In the early 1990s, Eli Lilly applied for patent protection in Canada for two chemical compounds, olanzapine and atomoxetine. The company had already obtained patents over the compounds, but asserted that it had evidence to support new uses for the compounds that merited further protection. The Canadian patent office granted the patents based on the content in the applications, but they remained subject to challenge.
Both patents ultimately were challenged on the grounds that there was insufficient evidence at the time of the applications to support the company’s claims. The Federal Court of Canada agreed, invalidating both patents. Eli Lilly proceeded to appeal the decision to the Federal Court of Appeal and later to the Supreme Court of Canada. The company lost the appeals, as the courts upheld the decision to invalidate the patents.
Under most circumstances, that would conclude the legal story as several Canadian courts reviewed Eli Lilly’s patent applications and ruled that they failed to meet the standards for patentability. Yet in June 2013, the company served notice that it planned to use the ISDS provisions in the North American Free Trade Agreement to claim that in light of the decisions, Canada was not compliant with its patent law obligations under the treaty. As compensation, Eli Lilly sought at least $500 million in damages.
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The Eli Lilly claim against Canada for hundreds of millions due to a court decision involving patent utility has attracted considerable attention with fears that the case foreshadows many more corporate lawsuits if the Trans Pacific Partnership becomes a reality. While the Canadian government has raised doubts about the independence of the Canadian Chamber of Commerce intervention in the case, the government must be a bit confused on where the U.S. stands on the issue. Yesterday, the U.S. Trade Representative issued its 2016 report on foreign trade barriers and stated the following on the case:
With respect to pharmaceuticals, the United States continues to have serious concerns about the impact of the patent utility requirements that Canadian courts have adopted.
That is consistent with the Eli Lilly argument, yet last month the U.S. State Department provided its own submission in the case. The U.S. government appears to undermine USTR arguments, seemingly siding with the Canada on the issue. The U.S. submission states each country has the right to determine how it implements the utility requirement, the possibility of revocation of patent rights, and for its patent laws to evolve:
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The last two Trouble with the TPP posts have focused on the agreement’s investor-state dispute settlement provisions, noting that they do not meet the standard set by the Canadian government in CETA and do not address key concerns over policy making as raised in the Bilcon case. The risks associated with ISDS rules are far more than just the subject of academic or legal debate. Experience shows that the cases can place billions of tax dollars at risk, threatening to wipe out the supposed “gains” created by trade deals.
The current legal battle between the Canadian government and international pharmaceutical giant Eli Lilly provides an illustration of what can happen when ISDS rules go wrong. In the early 1990s, the company applied for patent protection in Canada for two chemical compounds, olanzapine and atomoxetine. The company had already obtained patents over the compounds, but asserted that it had evidence to support new uses for the compounds that merited further protection. The Canadian patent office granted the patents based on the content in the applications, but they remained subject to challenge.
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The Canadian Chamber of Commerce has been one of the most vocal supporters of the TPP and intellectual property reform. It recently waded into the case that most clearly crystallizes the dangers of trade and IP in Canada: the Eli Lilly claim for compensation from Canadian taxpayers for hundreds of millions of dollars due to a pair of patent law decisions. Most patent experts believe that Canada has a strong defence, yet that has not stopped the foreign pharmaceutical company from seeking $500 million in damages.
Last month, several groups submitted amicus briefs to the dispute resolution panel, including one from the Canadian Chamber of Commerce (there is also a submission from CIPPIC and the Centre for Intellectual Property Policy). The Chamber suggests that declining spending in research and development may be due to legal uncertainty, despite years of declining research and development expenditures by international pharmaceutical companies in Canada that predates the Eli Lilly issue. The brief saves the money quote until the last paragraph:
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For the second time in less than a year, Canada and the EU have announced that they reached agreement on the Canada – EU Trade Agreement. Back in October 2013, there was an announcement of an agreement “in principle”. The announcement did not include a release of the text and the parties said there was still further work to be done on drafting and legal analysis. Yesterday, brought another announcement of an agreement on the text. Once again, the announcement did not include a release of the text and the parties said there was still further work to be done on legal review and translation into 23 languages.
Given the agreement is 1,500 pages, the additional work is expected to take a considerable amount of time. While government ministers claimed that CETA “is ready for debate and ratification”, the reality is that there cannot be a meaningful, informed debate without the actual text. Releasing it for full study and comment is the essential next step.
Analysis without the text is difficult, however, the combination of prior leaks and media reports indicate that Canada caved on its concerns regarding the potential replication of Eli Lilly-style pharmaceutical patent lawsuits.
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