2013 aippi agm - 2013 canadian ip law update aippi agm - 2013... · 2013 canadian ip law update...

2013 Canadian IP Law Update

Donald H. MacOdrumBereskin & Parr LLP

November 21, 2013

INTELLECTUAL PROPERTY

COMPREHENSIVE ECONOMIC AND TRADEAGREEMENT BETWEEN CANADA AND THE EU

• On 18 October 2013, Prime Minister Harper and European Commission President José Manuel Barroso announced an agreement in principle on a Comprehensive Economic and Trade Agreement (CETA) between Canada and the European Union.

• Text of CETA is not publicly available. Summary reports indicate that in the IP area, CETA will address:• Copyright – CETA reflects amendments by the Copyright Modernization Act which

brought Canada in line with WIPO treaties.• Geographical Indications – expansion to include GIs for certain foods and beers –

Asiago, feta, fontina, Gorgonzola and Munster cheeses have been identified. Procedures for handling GIs at the border.

• Patents• extended protection for pharmaceutical innovators – patent term extension up

to two years, but generic exports to be permitted during extension period; • right of appeal to innovators in PM(NOC) Regs proceedings

• Counterfeit Goods ‐ simple, fair, equitable and cost‐effective enforcement continues, leading to a more predictable regime for IP

• Trademarks and Industrial Designs – best endeavours to comply with international treaties – Singapore treaty re trademarks, Madrid protocol, Geneva Act of the Hague convention re industrial designs.

PATENTS

Patent Decisions (1)

• Teva Canada Ltd. v. Pfizer Canada Inc., 2012 SCC 60 (S.C.C. – LeBel J.) (Nov. 8, 2012), motion to vary judgment granted in part (S.C.C.) (June 4, 2013)

• Wenzel Downhole Tools Ltd. et al v. National‐Oilwell Canada Ltd., 2012 FCA 333 (F.C.A. – Gauthier J.A., dissent in part Mainville J.A.) (Dec. 20, 2012)

• Apotex Inc. v. Allergan Inc. et al 2012 FCA 308 (F.C.A. – Noël J.A.) (Nov. 23, 2012)• Baksh v. Probiohealth, LLC 2012 FC 1388 (F.C. – O’Reilly J.) (Dec. 3, 2012)• Apotex Inc. v. Merck Canada Inc. et al 2012 FC 1418 (F.C. – Hughes J.) (Dec. 4,

2012)• Apotex Inc. v. Warner‐Lambert Company LLC et al 2012 FCA 323 (F.C.A. – Nadon

J.A.) (Dec.5, 2012)• Apotex Inc. v. Abbott Laboratories Limited, 2013 ONSC 356 (Ont. S.C.J. – Quigley J.)

(Jan. 15, 2013), affirmed 2013 ONCA 555 (Ont. C.A.) (Sept. 12, 2013)


• Allergan Inc. et al v. Apotex Inc. 2013 ONSC 98 (Ont. S.C. – Chiappetta J.) (Jan. 16, 2013)

• Takeda Canada Inc. v. The Minister of Health et al 2013 FCA 13 (F.C.A. – Dawson J.A., dissent by Stratas J.A.) (Jan.18, 2013), application for leave to appeal to SCC dismissed (June 13, 2013)

• Seagatoys Co., Ltd et al v. The Attorney General of Canada 2013 FC 98 (F.C. O’Keefe J.) (Jan. 30, 2013)

• Coastal Contacts Inc. v. Elastic Path Software Inc., 2013 BCSC 133 (B.C.S.C. –Armstrong J.) (Jan. 30, 2013)

• Pfizer Canada Inc. et al v. Pharmascience Inc. et al 2013 FC 120 (F.C. – Hughes J.) (Feb. 4, 2013)

• The Minister of Health v. Celgene Inc. 2013 FCA 43 (F.C.A. – Gauthier J.A., NadonJ.A. dissenting) (Feb. 15, 2013)

• Teva Canada Limited. v. Novartis AG 2013 FC 141 (F.C. – Snider J.) (Feb. 19, 2013)


• Novartis Pharmaceurticals Canada Inc. v. Apotex et al 2013 FC 142 (F.C. – Snider J.) (Feb. 19, 2013)

• Safe Gaming system Inc. v. Atlantic Lottery Corporation et al 2013 FC 217 (F.C. –Aronovith Proth.) (Mar. 4, 2013)

• AstraZeneca Canada Inc. et al v. Ranbaxy Pharmaceuticals Canada Inc. et al 2013 FC 245 (F.C. – O’Keefe J.) (Mar. 5, 2013)

• AstraZeneca Canada Inc. et al v. Teva Canada Limited et al 2013 FC 245 (F.C. – Near J.) (Mar. 7, 2013)

• AstraZeneca Canada Inc. et al v. Teva Canada Limited et al 2013 FC 246 (F.C. – Near J.) (Mar. 7, 2013)

• AstraZeneca Canada Inc. v. Apotex Inc. 2013 FCA 77 (F.C.A. – Sharlow J.A.) (Mar. 11, 2013)

• Apotex Inc. v. H. Lundbeck A/s 2013 FC 192 (F.C. – Harrington J.) (Mar. 12, 2013)• Novartis Pharmaceticals Canada Inc. v. Teva Canada Limited et al 2013 FC2 83 (F.C.

– Hughes J.) (Mar. 19, 2013)

Patent Decisions (4)• Teva Canada Innovation v. Attorney General of Canada 2013 FC 448 (F.C. – Zinn J.)

(Apr. 30, 2013)• Apotex Inc. v. Pfizer Canada Inc. 2013 FC 493 (F.C. – O’Reilly J.) (May 10, 2013)• Bayer Inc. et al v. Cobalt Pharmaceuticals Company et al 2013 FC 573 (F.C. –

O’Reilly J.) (May 29, 2013)• Karolinska Institutet Innovations AB v. Attorney General of Canada 2013 FC 715

(F.C. – Hughes J.) (June 27, 2013)• Hoffmann‐La Roche Limited v. Apotex Inc. et al 2013 FC 718 (F.C. – Kane J.) (July 12,

2013)• Merck & Co., Inc. et al v. Apotex Inc. et al 2013 FC 751 (F.C. – Snider J.) (July 16,

2013)• Zero‐Spill Systems (Int'l) Inc. et al v. 614248 Alberta Ltd. et al 2013 FC 616 (F.C. ‐

Barnes J.) (July 18, 2013)

Patent Decisions (5) • Sanofi‐Aventis v. Apotex Inc. 2013 FCA 186 (F.C.A. – Pelletier J.A., additional

comments by Gauthier J.A. ) (July 24, 2013), application filed for leave to appeal to SCC

• Varco Canada Limited et al v. Pason Systems Corp. et al 2013 FC 750 (F.C. – Phelan J.)(Aug. 12, 2013)

• ABB Technology AG v. Hyundai Heavy Industries Co., Ltd., 2013 FC 947 (F.C. –Barnes J.)(Sept. 11, 2013)

• Aker Biomarine AS c. Neptune Technologies & bioressources inc., 2013 QCCS 4841 (Que. S.C. – Castonguay J.C.S.) (Sept. 11, 2013)

• The Procter & Gamble Company et al. v. Brushpoint Innovations Inc., 2013 ONSC 57 (Ont. S.C.J. – Charbonneau J.) (Sept. 13, 2013)

• Bell Helicopter Textron Canada Limitée v. Eurocopter 2013 FCA 219 (F.C.A. –Mainville J.A.) (Sept. 24, 2013)

• Novartis Pharmaceuticals Canada Inc. v. Cobalt Pharmaceuticals Company 2013 FC 985 (F.C. – Hughes J.) (Sept. 25, 2013)

• Hoffmann‐La Roche AG v. Commissioner of Patents 2013 FC 1001 (F.C. – Roy J.) (Sept. 30, 2013)

Patent Decisions (6) • Pfizer Canada Inc. et al v. Apotex Inc. et al 2013 FC 1036 (F.C. – Aalto Proth.) (Oct.

11, 2013)• Teva Canada Limited v. Novartis Pharmaceuticals Canada Inc. et al 2013 FCA 244

(F.C.A. – Gauthier J.A. (Oct. 15, 2013)• Distrimedic Inc. v. Dispill Inc. et al 2013 FC 1043 (F.C. – de Montigny J.) (Oct. 15,

2013)• Bayer Inc. et al v. Cobalt Pharmaceuticals Company et al 2013 FC 1061 (F.C. –

Hughes J.) (Oct. 22, 2013)• Abbvie Corporation et al v. Janssen Inc. 2013 FC 1148 (F.C. – Hughes J.) (Nov. 12,

2013)

Person Skilled in the Art

Hoffmann‐La Roche Limited v. Apotex Inc. et al 2013 FC 718 (F.C. – Kane J.) (July 12, 2013)• NOC prohibition application re valganciclovir hydrochloride 450 mg tablets

, a pro‐drug antiviral nucleoside“In my view, it is difficult to characterize the POSITA as an ordinaryperson possessing ordinary skill in the art given the expertise,experience and educational qualifications of the scientists engaged inthis research; even if they are considered ordinary vis— `a‐vis theirpeers, they are far from ordinary. In this case, these highly qualifiedexperts were in disagreement on most issues, but there was generalagreement on the POSITA.”

