Statutory Basis • "invention" means any new and useful art. . . • But the novelty requirement is set out in detail in s28.1/2 • An invention which is not new is “anticipated”
Rationale • The novelty requirement is a minimal standard for ensuring that the invention is a contribution to knowledge • At one time patents were granted individually on application to the king • This system was abused • Eg A monopoly in playing cards granted to a No monopolies for
Technical • When must an invention be new? • First to file v first to invent • Where must an invention be new? • Anywhere in the world • What does it mean for an invention to be new? • How similar does must the prior art be in order to anticipate the invention? • Where is the borderline with non-obviousness?
First-to-File/Invent • First-to-file • When two patent applications are filed for the same invention, the first person to file is entitled to the patent • All of the world except the US • US will be changing soon • First-to-invent • When two patent applications are filed for the same invention, the person who proves that they were the first to invent is entitled to the patent • This is established in an “interference” proceeding
First-to-File/Invent • The disadvantage of the first-to-invent standard is that it leads to litigation • Evidence of invention must be kept in case of interference proceedings • eg Engineering notebooks • Must be kept for long periods as interference can be declared long after issue • This is true for anyone who wants to apply for a US patent – not just US inventors
QualifiedAbsolute Novelty • Absolute Novelty • An invention is new if it is not part of the state of the art / prior art as of the priority date • What is the priority date? • What is the state of the art? • Qualified • One year grace period for disclosure by inventor
Filing Date v Claim Date • Claim date v filing date • Filing date is the date of filing of the Canadian application • Claim date is the date from which the Canadian application can claim priority • Often referred to as “priority date”
Claim / Priority Date • When is the “claim date”? • For patent applications filed only in Canada, it is simply the filing date: s 28.1(1) • However, the claim date is adjusted to allow for the international patent filing system • Claim date is filing date of international filing under PCT or other applicable treaty • So long as filing in Canada follows within one year
State of the Art • State of the art is all information • Made available to the public • By use or written or oral description • Anywhere in the world • As of the priority date
State of the Art • Plus all information • In Canadian patent applications with an earlier priority date, including convention filings • It is irrelevant whether the prior application has been published – it is considered as part of the state of the art even though it is secret • However, unpublished foreign applications are not part of the state of the art
State of the Art • Result: First to file wins
Prior Public Knowledge • S.28.2 (1)The subject-matter defined by a claim in an application for a patent in Canada (the "pending application") must not have been disclosed. . . • (b) before the claim date by a person not mentioned in paragraph (a) in such a manner that the subject-matter became available to the public in Canada or elsewhere; • Not previously disclosed to the public anywhere in the world
Prior Canadian Application • Or in a patent application . . . • (c) in an application for a patent that is filed in Canada by a person other than the applicant, and has a filing date that is before the claim date; or • Prior filing in Canada
Prior Convention Application • (d) in an application (the "co-pending application") for a patent that is filed in Canada by a person other than the applicant and has a filing date that is on or after the claim date if • [applicant has previously filed an application in a convention country] • [prior to the claim date] • [and claimed convention priority]
Qualified • Grace period after disclosure by inventor • (a) more than one year before the filing date by the applicant, or by a person who obtained knowledge, directly or indirectly, from the applicant, in such a manner that the subject-matter became available to the public in Canada or elsewhere;
Qualified • Note that grace period is not adjusted for international filing • Inventor has one year from disclosure to file in Canada • Many systems do not have a grace period • Do not count on it
Old Act – Pre-1993 • First-to-invent • Distinction between paper disclosure and use • Prior use outside Canada irrelevant • Two year grace period • For paper disclosure anywhere in the world • For prior use in Canada • Ie. First-to-invent could obtain patent so long as filed within 2 years of disclosure by anyone
What must be disclosed • Prior use , prior sale, prior publication, all had separate statutory bases at one time • Now simply “disclosed in such a manner that the subject matter became available to the public”
Old Law • Prior to 1996 distinguish • Paper anticipation • Prior use
Old Law • Paper Anticipation • The prior disclosure is only by means of a publication, ie the thing itself was never produced • The disclosure in the publication must be equal to the patent disclosure
Old Law • Prior Use • Where the thing itself is disclosed the rule is: • Infringement after = anticipation prior • Anything which would have infringed will be sufficient to anticipate • It does not matter if it would have been difficult to reverse engineer to discover the invention, or that it never in fact was reverse engineered
Enabling Disclosure • In order to anticipate invention, prior art must: • Disclose • AND • Enable
Disclosure • Must disclose the very thing that is claimed • A signpost, however, clear, upon the road to the patentee's invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee. • Sachs LJ, General Tire v Firestone Tire
Disclosure • The requirements that must be met before an invention should be held to have been anticipated by a prior publication must, for the purposes of practical utility, be equal to that given by the subsequent patent. . . . It is not enough to prove that an apparatus described in it could have been used to produce a particular result. There must be clear directions so to use it. • Thorson P. The King v. Uhlemann Optical Co.
