On the morning of March 14, a first-year UCLA medical student named Kayla Gu approached the microphone at a meeting of her university’s Board of Regents. Speaking in a white coat with a stethoscope around her neck, she urged the university to drop a patent claim pending at India’s high court, which the David Geffen School of Medicine filed in order to block generic production of the prostate cancer drug enzalutamide, trade name Xtandi. Though developed at UCLA with tens of millions in funding from the National Institutes of Health and the U.S. Army, the drug giant Pfizer is making billions in profits by pricing a standard course of the drug at $130,000.
“As medical students, we are proud to attend a public school with a social mission,” Gu told the regents, “[and] disheartened to see licensing decisions made here contribute to the rising cost of health care, and to keeping Xtandi out of the hands of poor people around the world.”
That Pfizer would try to protect a profitable drug from generic competition is not surprising. It is, in fact, exactly the kind of corporate behavior we should expect in a system based long-term monopoly patents. Gu’s question for the regents, one shared by the growing drug-access movement, is why a public university feels obliged to protect the industry’s criminal profit margins at the expense of many millions of human lives.
“If Dreamworks made a film about the Xtandi case, the David Geffen School of Medicine would be the bad guy,” says Jamie Love, of Knowledge Ecology International, one of the groups at the forefront of the protest against UCLA’s patent claim. “The school’s decision to aggressively pursue patent protection in India for a pill that costs nearly 30 times per capita income for that country is an enormous disappointment.”
The story of how UCLA became a Hollywood cancer villain is the story of a drug pipeline corroded and corrupted by monopoly patents, a corruption that reaches upstream to the NIH-funded labs where breakthrough research is conducted. The corruption of university labs is especially important, say reformers, because they represent an important vulnerability in a patent system. When new drugs are still being incubated in publically funded university labs, they can be pushed into open-access, royalty-free patent pools, and saved from the clutches of drug companies that will price them with Wall Street, not human or social needs, first in mind. This is how lifesaving HIV drugs became affordable in the late 1990s. A similar success occurred just last year, when Johns Hopkins granted the Medicines Patent Pool an exclusive royalty-free license to develop a promising tuberculosis drug.
“If we can pressure universities from within to mandate access and affordability, it’s possible to build a new approach to drug development, one NIH-funded university lab at a time,” says Merith Basey, executive director of Universities Allied for Essential Medicines (UAEM).
The UCLA case illustrates the challenge of making open-access agreements the new norm. On paper, the University of California professes to share the values and goals of drug-access groups like Basey’s and the Union of Affordable Cancer Treatment. In 2009, the UC system pledged to practice “humanitarian patenting and licensing strategies” that would reflect a “public benefit mission” and “promote access to new drugs, especially in the developing world.”
But the school’s legal efforts in New Delhi make a mockery of this pledge. Very few prostate cancer patients in India, or in any other country, can afford Xtandi sticker prices ranging from $30,000 (Canada) to more than $130,000 (the U.S.). If UCLA was committed to “humanitarian licensing practices,” it would get out of the way of the Indian companies that stand ready and able to start producing generic versions of Xtandi for as little as $200 per course.
UCLA is defending its position by pointing to the contractual language of its industry partnerships. In September 2017, UCLA’s Vice Chancellor of Health Sciences, John Mazziotta, wrote a letter to the Union of Affordable Cancer Treatment saying the school had to do Pfizer’s bidding because of “the terms of [a] licensing agreement [that gives] the licensee substantial input and control on [the patent’s] prosecution and maintenance.”
If UCLA wants to choose Pfizer’s side in the Xtandi fight, it can do that. But everyone should understand it is a choice. The school could as easily point to its “humanitarian” obligations as written in its institutional licensing guidelines, which can be read as contractual obligations to California, the U.S. and the human race. Instead, it has chosen to reinforce a corporate royalty and patent model. In the case of Xtandi, this model has rewarded the school’s coffers with roughly $500 million in royalties.
“Apparently, UCLA wants to preserve its relationships with companies for the next big blockbuster developed on campus,” says Reshma Ramachandran, a resident doctor at the UCLA-affiliated Los Angeles Medical Center and a UAEM board member.
“This product was developed at a public institution with taxpayer dollars, and then licensed to companies without guarantees for affordability. It’s alarming to see UCLA going even further to prevent generic competition here in the U.S. and in developing countries.”
Xtandi’s journey from a public lab to a patent fight followed a well-worn path. In 2005, after hatching the breakthrough drug, UCLA licensed it to a biotech firm, Medivation, that partnered with a larger company, Astellas Pharma, to bring it to market. When the FDA approved Xtandi for sale in 2012, the companies quickly racked up $2 billion by selling eight- to 12-month courses of the drug for six figures.
The drug’s early profits—combined with the growth of prostate cancer worldwide—drew the interest of bigger players and Wall Street. But before a major drug company spent billions on Medivation and the Xtandi license, they waited for the U.S. government to quash attempts by Democratic lawmakers and drug-access groups to license a generic version. This outcome was never in doubt, and in June 2016, NIH officially rejected an offer by Biolyse Pharmaceuticals to produce and sell generic versions of enzalutamide for five percent of the monopoly patent price. Shortly after the decision, Pfizer won a bidding war for Medivation, acquiring the company for $14 billion.
Other countries, however, remained a “threat” to global Xtandi profits. The biggest of these threats was the world’s generics superpower, that “pharmacy of the poor,” India. In 2016, the India Patent Office rejected UCLA/Pfizer’s first attempt to block generic competition, citing “obviousness and lack of patentable invention.” This set the stage for UCLA’s current appeal before India’s high court, in which Pfizer lawyers have power of attorney. Although UCLA makes no mention of its commercial partner in the filing, the school has admitted that it is essentially waging a proxy battle on behalf of Pfizer.
UCLA has responded to growing calls to withdraw its case with that squishiest of things: the announcement of a working group to study the problem. This working group, says the administration, will “evaluate our approach to technology licensing in ways that benefit California, the nation and the developing world.”
As it conducts this evaluation, millions of men with late-stage prostate cancer will die earlier than they have to. The majority of these people live in developing countries that depend on India for affordable generics. Though multiple Indian companies could begin producing the drug immediately, they are hand-tied until the resolution of UCLA’s claim. Last summer, a leading patient-activist in Chile, Pino Cataldo, died from prostate cancer before he could get the drug.
“The David Geffen School of Medicine and the Regents of the University of California know the consequences of what they are doing, because they have been told several times,” says Jamie Love. “They just don’t care.”