Common General KnowledgeBell Helicopter Textron Canada Limitée v. Eurocopter 2013 FCA 219 (F.C.A. –Mainville J.A.) (Sept. 24, 2013)• Common general knowledge does not amount to all information in the

public domain. • While the common general knowledge of the skilled person certainly

includes knowledge of patents, it does not include knowledge of allpatents:

• Nor does it include knowledge of all journal articles or other technical information

• It is well established that the common general knowledge is limited to knowledge which is generally known at the relevant time by skilled persons in the field of art or science to which the patent relates

• Trial judge made no error in determining the common general knowledge was from the field of conventional helicopter landing gear

Patent ConstructionPfizer Canada Inc. et al v. Pharmascience Inc. et al 2013 FC 120 (F.C. –Hughes J.) (Feb. 4, 2013)Claim construction – “pain”• Claims 4 to 16 are each directed to a specific type of pain. Claim 4 is inflammatory pain, claim

5 is neuropathic pain; claim 6 is cancer pain; claim 7 is postoperative pain; claim 8 is phantom limb pain; claim 9 is burn pain; claim 10 is gout pain; claim 11 is osteoarthritic pain; claim 12 is trigeminal neuralgia pain; claim 13 is acute herpetic and postherpetic pain; claim 14 is causalgia pain; claim 15 is idiopathic pain; claim 16 is fibromyalgia pain.

• An informed and purposive construction must, therefore, mean that the “pain” of claim 3 must include at least the specific “pains” claimed in claims 4 to 16.

• Description refers to these types of pain and others and “not limited” to those mentioned.• In light of this and the expert evidence, Hughes J. construed “pain” as found in claim 3 as a

broad term, encompassing all of the specific pains claimed in claims 4 to 16, and all of the specific pains mentioned in the description, and since description says “…but not limited to”, the term was broadened to include those pains that, as of the publication date would be reasonably related to the named pains.

Patent ConstructionPfizer v. Pharmascience (cont’d)

“[74] It appears that the patent draughtsmanis endeavouring to take advantage of twoworlds; narrow and broad. In patentacademic circles, this has sometimes beenreferred to as the “Angora Cat” approach asnoted by Lord Justice Jacob in EuropeanCentral Bank v Document Security SystemsInc, [2008] EWCA Civ 192, where he said, atparagraph 5 of the report:

“Professor Mario Franzosi likens apatentee to an Angora cat. When validityis challenged, the patentee says hispatent is very small: the cat with its fursmoothed down, cuddly and sleepy. Butwhen the patentee goes on the attack,the fur bristles, the cat is twice the sizewith teeth bared and eyes ablaze”.”

ConstructionTeva Canada Limited. v. Novartis AG 2013 FC 141 (F.C. – Snider J.) (Feb. 19, 2013)• Impeachment actions re patent re N‐phenyl‐2‐pyrimidine‐amine

derivatives including imatinib.• Principles of construction set out

“[76] I wish to emphasize that the claims – and not the disclosure – arethe essence of a patent and it is the claims that must be interpreted.While the specification, as a whole, will describe the invention, thescope of the monopoly is defined by the claims …[77] However, where necessary, the court may have resort to thedisclosure to assist in the exercise … Stated differently, the Courtshould construe the claims in light of the description in thespecification, assisted by experts as to the meaning of technical termsif such terms cannot be understood by the Court from reading thespecification …” [citations omitted]

ConstructionTeva v. Novartis (cont’d)Claim 46. … “a pharmaceutical composition for use in the chemotherapy of tumours.”• Some compounds are useful in treating one kind of tumor, others another

kind of tumors.• “and” used in specification is notoriously ambiguous – it takes its meaning

from the context• “conclude that it is not a reasonable construction of the '203 Patent to

conclude that the word “tumours” in Claim 46 means that any compound of Group 2 can treat both PDGF‐R and ABL‐driven tumours. Rather, the meaning to be ascribed to Claim 46 of the '203 Patent is that a Group 2 compound may be useful to treat either PDGF‐R or ABL tumours.”

ConstructionTeva v. Novartis (cont’d)“can be used” • Specification says that the compounds of formula I “can be used” as tumor

inhibiting ingredients.• In the context of the '203 Patent and the world of cancer research, the

word “can” does not convey a meaning of certainty; rather it should be equated to the term “potential”.

ConstructionBell Helicopter Textron Canada Limitée v. Eurocopter 2013 FCA 219 (F.C.A. –Mainville J.A.) (Sept. 24, 2013)• Action for infringement of patent re helicopter landing gear having an

integrated front piece off‐set from the vertical.• Claim 1:

1. Helicopter landing gear, comprising two skids each having a longitudinalground support surface and connected to a front cross piece and a rear crosspiece which are themselves attached to the structure of the helicopter byconnecting devices, the rear cross piece being attached by the ends of itsdescending branches to the rear part of said longitudinal support surfaces,characterized in that each of said skids has at the front an inclined transitionzone with double curvature orienting itself transversely in relation to saidlongitudinal ground support surfaces, above the plane of the latter, the twotransition zones together constituting, in this way, an integrated front crosspiece, offset in relation to the front delimitation of the plane of contact of thelongitudinal support surfaces of the skids on the ground.

ConstructionBell Helicopter v. Eurocopter (cont’d)• Issue re trial judge’s construction re rear cross piece• Trial judge held that a POSITA would understand that the rear crosspiece was

vertical or substantially vertical.• The patent did not specify that the rear cross piece has to be vertical or

substantially vertical. It did say that the rear cross piece may be connected in a conventional manner.

• Held no error. His construction logical and cogent.• “The words used in a patent must be looked at and understood ‘through the eyes

and with the common knowledge of a worker of ordinary skill in the field to which the patent relates’”.

• The vertical or substantially vertical nature of the rear cross piece, as well as the parallel nature of the front and rear cross pieces, were both well‐known characteristics of conventional helicopter landing gears included in the common general knowledge of the skilled person.

• But, it reads a limitation into the claim.

ConstructionBell Helicopter v. Eurocopter (cont’d)• Eurocopter said that trial judge erred in holding that the essential elements

included: (a) the “double curvature” of the transition zones; (b) the positioning of the transition zones at the very end of the skid forward of the ground contact point; and (c) the design type integration of the front cross piece into the skids, which does not allow for the substitution of the first curvature by a saddle or “tee” connection.

• These features repeated throughout the disclosure. (also in the characterizing section of the claim.)

• All experts but one agreed the elements were essential and the trail judge found the bare assertion to the contrary of one expert unconvincing.

• No error in finding these elements essential features of the claim.

ConstructionDistrimedic Inc. v. Dispill Inc. et al 2013 FC 1043 (F.C. – de Montigny J.) (Oct. 15, 2013)• Patent re tray for organizing a patient’s pills• “Positioning means” an essential element

• Positioning means solves a problem in the prior art identified in the patent

• “Positioning means” included in all independent claims• Both experts concluded it was an essential element• During prosecution, positioning means added to address a prior art

reference.• Such use of file history said not contrary to Free World because

objective fact of amendment different than a representation• However, in Free World the evidence which was ruled inadmissible

related to amendments to the claims required by the Patent Office

Patent ConstructionClaims

Hollick Solar Systems Limited. v. Matrix Energy Inc. 2012 FCA 174 F.C.A. –Létourneau J.A.) (June 11, 2012), affirming 2011 FC 1213 (F.C. – Scott J.)• Patent re solar air heating system. • Method and apparatus claims each with several elements. One element was “having

an inlet at the top of the air collection space” or similar language.• Trial judge held that the location of the air intake in the top half was an essential

feature of the claimed invention. • He also found that a variant having the inlet is located at or near the bottom of the air

collection space had poorer air flow and held that the variant has a material effect on the way the invention works.

• FCA affirmed:“The criterion is not whether the variant improves the performance of theinvention but rather does it have a significant effect on how the device functions,be it positive or negative.”

• [Compare: Electrolier v. Dominion [1934] S.C.R. 436 (S.C.C.) where a variant was found to perform the same function in the same way even though it was inferior.]

