[A2k] KEI Brownbag on Bilski case: Implications for Life
Science Patents
Malini Aisola
malini.aisola@keionline.org
Sun Sep 20 09:15:19 2009
In a ruling this week (see Prometheus Labs., Inc. v. Mayo Collaborative
Servs, http://www.cafc.uscourts.gov/opinions/08-1403r.pdf), the CAFC
opined that medical treatment and diagnostic methods are patent eligible
under the "machine-or-transformation" Bilski test.
See also:
http://www.patentdocs.org/2009/09/prometheus-laboratories-inc-v-mayo-collab=
orative-services-fed-cir-2009.html
The Supreme Court decision which is expected in 2010 could uphold,
reject, or modify the Bilski test and how it is applied to determine
patent eligibility.
October 2 is the deadline for interested parties to file briefs and respond=
to two questions framed in the certiorari petition:
"1. Whether the Federal Circuit erred by holding that a =E2=80=9Cprocess=E2=
=80=9D must
be tied to a particular machine or apparatus, or transform a particular
article into a different state or thing =E2=80=A6 despite this Court=E2=80=
=99s precedent
declining to limit the broad statutory grant of patent eligibility for
=E2=80=9Cany=E2=80=9D new and useful process beyond excluding patents for =
=E2=80=9Claws of
nature, physical phenomena, and abstract ideas.=E2=80=9D
2. Whether the Federal Circuit=E2=80=99s =E2=80=9Cmachine-or-transformation=
=E2=80=9D test for
patent eligibility, which effectively forecloses meaningful patent
protection to many business methods, contradicts the clear Congressional
intent that patents protect =E2=80=9Cmethod[s] of doing or conducting busin=
ess.=E2=80=9D
35 U.S.C. =C2=A7 273."
-----Original Message-----
From: Malini Aisola <malini.aisola@keionline.org>
Reply-to: malini.aisola@keionline.org
To: a2k discuss list <a2k@lists.essential.org>
Subject: [A2k] KEI Brownbag on Bilski case: Implications for Life
Science Patents
Date: Wed, 16 Sep 2009 12:11:53 -0400
http://keionline.org/node/577
KEI Brownbag on Bilski case: Scope of Patentable Subject Matter
by Malini Aisola
On September 10, 2009 KEI hosted a brownbag lunch to discuss the scope
of patentable subject matter, focusing specifically on the implications
for life-science patents of the Supreme Court's forthcoming review of
the Bilski Federal Circuit opinion. This is the first time since 1981
that the US Supreme Court will address the limits of patentable subject
matter.
The key U.S. statue on this issue is Section 101 of the patent law:
35 USC 101. Inventions patentable
Whoever invents or discovers any new and useful process,
machine, manufacture, or composition of matter, or any new and
useful improvement thereof, may obtain a patent therefor,
subject to the conditions and requirements of this title.
A common misunderstanding is that the Bilski case is only about patents
on business methods. In fact, the Bilski case is being briefed on all
aspects of patentable subject matter, including areas of the life
sciences, such as medial diagnostics patents.
The lunch featured presentations and discussion by three patent experts:
* Professor Brian Kahin, University of Michigan School of
Information and Senior Fellow at Computers and Communications
Industry Association (CCIA)
* Professor John R. Thomas, Georgetown University Law Center
* Professor Dan Ravicher, Cardozo Law School and the Public Patent
Foundation
The following are my notes from the discussion.
________________________________________________________________________
The notice of the meeting included these points:
Many concerns have been raised in the past 15 years about the
radical expansion of patentable subject matter to include all
forms of software, human activities (business methods), and
diagnostic information. This expansion took place with virtually
no public input. As one treatise puts it:
[B]road notions of patent eligibility appear to be in
the best interest of the patent bar, the PTO, and the
Federal Circuit [CAFC]. Workloads increase and
regulatory authority expands when new industries become
subject to the appropriations authorized by the patent
law. Noticeably absent from the private, administrative
and judicial structure is a high regard for the public
interest.[*]
As a result, virtually all human activity became subject to
patenting, including established civil liberties. As Professor
Thomas, Georgetown Law, has written, =E2=80=9Cthe patent law allows
private actors to impose more significant restraints on speech
than has ever been possible through copyright.=E2=80=9D A wide of
variety of tax avoidance strategies have been patented, despite
the opposition of the accounting profession. Patents
disadvantage open source software and threaten the development
of and use of open standards. Health care faces patents linking
symptoms and conditions with treatments.
Background on the Bilski Case
In April 1997, the applicants (Bernard L. Bilski and Rand A. Warsaw)
filed a business method patent application for a method of hedging risks
in commodities trading. The patent examiner rejected all the claims and
the applicants appealed the rejection to the Board of Patent Appeals and
Interferences (BPAI), which affirmed the rejection of the patent claims,
although on different grounds. Thereafter, the applicants appealed the
rejection to the Federal Circuit.
