Methods of Medical Treatment Claims Issues in Canada US and Europe by Konrad Sechley and Scott Foster

1. Methods of Medical
Treatment Claims: Issues
in Canada, US and Europe
Konrad Sechley and Scott Foster
November 27, 2012

2. Presenters
Scott Foster
Associate – Vancouver
604-891-2294
scott.foster@gowlings.com
Konrad Sechley
Principle, Patent Agent – Vancouver
604-443-7610
konrad.sechley@gowlings.com
2

3. Disclaimer
• Personal views of presenters
• Detailed and complex legal rules
3

4. Overview
• Methods of medical treatment
• Use claims
• Diagnostic methods
• Dosing ranges or regimens
4

5. Canada – Patent Eligible Subject Matter
• Section 2 of the Patent Act provides for the definition
of invention as follows:
“any new and useful art, process, machine, manufacture
or composition of matter, or any new and useful
improvement in any art, process, machine, manufacture
or composition of matter”
5

6. Agenda
• Methods of medical treatment
• Use claims
• Diagnostic methods
• Dosing ranges or regimens
6

7. Canada - Medical Treatment
It is trite law in Canada that methods of medical treatment
do not constitute patent eligible subject matter.
Public policy - to prevent a medical professional from being
barred from practicing a beneficial treatment that may be
based on their skill and judgment
7

8. Canada - Medical Treatment (cont.)
Tennessee Eastman Company et al. v. Commissioner
of Patents, SCC [1974]
• The patent included claims for a method for the surgical
bonding of body tissue using an ester of cyanoacrylic acid
• Section 41 Patent Act applied and restricted patents relating
to substances prepared by chemical processes and
intended for medicine
• The method of surgical treatment was found not to be
patent eligible because such subject matter does not fall
within the definition of "process" or "art”
8

9. Canada - Medical Treatment (cont.)
Imperial Chemical Industries Ltd. v. Canada
(Commissioner of Patents), FCA (1986)
• The invention claimed a method of cleaning dental plaque from teeth
by applying an aqueous composition
• It resulted in a cosmetic benefit and also the treatment of dental
caries
• The application was rejected as being a treatment of the human body
and not patent eligible as a result of Tennessee Eastman
• Held:
• Court confirmed that all methods of medical treatment are not a "process"
under section 2 of the Patent Act
• Although treatment of cavities is cosmetic, it also has a medical function
(treatment of caries)
9

10. Canada - Medical Treatment (cont.)
• Since Tennessee Eastman, the Canadian Patent
Office has rejected claims that are phrased as:
• methods of medical treatment involving therapeutic
treatment, and
• methods of surgical treatment in which the method
step requires actions by a surgeon or other medical
professional.
10

11. Canada - Medical Treatment (cont.)
Re Senentek (1997) 77 C.P.R. (3d) 21
• A method of treating skin cells to reduce the effects of aging
• Patent Appeal Board allowed the claims because aging is a
natural condition of the human body and not a disease
• The method should not be considered a method of medical
treatment since no pathological condition is remedied
Re General Hospital Corp. (1996) 74 C.P.R. (3d) 544
• Claims were directed to a method of preventing pregnancy
• Patent Appeal Board allowed the claims because pregnancy is a
natural condition, not a disease
11

12. Europe – Medical Treatment
European Patent Convention 1973 and 2000:
• Methods of medical treatment are not patent eligible in Europe
• EPC 1973
• Inventions, to be patent eligible, must be ‘susceptible of industrial
application’
• Art 52(4) provided a fiction that medical methods are not
susceptible of industrial application
• EPC2000
• Art 53(c) excludes medical methods per se from patent eligibility
• In both cases, exclusion does not extend to products for use
in such methods
12

13. Europe – Medical Treatment (cont.)
“treatment”
• Claims directed to solely cosmetic effects have been found
allowable.
•T144/83 – DU PONT / Appetite Suppressant
• A treatment causing a cosmetically beneficial loss of weight
of a person not suffering from obesity was not necessarily
beneficial to the health of that person, and consequently was
not considered to be a method for treatment barred from
patentability
•Therapy by “treatment relates to the treatment of a disease
in general or to a curative treatment in the narrow sense…”
13

