Brand name drugmakers may see another big win as a result of apreliminary trade dealbetween the U.S. and Mexico. As part of the pact, which seeks to update the 24-year-old North American Free Trade Agreement, drugmakers will get 10 years of patent exclusivity for biologics and access to more products eligible for protection — a move generic drugmakers strictly oppose, according to website Regulatory Focus.
U.S. law now grants brand name drugmakers 12 years of patent exclusivity, and there are no data protections included in the North America Free Trade Agreement.
In Mexico, drugmakers have just five years of patent exclusivity. Extending this exclusive patent period for Mexico and adding more products suitable for patent exclusivity has drawn criticism from generic drugmakers.
"U.S., Mexico and Canada should reject these provisions, which would benefit brand name drug companies to the detriment of public health and the affordability of medical care," the Association for Accessible Medicines, Canadian generic Pharmaceutical Association and Mexican Association of Generic Medicines stated in a news release to Regulatory Focus.
The issue of drug companies' exclusive patent period has become a central debate in the U.S. as generic drugmakers struggle against brand name manufacturers and their patents to bring biosimilars or generic competition to the marketplace.
Brand name drugmakers, who encouraged the administration to keep data protection at 12 years, sounded lukewarm about the preliminary deal.
PhRMA, the association representing big-name pharmaceutical companies, released the following statement: " We look forward to analyzing the final text of the agreement, once completed, to ensure it includes policies that protect against global free-riding, promote research and development and reward the innovation being pioneered by America’s biopharmaceutical companies for patients across the globe."
The trade deal also includes a clause that would expand "the scope of products eligible for protection," the news release from the U.S. Trade Representative Officestates.
Even if the patent exclusivity period is shorter in the U.S., having an expanded class of products eligible for patent exclusivity is another win for big pharma.
Read the full report here.