Patentable Subject MatterMethod of Medical Treatment

Novartis Pharmaceuticals Canada Inc. v. Cobalt Pharmaceuticals Company 2013 FC 985 (F.C. – Hughes J.) (Sept. 25, 2013)• NOC prohibition proceeding re drug containing zoledronic acid to be administered in

once‐yearly doses for the treatment of osteoporosis.• Hughes J. reviewed the jurisprudence re the non‐patentability of a method of medical

treatment said:[91] What the jurisprudence establishes is that a claim to a vendible product,including a substance intended for the treatment of a medical condition, can begood subject matter for a patent claim. Thus, claims such as the following areproper subject matter:

• the substance X for the treatment of Y• the substance X in the form of a 5 mg tablet for the treatment of Y

[92] What is improper subject matter is a claim that encompasses the skill of amedical professional, such as:

• the closure of a surgical incision by the use of adhesive X• the use of substance X in a dosage range between A and B for the treatmentof X


Novartis v. Cobalt (cont’d)• Hughes J. Held that, although some claims mentioned a specific dosage, all were

invalid. He said:“because each claim of the '201 patent, directly or by incorporation by reference,includes as well treatment by intermittent dosages with some claims specifying adosage range and others specifying specific dosages; and some claims claimingmore frequent intervals of dosing, and others less; that the claims include thatwhich lies within the skill of the medical practitioner and are thus invalid.”

• Some claims were “Swiss form” claims – use for the manufacture of a medicamentfor a particular use – but all were held invalid. Hughes J. said:

“this Court should disregard the artificial nature of a Swiss claim and look at whatis the real subject matter of the claim.”


Bayer Inc. et al v. Cobalt Pharmaceuticals Company et al 2013 FC 1061 (F.C. –Hughes J.) (Oct. 22, 2013)• Follows Novartis v. Cobalt. Use claims to a range of dosages invalid, use

claim to a specific dosage valid.

Patentable Subject MatterSelection Patent

Hoffmann‐La Roche Limited v. Apotex Inc. et al 2013 FC 718 (F.C. – Kane J.) (July 12, 2013)• NOC prohibition application re valganciclovir hydrochloride 450 mg tablets

, a pro‐drug antiviral nucleoside• Principles re selection patents reviewed.• “While the special advantages of the ’721 may in fact be significant, the

advantages of this invention over the purported genus of EP 329 are not sufficiently described to characterize this as a selection patent.”

• Held that it was a regular patent for a new compound

ObviousnessInventive Concept

Apotex Inc. v. Allergan Inc. et al 2012 FCA 308 (F.C.A. – Noël J.A.) (Nov. 23, 2012)• Appeal from decision of Hughes J. granting a NOC prohibition with respect to

its ophthalmic combination drug APO‐BRIMONIDINE‐TIMOP until the expiry ofthe ’764 patent

Background• In 2011 FC 1316, Crampton J. granted a NOC prohibition order against Sandoz

in respect of the same product and patent. In that case, Crampton J. construedthe patent, dismissed allegations of obviousness, lack of utility, lack of soundprediction, and found infringement. No appeal was taken from that decision.

• In 2012 FC 767, on different evidence, Hughes J. came to the oppositeconclusion as to obviousness. However, in view of what he considered to beserious issues as to comity and the need he perceived for the Court of Appealto address these issues, he granted the NOC prohibition order, even though hefound the invalidity allegation justified.


Apotex v. Allergan (cont’d) The 764 Patent• The ‘764 Patent relates to the use in combination of the medicinal

ingredients brimonidine and timolol (both known drugs) in solution (in asingle bottle) for the treatment of glaucoma.

• The patent said it satisfied a need for a “safe” and “effective” combinationdrug.

• The patent disclosed the results of a safety trial with the product ofExample 1, which is within the ranges in the claims.

• Under the heading Conclusions” the inventors state“The Combination administered BID demonstrated a favorable safetyprofile that was comparable to Timolol BID and better thanBrimonidine TID with regard to the incidence of adverse events anddiscontinuations due to adverse events.”


Apotex v. Allergan (cont’d) The 764 Patent – Claim 22• Only claim 22 was in issue. As reworded to refer to dependencies it was:

“Topical use of a therapeutically effective amount of an ophthalmicpharmaceutical composition for the treatment of glaucoma or ocularhypertension wherein the amount of brimonidine is 0.2 percent by weightand the amount of timolol is, 0.5 percent by weight, and from 0.001% byweight to less than 0.01% by weight of benzalkonium chloride.”

Inventive concept• In Sandoz, Crampton J. concluded that the improved safety profile and an

avoidance of an “afternoon trough” were part of the inventive concept. Herejected Sandoz’s contention that the inventive concept had to be discernedfrom the claims themselves and looked to the whole specification.

• In Apotex, Hughes J. also determined the inventive concept, but it did notinclude the improvement in safety, or avoidance of an afternoon trough.


Apotex v. Allergan (cont’d) Inventive concept – FCA (Noël J.A.)• Disagreed with Crampton J.A., re avoidance of an afternoon trough – held

it not part of the inventive concept. This concept was not clearly stated inthe patent and no general conclusions were drawn in the patent in respectof it.

• Application judge referred to difficulties re inventive concept, but did notpoint to any cases evidencing such difficulty.

• He recognized that the inventive concept was not discernible from theclaim, since he did not limit his analysis to the claim.

• He relied on one paragraph. Claim to be construed in light of the patent asa whole.

• On a purposive and complete reading of the patent, the improved safetyprofile forms part of the claimed invention.


Apotex v. Allergan (cont’d) Obviousness• Since application judge erred re inventive concept, conclusion on

obviousness cannot stand.• Only expert evidence on point is that improved safety profile was

unexpected.• There was a known combination product for another drug with timolol,

but it had no improved safety profile• Apotex asserts should not consider length of the clinical trial since it

conducted for regulatory approval, but results re safety profileunexpected. Nothing routine about this exercise

• Claimed invention not obvious

ObviousnessPrior Art

Abbvie Corporation et al v. Janssen Inc. 2013 FC 1148 (F.C. – Hughes J.) (Nov. 12, 2013)• Action for patent infringement, counterclaim for declaration of patent

invalidity• Motion by defendant to amend pleadings to add some new prior art

references refused.• Hughes J. observed:

• A party alleging invalidity on the basis of obviousness must present to the Court the “prior art” that a POSITA would have been expected to know about or find as of the relevant date. [para. 4]

• The prior art is not an absolute truth; it is what one party or the other will urge the Court that a person skilled in the art would have known or found. It is not a simple truth; it is an assertion as to what might have been. [para. 11]

• Compare wording of s. 28.3


Other cases where the inventive concept was not readily discernible from the claims and the Court added limitations from the specification to the inventive concept• AstraZeneca Canada Inc. et al v. Teva Canada Limited et al 2013 FC 245

(F.C. – Near J.) (Mar. 7, 2013) – NOC prohibition application re quietiapinefumarate extended release tablets – decreased occurrence of dose dumping and less frequent dosing regimen are key elements of the inventive concept – held: obvious

ObviousnessWenzel Downhole Tools Ltd. et al v. National‐Oilwell Canada Ltd., 2012 FCA 333 (F.C.A. – Gauthier J.A., dissent in part Mainville J.A.) (Dec. 20, 2012)

• Patent re a bi‐directional thrust bearing assembly for use in a downhole drilling motor (referred to as the 3103 Assembly)

• At trial, 2011 FC 1323 (F.C.) – Snider J. held that the claimed invention was obvious in view of the prior art (also anticipated).

• On appeal, FCA dismissed the appeal, Mainville J.A. dissenting re anticipation, but concurring re obviousness and in the result (but dissenting re anticipation).

ObviousnessWenzel v. National‐Oilwell (cont’d)• Trial judge held that the “obvious to try” approach was appropriate

(although neither party so argued)• Obvious to try not limited to chemical cases – could apply to a mechanical

case in a field where advances are often won by experimentation• But mere fact that tools are tested before sale does not make obvious to

try approach appropriate• Held by FCA: it was not appropriate to refer to the obvious to try approach

in this case. • However, trial judge found invention more or less self evident and that a

skilled person would be led to the invention from the prior art with little effort, thus satisfying the classical test for obviousness in Beloit v. Valmet

• No single or mandatory approach to obviousness• FCA should not intervene.

ObviousnessWenzel v. National‐Oilwell (cont’d)• In the trial reasons re obviousness, As to the relevant art, Snider J. said:

“There is no doubt that prior art from foreign jurisdictions may, in some circumstances be highly relevant to a discussion of obviousness. However, in this case, I have no evidence as to when or how the Japanese Patent and the German Patent were translated into English or how they might have come to be known to the person of ordinary skill in the art in this litigation. I find that neither the Japanese Patent nor the German Patent forms part of the general knowledge of our notional skilled person or prior art.”

