No. 08-964
IN THE
Supreme Court of the United States
_________
BERNARD L. BILSKI AND RAND A. WARSAW,
Petitioners,
v.
JOHN J. DOLL, ACTING UNDER SECRETARY OF
COMMERCE FOR INTELLECTUAL PROPERTY AND
ACTING DIRECTOR, PATENT AND TRADEMARK OFFICE,
Respondent.
________
On Writ of Certiorari to the
United States Court of Appeals
for the Federal Circuit
________
BRIEF OF PHARMACEUTICAL RESEARCH
AND MANUFACTURERS OF AMERICA AS AMICUS
CURIAE IN SUPPORT OF NEITHER PARTY
________
OF COUNSEL
HARRY J. ROPER
Counsel of Record
DAVID E. KORN
JENNER & BLOCK LLP
PHARMACEUTICAL
330 N. Wabash Avenue
RESEARCH AND
Chicago, IL 60611
MANUFACTURERS OF
(312) 222-9350
AMERICA
950 F St., N.W.
PAUL M. SMITH
Washington, D.C. 20004
MARC A. GOLDMAN
(202) 835-3400
DAVID Z. MOSKOWITZ*
JENNER & BLOCK LLP
1099 New York Avenue, N.W.
Suite 900
Washington, D.C. 20001
(202) 639-6000
*Admitted in NY only; supervised by
principals of the firm
Attorneys for Amicus Curiae
i
TABLE OF CONTENTS
TABLE OF AUTHORITIES....................................... ii
INTEREST OF AMICUS CURIAE.............................1
SUMMARY OF THE ARGUMENT............................3
ARGUMENT ...............................................................5
I. This Court Should Not Adopt a New Test for
the Boundaries of § 101. ........................................5
II. Patents for Medical Processes Have Long Been
Protected ................................................................8
III.Congress Balanced Competing Policy
Concerns and Concluded that Patents for
Medical Processes Should Be Protected..............12
IV.
The Purpose of Patent Law Requires
Protection of Medical-Process Patents................19
CONCLUSION ..........................................................31
ii
TABLE OF AUTHORITIES
CASES
Ex parte Brinkerhoff, 24 Dec. Comm’r 349
(1883), republished in New Decisions, 27
J. Pat. & Trademark Off. Soc’y 797
(1945)....................................................... 9, 10, 11
Burroughs Wellcome Co. v. Barr
Laboratories, Inc., 40 F.3d 1223 (Fed.
Cir. 1994)................................................11, 30-31
Diamond v. Chakrabarty, 447 U.S. 303
(1980)............................................................. 5, 19
Diamond v. Diehr, 450 U.S. 175 (1981).............. 5, 6
Dick v. Lederle Antitoxin Laboratories, 43
F.2d 628 (S.D.N.Y. 1930) .................................. 10
Edelman v. Lynchburg College, 535 U.S.
106 (2002).......................................................... 18
Ex parte Kettering, 35 U.S.P.Q. (BNA) 342
(Pat. Off. Bd. App. 1936)................................... 10
Laboratory Corp. of America Holdings v.
Metabolite Laboratories, Inc., 548 U.S.
124 (2006).................................................. 5, 7, 24
Morton v. New York Eye Infirmary, 17 F.
Cas. 879 (C.C.S.D.N.Y. 1862) (No. 9,865) .......... 9
Pallin v. Singer, 36 U.S.P.Q.2d (BNA) 1050
(D. Vt. 1995) ...................................................... 14
Prometheus Laboratories, Inc. v. Mayo
Collaborative Services, No. 2008-1403
(Fed. Cir.) ............................................................ 6
iii
Rohm & Haas Co. v. Roberts Chemicals,
Inc., 245 F.2d 693 (4th Cir. 1957) .................... 19
Scott Paper Co. v. Marcalus Manufacturing
Co., 326 U.S. 249 (1945) ................................... 24
Ex parte Scherer, 103 U.S.P.Q. (BNA) 107
(Pat. Off. Bd. App. 1954)............................. 10, 11
Ex parte Wappler, 26 U.S.P.Q. (BNA) 191
(Pat. Off. Bd. App. 1935)................................... 10
CONSTITUTIONAL PROVISIONS AND STATUTES
U.S. Const. art. I, § 8, cl. 8.................................... 19
21 U.S.C. § 355(b)(1) ............................................. 12
21 U.S.C. § 355(c)(2).............................................. 12
35 U.S.C. § 100(b).................................................. 19
35 U.S.C. § 101.............................................. passim
35 U.S.C. § 156(a).............................................. 4, 12
35 U.S.C. § 156(f) .................................................. 12
35 U.S.C. § 287...................................................... 27
35 U.S.C. § 287(c)(1).............................................. 15
35 U.S.C. § 287(c)(2)(A)......................................... 16
35 U.S.C. § 287(c)(2)(F)......................................... 16
35 U.S.C. § 287(c)(3).............................................. 15
Patent Act of 1952, Act of July 19, 1952,
Chapter 950, 66 Stat. 792................................. 19
American Inventor Protection Act of 1999,
Pub. L. No. 106-113, 113 Stat. 1501,
1501A-552 ......................................................... 24
iv
Drug Price Competition and Patent Term
Restoration Act of 1984 (“Hatch-Waxman
Act”), Pub. L. No. 98-417, 98 Stat. 1585
(1984)................................................................. 12
LEGISLATIVE MATERIALS
142 Cong. Rec. 26640 (1996)................................. 18
142 Cong. Rec. 26825-26 (1996)................ 14, 17, 27
H.R. 1127, 104th Cong. (1995).............................. 13
H.R. 12451, 57th Cong. (1902).............................. 13
H.R. 13679, 58th Cong. (1904).............................. 13
H.R. 3814, 104th Cong. § 619 (1996).................... 17
H.R. Rep. No. 104-863 (1996) (Conf.
Rep.) ...................................................... 16, 17, 18
S. 1334, 104th Cong. (1995).................................. 14
Medical Procedures Innovation and
Affordability Act and Inventor Protection
Act of 1995: Hearing Before the
Subcomm. on Courts and Intellectual
Property of the H. Comm. on the
Judiciary, 104th Cong. (1995) .................... 14, 20
OTHER AUTHORITIES
David E. Adelman, A Fallacy of the
Commons in Biotech Patent Policy, 20
Berkeley Tech. L.J. 985 (2005)......................... 24
Natasha N. Aljalian, The Role of Patent
Scope in Biopharmaceutical Patents, 11
B.U.J. Sci. & Tech. L. 1 (2005) ......................... 27
v
Catherine Arnst, Same Cancer Drugs, New
Applications, Bus. Week Online, June 3,
2007, at http://www.businessweek.com/
technology/content/jun2007/tc20070603_5
10760.htm ....................................................19-20
Mara G. Aspinall & Richard G.
Hammermesh, Realizing the Promise of
Personalized Medicine, Harv. Bus. Rev.,
Oct. 2007, at 108 ............................................... 28
Brief of Appellees, Prometheus
Laboratories, Inc. v. Mayo Collaborative
Services, No. 2008-1403 (Fed. Cir. Mar.
