Deeth

1. Methods of Medical Treatment FICPI Forum, Lisbon, November 2005 Douglas Deeth Deeth Williams Wall LLP

2. What is a Medicine • “any substance that is useful in the medical or surgical treatment of humans or animals” • Distinguished from a substance that is “apt to be used in connection with medical treatments” • Burton Parsons v. Hewlett Packard • Used for the “diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof” • Patented Medicines (Notice of Compliance) Regulations

3. Patentable Invention • 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 • Method = process

4. Patent Act, Section 41 • In the case of … substances prepared or produced by chemical processes and intended for food or medicine, the specification shall not include claims for the substance itself, except when prepared or produced by the methods or processes of manufacture particularly described and claimed … • Repealed, 1987

5. Basis for Rejecting Claims • Not an invention • Prohibition against claim to medicine • Non-economic • Professional skill • Lack of Utility • Not Reproducable or Controllable • “Public Policy”

6. Surgical Procedures • Tennessee Eastman v. Commissioner • Claim - surgical method for joining or bonding the surfaces of incisions or wounds in living animal tissue by applying [A] to at least one of the tissue surfaces to be bonded

7. Tennessee Eastman (Trial) • method not in the field of the manual or productive arts • does not produce a result that is essentially economic. • method lies essentially in the professional field of surgery and medical treatment of the human body, even although it may be applied at times by persons not in that field. • method is not an art or process within the meaning of s. 2(d) of the Patent Act

8. Tennessee Eastman (SCC) • Section 41 restricts the scope of patents “relating to substances prepared or produced by chemical processes and intended for food or medicine.” • The first principle proclaimed is that in the case of such inventions, “the specification shall not include claims for the substance itself except when prepared or produced by the methods or processes of manufacture particularly described in the claim…”

9. Tennessee Eastman (2) • This necessarily implies that the therapeutic use cannot be claimed by a process claim apart from that substance itself. • Otherwise, its use however prepared could be claimed as a method of treatment. • Making such a process claim would be an easy way out of the restriction in s. 41(1) • As methods of medical treatment are not contemplated in the definition of “invention” as a kind of “process,” the same must be true of a method of surgical treatment

10. Implications of Section 41 • Imperial Chemical – After section 41 repealed • Claims to “method of cleaning plaque or stains, including tobacco stains, from human teeth by applying thereto an aqueous composition [of A] in the form of dissolved water-soluble salt…being designed for direct application to teeth and being in a form for use in a non-sequential manner”

11. Imperial Chemical • Tennessee Eastman was “a clear and unequivocal statement that methods of medical treatment are not contemplated in the definition of invention as a kind of process…” • Not restricted to factual situations where section 41(1) of the Act applied

12. Cosmetic Treatment • the method does not produce a result that is essentially economic • “what individuals do to their own teeth as they stand before a mirror in their bathrooms is not a process in the economic sense which the patent was created to protect.

13. Use Claims - Shell Oil • Claims to a new use of a known compound, (mixed with an adjuvant) as a plant growth regulator. • The Supreme Court of Canada held that a new use of a known compound was an “invention” because, “it involved the application of new knowledge to effect a desired result which had an undisputed commercial value.” • Therefore, the claims met the requirement of any “new and useful art.” • However, it was not clear whether this principle extended to the pharmaceutical industry

14. Methods Not Medical Treatment • Diagnosis & evaluation • Prevention • Clinical testing • Naturally occurring conditions

15. Diagnostic Methods • Re Appln of Kevin McIntyre • claims to a method of evaluating the mechanical condition of a heart. A 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

16. MacIntyre (2) • commercial value of diagnostic methods cannot be assessed “as if they are processes for producing milled feedstock.” • “The test must be that some economic benefit can be realized by those who practice the method.” • the patent “can be worked on a commercial scale that is adequate and reasonable under the circumstances, and which will certainly result in some form of economic benefit for the practitioner” • Cf Tennessee Eastman

