Anticipation Andrew Reddon McCarthy Tetrault

Economic “Birthright” Even before the Statute of Monopolies (U.K.), 21 Jac. 1, c. 3 (1623), the Crown rewarded an inventor with a limited monopoly in exchange for public disclosure of "a new invention and a new trade within the kingdom... or if a man hath made a new discovery of any thing": Clothworkers of Ipswich Case (1653), 78 E.R. 147, at p. 148, where the court went on to say that the effect of an unjustified monopoly was "to take away free-trade, which is the birthright of every subject". - Binnie J – Freeworld Trust

“Invention” Section 2 – “new and useful” For a great idea that isn’t new – no patent The bargain Principal What is “new” enough for a patent?

Rice v. Chritstiani Concrete milkshake Prior secret user "Their Lordships' conclusion therefore is that the knowledge and user of Bayer and his associates, before December 21, 1922, although in Denmark and although secret and confidential, and not made available to the public, was, upon the true construction of s. 7 of the Act of 1923, sufficient to invalidate the appellant's patent." – [1931] A.C. 770, [1931] 4 D.L.R. 273, 48 R.P.C. 511 (Privy Council Canada Jun 26, 1931)

Reform Reform to require Disclosure to the Public Touchstone (mostly) of anticipation No monopoly for giving the public that which it already had or could get – no consideration

Codified In New Act Disclosure to the Public (28.2 (a) and (b)) First to File (28.2 (c) and (d))

Codified In New Act 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 disclosed28.2 (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; (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;

Examples of anticipatory acts DISCLOSURE prior enabling publication prior enabling use or sale, every element of claim must be present in prior disclosure active disclosure not required; sufficient if prior disclosure was passively made available to the public (e.g., doctoral thesis on bookshelf) exemplary anticipatory acts are no longer legislated (they were included in the Old Act, though)

Prior Publication Prior Art body of info/knowledge that qualifies as prior disclosures under s of the New Act - not restricted to information specific to person skilled in the art; rather, includes any disclosure to the public - anticipation based upon prior publication can only be based upon a single reference dusty shelf

Prior Use or Sale Baker Petrolite (FCA) – sale is not enough As a result of amendments made effective on October 1, 1989 … evidence of use or sale of the invention was no longer sufficient in itself to prove anticipation. …the test for anticipation by any means became disclosure of "the subject matter defined by a patent claim"(the invention) [...] "in such a manner that the subject matter became available to the public in Canada or elsewhere".

Baker Petrolite Not limited to prior use or sale Applies with necessary modifications to all modes of anticipation Foreshadows latest developments 8 Legal propositions (Rothstein JA)

Baker – 8 points 1. Sale to the public or use by the public alone is insufficient to prove anticipation. Disclosure of the invention is required to constitute anticipation under paragraph 28.2(1)(a).

2.For a prior sale or use to anticipate an invention, it must amount to "enabling disclosure”

3.The prior sale or use of a chemical product will constitute enabling disclosure to the public if its composition can be discovered through analysis of the product.

4.The analysis must be able to be performed by a person skilled in the art in accordance with known analytical techniques available at the relevant time.

5.In the context of patent anticipation under paragraph 28.2(1)(a), when reverse engineering is necessary and capable of discovering the invention, an invention becomes available to the public if a product containing the invention is sold to any member of the public who is free to use it as she or he pleases.

6. It is not necessary to demonstrate that a member of the public actually analyzed the product that was sold.

7.The amount of time and work involved in conducting the analysis is not determinative of whether a skilled person could discover the invention. The relevant consideration, in this respect, is only whether inventive skill was required.

8.It is not necessary that the product that is the subject of the analysis be capable of exact reproduction. It is the subject matter of the patent claims (the invention) that must be disclosed through the analysis.

Reeves Brothers – Old Act Convenient List of factors. Anticipatory Reference Must: (a) give an exact prior description (b) give directions which will inevitably result in something within the claims ("the infringement test") (c) give clear and unmistakable directions (d) give information which for the purpose of practical utility is equal to that given by the subject patent (e) convey information so that a person grappling with the same problem must be able to say "that gives me what I wish" (f) give information to a person of ordinary knowledge so that he must at once perceive the invention [without experimentation] (g) in the absence of explicit directions, teach an "inevitable result" which "can only be proved by experiments" (h) satisfy all these tests in a single document without making a mosaic

Sanofi-Synthelabo Canada Inc. v. Apotex Inc., 2008 SCC 61 Lots of Reeves rhetoric under New Act Some suggestion in Sanofi that rigid old rules may not apply. Adopts Synthon - two requirements for anticipation that were not expressly considered separately -- disclosure and enablement. –disclosure - whether or not it would be apparent to anyone at the time, whenever subject matter described in the prior disclosure is capable of being performed and is such that, if performed, it must result in the patent being infringed, the disclosure condition is satisfied. –enablement – whether the person skilled in the art would have been able to perform the invention

Dark Days? Chicora Bark – Amazonian natives Chicken soup - Decision T303/86 CPC/Flavour Concentrates, [1989] 2 EPOR 95 Metabolites- Merrell Dow Pharmaceuticals Inc v HN Norton & Co Ltd, [1995] UKHL 14 (26 October 1995) Crystals - Abbott (Sharlow J.): Abbott Laboratories v. Canada (Minister of Health) (2006), 56 C.P.R. (4th) 387 (F.C.A.)