14. US - Medical Treatment
• Method of treatment claims permitted in the US since 1954
• re Scherer (103 USPQ 107, 1954)
• 35 U.S.C. 271 - Infringement of patent.
• …whoever without authority makes, uses, offers to sell, or sells any patented
invention, within the United States… infringes the patent.
• 35 U.S.C. 281 - Remedy for infringement of patent.
• A patentee shall have remedy by civil action for infringement of his patent.
• 35 U.S.C. 287 (c) Limitation on damages...
• (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
provisions of sections 281, 283, 284, and 285 of this title shall not apply against
the medical practitioner or against a related health care entity with respect to
such medical activity.
• (2) For the purposes of this subsection: (A) the term “medical activity” means the
performance of a medical or surgical procedure on a body, but shall not
include (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 of a process in violation of a
biotechnology patent.
14

15. Agenda
• Methods of medical treatment
• Use claims
• Diagnostic methods
• Dosing ranges or regimens
15

16. Canada - Use
• “A method of treating condition Y by administering
compound X” is not patent eligible
• But can get around this issue by drafting use claims:
• “A use of compound X for treating condition Y” (Canadian Style)
• “A use of compound X in the preparation of a medicament for
treating condition Y” (Swiss style)
• “Compound X for use in the treatment of condition Y” (New
European Style)
16

17. Canada - New uses of old compounds
Shell Oil v. Canada (Commissioner of Patents) (1982), 67
C.P.R. (2d) 1 (SCC)
• Not a medical or surgical treatment
• Chemical compounds (new and old) mixed with an adjuvant discovered
to be useful as plant growth regulators
• Held that the invention lay in the application of an old compound to a new
use and patent eligible.
• The Court observed that the distinction between what is patent eligible is
based on whether the subject matter is related to professional skills on
the one hand or trade, industry, or commerce on the other.
17

18. Canada - New uses of old compounds (cont.)
Re Application for Patent of Wayne State University (1988)
22 C.P.R. (3d) 407 (PAB)
• The claims were directed to a new therapeutic method for reducing
metastasis and neoplastic growth in mammals
• The Patent Appeal Board extended the principle introduced by Shell Oil
and held that “use” claims could be a way to work around the prohibition
against methods of medical treatment
• A new medical use for an old compound is patent eligible
• Canadian patent office accepts claims directed to the use of
compositions, apparatuses, etc, in medical treatments provided there is
no active step of treatment directed (“administered” versus
“administration”)
18

19. Amazon case in Canada
• Amazon.com “one-click” decision
• One-year anniversary of the Federal Court of Appeal’s
Amazon.com decision on patentable subject matter
• April 2012 – CIPO published draft guidance on
patentable subject matter (with reference to diagnostic
methods and medical uses)
• November 2012 – The Commissioner recently
suggested that the guidelines will not be published
until 2013
19

20. Amazon case in Canada (cont.)
• Current issues - life sciences & law 2012/2013
• Authors wrote paper on draft guidelines
20

21. Recent decisions in Canada
• Teva v Pfizer (Viagra) SCC decision
• November 8, 2012, decision from Canada’s highest court
• Number of cascading claims
• Claim 1 covered 260 quintillion possible compounds used to treat
erectile dysfunction
• Claim 7 related to sildenafil for use in treating erectile dysfunction
21

22. Recent decisions in Canada (cont.)
• Teva v Pfizer (Viagra)
• According to the judgment, although Pfizer knew that sildenafil
was the effective compound, the specification did not identify
sildenafil as the one compound that was stated as being effective
in treating erectile dysfunction
• Held that this lack of information meant that Pfizer had failed to
disclose the invention sufficiently (section 27(3) Patent Act).
• According to the patent bargain theory, the patent was invalid
• Apotex v Pfizer Ireland Pharmaceuticals 2012 FC 1339:
• Granted summary judgment declaring same patent invalid
22