17. Detection • In re Appln of Goldenberg • methods of detection for detecting and localizing a tumor which produces or is associated with a cytoplasmic, intracellular or cell surface marker substance, without medically treating the tumour. • involved the injection of radio-labeled antibody substances which have a high specific activity and a high specificity for carcino-embryonic antigens, and which are specific to a variety of tumours

18. Goldenberg • 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 • no legal authority for this extension • Rejected Examiner’s position that anything is 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

19. Swift’s Application • Claim to method for improving the tenderness of meat by introducing a proteolytic enzyme into the vascular system of a living animal, and then slaughtering the animal after a period of time sufficient to permit substantially uniform distribution of the enzyme throughout the animal’s body but before the presence or effectiveness of the enzyme has been eliminated by the animal’s body processes

20. Swift’s Application • Distinguished in Tennessee Eastman as not relating to a method of medical or surgical treatment • In Goldenberg, Commissioner held that process of injecting a non-therapeutic substance into a human, even if it modified the metabolism, was not a method of medical treatment

21. General Hospital - Prevention • Claims directed to a method of preventing pregnacy which involved “administering [via a delivery system] • during the entire follicular phase of the menstrual cycle … an LHRH composition and sufficient levels of an estrogenic steroid to counteract the possibility of side effects which may develop during prolonged therapy with LHRH and • during the entire course of the luteal phase, the LHRH/estrogenic steroid combination in combination with a physiological amount of a progestational steroid

22. Senentek - Prevention • Claims directed to methods and compositions of ameliorating the adverse effects of aging, which involved contacting mammalian cells on the surface of a living animal with a cosmetic composition that contained an effective concentration of a 6-purine cytokinin

23. Naturally Occurring Conditions • Patent Appeal Board in both of these situations allowed the claims, holding that aging and pregnancy are natural conditions of the human body. Neither method involved the treatment of a pathological condition; neither method was a method of medical treatment • Q: Is hypertension a naturally occuring condition?

24. New Therapeutic Use • Merck & Co Application • Claim – use of an encapsulated cell line … for increasing milk in cows by in vivo implementation • Wayne State • Use of old compound in a therapeutic method for reducing metastasis and neoplastic growth in animals

25. Automated Procedures • Visx v. Nidex • The claims directed to a medical apparatus used to perform ultraviolet laser eye surgery by selective ablation of the anterior surface of the cornea. • The claims did not teach a method for effecting the operation but related to an apparatus with a combination of several elements

26. Visx • patents do not teach professional skills to surgeons or impose a limitation upon the surgeons’ skills. • assist a surgeon in his operation on the human eye. It focuses, directs and shapes the beam. It determines and controls an area of exposure and does the ablation. • All the surgeon does is prepare the patient and enter basic measurements into the computer

27. New Compounds • Merck & Co. v. Apotex Inc. • claims to compounds, compositions, and their use in prescription medicines for the treatment of hypertension • not for a method or methods of medical treatment. • specification acknowledged that administration for medical purposes could only be done by a person skilled in the art of prescribing medicines

28. New Compound in Formulation • Formulaton Claims • “a pharmaceutical composition for reducing hypertension comprising [active + carrier]” • Long line of cases holding that claims to active + carrier not allowable if active already patented • Active + carrier allowable in same application as claim to active

29. New Dosage Unit • Bayer v. Apotex – Nifedipine • claims to a new dosage unit for a known compound, Nifedipine a coronary dilator. • Claim 1 – a capsule comprising a gelatin shell containing N, PEG and lower alcohol, which could be released from capsule by biting to administer the Nifedipine perlingually

30. Not a method of treatment • “The claims … merely describe the physical characteristics of the capsule, and do not dictate how the capsule is to be used. • Although one can infer a method of treatment from the physical characteristics of the capsule, patent does not limit its use in any particular way. • The claims are to a coronary dosage unit form and do not relate to an area of professional skill

31. New Use of Old Compound • Apotex v. Wellcome • claims to use of various formulations of AZT in the treatment and prophylaxsis of AIDS and human retroviruses infections • claims covered various pharmaceutical formulations of AZT • some specified the uses to be made of the formulation - others not so limited • some directed to various methods of formulation

32. Apotex v. Wellcome - AZT • while the claims in issue had a medical purpose, they were directed towards the treatment of disease, the invention was not a method of medical treatment. • the claimed invention did not remove the need for professional skill and judgment • patent dealt with an economic area related to trade, commerce or industry

33. Treatment vs. Product • Supreme Court of Canada - “the AZT patent does not seek to “fence in” an area of medical treatment. It seeks the exclusive right to provide AZT as a commercial offering. How and when, if at all, AZT is employed is left to the professional skill and judgment of the medical profession.”

