Download 304B - American Bar Association

304B
AMERICAN BAR ASSOCIATION
ADOPTED BY THE HOUSE OF DELEGATES
AUGUST 8-9, 2011
RESOLUTION
RESOLVED, that the American Bar Association supports the principle that laws of nature,
physical phenomena, and abstract ideas are not eligible for patenting under 35 U.S.C § 101, even
if they had been previously unknown or unrecognized;
FURTHER RESOLVED, that the American Bar Association supports the principle that a patent
claim limited to a new application of a law of nature or physical phenomenon meets the
requirements of Section 101 where such new application manifests itself in a process, machine,
manufacture, or composition of matter, including a process, other than a mental process, for the
treatment of a particular disease or other medical condition.
304B
REPORT
The Section of Intellectual Property Law requests that the House of Delegates approve
this Resolution, which would support an Association amicus curiae brief in the U.S. Supreme
Court in the case of Mayo Collaborative Services v. Prometheus Laboratories, Inc., Case No. 101150. On June 20, 2011, the Supreme Court granted a petition for certiorari to review the
decision of the U.S. Court of Appeals for the Federal Circuit (Prometheus Labs., Inc. v. Mayo
Collaborative Services, 628 F.3d 1347 (Fed. Cir. 2010) (Prometheus II)). This report cannot be
considered by the House of Delegates at a time later than the 2011 Annual Meeting, because the
deadline for filing an amicus brief in the Supreme Court will be reached before the next meeting
of the House of Delegates.
Introduction and Background
The resolution deals with an issue of fundamental importance to the patent bar and the
public in general, namely, the interpretation of Section 101 of the patent statute (35 U.S.C. §
101). Section 101 defines the types of inventions and discoveries that are eligible for patent
protection.1 The Supreme Court has twice accepted Prometheus for review. In 2009, the Federal
Circuit reversed the district court’s summary judgment that the Prometheus patent was invalid
under Section 101 and concluded that the subject matter defined by the patent claims was
eligible for patent protection. The accused infringer, Mayo, petitioned for certiorari, and
following its decision in Bilski v. Kappos, 130 S. Ct. 3218 (2010), the Supreme Court granted the
petition, vacated the Federal Circuit’s decision and remanded for further consideration in view of
its holding in Bilski. On remand, the Federal Circuit again held that the subject matter defined by
the Prometheus patent claims was eligible for patent protection under Section 101. Mayo again
sought review by the Supreme Court, and certiorari was granted on June 20, 2011.
1
The issue of subject matter eligibility for patenting under section 101 has been previously addressed in policy
adopted by the House of Delegates.
At the 2009 Annual Meeting, the House of Delegates approved a resolution supporting application by the
Supreme Court of incremental development of jurisprudential doctrine for determining patent eligibility, opposing
fixed and specific requirements for such eligibility, and specifically opposing a requirement that a process be tied to
a specific machine or transform an article into a different state or thing to be patent eligible. The decision of the
Supreme Court in the case that prompted the development of the ABA policy was consistent with the policy adopted
by the HOD, in both result and rationale. Bilski v. Kappos, 130 S. Ct. 3218 (2010).
At the 2004 Annual Meeting, the House of Delegates approved a recommendation opposing limitations on the scope
of patentable subject matter beyond those set forth in 35 U.S.C. § 101, and specifically opposing statutory restriction
on the use of USPTO appropriated funds if that restriction has the effect of imposing additional subject matter
limitations on patent eligibility.
These two ABA policies are similar to the current recommendation in that all three address the same broad
issues of patentability; the previous policies are not directly relevant to the issues that are the subject of this
recommendation, and those policies would not be affected by its adoption.
