Pharma Trade Marks in Canada and the United States - What’s new?

Cynthia RowdenPartner,

Bereskin & ParrToronto, Canada

Bereskin & Parr LLP

Overview

Selecting the right grounds of application Allegations of “fraud” Confusing trade marks Trade dress cases Advertising issues

Filing Issues

Canada applicants must select a “filing ground” 4 options:

(1) use

(2) proposed use

(3) use and registration abroad

(4) making known

Filing Issues (cont’d)

Allergan v. Lancôme (TMOB, 2008)

Lancôme filed for MYOTOX for cosmetics on basis of “useand registration abroad”

Allergan opposed, relying upon confusion with BOTOX marks and challenged claim to “use”

Lancôme filed no evidence of use, anywhere application failed

Important to ensure that filing grounds are properly selected

Filing Grounds - United States

Honda Motor Co. v. Winkelman (TTAB, 2009)

Application for V.I.C filed, under s. 44(e) of Lanham Act (foreign reg’n) plus a claim to “bona fide intent to use”

Opponent alleged applicant had no real intent to use Applicant unable to file any evidence to support this

claim - no business plan, strategy, no identified channels of trade

Filing Grounds - United States (cont’d)

Honda Motor Co. v. Winkelman (cont’d)

TTAB noted that applicant must be able to show both an ability and willingness to use its mark in the United States for identical wares

NB that US applicants must use before registration - fair to insist on bona fide intent to use for foreign applicants

Impact of False Statements

United States

Medinol v. Neuro Vasx (TTAB 2003)

Registration for NEUROVASX expunged on the basis that registration obtained by fraud

Statement of use filed for both catheters and stents, but no use on stents

Impact of False Statements

United States

Medinol(cont’d)

Held - fraud since the applicant knew or ought to have known that there was no use on stents

Result • viewed as lowering the standard of fraud• much time spent reviewing, amending

registrations

Impact of False Statements (cont’d)

Herbaceuticals, Inc. vs. Xel Herbaceuticals (TTAB, 2008)

challenge to 4 registrations Xel admitted wares included goods it had failed to use argued - registrations (single class) should be partially

expunged (NB its attorney had filed statements)

Impact of False Statements (cont’d)

Held - “ought to have known”

• intent to commit fraud not required• is fraud if is a false material statement he

knew or ought to have known was false

Impact of False Statements (cont’d)

G & W Labs Inc. v. GW Pharma (TTAB, 2009)

in a multi-class application, fraud will only impact class where fraud alleged

registration as a whole will not fall

Impact of False Statements (cont’d)

Canada

Parfums de Coeur v. Christopher Asta (FC, 2009)

Expungement action based on claim of false declarationof use when registered

Respondent (registrant) sought to delete goods before expungement proceedings

Declaration of use filed for all goods, only some in use

Impact of False Statements (cont’d)

Claimed that he was not aware that all goods needed to be used

Applicant for expungement argued that Medinol reasoning should be followed

Court described US law as “draconian”, and refused to expunge registration

United States - A Change?

Bose Corporation v. Hexawave, Inc. (CAFC 2009) (appeal from TTAB)

Bose renewed WAVE in 2001 for many wares but no use on tapes, players since 1997 (no sales, but repairs)

U.S. renewal applications require statement of use Bose counsel testified that he thought statement was

true TTAB held that this was “fraud”

United States - A Change? (cont’d)

CAFC held: Medinol improperly lowered standard of fraud to simple

negligence fraud is more than simple negligence, is knowingly

making a false, material representation with intent to deceive

must be clear and convincing evidence of intent to deceive

NB - Bose challenge came as part of United States opposition proceedings

Fraud: A New U.S. Standard

Daimler Chrysler Corp. v. American Motors (TTAB 2010)

must have evidence to show intent to deceive, or reckless disregard for the truth

Also - Herbaceuticals - overturned in 2010

Opposition Proceedings

Burden of Proof

Canada: Once opponent meets evidentiary burden to produce facts to support opposition grounds - onus shifts to applicant

United States: Opposer has burden of proof in confusion claim

Opposition Proceedings (cont’d)

Procedure

Canada: Validity of Opponent’s trade mark not at issue in opposition (scope of protection may be relevant)

United States: Applicant may counterclaim for cancellation

Canadian Oppositions (Word Marks)

Applied Mark Opponent’s Mark ResultZELOXZAR(AstraZeneca)

cancer medication

ZELDOX(Pfizer Products)

neurological condition

• application refused• doctors, pharmacists not likely confused• but no evidence re: patients• “even” probability of confusion

REJUGEL(Merz Pharma)

cosmetic medication

RENAGEL(Genzyme)

used in medications for kidney disease

• application allowed• no similarity on wares, users, channels of trade• similar element (gel) is common to the trade

BELLATOX(Toutounghi)

anti-wrinkle medication

BOTOX(Allergan Inc.)

anti-wrinkle medication

• application refused• reputation of opponent’s mark• resemblance of marks, ideas suggested

Canadian Oppositions (Word Marks)

Applied Mark Opponent’s Mark ResultMANGEN(Burczynski)

arthritis, cataracts

MACUGEN(Eyetech Pharmaceutical)

treatment for macular degeneration

• application refused• resemblance in wares, channels of trade

PREOS(Biofarma, S.A.)

treatment of osteoporosis

PROTOS(NPS Pharmaceutical)

treatment of osteoporosis

• application refused• marks confusing• affirmed on appeal

SAB-BETAXOLOL(Sabex Inc.)

