Features

Luis Cabrera Urrea – Sandoz

Legal chief leads Sandoz Mexico into battle over access to generics

Luis Cabrera Urrea’s eyes light up when he describes the challenges of his role as legal head for Sandoz Mexico, Central America and the Caribbean, an affiliate of the global leader in generic pharmaceuticals. A litigator at heart, Cabrera believes in generics and sees his company’s efforts to make affordable, high-quality drugs available to the masses as a David-and-Goliath battle.

“If you are on the innovators’ side, you have the weapon,” he says, extending his thumb and index finger and brandishing the imaginary pistol like a gunslinger from an old Western. “You own the patent. You use the patent and shoot at anyone who wants to launch a generic version of your product.”

Luis Cabrera Urrea | Legal Head & Compliance Officer | Sandoz

Luis Cabrera Urrea | Legal Head | Sandoz

As Sandoz’s counsel, Cabrera is always watching which patents are expiring and helping to decide how Sandoz should launch new products in Mexico, Central America and the Caribbean. For example, he could seek an opinion that Sandoz is not infringing on a patent, or he could try to cancel the patent with the help of outside counsel. In Mexico, some patents are granted despite not meeting all legal requirements, so generics have occasionally successfully challenged them.

Having worked for Novartis, a brand-name drug manufacturer also known as an innovator (Sandoz is a division of Novartis, which is in the process of spinning it off), Cabrera has been helping launch generics for 12 years now, and there’s no question what he finds more fulfilling.

“It’s very rewarding as a lawyer to try to improve access to medicines in order to give patients more opportunities to take care of their health,” he says.

Fighting delay tactics

The contest between generic and patented pharmaceuticals has recently become a race against time for both sides.

“Lately, in these last couple of years, it has been very difficult to have a date of loss of exclusivity [of patents],” Cabrera says. “All the originators, the pharmaceutical companies that have patents, try in Mexico to extend the patent life and exclusivity.”

Case in point: Sandoz Mexico wanted to market a specialty molecule to treat cardiovascular problems. But in late 2021, the pharmaceutical company holding the relevant patent extended the patent by another year.

So, Cabrera and his team drafted a legal assessment in coordination with the global team and launched legal actions based on its conclusions. Those included a constitutional trial, or amparo action, in which he argued Sandoz had the right to receive an expedited answer on its marketing authorization application.

“And we finally got the marketing authorization,” Cabrera says. “The action that we started was successful. And now we are able to market the product and benefit patients.”

Winning a ‘biosimilar’ battle

Another project involves an anti-rheumatoid arthritis biosimilar that is a generic form of a drug for that illness. Rheumatoid arthritis is a painful condition that is difficult to treat and can require heavy-duty painkillers.

In this case, Cabrera had the intellectual property front covered: Sandoz was a licensee of that patent. However, the biologic company used two international treaties to block competition from the market—NAFTA (which was later replaced by the T-MEC free-trade agreement); and the TRIPS agreement, a set of intellectual-property standards for seven categories of IP. It also filed litigation to stop the launch of the generic.

Luis Cabrera Urrea | Legal Head & Compliance Officer | Sandoz

Specifically, the biologic company went to Mexico’s Ministry of Health and requested regulatory exclusivity, then got a preliminary injunction to stop all marketing authorizations. Cabrera and his team filed amparo suits to learn what the justification was for the regulatory exclusivity claim and to unblock Sandoz’s marketing authorization. After a ruling in Sandoz’s favor, Sandoz finally got the marketing authorization.

At stake for Sandoz Mexico is an attractive market for its biosimilar—the product would be sold on both private and public markets there (a more difficult legal challenge for Cabrera, but a rewarding path for his company)—and the resulting profits. At stake for rheumatoid arthritis patients is affordable treatment of a debilitating condition.

Falling in love with patent litigation

While he is now a specialist in intellectual property, Cabrera defines himself as a litigator above all. A 2007 graduate of Universidad La Salle, where he earned his law degree, Cabrera also studied constitutional trials and later obtained a specialization degree in intellectual property from Universidad Panamericana. He also received his master’s there before completing business training at IPADE Business School in 2022.

After starting his legal career as a law clerk at Bufete Ostos Abogados in 2005, Cabrera became an attorney at Chevez, Ruiz, Zamarripa y Cia two years later.

“My main experience is to be in trial,” he says. “And once I got to a law firm which specialized in intellectual property, and I started to see these kinds of cases—related to pharmaceuticals, to generics—once I got there, I was in love with these cases. And more specifically, patent litigation cases.”

Cabrera also gained valuable experience at his next role, appeal manager at the National Commission for the Pension System, and as a senior legal manager at Novartis after that. (He returned to private practice between 2010 and 2015, with a stint as an associate at Arochi & Lindner in particular teaching him more about pharmaceutical patent cases.)

For now, Cabrera is happy where he is, defending generic medicines against pharma behemoths.

“I don’t know what’s going to happen in the future, because I don’t have a crystal ball, but I am sure that I would like to make this my life’s work,” he says. “To be in this environment of the generics and the pharmaceutical companies, life sciences and intellectual property—for me that is the most important part of my career.”

View this feature in the Vanguard Spring I 2023 Edition here.

Published on: March 2, 2023

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