-2-
304B
The Section of Intellectual Property Law does not recommend that the Association take a
position on the ultimate question of patent-eligibility of the invention defined by the patent
claims at issue. The Federal Circuit concluded that the claims of the respondent’s patent are not
directed to a natural phenomenon or law of nature (as argued by petitioner), but instead include
steps that require application of a natural phenomenon. Prometheus II, 628 F.3d at 1355 (“As
before, we again hold that Prometheus's asserted method claims recite a patent-eligible
application of naturally occurring correlations between metabolite levels and efficacy or toxicity,
and thus do not wholly preempt all uses of the recited correlations.”) On the assumption that the
Federal Circuit’s construction of the respondent’s claims is correct, the Section of Intellectual
Property recommends support of the Federal Circuit’s position that respondent’s claims include
steps directed to an application of a law of nature and therefore define patent-eligible subject
matter.
The Section of Intellectual Property Law does not recommend that the Association take a
position on whether the Federal Circuit’s interpretation of the claims is correct, but does
recommend support of the position that claims that include steps directed to an application of a
law of nature do define patent-eligible subject matter. Thus, the Section recommends that the
Association’s amicus brief be filed in support of neither party, recognizing, however, that if the
Supreme Court affirms the Federal Circuit’s interpretation of respondent’s claims, then the
Section’s position would support the respondent.
The claims deal with a process for optimizing the therapeutic efficacy of a method for
treating an immune-mediated gastrointestinal disorder, such as Crohn’s disease. A representative
claim of the Prometheus patent reads as follows:
A method of optimizing therapeutic efficacy for treatment of an immunemediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said
immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immunemediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8 x 108 red blood
cells indicates a need to increase the amount of said drug subsequently
administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8 x 108 red
blood cells indicates a need to decrease the amount of said drug subsequently
administered to said subject.
In general the method defined by this claim involves the administration of a pro-drug,
such as a 6-mercaptopurine, to a patient suffering from immune-mediated gastrointestinal
disorders. According to the patent, the pro-drug is metabolized in the human body to certain
metabolites, such as 6-thioguanine. The patent indicates that patients treated with these types of
drugs sometimes experience toxic side effects if the dosage is too high or lack of efficacy if the
-3-
304B
dosage is too low. To solve this problem, the patent describes a process that involves
administering the pro-drug, determining the level of the metabolite in the bloodstream and
comparing the metabolite blood levels to certain established minimum and maximum values,
such that the dosage can be optimized to insure therapeutic efficacy with minimal side effects.
The patented method allows physicians to determine an appropriate dosage quickly without
either treating with an ineffective amount of drug or exposing the patient to toxic side effects.
The petitioner argues that the conversion of the drug to the metabolite is the result of
natural enzymatic processes in the body, and that the relationships between metabolite blood
levels and efficacy or side effects are natural correlations, i.e., natural phenomena or abstract
ideas. According to the petitioner, the physician is not required by the claim to act on the
correlations (i.e., to adjust the dosage) and, therefore, infringes just by thinking of the
correlation. Thus, the petitioner contends that the claimed method preempts all use of the natural
correlations and therefore is not eligible for patent protection.
The petition for certiorari granted by the Supreme Court framed the question as follows:
This case concerns whether a patentee can monopolize basic, natural biological
relationships. The Court has twice granted certiorari on the question presented,
without yet resolving the issue. Last year, it granted certiorari, vacated, and
remanded in this case to allow the Federal Circuit to reconsider this question in
light of Bilski v. Kappos, 130 S.Ct. 3218 (2010). And seven years ago it granted
certiorari but dismissed the writ as improvidently granted in Laboratory Corp. of
America Holdings v. Metabolite Laboratories, Inc., 548 U.S. 124, 135 (2006),
because petitioner there had not adequately preserved the question. The question
presented here is: Whether 35 U.S.C. § 101 is satisfied by a patent claim that
covers observed correlations between blood test results and patient health, so that
the claim effectively preempts all uses of the naturally occurring correlations,
simply because well-known methods used to administer prescription drugs and
test blood may involve “transformations” of body chemistry.
