Supreme Court Ruling Paves the Way for Generic Version of Viagra® - Teva Canada to Sell Sildenafil Tablets in Canada

Supreme Court Ruling Paves the Way for Generic Version of Viagra® - Teva 
Canada to Sell Sildenafil Tablets in Canada 
Decision will result in increased access and significant cost savings for 
Canadian consumers 
TORONTO, Nov. 8, 2012 /CNW/ - Today's decision by the Supreme Court of Canada 
paves the way for pharmaceutical manufacturer, Teva Canada Limited, to begin 
marketing Sildenafil Citrate tablets, the generic version of Viagra®. The 
ruling comes more than five years after proceedings were initiated by Teva 
Canada under the Patented Medicines (Notice of Compliance) Regulations 
challenging the patent of the Pfizer drug first introduced in 1998 to treat 
erectile dysfunction. 
The successful outcome follows several years of litigation that saw the 
Federal Court issue a prohibition order against Teva Canada (June 2009); Teva 
Canada's appeal of the decision which was dismissed by the Federal Court of 
Appeal (September 2010); and ultimately its successful appeal to the Supreme 
Court of Canada this past April. 
Following a lengthy appeals process, today's positive decision reaffirms the 
necessity to challenge patents such as this which would extend the brand's 
monopoly far beyond the expiry of the initial patent. 
"In Canada, the majority of generic drug launches are achieved through lengthy 
and costly litigation. From the beginning, Teva Canada took the lead in 
bringing a generic form of Sildenafil to consumers, despite repeated legal 
setbacks," said Teva Canada President& CEO, Barry Fishman. "However, 
companies like Teva Canada incur significant legal costs to challenge numerous 
weak or frivolous patents on many products and these investments ultimately 
benefit all payers and contribute to the sustainability of our health care 
system." 
Mr. Fishman added that a new generic version of Viagra® will not only result 
in millions in savings to consumers, but it will make this medication 
accessible to people who might otherwise not been able to afford it. It is 
expected that Teva Canada's generic version will be priced significantly lower 
than Viagra®. 
"Through such litigation, generics have generated cumulative savings for 
Canadians of more than $20 B compared to awaiting patent expiry," added Mr. 
Fishman. "There's no doubt that legal challenges to brand drug patents result 
in a spillover benefit to patients, drug plans sponsors, and the health care 
system as a whole. Teva Canada will continue to lobby the Canadian government 
for policies and regulations that encourage its future investment in 
litigation to provide cost-effective generic products that save Canadians 
money," he concluded. 
About Teva Canada Limited 
Teva Canada Limited headquartered in Toronto, has provided affordable 
healthcare solutions for more than 45 years, with more than 205,000* 
prescriptions filled with our products every day. Originally Novopharm 
Limited, Teva Canada specializes in the development, production and marketing 
of high quality generic prescription pharmaceuticals and through our branded 
division, Teva Canada Innovation, focuses on a diverse line of innovative 
products in a variety of therapeutic areas. Teva Canada employs more than 
1,500 people, markets more than 250 products in Canada and is a division of 
Teva Pharmaceutical Industries Ltd., the world's largest generic drug maker. 
For more information, visit: www.tevacanada.com 
Teva's Safe Harbor Statement under the U.S. Private Securities Litigation 
Reform Act of 1995: 
The following discussion and analysis contains forward-looking statements, 
which express the current beliefs and expectations of management. Such 
statements involve a number of known and unknown risks and uncertainties that 
could cause our future results, performance or achievements to differ 
significantly from the results, performance or achievements expressed or 
implied by such forward-looking statements. Important factors that could cause 
or contribute to such differences include risks relating to: our ability to 
develop and commercialize additional pharmaceutical products, competition from 
the introduction of competing generic equivalents and due to increased 
governmental pricing pressures, the effects of competition on sales of our 
innovative medicines, especially Copaxone® (including competition from 
innovative orally-administered alternatives as well as from potential generic 
equivalents), potential liability for sales of generic medicines prior to a 
final resolution of outstanding patent litigation, including that relating to 
our generic version of Protonix®, the extent to which we may obtain U.S. 
market exclusivity for certain of our new generic medicines, the extent to 
which any manufacturing or quality control problems damage our reputation for 
high quality production and require costly remediation, our ability to 
identify, consummate and successfully integrate acquisitions (including the 
acquisition of Cephalon), our ability to achieve expected results through our 
innovative R&D efforts, dependence on the effectiveness of our patents and 
other protections for innovative medicines, intense competition in our 
specialty pharmaceutical businesses, uncertainties surrounding the legislative 
and regulatory pathway for the registration and approval of 
biotechnology-based medicines, our potential exposure to product liability 
claims to the extent not covered by insurance, any failures to comply with the 
complex Medicare and Medicaid reporting and payment obligations, our exposure 
to currency fluctuations and restrictions as well as credit risks, the effects 
of reforms in healthcare regulation and pharmaceutical pricing and 
reimbursement, adverse effects of political instability and adverse economic 
conditions, major hostilities or acts of terrorism on our significant 
worldwide operations, increased government scrutiny in both the U.S. and 
Europe of our agreements with brand companies, interruptions in our supply 
chain or problems with our information technology systems that adversely 
affect our complex manufacturing processes, the impact of continuing 
consolidation of our distributors and customers, the difficulty of complying 
with U.S. Food and Drug Administration, European Medicines Agency and other 
regulatory authority requirements, potentially significant impairments of 
intangible assets and goodwill, potential increases in tax liabilities 
resulting from challenges to our intercompany arrangements, the termination or 
expiration of governmental programs or tax benefits, any failure to retain key 
personnel or to attract additional executive and managerial talent, 
environmental risks, and other factors that are discussed in our Annual Report 
on Form 20-F for the year ended December 31, 2011 and in our other filings 
with the U.S. Securities and Exchange Commission ("SEC"). Forward-looking 
statements speak only as of the date on which they are made, and we undertake 
no obligation to update any forward-looking statements or other information 
contained in this report, whether as a result of new information, future 
events or otherwise. 
(*)Source: IMS Compuscript MAT February 2012
® Registered trademark of Pfizer Inc. 
Media Inquiries: 
Teva Pharmaceuticals Denise Bradley Vice-President, Corporate Communications 
- Americas P. 215.591.8974 F. 215.591.8826 denise.bradley@tevapharm.com 
SOURCE: Teva Canada Limited 
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CO: Teva Canada Limited
ST: Ontario
NI: MTC HEA LAW VERDICTS LAWVIEWS  
-0- Nov/08/2012 16:14 GMT
 
 
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