In October 2008, the Court of Appeals for the Federal Circuit (CAFC)
rejected again Bilski's appeal on grounds of ineligible patentable
subject matter.
In deciding the case, the Federal Circuit employed a test of machine
implementation or physical transformation, which the patent application
failed to meet. As explained by the Federal Circuit, the
machine-or-transformation is explained as:
"A claimed process is surely patent-eligible under =C2=A7101 if: (1=
)
it is tied to a particular machine or apparatus, or (2) it
transforms a particular article into a different state or
thing."
The CAFC ruling is considered to have limited the scope of patentable
subject by defining the range of processes that can be patented.
However, the Supreme Court consented to undertake a review of this
decision which will be completed soon. This will be the first Supreme
Court decision on the scope of patentable subject matter in 28 years. 44
amicus briefs have already been filed and can be found here [1]. The
deadline to file briefs is October 2, 2009.
Dan Ravicher, Public Patent Foundation and Cardozo Law School provided
some background and an analysis of how the Supreme Court's decision will
determine the patentability of business methods and software, but also
dramatically impact life sciences patents. Ravicher alerted that this
case is not just about business methods or software patents but about
the bigger issue: what processes are patentable under US law, including
biotechnology and medical processes.
Ravicher provided examples to illustrate how the biotechnology and
pharmaceutical industries may be affected by precedent of patentable
subject set in other innovative industries. For instance, in Microsoft
vs. AT&T, Eli Lilly filed a brief [2] arguing that the patent claim for
computer software was ineligible as subject matter, a position supported
by the Supreme Court's decision. In the case of Classen Immunotherapies
v. Biogen IDEC in December 2008, the Federal Circuit relied on Bilski to
render invalid a patent claim for a method of determining whether an
immunization schedule affected the incidence or severity of a disease.
In the Supreme Court review of Bilski, so far 5 amicus briefs have been
filed that directly address the ruling's implications for biotechnology
and pharmaceuticals:
1. BIO, AdvaMed, WARF and the University of California [3]. The
brief asserts that biotechnology and medical technology require
broad patent eligibility in order to produce growth in the
industry and protect investments (referencing the landmark
ruling in Diamond v. Chakrabarty regarding patentability of
genetic materials) and that the use of the
"machine-or-transformation" test to bio process patents and
biomarkers would wreck 'havoc' on the biotech industry.
2. Novartis [4]. This brief argues that the dissent in Lab. Corp.
v. Metabolite (by Justice Breyer and joined by Justices Stevens
and Souter) was erroneous, the "machine-or-transformation" test
should not be implemented as a one-size-fits-all solution
regardless of the ruling on Bilski's claim because such a
decision would threaten protection to diagnostic-processes.
Further, the only exclusion to the scope laid out in =C2=A7101 is
processes that preempt laws of nature, natural phenomena, or
abstract ideas. Processes that are applications of laws of
nature, such as diagnostic-processes, should remain eligible for
patent protection.
3. Georgia Biomedical Partnership, Inc [5]. The brief holds that
the Federal Circuit's ruling and mandatory use of the
"machine-or-transformation" test is inconsistent with the
Supreme Court's precedent on patent eligibility and also the
Patent Code. Section 287(c) of the Patent Code exempts medical
practitioners from patent infringement during performance of a
medical activity. Congress' intention in drafting this section
of the statute was to protect doctors without limiting the
patenting of medical activities. Thus, the biomedical and
biotechnological processes referred to in Section 287(c) are
inherently patentable under =C2=A7101 and fall under a broader rang=
e
than covered under the Bilski test. The filers of the brief seek
a reversal in order to prevent further reliance on the Bilski
test to deny patent claims such as in Classes which, in their
opinion, was decided incorrectly.
4. Medtronic, Inc [6]. The brief urges the Supreme Court not to
adopt the standard set in Bilski and provides examples of
medical and biotechnological processes that risk being deemed
ineligible subject matter. Use of the
"machine-or-transformation" test would render patient diagnosis,
monitoring and medical data management, and personalized
medicine unpatentable. Consequences of the Bilski test would be
to impede the prompt disclosure of medical technology through
patenting and discourage investment in medical innovation.