The petitioner’s primary argument is that, if valid, the claim would preempt all uses of
the natural correlation between metabolite blood levels and drug efficacy and side effects, and
therefore is contrary to Supreme Court precedent.
The Federal Circuit interpreted the “wherein” clauses of the claims as being directed to
the application of the natural correlation. If the Supreme Court affirms that interpretation, the
Section of Intellectual Property Law believes that the claims define patent-eligible subject
matter. Patent protection for such methods is important to incentivize investment into the
research and development that are necessary to bring novel human diagnostic and personal
medicine procedures to the benefit of the public. Contrary to petitioner’s argument, as construed
by the Federal Circuit, the methods defined by the claims at issue, when considered as a whole,
are not laws of nature, physical phenomena, or abstract ideas, which the Supreme Court has held
are the only limitations on the scope of patent-eligible subject matter under Section 101. Bilski,
130 S. Ct. at 3225. The fact that a patent claim incorporates a new application of a natural
-4-
304B
correlation does not remove the claimed methods from subject matter for which patent protection
should be available.
The Court of Appeals Decisions
In its September 2009 decision, the Federal Circuit reversed the district court’s summary
judgment that the claimed methods were unpatentable under Section 101. Prometheus Labs., Inc.
v. Mayo Collaborative Services, 581 F.3d 1336 (Fed. Cir. 2009) (“Prometheus I”). The Federal
Circuit applied the “machine or transformation” test set forth in its decision in In re Bilski, 545
F.3d 943 (Fed. Cir. 2008) (en banc), aff’d, Bilski v. Kappos, 130 S. Ct. 3218 (2010). Under that
test "[a] claimed process is surely patent-eligible under § 101 if: (1) it is tied to a particular
machine or apparatus, or (2) it transforms a particular article into a different state or thing." Id.,
at 954. The court held that the claims required both administering the drug (in effect, a method
of treatment) and determining the level of metabolite and were not merely directed to a
correlation.
According to the Federal Circuit’s decision in Prometheus I, the asserted claims met the
Bilski test for patentable subject matter because they “‘transform an article into a different state
or thing,’ and this transformation is ‘central to the purpose of the claimed process.’” Id. at 1345.
The Federal Circuit held that the transformation “necessarily” occurred in the human body when
the drug is administered, because it is “the entire purpose of administering these drugs.” Id. at
1345.
The Federal Circuit also reasoned that the “determining” step is transformative and
central to the claimed method, because “those levels cannot be determined by mere inspection.”
Id. at 1347. Put another way, “[m]easuring the levels of 6-TG and 6-MMP is what enables
possible adjustments to thiopurine drug dosage to be detected for optimizing efficacy or reducing
toxicity during a course of treatment.” Id.
The Federal Circuit acknowledged that the asserted claims contained mental steps that
were “not patent-eligible per se.” Id. at 1348. However, the Court reasoned that a “mental step
does not, by itself, negate the transformative nature of prior steps.” Id. The data obtained from
administering and determining steps for use in the mental step were obtained by steps “well
within the realm of patentable subject matter.” Id. “The addition of the mental step to the claimed
methods thus does not remove the prior two steps from that realm.” Id. The Court held that “even
though a fundamental principle itself is not patent-eligible, processes incorporating a
fundamental principle may be patent-eligible.” Id. at 1349 (quoting In re Bilski 545 F.3d at 958).
Following the decision in Prometheus I, Mayo filed a petition for certiorari with the Supreme
Court.
On June 28, 2010, while the petition for certiorari in Prometheus I was pending, the
Supreme Court issued its decision in In re Bilski. In that decision, the Supreme Court held that
the Federal Circuit’s “machine or transformation” test, while providing a valuable clue in
determining whether a patent claim is directed to patent-eligible subject matter, is not the sole
test for Section 101 compliance. The Supreme Court reviewed the history of Section 101 and its
own precedent and held that,
-5-
304B
Section 101 thus specifies four independent categories of inventions or
discoveries that are eligible for protection: processes, machines, manufactures,
and compositions of matter. "In choosing such expansive terms . . . modified by
the comprehensive 'any,' Congress plainly contemplated that the patent laws
would be given wide scope." Diamond v. Chakrabarty, 447 U.S. 303, 308,100 S.
