Novelty

Statutory Basis "invention" means any new and useful art... "invention" means any new and useful art... But the novelty requirement is set out in detail in s28.1/2 But the novelty requirement is set out in detail in s28.1/2 An invention which is not new is “anticipated” 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 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 At one time patents were granted individually on application to the king This system was abused This system was abused Eg A monopoly in playing cards granted to a No monopolies for Eg A monopoly in playing cards granted to a No monopolies for

Technical When must an invention be new? When must an invention be new? First to file v first to invent First to file v first to invent Where must an invention be new? Where must an invention be new? Anywhere in the world Anywhere in the world What does it mean for an invention to be new? What does it mean for an invention to be new? How similar does must the prior art be in order to anticipate the invention? How similar does must the prior art be in order to anticipate the invention? Where is the borderline with non-obviousness? Where is the borderline with non-obviousness?

First-to-File/Invent First-to-file First-to-file When two patent applications are filed for the same invention, the first person to file is entitled to the patent 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 All of the world except the US US will be changing soon US will be changing soon First-to-invent 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 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 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 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 Evidence of invention must be kept in case of interference proceedings eg Engineering notebooks eg Engineering notebooks Must be kept for long periods as interference can be declared long after issue 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 This is true for anyone who wants to apply for a US patent – not just US inventors

Qualified Absolute Novelty Absolute 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 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 priority date? What is the state of the art? What is the state of the art? Qualified Qualified One year grace period for disclosure by inventor One year grace period for disclosure by inventor

Filing Date v Claim Date Claim date v filing date Claim date v filing date Filing date is the date of filing of the Canadian application Filing date is the date of filing of the Canadian application Claim date is the date from which the Canadian application can claim priority Claim date is the date from which the Canadian application can claim priority Often referred to as “priority date” Often referred to as “priority date”

Claim / Priority Date When is the “claim date”? When is the “claim date”? For patent applications filed only in Canada, it is simply the filing date: s 28.1(1) 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 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 Claim date is filing date of international filing under PCT or other applicable treaty So long as filing in Canada follows within one year So long as filing in Canada follows within one year

State of the Art State of the art is all information State of the art is all information Made available to the public Made available to the public By use or written or oral description By use or written or oral description Anywhere in the world Anywhere in the world As of the priority date As of the priority date

State of the Art Plus all information Plus all information In Canadian patent applications with an earlier priority date, including convention filings 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 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 However, unpublished foreign applications are not part of the state of the art

State of the Art Result: First to file wins 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... 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; (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 Not previously disclosed to the public anywhere in the world

Prior Canadian Application Or in a patent 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 (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 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 (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] [applicant has previously filed an application in a convention country] [prior to the claim date] [prior to the claim date] [and claimed convention priority] [and claimed convention priority]

Qualified Grace period after disclosure by inventor 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; (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 Note that grace period is not adjusted for international filing Inventor has one year from disclosure to file in Canada Inventor has one year from disclosure to file in Canada Many systems do not have a grace period Many systems do not have a grace period Do not count on it Do not count on it

Old Act – Pre-1993 First-to-invent First-to-invent Distinction between paper disclosure and use Distinction between paper disclosure and use Prior use outside Canada irrelevant Prior use outside Canada irrelevant Two year grace period Two year grace period For paper disclosure anywhere in the world For paper disclosure anywhere in the world For prior use in Canada For prior use in Canada Ie. First-to-invent could obtain patent so long as filed within 2 years of disclosure by anyone 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 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” Now simply “disclosed in such a manner that the subject matter became available to the public”

Old Law Prior to 1996 distinguish Prior to 1996 distinguish Paper anticipation Paper anticipation Prior use Prior use

Old Law Paper Anticipation Paper Anticipation The prior disclosure is only by means of a publication, ie the thing itself was never produced 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 The disclosure in the publication must be equal to the patent disclosure

Old Law Prior Use Prior Use Where the thing itself is disclosed the rule is: Where the thing itself is disclosed the rule is: Infringement after = anticipation prior Infringement after = anticipation prior Anything which would have infringed will be sufficient to anticipate 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 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

Current Law: Enabling Disclosure

Enabling Disclosure In order to anticipate invention, prior art must: In order to anticipate invention, prior art must: Disclose Disclose AND AND Enable Enable

