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 
 
 
 


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 
 
 


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. 


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. 
 
 


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. 
 
 


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.  
 
 


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.  
 
 


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 
 
 


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.   
 
 


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. 
 
 


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 
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