Ct. 2204, 65 L. Ed. 2d 144 (1980). Congress took this permissive approach to
patent eligibility to ensure that "'ingenuity should receive a liberal
encouragement.' Id., at 308-309, 100 S. Ct. 2204, 65 L. Ed. 2d 144 (quoting 5
Writings of Thomas Jefferson 75-76 (H. Washington ed. 1871)).
The Court's precedents provide three specific exceptions to § 101's broad
patent-eligibility principles: "laws of nature, physical phenomena, and abstract
ideas." Chakrabarty, supra, at 309, 100 S. Ct. 2204, 65 L. Ed. 2d 144.
130 S. Ct. at 3225.
Following its decision in Bilski, the Supreme Court granted certiorari in Prometheus I,
and summarily vacated and remanded the decision, with instructions that the Federal Circuit
reconsider its decision in light of the Supreme Court’s decision in Bilski.
On December 17, 2010, the Federal Circuit issued its decision in Prometheus II, again
finding the claims of the Prometheus patents to be drawn to patentable subject matter.
Prometheus argued that, in view of the Supreme Court’s Bilski decision, “patents that do
not satisfy the machine-or-transformation test are not necessarily unpatentable” and “that claims
that satisfy the machine-or-transformation test,” as the Federal Circuit found in Prometheus I,
“necessarily satisfy Section 101.” Id. at 1354. Mayo argued that the “claims are invalid because
they preempt all practical use of naturally occurring correlations between metabolite levels and
drug efficacy and any machine or transformation present in the claims is merely insignificant
post-solution activity.” Id.
The Federal Circuit held for Prometheus, noting that the Supreme Court “did not disavow
the machine-or-transformation test” and again concluded that “Prometheus’ asserted method
claims recite patent-eligible application of naturally occurring correlations between metabolite
levels and efficacy or toxicity, and thus do not wholly preempt all uses of the recited
correlations.” Id. at 1355. Specifically, the Federal Circuit found that the claims do not preempt
all uses of natural correlations, but instead “utilize them in a specific series of steps” that
“involve a particular application of the natural correlations: the treatment of a specific disease by
administering specific drugs and measuring specific metabolites.” Id.
Inventions Should Not be Denied Patent Eligibility Under Section 101 Merely Because they
Include an Application of a Law of Nature
As the Supreme Court held in Bilski, a broad reading of Section 101 is mandated by both
the expansive text of the statute and Supreme Court precedent. The Supreme Court’s precedents
provide three specific exceptions to the broad patent-eligibility principles of Section 101: laws of
nature, physical phenomena, and abstract ideas. The Supreme Court has held that “these
-6-
304B
exceptions have defined the reach of the statute as a matter of statutory stare decisis going back
150 years.” Bilski, 130 S. Ct. at 3225 (citation omitted).
A broad reading of Section 101 is also supported by the fact that “[t]he § 101 patenteligibility inquiry is only a threshold test.” Bilski, 130 S. Ct. at 3225; see also 35 U.S.C. § 101 (a
claim drawn to patent eligible subject matter is entitled to a patent only “subject to the conditions
and requirements of this title”). Thus, Section 101 is a coarse filter, with more rigorous
patentability analysis required by 35 U.S.C. §§ 102 (novelty), 103 (non-obviousness), and 112
(adequate written description and enablement support, best mode disclosure and definiteness of
claim language).