• Surely this is wrong. Inventions are patented in Canada from all over the world. There is no basis for assuming the skilled person lives in Canada and speaks only English (or French)

• S. 28.3 says available to the public – that is the public anywhere – the same language as used in s. 28.2

• FCA did not address this point.

ObviousnessPfizer Canada Inc. et al v. Pharmascience Inc. et al 2013 FC 120 (F.C. –Hughes J.) (Feb. 4, 2013)• NOC prohibition application re pregablin for use in treating pain• While anticonvulsants were looked at as a fruitful field to try, one would

not know, until it was tested, whether it worked in fact, and without any harmful effects.

• Not obvious• There are areas of technology such as pharmaceuticals and biotechnology

which are heavily dependant on research, where workers are faced with many possible answers to explore but have little idea if any one of them will prove fruitful ‐ denial of patent protection such cases would act as a significant deterrent to research: MedImmune Limited v Novartis Pharmaceuticals UK Limited, [2012] EWCA Civ 1234.

ObviousnessAstraZeneca Canada Inc. et al v. Ranbaxy Pharmaceuticals Canada Inc. et al 2013 FC 245 (F.C. – O’Keefe J.) (Mar. 5, 2013)• NOC prohibition application re enteric coated omeprazole tablets• Application granted. Allegation of obviousness not justified.• Obvious to try test applied• Discussion of motive which in some cases can support and in other cases

refute obviousness• Even if it was obvious to seek a solution for enteric coating for

omeprazole, it was not an easy solution and would likely have dissuaded a person skilled in the art.

• Not more or less self evident to try to obtain the invention

Obviousness

AstraZeneca Canada Inc. et al v. Teva Canada Limited et al 2013 FC 245 and 2013 246 (F.C. – Near J.) (Mar. 7, 2013) • NOC prohibition applications re quietiapine fumarate extended release

tablets – two applications re different dosage strengths• Decreased occurrence of dose dumping and less frequent dosing regimen are

key elements of the inventive concept• Held: obvious• The determinative issue in this case is whether it was more or less self‐

evident that if the skilled person combined quetiapine with a known sustained release formulation, the result would be a sustained release formulation of quetiapine.

• Obvious to try test is appropriate. Need not be obvious that successful results will be achieved – sufficient if it was more or less self‐evident to conduct routine experimentation with a fair expectation of success.

Obviousness

AstraZeneca v. Teva (F.C. – Near J.) (cont’d) • Obvious to try factors”

• Self evident – fair expectation of success is the test• Extent, Nature and Effort Required to Achieve Invention ‐ no evidence as

to how arduous the testing was ‐ choice of HPMC and its specific grades would have been the product of routine experimentation

• Motivation:• Do not focus on the motivation of one member of the skilled team –

while the POSITA may be a team, “it is a notional skilled person upon whom the characteristics of the real‐life team are layered, and not a notional skilled team.”

• Motive to create a sustained release formulation to reduce dosing frequency.

Obviousness

AstraZeneca v. Teva (F.C. – Near J.) (cont’d) • Obvious to try factors”

• Motivation (cont’d):• Characteristics of quetiapine (a) large dose size; (b) solubility; (c)

partition coefficient; (d) extent of metabolism; and (e) duration of action would not have taught away from a sustained release formulation. The person skilled in the art would not have viewed them as “lions in the path”, but rather as paper tigers.

• The fact that there may have been a number of possible formulations, does not mean that the alleged invention is not obvious.

• Actual Course of Conduct• No evidence led by AstraZeneca re difficulty of trials conducted or

whether its inventors had knowledge above the POSITA• Adverse inference drawn

Obviousness

AstraZeneca v. Teva (F.C. – Near J.) (cont’d) • Conclusion

• The prior art motivated the skilled person to find the solution the patent addresses, which is to decrease dosing frequency and avoiding dose dumping.

• The prior art clearly taught that sustained release formulations were commonly used to achieve this purpose, HPMC being the most commonly used gelling agent in such formulations.

• It was more or less self‐evident to try to obtain a sustained release formulation of quetiapine using HPMC, and that the person skilled in the art would have had a fair expectation of success.

• Unnecessary to address the parties’ arguments with respect to commercial success and unexpected benefits.

ObviousnessApotex Inc. v. H. Lundbeck A/S 2013 FC 192 (F.C. – Harrington J.) (Mar. 12, 2013)• Action to impeach Old Act patent re escitalopram ((+)‐citalopram)• [In prior NOC prohibition application held obviousness allegation not

justified ].• Held not obvious

• The innovative concept of the claim was a substance, (+)‐Citalopram, useful as an anti‐depressant, a new substance .

• The prior state of the art did not explain how to achieve (+)‐Citalopram and did not disclose the qualities of the two enantiomers.

• These differences constituted steps which would not have been obvious to the person skilled in the art. They required a degree of invention.

• It was not more or less evident that what was done ought to have worked.

ObviousnessApotex v. H. Lundbeck (cont’d)• Observed Held not obvious

• Re motivation:“… I am troubled by the concept of motivation. Wishing does not makesomething come true. Wishing does not make something easier. A motive isdefined as that which moves or tends to move a person to a particular course ofaction (Oxford Dictionary). On the other hand, there may not have been reasonto do something at a particular point in time. For instance, there may have beenlittle interest in increasing automobile fuel efficiency in the 1950s. Lack ofinterest would not give rise to a patent if what was eventually done wasobvious.”

• The party claiming obviousness must not only be able to demonstrate that the prior art exists, but to show how the POSITA would have been led to combine the relevant components from the mosaic of prior art.

• An assembly of literature which might, have led to (+)‐Citalopram involved a considerable degree of inventiveness.

ObviousnessNovartis Pharmaceuticals Canada Inc. v. Teva Canada Limited et al 2013 FC 283 (F.C. – Hughes J.) (Mar. 19, 2013), affirmed 2013 FCA 244 (F.C.A. – Gauthier J.A.)(Oct. 15, 2013)• NOC prohibition applications re zoledronic acid IV infusion based on patents 1,338,895

(“895”) and 1,338,937 (“937”).• Held claims in issue of the patents not obvious• Commented that one cannot raise the bar too high in respect of obviousness.

Research ought to be rewarded, not discouraged, citing Medimmune Limited v Novartis Pharmaceuticals UK, [2012] EWCA Civ 1234.

• On appeal Teva argued that judge set the test to establish obviousness too high. • FCA disagreed. Gauthier J.A. said:

[6] We cannot agree that the Judge applied a higher standard than that set out inSanofi to determine whether or not the ‘937 Patent was obvious. It is clear in our viewthat the Judge’s conclusion at paragraph 159 is based on the test set out by theSupreme Court of Canada. The comments in paragraph 161 of his reasons are simplyrhetorical embellishments and added nothing to the statement already made byRothstein J. in Sanofi at paragraph 64 that:

The patent system is intended to provide an economic encouragement for researchand development. It is well known that this is particularly important in the field ofpharmaceuticals and biotechnology. [emphasis added]

ObviousnessHoffmann‐La Roche Limited v. Apotex Inc. et al 2013 FC 718 (F.C. – Kane J.) (July 12, 2013)• NOC prohibition application re valganciclovir hydrochloride 450 mg tablets , a

pro‐drug antiviral nucleoside• Patent relates to valganciclovir – the L‐monovaline ester of the known drug

ganciclovir• Held invention obvious

• the invention was obvious to try. • there was a clear motivation to pursue the invention.• There were a limited number of predictable solutions to pursue. • The addition of the mono‐L‐valine ester to ganciclovir to improve its

bioavailability was more than mere speculation; it was self‐evident that it ought to work based on the acyclovir research and on the prior art.

• While testing and research would be required, it would not be long or arduous for the skilled person armed with the common general knowledge of the day.

ObviousnessSanofi‐Aventis v. Apotex Inc. 2013 FCA 186 (F.C.A. – Pelletier J.A.) (July 24, 2013)• Action to impeach patent combined with an infringement action.• Patent re clopidogrel (“Plavix”)• In prior NOC prohibition proceedings, SCC held not obvious• At trial, Boivin J. on the evidence before him found claims obvious.• Held by FCA – appeal allowed – trial judge erred in holding patent obvious.• Key factor in the SCC obvious to try analysis was the lack of knowledge of

the properties of the enantiomers of the compounds of the prior genus patent, including the racemate from which clopidogrel was obtained.

• Absent that knowledge, it was not obvious to try to resolve the racemate, or any other compound, so as to obtain the enantiomer having those advantageous properties.