23. Europe - use claims
EPC1973
• A claim to a product must be novel and inventive to be patent eligible
• Requirements for novelty are set out in Art 54 – must “…not form part of
the state of the art”
• Art 54(5) provides a statutory exception for medicinal products to the
normal novelty rules.
• Even if such a product is itself not new, it is patent eligible for use in any
medical method provided ‘its use for any (medical treatment) method is not
comprised in the state of the art’.
• In G05/83 (EISAI) the Enlarged Board of Appeal of the EPO held that Art
54(5) enables the inventor of a first medical use to obtain purpose-limited
product protection for a known substance or composition
23

24. Europe - use claims (cont.)
EPC1973
• The exception in Art 54(5) did not apply to second and subsequent
medical uses (G05/83 (EISAI))
• In G05/83 (EISAI) for second and subsequent medical uses, the EPO
approved of Swiss form claims
• This claim was referred to as the “Swiss” claim, after the then-practice of
the Swiss Federal Intellectual Property Office
• Also known as a second medical use claim, this claim takes the form:
“compound X for use in the manufacture of a composition
for the treatment of disease Y”
• “compound X for use in the manufacture of a composition…” removes
the claim from the ambit of methods of treatment as it is directed to a
method of manufacture
• “… for the treatment of disease Y” describes the use of the composition
and provides the novelty of the claim
24

25. Europe - use claims (cont.)
EPC2000
• Came into force on December 13, 2007.
• Art 53(c) EPC2000 removes the fiction about industrial applicability. It
simply declares that patents may not be granted for medical methods.
• But even more significantly new Art 54(5) provides for novelty of second
and subsequent medical uses (codification of G05/83)
• A Enlarged Board of Appeal decision (G2/08) determined that Swiss
claims are no longer admissible in Europe under EPC2000.
• Instead, a method of treatment can be protected by a claim of the form
"Substance X for use in the treatment of condition Y by steps Z“.
25

26. US use claims
Use claim format generally not accepted in the US
MPEP 2173.05(q) “Use” Claims
• Attempts to claim a process without setting forth steps involved in the process
raises an issue of indefiniteness under 35 U.S.C. 112, 2nd para.
• “A process for using monoclonal antibodies of claim 4 to isolate and purify
human fibroblast interferon.”
• held to be indefinite as it recites a use without any active, positive steps delimiting
how this use is practiced. (Ex parteErlich, 3 USPQ2d 1011,1986).
• “The use of a high carbon austenitic iron alloy having a proportion of free
carbon as a vehicle brake part subject to stress by sliding friction.”
• improper definition of a process (Ex parteDunki, 153 USPQ 678, 1967)
• “The use of a sustained release therapeutic agent in the body of ephedrine
absorbed upon polystyrene sulfonic acid.”
• the claim was definite, but not a proper process claim under 35 U.S.C. 101:(Clinical
Products Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475,1966),
26

27. US use claims (cont.)
• MPEP 2173.05(q) “Use” Claims (cont)
A “USE” CLAIM SHOULD BE REJECTED UNDER
ALTERNATIVE GROUNDS BASED ON 35 U.S.C 101
AND 112
In view of the split of authority as discussed above, the
most appropriate course of action would be to reject a
“use” claim under alternative grounds based on 35
U.S.C. 101 and 112.
27

28. Agenda
• Methods of medical treatment
• Use claims
• Diagnostic methods
• Dosing ranges or regimens
28

29. Canada- diagnostic methods
Diagnosis and evaluation
• Generally speaking, not a method of medical treatment and
therefore patent eligible
In re Application for Patent of Goldenberg (1988), 22 C.P.R.
(3d) 159
• Application claimed a method of locating a tumour through the
administration of radio-labelled antibody substances to the body
• Examiner: claims were directed to a method that modified the metabolism
of the human body and that was equivalent to a method of medical
treatment.
• Commissioner: Rejected Examiner’s position that anything injected into a
human body will change its metabolism and is therefore a treatment of
the human body, whether or not the substance injected has a therapeutic
effect…
• Only methods of medical treatment in the strict sense excluded
29