The proposed resolution is also consistent with existing ABA policy on the subject of
patent-eligible subject matter under Section 101. Specifically, existing ABA policy “supports the
existing principle that laws of nature, physical phenomena, and abstract ideas are not patentable,
even if they are new and non-obvious” and “supports application by the Supreme Court of the
United States of the common-law tradition of incremental development of jurisprudential
doctrine for determining patent-eligible subject matter under 35 U.S.C. § 101.” That policy
“opposes formulations by courts of tests to determine patent-eligible subject matter under 35
U.S.C. § 101 in a manner that articulates fixed and specific requirements that adversely affect
yet-to-be conceived but deserving inventions in emerging or unknown technologies.” The policy
further “opposes a requirement that a process be explicitly tied to a particular machine or
apparatus, or transform a particular article into a different state or thing (i.e., the "machine-ortransformation" test), in order to be eligible for patenting under 35 U.S.C. § 101, but favors, in
principle, an evenly applied and more generalized subject-matter bar on claims that would
preempt the use of an abstract idea, thereby better effectuating the broad statutory grant of patent
eligibility under 35 U.S.C. § 101 and Supreme Court precedent declining to limit that grant,
while ensuring the unfettered use of abstract ideas. Passed ABA2009A302. ABA policy also
“[s]upports the role of U.S. patent law in encouraging and rewarding scientific and technical
research and innovation,” and “opposes any restriction or limitation on the use of funds [obtained
from Congress] if that restriction or limitation has or may have the effect of imposing any subject
matter limitation on the patents which the Patent and Trademark Office may issue, in addition to
the statutory limitations on the scope of patentable subject matter set forth in 35 U.S.C. § 101.”
ABA Policy 04A104.
The petitioner challenges the claims at issue on grounds that they contain and broadly
preempt the use of steps that apply a natural phenomenon, namely, the correlation between blood
levels of the drug metabolite to the efficacy and side effects of the drug. As discussed above, the
Federal Circuit rejected this argument and held that the claims contain both transformative steps
and refer to an application of the natural correlation. The fact that a claim includes steps applying
a law of nature or abstract idea should not remove the claimed process as a whole from patent
eligibility. To some degree, all human-designed processes utilize specific applications of natural
laws or phenomena, because all such processes are governed by natural laws. In other words, all
processes that operate in a physical world employ natural laws. Thus, as long as the patent does
not claim or preempt purely natural phenomena, methods or processes for treating diseases
should be patent eligible under Section 101.
-7-
304B
The claims at issue, when considered as a whole, do not cover prohibited “laws of nature,
physical phenomena, and abstract ideas.” The first step of the claim requires administration of a
certain drug to a patient. This “administering” step does not occur in nature. It is a humandesigned and implemented step for the treatment of a patient having an immune-mediated
gastrointestinal disorder. The second step requires a determination of the level of the drug’s
metabolite in the patients’ bloodstream. Again, this “determining” step is not something that
occurs in nature. It is carried out by scientifically trained personnel using sophisticated analytical
chemistry techniques. Similarly, the combination of the “administering” and “determining” steps
does not occur naturally. That human-designed combination is an essential aspect of the patented
process. The “wherein” clauses in the claims have been construed by the Federal Circuit as
involving a new application of a correlation between the metabolite levels and the efficacy and
safety of the drug, and provide the person administering the treatment with valuable information
about the optimal dosage of drug to administer. Supreme Court precedent does not compel a
conclusion that the inclusion of the correlation steps removes the claimed process as a whole
from patent eligibility. Indeed, Supreme Court precedent precludes dissecting of the claim and
ignoring the physical process steps:
Finally, in [Diamond v. Diehr, 450 U.S. 175, 182, 101 S. Ct. 1048, 67 L. Ed. 2d
155 (1981)], the Court established a limitation on the principles articulated in
[Gottschalk v. Benson, 409 U.S. 63 (1972)] and [Parker v. Flook, 437 U.S. 584
(1978)]. The application in Diehr claimed a previously unknown method for
"molding raw, uncured synthetic rubber into cured precision products," using a
mathematical formula to complete some of its several steps by way of a computer.