30, 2009)...........................................................6-7
Richard P. Burgoon, Jr., Silk Purses, Sows
Ears and Other Nuances Regarding 35
U.S.C. § 287(c), 4 U. Balt. Intell. L.J. 69
(1996)................................................................. 14
Dan L. Burk & Mark A. Lemley, Policy
Levers in Patent Law, 89 Va. L. Rev.
1575 (2003)........................................................ 25
John Calfee, The Golden Age of Medical
Innovation, The American (Mar./Apr.
2007),
available at
http://www.american.com/archive/2007/m
arch-april-magazine-contents/the-golden-
age-of-medical-innovation/ ......... 1, 19, 20, 25, 31
Deloitte Consulting LLP, Avoiding No
Man’s Land: Potential Unintended
Consequences of Follow-On Biologics
(Mar. 2009)........................................................ 22
vi
Joseph A. DiMasi & Henry G. Grabowski,
The Cost of Biopharmaceutical R&D: Is
Biotech Different?, 28 Managerial &
Decision Econ. 469 (2007)................................. 22
FTC, To Promote Innovation: The Proper
Balance of Competition and Patent Law
and Policy (Oct. 2003), available at
http://www.ftc.gov/os/2003/10/innovationr
pt.pdf ..................................................... 22, 23, 24
Philip J. Hilts, Experimental Drug AZT
Was Designed for Tumors; Skill, Luck
Led to Promising Tests on AIDS, Wash.
Post, Sept. 19, 1986, at A11.........................30-31
Peter Huber, Who Pays for a Cancer Drug?,
Forbes, Jan. 12, 2009, at 72 ............................. 28
James W. Hughes et al., “Napsterizing”
Pharmaceuticals: Access, Innovation, and
Consumer Welfare (Nat’l Bureau of Econ.
Res., Working Paper No. 9229, 2002) .............. 25
Teresa Kelton, Pharmacogenomics: The Re-
Discovery of the Concept of Tailored
Drug Therapy and Personalized
Medicine, 19 Health Law. 1 (2007) .............21-22
Frank R. Lichtenberg, The Impact of New
Drug Launches on Longevity: Evidence
from Longitudinal, Disease-Level Data
from 52 Countries, 1982-2001, 5 Int’l J. of
Health Care Fin. & Econ. 47 (2005)................... 1
vii
Todd Martin, Patentability of Methods of
Medical Treatment: A Comparative
Study, 82 J. Pat. & Trademark Off. Soc’y
381 (2000)...............................................14, 27-28
William D. Noonan, Patenting Medical and
Surgical Procedures, 77 J. Pat. &
Trademark Off. Soc’y 651
(1995)........................................... 9, 11, 13, 25, 26
PhRMA, PHARMACEUTICAL
INDUSTRY
PROFILE 2009 (2009) ........................................... 1
Arti K. Rai, Fostering Cumulative
Innovation in the Biopharmaceutical
Industry: The Role of Patents and
Antitrust, 16 Berkeley Tech. L.J. 813
(2001)................................................................. 26
Andres Rueda, Cataract Surgery, Male
Impotence, Rubber Dentures and a
Murder Case -- What’s so Special About
Medical Process Patents?, 9 U. Balt.
Intell. Prop. L.J. 109 (2001).............20, 28-29, 31
Maya Said et al., Continued Development of
Approved Biological Drugs: A
Quantitative Study of Additional
Indications Approved Postlaunch in the
United States (Boston Consulting Group,
White Paper, Dec. 2007), available at
http://www.bcg.com/impact_expertise/pub
lications/files/Biologics_Dec07_final.pdf..... 2, 28,
29, 30
viii
Michael J. Shuster & Pauline Farmer-
Koppenol,
Protecting Patents for
Personalized Medicine, BioPharm Int’l
(Sept. 1, 2008), available at
http://biopharminternational.findpharma
.com/biopharm/article/articleDetail.jsp?id
=545358............................................................. 21
U.S. Dep’t of Commerce, Int’l Trade Admin.,
Pharmaceutical Price Controls in OECD
Countries: Implications for U.S.
Consumers, Pricing, Research and
Development, and Innovation (Dec.
2004),
available at
http://www.ita.doc.gov/td/chemicals/drug
pricingstudy.pdf .......................................2, 22-23
John P. Walsh et al., Effects of Research
Tool Patents and Licensing on
Biomedical Innovation, in Patents in the
Knowledge-Based Economy 285 (Wesley
M. Cohen & Stephen A. Merrill eds.,
2003)............................................................ 24, 27
INTEREST OF AMICUS CURIAE1
The Pharmaceutical Research and Manufacturers
of America (“PhRMA”) is a voluntary, nonprofit
association that represents the country’s leading
research-based pharmaceutical and biotechnology
companies. In the past decade, PhRMA’s members
have invested more than $350 billion to discover and
develop new medicines and new uses for existing
medicines, leading to huge benefits to patients. See
PhRMA, PHARMACEUTICAL INDUSTRY PROFILE 2009
50 (2009).
New medicines accounted for 40 percent of the
increase in life expectancy between 1986 and 2000.
See Frank R. Lichtenberg, The Impact of New Drug
Launches on Longevity: Evidence from Longitudinal,
Disease-Level Data from 52 Countries, 1982-2001, 5
Int’l J. of Health Care Fin. & Econ. 47, 71 (2005).
The benefits from new uses for existing medicines
are also vast. Today, “the most important advances
in treatment often come from products which have
been on the market for a while but whose properties
were not completely understood until intensive
research after the drug was introduced.” John
Calfee, The Golden Age of Medical Innovation, The
American (Mar./Apr. 2007), available at
http://www.american.com/archive/2007/march-april-
magazine-contents/the-golden-age-of-medical-
1 The parties have consented to the filing of this brief. No
counsel for a party authored this brief in whole or in part, and
no counsel or party made a monetary contribution intended to
fund the preparation or submission of this brief. No person
other than amicus curiae or its counsel made a monetary
contribution to its preparation or submission.
2
innovation/. These include, for example, the use of
AZT to treat HIV and multiple uses of Herceptin and
Avastin to treat different types of cancer.
The issue in this case will potentially have
significant impact on PhRMA’s members.2 A ruling
limiting the scope of patentability under § 101, 35
U.S.C. § 101, potentially could limit the patentability
of medical processes, dramatically diminishing
incentives for innovation. A 2004 Department of
Commerce study estimated that the average cost of
bringing a new drug to market is approximately $1.3
billion, including the costs for unsuccessful drugs.
See U.S. Dep’t of Commerce, Int’l Trade Admin.,
Pharmaceutical Price Controls in OECD Countries:
Implications for U.S. Consumers, Pricing, Research
and Development, and Innovation 30-31 (Dec. 2004),
available at http://www.ita.doc.gov/td/chemicals/
drugpricingstudy.pdf. The costs of developing new
uses for existing drugs are also substantial. As the
Boston Consulting Group explains, “the size and the
complexity of the clinical trials for each new
indication are similar to the size and the complexity
of those conducted prelaunch and . . . the failure
rates remain high.” Maya Said et al., Continued
Development of Approved Biological Drugs: A
Quantitative Study of Additional Indications
Approved Postlaunch in the United States 6 (Boston
Consulting Group, White Paper, Dec. 2007),
available at http://www.bcg.com/impact_expertise/
publications/files/Biologics_Dec07_final.pdf. In the
absence of the incentives provided by patent
2 A list of PhRMA members can be found at
http://www.phrma.org/member_company_list.