30. Canada- diagnostic methods (cont.)
In re Application for Patent of Kevin McIntyre (1992), 53
C.P.R. (3d) 532
• Claims to a method of evaluating the mechanical condition of a heart:
•pulse signal, representative of arterial pulsation, was provided non-
invasively to the patient, the patient was then subjected to a heart
straining manoeuvre. The change in the pulse signal after the
manoeuvre relative to the pulse signal prior to the manoeuvre was
recorded
•PAB held that the method claimed has a commercial value as expected for
a diagnostic procedure and the application was allowed
30

31. Europe - diagnostic methods
EPC1973
• Excluded from patentability diagnostic methods practised on the
human or animal body (Art 52(4))
EPC2000
• Excludes from patentability diagnostic methods practised on the
human or animal body (Art 53(c))
31

32. Europe - diagnostic methods (cont.)
Decision G1/04 (Enlarged Board of Appeal)
•Narrowly interpreted exclusion for “diagnostic methods” and held
that a claimed diagnostic method is excluded from patentability only
if it includes all of the following steps:
I. Examination of the patient and collection of data;
II. Comparing the data with standard values;
III. Noting deviations from the standard values; and
IV. Making the diagnosis (i.e. the mental step that involves attributing
any deviation from standard values to a particular clinical
manifestation, enabling the choice of therapy to be determined),
•If any of the steps I-IV are absent from the claim, method is not
excluded from patent eligibility
•Thus, methods which lead to intermediate results but fall short of
providing a complete diagnosis are allowable such as:
“A method for obtaining blood pressure measurements (or other physical
quantities)…”
32

33. US - Diagnostic Methods
Recent challenges to method claims in the US:
Classen v Biogen (2006-1634, Aug 31, 2011; on remand from USSC)
• 3 patents: 6,638,739; 6,420,139; and 5,723,283;
Claim 1 from ‘739:
1. A method of immunizing a mammalian subject which comprises:
I. screening a plurality of immunization schedules . . . by
a. identifying [first and second patient populations that were
immunized with] . . . “infectious disease-causing organism associated
immunogens according to” . . . [first and second immunization schedules] and
b. comparing the effectiveness of said first and second screened
immunization schedules in protecting against or inducing a chronic
immune-mediated disorder …
II. immunizing said subject according to a subject immunization schedule . . . [with] . .
. lower risk . . .
• Claim 1 from ‘739 (and ‘139) included a final step of
immunizing
33

34. US - Diagnostic Methods: Classen (cont)
• Court concluded that the ‘739, ‘139 and ‘238 claims are
directed to “tangible specific application”
• The ‘739 (and ‘139) claim “includes the subsequent step of
immunization on an optimum schedule,”
• claims directed to a specific application and practical use of
the obtained knowledge;
• provided a step involving extra-solution activity; sufficient to
satisfy § 101.
• However - "methods that simply collect and compare data,
without applying the data in a step of the overall method,
may fail the § 101 filter”
• this was the problem with claim 1 from ‘238 which was
characterized as directed to “data gathering or insignificant
extra-solution activity”
34

35. US - Diagnostic Methods: Classen (cont)
• Claim 1 from ‘283:
• 1. A method of determining whether an immunization schedule affects the
incidence or severity of a chronic immune-mediated disorder in a treatment group
of mammals, relative to a control group of mammals, which comprises
immunizing mammals in the treatment group of mammals with one or more
doses of one or more immunogens, according to said immunization schedule, and
comparing the incidence, prevalence, frequency or severity of said chronic
immune-mediated disorder or the level of a marker of such a disorder, in the
treatment group, with that in the control group.
• characterized as “a method ‘determining whether an
immunization schedule affects the incidence or severity
of a chronic immune-mediated disorder’ by reviewing
information on whether an immunization schedule affects
the incidence or severity of a chronic immune mediated
disorder… but does not require using this information for
immunization purposes”
35

