1. Intellectual Property: Patenting Procedure and Requirements for Patentability T.T. Lang

2.  What is a patent?  A patent is a government granted monopoly  Exclusive right to make, use or sell an invention  The right to exclude others from making, using or selling an invention What Is a Patent?

3.  What is an invention?  New or useful art, process, machine, manufacture or composition of matter  Improvements  Defined in s.2 of the patent act Patents are granted for inventions

4. Patent Is a Business Asset  Value of a patent is determined by the subject matter  Some patents are very valuable and others are less so  Value may also be determined by enforceability

5. Patent Act – Federal Legislation  Patents are entirely a creature of statute  No common law basis, case law interprets and applies provisions of the Patent Act  Patent Rules govern procedural aspects of applying for a patent

6. Section 27 – Patent Act  (1) authority to grant patents to inventors  (3) defines what is necessary by way of description  (4) requires claims that are distinct and explicit  (8) provides an exclusion for mere scientific principle or abstract theorem

7. Parts of a Patent  Claims  Serve to define the invention to be protected  Description and drawings  Serve to teach  Addressed to a person skilled in the art  Disclose the best mode – machine  As contemplated by the inventor

8. Consolboard Inc. v. Macmillan Bloedel (Sask.) Ltd. (1978), 63 CPR (2d)  Enabling disclosure is the heart of the patent system  Patent is entirely directed at those skilled in the art  Claim construction  In FCT, for infringement or validity opinion  Done from point of view of person skilled in the art, at the date of patent publication [whirlpool and FreeWorld trust cases]

9.  Utility is a very low threshold and does not need to be explicitly stated

10. Requirements for Patentability  Must be an “invention” as defined in the Act  Subject matter  Must be new (“novel”, “unanticipated”)  Must be non-obvious (“inventive”)  Must have utility  Applicant must be the inventor, or have derived rights from the inventor  Naming proper inventor (Apotex inc. V. Wellcome foundation (1998) 79 CPR (3d) 193) & (Q’max case)

11. What Is Patentable Subject Matter?  Living Matter:  Grant to lower life forms:  Diamond v. Chakrabarty (US)  Abitibi Co.  Not higher life forms:  Harvard Mouse – Patent Appeal Board  Harvard Mouse – Federal Court  Harvard Mouse – Supreme Court of Canada

12. Harvard Mouse Patent

13. What Can’t Be Patented?  Higher life forms  Methods of medical treatment  Scientific principles or abstract theorems (Section 27(8))  Software  Business methods  Professional methods – interpretive or judgmental reasoning

14. Methods of Medical Treatment  Tennesee Eastman v. Commissioner  A chemical used as an adhesive was known  The new discovery was that it bonded human tissue – used in place of stitches to close wounds  SCC held that methods of medical surgical treatment are not inventions  EPO has a similar ban  USPTO allows such claims

15. What Is Patentable Subject Matter?  Surgical treatment  No  Diagnostic methods  Yes – not a method of medical treatment  Preventative medicine  Questionable – no case law  Contraceptive methods  Yes – (re. General Hospital)  Medicines  Yes  Medical devices  Yes

16. In the Claims  A method for treating Disease X, comprising administering an effective amount of compound Y to a patient  No  Use of compound Y for treating cancer disease  Use of compound Y for preparation of a medicament for treating cancer disease  Use of compound Y for the amelioration of the effects of disease X

17.  Use of compound Y for therapeutic treatment  No

18. Software  Software is not patentable as an article  Software is patentable as a method, provided that the method involves more than just a calculation (Schlumberger)  May be considered a mere mathematical algorithm  Hardware (system) which relies on software is patentable (re. Westinghouse)

19. Business Method  Methods of doing business  Not patentable in Canada (lack of utility)

20. Few Examples: Patentable?  A new way to wager in a poker game  No, lack utility (progressive games decision)  A wallpaper pattern that is a nice design  No, lack utility, industrial design subject matter  A wallpaper pattern of proven therapeutic value  Yes, has utility

21.  A method of anger management training  No, business method, requires professional skill  A heart valve for implantation in a human heart  Yes, not a medical treatment, medical device  A new crack cocaine pipe  Yes, even illicit subject matter is patentable

22. IP Trail: Patenting an Invention 1. Innovation/ development 2. Patenting strategy Filing program Publication Examination 3. Patent prosecution Amendments 4. Issuance 5. Commercialization 6. Infringement/validity

23. What Are the Costs?  Filing fee - $300  Examination fee - $400  Final fee - $300  Maintenance fee – payable commencing 2 nd anniversary of filing date and annually thereafter  Different from US – due 3 times, larger amount  Reinstatement fee - $200

24. Maintenance Fee  Is a government fee  Must be paid at the CIPO  For both pending applications and issued patents to keep them in good standing  Applicant may claim “small entity” status  Pay half of the fees of a “large entity”  In Canada, “small entity” refers to an entity that employs 50 or fewer employees or a university

25.  In the US, “small entity” refers to a company with 500 or fewer employees, a non-profit organization or an independent inventor

26. Claiming Small Entity Barton No-Till and Flexi-Coil v. Dutch Industries  Small entity status:  Is critical to determine whether applicable to applicant;  Whether there is a likelihood that the “entity” status may change  Will not be questioned by CIPO for correctness  Patent rights may be entirely lost through improper assertion of small entity status

27.  Does not apply to entity which  has transferred or licensed,  or is obligated to transfer or license, any right to the invention to a third party which does not qualify as a small entity  CIPO has no discretion to accept top-up payments to correct underpaid patent maintenance fees from small entity to large entity  CIPY currently does not accept corrective payments

28. Grant of Patents  s.42 – exclusive rights to make, construct, use or sell the invention  s.44 – 20 year term  From the filing date (Canadian filing)  From the filing date, or earliest priority date, if a request made claiming priority of earlier filed application (US filing)  s.43 – presumption of validity  s.46 – subject to payment of maintenance fees

29. Amendments to Patents  During prosecution/final fee not paid  s.38.2(2) must be satisfied  Matter that may be reasonably inferred from the specification/drawings may be entered  No new subject matter may be added  Notice of allowance  In addition to s.38.2(2)  No amendments that would necessitate a further search by examiner or change part of invention  Correction of clerical error

30. Post-Issuance Amendments  Disclaimer – amend a patent to claim less than what was claimed in the original patent  For all or part of a claim  Anytime during life of patent  Can narrow, but not broaden claim  Prescribed fee  Re-examination  Any person can request  During life of patent  On basis of prior art only  Cannot broaden claims  No change to disclosure  Open to public inspection

31.  Re-issue  Defective patent may be corrected  Can broaden or narrow claim  Must be made within 4 years of issuance of original patent  Section 8 clerical error  Anytime  Prescribed fee

32. Opposition of a Patent Before Patent Office  Canada – CIPO  Pre-issuance  Protest (Rule 10 & s.34.1)  Post-issuance  Re-examination (s.48.1)  US – USPTO  Pre-issuance  Interference proceedings  Post-issuance  Re-examination

33.  EPO  Pre-issuance  Between publication and issuance  Can present written observations on patentability  To influence refusal of patent  No right to be heard or be informed of examiner’s reaction  Post-issuance  Within 9 months  Any person may commence opposition proceeding