Last updated on April 17, 2014 at 9:24 EDT

Supreme Court Ruling Paves the Way for Generic Version of Viagra(R) – Teva Canada to Sell Sildenafil Tablets in Canada

November 8, 2012

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

Source: PR Newswire