3
protection for novel processes, much of the promising
research for new methods of diagnosis and treatment
will not occur. The ability to patent products alone is
insufficient to provide the necessary incentives,
because many of the new methods make use of
products that are already known and that therefore
are not patentable (or have already been patented).
SUMMARY OF THE ARGUMENT
This Court should ensure that however the scope
of patentability is assessed under § 101, inventors
retain the ability to patent medical processes,
especially methods of diagnosis and treatment that
make use of pharmaceuticals. PhRMA expresses no
view on the Bilski patent itself. As for the machine
or transformation test the Federal Circuit adopted,
PhRMA believes there is no need for a new test
because the existing prohibition on patenting of laws
of nature and abstract ideas is sufficient. If this
Court nonetheless adopts the Federal Circuit’s test
or some other test, it should make clear that medical-
process patents that make use of pharmaceuticals
fall within it.
To do otherwise would be a radical departure
from a long history of patent protection. Patents for
medical processes have been issued since the 1800s,
and, while there was some question about their
patentability for a period of time, a number of
decisions in the 1930s, culminating in a Board of
Patent Appeals decision in 1954, made clear that
medical processes are patentable. Since then
thousands of patents have issued for medical
processes.
4
Eliminating patent protection for medical
processes would not only deviate from a long history
of administrative and judicial decisions on the
patentability of such processes, it would also be
inconsistent with Congress’s clear intent. Under the
Hatch-Waxman Act, Congress has expressed its clear
intent that these processes be patentable. It has, for
example, provided for patent term extensions for
patents covering a “method of using” a drug product,
35 U.S.C. § 156(a). Furthermore, both at the
beginning and the end of the twentieth century,
Congress decided not to enact legislation that would
have restricted the patentability of medical
processes. On the second occasion, Congress instead
enacted a statute that balanced the interests of
physicians and of inventors by immunizing
physicians from the remedy provisions of the patent
laws when they infringe certain method patents but
not when they infringe patents for new uses of
pharmaceuticals. Congress did not change the scope
of patentability at all. Congress thus made clear
that medical processes remain patentable.
That makes sense in light of the goal of the
patent laws to promote the useful arts. Given the
high cost, length and uncertainty of pharmaceutical
development, there is a consensus that, in the
absence of patent protection, there would be a
significant reduction in development of new uses for
existing pharmaceuticals, as well as other
innovations in medical processes. Thus, it is critical
that this Court interpret § 101 in a manner that
protects patents for medical processes, particularly
new uses for existing pharmaceuticals.
5
ARGUMENT
I. This Court Should Not Adopt a New Test for the
Boundaries of § 101.
This Court has repeatedly made clear the
breadth of the patent law and the bounds of
patentability, excluding from the scope of patent
protection only “laws of nature, natural phenomena,
and abstract ideas.” Diamond v. Diehr, 450 U.S. 175,
185 (1981); see also Diamond v. Chakrabarty, 447
U.S. 303, 308-09 (1980). Under these principles,
medical-process patents will be generally protected.
Any medical process that makes use of
pharmaceuticals, for example, will come within the
scope of § 101, because the pharmaceutical is not a
law of nature, natural phenomenon or abstract idea.3
There is no need for further limits. The existing
limits can be applied flexibly, consistent with the
statutory language, to carry out the goals of the
patent law.
3 In some cases, under this approach, there may be debate
about whether a particular medical process that does not use
pharmaceuticals is patentable. Justice Breyer applied such an
approach in his dissent in Laboratory Corp. of America
Holdings v. Metabolite Laboratories, Inc., 548 U.S. 124 (2006)
(Breyer, J., dissenting). PhRMA does not here take a position
on whether Justice Breyer’s dissent was correct on the facts of
that case. But it is clear that under this approach, processes
that use pharmaceuticals should be protected. However, at
least one court has interpreted Justice Breyer’s interpretation
of this Court’s case law to suggest otherwise. See infra n.5.
The risk of a lower court misinterpretation that overly restricts
the scope of § 101 will only be magnified if a new and more
uncertain test is grafted onto existing limits to the scope of
processes that are patentable.
6
In contrast, any additional test designed to
narrow the scope of § 101 risks changing the focus in
future cases from the purpose of the patent law to
formalistic debates on the meaning of a specific
court-created test. For example, while the Federal
Circuit’s Bilski test, properly understood, will protect
critical medical processes that make use of
pharmaceuticals, there is a significant risk that
courts will not interpret it to do so. Under the
Federal Circuit’s test, process patents are protected
if they operate on a machine or transform matter.
See, e.g., In re Bilski, 545 F.3d 943, 962 (Fed. Cir.
2008).4 Because patents for the use of
pharmaceuticals involve transformation of the
pharmaceuticals themselves, as well as the patient,
PhRMA believes that such patents come within the
scope of § 101 under the Federal Circuit’s test.
Nonetheless, there is some debate about this. In
a case currently pending in the Federal Circuit,
Prometheus Laboratories, Inc. v. Mayo Collaborative
Services, No. 2008-1403, Mayo Collaborative
Services argues that even in a case involving
administration of a drug for diagnostic purposes that
results in production of metabolites within the body,
there is no requisite transformation within the
meaning of Bilski.5 Brief of Appellees at 32-36 (Mar.
4 The Federal Circuit purports to derive its test from this
Court’s case law, but, what this Court had made clear is that
processes that use a machine or transform matter are
patentable. See, e.g., Diehr, 450 U.S. at 184. This Court has
never held that processes that do not use a machine or
transform matter are excluded from patentability.
5 The patents at issue in Prometheus concern techniques to
relieve pain for those suffering from Crohn’s disease and other
7
30, 2009). Moreover, there is some question as to
whether medical processes that do not use
pharmaceuticals are “transformative” in the
requisite sense even though, as shown below,
Congress clearly intends them to be patentable.
Thus, if the Federal Circuit’s test is upheld by
this Court, there is cause for concern that later cases
will devolve into technical debates on the meaning of
“transformation,” divorced from the goals of the
patent law and from Congress’s clear intent to
ensure the protection of medical-process patents. In
debilitating diseases of the digestive system. As the district
court construed the claims, each claim involved the step of
administering the drug and determining metabolite levels,
which were not naturally occurring compounds, for diagnostic
purposes to evaluate an adjustment in dosage. Prior to the
Federal Circuit’s decision in Bilski¸ the district court held these
claims unpatentable, without applying the transformation test,
based on its interpretation of Justice Breyer’s dissenting
opinion in Metabolite, 548 U.S. at 125 (Breyer, J., dissenting).
The district court’s opinion evidences the risks of
misapplication even of the current limits of § 101, as
interpreted by Justice Breyer. In Metabolite, the
homocysteines that were measured were naturally occurring.