5. PhRMA [7]. Taking no view on Bilski itself and business method
patents, PhRMA argues that the Court should not adopt a new test
that could potentially, based on the interpretation of the test,
limit the scope of patentability for medical processes that make
use of pharmaceuticals. There is already debate over whether
these processes are 'transformative' and hence meet the
requirements of the "machine-or-transformation" test. The brief
goes on to state:
"If this Court nonetheless adopts the Federal Circuit=E2=80=
=99s
Bilski test, it should make clear either that (1) under
that test, medical processes, particularly processes
involving the administration of pharmaceuticals, are
patentable, or (2) the test is limited to business
method patents and other tests may be appropriate for
medical-process or other patents. Alternatively, if this
Court adopts a different approach to the scope of =C2=A7 10=
1
than the Federal Circuit adopted in Bilski, it should
ensure that that test protects the patentability of
medical process patents."
Hence, PhRMA has sought to ensure that the decision on Bilski
will not have any implications for medical process claims or
limiting the patent eligibility of "methods of medical treatment
and diagnosis, especially methods for new uses of existing
pharmaceuticals"
Ravicher further commented that it is unclear what positions the Supreme
Court judges take but that is it important for interested parties,
especially consumer advocates, to express their views on these issues,
particularly as they relate to life science patents.
James Love raised several points in response to the concerns raised in
the 5 briefs:
* There is a fundamental distortion in the current patent system
in the area of biotechnology. Patents are conceptualized as
tools to protect investment instead of protecting innovation.
But several mechanisms to reward innovation investment in the
biomedical field, other than patents, currently exist or have
been proposed, e.g., New proposed legislation with data
exclusivity for biologics, Orphan Drug Act, FDA's Priority
Review Voucher to reward innovation for neglected diseases,
Medical Innovation Prize Fund Bill. The government has the
option of using many such instruments to reward and create
incentives for biotechnological and pharmaceutical inventions,
that are independent and lie outside the patent system.
* The dangers of excessive patenting are many- stifling follow on
innovation (especially involving complex inventions),
anti-competitive practices, formation of patent thickets, etc.
In the biomedical area, patent protections, patent linkage and
the practice of 'evergreening' have led to an untenable system
of excessively high prices for lengthy period of times, a
situation that retracts from the benefits the inventions are
obligated to provide.
* Further, there are several areas where the unhindered freedom to
innovate is essential for growth in science (e.g., data
interpretation, methods of medical diagnosis). The ethical
issues in withholding one kind of subject matter may vary for a
different kind, this merits further scrutiny.
During the discussion that followed, topics such as the infringement
provisions in Section 271, the constitutional clause on =E2=80=9Cuseful art=
s=E2=80=9D,
ethics of withholding knowledge on diagnostic and processes, and
specific repercussions of the decision on life science patents were also
deliberated.
According to John Thomas, Georgetown University Law Center, the language
in Section 101 of the Patent Law can be read as quite inclusive
concerning the scope of patentable subject matter. The courts and the
USPTO have for many years set certain limits, excluding abstract ideas
and laws of nature from being patentable. The Bilski test presents the
Court with one possible way to define the boundaries or the exceptions
to patent eligibility.
By way of its decision, the Supreme Court will also have the option of
restricting the use of the Bilski test to a given field of technology
and setting distinct standards for different industry sectors. In this
regard, Article 27 of the TRIPS agreement was raised during the
discussions. In the event that the Court chooses to adopt one general
rule, participants at the meeting were of the opinion that the Bilski
=E2=80=9Cmachine-or-transformation=E2=80=9D test might be a reasonable choi=
ce. Ravicher
shared his opinion that although he disagreed with the way the
=E2=80=9Cmachine-or- transformation=E2=80=9D test was created or justified =
by the CAFC,
the result is right, and might be usefully defending under a different
rationale.
Parties interested in filing briefs should do so by October 2.
[*] Roger E.Schechter and John R. Thomas, Intellectual Property, West
Hornbook Series, 2003, p. 314
________________________________________________________________________
Links:
[1]http://www.patentlyo.com/patent/2009/08/briefs-in-bilski.html
[2]http://www.patentlyo.com/patent/Microsoft_20v[1]._20AT_26T_20Lilly_20Ami=
cus_20_28corrected_29.pdf
[3]http://www.patentlyo.com/08-964-tsac-biotechnology-industry-organization=
-et-al..pdf
[4]http://www.patentlyo.com/08-964tsacnovartiscorporation.pdf
[5]http://www.patentlyo.com/08-964-georgia-biomedical-partnership-inc.pdf
[6]http://www.patentlyo.com/08-964-medtronic.pdf
[7]http://www.patentlyo.com/08-964-phrma-et-al..pdf
--
Malini Aisola
Knowledge Ecology International
1621 Connecticut Avenue NW, Suite 500, Washington DC 20009
malini.aisola@keionline.org|Tel: +1.202.332.2670|Fax: +1.202.332.2673
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--
Malini Aisola
Knowledge Ecology International
1621 Connecticut Avenue NW, Suite 500, Washington DC 20009
malini.aisola@keionline.org|Tel: +1.202.332.2670|Fax: +1.202.332.2673