ObviousnessSanofi‐Aventis v. Apotex (cont’d)• Trial judge focused on whether it was obvious to resolve the racemate.• New evidence at trial does not detract from fact that the properties of the

racemate and the enantiomers was not known• As a result, the Trial Judge found himself in exactly the same position as

did the Supreme Court when it decided patent not obvious• The focus of the obviousness analysis by SCC was not the difficulty in

separating the racemates covered by the genus Patent, but the unknown properties of the resulting enantiomers.

• Given that the Trial Judge applied the test for obviousness set out by the SCC and given that he applied it to the same material facts as the SCC, he ought to have come to the same conclusion.

• There were separate concurring reasons by Gauthier J.A.

ObviousnessBell Helicopter Textron Canada Limitée v. Eurocopter 2013 FCA 219 (F.C.A. –Mainville J.A.) (Sept. 24, 2013)• Patent re helicopter landing gear having front crosspiece integrated with

skids and offset from vertical.• Bell Helicopter submitted that the Judge erred in his obviousness analysis

by defining the inventive concept of the Patent with reference to the specification, and by incorporating advantages related to ground resonance behaviour and load factor reduction which are mentioned in the specification but not specifically set out in the patent claims themselves.

• Bell submitted that the construction of the inventive concept must flow from the claims (not the specification) using the same approach as for the initial claim construction.

ObviousnessBell Helicopter v. Eurocopter (cont’d)• FCA disagreed.• In Apotex v. Sanofi‐Synthelabo, SCC held that when the inventive concept

is not apparent from the patent claims, recourse can be had to the specification.

• FCA recently held in Allergan v. Canada that the utility of the invention as disclosed in the specification may be considered in determining the inventive concept.

• Authorities cited by Bell do not support its proposition.• No error by trial judge.

ObviousnessZero‐Spill Systems (Int'l) Inc. et al v. 614248 Alberta Ltd. et al 2013 FC 616 (F.C. ‐Barnes J.) (July 18, 2013)• Three patents related to oil field fluid containment products ‐064, 375 and 265

Patents.• 375 Patent not invalid for obviousness• 064 and 265 Patents are invalid for obviousness.

ObviousnessOther cases re obviousness:• Varco Canada Limited et al v. Pason Systems Corp. et al 2013 FC 750 (F.C.

Phelan J.)(Aug. 12, 2013) ‐ autodriller for use with oil drilling rig to regulate the release of a drill string during the drilling of a borehole ‐ Held not obvious

“Given the need and the commercial advantage of the invention, if it was so obvious in a field as rich and energetic as oil production with so many well‐trained people, it is strange that it was not invented before.”

• ABB Technology AG v. Hyundai Heavy Industries Co., Ltd., 2013 FC 947 (F.C. –Barnes J.)(Sept. 11, 2013) ‐ two patents re medium voltage gas‐insulated switchgear – both patents held invalid as obvious

ObviousnessOther cases re obviousness:• Novartis Pharmaceuticals Canada Inc. v. Cobalt Pharmaceuticals Company

2013 FC 985 (F.C. – Hughes J.) (Sept. 25, 2013) ‐ drug containing zoledronicacid to be administered in once‐yearly doses for the treatment of osteoporosis – held not obvious – the inventor “dared to go beyond what a person of ordinary still in the art would have done at the time. He unexpectedly achieved a good result.”

• Bayer Inc. et al v. Cobalt Pharmaceuticals Company et al 2013 FC 1061 (F.C. –Hughes J.) (Oct. 22, 2013) – combination product of drospirenone + ethinylestradiol ‐ 426 Patent held not obvious – invention “not self evident; it was contrary to the thinking at the time, and was not obvious – 728 Patent not obvious ‐ “no evidence that a person skilled in the art would have found in the '607 patent sufficient to motivate an inquiry that would have been likely to lead to the invention claimed in the ‘728 patent.”

ObviousnessOther cases re obviousness:• Distrimedic Inc. v. Dispill Inc. et al 2013 FC 1043 (F.C. – de Montigny J.)

(Oct. 15, 2013) – patent re tray for organizing pills ‐ not obvious or anticipated by prior art patent – it does not provide disclosure of how to perform or make the claimed invention.

• Teva Canada Limited v. Novartis Pharmaceuticals Canada Inc. et al 2013 FCA 244 (F.C.A. – Gauthier J.A. (Oct. 15, 2013) – appeal from NOC prohibition order re patent covering zoledronic acid I.V. infusion ‐ appeal dismissed – application judge did not apply a higher standard ‐ he did conduct an analysis of the differences between the inventive concept and the state of the art ‐ there is no single or mandatory approach for the conduct of this inquiry.

AnticipationWenzel Downhole Tools Ltd. et al v. National‐Oilwell Canada Ltd., 2012 FCA 333 (F.C.A. – Gauthier J.A., dissent in part Mainville J.A.) (Dec. 20, 2012)• Patent re a bi‐directional thrust bearing assembly for use in a downhole

drilling motor (referred to as the 3103 Assembly) • At trial, 2011 FC 1323 (F.C.) – Snider J. dismissed the action, holding that

the claimed invention was:• anticipated by a 3103 assembly which was rented prior to the claim

date.• Obvious in view of the prior art.

• On appeal, FCA dismissed the appeal on both issues, Mainville J.A. dissenting re anticipation, but concurring re obviousness and in the result.

AnticipationWenzel v. National‐Oilwell (cont’d)• A downhole tool containing the 3103 Assembly was rented more than one

year before the filing date • Issue whether it was disclosed so it was available to the public.• The internal workings of the rented downhole tool, including the 3103

Assembly, was were not visible from an external examination of the tool. In fact, it was never opened.

• Snider J. held that the party renting the tool was free at law and equity to examine the tools and to use whatever information resulted from such examination, even though this was not in fact done.

• She noted that for anticipation it is not necessary to demonstrate that anyone analyzed a product sold without restriction: Baker v. Canwell(FCA), or that anyone read a book in a library: Lux Traffic Controls v. Pike Signal (UK Pat.Ct.)

AnticipationWenzel v. National‐Oilwell (cont’d)• Gauthier J.A. (Nadon J.A. concurring) agreed. She said:

• The test for anticipation is an objective one. Whether or not a real person fitting the description of the POSITA was actually present at the drilling site is irrelevant, as is what actually happened at the site during the rental period.

• Becoming available means that, the public had an opportunity to access the information that is the invention. It does not require that one actually took advantage of this opportunity.

• Being available does not require that access to the information be easy, simply that it be possible using known methods and instruments

AnticipationWenzel v. National‐Oilwell (cont’d)• Gauthier J.A. (cont’d):

• Information in a book in a library is available to the public even if it is in Japanese and the library is in a remote village where no one speaks Japanese or has a Japanese dictionary .

• Trial judge found that the tool was available for more than a visual inspection and could have been dismantled and the internal workings inspected.

• The fact that appropriate tools may not have been usually available at the drilling site or that opening of the joints is not usually done at a drilling site is irrelevant. No evidence that the lessee was prohibited from examining it at the site or in a machine shop.

AnticipationWenzel v. National‐Oilwell (cont’d)• At trial, Snider J. also concluded that there was anticipation because

Wenzel had an assembly drawing and that it was available because Wenzel testified that he would have reviewed the assembly drawing with the customer had they asked.• How is this relevant? There cannot be anticipation by a document

which was not in fact disclosed to the public.• Gauthier J.A. concluded it was not necessary to address this but said that

nothing in her reasons should be construed as an endorsement of the conclusion of Snider J. in that respect.

AnticipationWenzel v. National‐Oilwell (cont’d)Mainville J.A. disagreed with the decision re anticipation.• Prior use is not enough for anticipation, there must be disclosure and

enablement.• For disclosure, the skilled person must be in a position to understand the

invention with no room for trial or experimentation: Apotex v. Sanofi‐Synthelabo (SCC)

• For enablement, the issue is whether the skilled person would be able to work the invention without undue burden and, when considering whether there is undue burden, the nature of the invention must be taken into account: Apotex v. Sanofi‐Synthelabo (SCC)

• Accepted principles set out in Baker v. Canwell that there is disclosure if product can be analyzed – need not prove anyone did so.

• But concluded that it not proved that this was so in this case– the only evidence was from Wenzel and his evidence was that the tool would not be taken apart at the site

• The drawing, which was never disclosed, cannot be an anticipation.

AnticipationVarco Canada Limited et al v. Pason Systems Corp. et al 2013 FC 750 (F.C. Phelan J.)(Aug. 12, 2013)• Patent re an autodriller for use with oil drilling rig to regulate the release

of a drill string during the drilling of a borehole.• Not anticipated by various patents• Issue re disclosure by inventor

– Inventor arranged to test a prototype at a Union Pacific well– No formal confidentiality agreement– Inventor personally did the drilling and kept the prototype locked – no

material disclosure made– “It is well established that prior use that is experimental is not prior

use.” – No anticipation

[Different result on the facts from Wenzel v. National –Oilwell.]