450 U.S., at 177, 101 S. Ct. 1048, 67 L. Ed. 2d 155. Diehr explained that while an
abstract idea, law of nature, or mathematical formula could not be patented, "an
application of a law of nature or mathematical formula to a known structure or
process may well be deserving of patent protection." Id., at 187, 101 S. Ct. 1048,
67 L. Ed. 2d 155. Diehr emphasized the need to consider the invention as a whole,
rather than "dissect[ing] the claims into old and new elements and then . . .
ignor[ing] the presence of the old elements in the analysis." Id., at 188, 101 S. Ct.
1048, 67 L. Ed. 2d 155. Finally, the Court concluded that because the claim was
not "an attempt to patent a mathematical formula, but rather [was] an industrial
process for the molding of rubber products," it fell within § 101's patentable
subject matter. Id., at 192-193, 101 S. Ct. 1048, 67 L. Ed. 2d 155.
Bilski, 130 S. Ct. at 3230 (emphasis added).
As in the process at issue in Diehr, as construed by the Federal Circuit, the claims of the
Prometheus patent do not attempt to patent the natural correlation between blood metabolite
levels and safety/efficacy. Instead, as so construed, they are directed to a treatment method that
includes human designed and implemented steps and apply the natural correlation in that
treatment method.
-8-
304B
Conclusion
Methods of the type described in the Prometheus patents are important in the field of
personal medicine, in which diagnosis or monitoring of the patient is used for optimizing the
treatment. As the facts of the Prometheus case illustrate, commercial products are developed to
assist physicians and patients in implementing the claimed method. What is in dispute is whether
others, who have not invested in the research and development required to invent such methods
and bring them to fruition, can nevertheless develop and profit from commercial products
designed to implement the claimed method. A basic purpose of the patent system is to provide an
economic incentive to inventors and investors to discover and develop new methods and
products for the overall benefit of society. Denying patent eligibility to methods that involve the
application of natural phenomena or laws of nature would remove this incentive.
Respectfully submitted,
Marylee Jenkins, Chair
Section of Intellectual Property Law
August 2011
-9-
304B
GENERAL INFORMATION FORM
Submitting Entity:
Section of Intellectual Property Law
Submitted by:
Marylee Jenkins, Section Chair
1.
Summary of Resolution
The resolution calls for the Association to adopt policy relating to determining the scope
of subject matter that is eligible for patenting under the Patent Act and judicial
interpretations of that Act. The resolution begins with recognition that laws of nature,
physical phenomena and abstract ideas are not eligible for patenting, even if they had
been previously unknown or unrecognized. The resolution supports the principle that a
patent claim limited to a new application of a law of nature or physical phenomena may
meet the requirements of § 101. Finally, the resolution supports eligibility for a patent
claim where such new application is a process, machine, manufacture, or composition of
matter, including a process for the treatment of a particular disease or other medical
condition.
2.
Approval by Submitting Entity
The Section Council approved the resolution on July 18, 2011.
3.
Has This or a Similar Recommendation Been Submitted to the House of Delegates or
Board of Governors Previously?
The House of Delegates has previously adopted recommendations relating to subject
matter eligible for patenting.
At the 2009 Annual Meeting, the House of Delegates approved a resolution supporting
application by the Supreme Court of incremental development of doctrine for
determining patent eligibility, opposing fixed and specific requirements there for, and
specifically opposing a requirement that a process be tied to a specific machine or
transform an article into a different state or thing to be patent eligible.
At the 2004 Annual Meeting, the House of Delegates approved a recommendation
opposing limitations on the scope of patentable subject matter beyond those set forth in
35 U.S.C. § 101, and specifically opposing statutory restriction on the use of USPTO
appropriated funds if that restriction has the effect of imposing additional subject matter
limitations on patent eligibility.
