January 20, 2020

January 20, 2020

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New Revised USMCA Trade Deal Affects Intellectual Property Rights, But Not Exclusivity Period For Biologics

On December 10, 2019, an agreement was reached between the United States, Mexico, and Canada on amendments to the U.S.-Mexico-Canada Agreement (“USMCA”).  The USMCA, if ratified by each respective country, would replace the North American Free Trade Agreement (“NAFTA”), which has been in effect since January 1, 1994. 

As part of the amendments, a provision of the USMCA that would have guaranteed 10 years of exclusivity for biologic drugs was struck.  This provision was opposed by House Democrats over concerns that it would raise drug prices, decrease drug competition, and limit Congress’s ability to alter the period of exclusivity in the future.  In the U.S., biologics already enjoy 12 years of protection under the Biologics Price Competition and Innovation Act (“BPCIA”).  However, the 10-year provision would have increased the protection in Canada and Mexico, which are at 8 and 5 years, respectively.  Other concerns regarding the provision related to how “biological product” was defined.  The BPCIA includes a carve-out for chemically synthesized polypeptides.  The USMCA provision did not include such an exception, and some opponents argued this would require broadening the coverage of the BPCIA.  The biologic exclusivity provision was also opposed by the Association for Accessible Medicines, a trade association representing manufacturers and distributors of generic prescription drugs, which declared the revision “a victory for America’s patients” by “creat[ing] greater opportunities for patients in Mexico, Canada and the United States to access less expensive medicines and promot[ing] a competitive pharmaceutical market across the three countries.”  As a result of the provision’s omission, the status quo for biologic exclusivity will remain unchanged, and there will be no lengthening of the exclusivity period in Canada and Mexico.

The U.S. Chamber of Commerce expressed disappointment over the removal of the provision, stating that “the original biologics provision would have resulted in more funding for innovative medical research with no additional cost to U.S. consumers.”  The Biotechnology Innovation Organization, the world’s largest trade association representing the biotechnology industry, released a statement claiming that the removal of the provision “declares open season on these innovators and sends a clear message that the U.S. government will stand idly by while foreign entities attack American intellectual property, American jobs and America’s global leadership in medical innovation.”

The revised USMCA also strengthens other intellectual property rights, none of which require changes to U.S. law.  Some of these include providing full national treatment for copyright and related rights, providing a minimum copyright term of author’s life plus 70 years or publication plus 75 years, and establishing safe harbors to deter online piracy and provide enforcement mechanisms for digital goods.  It also strengthens civil and criminal protections for trade secrets, and mandates patent term extensions for unreasonable patent office and regulatory delays.  A more comprehensive summary of the intellectual property rules established by the USMCA from the Office of the United States Trade Representative can be found here.

The Mexican Senate has already ratified the amended USMCA.  Ratification by the U.S. (which will require majority approval by both the House and Senate) and Canada is expected in early 2020.

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About this Author

Aarti Shah, Mintz Levin Law Firm, Washington DC, Intellectual Property and Litigation Law Attorney
Member

Aarti focuses her practice on patent litigation and has particular experience as trial counsel, having served in the US International Trade Commission (ITC) as a senior investigative attorney prior to joining Mintz Levin. During her tenure at the ITC’s Office of Unfair Import Investigations, she served as lead counsel for the federal government in seven trials and in over 25 investigations, covering trade secrets, trademarks, and electrical, computer, mechanical, and chemical patents.

 

202-434-7408
Thomas Wintner IP Attorney Mintz Levin Boston
Member

Tom is an intellectual property and commercial litigator who is equally at home handling cases in trial and appellate courts. Tom counsels clients in a variety of industries, including life sciences, health care, higher education, and real estate. He has extensive experience with patent litigation, trade secrets, and other intellectual property matters, especially those involving pharmaceutical and biologic drugs and diagnostics. Tom also has extensive experience with class action litigation in both federal and state court.

Tom's intellectual property work draws on his prior experience as a research chemist and college dean. He has particular experience in patent and trade secret cases involving pharmaceuticals, biotech, diagnostics, the Hatch-Waxman Act (for small molecule drugs), and the Biologics Price Competition and Innovation Act (for large-molecule biologics/biosimilars).  He also has tried cases before the International Trade Commission and the Patent Trial and Appeal Board (IPRs/PGRs).

Outside of intellectual property, Tom handles a variety of commercial litigation matters, including class action defense.

Tom clerked for the Honorable Boyce F. Martin Jr. on the United States Court of Appeals for the Sixth Circuit. Before attending law school, he served as Associate Dean of the Faculty at Williams College.

617-348-1625
Nana Liu Associate Mintz Life Sciences, Pharmaceuticals,Patent Litigation, International Trade Commission, Hatch-Waxman,  ANDA Litigation,
Associate

Nana focuses her practice on intellectual property litigation, including matters at the International Trade Commission (ITC) and Hatch-Waxman pharmaceutical cases. She also assists with litigation in federal district courts and appellate litigation at the US Court of Appeals for the Federal Circuit. She primarily represents companies in the life sciences industry.

Prior to joining Mintz Levin, Nana served as a judicial law clerk to the now-retired Hon. Andrew R. Grainger of the Massachusetts Appeals Court.

While earning her law degree, Nana was a law clerk at a Massachusetts-...

617-348-1703