AnticipationHoffmann‐La Roche Limited v. Apotex Inc. et al 2013 FC 718 (F.C. – Kane J.) (July 12, 2013)• NOC prohibition application re valganciclovir hydrochloride 450 mg tablets

, a pro‐drug antiviral nucleoside• Patent relates to valganciclovir – the L‐monovaline ester of the known

drug ganciclovir• Claim 1 to the compound or a salt in the form of its (R)—or (S)—

diastereomers, or in the form of mixtures of the two diastereomers.• Narrower claims to particular isomers, or salts or of particular crystallinity.

Also process claims.• Issue re anticipation by a European patent application, EP 329.• The patent did not expressly disclose valganciclovir, but it did disclose

both mono‐ and bis‐esters of ganciclovir

AnticipationHoffmann‐La Roche v. Apotex (cont’d)• Kane J. reviewed the jurisprudence, particularly the review of the law by

Hughes J. in Abbott v. Canada 2008 FC 1359, affirmed 2009 FCA 94 and his comment that the level of proof of an inevitable result was the normal balance of probabilities civil burden.

• She stated the issue as follows:“230. In the present case the issue is whether the prior art, EP 329,although not an exact description of the invention, would have beensufficient so that the POSITA, willing to understand it, wouldunderstand what was invented, without trial and error? Would thisdisclosure have enabled the POSITA to carry out what was disclosed,based on their common general knowledge, and make the invention,valganciclovir, with some routine trial and error or experimentation?Would this result in infringing the claims of the ’721 Patent, on abalance of probabilities?”

AnticipationHoffmann‐La Roche v. Apotex (cont’d)• Kane J. found disclosure of the invention – the mono‐L‐valine ester of

ganciclovir (valganciclovir). She noted that:• The L‐valine ester was indicated as preferred• Both the mono‐ and bis‐ester, although it preferred and exemplified

only the bis‐esters. A POSITA would understand it taught both.• She said (para. 235): “With this disclosure, the skilled person would

engage in routine chemistry, as noted by the Apotex experts. No further inventive step would be required as all the compounds were disclosed.”

• Enablement was not disputed.

AnticipationHoffmann‐La Roche v. Apotex (cont’d)Comments• This decision properly held that a disclosure which discloses multiple

compounds is an anticipation if there is an enabling disclosure of the invention.

• However, it is unclear from the decision whether the proper test for disclosure was employed. While the judge acknowledges that the POSITA, must understand without trial and err that the invention is disclosed, in discussing the disclosure she appears to say that the invention would be disclosed by the POSITA engaging in routine chemistry.

AnticipationBell Helicopter Textron Canada Limitée v. Eurocopter 2013 FCA 219 (F.C.A. –Mainville J.A.) (Sept. 24, 2013) • Anticipation is assessed under an objective test in order to determine if

two essential requirements have been met: (a) prior disclosure has occurred, and (b) that disclosure allowed the enablement of the invention

• Bell asserted anticipation based on obstacle strike documents in which some drawings showed a front inclination

• Trial judge found that the drawings were not clear and that “the double curvature which is an essential element of claim 1 of the ‘787 Patent is missing.”

• No error• Illustrations not conclusive and accompanying text not helpful, so

submissions based on speculation. Does not meet test for anticipation.

AnticipationZero‐Spill Systems (Int'l) Inc. et al v. 614248 Alberta Ltd. et al 2013 FC 616 (F.C. ‐ Barnes J.) (July 18, 2013)• Three patents related to oil field fluid containment products ‐ 064, 375

and 265 Patents.• 375 Patent not anticipated – one prior use does not have a sealing

mechanism; another prior use does not incorporate the claimed telescopic sealing mechanism – (but not infringed)

• O64 Patent was anticipated by two prior patents which describe the same features. One of the patens said to be primitive and cumbersome as compared to the patent, but it achieves the same purpose by the same means. Also anticipated by the prior use of lower trays.

• No anticipation issue re 265 Patent.

Double PatentingBayer Inc. et al v. Cobalt Pharmaceuticals Company et al 2013 FC 1061 (F.C. –Hughes J.) (Oct. 22, 2013)• NOC prohibition proceeding re drospirenone + ethinylestradiol

combination product for birth control based on patents No. 2,179,728 and 2,382,426.

• Double patenting asserted re 728 Patent based on 426 Patent an another patent (780 Patent)

• Held as to 426 Patent: it is obvious that 728 Patent cannot be challenged based on 426 Patent since 426 Patent has a later expiry date. • 426 Patent had an earlier date of grant, but a later filing date.

• Held as to 780 Patent: it does not teach anything that would make that which is claimed in the '728 patent obvious.

UtilityTeva Canada Ltd v. Pfizer Canada Inc, 2012 SCC 60 (S.C.C. – LeBel J.) (Nov. 8, 2012)• SCC said that no requirement to disclose the utility, but there are some

exceptions,• e.g. for a selection patent, the utility forms part of the invention and must be

disclosed• In Teva v. Pfizer SCC concluded findings showed compounds other than

sildenafil did not work. Since claim related to a new use of an old compound,held utility was part of the invention so the utility of sildenafil had to bedisclosed.

• The patent disclosed data and reasoning to support its prediction for thebroader claims, which were not in issue. Its was sufficiency was notdetermined.

• Is this decision limited to its facts – i.e. where the patentee knows that onlyone chemical works for the claimed use and does not disclose which one?

• Or, does it mean that where the use of multiple compounds are claimed basedon a prediction, the identity of any compounds tested and found successfulmust be disclosed?

Utility – Sound PredictionTeva v. Pfizer (S.C.C.)(cont’d)• The SCC said that sound prediction was not an issue – claims to sildenafil

were the only claims in issue and it had been shown to be useful ‐ so therewas no need to consider whether there is an “enhanced” or “heightened”disclosure requirement with respect to sound predictions.

• This may indicate a willingness of the SCC to reconsider this point.• However, until SCC does reconsider it, this decision did not change the

disclosure requirement for sound prediction stated by the SCC in Apotex v.Wellcome 2002 SCC 77 and affirmed by the FCA in Eli Lilly v. Apotex 2009FCA 97 and Eli Lilly v. Teva 2011 FCA 220.

Utility – Sound PredictionPfizer Canada Inc. et al v. Pharmascience Inc. et al 2013 FC 120 (F.C. –Hughes J.) (Feb. 4, 2013)• NOC prohibition application re pregablin for use in treating pain• Hughes J. reviewed the history of the jurisprudence relating to sound

prediction of utility. • He noted that, prior to the Teva v. Pfizer decision of the SCC, it was well

established that where utility was not demonstrated it could be established by sound prediction provided that a factual basis and a sound line of reasoning had been set out in the description in the patent.

• Since the SCC expressly left the issue open, this remains good law.

Utility – Sound PredictionPfizer v. Pharmascience (cont’d)• Hughes J. held that claim 3 is invalid since:

• It embraces pain which cannot be treated, as well as pain which, as of 1997, could not have been predicted as treatable by pregabalin.

• There is no factual basis and no line of reasoning set out in the patent from which a person skilled in the art could make a sound prediction that the racemate would be useful in treating the variety of pain encompassed by claim 3 or even some of them.

UtilityBayer Inc. et al v. Cobalt Pharmaceuticals Company et al 2013 FC 1061 (F.C. –Hughes J.) (Oct. 22, 2013) • NOC prohibition application re combination product of drospirenone +

ethinylestradiol ‐ two patents • Determine promise – statement of advantages not a promise • 426 Patent – promise: “To ensure good bioavailability of the compound, it

is therefore advantageously provided in a form that promotes rapid dissolution thereof.”

• 728 Patent – studies done consistent with the promise of the patent• Allegations of inutility not justified.

Utility ‐ Sound Prediction

Sanofi‐Aventis v. Apotex Inc. 2013 FCA 186 (F.C.A. – Pelletier J.A.) (July 24, 2013)• Action to impeach Patent re clopidogrel bisulfate joined with an action for

infringement of that patent.• Patent found valid by SCC in NOC prohibition application• Utility and sound prediction not addressed by SCC• Trial judge held patent invalid for lack of sound prediction of utility• Trial judge found that the patent promised that the invention would be

useful in treating humans• He found that the utility of clopidogrel in humans had not been

demonstrated at the time of the patent application.• He found that that Sanofi established a “track record” and a line of

reasoning to predict utility in humans, but since track record not disclosed in the patent, it was invalid.