In contrast, in Prometheus, the metabolites measured were the
result of administration of a non-naturally occurring
pharmaceutical, which is neither an abstract idea nor a natural
law and the use of which inherently limits the scope of the
patent. Moreover, the district court ignored that the
pharmaceutical administered was transformative, which under
this Court’s case law, should have made clear the process was
protected. The district court’s opinion thus shows how even the
current limits on § 101 can be misapplied to limit unduly the
scope of patent protection. Grafting additional limits on top of
those will simply multiply those risks.
8
other words, the test adopted, whether the Federal
Circuit’s test or some variant, may become
talismanic, with arguments focused on the terms of
the test rather than on the terms used by, and
purposes of, Congress. This Court should retain the
focus on Congress’s words and purpose.
If this Court nonetheless adopts the Federal
Circuit’s 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 § 101 than the
Federal Circuit adopted in Bilski, it should ensure
that that test protects the patentability of medical-
process patents.
II. Patents for Medical Processes Have Long Been
Protected
The patent laws have long protected the
patenting of medical processes, such as the process of
using a particular drug for treatment. The Patent
Act itself always protected the patenting of processes
and made no exception for medical processes.6 Early
patents for medical processes included (1) patent
4,848, issued in 1846 for surgical anesthesia with
ether, (2) patent 58,034, issued in 1866 for an
improved method of curing rheumatism, (3) patent
6 The Patent Act of 1793 used the term “art,” which Congress
replaced with the term process when it enacted the current
version of § 101 in 1952. See Bilski, 545 F.3d at 951 n.4.
9
65,044, issued in 1867 for an improved method of
treating affection of the skin, (4) patent 506,449,
issued in 1893 for a method of treating diseases
electrically, (5) patent 2,008,526, issued in 1935 for
treating hepatomegaly with electrical current, and
(6) patent 2,322,245, issued in 1943 for a method of
transcutaneous injection.
While the Patent Act on its face always
encompassed medical processes, there was a period
of time when judicial decisions cast some doubt on
the patentability of such processes. In 1862, in
Morton v. New York Eye Infirmary, 17 F. Cas. 879
(C.C.S.D.N.Y. 1862) (No. 9,865), the New York
Circuit Court rejected a patent for the use of ether, a
known agent, as an anesthetic, because the patent
was for a new effect for a well-known process of
inhaling ether. However, some interpreted Morton
as broadly holding that medical treatments were not
patentable processes. In Ex parte Brinkerhoff, the
Commissioner of Patents adopted such reasoning as
one basis for rejecting the patent at issue, explaining
that “[t]he methods or modes of treatment of
physicians of certain diseases are not patentable.”
24 Dec. Comm’r 349 (1883), republished in New
Decisions, 27 J. Pat. & Trademark Off. Soc’y 797, 798
(1945). His rationale was that the result of any
method of treatment was uncertain. Brinkerhoff was
affirmed on a technicality, but the appeals court left
open “the question of how far patents can ‘invade the
right of protecting health.’” William D. Noonan,
Patenting Medical and Surgical Procedures, 77 J.
Pat. & Trademark Off. Soc’y 651, 654 (1995).
10
Whatever the implications of Brinkerhoff, patents
for medical processes continued to be granted. See
supra, at 9. Moreover, in the 1930s, both courts and
the Board of Patent Appeals upheld patents for
medical processes. In Dick v. Lederle Antitoxin
Laboratories, 43 F.2d 628, 630 (S.D.N.Y. 1930), the
court rejected arguments that a method of operating
by injecting toxin into a person was not patentable.
Similarly, the Board of Patent Appeals found
patentable methods for shrinking living tissue, Ex
parte Wappler, 26 U.S.P.Q. (BNA) 191 (Pat. Off. Bd.
App. 1935), and for producing fever in the human
body, Ex parte Kettering, 35 U.S.P.Q. (BNA) 342
(Pat. Off. Bd. App. 1936).
Subsequently, the Board of Patent Appeals
cleared up any lingering confusion and made explicit
that medical processes are patentable. In Ex parte
Scherer, 103 U.S.P.Q. (BNA) 107 (Pat. Off. Bd. App.
1954), the Board upheld a patent claim for a method
of using a fluid jet, instead of a hypodermic needle, to
inject fluid into the human body. The Board held
that it was irrelevant that the usefulness of the
claim depended on the reaction of the human body,
explaining that “[t]here is nothing in the patent
statute which categorically excludes such methods,
nor has any general rule of exclusion been developed
by decisions.” Id. at 110. The Board noted that
“[c]laims involving treatment of the human body
have been allowed on appeal.” Id. at 109-10 (citing
Wappler and Kettering). The Board distinguished
both Morton and Brinkerhoff, suggesting that the
Brinkerhoff case was based on double patenting and
that the additional reasoning of Brinkerhoff did not
11
justify categorical rejection of patents for medical
methods:
The only specific reason given is
uncertainty of results, which does not
appear to be a valid reason for
categorically refusing all methods, and
which reason is more properly
considered under the question of utility
which is a separate and distinct
requirement for patentability. To the
extent that Ex parte Brinkerhoff holds
or implies that all medical or surgical
methods are unpatentable subject
matter merely because they involve
treating the human body, that decision
is expressly overruled.
Id. at 110. Since Scherer, patents for medical
procedures have been routinely granted. See
Noonan, 77 J. Pat. & Trademark Off. Soc’y, at 658-
70, tbl. 1 (listing representative medical method
patents). Courts, including the Federal Circuit, have
routinely upheld such patents. See, e.g., Burroughs
Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1225-
26, 1230 (Fed. Cir. 1994) (upholding against an
inventorship challenge patents for use of AZT to
treat HIV). It would be a radical departure, indeed,
if this Court were to adopt a test that called into
question the patentability of such inventions.
12
III.
Congress Balanced Competing Policy
Concerns and Concluded that Patents for Medical
Processes Should Be Protected.
Congress has effectively ratified the longstanding
administrative and judicial interpretation that
medical processes are patentable under § 101.
Indeed, not only is Congress aware of this
longstanding policy, Congress has made clear that it
believes such processes are and should be patentable.
For example, under the Drug Price Competition and
Patent Term Restoration Act of 1984 (“Hatch-
Waxman Act”), Pub. L. No. 98-417, 98 Stat. 1585
(1984), Congress specifically required all applicants
to the Food and Drug Administration for approval of
a new drug to list any patents related to the drug,
including any patent “which claims a method of
using such drug.”7 21 U.S.C. § 355(b)(1).
Subsequently, applicants must provide supplemental
information when any new patents issue, including
new patents on methods of use. Id. § 355(c)(2). Lest
there be any doubt that Congress intended new
methods of use to be patentable, the Hatch-Waxman
Act provides, under certain conditions, for patent
term extensions both for a “method of using a [drug]
product” and for a “method of manufacturing a [drug]
product.” 35 U.S.C. § 156(a); see also id. § 156(f)
(defining “product” to include drug products).
Obviously, Congress would not have passed these
7 Information about these patents is then published as part of
the FDA’s Approved Drug Products with Therapeutic
Equivalence Evaluations, commonly referred to as the “Orange
Book.”
