Subject Matter of Patents

1. Subject Matter of Patents For an invention to be patentable, it must be of the right subject matter. See. 2 of Patent Act

2. Importance of distinctions The importance of the distinction is that not ALL inventions are patentable under Canadian law.

3. S. 2 of the Patent Act s. 2 of the Patent Act provides that “invention means any new and usefulart, process, machine, manufacture or composition of matter, OR any new and useful improvement in any art, process, machine, manufacture or composition of matter.” • S. 27 (8) provides that “patents are not available for mere scientificprinciples or abstract theorem.” Patentable “invention” have thus been described, rather than defined. The list of categories of patentable inventions is not closed.

4. United States Patent Act • “Whoever invents or discovers any new and useful process, machine, manufacture or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title” 35 USC 101.

5. Does Judicial Attitude Matter? Despite the similarity in the wording of both statutes, the U.S. has a more liberal regime.

6. Art. 27 TRIPS • “Subject to the provisions of paragraphs 2 and 3, patents SHALL be available for ANY inventions, whether products or processes, IN ALL FIELDS OF TECHNOLOGY, provided that they are new, involve an inventive step and are capable of industrial application. …

7. Plants, (provided there is a sui generis regime) Animals Inventions which commercial exploitation thereof would endanger ordre public or morality diagnostic, therapeutic and surgical methods for the treatment of humans or animals, Inventions which are prejudicial to the environment, plant life or health, or human and animal life Exceptions to Art. 27 TRIPs

8. The status of TRIPS in Canada • The WTO/TRIPs agreement applies in Canada • The obvious implication is that a combined reading of sections 2, and 27 of the Canadian Patent Act, and Art 27 of TRIPs defines the scope of patentable subject matter in Canada.

9. Non-patentable Subject Matter • Scientific principles and abstract theorems; • Ideas and Concepts; • Methods of Medical Practice; • Products of Nature; • Substances intended for food; • Aggregates; • Complex life forms.

10. Scientific Principles • Scientific principles or abstract theorems are not patentable subject matter. Items covered by this statutory exception include: • Accounting principles; • Mathematical formulae; • Rules of a game. • Query: What of business methods?

11. Scientific Principles • A scientific idea which has not yet been embodied is not per patentable. However, a scientific idea with a method for its practical application is patentable. See Shell Oil v. Commr of Patents • Similarly, a mathematical formula cannot be patented. • Whether the calculation is done by humans or by computers, no patent may issue for abstract theorems. • Query: what of computer programs?

12. Scientific Principles • Further, where mathematical calculations are part of a system which does not relate solely to such calculations but has a larger purpose, for eg, computer programmes used in a machined operation, it may be patentable. See Re Mobil’s Application. • Similarly, a claim directed to an algorithm that contains at least one piece of hardware is patentable. See Motorola Inc Patent Application.

13. Scientific Principles • The non-patentability of innovative ideas or concepts is a matter of interesting debate. Philosophically, it is difficult to rationalize. • In practice, it is often difficult to distinguish theorems from products or processes which embody or exploit those theorems. Virtually all patentable inventions exploit or embody scientific principles, theorems or laws. However, there is a juridical demarcation between “theoretical” and “applied” science.

14. Distinctions b/w Theoretical and Applied Science • Patent law professes to reward applied science (technology) rather than purely theoretical ideas. Until an “idea” or “scientific principle” is soundly predictable to be workable or has been “embodied” or “reduced” to a workable machine, process, or product, no idea or scientific principle, no matter how brilliant, would be patentable.

15. Professional Skills • Professional and personal skills are debarred from patentability. In Lawson v. Commissioner of Patents, an application for patent for a sub-divided parcel of land with lots delineated in the shape of a champagne glass was rejected. Ruling on whether the so-called ‘champagne principle’ (in itself, a display of professional art) embodied in the application was patentable, Cattanach, J. reasoned as follows:

16. Cattanach, J. cont’d • “…professional skills are not the subject-matter of a patent. If a surgeon were to devise a method of performing a certain type of operation he cannot obtain an exclusive property or privilege therein. Neither can a barrister who has devised a particular method of cross-examination or advocacy obtain a monopoly thereof.”

17. Laws of Nature • Similarly, discoveries of the “laws of nature” are not patentable. The rationale for this has been that the discoverer of laws of nature or of natural phenomenon is not the “inventor” of the law(s) in question. • Query: How does this principle sit with recent patents on genetic matter such as ESTs, cDNAs, and Single Nucleotide Polymorphisms (SNPs)? A possible answer is that they are treated as physical matter (chemicals).

18. Methods of Medical Treatment • This is a very controversial aspect of patent law. In addition to policy considerations, there is difficulty in delineating precisely the boundary between medical products and medical methods. • In addition, a medicine must be distinguished from a drug. A medicine includes any substance that is useful in the medical or surgical treatment of humans or of animals. A drug is something that contains, inter alia, a medicine.