Sanofi‐Aventis v. Apotex ( cont’d)• FCA affirmed that the held the promise of the patent is the standard

against which the utility of the invention described in the patent is measured.

• But the FCA held that the trial judge erred in his construction of the patent and in finding an explicit promise of utility to treat humans.

• The experts did not find such an explicit promise – one of the experts concluded there was such a promise by various inferences.

• The Trial Judge needed to clearly explain why he saw an “explicit promise” for use in humans when the expert did not point to any explicit promise.

• As to the inference, the indications in the patent are consistent with human use, they are not inconsistent with other uses.

• There is a distinction between the potential use of an invention and an explicit promise to achieve a specific result. .

Utility ‐ Sound PredictionSanofi‐Aventis v. Apotex ( cont’d)• Trial judge supported his conclusion by noting the patent was a selection

patent and the genus patent promised utility in humans• This was an error

(1) it is improper to construe a patent with an eye to its validity. The Trial Judge erred when he read into the patent a promise of use in humans in order to validate the patent as a selection patent, then used this promise in order to invalidate it for lack of utility.

(2) The patent was a valid selection patent because it disclosed an advantage over the genus patent.“That unexpected advantage need not be an improvement on every aspect of the invention described in the genus patent, though it may be. It is sufficient that it is a new and useful improvement on some aspect of that invention.”

• The trial judge erred in his construction of the promise.• The advantages over the genus patent disclosed in the patent were

demonstrated – no lack of utility.

Utility ‐ Sound PredictionSanofi‐Aventis v. Apotex ( cont’d) – Gauthier J.A. concurring reasons• Why include comments re purpose when not necessary for Canadian law?

May be to support an advantage necessary for an invention, but may be to show industrial application for European law.

• “… one must be careful not to treat each reference to a practical purpose as a promise of a specific result… ”

• Statements as to a specific result re an invention of a new use or a new process to make an old product to obtain a specific result should be distinguished from statements of practical utility of a new product.

• Trial judge found that POSITA would know that at the relevant time that one cannot reasonably predict any useful use of clopidogrel in humans from the properties and advantages demonstrated in the patent. Therefore would not construe references as a promise.

• A patentee should be able to assume that the specific limits of his or her statement will be properly understood by a POSITA.

Utility ‐ Sound PredictionSanofi‐Aventis v. Apotex ( cont’d) – Gauthier J.A. concurring reasons• SCC’s comments in Consolboard with respect to a promise of specific

result were made in a case raising issues of demonstrated utility. One must be particularly prudent when one seeks to extend Consolboard’sprinciples to statements clearly based on expectations.

• If this is not so, then this case demonstrates the seriousness of some of the criticisms set out in Professor Norman Siebrasse’s article “Must the Factual Basis for Sound Prediction be Disclosed in the Patent?” (2012) 28 C.I.P.R. 39.

• “It is clear that the Trial Judge was satisfied that the patent application was not filed on the basis of mere speculation. The patentee had a solid track record based on an extensive research program and a reasonably sound line of reasoning. It is not challenged here that the invention is indeed useful and extensively used.”

Utility ‐ Sound PredictionSanofi‐Aventis v. Apotex ( cont’d) – Gauthier J.A. concurring reasons• In AZT, invention was a new utility which was the invention and had to be

described. Herethe public received all the information necessary to make and use clopidogrel, the invention claimed in the patent.

• The Trial Judge found that the advantages necessary to make the selection inventive and thus justify the grant of a monopoly on clopidogrel were fully and properly described and demonstrated in the patent.

• In such a case, the level of disclosure required by law should be lower.• If the Trial Judge’s construction was correct, the clear indication in the

Patent that use in humans was predicted as opposed to demonstrated should be sufficient at law to meet the test for sound prediction.

• Indeed, this is enough to enable the public to know that such practical application was not demonstrated at the time the patent application was filed. Therefore, the public would have the ability to challenge the monopoly based on whether it was granted on mere speculation, and determine whether the inventor in fact had the required factual basis and sound line of reasoning to support this statement at the relevant time.


Teva Canada Limited. v. Novartis AG 2013 FC 141 (F.C. – Snider J.) (Feb. 19, 2013)• Impeachment actions re patent re N‐phenyl‐2‐pyrimidine‐amine

derivatives including imatinib.• [161] Utility is determined at the Canadian filing date based on the state

of the art and information available at that time …. Evidence and knowledge available after the filing date cannot establish utility … [citations omitted]

• Utility can be demonstrated or soundly predicted• [164] Sound prediction is not a free‐standing statutory requirement.

Rather, it is a way of showing that an invention is useful when the invention has not been directly demonstrated to work. Its introduction into Canadian law was not, as I understand it, to give a crushing hammer to those who challenge patents.


Teva v. Novartis (cont’d)• Promise – compounds have the potential to treat either PDGF‐R or ABL

associated diseases• Not necessary that every claim have the same utility ‐ patent discloses

four aspects – compounds, processes, medicaments, and therapeutic uses and also subdivides into groups of compounds

• Use claims (45‐48) promise the potential for in vivo efficacy• Process claims – promised utility is to provide a process to make the

claimed compounds• As to compound claims – utility of 25 claims demonstrated, 2 claims

soundly predicted, 4 claims not demonstrated or soundly predicted [264]• As to use claims ‐


Teva v. Novartis (cont’d)• [271] The question of sound prediction is one of fact … The inventors must be

able to show that, at the relevant time, they were in possession of a factual basis upon which they could articulate the desired result. The perspective being examined at this stage is a subjective one. The knowledge, activities and endeavours of the inventors themselves must be considered

• Patentee had a factual basis for predicting the utility of the Group 2 compounds in the chemotherapy of tumours. Although a few tests may have been inconclusive, not a single test demonstrated a negative result.

• FCA acknowledged that expert evidence relating to the knowledge of the skilled person might bridge the gap between the factual basis disclosed in the patent and the prediction of the inventor : Apotex v. Pfizer 2011 FCA 236 at paras 45‐47, but must be caution re doing so.

• There was an articulable line of reasoning for the use of the Group 2 compounds to treat CML

• But an articuable line of reasoning for the use of Group 1 compounds to treat atherosclerosis or for the chemotherapy of tumours was not established.


Teva v. Novartis (cont’d)• [323] The fact that all of the Ciba‐Geigy tests are not described in the patent is

not, in my view, fatal to Novartis’s case. … the question is whether sufficient information was disclosed to allow the person of ordinary skill in the art to soundly predict that the compound of Claim 29 (imatinib) would be useful for the chemotherapy of tumours.

• [324] A patentee cannot simply rely on the prior art to satisfy the requirements of disclosure; a patent must provide more disclosure than the prior art to satisfy the requirements of sound prediction: Apotex v. Pfizer 2011 FCA 236 at para. 44

• [326] …the disclosed information, together with the common general knowledge at that time, supports the sound prediction of the utility of Claim 46 when read together with Claim 29.

• While further work would need to be done before any of the compounds –including imatinib – could be brought to market, that goes beyond what is required for sound prediction


Teva v. Novartis (cont’d)• Utility of Group 2 compounds soundly predicted.• [335] On the other hand, I find it difficult to conclude that the utility of the

Group 1 compounds in either the chemotherapy of tumours or the treatment of atherosclerosis could have been soundly predicted as of April 1, 1993. While the Group 1 compound claims have demonstrated utility as selective inhibitors of PKC, the evidence of how this would translate to treatment of atherosclerosis or chemotherapy of tumours is not clear. This does not invalidate any of the use claims since these claims are to be read together with the individual compound claims. [emphasis added]

Utility – Sound PredictionApotex Inc. v. H. Lundbeck A/S 2013 FC 192 (F.C. – Harrington J.) (Mar. 12, 2013)• Action to impeach old act patent re escitalopram ((+)‐citalopram• Asserted that the patent promised that (+)‐Citalopram will be a more

potent antidepressant than citalopram in humans, but that the inventor did not have data demonstrating that or from which it could be soundly predicted.

• Held: the patent did not so promise• No explicit statement either in the disclosure or in the claims.• The Apotex experts did not explain why the POSITA would infer a promise

that (+)‐Citalopram was better• “The claim portion of the specification takes precedence over the disclosure

portion in that the disclosure is read so as to understand what is meant by the claims“ but not to enlarge or contract the scope of the claims as written and thus understood”


Bell Helicopter Textron Canada Limitée v. Eurocopter 2013 FCA 219 (F.C.A. –Mainville J.A.) (Sept. 24, 2013)• Patent re helicopter landing gear having front crosspiece integrated with

skids and offset from vertical.• Trial judge found all claims but claim 15 invalid since they extend to

include product with rearward inclination and no basis for predicting it would have the promised utility.