Light In the Tunnel “But the infringement must not be merely a possible or even likely consequence of performing the invention disclosed by the prior disclosure. It must be necessarily entailed. If there is more than one possible consequence, one cannot say that performing the disclosed invention will infringe [emphasis added]” Synthon BV v. SmithKline Beecham plc, [2005] UKHL 59, at para. 23.

More Light? Sanofi –enablement –good facts racemate/isomer –selection patents only? –NO TESTING! Disclosure & Enablement

Abbott Laboratories v. Canada (Minister of Health), 2008 FC For there to be anticipation there must be both disclosure and enablement of the claimed invention. 2. The disclosure does not have to be an "exact description" of the claimed invention. The disclosure must be sufficient so that when read by a person skilled in the art willing to understand what is being said, it can be understood without trial and error. 3. If there is sufficient disclosure, what is disclosed must enable a person skilled in the art to carry out what is disclosed. A certain amount of trial and error experimentation of a kind normally expected may be carried out. 4. The disclosure when carried out may be done without a person necessarily recognizing what is present or what is happening. 5. If the claimed invention is directed to a use different from that previously disclosed and enabled then such claimed use is not anticipated. However if the claimed use is the same as the previously disclosed and enabled use, then there is anticipation. 6. The Court is required to make its determinations as to disclosure and enablement on the usual civil burden of balance and probabilities, and not to any more exacting standard such as quasi-criminal. 7. If a person carrying out the prior disclosure would infringe the claim then the claim is anticipated.

First To File Codified 28.2 (c) and (d) – Big Change from first to invent Co-pending applications can anticipate (not intuitive).

First to File Not disclosed: (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;

Co-pending applications (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 : …. the co-pending application …. has priority

Has Priority? (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 (i) the co-pending application is filed by (A) a person who has, or whose agent, legal representative or predecessor in title has, previously regularly filed in or for Canada an application for a patent disclosing the subject-matter defined by the claim, or (B) a person who is entitled to protection under the terms of any treaty or convention relating to patents to which Canada is a party and who has, or whose agent, legal representative or predecessor in title has, previously regularly filed in or for any other country that by treaty, convention or law affords similar protection to citizens of Canada an application for a patent disclosing the subject-matter defined by the claim, (ii) the filing date of the previously regularly filed application is before the claim date of the pending application, (iii) the filing date of the co-pending application is within twelve months after the filing date of the previously regularly filed application, and (iv) the applicant has, in respect of the co-pending application, made a request for priority on the basis of the previously regularly filed application

Concepts Claim – by – Claim –Invalidity is assessed claim by claim –severability Claim Date –Claim Date – Priority or Canadian filing? –Different claims can have different dates –Priority filing must give enabling disclosure of subsequent claim or left to filing date

Absolute Novelty EU Concept any prior disclosure anticpates not in NAFTA countries one year grace period for disclosure by the applicant (28.2(a)) see slide 7

Pitfall Based on Canadian Filing date NOT Claim Date –literature article in US disclosing invention –one year to file in US –file one year later in Canada and claim priority to US filing (28.2(1)(a)) –anticipated more than one year before the FILING DATE not the CLAIM DATE

Sanofi-Synthelabo Canada Inc. v. Apotex Inc., 2008 SCC 61 Lots of Reeves rhetoric under new Act Some suggestion in Sanofi that rigid old rules may not apply Adopts Synthon - two requirements for anticipation that were not expressly considered separately, prior disclosure and enablement. –disclosure - whether or not it would be apparent to anyone at the time, whenever subject matter described in the prior disclosure is capable of being performed and is such that, if performed, it must result in the patent being infringed, the disclosure condition is satisfied. –enablement – whether the person skilled in the art would have been able to perform the invention

ONUS After the patent is issued, it shall, in the absence of any evidence to the contrary, be valid and avail the patentee and the legal representatives of the patentee for the term mentioned in section 44 or 45, whichever is applicable Supreme Court says it’s a “weakly worded presumption” Apotex Inc. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153 “the statutory "presumption" adds little to the onus already resting, in the usual way, on the attacking party”

Next Week Please read: case summary for the Sanofi case at: ications/apotex-sanofi-case-comment.pdfhttp:// ications/apotex-sanofi-case-comment.pdf