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.


SOURCE: Teva Canada Limited

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Teva Pharmaceuticals 
Denise Bradley
Vice-President, Corporate Communications - Americas
P. 215.591.8974
F. 215.591.8826
denise.bradley@tevapharm.com