Disclosure • Nor is it sufficient to show that it contained suggestions which, taken with other suggestions, might be shown to foreshadow the invention or important steps in it. There must be more than the nucleus of an idea which, in the light of subsequent experience, could be looked on as being the beginning of a new development. • Thorson P. The King v. Uhlemann Optical Co.
Enablement • Must provide sufficient information for a person skilled in the art to be able to arrive at the invention that has been disclosed • Enablement means that the ordinary skilled person would have been able to perform the invention which satisfies the requirement of disclosure. • Synthon
Enablement • Some trial and error is permitted at the enablement stage • Contrast disclosure which requires the flag to be planted at the precise location • E.g. Invention claims chemical compound which was previously sold in the open market • Disclosure is satisfied • Enablement is satisfied IF skilled chemist can ‘reverse engineer’ the compound
Enablement • The prior patent must provide enough information to allow the subsequently claimed invention to be performed without undue burden. . . . If inventive steps are required, the prior art will not be considered as enabling. However, routine trials are acceptable and would not be considered undue burden • Sanofi
Enabling Disclosure • No longer true that “Infringement after = anticipation prior” • If the use did not enable a person skilled in the art to perform • Infringement after • But not anticipating before
Rationale • An invention is a piece of information. Making matter available to the public within the meaning of section 2(2) therefore requires the communication of information. The use of a product makes the invention part of the state of the art only so far as that use makes available the necessary information. • Merrell Dow v Norton HL, per Lord Hoffmann
Rationale • Old approach viewed an invention as a thing • New approach views invention as information • Difference is important only when disclosure of the thing is not equivalent to disclosure of the information
Example • Same chemical as claimed in patent was sold on the open market and • (1) Formula / method of manufacture is not publically known and cannot be determined from the chemical itself • Not enabling • (2) Formula can be determined from compound itself by skilled chemist using standard techniques • Enabling
Merrell Dow v Norton • Merrell Dow held expired patent on terfenadine. • Anti-histamine • Then discovered active metabolite and patented that. • Active metabolite is inevitably made when terfenadine is swallowed. • Norton sells terfenadine. • Is patent on active metabolite is invalid as anticipated by prior use or terfenadine patent?
Merrell Dow v Norton • No anticipation by use • When terfenadine swallowed by end-consumers. • Who then make active metabolite • Not anticipated on this basis: • Use disclosed “no information to the public about the nature of the product or how to make it.” • Recall: “the product” = active metabolite
Merrell Dow v Norton • Anticipation by terfenadine patent • Disclosed = Yes • “In this case, knowledge of the acid metabolite was in my view made available to the public by the terfenadine specification under the description "a part of the chemical reaction in the human body produced by the ingestion of terfenadine and having an anti-histamine effect".”
Merrell Dow v Norton • Anticipation by terfenadine patent • Enabled = Yes • Anyone would know who to make the active metabolite – by swallowing terfenadine • (Note: for the purposes of the litigation, patent was construed to claim only active metabolite in the human body)
Apotex v Sanofi-Synthelabo • Selection patent = ‘777 clopidogrel bisulfate • Genus = ‘875 – large class of compounds, encompassing clopidogrel bisulfate • Claim specifies a class of free bases, including clopidogrel, and pharmaceutically acceptable salts, which include the bisulfate: total # in class = approx. 250,000
Apotex v Sanofi-Synthelabo • Sanofi holds • Enabling disclosure approach to anticipation from Synthon is correct • Selection patents are valid in principle
Apotex v Sanofi-Synthelabo • On the facts – No disclosure in prior art • “If in reading the genus patent the special advantages of the invention of the selection patent are not disclosed, the genus patent does not anticipate the selection patent.”
Apotex v Sanofi-Synthelabo • On the facts – No enablement in prior art (obiter) • For anticipation, the genus patent must provide enough information so as to allow the selected invention to be performed without undue burden. In this case, the applications judge concluded that the ‘875 patent did not specifically lead to the claimed invention. He noted, on the record before him, that if one were to follow the teachings of the prior art, one would obtain racemates, never their isomers.
Apotex v Sanofi-Synthelabo • Discovering the special properties of the enantiomer of clopidogrelbisulfate was undue, whether or not it was inventive (non-obvious) • In determining whether the enablement step for proving anticipation has been met, it is important to note that routine trials are acceptable but inventive steps are not permitted. • Court ultimately concluded that it was in fact non-obvious
Public • The inventor can disclose to others so long as the disclosure is confidential • Eg to raise money • Saunders Airglide • Grace period does not run because there is no disclosure in the relevant sense
Public • Disclosure is made to the public so long as the use is not secret • There is no requirement that the use be actively publicized • Windsurfer cases
Public • Disclosure to any public anywhere in the world • “or elsewhere” s28.2 • E.g. use in India anticipates invention in US (Turmeric)
Windsurfer cases • Why is isolated prior use a bar to patentability?