glaucoma medication (with bextaxolol)

(Sanofi Synthelabo)

• descriptive grounds• application allowed• not generic/descriptive as a whole

U.S. Oppositions (Word Marks)

Applied Mark Opponent’s Mark ResultDERMOGESIC(Kumar & Johnson)

post-surgical analgesic

DURAGESIC(Johnson & Johnson)

transdermal patch

• application refused• confusion especially because of consequences of patient confusion (fame not shown)

CERAFLU(Cera Products Inc.)

oral hydration, nutritional supplement

THERAFLU(Novartis AG)

cough & cold

• application refused• confusing• opponent’s marks famous• famous marks “cast a long shadow”

NB - applicant had other CERA marks

NITRO(Advanced Nutrition)

animal feeds

3NITRO(Alpharma Inc.)

growth hormone for chickens, turkey, swine

• application allowed• confusion not found

U.S. Oppositions (Word Marks)

Applied Mark Opponent’s Mark ResultPROBOTIX(Bio-elements, Inc.)

skin cream

BOTOX(Allergan)

pharmaceutical for skin treatment

• application refused• importance of fame of opponent’s trade mark• trade channels overlapped

CLARITY(Diagnostic Test Group)

diagnostic test strips/reagents

CLARATIN/CLARINEX(Schering Corporation)

antihistamines

decongestants

• application refused• res judicata in view of previous adverse opposition decisions

DIGEST-RX(Jared R. Wheat)

vitamins, dietary supplements

DIGESTIVE HX(Invite Health Inc.)

dietary and nutritional supplements

• application refused• confusion

NB - applicant did not contest

Trade Dress Cases - Canada

Canada History of vigorous opposition by generic drug

companies and associations to pill trade dress applications

General principles:

• appearance of tablet - shape + colour can be a trade mark

• tablet must not designate a kind of medication

Trade Dress Cases - Canada (cont’d)

• description of the trade mark is very important - must confirm that it is not the tablet but instead colour applied to visible surface of the tablet

• relevant market is doctors, pharmacists & patients

must show that all can and do use the trade dress in choosing whether to prescribe, dispense or request the drug in question

Trade Dress Cases - Canada (cont’d)

• distinctiveness will always be an important hurdle

applicant will have burden of proving distinctiveness

NB - relevant dates

• applicant must show that colour/shape distinguishes applicant from all other manufacturers, even non-competing products

Canadian Pill Shapes

Canadian pill designs

Canadian Pill Shapes

Canadian pill designs

Trade Dress Cases - U.S.

biggest hurdle has been “functionality” original cases held colour - merely a medium

to suspend medication

1959 - Norwich Pharmacal v. Sterling Drug PEPTO BISMOL colour was functional - soothing to patients

Trade Dress Cases - U.S. (cont’d)

1980 - Ives Labs v. Darby Drug

claim against drug manufacturer colour/size/shape had both therapeutic

affect + assisted patients to identify product, distinguished from other medications

Trade Dress Cases - U.S. (cont’d)

2002 - Shire US v. Barr Labs

functional particularly if colour varied with strength

appeal (03) affirmed - is this a policy to promote generic drug substitutes?

Trade Dress Cases - U.S. (cont’d)

U.S. Trade Mark Registrations for Pill Shapes

Advertising - Canada

Traditionally very little prescription pharma advertising

1978 - changes lead to 2 types of ads

2000 - beginning of • “reminder” ads on TV - trade mark may appear

but no info on purpose, effectiveness• “help seeking” or “disease awareness” ads -

inform patients of options for treatment but trade mark does not appear

Advertising - Canada (cont’d)

Pre-clearance of all advertising by:

• Pharmaceutical Advertising Advisory Board• Advertising Standards Canada• Rx & D Code of Ethics (with penalties)

Advertising - Canada (cont’d)

Canwest Mediaworks Inc. v. AG of Canada

Dec 2005

Charter challenge to statutory prohibition on direct-to-consumer advertising of prescription goods on basis of infringement on freedom of expression

several intervenors - eg. Canadian Nurses Union, Society of Diabetic Rights (concerns re: employee health plan costs)

Advertising - Canada (cont’d)

Canwest Mediaworks Inc. v. AG of Canada (cont’d)

direct to consumer advertising allowed only in United States and New Zealand (U.S. $4.8 billion spent)

similar restrictions in place against tobacco advertising successfully challenged

hearing scheduled for June 2009 • indefinite adjournment granted - Canwest in serious

financial difficulty

Advertising - U.S.

Also permits “direct to consumer” ads that are “full products ads”

voluntary approval and review by Division of Drug Marketing, Advertising & Communications (DDMAC)

ads can show trade mark must include health claims and major side

effects, contraindications and risk info

Advertising - U.S. (cont’d)

TV ads must also:

• refer viewers to concurrent print ads • suggest that patients consult health care

professional• show phone no. and website• encourage reporting of side-effects

Advertising - U.S. (cont’d)

2009• various challenges to U.S. advertising on decency

grounds, or until more experience with drugs• Bayer Pharmaceuticals ordered to run ads to correct

“deceptive” ads for YAZ (birth control pill)• AG of 35 states settled with Schering Plough & Merck

because of alleged “over-statements” re VYTORIN• ongoing study of online drug ads (FDA hearings) eg.

on and • proposal to drop tax deductions for advertising

(dropped)

Bereskin & Parr LLP