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Pharma Trade Marks in Canada and the United States - Whats new? Cynthia Rowden Partner, Bereskin & Parr Toronto, Canada Bereskin & Parr LLP.

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Presentation on theme: "Pharma Trade Marks in Canada and the United States - Whats new? Cynthia Rowden Partner, Bereskin & Parr Toronto, Canada Bereskin & Parr LLP."— Presentation transcript:

1 Pharma Trade Marks in Canada and the United States - Whats new? Cynthia Rowden Partner, Bereskin & Parr Toronto, Canada Bereskin & Parr LLP

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

3 Filing Issues Canada applicants must select a filing ground 4 options: (1) use (2) proposed use (3) use and registration abroad (4) making known

4 Filing Issues (contd) Allergan v. Lancôme (TMOB, 2008) Lancôme filed for MYOTOX for cosmetics on basis of use and 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

5 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 regn) 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

6 Filing Grounds - United States (contd) Honda Motor Co. v. Winkelman (contd) 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

7 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

8 Impact of False Statements United States Medinol(contd) 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

9 Impact of False Statements (contd) 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)

10 Impact of False Statements (contd) 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

11 Impact of False Statements (contd) 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

12 Impact of False Statements (contd) Canada Parfums de Coeur v. Christopher Asta (FC, 2009) Expungement action based on claim of false declaration of use when registered Respondent (registrant) sought to delete goods before expungement proceedings Declaration of use filed for all goods, only some in use

13 Impact of False Statements (contd) 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

14 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

15 United States - A Change? (contd) 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

16 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

17 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

18 Opposition Proceedings (contd) Procedure Canada: Validity of Opponents trade mark not at issue in opposition (scope of protection may be relevant) United States: Applicant may counterclaim for cancellation

19 Canadian Oppositions (Word Marks) Applied MarkOpponents MarkResult ZELOXZAR (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 opponents mark resemblance of marks, ideas suggested

20 Canadian Oppositions (Word Marks) Applied MarkOpponents MarkResult MANGEN (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

21 U.S. Oppositions (Word Marks) Applied MarkOpponents MarkResult DERMOGESIC (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 opponents 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

22 U.S. Oppositions (Word Marks) Applied MarkOpponents MarkResult PROBOTIX (Bio-elements, Inc.) skin cream BOTOX (Allergan) pharmaceutical for skin treatment application refused importance of fame of opponents 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

23 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

24 Trade Dress Cases - Canada (contd) 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

25 Trade Dress Cases - Canada (contd) 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

26 Canadian Pill Shapes Canadian pill designs

27 Canadian Pill Shapes Canadian pill designs

28 Trade Dress Cases - U.S. biggest hurdle has been functionality original cases held colour - merely a medium to suspend medication Norwich Pharmacal v. Sterling Drug PEPTO BISMOL colour was functional - soothing to patients

29 Trade Dress Cases - U.S. (contd) 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

30 Trade Dress Cases - U.S. (contd) Shire US v. Barr Labs functional particularly if colour varied with strength appeal (03) affirmed - is this a policy to promote generic drug substitutes?

31 Trade Dress Cases - U.S. (contd) U.S. Trade Mark Registrations for Pill Shapes

32 Advertising - Canada Traditionally very little prescription pharma advertising changes lead to 2 types of ads 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

33 Advertising - Canada (contd) Pre-clearance of all advertising by: Pharmaceutical Advertising Advisory Board Advertising Standards Canada Rx & D Code of Ethics (with penalties)

34 Advertising - Canada (contd) 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)

35 Advertising - Canada (contd) Canwest Mediaworks Inc. v. AG of Canada (contd) 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

36 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

37 Advertising - U.S. (contd) 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

38 Advertising - U.S. (contd) 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)

39 Bereskin & Parr LLP

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