Disclosure Must disclose the very thing that is claimed 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. 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 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. 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. 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. 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. 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 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. Enablement means that the ordinary skilled person would have been able to perform the invention which satisfies the requirement of disclosure. Synthon Synthon

Enablement Some trial and error is permitted at the enablement stage Some trial and error is permitted at the enablement stage Contrast disclosure which requires the flag to be planted at the precise location 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 E.g. Invention claims chemical compound which was previously sold in the open market Disclosure is satisfied Disclosure is satisfied Enablement is satisfied IF skilled chemist can ‘reverse engineer’ the compound 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 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 Sanofi

Enabling Disclosure No longer true that “Infringement after = anticipation prior” No longer true that “Infringement after = anticipation prior” If the use did not enable a person skilled in the art to perform If the use did not enable a person skilled in the art to perform Infringement after Infringement after But not anticipating before 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. 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 Merrell Dow v Norton HL, per Lord Hoffmann

Rationale Old approach viewed an invention as a thing Old approach viewed an invention as a thing New approach views invention as information New approach views invention as information Difference is important only when disclosure of the thing is not equivalent to disclosure of the 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 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 (1) Formula / method of manufacture is not publically known and cannot be determined from the chemical itself Not enabling Not enabling (2) Formula can be determined from compound itself by skilled chemist using standard techniques (2) Formula can be determined from compound itself by skilled chemist using standard techniques Enabling Enabling

Merrell Dow v Norton Merrell Dow held expired patent on terfenadine. Merrell Dow held expired patent on terfenadine. Anti-histamine Anti-histamine Then discovered active metabolite and patented that. Then discovered active metabolite and patented that. Active metabolite is inevitably made when terfenadine is swallowed. Active metabolite is inevitably made when terfenadine is swallowed. Norton sells terfenadine. Norton sells terfenadine. Is patent on active metabolite is invalid as anticipated by prior use or terfenadine patent? Is patent on active metabolite is invalid as anticipated by prior use or terfenadine patent?

Merrell Dow v Norton No anticipation by use No anticipation by use When terfenadine swallowed by end-consumers. When terfenadine swallowed by end-consumers. Who then make active metabolite Who then make active metabolite Not anticipated on this basis: Not anticipated on this basis: Use disclosed “no information to the public about the nature of the product or how to make it.” Use disclosed “no information to the public about the nature of the product or how to make it.” Recall: “the product” = active metabolite Recall: “the product” = active metabolite

Merrell Dow v Norton Anticipation by terfenadine patent Anticipation by terfenadine patent Disclosed = Yes 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".” “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 Anticipation by terfenadine patent Enabled = Yes Enabled = Yes Anyone would know who to make the active metabolite – by swallowing terfenadine 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) (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 Selection patent = ‘777 clopidogrel bisulfate Genus = ‘875 – large class of compounds, encompassing 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 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 Sanofi holds Enabling disclosure approach to anticipation from Synthon is correct Enabling disclosure approach to anticipation from Synthon is correct Selection patents are valid in principle Selection patents are valid in principle

Apotex v Sanofi-Synthelabo On the facts – No disclosure in prior art 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.” “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) 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. 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 clopidogrel bisulfate was undue, whether or not it was inventive (non-obvious) Discovering the special properties of the enantiomer of clopidogrel bisulfate 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. 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 Court ultimately concluded that it was in fact non-obvious

Available to the “public”

Public The inventor can disclose to others so long as the disclosure is confidential The inventor can disclose to others so long as the disclosure is confidential Eg to raise money Eg to raise money Saunders Airglide Saunders Airglide Grace period does not run because there is no disclosure in the relevant sense 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 Disclosure is made to the public so long as the use is not secret There is no requirement that the use be actively publicized There is no requirement that the use be actively publicized Windsurfer cases Windsurfer cases

Public Disclosure to any public anywhere in the world Disclosure to any public anywhere in the world “or elsewhere” s28.2 “or elsewhere” s28.2 E.g. use in India anticipates invention in US (Turmeric) E.g. use in India anticipates invention in US (Turmeric)

Windsurfer cases Why is isolated prior use a bar to patentability? Why is isolated prior use a bar to patentability?