13
provisions if it did not intend for these processes to
be patentable.
Moreover, on multiple occasions, Congress
considered but did not pass legislation that would
have excluded medical and surgical methods and
devices from the field of patentable subject matter.
The 57th and 58th Congresses considered such
legislation in 1902 and again in 1904. H.R. 12451,
57th Cong. (1902); H.R. 13679, 58th Cong. (1904). At
the time, the Report of the House Committee on
Patents noted that it had been the practice of the
Patent Office to grant such patents and further
noted that the state of the law on patenting
therapeutic methods was unsettled. See Noonan, 77
J. Pat. & Trademark Off. Soc’y at 654. Congress did
not pass this legislation. See id.
In the 1990s, Congress again considered and
rejected legislation to eliminate medical processes
from the scope of patent protection. Instead,
Congress immunized doctors from lawsuits for
infringing a subset of these patents -- a subset that
does not include patents for processes for the use of
particular pharmaceuticals. By doing so, Congress
made clear its understanding that medical-process
patents are within the scope of § 101.
In particular, on March 3, 1995, Congressman
Greg Ganske introduced H.R. 1127, which would
have precluded the issuance of a patent for any
medical procedure that did not use a patentable
product. H.R. 1127, 104th Cong. (1995). A
companion bill in the Senate, introduced on October
18, 1995, rather than precluding the patenting of
14
medical processes, sought to redefine what would
constitute infringement of patents for medical
processes. S. 1334, 104th Cong. (1995). This bill
would have defined activities by medical
professionals as non-infringing even if they made use
of patented processes. Id.
These bills were drafted as a result of a
controversy over a lawsuit by one physician against
another for purportedly infringing a patent on a
method of cataract surgery (the “Pallin case,” see
Pallin v. Singer, 36 U.S.P.Q.2d (BNA) 1050 (D. Vt.
1995)). See 142 Cong. Rec. 26825-26 (1996)
(statement of Sen. Frist). Doctors became concerned
that they would be sued for using particular surgical
procedures. Arguably, this concern was vastly
overblown. Although medical-process patents had
been extant for decades, the Pallin case has been
cited as the first of its type to go to trial. Todd
Martin, Patentability of Methods of Medical
Treatment: A Comparative Study, 82 J. Pat. &
Trademark Off. Soc’y 381, 405 (2000).
In any event, Congress ultimately did not respond
to the Pallin case by reducing the scope of
patentability or declaring physician actions to be
non-infringing. Indeed, neither bill attracted broad
support. See Richard P. Burgoon, Jr., Silk Purses,
Sows Ears and Other Nuances Regarding 35 U.S.C.
§ 287(c), 4 U. Balt. Intell. L.J. 69, 80 (1996). Instead,
after the House held hearings on the proposed bills,
Medical Procedures Innovation and Affordability Act
and Inventor Protection Act of 1995: Hearing Before
the Subcomm. on Courts and Intellectual Property of
the H. Comm. on the Judiciary, 104th Cong. (1995)
15
[hereinafter Hearing on H.R. 1127 ], Congress took a
more nuanced approach. Under the enacted
legislation, medical processes remain patentable,
infringers other than medical professionals are
subject to suit and award of remedies, and medical
professionals who use patented processes are still
deemed to infringe.
Instead of changing the scope of patentability,
Congress protected the interests of medical
professionals by exempting them, with important
exceptions, from the remedial provisions of the
patent laws when they are performing a medical
activity.8 Even this exemption does not apply to new
uses of pharmaceuticals. That is because the statute
excludes from the definition of “medical activity,”
and thus from the immunity provision, the following:
“(i) the use of a patented machine, manufacture, or
composition of matter in violation of such patent, (ii)
the practice of a patented use of a composition of
matter in violation of such patent, or (iii) the practice
8 See 35 U.S.C. § 287(c)(1) (“With respect to a medical
practitioner’s performance of a medical activity that constitutes
an infringement under section 271(a) or (b) of this title, the
[remedial] provisions . . . of this title shall not apply against the
medical practitioner or against a related health care entity with
respect to such medical activity.”). The statute does not
immunize the activities of persons involved in the commercial
development, manufacture, sale, importation, or distribution of
drugs, devices, biotechnology products, or the provision of
pharmacy or clinical laboratory services (other than clinical
laboratory services provided in a physician’s office). See 35
U.S.C. § 287(c)(3).
16
of a process in violation of a biotechnology patent.”
35 U.S.C. § 287(c)(2)(A).9
The exception for use of “a composition of matter”
means that Congress concluded that medical
practitioners remain subject to the remedial
provisions of the patent law when they violate
patents for new uses of pharmaceuticals. According
to the Conference Report, “‘Uses of compositions of
matter’ include, without limitation, novel uses of
drugs, . . . novel methods of combining drug
therapies, and novel methods for providing genetic or
other biological materials to a patient (including
gene therapies).” H.R. Rep. No. 104-863, at 853
(1996) (Conf. Rep.). The report gives two examples of
situations where doctors would not be immunized:
(1) “a claim that recites only the novel use of a drug
for the treatment of diabetes that involves the
administration of a drug at a particular time of day
and/or at a specified dose and/or with a specified
concomitant medicinal therapy,” and (2) a claim for a
method of transplant surgery that uses a novel
anesthetic or a novel dosing schedule for that
9 With respect to patented processes that use a composition of
matter, the statute further states that “the term ‘patented use
of a composition of matter’ does not include a claim for a
method of performing a medical or surgical procedure on a body
that recites the use of a composition of matter where the use of
that composition of matter does not directly contribute to
achievement of the objective of the claimed method.” 35 U.S.C.
§ 287(c)(2)(F). In other words, if a patented process merely
adds a reference to a drug or other composition of matter for no
reason other than, for example, to circumvent the immunity
provisions, the immunity provisions are still applicable.
17
anesthetic. Id. at 853-54.10 Thus, new regimens for
administering a drug and new uses for a drug are
both subject to full protection.
In explaining the foregoing legislation, which he
had introduced, Senator Frist contrasted
“innovations in pure procedures -- such as discovery
of a better way to suture a wound or set a broken
bone” with “innovations in medical drugs and
devices.” 142 Cong. Rec. 26825 (1996) (statement of
Sen. Frist). He explained that enforcement against
doctors of patents claiming “pure procedures” would
be disastrous, and innovations in these areas would
happen without “the midwifery of patent law.” Id.
But because of the need to recoup investments, “[t]he
appropriateness and importance of allowing patents
for pharmaceuticals and medical devices is now well-
established.” Id. He noted that the Ganske
amendment proposed in the House “could have
impacted many worthwhile patents in biotechnology
and pharmacology.”11 Id. In contrast, the legislation
Senator Frist proposed, “would in no way, however,
change patent law with respect to biotechnology,
medical devices, drugs, or their methods of use. As a
10 Use of compositions of matter does not include uses of
medical devices or other machines. See id.
11 After the initial legislation he proposed in the House,
Congressman Ganske proposed an amendment that was similar
to his original proposal except that it exempted from the
proposed changes patents “for a new use of a composition of
matter or biotechnological process.” H.R. 3814, 104th Cong.
