• Save
Methods of Medical Treatment Claims Issues in Canada US and Europe
Upcoming SlideShare
Loading in...5
×
 

Methods of Medical Treatment Claims Issues in Canada US and Europe

on

  • 3,101 views

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

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

Statistics

Views

Total Views
3,101
Views on SlideShare
2,639
Embed Views
462

Actions

Likes
0
Downloads
0
Comments
0

13 Embeds 462

http://www.gowlings.com 309
http://www.mondaq.com 75
http://accessibility_checker.siteimprove.com 29
http://194.88.95.59 18
http://m.gowlings.com 11
http://devwep01.gowlings.corp 7
http://webiis02.mondaq.com 4
http://gowlinks.gowlings.corp 3
http://webiis06.mondaq.com 2
http://webiis05.mondaq.com 1
http://translate.googleusercontent.com 1
https://twitter.com 1
http://www.google.ca 1
More...

Accessibility

Categories

Upload Details

Uploaded via as Adobe PDF

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment

Methods of Medical Treatment Claims Issues in Canada US and Europe Methods of Medical Treatment Claims Issues in Canada US and Europe Presentation Transcript

  • Methods of Medical Treatment Claims: Issues in Canada, US and EuropeKonrad Sechley and Scott FosterNovember 27, 2012
  • PresentersScott FosterAssociate – Vancouver604-891-2294scott.foster@gowlings.comKonrad SechleyPrinciple, Patent Agent – Vancouver604-443-7610konrad.sechley@gowlings.com 2
  • Disclaimer• Personal views of presenters• Detailed and complex legal rules 3
  • Overview• Methods of medical treatment• Use claims• Diagnostic methods• Dosing ranges or regimens 4
  • 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
  • Agenda• Methods of medical treatment• Use claims• Diagnostic methods• Dosing ranges or regimens 6
  • Canada - Medical TreatmentIt is trite law in Canada that methods of medical treatmentdo not constitute patent eligible subject matter.Public policy - to prevent a medical professional from beingbarred from practicing a beneficial treatment that may bebased on their skill and judgment 7
  • Canada - Medical Treatment (cont.)Tennessee Eastman Company et al. v. Commissionerof 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
  • 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
  • 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
  • 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 remediedRe 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
  • Europe – Medical TreatmentEuropean 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
  • 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
  • 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 practitioners 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
  • Agenda• Methods of medical treatment• Use claims• Diagnostic methods• Dosing ranges or regimens 15
  • 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
  • Canada - New uses of old compoundsShell Oil v. Canada (Commissioner of Patents) (1982), 67C.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
  • 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
  • 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
  • Amazon case in Canada (cont.)• Current issues - life sciences & law 2012/2013 • Authors wrote paper on draft guidelines 20
  • 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
  • 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
  • Europe - use claimsEPC1973 • 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
  • 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
  • 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
  • US use claimsUse claim format generally not accepted in the USMPEP 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
  • 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
  • Agenda• Methods of medical treatment• Use claims• Diagnostic methods• Dosing ranges or regimens 28
  • Canada- diagnostic methodsDiagnosis and evaluation • Generally speaking, not a method of medical treatment and therefore patent eligibleIn 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
  • Canada- diagnostic methods (cont.)In re Application for Patent of Kevin McIntyre (1992), 53C.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
  • Europe - diagnostic methodsEPC1973 • 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
  • 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
  • US - Diagnostic MethodsRecent 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
  • 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
  • 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: MayoMayo 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: PerkinelmerPerkinelmer 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: MyriadAMP v Myriad: (USCAFC, No 2010-1406, Aug 16, 2012 – under appeal)• 15 claims from 7 patients challengedClaim1 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
  • 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
  • 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
  • Agenda• Methods of medical treatment• Use claims• Diagnostic methods• Dosing ranges or regimens 41
  • 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 patients 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
  • 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
  • Canada - Dosage Regimes (cont.)In Re Allergan, Inc. Patent Application No. 2,300,723 (2009) 79C.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
  • Canada - Dosage UnitsDosage 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 valueMerck & 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
  • 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
  • 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
  • Closing remarks• Methods of medical treatment• Use claims• Diagnostic methods• Dosing ranges or regimens 48
  • Thank You Konrad Sechley Scott Foster Tel: 604-443-7610 Tel: 604-891-2294 Email: konrad.sechley@gowlings.com Email: scott.foster@gowlings.commontréal  ottawa  toronto  hamilton  waterloo region  calgary vancouver  beijing  moscow  london