1. Patent & Trade Secrets Law Bill Richardson and Ariel Neuer University of Toronto February 28, 2012

2. 2 Other Attacks on Validity

3. 3 Sufficiency (1/4) PatenteeSociety Gain -Monopoly over invention -Disclosure of the nature and working of the invention -Incentive for people to invent Price -“hard coinage” of disclosure -Grant of monopoly restricts others Description of the invention is quid pro quo

4. 4 Sufficiency (2/4) Patent Act 27. (3) The specification of an invention must (a) correctly and fully describe the invention and its operation or use as contemplated by the inventor; (b) set out clearly the various steps in a process, or the method of constructing, making, compounding or using a machine, manufacture or composition of matter, in such full, clear, concise and exact terms as to enable any person skilled in the art or science to which it pertains, or with which it is most closely connected, to make, construct, compound or use it; …

5. 5 Sufficiency (3/4) Only 2 questions relevant to type of information required under 27(3): –What is your invention? –How does it work?

6. 6 Sufficiency (4/4) A question of mixed fact and law Key issue: Can POSITA successfully practice the invention? simple experimentation  OK “inventive” experimentation  Not OK.

7. 7 Utility

8. 8 Utility (1/7) Derives from s. 2 of Patent Act: “‘invention’ means 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;”

9. 9 Utility (2/7) To establish inutility, the patent must either: –not operate at all or –not do what the specification promises it will do Disclosure and date of invention important (see below)

10. 10 Utility (3/7) Where no result promised, a “mere scintilla” of utility will suffice However, if a result is promised, utility will be measured against that promise –The question is whether the invention does what the patent promises it will do.

11. 11 Utility (4/7) There must have been a demonstration of utility by the Canadian filing date However, no requirement to prove utility in patent so long as can prove it in response to legal challenge Otherwise, there must have been a “sound prediction” of the utility by the Canadian filing date Premise of sound prediction: No patent for a lucky guess

12. 12 Utility (5/7) Sound prediction requirements: (1) there must be a factual basis for the prediction; (2) the inventor must have an articulable line of reasoning (3) disclosure of the factual basis and line of reasoning must be in the patent

13. 13 Utility (6/7) Dates and disclosure are important Was utility established as of filing date? –(a) if so, no requirement to disclose support for utility in patent –(b) if not  sound prediction  patent must disclose factual data on which the prediction is based and line of reasoning

14. 14 Utility (7/7) If a patent claim includes within its scope subject matter lacking utility (“inoperable species”), the entire claim is invalid Entire claim Inoperable species

15. 15 Ambiguity

16. 16 Ambiguity (1/4) Patent Act, S. 27(4) “The specification must end with a claim or claims defining distinctly and in explicit terms the subject-matter of the invention for which an exclusive privilege or property is claimed.”

17. 17 Ambiguity (2/4) Claims must be: sufficiently explicit so as to inform the reader as to what is within and what is not within its ambit

18. 18 Ambiguity (3/4) Claim must NOT be: –unclear or given insufficient direction as to its boundaries (fences) –vague –interpreted in more than one way, so that it would be impossible for anyone to know whether something falls within

19. 19 Ambiguity (4/4) A claim is construed according to principles of claims construction enunciated by the S.C.C. (see Free World Trust) The language of the claims must be read in light of the specification as a whole, although only the language of the claims that determines the scope

20. 20 Overbreadth

21. 21 Overbreadth (1/2) Patent Rules, S. 84 “The claims shall be clear and concise and shall be fully supported by the description independently of any document referred to in the description.” See also Patent Act s. 27(3) and (4)

22. 22 Overbreadth (2/2) Patentee can: –Claim less than that which is disclosed Patentee cannot –Claim more than that which is disclosed  overbreadth

23. 23 Section 53

24. 24 Section 53 (1/5) Patent Act, 53(1): “A patent is void if any material allegation in the petition of the applicant in respect of the patent is untrue, or if the specification and drawings contain more or less than is necessary for obtaining the end for which they purport to be made, and the omission or addition is wilfully made for the purpose of misleading.”

25. 25 Section 53 (2/5) Allegations under s. 53 implicate the notion of fraud The onus is on the party alleging an intention to mislead to prove it Allegation should not be made lightly, without a sufficient evidentiary foundation There are serious cost consequences to an unproven allegation

26. 26 Section 53 (3/5) (1) Untrue material allegation plain reading: no requirement for wilfulness Some cases have discussed wilfulness when considering this part of the section Cases suggest that the focus is on materiality An untrue statement, even if made without intention, will void a patent if it is material.

27. 27 Section 53 (4/5) (2) Wilfully misleading omission/addition Proof of wilfulness is an essential element Can be made out by evidence from which intent to mislead can be inferred

28. 28 Section 53 (5/5) Truth of the allegations considered as of the time of issue of the patent.

29. 29 Overlap of Grounds “ I have deliberately bundled all of the topics listed in the title of this portion of these Reasons, “Anticipation/Obviousness/Sound Prediction/Sufficiency of Disclosure” together. There is one issue to be considered namely, the validity of the ’356 patent. There is a tendency in the jurisprudence to pigeonhole arguments respecting validity into certain categories such as “anticipation” or “obviousness” and so forth. Each category has collected about itself an accumulation of jurisprudence. Each category tends to be argued separately creating, on occasion, contradictions, inconsistencies and gaps.” Eli Lilly Canada Inc. v. Apotex Inc., 2008 FC 142 at para 64 (Hughes J)

30. 30 Miscellany –Disclaimer: –Patentee may amend a patent to claim less than what was claimed in the original patent –Must arise through mistake, accident or inadvertence –Re-examination: –Any person can request that patent claims be re-examined by the patent office –Rarely used in practice, since patentee has ability to amend claims –Maintenance fees: –A patent can lapse if patentee fails to pay fees in a timely manner and remedial action is not taken

31. 31 Case studies –Why are these claims/patents invalid? –Patent for pills that promise to lengthen body parts or to burn away 20 lbs in 2 weeks –Patent for chemical process; however key step in process is omitted in disclosure

32. 32 Case Study #2 (Utility) News report: mice suffering from fur loss regained their fur when injected with compound (“astressin-B”) http://www.thestar.com/news/sciencetech/science/article/944343--scientists-cure-baldness-in-mice Would a claim for treatment of hair loss in humans based on the mouse study be valid?