§ 619 (1996) (as passed by House, July 24, 1996). So even the
amendment Senator Frist criticized as inadequately protecting
patents related to pharmaceuticals had already exempted
compositions for new uses of pharmaceuticals.
18
result, this narrowly tailored legislation would in no
way discourage the important research being done in
these areas of medicine.” Id. (emphasis added). The
legislation Senator Frist proposed was adopted with
slight alterations in the Conference Committee.12
In enacting this legislation, Congress thus
balanced competing policy objectives. While it
protected medical practitioners from lawsuits based
on claimed advances in “pure procedures” such as
surgical techniques that might not require
substantial investments to develop, Congress did not
permit medical practitioners to use patented
processes that make use of pharmaceuticals, or
similar inventions that require substantial
investment. And it decided not to reduce the scope of
patentability for any medical processes.
Under this Court’s case law, when Congress
amends a statute without “casting doubt” on
administrative or judicial interpretation, that is
evidence of its ratification of the interpretation. See
Edelman v. Lynchburg College, 535 U.S. 106, 117-18
(2002). That principle applies even more clearly here
where Congress amended the statute in a way that
itself makes clear its adoption of the administrative
12 Even in this form the legislation drew strong objections. For
example, Senator Orrin Hatch (R-Utah), Chairman of the
Senate Judiciary Committee (which has jurisdiction over patent
matters), wrote in a letter to the Senate Majority Leader that
the section “constitutes a significant departure from principals
of American patent law that have been on the books for over
two hundred years. The amendment would preclude a certain
class of patent-holders from enforcing their patent rights
against infringement, a change that renders these patents
virtually meaningless.” See 142 Cong. Rec. 26640 (1996).
19
and judicial interpretation that medical processes
are patentable and where Congress in a separate
statute, the Hatch-Waxman Act, further
demonstrated its agreement with this interpretation.
This Court should respect Congress’s clear intent.
IV. The Purpose of Patent Law Requires
Protection of Medical-Process Patents.
There is an additional reason why this Court
should take care to assure the continued
patentability of medical processes. Such
patentability serves the primary purpose of patent
law: to advance the useful arts by providing an
incentive for innovations. Chakrabarty, 447 U.S. at
307; U.S. Const. art. I, § 8, cl. 8. That is particularly
true for processes that make use of pharmaceuticals.
Patenting new uses for existing products has been an
established part of patent law since the Patent Act of
1952, Act of July 19, 1952, Ch. 950, 66 Stat. 792. See
35 U.S.C. § 100(b); Rohm & Haas Co. v. Roberts
Chems., Inc., 245 F.2d 693, 699 (4th Cir. 1957). Such
patents are critical to the advancement of medical
care.
Today, much of the innovation in medical care
comes from intensive study of possible new uses for
existing drugs. Calfee, The Golden Age of Medical
Innovation, supra. As one article points out in
discussing the June 2007 annual meeting of the
American Society of Clinical Oncology, “[w]hereas
breakthrough advances in new, targeted therapies
stole headlines at recent years’ gatherings, the
current highlights are studies showing improved
uses for . . . established drugs.” Catherine Arnst,
20
Same Cancer Drugs, New Applications, Bus. Week
Online, June 3, 2007, at
http://www.businessweek.com/technology/content/
jun2007/tc20070603_510760.htm. For example,
Herceptin, which was originally approved for one
use, was subsequently found, when administered
after surgery, to reduce the odds of a recurrence of a
type of breast cancer by half, suggesting, according to
the New England Journal of Medicine, “a dramatic
and perhaps permanent perturbation of the natural
history of the disease, maybe even a cure.” Calfee,
The Golden Age of Medical Innovation, supra
(describing studies in the New England Journal of
Medicine and the British medical journal, The
Lancet).
Patents issued for processes that make use of
already-known products include “the use of AZT to
treat AIDS, the application of minoxidil to treat
baldness, the administration of a known sugar
solution (mannitol) to get drugs into the brain, and
the use of a cough medicine (dextromethorphan) to
help stroke victims.” Hearing on H.R. 1127, supra,
at 67 (prepared testimony of William D. Noonan,
M.D., Klarquist, Sparkman, Campbell, Leigh and
Whinston). In these cases, the product itself is not
patentable (or has already been patented), because it
is already known. “The practice has therefore been
to patent as a ‘useful process’ the use of a known
drug for a recently discovered purpose.” Andres
Rueda, Cataract Surgery, Male Impotence, Rubber
Dentures and a Murder Case -- What’s so Special
About Medical Process Patents?, 9 U. Balt. Intell.
Prop. L.J. 109, 146 (2001). The patentability of
21
medical processes provides an incentive for
researching the new use.
The need for the incentives provided by the
patent system also extends to personalized medicine,
which seeks to individualize treatment for patients.
It does so by identifying genetic, genomic, and
clinical information which is translated into precise
diagnostic tests and targeted therapies that address
a person’s susceptibility of developing disease, the
course of disease, and its response to treatment.
Personalized medicine will allow physicians to make
the most effective clinical decisions for individual
patients and has the potential to improve drug
efficiency, lower costs from adverse events through
more targeted therapies, and save lives.13
“[T]argeted drug therapies selected for individual
patients based on genetic predisposition” will allow
doctors to guide “medication selection and dosage
regimens that ensure maximal drug efficiency and
minimal adverse drug reaction.” Teresa Kelton,
Pharmacogenomics: The Re-Discovery of the Concept
of Tailored Drug Therapy and Personalized
13 For example, one early success in personalized medicine
involves the measuring of HER2/neu amplification in breast
cancer patients. Michael J. Shuster & Pauline Farmer-
Koppenol, Protecting Patents for Personalized Medicine,
BioPharm Int’l (Sept. 1, 2008), available at
http://biopharminternational.findpharma.com/biopharm/article/
articleDetail.jsp?id=545358. For those patients whose tumors
carry this amplification, the drug Herceptin reduces risk or
recurrence by half. Id. For those patients whose tumors do not
carry this amplification, the product does not have the same
benefit.
22
Medicine, 19 Health Law. 1, 1 (2007). However, “[i]n
order for personalized medicine to become a reality,
drug innovators will need a regulatory environment
that allows a return on their investments in research
and development.” Deloitte Consulting LLP,
Avoiding No Man’s Land: Potential Unintended
Consequences of Follow-On Biologics 17 (Mar. 2009).
The development of a new medicine, or a new use
for an existing medicine, is extremely expensive.
Because of the difficulty of developing new medicines
and the high safety and effectiveness standards that
they must meet, relatively few research avenues are
successful. Only 20 in 5,000 compounds that are
screened enter preclinical testing in laboratories and
on animals. FTC, To Promote Innovation: The
Proper Balance of Competition and Patent Law and
Policy, ch. 3, at 6 (Oct. 2003), available at
http://www.ftc.gov/os/2003/10/innovationrpt.pdf.
Even if a compound is determined to be safe enough
to test on humans, there must be three phases of
clinical testing to determine safety and efficacy
before the FDA can give final approval for
marketing. Id. As a result, the development and
commercialization of a drug is a very lengthy and
uncertain process, often taking more than a decade.