34. New Use vs. Formulation • Federal Court of Appeal • Claim 1 – pharmaceutical formulation comprising AZT and a carrier • Held invalid – not limited to new use • Shell Oil distinguished because Shell claimed a “plant growth regulant”

35. Scope of Claims Questioned • Claims to use of AZT in the treatment or prophlyaxis of all human retroviral infections • overbroad - utility not established • Claims to use of AZT for treatment of AIDS infection • invalid – “AIDS infection” ambiguous

36. Enforcement of Use Claims • Infringement proceedings • Patentee may have to show inducing or procuring infringement by defendant • NOC Proceedings • Only question is whether there will be some use of product in an infringing way • Concern about new use monopolizing all uses of an old product

37. Utility • “useful art or process” rather than a fine art to meet the utility requirement. A “fine art” has been defined as subject matter where the result produced is solely the exercise of personal skills, mental reasoning or judgment or has only intellectual meaning or aesthetic appeal • Ref to Kerr in TE

38. Utility of Use Claims • Reproducibility – requirement for skill and knowledge may lead to lack of reproducibility and inability to “fully disclose” the invention.

39. Predictability • predictability • predicting therapeutic activity vs sound prediction of utility as a medicine in the human body • prediction vs subsequent proof • lack of utility vs lack of testing • utility required for new use is either demonstration or sound prediction of utility based on information and expertise then available • sound prediction does not mean certainty • but "predictability of chemical reactions not = predictability of pharmacological effects and thus of pharmacological utility

40. U.S.A.- Morton • Morton v. New York Eye Infirmatory – 1862 • claimed the performance of surgical operations using ether. • compound and the process of inhaling vapours were old • “invention” rested in the discovery of a new utility for use of increased amount of ether and was not patentable.

41. Morton • The court in rejecting the patent stated that “neither the natural functions of an animal upon which or through which it [a discovery] may be designed to operate, nor any of the useful purposes to which it may be applied, can form any essential parts of the combination, however they may illustrate and establish its usefulness.”

42. Brinkerhoff - 1883 • methods of medical treatment are “discoveries which may in a majority of cases under certain conditions particular accomplish certain results, but no method or mode of treatment under all circumstances, and in all cases will produce upon all persons the same result” • “to grant a patent for a particular method of treatment would have a tendency to deceive the public by leading it to believe that the method therein described and claimed would produce the desired result in all cases”

43. Scherer - 1954 • Claim to “a new method of injecting medicaments by a pressure jet.” • result “not dependant on the psychological and physiological reactions of the human body but involves only the purely physical characteristics of the human flesh.” • uncertainty of results is not “an appropriate reason to deny the patentability of all methods” • more properly considered a question of utility

44. No Remedy against Doctors • 35 U.S.C. Section 287(c) • remedies against patent infringement shall not apply to medical practitioners and related health entities for the performance of a medical activity

45. What CIPO will not search • methods of medical treatment of living humans and non-humans intended to improve the function or health of a living part of a body which include the manipulation of the body or its organs or tissues using electrical or mechanical means for the prevention or treatment of pathological conditions; • surgical methods (invasive procedures) • methods of use claims and use claims including manipulative steps.

46. What CIPO Will Search • A search will be carried out for the following subject matter, provided that they do not include surgical steps • Diagnostic methods • Cosmetic Methods • Methods of treatment of animals to derive an economic benefit

47. What can be claimed • Use of A to treat hypertension • Use of A to prepare a formulation for the treatment of hypertension • Formulation comprising A + excipients for the treatment of hypertension • An anti-hypertensive formulation comprising A + excipients