Process for invalidating a patent
No one can determine whether an issued patent will be found valid or invalid at court – nor whether any higher courts will respect lower courts’ decisions.
And no one knows what this turbulent body of law will even look like, twelve months from now.
The NAFTA claim alleges that several Canadian court rulings invalidating the patents for Eli Lilly's drugs Straterra and Zyprexa were illegal under international law because they violated Canada's obligations under Chapter 11 of NAFTA, the international trade treaty that covers the U. Chapter 11 protects the investments of companies and investors from NAFTA countries that operate in other NAFTA states.
Eli Lilly alleges Canada violated the provisions of Chapter 11 that guarantee fair and equal treatment to foreign investors and protect them from expropriation of their investments."Patent decisions in Canada over the last decade not only fly in the face of long-established international standards, but they're subjective and completely unpredictable," Doug Norman, vice-president and general patent counsel for Eli Lilly, said in a statement issued Friday."The standard seems to be that there is no standard."A Federal Court decision in 2010 invalidated Eli Lilly's patent for Strattera (atomoxetine), a drug used to treat attention deficit hyperactivity disorder (ADHD), six years before it was due to expire.
Federal Court decisions in 20 voided the patent for Zyprexa (olanzapine), an anti-psychotic drug used to treat schizophrenia, which was to expire in April 2011.
The challenges to both patents were initiated by the generic drug company Novopharm (later renamed Teva Canada Ltd.).
Various consumer advocacy organizations on both sides of the U.
S.-Canada border have expressed concern over the company's attempts to challenge domestic court decisions before an international trade tribunal and over the broad investor rights that the NAFTA treaty affords to companies. C.-based government watchdog organization Public Citizen and the global consumer rights group Sum of Us have all spoken out against Eli Lilly's complaint, and Sum of Us created an online petition calling on Eli Lilly to drop the suit.
I was the Southwest Bureau manager for Forbes in Houston from 1999 to 2003, when I returned home to Connecticut for a Knight fellowship at Yale Law Sch...
It argues that unlike other jurisdictions, Canada has an "elevated standard" when it comes to demonstrating the utility of a new drug and doesn't use the widely accepted threshold that demands only that patent holders show their invention has a "scintilla" of utility."In a series of decisions issued since 2005, the Federal Court of Canada and the Federal Court of Appeal have created a new judicial doctrine whereby utility is assessed not by reference to the requirement in the Patent Act that an invention be 'useful' but rather against the 'promise' that the courts derive from the patent specification," Eli Lilly wrote in its June notice of intent."This non-statutory 'promise doctrine' is not applied in any other jurisdiction in the world."In its statement Friday, the company's patent counsel said that the Canadian courts' approach to assessing the promise of drug patents could deter companies from developing new drugs for sale in Canada."It’s impossible to know what specific 'promise' can be implied from an application, and how much data are needed to support it," Norman said.
"If this pattern persists, the already challenging business of medical innovation will become all the more difficult in Canada."But consumer rights groups and some patent lawyers say Canada's approach to patents is not that different in spirit to that of other countries and has generally worked in the favour of large drug companies like Eli Lilly, and that, in any event, countries have a right to define "usefulness" in their own way.
All three questions are controlled much more strongly by the capricious sentiments of the patent office than by objective evidence or the rule of law.
1675; subsections (b)(2)(B) and (b)(4)(B) amended Nov.