See Joseph A. DiMasi & Henry G. Grabowski, The
Cost of Biopharmaceutical R&D: Is Biotech
Different?, 28 Managerial & Decision Econ. 469, 475-
76 (2007). Because of this lengthy and difficult
process, the average cost of bringing a new drug to
market is approximately $1.3 billion when the cost of
unsuccessful efforts is taken into account. See U.S.
Dep’t of Commerce, Int’l Trade Admin.,
23
Pharmaceutical Price Controls in OECD Countries,
supra, at 30-31. And this cost must be recouped in a
patent term that is often effectively much shorter
than the statutory term because of the length of the
review and approval process. FTC, To Promote
Innovation, supra, ch. 3, at 7 (explaining that “the
effective patent life for a drug patent -- even with
patent term restoration [under the Hatch-Waxman
Act] -- is typically about 11 years, substantially
shorter than the 20-year statutory patent term”
(footnote omitted)). Even drugs that make it to
market do not generally cover their development
costs. See id., ch. 3, at 5 (reporting on statements
from PhRMA).
Because of the expense and difficulty of
developing pharmaceuticals, patent protection is
crucial. As a Federal Trade Commission report
explained after gathering evidence on the costs and
benefits of patent protection, “[p]articipants in the
Hearings overwhelmingly expressed the view that
patent rights for pharmaceuticals are essential for
brand-name companies to prevent free riding and
recoup their significant investments.” FTC, To
Promote Innovation, supra, ch. 3, at 9. Indeed,
“pharmaceutical industry participants reported that
60% of inventions would not have been developed
and 65% would not have been commercially
introduced absent patent protection.” Id., ch. 2, at 11
(citing Edwin Mansfield, Patents and Innovation:
24
An Empirical Study, 32 Mgmt. Sci. 173, 175
(1986)).14
There are no significant countervailing
considerations. Some have argued that particular
patents have too broad a preemptive effect, a concern
expressed by Justice Breyer in Metabolite. 548 U.S.
at 126-28. These concerns do not apply to most
pharmaceutical patents. First, patents on uses of
particular pharmaceuticals are inherently limited in
scope. Second, the complexity of biological systems
means there are generally multiple pathways for
understanding and treating most diseases.15 Third,
14 In addition to providing incentives for invention, patent
protection also helps ensure quick disclosure of inventions that
do occur. See Scott Paper Co. v. Marcalus Mfg. Co., 326 U.S.
249, 255 (1945). The PTO reports that as a result of the
American Inventor Protection Act of 1999, Pub. L. No. 106-113,
113 Stat. 1501, 1501A-552, “roughly 90 percent of all pending
patent applications are published at eighteen months.” FTC, To
Promote Innovation, supra, ch. 1, at 26. In the absence of
patent protection, however, inventors would have no incentive
to disclose their invention until after completion of the lengthy
FDA approval process. And even then they would only be
required to disclose the use, not the underlying research. This
is important in the pharmaceutical industry. The FTC cited
testimony from pharmaceutical and biotech representatives,
including those from generic pharmaceutical firms, explaining
that patent disclosures guide efforts to design around patents
and lead to other efforts at innovation. Id., ch. 3, at 1-2, 4.
15 See, e.g., David E. Adelman, A Fallacy of the Commons in
Biotech Patent Policy, 20 Berkeley Tech. L.J. 985, 1010-17
(2005); John P. Walsh et al., Effects of Research Tool Patents
and Licensing on Biomedical Innovation, in Patents in the
Knowledge-Based Economy 285, 292, 304-05 (Wesley M. Cohen
& Stephen A. Merrill eds., 2003). Indeed, many of the recent
drugs with multiple new uses have quickly spawned competitor
25
patent law itself imposes significant limits on the
breadth of patents, and these requirements are
applied far more rigorously in the biomedical area
than elsewhere.16 Finally, to the extent broad
patents are issued and not licensed, there is a
substantial economic literature suggesting that
society nevertheless benefits because “innovation
would drop substantially in the pharmaceutical
industry in the absence of effective patent
protection.” See Dan L. Burk & Mark A. Lemley,
Policy Levers in Patent Law, 89 Va. L. Rev. 1575,
1615-17 (2003) (explaining that the prospect theory,
that patents should be broad, stand alone, and confer
almost total control “maps most closely onto
invention in the pharmaceutical industry”); see also
James W. Hughes et al., “Napsterizing”
Pharmaceuticals: Access, Innovation, and Consumer
Welfare (Nat’l Bureau of Econ. Res., Working Paper
No. 9229, 2002) (finding that eliminating patent
drugs with similar characteristics. Calfee, The Golden Age of
Medical Innovation, supra.
16 See, e.g., Dan L. Burk & Mark A. Lemley, Policy Levers in
Patent Law, 89 Va. L. Rev. 1575, 1590 (2003) (noting that
biopharmaceutical and biotech patent prosecution takes a much
longer time than does the prosecution of patents in other fields);
Noonan, 77 J. Pat. & Trademark Off. Soc’y at 661 (“[T]he
requirement that an invention must be a ‘nonobvious’ advance
to be patentable is particularly strictly applied in all the
biological examining groups. The likelihood that a biological
patent application will successfully issue as a patent is about
one-half of the likelihood of success in conventional mechanical
and electrical cases. Many biological patents that emerge from
this rigorous patenting process are narrow in scope, difficult to
enforce, and unlikely to cover anything that will be widely or
successfully used in practice.”).
26
protection on pharmaceuticals would cost future
consumers three dollars in lost innovation benefits
for every dollar saved in reduced drug prices).
Even scholars who advocate narrow patent rights
in some contexts, recognize the importance of patent
rights for biopharmaceutical patents. One such
scholar explains:
In the specific context of the
biopharmaceutical industry, the claim
that broad, monopoly-conferring rights
on nascent invention can provide a
necessary spur to further innovation
may well have merit. As matters
currently stand, the research path from
initial discovery of a potentially
relevant DNA sequence or receptor to
identification of a drug that is ready for
clinical testing can be quite risky,
lengthy, and expensive.
Arti K. Rai, Fostering Cumulative Innovation in the
Biopharmaceutical Industry: The Role of Patents and
Antitrust, 16 Berkeley Tech. L.J. 813, 828-29 (2001).
Even among physicians, who historically have
had concerns about patents that limit products used
in, or processes of, treatment, “there seems to be
general agreement that drugs and medical devices
should be patentable, because they often require
enormous expenditures.” Noonan, 77 J. Pat. &
Trademark Off. Soc’y at 656.17 Thus, there is broad
17 Any continued criticism of patents for medical processes has
generally been directed to patents for surgical techniques and
27
consensus on the importance of patent rights to
pharmaceutical development. See, e.g., Natasha N.
Aljalian,
The Role of Patent Scope in
Biopharmaceutical Patents, 11 B.U.J. Sci. & Tech. L.
