methods of medical treatment claims issues in canada us and europe

Methods of Medical

Treatment Claims: Issues

in Canada, US and Europe

Konrad Sechley and Scott Foster

November 27, 2012

Presenters

2

Konrad Sechley

Principle, Patent Agent – Vancouver

604-443-7610

[email protected]

Scott Foster

Associate – Vancouver

604-891-2294

[email protected]

3

Disclaimer

• Personal views of presenters

• Detailed and complex legal rules

4

Overview

• Methods of medical treatment

• Use claims

• Diagnostic methods

• Dosing ranges or regimens

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”

6

Agenda


• Use claims



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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

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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”

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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)

• 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


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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

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

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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…”

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.

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Agenda


• Use claims



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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)

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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.

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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”)

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

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Amazon case in Canada (cont.)

• Current issues - life sciences & law 2012/2013 • Authors wrote paper on draft guidelines

20

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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

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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

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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

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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

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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“.

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),

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• 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.

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US use claims (cont.)

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Agenda


• Use claims



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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

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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

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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))

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)…”

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

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US - Diagnostic Methods

• 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

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

US - Diagnostic Methods: Classen (cont)

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

US - Diagnostic Methods: Mayo

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

US - Diagnostic Methods: Perkinelmer

38

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

US - Diagnostic Methods: Myriad

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.”

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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

US - Diagnostic Methods: Myriad (cont)

41

Agenda


• Use claims



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

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

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

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

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

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)

48

Closing remarks


• Use claims



Thank You

montréal ottawa toronto hamilton waterloo region calgary vancouver beijing moscow london

Scott Foster

Tel: 604-891-2294

Email: [email protected]

Konrad Sechley

Tel: 604-443-7610

Email: [email protected]

methods of medical treatment claims issues in canada us and europe

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