36. US - Diagnostic Methods: Mayo
Mayo V Prometheus (USSC, No 10-1150, March 20, 2012):
• 1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated
gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject…; and
(b) determining the level of 6-thioguanine in said subject…,
wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells
indicates a need to increase the amount of said drug subsequently administered to said
subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood
cells indicates a need to decrease the amount of said drug subsequently administered to
said subject.
• claim defined a natural relationship between metabolite concentration
in the blood and the probability that the metabolite will either be
therapeutically effective or harmful to the patient
• a claim must define more than a law of nature, must describe “an
application of a law of nature or mathematical formula to a known
structure of process” (citing Diehr 450 U. S. 175, 185 ,1981)
36

37. US - Diagnostic Methods: Perkinelmer
Perkinelmer v Intema (Appeal No 2011-1577, USFC Nov. 20, 1012):
• Diagnosing Down’s syndrome using known biomarkers
A method of determining whether a pregnant woman is at an increased risk of having a fetus with
Down’s syndrome, the method comprising the steps of:
measuring the level of at least one screening marker from a first trimester of pregnancy by:
(i) assaying a sample . . . ; and/or
(ii) measuring at least one first ultrasound screening marker from an ultrasound scan . . .;
measuring the level of at least one second screening marker from a second trimester of pregnancy,
the at least one second screening marker from the second trimester of pregnancy being different from
the at least one first screening marker from the first trimester of pregnancy, by:
(i) assaying a sample . . .; and/or
(ii) measuring at least one second ultrasound screening marker from an ultrasound scan . . .; and
determining the risk of Down’s syndrome by comparing the measured levels of both the at least one first
screening marker from the first trimester of pregnancy and the at least one second screening marker
from the second trimester of pregnancy with observed relative frequency distributions of marker levels
in Down’s syndrome pregnancies and in unaffected pregnancies.
• “Because the asserted claims recite an ineligible mental step and natural
law, and no aspect of the method converts these ineligible concepts into
patentable applications of those concepts, the claims cannot stand.”
37

38. US - Diagnostic Methods: Myriad
AMP v Myriad: (USCAFC, No 2010-1406, Aug 16, 2012 – under appeal)
• 15 claims from 7 patients challenged
Claim1 from 5,747,282:
1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having
the amino acid sequence set forth in SEQ ID NO:2.
• “Mayo does not control the question of patent-eligibility of
such claims. They are claims to compositions of matter,
expressly authorized as suitable patent-eligible subject
matter in § 101…The isolated DNA molecules before us
are not found in nature. They are obtained in the laboratory
and man-made, the product of human ingenuity”
• Isolated DNA patentable – the act of cleaving covalent
bonds during isolation alters the chemical identity of DNA
38

39. US - Diagnostic Methods: Myriad (cont)
Claim 1 from 5,709,999 (emphasis noted in decision):
1. A method for detecting a germline alteration in a BRCA1 gene, said
alteration selected from the group consisting of the alterations set forth in
Tables 12A, 14, 18 or 19 in a human which comprises analyzing a sequence
of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a
sequence of BRCA1 cDNA made from mRNA from said human sample with
the proviso that said germline alteration is not a deletion of 4 nucleotides
corresponding to base numbers 4184-4187 of SEQ ID NO:1.
• Methods claims compare patients sequence with isolated
sequence - law of nature/mental process, not patentable
• Claims do not apply the step of comparing two nucleotide
sequences in a process – “the step of comparing two
DNA sequences is the entire process that is claimed.”
39

40. US - Diagnostic Methods: Myriad (cont)
Claim 20 from 5,747,282 (emphasis noted in decision):
20. A method for screening potential cancer therapeutics which comprises:
growing a transformed eukaryotic host cell containing an altered BRCA1
gene causing cancer in the presence of a compound suspected of being a
cancer therapeutic, growing said transformed eukaryotic host cell in the
absence of said compound, determining the rate of growth of said host cell
in the presence of said compound and the rate of growth of said host cell in
the absence of said compound and comparing the growth rate of said host
cells, wherein a slower rate of growth of said host cell in the presence of
said compound is indicative of a cancer therapeutic.
• method for screening potential cancer therapeutics by
changes in cell growth rates of transformed cells are
patent-eligible: “a transformed cell, …is made by man, in
contrast to a natural material.”
40