• He held claim 15 (which is limited to a forward inclination) valid.• “If the inventor does not make in the patent an explicit promise of a

specific result, the threshold to find utility will be low; if, on the other hand, the inventor makes an explicit promise of a specific result, then utility will be assessed by reference to the terms of the explicit promise.”


Bell Helicopter v. Eurocopter (cont’d)• Trial judge did not err in finding claim 15 (limited to forward inclination)

valid.• It was not necessary for Eurocopter to test every minute variant of the

inclination of the integrated front cross piece which was offset forwards in order to establish utility

• Trial judge found that once a skilled person had chosen a design where the front cross piece is offset forwards, he would have no difficulty choosing which inclination will provide the best result, depending on the general design and weight of the structure of the helicopter.


Bell Helicopter v. Eurocopter (cont’d)• Trial judge did not err in finding all claim but claim 15 invalid.• Eurocopter argued that doctrine of sound prediction is limited to

pharmaceutical inventions.• It argued that the utility of mechanical inventions can be demonstrated

through mathematical calculations relying on the known rules of the science of physics.

• FCA disagreed that doctrine of sound prediction is limited to pharmaceutical inventions. SCC said in AZT that it could be applied more generally and it has been in other cases.

• What amounts to demonstrated utility would be evidence that establishes that the embodiment at issue does in fact work in a manner that gives rise to the advantages stated in the patent.

• Calculations and mathematical modeling are, by their very essence, a prediction of a given utility. (May be exceptions.)

Sufficiency of Disclosure

Adequate disclosure in the specification is a precondition for the granting of a patent.

Teva Canada Ltd v Pfizer Canada Inc, 2012 SCC 60 (S.C.C.) at para. 34

Sufficiency of DisclosureTeva Canada Ltd v. Pfizer Canada Inc, 2012 SCC 60 (S.C.C. – LeBel J.) (Nov. 8,. 2012)• NOC prohibition proceeding re sildenafil (active ingredient in Viagra) based

on 446 Patent re treatment of ED ‐ 27 claims, including claim 1 to a very broad class (260 quintillion compounds) cascading narrower claims (and broad claims to a cGMP PDEv inhibitor, not in issue).

• Patent claims included claims 6 and 7, each to the use of a specific chemical for the manufacture of a medicament to treat ED. Claim 7 was to such use of sildenafil.

• Pfizer relied only upon claim 7 and dependent claims as limited to use of sildenafil.

Sufficiency of DisclosureTeva v. Pfizer (S.C.C.) (cont’d)• Pfizer had conducted in vitro tests (reported in the patent) from which it

predicted that the class of chemicals would be effective and had conducted tests with healthy volunteers to show safety.

• Pfizer had only conducted patient tests with one compound. Such tests showed sildenafil was effective in treating ED. None of the other compounds in the patent had been tested in such patient tests.

• 446 Patent includes the statement that “one of the especially preferred compounds induces penile erection in impotent males” It did not identify that compound as sildenafil.

Sufficiency of DisclosureTeva v. Pfizer (cont’d)Application decision• Application judge found that a skilled person would not know sildenafil

was the tested compound or how to choose between the broad class ofcompounds of claim 1. Would take a “minor research project” todetermine this.

• Application judge relied on authorities which had held that each of theclaims represented a separate monopoly and that each claim had to beviewed separately in relation to the disclosure. Found disclosure sufficientfor the invention of sildenafil claimed in claim 7.

FCA Decision• FCA affirmed

Sufficiency of DisclosureTeva v. Pfizer (cont’d)Nature of the Invention• S. 36 says a patent to be granted for one invention (although patent not invalid if

later held there is more than one invention).• Look to the whole specification, not just the claims, to determine the nature of the

invention.• Boehringer did not say that every claim is a separate invention.• Must assess issue, where raised, on a case‐by‐case basis.• The issue is whether the claimed aspects are linked so as to form a single general

inventive concept.• In this case, the patent suggests that the entire class of claimed compounds will be

effective in treating ED. No use of plural word “inventions”• Difficult for patentee to assert there are multiple inventions since, during the

application stage, it did not separate the inventions by filing a divisional application• SCC decision left open the possibility that a patent may disclose more than one

invention..

Sufficiency of DisclosureTeva v. Pfizer (cont’d)Sufficiency of Disclosure• Compliance with s. 27(3) lies at the heart of the patent system.• Court must consider the whole specification, not just the claims.• What is your invention?” and “How does it work?” are not the only relevant

questions.• The description must be such as to enable a person skilled in the art or the field of

the invention to produce it using only the instructions contained in the disclosure.• The application judge found that the skilled reader would have had to undertake a

minor research project to determine what the true invention was.• The SCC interpreted the findings of the application judge as finding that the

compounds other than sildenafil did not work.• Here inventor knew sildenafil had been found effective and the other chemicals had

been found not to work. This had to be disclosed. No explanation for non disclosure.• Patentees cannot be allowed to “game” the system in this way• Patent found invalid.

Sufficiency of DisclosureTeva v. Pfizer (cont’d)Postscript 1• Following the SCC decision, Pfizer filed a motion to vary the order.• Decision on the motion issued June 4, 2013• Held: reasons and order amended to say that Teva had established its allegation that

the 446 Patent was invalid and dismissing the application.Postscript 2• Also, following the SCC decision, in a pending action to impeach the validity of the

patent, Apotex filed a motion for summary judgment.• In Apotex Inc. v. Pfizer Ireland Pharmaceuticals 2012 FC 1339 (Nov. 20, 2012), Zinn J.

granted the motion for summary judgment and declared the patent invalid.• Zinn J. said that the SCC decision was binding on the Court, even if the SCC granted

Pfizer’s motion to modify the judgment – issue a question of construction and hencea question of law.

• An appeal was heard October 15, 2013 by Sharlow, Dawson and Mainvile JJ.A.,decision reserved.

Sufficiency of DisclosureTeva Canada Limited. v. Novartis AG 2013 FC 141 (F.C. – Snider J.) (Feb. 19, 2013)Nature of the Invention• Impeachment actions re patent re N‐phenyl‐2‐pyrimidine‐amine

derivatives• Two groups of compounds:

• Group 1 inhibit PKC, as well as PDGF‐R or v‐ABL kinases• Group 2 (one of which is imatinib) inhibit PDGF‐R and ABL kinases but

do not inhibit PKC• There is a strong link among all of the claims which leads to conclude that

there is a single inventive concept. Alternatively, there are two inventions: one including the Group 1 compounds and the second including the Group 2 compounds.

Sufficiency of DisclosureTeva. v. Novartis (cont’d)Nature of the Invention• [351] … the essence of the '203 Patent is the invention of a class of

compoundsHowever• [355] I also believe that it may be more in keeping with the nature of the

invention disclosed by the '203 Patent to treat the '203 Patent as being twoinventions: one for each of Group 1 and Group 2. Unlike Sildenafil (SCC), inwhich there was nothing to distinguish sildenafil from any of the other claimedcompounds (para 66), there is an undisputed evidentiary basis for the twoinventions of the ‘203 Patent. As acknowledged by every one of the experts,the two groups of compounds are readily identifiable by a person of ordinaryskill in the art. Throughout the disclosure and the claims themselves, there is aclear delineation of the two groups of compounds. Not only can thecompounds be identified by their organic structure, the potential use of eachgroup is clearly set out. This does not mean that I should consider each claimas a separate invention; rather, groups of claims could be considered together.

Sufficiency of DisclosureTeva. v. Novartis (cont’d)Sufficiency• A lack of data cannot in and of itself result in a finding of insufficiency:

Pfizer v Canada 2008 FCA 108 at para. 56• Rather, one must ask whether the omission of the data from the patent

prevents the person of ordinary skill in the art from using the invention ascontemplated by the inventor.

• No requirement to disclose the best mode for inventions that are notmachines: s. 27(3)

• Section 27(3) is not meant to invalidate patents on the basis of distinctionswhich do not underlie the true invention.

• Disclosure sufficient.

Sufficiency of DisclosureNovartis Pharmaceuticals Canada Inc. v. Teva Canada Limited et al 2013 FC 283 (F.C. – Hughes J.) (Mar. 19, 2013), affirmed 2013 FCA 244 (F.C.A. –Gauthier J.A.)(Oct. 15, 2013)• NOC prohibition applications re zoledronic acid IV infusion based on two Old

Act patents.• Issue re date at which sufficiency of disclosure to be assessed.• Hughes J. has a lengthy discussion and concluded that the material date is the

date of publication• Did not follow Biogen v. Medeva (H.L.) which held relevant date is

application date. Said that Teva v. Pfizer requires a different consideration.• Publication date is the date that the public is seized with the applic

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