1, 47 (2005) (“The promise of full patent rights for
successful discovery is important motivation for
inventors entering the unpredictable, competitive
biopharmaceutical area.”); John P. Walsh et al.,
Effects of Research Tool Patents and Licensing on
Biomedical Innovation, in Patents in the Knowledge-
Based Economy 285, 286-87 (Wesley M. Cohen &
Stephen A. Merrill eds., 2003) (“There is widespread
consensus that patents have long benefited
biomedical innovation. A forty-year empirical legacy
suggests that patents are more effective, for
example, in protecting the commercialization and
licensing of innovation in the drug industry than in
any other.”).
The need for patent protection for new uses
(“indications”) for existing drugs is just as great as
the need for patent protection of the initial product.
Even in Europe, where the law is more restrictive
and generally precludes patenting of methods of
medical treatment, the law permits patenting of
known products for new medical uses. Martin, 82 J.
research tools. The American Medical Association, for example,
which once took the view that patenting of surgical instruments
was unethical, later reversed itself. See Martin, 82 J. Pat. &
Trademark Off. Soc’y at 388-89. And while it continues to
oppose process patents for surgical techniques, it signed on to
the approach Congress took in its 35 U.S.C. § 287, as Senator
Frist explained in his floor speech. See 142 Cong. Rec. 26825
(1996) (statement of Sen. Frist). That approach eliminated any
problems with patenting of surgical techniques.
28
Pat. & Trademark Off. Soc’y at 396. As discussed
above, news uses for existing drugs make up a
critical part of medical research. As of 2007, 47
percent of biologics that were evaluated in one study
have had at least one new FDA-approved indication
after the initial approval. See Said et al., Continued
Development of Approved Biological Drugs, supra, at
3.18
Like development of the initial product,
development of new uses is costly and time
consuming. As one author explains: “A substantial
amount of laboratory research conducted by
pharmaceutical companies involves the expensive
and painstaking evaluation of known drugs and
compounds for unknown curative properties.”
Rueda, 9 U. Balt. Intell. Prop. L.J. at 146 (citing The
18 Other types of medical-process patents are also
important. For example, there are important patents on
methods for diagnosis and optimization with respect to
individual patients. Standard drug treatments have only a 25%
rate of efficacy in cancer patients in part because each patient
is biologically unique. See Mara G. Aspinall & Richard G.
Hammermesh, Realizing the Promise of Personalized Medicine,
Harv. Bus. Rev., Oct. 2007, at 108, 111 (citing Brian B. Spear et
al., Clinical Application of Pharmacogenetics, 7 Trends in
Molecular Med. 201 (2001)). Determining optimal treatments
can be costly. See Peter Huber, Who Pays for a Cancer Drug?,
Forbes, Jan. 12, 2009, at 72. Patent protection provides a key
incentive for development of such methods of optimization.
Patents in this area include U.S. Pat. No. 7,348,149 (Mar. 25,
2008) (“Methods of Diagnosing Parkinson’s Disease”); U.S. Pat.
No. 6,770,029 (Aug. 3, 2004) (“Disease Management System
and Method Including Correlation Assessment”); U.S. Pat. No.
6,087,090 (July 11, 2000) (“Method for Predicting Drug
Response”).
29
FDA Approval Process: Hearing Before the Health
and Environment Subcomm. of the H. Commerce
Comm., 104th Cong. (1996)). One reason the work
on new indications is expensive is that just like with
the initial indication, in order to obtain FDA
approval for a new indication, the innovator must
submit data from clinical trials regarding the
treatment’s safety and efficacy in a particular
patient population.
The FDA review and approval process is also
lengthy. In 2007, the Boston Consulting Group
conducted an analysis of 58 biologics consisting of
biotechnology-derived protein products that were
approved under the Public Health Service Act
between 1986 and 2006. Said et al., Continued
Development of Approved Biological Drugs, supra, at
2. It found that FDA review of a new indication for
an existing biologic typically takes three to six years.
Id. at 5. Companies whose products are approved
typically accrue significant expenses even after FDA
approval, including research on new indications and
studies that are the subject of commitments made to
FDA for post-approval research. As a result of
factors such as these, development of new indications
for existing drugs is very costly: while “[n]o
comprehensive estimates currently exist that capture
the full extent of investment occurring after the
initial approval, . . . considering that the size and the
complexity of the clinical trials for each new
indication are similar to the size and the complexity
of those conducted prelaunch and that the failure
rates remain high, such costs are likely high and
represent an important part of the overall R&D
30
investment in researching and developing new
therapeutic biologics.” Id. at 6. Because of the
substantial expense of developing new indications,
the Boston Consulting Group concluded that patent
protection is important to promoting the
development of new indications. Id.
Of course, a company that owns a patented
product already has some incentive to research
additional indications for that product. But that
incentive often will not be sufficient because by the
time the new indication is approved little or no time
may be left in the patent protection for the product.
The Boston Consulting Group found that one-third of
the new indications were approved more than seven
years after the approval of the initial indication. Id.
at 3. And often it takes much longer. Biologics on
the market for 11 years are still expected to have on
average one additional indication approved over the
remainder of their lifetime. Id. at 4.
Moreover, new uses for existing products may be
developed by companies other than the original
innovator; companies that have no patent protection
over the product. They may also be developed using
products never subject to patent protection or no
longer subject to such protection. For example, the
patents for the use of AZT to treat human
immunodeficiency virus (HIV) constituted new use of
a well-known composition.19 See Burroughs
19 AZT was originally developed in 1964 as a potential cure for
cancer. The inventor never sought a patent because tests
showed that it “failed miserably” at its intended purpose. See
Philip J. Hilts, Experimental Drug AZT Was Designed for
31
Wellcome, 40 F.3d at 1225-26, 1230 (describing these
patents and fact that the compound AZT was already
well known). For these companies, the only patent
protection they can receive comes in the form of a
patent on a medical process.
Eliminating patent protection would severely
restrict medical research. See Rueda, 9 U. Balt.
Intell. Prop. L.J. at 132 (“A serious concern weighing
against stripping medical processes from patent
protection is the impact such a move would have on
incentives. Without intellectual property protection,
companies and individuals who otherwise may have
poured time and resources towards medical process
research may not do so.”). One author, who
emphasizes that the greatest gains in medical
research are coming from the invention of new
indications, explains that “[t]he surest way to hobble
medical technology is to damage intellectual property
(IP) protections, mainly patents.” Calfee, The
Golden Age of Medical Innovation, supra.
CONCLUSION
Given the importance of patent protection to
incentivize research, the history of protection of
medical-process patents, and Congress’s
unambiguous intent, this Court should make clear,
whatever result it reaches with respect to the Bilski
patent, that methods of medical treatment and
diagnosis, especially methods for new uses of existing
pharmaceuticals, remain patentable. It should not
adopt a new test for patentability that risks
Tumors; Skill, Luck Led to Promising Tests on AIDS, Wash.
Post, Sept. 19, 1986, at A11.
32
changing future cases into formalistic debates on the
meaning of the court-created test. If it nonetheless
adopts such a test, it should make clear that medical-
process patents fall within it.
Respectfully
submitted,
OF COUNSEL
HARRY J. ROPER
Counsel of Record
DAVID E. KORN
JENNER & BLOCK LLP
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