41. Agenda
• Methods of medical treatment
• Use claims
• Diagnostic methods
• Dosing ranges or regimens
41

42. Canada - Dosage Regimes
• Dosing Regimes
• Generally speaking, medical use claims which include specific dosage
regimes are directed to methods of medical treatment and therefore
unpatentable.
• In Axcan Pharma Inc. v. Pharmascience Inc. (2006) FC 527, 50
C.P.R. (4th) 321
• Patent claimed a pharmaceutical composition for treatment of biliary
cirrhosis (PBC) that specified a particular dose (13-15mg/kg/day)
• The court compared a dosage unit and a dosage range and held that the
latter would be determined by a physician based on factors such as a
patient's weight
• The dosage range required a physician’s skill and judgment to select the
appropriate value based on information from the patient
• As the claim was directed to a dosage range, and as a dosage range is
not a vendible product, the patent was held to be invalid
42

43. Canada - Dosage Regimes (cont.)
Janssen Inc. v. Mylan Pharmaceuticals ULC, (2010) FC 1123
• The patent claimed an escalating dosage titration schedule for galantamine
in the treatment of Alzheimer’s disease.
• It was held that the claims at issue contained a dosage range that required
a physician’s skill and judgment to select the appropriate value based on
information from the patient – in this case the patient’s response to
treatment
• Held to be in the physicians area of expertise and therefore directed to
methods of medical treatment
43

44. Canada - Dosage Regimes (cont.)
In Re Allergan, Inc. Patent Application No. 2,300,723 (2009) 79
C.P.R. (4th) 161 PAB
• The PAB ruled that a claim reciting a dosage range of 50 to 300 units of
botulinum toxin for treating pain was a method of medical treatment
44

45. Canada - Dosage Units
Dosage Units
• If a claim specifies a dosage form the claim may not be a method of
medical treatment
• Should be directed to a vendible product having real economic value
Merck & Co. v. Pharmascience 2010 FC 510
• A claim to a 1 mg tablet taken as a daily dose was held to be patent
eligible subject matter on the basis that it is a “vendible product” and no skill
or judgment of a physician is required.
Merck & Co. Inc. v. Apotex, 2005 FC 755
• A claim directed to 70 mg of a particular drug on a once-weekly dosing
interval was also held to be patent eligible subject matter.
Based on these court decisions, a fixed amount of a drug administered on a
fixed schedule may not be considered a method of medical treatment and
therefore might constitute patentable subject matter
45

46. Europe - Dosage Regimes
• Enlarged Board of Appeal decision G2/08
• The claim at issue was directed to the use of a sustained-release
nicotinic acid in the treatment of abnormal levels of lipids in the blood
where the novel feature was providing the drug "once per day prior to
sleep"
• EBA held that a novel and inventive dosage regime is patent eligible,
even where that dosage regime is the only novel feature of a known drug
to treat a known illness
• Novelty can reside not only in a new dosage regime, but also in features
such as the class of patients to be treated or the method of administration
for a known disease
46

47. USA- Dosage Regimes
• Method claims reciting dosage regimes permitted if they
apply the outcome from a step of comparing, or a
determining step and describe:
• “an application of a law of nature or mathematical formula to a
known structure of process”
(Mayo v Prometheus; USSC, No 10-1150, March 20, 2012)
• a “tangible specific application”
(Classen v Biogen 2006-1634, Aug 31, 2011)
• and/or provides more than:
• “data gathering or insignificant extra-solution activity”
(Classen v Biogen 2006-1634, Aug 31, 2011)
47

48. Closing remarks
• Methods of medical treatment
• Use claims
• Diagnostic methods
• Dosing ranges or regimens
48

49. Thank You
Konrad Sechley Scott Foster
Tel: 604-443-7610 Tel: 604-891-2294
Email: konrad.sechley@gowlings.com Email: scott.foster@gowlings.com
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