19. Patents on Medicines & Drugs • Chemical compositions intended for medicines can be the subject of claims in a patent. • The Patented Medicines (Notice of Compliance) Regulations defines a medicine as “a substance intended or capable of being used for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof”. • Query: Is a substance for “softening the blows” of old age a medicine?

20. Patents on Medicines and Drugs • Methods for the delivery of medicines are treated differently from medicines. The former is not patentable. Thus, inhalers, patches, slow-release capsules, kits designed to dispense tablets in accordance with a particular regimen, are ALL unpatentable. • The test is whether the product itself is administered to the patient or whether it is used to administer a substance. The former is patentable, the latter is not.

21. Methods of Medical Treatment • A method claim for treatment of the human body in any medical manner with a substance is not patentable. See Imperial Chemicals Industries Ltd. • For a fuller analysis, see Tennessee Eastman

22. Tennessee Eastman v. Comm’r • Appellants sought to obtain a patent for a method of surgical bonding of body tissues that comprised the application to at least one of the tissue surfaces to be bonded an adhesive composition comprising a monomeric ester of a-cyanoacrylic acid.

23. The New Claim • The substance in question was part of the prior art and the invention lay in the unexpected result that the defined esters of a-acyanoacrylic acid polymerize from the liquid to the solid state by an anionic polymerization mechanism and have a marked affinity for adhering to surfaces of living tissue. The real issue then was whether a new use for surgical purposes of a known substance can be claimed as an invention.

24. The Ratio decidendi of the Comm’r • The Comm’r refused the application on the basis that the a-cyanoacrylates only obtain their usefulness when they are used on living tissues in living bodies and, therefore, in a process of surgical or medical treatment and do not constitute patentable subject matter. On appeal, the lower court affirmed the decision of the Comm’r of Patents.

25. The Reasoning of the Court • “The method here does not lay in the field of the manual or productive arts nor, when applied to the human body, does it produce a result in relation to trade, commerce or industry or a result that is essentially economic. The adhesive itself may enter into commerce, and the patent for the process, may if granted may also be sold, but it does not follow that the method and its result are related to commerce. The method lies essentially in the professional field of surgery …”

26. Tennessee at the Supreme Court • In the opinion of the Supreme Court, a new substance that is useful in the medical or surgical treatment of humans and animals is a patentable invention. Similarly, a process for manufacturing such substances is patentable. But a surgical or medical method of treatment is not patentable.

27. Clarity in judicial dicta? • The decisions of the court on the patentability of medical methods are sometimes inconsistent. In Re Application of Ackerman, a method of administering vaccine was denied a patent. In Imperial Chemical, a method of cleaning teeth was denied patent protection but in Re Application for Patent of Goldenberg, a diagnostic method was held patentable. Diagnostic agents, methods of contraception, etc have been patented.

28. Defining Medicine • It is sometimes a difficult task to draw the line b/w what is a medicine and what is only a product apt to be used in connection with medical instruments. • While professional skills of physicians remain unpatentable, vendible methods of delivering medical services are patentable.

29. Public policy and Medical Procedure Patents • Given the peculiar nature of medical practice, courts and legislatures are often wary of extending patent rights to medical procedures. • In the US, the case of Pallin v. Singer triggered the enactment of s. 287 of the Patent Act which invalidates patents in respect of “a medical practitioner’s performance of a medical activity.” This is limited to “the performing of a medical or surgical procedure on a body.”

30. Pallin v. Singer • Samuel Pallin and Jack Singer were both ophthalmologists. The former discovered a new and useful surgical technique for use during cataract surgery. The benefit of the technique lay in the fact that it dispensed with sutures to close eye incisions. He patented his technique and charged all surgeons $17 dollars for every surgical operation performed with his technique. Singer applied his technique without a license from Pallin. The latter sued and lost.

31. The position in Australia • Australian courts have validated patents on medical procedures. In Joos v. Commissioner of Patents, they even went further to draw a distinction between processes for the treating of diseases and processes for cosmetic appearance of the body. The latter are patentable. • Query? Given the social construction of some “diseases,” how does one distinguish “cosmetic appearance” from some “diseases”? See Bristol-Myers Squibb [2000] A.I.P.C. 91.

32. Anesthetic Supplies V. Rescare • The Australian High Court had to determine whether Prof. Collin Sullivan’s discovery that the application of Continuous Positive Air Pressure (CPAP) through the nostrils during sleep which alleviated obstructed sleep apnea, was patentable. It was alleged that Rescare had infringed Sullivan’s “invention.” Although the court invalidated the patent on the grounds of obviousness, a plurality of the judges held that medical procedures were patentable.