August 16, 2017
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – Although the dust may have settled from a Canadian lawsuit Eli Lilly (LLY) lost over patents for two of its drugs, Zyprexa and Strattera, questions remain over the manner in which Indianapolis-based Eli Lilly fought in court.
Did Eli Lilly attorneys come up with a fictional legal premise to support its patent claims? One media analysis seems to suggest that’s exactly what happened. In a Stat News expose it appears Lilly created its own legal rules to challenge the Canadian laws over the loss of two patents. Additionally, the pharma giant generated false reports to support the manufactured legal rule, Stat said. The lawsuit was filed in 2013, but the roots go back much longer, all the way to 1991. According to the Stat News expose, Lilly applied for its patents in Canada using the same language it used when applying for patents in the United States. The company did not consider any specificities in Canadian law when making its application, Stat said.
Patents are granted in order to provide a manufacturer exclusivity for a set amount of time. But it appears Lilly had a problem when it came to patents for Zyprexa, an antipsychotic, and Strattera, a treatment for attention deficit and hyperactivity disorder. Stat noted the company already had patents on the drugs and could not earn a double patent. To remedy this, the company had to demonstrate a new use for the already patented drug, which it did. Those patents were challenged by Novopharm, a Canadian generic company that has since been acquired by Teva (TEVA). Novopharm said the company had no basis for new drug applications in its challenge to Lilly, Stat said. Canadian judges sided with Novopharm.
This is when Lilly invented its own legal rule, Stat said.
“It created the fictional legal rule that, after several failed formulations, came to be known as the promise utility doctrine or just the promise doctrine. It was loosely based on the requirement in both U.S. and Canadian law that an invention be ‘useful’ in order to gain a patent,” Stat said.
Lilly claimed that the patents for the two drugs were “unfairly invalided by Canadian courts after challenges by generic manufacturers.” The company said in its filings that the standards for a manufacturer were “too high” for companies to secure patents.
Lilly’s argument was persuasive, but Stat showed through its analysis that no such promise doctrine existed in Canadian law. But it wasn’t just the invention of a previously unknown rule. Stat said Lilly also went out of its way to “create fake news” about the promise doctrine.
“It did this by including with the five real cases patents that were so bad they would have been thrown out no matter what; by adding cases that had nothing to do with the doctrine; by including cases from before the company claimed the promise doctrine began; and by counting the same invalid patent multiple times,” Stat said.
In March of this year, a tribunal under the North American Free Trade Act (NAFTA) ruled against Lilly’s claim. In a unanimous decision, the tribunal “determined that there had been no radical change in Canadian law and no evidence of discrimination against pharmaceutical patents,” according to Stat’s report.