based on the
Guidance, it would appear that none of the
following are patent-eligible subject matter: isolated chemical
compound from crude oil useful as a lubricant, isolated chemical
compound from plant useful as a drug, isolated antibiotic produced
by bacteria, isolated protein from animal useful to cure/ameliorate
human disease, and isolated plant/human genes/proteins (unless
claimed as cDNA). In particular, the Guidance seems to
call into question the longstanding Office policy of considering
highly purified natural products as being patent eligible. In
Myriad, the Supreme Court sidestepped this problem by
indicating that their decision necessarily applied only to DNA and
that DNA was unusual because DNA can be viewed as information as
well as a chemical compound.
Regardless of one's views concerning the Guidance,
inventors and patent practitioners must now try to adopt methods of
ensuring meaningful patent protection for intellectual property
that can be interpreted as containing a "product of
nature" or as involving a "natural law." In the case
of protecting intellectual property that might contain a
"product of nature" (as understood by an examiner), one
might consider including multiple claims having
varying degrees of modifications to the naturally occurring
product. At the same time, if one is to apply for a patent in
Europe, it is important to keep in mind that European patent law
thus far remains unchanged in view of Myriad. As such,
although Europe forbids the patenting of particular human genes or
elements, one can still claim such a gene or element so
long as an industrial application for the gene or element is
disclosed in the application. In summary, if claiming a product
that might contain a "product of nature," it would be
advisable to include broad claims that might be
allowable in Europe (or other foreign patent offices) as well as
subsequent claims with further modifications to the product.
Similarly, when protecting intellectual property involving a
"law of nature," for U.S. filings, one must take care to:
1) limit the claim(s) to a particular application of the natural
law, 2) not preempt all uses of the natural law, and 3) include
unconventional steps that integrate the natural law into the
claimed process which applies it. It is also advisable to keep
one's claim(s) as broad as possible when filing in Europe (or
other foreign patent offices), while still obeying the particular
laws of the European Patent Office (EPO). For example, although in
Prometheus the Supreme Court ruled that diagnostic patents
based solely on the application of a natural law are no longer
patentable in the U.S., the EPO holds that an invention involving
the practical application of a discovery or theory is patentable
(with certain limitations pertaining to interaction with and
treatment of a human/animal body). As such, a claim to the
diagnostic invention at the center of Prometheus was
previously allowed by the EPO as an in vitro method for
determining the efficacy of a treatment. Thus, it is important to
determine if one's product can be interpreted to contain a
"law of nature" and appropriately adjust one's claims
for prosecution in the U.S. versus abroad.
Going forward, it will be interesting to see how the
Guidance impacts the types of patents and claims applied
for by inventors both inside and outside the biotechnology
industry, as the concepts of "natural products" and
"laws of nature" extend not just to chemicals and
biological matter. Ultimately, the Guidance is simply an
administrative tool that has no force of law. The implications of
the Supreme Court's decisions and the impact of this
Guidance will undoubtedly take many years to unfold and
will inevitably be shaped by litigation and judicial decisions. For
instance, it seems likely to the authors that should the USPTO deny
patentability of natural products based on isolation and purity,
the courts may not uphold such a denial. Similarly, court
challenges to the validity of currently existing purified natural
product patents are not likely to succeed, at least on
Myriad grounds. There has not been sufficient time for any
of possible approaches suggested above to demonstrate success (or
failure) during prosecution of a patent application. These points
are presented for discussion purposes and not as suggested
actions.
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.