OTHER INVALIDITY CHALLENGES Bill Richardson University of Toronto Thursday, March 8, 2018

OVERVIEW Introduction to Topic Inutility Ambiguity Overbreadth Insufficiency Material Misrepresentation Overlap of Invalidity Grounds

Inutility (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;”

Inutility (2/7) To establish inutility, the patent either will: not operate at all not do what the specification promises it will do. Supreme Court of Canada struck down the Promise Doctrine in 2017 Previously, if a result was promised, utility was to be measured against that promise

Inutility (3/7) A “mere scintilla” of utility will suffice Supreme Court of Canada laid out new test for utility: Identify the subject-matter of the claimed invention; and Ask whether that subject-matter is useful, in that it is capable of even a scintilla of any practical purpose that is related to the nature of the subject-matter of the claimed invention

Inutility (4/7) There must have been a demonstration of utility by the Canadian filing date Otherwise, there must have been a “sound prediction” of the utility by the Canadian filing date No patent for a lucky guess

Inutility (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

Inutility (6/7) Dates 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

Inutility (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

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.”

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

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

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

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)

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

Insufficiency (1/4) Description of the invention is quid pro quo Applicant’s gain: monopoly over invention Applicant’s price: “hard coinage” of disclosure Society’s gain: disclosure of the nature and working of the invention encourages people to invent Society’s price: Grant of monopoly

Insufficiency (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; …

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

Insufficiency (4/4) Key issue: Can POSITA successfully use the invention simple experimentation OK “inventive” experimentation Not OK.

Material Misrepresentation (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.”

Material Misrepresentation (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

Material Misrepresentation (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.

Material Misrepresentation (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

Material Misrepresentation (5/5) Truth of the allegations considered as of the time of issue of the patent.

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)