The U.S. pharmaceutical industry is going after Canada’s allegedly lax patent protection standards and wants the U.S. to instead enforce the standards of the North American Free Trade Agreement.
The Pharmaceutical Research and Manufacturers of America (PhRMA) said in recent comments to the U.S. Trade Representative that contrary to NAFTA “and longstanding international obligations and norms, the Canadian judiciary has created a new and heightened standard for determining patent ‘utility.’” This standard, called the “promise doctrine,” has led to 28 court decisions invalidating 25 biopharmaceutical patents for lack of utility since 2005, PhRMA said.
PhRMA said that as part of the Trump administration’s renegotiation of NAFTA, it should enforce NAFTA’s existing patent standard. U.S. Trade Representative Robert Lighthizer informed Congress in May of the Trump administration’s intent to renegotiate NAFTA, saying the trade deal has been hurting U.S. competitiveness and jobs. Comments on the renegotiation were due June 12. The USTR will host a public hearing on the subject June 27. The agency will publish a summary of its specific NAFTA negotiating objectives around July 17, before formal negotiations begin.
Kristina M. Lybecker, associate professor of economics at Colorado College, told me Canada’s promise doctrine “creates an additional layer of expectation for the innovator.”
“Having to meet the utility standard [in the promise doctrine] means that in advance of knowing what your innovation really is going to do, you have to in a sense make promises about what treatment it’s going to be able to afford to people,” Lybecker said. “I think that from the innovation standpoint this is an additional barrier to getting products to market because it’s impossible to predict in advance what your drug is going to do and if you end up with something that doesn’t deliver in the same way or delivers something different, then you’re in violation of the utility standard.”
“That’s what’s happened in the court decisions. They’ve found that the promise doctrine has been violated because the drugs didn’t do what was promised in the patent application and then they’ve been revoked,” Lybecker said.
However, an advocacy group that has criticized the pharmaceutical industry’s patent stance expressed disappointment with the NAFTA comments. Judit Rius Sanjuan, U.S. manager and legal policy adviser of Doctors Without Borders’ Access Campaign, told me “we’re very disappointed with the submission by PhRMA. It’s completely disconnected with the reality of high drug and vaccine prices that we see around the world.”
“It seems PhRMA is still intent on advocating for stronger monopolies and stronger protections without really recognizing that countries have the right and also the obligation to have tools that are legally available, according to international law, to promote competition and restrict abusive patenting strategies of pharmaceutical companies,” Sanjuan said.
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