4.
What Existing Association Policies are Relevant to This Recommendation and Would
They be Affected by its Adoption?
The policies referenced in paragraph 3 are similar to this recommendation in that they
address the same broad issue of patent eligibility, but they are not directly relevant to this
recommendation, and would not be affected by its adoption.
- 10 -
304B
5.
What Urgency Exists Which Requires Action at This Meeting of the House?
On June 20, the U.S. Supreme Court granted a writ of certiorari to review a decision of
the U.S. Court of Appeals for the Federal Circuit in a case that addresses the issues that
are the subject of this resolution. The resolution would support the filing of an ABA brief
amicus curiae. The report cannot be considered by the House of Delegates at a time later
than the 2011 Annual Meeting since the deadline for filing the amicus brief in the
Supreme Court will be reached before the next meeting of the House of Delegates.
6.
Status of Matter
The status of the issue is discussed in the preceding paragraph.
7.
Cost to the Association (both direct and indirect costs).
Adoption of the recommendations would not result in additional direct or indirect costs to
the Association.
8.
Disclosure of Interest
There are no known conflicts of interest with regard to this recommendation.
9.
Referrals
This recommendation is being distributed to each of the Sections and Divisions and
Standing Committees of the Association.
10.
Contact Person (prior to meeting)
Donald R. Dunner
Section Delegate to the House of Delegates
Finnegan, Henderson,
Farabow, Garrett & Dunner LLP
901 New York Avenue, N.W.
Washington, DC 20001-4413
Ph: 202 408-4062
Fax: 202 408-4400
[email protected]
cell: 202 251-1893
11.
Contact Persons (who will present the report to the House)
Donald R. Dunner (See item 10 above)
- 11 -
304B
EXECUTIVE SUMMARY
1.
Summary of the Resolution
The resolution calls for the Association to adopt policy relating to determining the
scope of subject matter that is eligible for patenting under the Patent Act and
judicial interpretations of that Act. The resolution begins with recognition that
laws of nature, physical phenomena and abstract ideas are not eligible for
patenting, even if they had been previously unknown or unrecognized. The
resolution supports the principle that a patent claim limited to a new application of
a law of nature or physical phenomena may meet the requirements of § 101.
Finally, the resolution supports eligibility for a patent claim where such new
application is a process, machine, manufacture, or composition of matter,
including a process for the treatment of a particular disease or other medical
condition.
2.
Summary of the Issue that the Resolution Addresses
On June 20, 2011, the Supreme Court granted a petition for certiorari to review a
decision of the U.S. Court of Appeals for the Federal Circuit that presents the
issue that is addressed in the policy. Mayo Collaborative Services v. Prometheus
Laboratories, Inc., Case No. 10-1150; decision below Prometheus Labs., Inc. v.
Mayo Collaborative Services, 628 F.3d 1347 (Fed. Cir. 2010). The issue is the
eligibility for patenting of a process for optimizing the therapeutic efficacy of a
method for treating a disease. The Federal Circuit held the process to be patenteligible subject matter under § 101. The petitioner urges reversal of the decision,
on grounds that the claims seek to patent and monopolize natural biological
relationships between drugs administered to a person and the person’s metabolic
reaction thereto. Petitioner asserts that the claims are directed to laws of nature,
which the Supreme Court has been held to ineligible for patenting.
3.
Please Explain How the Proposed Policy Position will Address the Issue
The policy would support the filing of an ABA brief amicus curiae addressing the
issue of subject matter patent eligibility generally, and eligibility in circumstances
presented in this case. The policy would support a brief taking the position that a
claim directed to a new application of a law or nature or physical phenomenon is
patent eligible where that new application is a process, machine, manufacture, or
composition of matter. This would include circumstances in which the claim is to
a process for the treatment of a particular disease or other medical condition.
4.
Summary of Minority Views
None known at this time.
- 12 -