Landmark Ruling by Federal Appeal Court is a Victory for Innovation in Canada

OTTAWA, Dec. 10 /CNW/ - The Federal Court of Appeal has released a unanimous decision upholding some important safeguards in Canada's Intellectual Property (IP) Regime which are crucial to facilitating Canadian patient access to new medicines and to building a stronger, internationally competitive life sciences industry in Canada.

"This is a clear victory for innovation in Canada," said Russell Williams, President of Canada's Research-Based Pharmaceutical Companies (Rx&D). "It supports our collective goal to make Canada a world leader in creating jobs and opportunities in the knowledge economy."

The ruling upholds a 2009 decision by the Federal Court of Canada which dismissed an application by the generic drug industry challenging the federal government's right to improve Canada's IP regime. The Food and Drug Regulations which came into effect in 2006 after widespread consultations with the research community, industry and academia, currently provide 8 years of data protection for the scientific discoveries of innovative pharmaceutical companies.

These improvements support the development of new life saving and life improving medicines and vaccines in Canadian laboratories and universities, and facilitate access by Canadian patients to these innovative medicines and vaccines.

Before the changes were made, Canada was in contravention of its international trade obligations because it had no enforceable data protection. In contrast, Canada's major trading partners have not only implemented effective data protection, but some like the European Union provide a longer period of data protection of 10 years. More recently, the Obama administration implemented 12 years of data protection for cutting edge innovative biologics in the United States.

While further improvement to Canada's data protection are still required to match the standards set by our major trading partners, the decision adds clarity and supports fairness in the IP regime despite a constant stream of litigation by generic companies that clogs courts and increases costs without any benefit to patient care or life sciences research in Canada. In contrast, improving data protection will help Canada build its knowledge-based economy and sustain the health care system.

Mr. Williams concludes, "This is an important step but Canada still faces a significant innovation gap compared to other developed and emerging countries. Setting healthcare costs against IP improvements is both misleading and counterproductive. Other countries view IP protection as part of the solution, rather than a cost driver. They recognize that their future depends upon cultivating and encouraging knowledge industries such as the life sciences sector. We need to sit down with governments and others in life sciences to improve our IP regime so that it meets or exceeds those of our global competitors."

Key Facts About Rx&D Member Companies' Canadian Contribution

• Over $1 billion invested annually in research and development (R&D) in Canada.
• Responsible for investing highest proportion of R&D-as-a-percent-of-sales of all top 100 corporate research and development investors.
• Is the most research intensive sector of Canada's top 100 corporate research and development investors.
• New medicines and vaccines improve and save lives while contributing to the sustainability of our health care system by reducing hospitalization and other health costs.
• Canadians are continuing to receive excellent value for their patented prescription medicines which over the past decade have been on average 7 % below the international price median.

About Rx&D

Rx&D is the association of leading research-based pharmaceutical companies dedicated to improving the health of Canadians through the discovery and development of new medicines and vaccines. Our community represents 15,000 men and women working for 50 member companies and invests more than $1 billion in research and development each year to fuel Canada's knowledge-based economy. Guided by our Code of Ethical Practices, our membership is committed to working in partnership with governments, healthcare professionals and stakeholders in a highly ethical manner.

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and to obtain a copy of the ruling contact:

François Lessard
Communications
Telephone: [phone]
E-mail: [email protected]